Commission Implementing Regulation (EU) 2025/1905 of 11 September 2025 granting a Union authorisation for the biocidal product family desmanol pure in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journal EN of the European Union L series 2025/1905 3.10.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1905 of 11 September 2025 granting a Union authorisation for the biocidal product family ‘desmanol pure’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products(1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:

(1) On 19 April 2016, Schülke & Mayr GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘desmanol pure’ of product-type 1, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Austria had agreed to evaluate the application. The application was recorded under case number BC-GA023097-64 in the Register for Biocidal Products.

(2) ‘desmanol pure’ contains propan-2-ol as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 1.

(3) On 13 June 2024, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

(4) On 13 December 2024, the Agency submitted to the Commission its opinion(2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘desmanol pure’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ‘desmanol pure’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(6) of that Regulation.

(6) On 8 January 2025, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘desmanol pure’.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2) Opinion of 28 November 2024 on the Union authorisation of the biocidal product family ‘desmanol pure’ (ECHA/BPC/455/2024),

https://echa.europa.eu/opinions-on-union-authorisation.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 1/274EN OJ L, 3.10.2025

HAS ADOPTED THIS REGULATION:

Article 1 A Union authorisation with authorisation number EU-0033833-0000 is granted to Schülke & Mayr GmbH for the making available on the market and use of the biocidal product family ‘desmanol pure’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 23 October 2025 until 30 September 2035.

Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 11 September 2025.

For the Commission The President Ursula VON DER LEYEN 2/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY Desmanol pure Product type(s) PT01: Human hygiene

Authorisation number:EU-0033833-0000 R4BP asset number:EU-0033833-0000 PART I FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name Name desmanol pure

1.2. Product type(s) Product type(s) PT01: Human hygiene

1.3. Authorisation holder Name Schuelke & Mayr GmbH Name and address of the authorisation holder Address Robert-Koch-Str. 2 22851 Norderstedt DE Authorisation number EU-0033833-0000 R4BP asset number EU-0033833-0000 Date of the authorisation 23 October 2025 Expiry date of the authorisation 30 September 2035

1.4. Manufacturer(s) of the product Name of manufacturer Schülke & Mayr GmbH Address of manufacturer Robert-Koch-Str. 2 22851 Norderstedt Germany Location of manufacturing sites Schülke & Mayr GmbH site 1 Robert-Koch-Str. 2 22851 Norderstedt Germany Name of manufacturer BOCHEMIE a.s.

Address of manufacturer Lidická 326 735 95 Bohumín Czechia Location of manufacturing sites BOCHEMIE a.s. site 1 Lidická 326 735 95 Bohumín Czechia

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 3/274EN OJ L, 3.10.2025 Name of manufacturer Prisman Chemie GmbH Address of manufacturer Otto-Hahn-Ring 6-18 64653 Lorsch Germany Location of manufacturing sites Prisman Chemie GmbH site 1 Otto-Hahn-Ring 6-18 64653 Lorsch Germany Name of manufacturer A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH Address of manufacturer Otto-Brenner-Straße 16 21337 Lüneburg Germany Location of manufacturing sites A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH site 1 Otto-Brenner- Straße 16 21337 Lüneburg Germany Name of manufacturer Lysoform Dr. Hans Rosemann GmbH Address of manufacturer Kaiser-Wilhelm-Straße 133 12247 Berlin Germany Location of manufacturing sites Lysoform Dr. Hans Rosemann GmbH site 1 Kaiser- Wilhelm-Straße 133 12247 Berlin Germany Name of manufacturer Sterisol AB Address of manufacturer Kronoängsgatan 3 592 23 Vadstena Sweden Location of manufacturing sites Sterisol AB site 1 Kronoängsgatan 3 592 23 Vadstena Sweden Name of manufacturer Rudolf Dankwardt GmbH Address of manufacturer Gutenbergring 50-52 22848 Norderstedt Germany Location of manufacturing sites Rudolf Dankwardt GmbH site 1 Gutenbergring 50-52 22848 Norderstedt Germany Name of manufacturer Rudolf Dankwardt GmbH - Jessenitz Address of manufacturer Lagerstr. 15 19249 Jessenitz - Werk / Lübtheen Germany Location of manufacturing sites Rudolf Dankwardt GmbH - Jessenitz site 1 Lagerstr. 15 19249 Jessenitz - Werk / Lübtheen Germany 4/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

1.5. Manufacturer(s) of the active substance(s) Active substance Propan-2-ol Name of manufacturer Ineos Solvents Germany GmbH (formerly Sasol) Address of manufacturer Römerstraße 733 47443 Moers Germany Location of manufacturing sites Ineos Solvents Germany GmbH (formerly Sasol) site 1 Römerstraße 733 47443 Moers Germany Ineos Solvents Germany GmbH (formerly Sasol) site 2 Shamrockstr. 88 44643 Herne Germany Active substance Propan-2-ol Name of manufacturer Shell Chemicals Europe B.V.

Address of manufacturer Postbus 2334 3000 CH Rotterdam Netherlands (the) Location of manufacturing sites Shell Chemicals Europe B.V. site 1 BV/Shell Nederland Raffinaderij B.V. Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the)

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1. Qualitative and quantitative information on the composition of the family Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 63,1 - 75 % (w/w) substance 1-Tetradecanol Tetradecan- Non-active 112-72-1 204-000-3 0 - 0,5 % (w/w) 1-ol substance

2.2. Type(s) of formulation Formulation type(s) AL Any other liquid PART II SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier Identifier desmanol pure meta SPC1

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 5/274EN OJ L, 3.10.2025

1.2. Suffix to the authorisation number Number 1-1

1.3. Product type(s) Product type(s) PT01: Human hygiene

2. META SPC 1 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 - 75 % (w/w) substance 1-Tetradecanol Tetradecan- Non-active 112-72-1 204-000-3 0,25 - 0,5 % (w/w) 1-ol substance

2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s) AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

H412: Harmful to aquatic life with long lasting effects.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P273: Avoid release to the environment.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

6/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #1 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 7/274EN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

The product is restricted to adult use only.

4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months 8/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.2. Use description Table 2 Use #2 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 9/274EN OJ L, 3.10.2025

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.3. Use description Table 3 Use #3 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use 10/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 11/274EN OJ L, 3.10.2025

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump 5 ml (a cupped hand) into the palm (2-4 pump strokes). Rub your hands and forearms for at least 45 seconds. Repeat the step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub should only be done under aseptic conditions.

4.3.2. Use-specific risk mitigation measures ---

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.4. Use description Table 4 Use #4 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry 12/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Industrial

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 13/274EN OJ L, 3.10.2025

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.5. Use description Table 5 Use #5 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional) 14/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

The product is restricted to adult use only.

4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 15/274EN OJ L, 3.10.2025

4.6. Use description Table 6 Use #6 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 16/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

Product is restricted to adult use only.

4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.7. Use description Table 7 Use #7 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 17/274EN OJ L, 3.10.2025 Field(s) of use Indoor use Use #7.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g.

hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #7.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #7.1.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #7.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #7.1.: as required (typically 25 applications per day) Use #7.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 18/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) (2-4 pump strokes) of the product into the palm or else pump 5 ml (a cupped hand) into the palm. Rub your hands and forearms for at least 45 seconds. Repeat that step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.7.2. Use-specific risk mitigation measures ---

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 19/274EN OJ L, 3.10.2025

4.8. Use description Table 8 Use #8 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Use #8.1.: (Professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice, cosmetic studios, elderly care, and in industrial areas like pharma or food production industry.

Use #8.2.: (Professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #8.1.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #8.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #8.1.: as required (typically 25 applications per day) Use #8.2.: as required (typically 4 applications per day) 20/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms.

Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 21/274EN OJ L, 3.10.2025

4.8.2. Use-specific risk mitigation measures ---

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.9. Use description Table 9 Use #9 Surgical hand rub - professional user – bacteria, yeasts – pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional 22/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time.

Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.9.2. Use-specific risk mitigation measures ---

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 23/274EN OJ L, 3.10.2025

4.10. Use description Table 10 Use #10 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Use #10.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use # 10.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #10.1.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #10.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #10.1.: as required (typically 25 applications per day) Use #10.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional 24/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against limited spectrum virucidal activity): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms.

Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.10.2. Use-specific risk mitigation measures ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 25/274EN OJ L, 3.10.2025

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

Avoid contact to eyes.

Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

26/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 27/274EN OJ L, 3.10.2025

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) desmanol® Market area: EU pure Septoderm® Market area: EU liquid

Wrights Market area: EU alcohol hand rub

Rely alcohol Market area: EU hand rub

HS Market area: EU Handisinfec­ tion liquid

Profect Hand Market area: EU disinfection liquid desmanol® Market area: EU hand disinfection sensiva® Market area: EU hand disinfection liquid desmanol® Market area: EU N hand disinfection

unodent Market area: EU hand disinfection

eurosept Market area: EU hand disinfection

Innocid Market area: EU Händedesin­ fektion desmanol® Market area: EU pure pro desmanol® Market area: EU pure expert desmanol® Market area: EU pure clever 28/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 desmanol® Market area: EU pure universal desmanol® Market area: EU pure pocket desmanol® Market area: EU pure client micro­ Market area: EU shield® hand rub micro­ Market area: EU shield® pure Halasept 792 Market area: EU Authorisation number EU-0033833-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 % (w/w) substance 1-Tetradecanol Tetradecan-1-ol Non-active 112-72-1 204-000-3 0,5 % (w/w) substance

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 2 identifier Identifier desmanol pure meta SPC2

1.2. Suffix to the authorisation number Number 1-2

1.3. Product type(s) Product type(s) PT01: Human hygiene

2. META SPC 2 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 - 75 % (w/w) substance 1-Tetradecanol Tetradecan- Non-active 112-72-1 204-000-3 0,25 - 0,5 % (w/w) 1-ol substance

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 29/274EN OJ L, 3.10.2025

2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

H412: Harmful to aquatic life with long lasting effects.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P273: Avoid release to the environment.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #11 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use 30/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

The product is restricted to adult use only.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 31/274EN OJ L, 3.10.2025

4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.2. Use description Table 2 Use #12 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- 32/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm (1-2 pump strokes) or else pump it into the palm. Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 33/274EN OJ L, 3.10.2025

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.3. Use description Table 3 Use #13 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) 34/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time.

Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.3.2. Use-specific risk mitigation measures ---

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 35/274EN OJ L, 3.10.2025

4.4. Use description Table 4 Use #14 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Industrial

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials 36/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 37/274EN OJ L, 3.10.2025

4.5. Use description Table 5 Use #15 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 38/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

The product is restricted to adult use only.

4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.6. Use description Table 6 Use #16 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 39/274EN OJ L, 3.10.2025 Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio).

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency: as required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

The product is restricted to adult use only.

4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 40/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.7. Use description Table 7 Use #17 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use

Field of use description: #Use 17.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio).or in industrial areas, e.g. pharma or food production industry #Use 17.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards etc.), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate: #Use 17.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total) #Use 17.2.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency: #Use 17.1.: as required (typically 25 applications per day) #Use 17.2.: as required (typically 4 applications per day)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 41/274EN OJ L, 3.10.2025 Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.7.2. Use-specific risk mitigation measures --- 42/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.8. Use description Table 8 Use #18 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Use #18.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry.

Use #18.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 43/274EN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Use #18.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total) Use #18.2.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency: #Use 18.1.: as required (typically 25 applications per day) #Use 18.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

44/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.8.2. Use-specific risk mitigation measures ---

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.9. Use description Table 9 Use #19 Surgical hand rub - professional user – bacteria, yeasts – pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 45/274EN OJ L, 3.10.2025 Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.9.2. Use-specific risk mitigation measures ---

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 46/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.10. Use description Table 10 Use #20 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Use #20.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #20.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #20.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total) Use #20.2.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 47/274EN OJ L, 3.10.2025

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #20.1.: as required (typically 25 applications per day) Use #20.2.: as required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

48/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.10.2. Use-specific risk mitigation measures ---

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.11. Use description Table 11 Use #21 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (in case of special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: -

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 49/274EN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

The product is restricted to adult use only.

4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

Avoid disinfection in the presence of children <6 years.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months 50/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.12. Use description Table 12 Use #22 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 51/274EN OJ L, 3.10.2025

4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.12.2. Use-specific risk mitigation measures ---

4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from directsunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.13. Use description Table 13 Use #23 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) 52/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

The product is restricted to adult use only.

4.13.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 53/274EN OJ L, 3.10.2025

4.14. Use description Table 14 Use #24 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 54/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.14.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.14.2. Use-specific risk mitigation measures ---

4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 55/274EN OJ L, 3.10.2025 Avoid contact to eyes.

Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

56/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) desmanol® Market area: EU pure gel Septoderm® Market area: EU IPA gel

Wrights Market area: EU alcohol hand gel

Rely alcohol Market area: EU hand gel

HS Hand Market area: EU disinfection gel

Profect Hand Market area: EU disinfection gel sensiva® Market area: EU hand gel desmanol® Market area: EU N gel

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 57/274EN OJ L, 3.10.2025

unodent Market area: EU hand gel

eurosept gel Market area: EU

Innocid Market area: EU Händedesin­ fektions-Gel desmanol® Market area: EU pure gel pro desmanol® Market area: EU pure gel expert desmanol® Market area: EU pure gel clever desmanol® Market area: EU pure gel universal desmanol® Market area: EU pure gel pocket desmanol® Market area: EU pure gel client micro­ Market area: EU shield® gel micro­ Market area: EU shield® pure gel Authorisation number EU-0033833-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 % (w/w) substance 1-Tetradecanol Tetradecan- Non-active 112-72-1 204-000-3 0,5 % (w/w) 1-ol substance 58/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 3 identifier Identifier desmanol pure meta SPC3

1.2. Suffix to the authorisation number Number 1-3

1.3. Product type(s) Product type(s) PT01: Human hygiene

2. META SPC 3 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 - 75 % (w/w) substance

2.2. Type(s) of formulation of the meta SPC 3 Formulation type(s) AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 59/274EN OJ L, 3.10.2025 P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #25 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional) 60/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

The product is restricted to adult use only.

4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.2. Use description Table 2 Use #26 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 61/274EN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 62/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.3. Use description Table 3 Use #27 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 63/274EN OJ L, 3.10.2025 Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

64/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.3.2. Use-specific risk mitigation measures ---

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.4. Use description Table 4 Use #28 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Industrial

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 65/274EN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 66/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.5. Use description Table 5 Use #29 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 67/274EN OJ L, 3.10.2025

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

The product is restricted to adult use only.

4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.6. Use description Table 6 Use #30 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use 68/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency: as required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

The product is restricted to adult use only.

4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 69/274EN OJ L, 3.10.2025

4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.7. Use description Table 7 Use #31 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Use #31.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g.

pharma or food production industry Use #31.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- 70/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Use #31.1.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #31.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #31.1.: as required (typically 25 applications per day) Use #31.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 71/274EN OJ L, 3.10.2025 Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.7.2. Use-specific risk mitigation measures ---

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.8. Use description Table 8 Use #32 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable 72/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Field(s) of use Indoor use Use #32.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry.

Use #32.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas, e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices).

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #32.1.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #32.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #32.1: as required (typically 25 applications per day) Use #32.2: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 73/274EN OJ L, 3.10.2025

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.8.2. Use-specific risk mitigation measures ---

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.9. Use description Table 9 Use #33 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use 74/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 75/274EN OJ L, 3.10.2025 Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.9.2. Use-specific risk mitigation measures ---

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.10. Use description Table 10 Use #34 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Use #34.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio).

Use #34.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices).

76/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #34.1.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #34.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #34.1.: as required (typically 25 applications per day) Use #34.2.: as required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 77/274EN OJ L, 3.10.2025 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.10.2. Use-specific risk mitigation measures ---

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

Avoid contact to eyes.

Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

78/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 79/274EN OJ L, 3.10.2025

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) desmanol® Market area: EU pure light Authorisation number EU-0033833-0003 1-3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 % (w/w) substance

1. META SPC 4 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 4 identifier Identifier desmanol pure meta SPC4

1.2. Suffix to the authorisation number Number 1-4

1.3. Product type(s) Product type(s) PT01: Human hygiene

2. META SPC 4 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 4 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 - 75 % (w/w) substance 80/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

2.2. Type(s) of formulation of the meta SPC 4 Formulation type(s) AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #35 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 81/274EN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases).

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

The product is restricted to adult use only.

82/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.2. Use description Table 2 Use #36 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 83/274EN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

84/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.3. Use description Table 3 Use #37 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 85/274EN OJ L, 3.10.2025 Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.3.2. Use-specific risk mitigation measures ---

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 86/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.4. Use description Table 4 Use #38 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Industrial

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 87/274EN OJ L, 3.10.2025

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months 88/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.5. Use description Table 5 Use #39 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 89/274EN OJ L, 3.10.2025

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

The product is restricted to adult use only.

4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.6. Use description Table 6 Use #40 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable 90/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

The product is restricted to adult use only.

4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 91/274EN OJ L, 3.10.2025

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.7. Use description Table 7 Use #41 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Use #41.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #41.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #41.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total) Use #41.2.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency: #Use 41.1.: as required (typically 25 applications per day) #Use 41.2.: as required (typically 4 applications per day) 92/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

For additional mycobactericidal efficacy repeat that step one more time.

Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 93/274EN OJ L, 3.10.2025

4.7.2. Use-specific risk mitigation measures ---

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.8. Use description Table 8 Use #42 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Use #42.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #42.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- 94/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Use #42.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total) Use #42.2.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #42.1.: as required (typically 25 applications per day) Use #42.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

For additional mycobactericidal efficacy repeat that step one more time.

Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 95/274EN OJ L, 3.10.2025 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.8.2. Use-specific risk mitigation measures ---

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.9. Use description Table 9 Use #43 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) 96/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.9.2. Use-specific risk mitigation measures ---

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 97/274EN OJ L, 3.10.2025

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.10. Use description Table 10 Use #44 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Use #44.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #44.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #44.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

98/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Contact time: 60 sec. (in total) Use #44.2.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #44.1.: as required (typically 25 applications per day) Use #44.2.: as required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (Efficacy against bacteria, yeasts, and enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

For additional mycobactericidal efficacy repeat that step one more time.

Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 99/274EN OJ L, 3.10.2025 All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.10.2. Use-specific risk mitigation measures ---

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.11. Use description Table 11 Use #45 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/

special case: conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - 100/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

The product is restricted to adult use only.

4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

Avoid disinfection in the presence of children <6 years.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 101/274EN OJ L, 3.10.2025

4.12. Use description Table 12 Use #46 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

The product is restricted to adult use only.

102/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.12.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.13. Use description Table 13 Use #47 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description:

Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users Professional

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 103/274EN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.13.2. Use-specific risk mitigation measures ---

4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 104/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.14. Use description Table 14 Use #48 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/

special case: conjunctivitis).

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 105/274EN OJ L, 3.10.2025

4.14.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

The product is restricted to adult use only.

4.14.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

Avoid disinfection in the presence of children <6 years.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

Avoid contact to eyes.

Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

106/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 107/274EN OJ L, 3.10.2025

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) desmanol® Market area: EU pure light gel Authorisation number EU-0033833-0004 1-4 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 % (w/w) substance

1. META SPC 5 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 5 identifier Identifier desmanol pure meta SPC5

1.2. Suffix to the authorisation number Number 1-5

1.3. Product type(s) Product type(s) PT01: Human hygiene

2. META SPC 5 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 5 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 63,1 - 63,1 % (w/w) substance 108/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

2.2. Type(s) of formulation of the meta SPC 5 Formulation type(s) AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #49 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 109/274EN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Bactericidal, yeasticidal, virucidal activity against enveloped

viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 110/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

The product is restricted to adult use only.

4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.2. Use description Table 2 Use #50 Hygienic hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 111/274EN OJ L, 3.10.2025

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Bactericidal, yeasticidal, virucidal activity against enveloped

viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 112/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.3. Use description Table 3 Use #51 Surgical hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 113/274EN OJ L, 3.10.2025

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

2 x 5 mL per disinfection, corresponding to 2 x 2.76 g a.s.

Contact time 180 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 114/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.3.2. Use-specific risk mitigation measures ---

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.4. Use description Table 4 Use #52 Hygienic hand rub - industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 115/274EN OJ L, 3.10.2025

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Bactericidal, yeasticidal, virucidal activity against enveloped viruses,:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Industrial

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 116/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.5. Use description Table 5 Use #53 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 117/274EN OJ L, 3.10.2025

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Bactericidal, yeasticidal, virucidal activity against enveloped

viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

The product is restricted to adult use only.

118/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.6. Use description Table 6 Use #54 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 119/274EN OJ L, 3.10.2025 Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Bactericidal, yeasticidal, virucidal activity against enveloped

viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

The product is restricted to adult use only.

4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment --- 120/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE): 36 months

4.7. Use description Table 7 Use #55 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Use #55.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry.

Use #55.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 121/274EN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Use #55.1.: Bactericidal, yeasticidal, virucidal activity against

enveloped viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total) Use #55.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.

Contact time: 180 sec. (in total)

Number and timing of application:

Frequency:

Use #55.1.: as required (typically 25 applications per day) Use #55.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

Surgical hand rub disinfection:

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

122/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.7.2. Use-specific risk mitigation measures ---

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.8. Use description Table 8 Use #56 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 123/274EN OJ L, 3.10.2025

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Use #56.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry.

Use #56.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #56.1.: Bactericidal, yeasticidal, virucidal activity against

enveloped viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total) Use #56.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.

Contact time: 180 sec. (in total)

Number and timing of application:

Frequency:

Use #56.1.: as required (typically 25 applications per day) Use #56.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials 124/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

Surgical hand rub:

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.8.2. Use-specific risk mitigation measures ---

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 125/274EN OJ L, 3.10.2025

4.9. Use description Table 9 Use #57 Surgical hand rub - professional user – bacteria, yeasts, fungi – pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Bactericide, yeasticide, fungicide:

2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.

Contact time: 180 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials 126/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.9.2. Use-specific risk mitigation measures ---

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

4.10. Use description Table 10 Use #58 Hygienic/surgical hand rub - professional user – bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 127/274EN OJ L, 3.10.2025

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Use #58.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #58.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #58.1.: Bactericidal, yeasticidal, virucidal activity against

enveloped viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total) Use #58.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.

Contact time: 180 sec. (in total)

Number and timing of application:

Frequency:

Use #58.1.: as required (typically 25 applications per day) Use #58.2.: as required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: HDPE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE 128/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

Surgical hand rub:

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.10.2. Use-specific risk mitigation measures ---

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 129/274EN OJ L, 3.10.2025

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

Avoid contact to eyes.

Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

130/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 131/274EN OJ L, 3.10.2025

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Septo­ Market area: EU derm® soft

septosoft Market area: EU

pluradent Market area: EU hand disinfec­ tion

Dezosept Market area: EU Authorisation number EU-0033833-0005 1-5 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 63,1 % (w/w) substance

1. META SPC 6 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 6 identifier Identifier desmanol pure meta SPC6

1.2. Suffix to the authorisation number Number 1-6

1.3. Product type(s) Product type(s) PT01: Human hygiene

2. META SPC 6 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 6 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 63,14 - 63,14 % (w/w) substance 132/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

2.2. Type(s) of formulation of the meta SPC 6 Formulation type(s) AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

EUH066: Repeated exposure may cause skin dryness or cracking.

EUH208: Contains Isoeugenol. May produce an allergic reaction.

Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #59 Hygienic hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 133/274EN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, tuberculosis bacteria, and enveloped

viruses: 5 ml per disinfection, corresponding to 2.76 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 125, 500 1 000 ml

Packaging: HDPE

Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

134/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.1.2. Use-specific risk mitigation measures ---

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed.

Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life: 36 months

4.2. Use description Table 2 Use #60 Surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 135/274EN OJ L, 3.10.2025 Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, tuberculosis bacteria, and enveloped

viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 125, 500 1 000 ml

Packaging: HDPE

Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 136/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed.

Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life: 36 months

4.3. Use description Table 3 Use #61 Hygienic/surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Use #61.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #61.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #61.1.: Against bacteria, yeasts, tuberculosis bacteria, and

enveloped viruses: 5 ml per disinfection, corresponding to 2.76 g a.s.

Contact time: 30 sec.

Use #61.2.: Against bacteria, yeasts, tuberculosis bacteria, and

enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x

1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

Use #61.1.: as required (typically 25 applications per day) Use #61.2.: as required (typically 4 applications per day) Category(ies) of users Professional

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 137/274EN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 125, 500 1 000 ml

Packaging: HDPE

Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.

Surgical hand rub: Make sure that your hands and forearms are kept moist by the product for the entire application time.

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.3.2. Use-specific risk mitigation measures ---

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 138/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed.

Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life: 36 months

4.4. Use description Table 4 Use #62 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria and yeasts: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 125, 500 1 000 ml

Packaging: HDPE

Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 139/274EN OJ L, 3.10.2025

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed.

Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life: 36 months

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 6

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

Avoid contact to eyes.

Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

140/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 141/274EN OJ L, 3.10.2025

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) AntiLy1 Market area: EU Authorisation number EU-0033833-0006 1-6 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 63,14 % (w/w) substance

1. META SPC 7 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 7 identifier Identifier desmanol pure meta SPC7

1.2. Suffix to the authorisation number Number 1-7

1.3. Product type(s) Product type(s) PT01: Human hygiene

2. META SPC 7 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 7 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 63,14 - 63,14 % (w/w) substance 142/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

2.2. Type(s) of formulation of the meta SPC 7 Formulation type(s) AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #63 Hygienic hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 143/274EN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, tuberculosis bacteria, and enveloped

viruses: 5 ml per disinfection, corresponding to 2.76 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 125, 500 1 000 ml

Packaging: HDPE

Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

144/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.1.2. Use-specific risk mitigation measures ---

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed.

Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life: 36 months

4.2. Use description Table 2 Use #64 Surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 145/274EN OJ L, 3.10.2025 Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, tuberculosis bacteria, and enveloped

viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 125, 500 1 000 ml

Packaging: HDPE

Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 146/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed.

Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life: 36 months

4.3. Use description Table 3 Use #65 Hygienic/surgical hand rub - professional user - bacteria, yeasts, tuberculosis bacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Use #65.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #65.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #65.1.: Against bacteria, yeasts, tuberculosis bacteria, and

enveloped viruses: 5 ml per disinfection, corresponding to 2.76 g a.s.

Contact time: 30 sec.

Use #65.2.: Against bacteria, yeasts, tuberculosis bacteria, and

enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x

1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

Use #65.1.: as required (typically 25 applications per day) Use #65.2.: as required (typically 4 applications per day) Category(ies) of users Professional

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 147/274EN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 125, 500 1 000 ml

Packaging: HDPE

Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.

Surgical hand rub: Make sure that your hands and forearms are kept moist by the product for the entire application time.

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.

5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have

the following minimum labelling information: * The authorisation number; * The trade name of the biocidal product; * The identity and content of each active ingredient; * The instructions for use, including the incorporation time required for the biocidal action;

* The information according to CLP.

4.3.2. Use-specific risk mitigation measures ---

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 148/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed.

Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life: 36 months

4.4. Use description Table 4 Use #66 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping – indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub disinfection product for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria and yeasts: 2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 125, 500 1 000 ml

Packaging: HDPE

Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)

Canister: 5, 10, 20, 30 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

Drum: 220 l

Packaging: HDPE

Closure: HDPE, LDPE, PP or a combination of these materials

IBC: 1 000 l

Packaging: HDPE with steel frame

Closure: HDPE, LDPE, PP or a combination of these materials

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 149/274EN OJ L, 3.10.2025

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed.

Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life: 36 months

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 7

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

Avoid contact to eyes.

150/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 151/274EN OJ L, 3.10.2025 Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) AntiLy2 Market area: EU Authorisation number EU-0033833-0007 1-7 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 63,14 % (w/w) substance

1. META SPC 8 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 8 identifier Identifier desmanol pure meta SPC8

1.2. Suffix to the authorisation number Number 1-8

1.3. Product type(s) Product type(s) PT01: Human hygiene 152/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

2. META SPC 8 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 8 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 - 75 % (w/w) substance 1-Tetradecanol Tetradecan- Non-active 112-72-1 204-000-3 0,25 - 0,5 % (w/w) 1-ol substance

2.2. Type(s) of formulation of the meta SPC 8 Formulation type(s) AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

H412: Harmful to aquatic life with long lasting effects.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P273: Avoid release to the environment.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 153/274EN OJ L, 3.10.2025

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #67 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials 154/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

The product is restricted to adult use only.

4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life: Bottle (PE) and bag/sachet (PE): 6 days

4.2. Use description Table 2 Use #68 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 155/274EN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

156/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.3. Use description Table 3 Use #69 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and viruses (limited spectrum virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 157/274EN OJ L, 3.10.2025 Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump 5 ml (a cupped hand) into the palm (2-4 pump strokes). Rub your hands and forearms for at least 45 seconds. Repeat the step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.3.2. Use-specific risk mitigation measures ---

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days 158/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.4. Use description Table 4 Use #70 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Industrial

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 159/274EN OJ L, 3.10.2025

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.5. Use description Table 5 Use #71 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- 160/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

The product is restricted to adult use only.

4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 161/274EN OJ L, 3.10.2025

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.6. Use description Table 6 Use #72 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency: as required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml 162/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

The product is restricted to adult use only.

4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.7. Use description Table 7 Use #73 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 163/274EN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Use #73.1 .: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g.

pharma or food production industry Use #73.2 .: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #73.1.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #73.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Frequency:

Use #73.1.: as required (typically 25 applications per day) Use #73.2.: as required (typically 4 applications per day)

Number and timing of application:

Frequency:

Use #73.1.: as required (typically 25 applications per day) Use #73.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional 164/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) (2-4 pump strokes) of the product into the palm or else pump 5 ml (a cupped hand) into the palm.

Rub your hands and forearms for at least 45 seconds. Repeat that step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.7.2. Use-specific risk mitigation measures ---

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 165/274EN OJ L, 3.10.2025

4.8. Use description Table 8 Use #74 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Use #74.1.: (Professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice, cosmetic studios, elderly care, and in industrial areas like pharma or food production industry.

Use #74.2.: (Professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #74.1.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #74.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #74.1.: as required (typically 25 applications per day) Use #74.2.: as required (typically 4 applications per day) 166/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.8.2. Use-specific risk mitigation measures ---

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 167/274EN OJ L, 3.10.2025

4.9. Use description Table 9 Use #75 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 168/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time.

Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.9.2. Use-specific risk mitigation measures ---

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.10. Use description Table 10 Use #76 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 169/274EN OJ L, 3.10.2025 Field(s) of use Indoor use Use #76.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #76.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: --- Application rate(s) and frequency Application Rate:

Use #76.1.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #76.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #76.1.: as required (typically 25 applications per day) Use #76.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

170/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.10.2. Use-specific risk mitigation measures ---

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 8

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

Avoid contact to eyes.

Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 171/274EN OJ L, 3.10.2025

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

172/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) desmanol® Market area: EU pure Septoderm® Market area: EU liquid

Wrights Market area: EU alcohol hand rub

Rely alcohol Market area: EU hand rub

HS Market area: EU Handisinfec­ tion liquid

Profect Hand Market area: EU disinfection liquid desmanol® Market area: EU hand disinfection sensiva® Market area: EU hand disinfection liquid desmanol® Market area: EU N hand disinfection

unodent Market area: EU hand disinfection

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 173/274EN OJ L, 3.10.2025

eurosept Market area: EU hand disinfection

Innocid Market area: EU Händedesin­ fektion desmanol® Market area: EU pure pro desmanol® Market area: EU pure expert desmanol® Market area: EU pure clever desmanol® Market area: EU pure universal desmanol® Market area: EU pure pocket desmanol® Market area: EU pure client micro­ Market area: EU shield® hand rub micro­ Market area: EU shield® pure

Halasept Market area: EU 792 Authorisation number EU-0033833-0008 1-8 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 % (w/w) substance 1-Tetradecanol Tetradecan- Non-active 112-72-1 204-000-3 0,5 % (w/w) 1-ol substance

1. META SPC 9 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 9 identifier Identifier desmanol pure meta SPC9 174/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

1.2. Suffix to the authorisation number Number 1-9

1.3. Product type(s) Product type(s) PT01: Human hygiene

2. META SPC 9 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 9 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 - 75 % (w/w) substance 1-Tetradecanol Tetradecan- Non-active 112-72-1 204-000-3 0,25 - 0,5 % (w/w) 1-ol substance

2.2. Type(s) of formulation of the meta SPC 9 Formulation type(s) AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

H412: Harmful to aquatic life with long lasting effects.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P273: Avoid release to the environment.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 175/274EN OJ L, 3.10.2025 P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #77 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) 176/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

The product is restricted to adult use only.

4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 177/274EN OJ L, 3.10.2025

4.2. Use description Table 2 Use #78 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials 178/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm (1-2 pump strokes) or else pump it into the palm. Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.3. Use description Table 3 Use #79 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 179/274EN OJ L, 3.10.2025 Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time.

Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.3.2. Use-specific risk mitigation measures --- 180/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.4. Use description Table 4 Use #80 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Industrial

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 181/274EN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days 182/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.5. Use description Table 5 Use #81 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 183/274EN OJ L, 3.10.2025

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

The product is restricted to adult use only.

4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.6. Use description Table 6 Use #82 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use 184/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio).

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency: as required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 185/274EN OJ L, 3.10.2025

4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

The product is restricted to adult use only.

4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.7. Use description Table 7 Use #83 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use #Use 83.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) or in industrial areas, e.g. pharma or food production industry 186/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 #Use 83.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards etc.), doctor or dental practice Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate: #Use 83.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total) #Use 83.2.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency: #Use 83.1.: as required (typically 25 applications per day) #Use 83.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 187/274EN OJ L, 3.10.2025

Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.7.2. Use-specific risk mitigation measures ---

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.8. Use description Table 8 Use #84 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Use #84.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry.

Use #84.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) 188/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Use #84.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total) Use #84.2.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency: #Use 84.1.: as required (typically 25 applications per day) #Use 84.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses):

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 189/274EN OJ L, 3.10.2025

Surgical hand rub disinfection:

Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.8.2. Use-specific risk mitigation measures --

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.9. Use description Table 9 Use #85 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) 190/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.9.2. Use-specific risk mitigation measures ---

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 191/274EN OJ L, 3.10.2025

4.10. Use description Table 10 Use #86 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Use #86.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #86.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Use #86.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total) Use #86.2.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #86.1.: as required (typically 25 applications per day) Use #86.2.: as required (typically 4 applications per day) Category(ies) of users Professional 192/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses):

Pour 3 ml of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.

Surgical hand rub disinfection:

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.10.2. Use-specific risk mitigation measures ---

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 193/274EN OJ L, 3.10.2025

4.11. Use description Table 11 Use #87 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (in case of special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 194/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

The product is restricted to adult use only.

4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

Avoid disinfection in the presence of children <6 years.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.12. Use description Table 12 Use #88 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: -

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 195/274EN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

4.12.2. Use-specific risk mitigation measures ---

4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days 196/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.13. Use description Table 13 Use #89 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 197/274EN OJ L, 3.10.2025

4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

The product is restricted to adult use only.

4.13.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.14. Use description Table 14 Use #90 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) 198/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.14.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

4.14.2. Use-specific risk mitigation measures ---

4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 199/274EN OJ L, 3.10.2025

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 9

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

Avoid contact to eyes.

Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

200/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) desmanol® Market area: EU pure gel Septoderm® Market area: EU IPA gel

Wrights Market area: EU alcohol hand gel

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 201/274EN OJ L, 3.10.2025

Rely alcohol Market area: EU hand gel

HS Hand Market area: EU disinfection gel

Profect Hand Market area: EU disinfection gel sensiva® Market area: EU hand gel desmanol® Market area: EU N gel

unodent Market area: EU hand gel

eurosept gel Market area: EU

Innocid Market area: EU Händedesin­ fektions-Gel desmanol® Market area: EU pure gel pro desmanol® Market area: EU pure gel expert desmanol® Market area: EU pure gel clever desmanol® Market area: EU pure gel universal desmanol® Market area: EU pure gel pocket desmanol® Market area: EU pure gel client micro­ Market area: EU shield® gel micro­ Market area: EU shield® pure gel Authorisation number EU-0033833-0009 1-9 202/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 % (w/w) substance 1-Tetradecanol Tetradecan- Non-active 112-72-1 204-000-3 0,5 % (w/w) 1-ol substance

1. META SPC 10 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 10 identifier Identifier desmanol pure meta SPC10

1.2. Suffix to the authorisation number Number 1-10

1.3. Product type(s) Product type(s) PT01: Human hygiene

2. META SPC 10 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 10 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 - 75 % (w/w) substance

2.2. Type(s) of formulation of the meta SPC 10 Formulation type(s) AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

EUH066: Repeated exposure may cause skin dryness or cracking.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 203/274EN OJ L, 3.10.2025 Precautionary statements P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #91 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) 204/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application method(s) Method: Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

The product is restricted to adult use only.

4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 205/274EN OJ L, 3.10.2025

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.2. Use description Table 2 Use #92 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional 206/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 207/274EN OJ L, 3.10.2025

4.3. Use description Table 3 Use #93 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and limited spectrum

virucidal activity: 2 x 5 ml per disinfection, corresponding to 2 x

3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials 208/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.3.2. Use-specific risk mitigation measures ---

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.4. Use description Table 4 Use #94 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 209/274EN OJ L, 3.10.2025 Field(s) of use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Industrial

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 210/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.5. Use description Table 5 Use #95 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 211/274EN OJ L, 3.10.2025

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

The product is restricted to adult use only.

4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.6. Use description Table 6 Use #96 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use 212/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 213/274EN OJ L, 3.10.2025 Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

The product is restricted to adult use only.

4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.7. Use description Table 7 Use #97 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable 214/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Field(s) of use Indoor use Use #97.1.: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g.

hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #97.2.: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g.

hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Use #97.1.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #97.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #97.1.: as required (typically 25 applications per day) Use #97.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 215/274EN OJ L, 3.10.2025

4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses):

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.7.2. Use-specific risk mitigation measures ---

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.8. Use description Table 8 Use #98 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable 216/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Field(s) of use Indoor use Use #98.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry.

Use #98.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas, e.g. hospital, ICU/ intensive care unit, pediatric wards, medical practices).

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Use #98.1.: Against bacteria, yeasts, mycobacteria, and enveloped

viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #98.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #98.1: as required (typically 25 applications per day) Use #98.2: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 217/274EN OJ L, 3.10.2025

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses):

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.8.2. Use-specific risk mitigation measures ---

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.9. Use description Table 9 Use #99 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) 218/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.9.2. Use-specific risk mitigation measures ---

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 219/274EN OJ L, 3.10.2025

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.10. Use description Table 10 Use #100 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Use #100.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio).

Use #100.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices).

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Use #100.1.: Against bacteria, yeasts, mycobacteria, and

enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Use #100.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

220/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #100.1.: as required (typically 25 applications per day) Use #100.2.: as required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (incl. activity against enveloped viruses):

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.

Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.10.2. Use-specific risk mitigation measures ---

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 221/274EN OJ L, 3.10.2025

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 10

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

Avoid contact to eyes.

Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

222/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 223/274EN OJ L, 3.10.2025

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) desmanol Market area: EU ® pure light Authorisation number EU-0033833-0010 1-10 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 % (w/w) substance

1. META SPC 11 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 11 identifier Identifier desmanol pure meta SPC11

1.2. Suffix to the authorisation number Number 1-11

1.3. Product type(s) Product type(s) PT01: Human hygiene

2. META SPC 11 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 11 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 - 75 % (w/w) substance

2.2. Type(s) of formulation of the meta SPC 11 Formulation type(s) AL Any other liquid 224/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #101 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 225/274EN OJ L, 3.10.2025

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases).

Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

The product is restricted to adult use only.

226/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.2. Use description Table 2 Use #102 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: -

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 227/274EN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 228/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.3. Use description Table 3 Use #103 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 229/274EN OJ L, 3.10.2025

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.3.2. Use-specific risk mitigation measures ---

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.4. Use description Table 4 Use #104 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use 230/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Industrial

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 231/274EN OJ L, 3.10.2025

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.5. Use description Table 5 Use #105 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - 232/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

The product is restricted to adult use only.

4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 233/274EN OJ L, 3.10.2025

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.6. Use description Table 6 Use #106 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional) 234/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

The product is restricted to adult use only.

4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 235/274EN OJ L, 3.10.2025

4.7. Use description Table 7 Use #107 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Use #107.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #107.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Use #107.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total) Use #107.2.: Against bacteria, yeasts, mycobacteria, and

enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x

3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency: #Use 107.1.: as required (typically 25 applications per day) #Use 107.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional 236/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses):

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

Surgical hand rub disinfection:

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.7.2. Use-specific risk mitigation measures ---

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 237/274EN OJ L, 3.10.2025

4.8. Use description Table 8 Use #108 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable Field(s) of use Indoor use Use #108.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #108.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Use #108.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total) Use #108.2.: Against bacteria, yeasts, mycobacteria, and

enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x

3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #108.1.: as required (typically 25 applications per day) Use #108.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional 238/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (Efficacy against bacteria, yeasts and enveloped viruses):

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

Surgical hand rub disinfection:

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.8.2. Use-specific risk mitigation measures ---

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 239/274EN OJ L, 3.10.2025

4.9. Use description Table 9 Use #109 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 240/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.9.2. Use-specific risk mitigation measures ---

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect theenvironment ---

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.10. Use description Table 10 Use #110 Hygienic/surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Mycobacteria

Common name: Mycobacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 241/274EN OJ L, 3.10.2025 Field(s) of use Indoor use Use #110.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #110.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Use #110.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s.

Contact time: 30 sec.

Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s.

Contact time: 60 sec. (in total) Use #110.2.: Against bacteria, yeasts, mycobacteria, and

enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x

3.16 g a.s.

Contact time: 90 sec. (in total)

Number and timing of application:

Frequency:

Use #110.1.: as required (typically 25 applications per day) Use #110.2.: as required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) 242/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (Efficacy against bacteria, yeasts, and enveloped viruses):

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.

Surgical hand rub disinfection:

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.10.2. Use-specific risk mitigation measures ---

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.11. Use description Table 11 Use #111 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases/

special case: conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: -

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 243/274EN OJ L, 3.10.2025 Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.11.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

The product is restricted to adult use only.

4.11.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

Avoid disinfection in the presence of children <6 years.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --- 244/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.12. Use description Table 12 Use #112 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 245/274EN OJ L, 3.10.2025

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.12.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

The product is restricted to adult use only.

4.12.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging --

4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.13. Use description Table 13 Use #113 Hygienic hand rub - professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis) 246/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.13.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

4.13.2. Use-specific risk mitigation measures ---

4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 247/274EN OJ L, 3.10.2025

4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.14. Use description Table 14 Use #114 Hygienic hand rub - non-professional user - viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Viruses (limited spectrum virucidal activity) stage) Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas. (e.g. in case of diseases/

special case: conjunctivitis) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s.

Contact time: 120 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials 248/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.14.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.

The product is restricted to adult use only.

4.14.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

Avoid disinfection in the presence of children <6 years.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 11

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 249/274EN OJ L, 3.10.2025 Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

Avoid contact to eyes.

Do not eat, drink or smoke when using this product.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

250/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) desmanol Market area: EU ® pure light gel Authorisation number EU-0033833-0011 1-11 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 75 % (w/w) substance

1. META SPC 12 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 12 identifier Identifier desmanol pure meta SPC12

1.2. Suffix to the authorisation number Number 1-12

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 251/274EN OJ L, 3.10.2025

1.3. Product type(s) Product type(s) PT01: Human hygiene

2. META SPC 12 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 12 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 63,1 - 63,1 % (w/w) substance

2.2. Type(s) of formulation of the meta SPC 12 Formulation type(s) AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12 Hazard statements H225: Highly flammable liquid and vapour.

H319: Causes serious eye irritation.

H336: May cause drowsiness or dizziness.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P261: Avoid breathing spray.

P264: Wash hands thoroughly after handling.

P271: Use only outdoors or in a well-ventilated area.

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P312: Call a POISON CENTER if you feel unwell.

P312: Call a doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical attention.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to in accordance with local and national regulations.

P501: Dispose of container to in accordance with local and national regulations.

252/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #115 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Bactericidal, yeasticidal, virucidal activity against enveloped

viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 253/274EN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.1.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts, enveloped viruses:

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

The product is restricted to adult use only.

4.1.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days 254/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.2. Use description Table 2 Use #116 Hygienic hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activit)y - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Bactericidal, yeasticidal, virucidal activity against enveloped

viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Professional

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 255/274EN OJ L, 3.10.2025

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.2.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

4.2.2. Use-specific risk mitigation measures ---

4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days 256/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.3. Use description Table 3 Use #117 Surgical hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.

Contact time 180 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 257/274EN OJ L, 3.10.2025

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.3.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.3.2. Use-specific risk mitigation measures ---

4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.4. Use description Table 4 Use #118 Hygienic hand rub - industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use 258/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Bactericidal, yeasticidal, virucidal activity against enveloped

viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 25 applications per day) Category(ies) of users Industrial

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 259/274EN OJ L, 3.10.2025

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.4.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Efficacy against bacteria, yeasts, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

4.4.2. Use-specific risk mitigation measures ---

4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.5. Use description Table 5 Use #119 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells 260/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Bactericidal, yeasticidal, virucidal activity against enveloped

viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 261/274EN OJ L, 3.10.2025

4.5.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses):

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

The product is restricted to adult use only.

4.5.2. Use-specific risk mitigation measures Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.

Do not use near domestic animals.

In case of skin dryness, use appropriate skin care lotion.

Use is restricted for adults only.

4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage ---

4.6. Use description Table 6 Use #120 Hygienic hand rub - non-professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable 262/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Field(s) of use Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Bactericidal, yeasticidal, virucidal activity against enveloped

viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 3 applications per day) Category(ies) of users General public (non-professional)

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.6.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub:

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

The product is restricted to adult use only.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 263/274EN OJ L, 3.10.2025

4.6.2. Use-specific risk mitigation measures In case of skin dryness, use appropriate skin care lotion.

4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE) and bag/sachet (PE): 6 days

4.7. Use description Table 7 Use #121 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable 264/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Field(s) of use Indoor use Use #121.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry.

Use #121.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Use #121.1.:

Bactericidal, yeasticidal, virucidal activity against enveloped

viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total) Use #121.2.: : 2 x 5 ml per disinfection, corresponding to 2 x

2.76 g a.s.

Contact time: 180 sec. (in total)

Number and timing of application:

Frequency:

Use #121.1.: as required (typically 25 applications per day) Use #121.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 265/274EN OJ L, 3.10.2025

4.7.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub:

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

Surgical hand rub disinfection:

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.7.2. Use-specific risk mitigation measures ---

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.8. Use description Table 8 Use #122 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells 266/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable Field(s) of use Indoor use Use #122.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas like pharma or food production industry.

Use #122.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Use #122.1.: Bactericidal, yeasticidal, virucidal activity against

enveloped viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total) Use #122.2.: 2 x 5 ml per disinfection, corresponding to 2 x

2.76 g a.s.

Contact time: 180 sec. (in total)

Number and timing of application:

Frequency:

Use #122.1.: as required (typically 25 applications per day) Use #122.2.: as required (typically 4 applications per day) Category(ies) of users Industrial Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 267/274EN OJ L, 3.10.2025

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

4.8.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses):

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

Surgical hand rub:

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.8.2. Use-specific risk mitigation measures ---

4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days 268/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025

4.9. Use description Table 9 Use #123 Surgical hand rub - professional user - bacteria, yeasts, fungi - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells Field(s) of use Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Bactericide, yeasticide, fungicide:

2 x 5 ml per disinfection, corresponding to 2 x 2.76 g a.s.

Contact time: 180 sec. (in total)

Number and timing of application:

Frequency:

As required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 269/274EN OJ L, 3.10.2025

4.9.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product..

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.9.2. Use-specific risk mitigation measures ---

4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

4.10. Use description Table 10 Use #124 Hygienic/surgical hand rub - professional user - bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: bacteria

Development stage: vegetative cells

Scientific name: Yeasts

Common name: yeasts

Development stage: vegetative cells

Scientific name: Fungi

Common name: fungi

Development stage: vegetative cells

Scientific name: Tuberculosis bacteria

Common name: Tuberculosis bacteria

Development stage: vegetative cells

Scientific name: Enveloped viruses

Common name: Enveloped viruses

Development stage: not applicable

Scientific name: Viruses (limited spectrum virucidal activity)

Common name: Viruses (limited spectrum virucidal activity)

Development stage: not applicable 270/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Field(s) of use Indoor use Use #124.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #124.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) Application method(s) Method: Pouring or pumping (dispenser specification: drop pump/

output: drip)

Detailed description: - Application rate(s) and frequency Application Rate:

Use #124.1.: Bactericidal, yeasticidal, virucidal activity against

enveloped viruses:

3 ml per disinfection, corresponding to 1.65 g a.s.

Contact time: 30 sec.

Limited spectrum virucidal activity, fungicidal and tuberculocidal

efficacy:

2 x 3 ml per disinfection, corresponding to 2 x 1.65 g a.s.

Contact time: 60 sec. (in total) Use #124.2.: 2 x 5 ml per disinfection, corresponding to 2 x

2.76 g a.s.

Contact time: 180 sec. (in total)

Number and timing of application:

Frequency:

Use #124.1.: as required (typically 25 applications per day) Use #124.2.: as required (typically 4 applications per day) Category(ies) of users Professional

Pack sizes and packaging material Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml

Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE

Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ;

Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials

Abbreviations: HDPE (high-density polyethylene), PP

(polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low- density polyethylene), EVA (ethylene vinyl acetate), POM

(polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium)

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 271/274EN OJ L, 3.10.2025

4.10.1. Use-specific instructions for use The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.

Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses):

Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.

Surgical hand rub:

Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.

Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.

4.10.2. Use-specific risk mitigation measures ---

4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment ---

4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging ---

4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Protect from direct sunlight.

Store at room temperature in the original container.

Shelf life:

Bottle (PE), bag/sachet (PE): 6 days

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 12

5.1. Instructions for use

Application technique:

Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.

Step 3: Open fingers and rub the finger webs. Reverse and repeat action.

Step 4: Rub palm to palm with fingers interlocked (5 times).

Step 5: Rub thumb of each hand using a rotating movement.

Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.

Do not use the product together with other products.

Always read the label or leaflet before use and follow all the instructions provided.

Keep out of reach of children and non-target animals/pets.

Avoid contact to eyes.

Do not eat, drink or smoke when using this product.

272/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/ojEN OJ L, 3.10.2025 Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

5.2. Risk mitigation measures ---

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect effects:

None.

First aid instructions:

General information Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.

If medical advice is needed, have product container or label at hand.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

Information to Healthcare personnel/doctor: Initiate life support measures if needed, Most important symptoms and effects, both acute and delayed Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.

Emergency measures to protect the environment:

Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).

Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

In case of contamination of soil or water bodies notify the competent authorities.

Beware of the explosion danger.

Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).

Use non-sparking tools and explosion-proof equipment.

Take precautionary measures against static discharge.

Ensure electrical continuity by bonding and grounding (earthing) all equipment.

5.4. Instructions for safe disposal of the product and its packaging Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.

Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.

ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj 273/274EN OJ L, 3.10.2025 Avoid (direct) release (of undiluted product) to the environment/sewage system.

Do not empty into drains.

Dilute spills with water and mop up.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage ---

6. OTHER INFORMATION

Recommendation for professional use:

P280 Wear eye protection Please be aware of the European reference value of 129.2 mg/m3for the active substance propan-2-ol (CAS No.:

67-63-0) which was used for the risk assessment of the biocidal product family.

With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Septoderm® Market area: EU soft

septosoft Market area: EU

pluradent Market area: EU hand disinfection

Dezosept Market area: EU Authorisation number EU-0033833-0012 1-12 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Propan-2-ol Active 67-63-0 200-661-7 63,1 % (w/w) substance 274/274 ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj