Commission Implementing Regulation (EU) 2025/1885 of 11 September 2025 granting a Union authorisation for the biocidal product family BPF Propan-2-ol Dr Deppe 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 2025/1885 19.9.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1885 of 11 September 2025 granting a Union authorisation for the biocidal product family ‘BPF Propan-2-ol Dr Deppe’ 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 29 June 2016, Laboratorium Dr. Deppe 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 ‘BPF Propan-2-ol Dr Deppe’ of product-type 1, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-GH025503-55 in the Register for Biocidal Products.

(2) ‘BPF Propan-2-ol Dr Deppe’ 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 27 May 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 ‘BPF Propan-2-ol Dr Deppe’ 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 ‘BPF Propan-2-ol Dr Deppe’ 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 ‘BPF Propan-2-ol Dr Deppe’.

(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 ‘BPF Propan-2-ol Dr Deppe’ (ECHA/BPC/454/2024), https://echa.europa.eu/opinions-on-union-authorisation.

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 1/28EN OJ L, 19.9.2025

HAS ADOPTED THIS REGULATION:

Article 1 A Union authorisation with authorisation number EU-0033834-0000 is hereby granted to Laboratorium Dr. Deppe GmbH for the making available on the market and use of the biocidal product family ‘BPF Propan-2-ol Dr Deppe’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 9 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 2/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025 ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY BPF Propan-2-ol Dr Deppe Product type(s) PT01: Human hygiene

Authorisation number: EU-0033834-0000 R4BP asset number: EU-0033834-0000 PART I FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name Name BPF Propan-2-ol Dr Deppe

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

1.3. Authorisation holder Name Laboratorium Dr. Deppe GmbH Name and address of the authorisation holder Address Hooghe Weg 35 47906 Kempen DE Authorisation number EU-0033834-0000 R4BP asset number EU-0033834-0000 Date of the authorisation 9 October 2025 Expiry date of the authorisation 30 September 2035

1.4. Manufacturer(s) of the product Name of manufacturer Laboratorium Dr. Deppe GmbH Address of manufacturer Hooghe Weg 35 47906 Kempen Germany Location of manufacturing sites Laboratorium Dr. Deppe GmbH site 1 Laboratorium Dr. Deppe GmbH, Hooghe Weg 35 47906 Kempen Germany Laboratorium Dr. Deppe GmbH site 2 Laboratorium Dr. Deppe GmbH, Am Selder 35 47906 Kempen Germany

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 3/28EN OJ L, 19.9.2025

1.5. Manufacturer(s) of the active substance(s) Active substance Propan-2-ol Name of manufacturer Brenntag GmbH Address of manufacturer Stinnes-Platz 1 45472 Muelheim an der Ruhr Germany Location of manufacturing sites Brenntag GmbH site 1 Shell Nederland Raffinaderij B.V., Vondelingenweg 601, Vondelingenplaat 3196KK Rotterdam Netherlands (the) Brenntag GmbH site 2 Exxon Mobil Chemical Plant, 4999 Scenic Highway LA 70805 Baton Rouge United States (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 Active 67-63-0 200-661-7 63,14-64 % (w/w) substance

2.2. Type(s) of formulation Formulation type(s) AL Any other liquid XX: wipes impregnated with liquid, ready-to-use PART II SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier

Identifier Meta SPC: meta SPC 1

1.2. Suffix to the authorisation number Number 1-1

1.3. Product type(s) Product type(s) PT01: Human hygiene 4/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025

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 Active 67-63-0 200-661-7 63,14-64 % (w/w) 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.

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.

P233: Keep container tightly closed.

P240: Ground and bond container and receiving equipment.

P241: Use explosion-proof electrical, ventilating, lighting equipment.

P243: Take actions to prevent static discharges.

P261: Avoid breathing vapours.

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 / doctor if you feel unwell.

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

P370+P378: In case of fire: Use CO , dry chemical, or 2 foam to extinguish.

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 5/28EN OJ L, 19.9.2025 P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents to conform with local / regional / national / international regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use # 1.1 – Hygienic Handrub, General – BP01 Product type PT01: Human hygiene Where relevant, an exact description of the n/a authorised use Target organism(s) (including development Common name: Bacteria stage)

Common name: Tuberculosis bacteria

Common name: Yeasts

Common name: Enveloped viruses Field(s) of use Indoor use In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.: — Domestic use — Recreational areas Application method(s) Method: Handrub (hygienic), liquid dispensing onto hands

Detailed description:

The product is ready to use (RTU).

Application rate(s) and frequency Application Rate:

Adults and children of 12 years and above: 3 ml. The amount of liquid shall resemble the size of a large-sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).

Children under 12 years: 1,5 ml (The number of pumps with the dosing system equivalent to 1,5 ml of the product to be specified by the authorisation holder within the product information).

RTU

Number and timing of application:

Frequency:

Adults and children of 12 years and above: Up to 10 × per day Children under 12 years: Up to 3 × per day Category(ies) of users General public (non-professional) 6/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025 Pack sizes and packaging material — 1 000 ml bottle – high density polyethylene (HDPE) + polypropylene (PP) screw cap (with and without low density polyethylene (LDPE) nozzle) — 500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle) — 250 ml bottle – HDPE + PP screw flip top cap — 150 ml bottle – HDPE + PP screw flip top cap — 100 ml bottle – HDPE + PP screw flip top cap

Abbreviations:

HDPE: high density polyethylene

LDPE: low density polyethylene PP: polypropylene

4.1.1. Use-specific instructions for use The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.

The product is ready-to-use. The product shall be either applied directly or used in a dispenser or with a pump.

Step 1: Apply the following amount of disinfectant: — Adults and children of 12 years and above: 3 ml — Children under 12 years: 1,5 ml 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.

Keep wet for 30 seconds against bacteria, yeast, tuberculosis bacteria and enveloped viruses.

Do not rinse.

Repeat if renewed hand disinfection is required.

Adults and children of 12 years and above: up to 10 × per day Children under 12 years: up to 3 × per day

4.1.2. Use-specific risk mitigation measures Use for children (age > 1 year) only under supervision of an adult.

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 See general directions for use of Meta SPC 1.

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta SPC 1.

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 7/28EN OJ L, 19.9.2025

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of Meta SPC 1

4.2. Use description Table 2 Use #1.2 – Hygienic Handrub, Professional – BP01 Product type PT01: Human hygiene Where relevant, an exact description of the n/a authorised use Target organism(s) (including development Common name: Bacteria stage)

Common name: Tuberculosis bacteria

Common name: Yeasts

Common name: Enveloped viruses Field(s) of use Indoor use In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.: — Domestic use (home care etc.); — Institutional use (research etc.);

— Industrial applications, e.g. food, cosmetic, pharmaceutical industry etc.; — Restaurants and large-scale/canteen kitchens; — Recreational areas.

Application method(s) Method: Handrub (hygienic), liquid dispensing onto hands

Detailed description:

The product is ready to use (RTU).

Application rate(s) and frequency Application Rate:

Adult: 3 ml. The amount of liquid shall resemble the size of a large- sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).

RTU

Number and timing of application:

Frequency: Adult: Up to 25 × per day Category(ies) of users Professional Pack sizes and packaging material — 5 000 ml canister - HDPE + HDPE screw cap — 1 000 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle) — 500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle) — 250 ml bottle – HDPE + PP screw flip top cap — 150 ml bottle – HDPE + PP screw flip top cap — 100 ml bottle – HDPE + PP screw flip top cap

4.2.1. Use-specific instructions for use The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.

8/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025 The product is ready-to-use. The product shall be either applied directly or used in a dispenser or with a pump.

Step 1: Apply the following amount of disinfectant: — Adult: 3 ml 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.

Keep wet for 30 seconds against bacteria, yeast, tuberculosis bacteria and enveloped viruses.

Do not rinse.

Repeat if renewed hand disinfection is required (Adult: Up to 25 × per day).

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.

Transferring the content of larger packages to e.g. dispenser vessels is possible as far as hygienic requirements for the ambient conditions and for the materials used are met and contamination of the product can be safely excluded.

The canister must be equipped with canister pump dispenser or canister valve. The smaller vessel shall be fitted with a funnel.

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 See general directions for use of Meta SPC1.

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 See general directions for use of Meta SPC 1.

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta SPC 1.

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of Meta SPC 1.

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 9/28EN OJ L, 19.9.2025

4.3. Use description Table 3 Use #1.3 – Surgical Handrub – BP01 Product type PT01: Human hygiene Where relevant, an exact description of the n/a authorised use Target organism(s) (including development Common name: Bacteria stage)

Common name: Tuberculosis bacteria

Common name: Yeasts

Common name: Enveloped viruses Field(s) of use Indoor use Surgical handrub Application method(s) Method: Handrub (surgical), liquid dispensing onto hands and lower arms

Detailed description:

The product is ready to use (RTU).

Application rate(s) and frequency Application Rate:

6-12 ml for 90 seconds contact time RTU

Number and timing of application:

Frequency: Up to 4 × per day.

Category(ies) of users Professional Pack sizes and packaging material — 5 000 ml canister – HDPE + HDPE screw cap — 1 000 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle) — 500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle) — 250 ml bottle – HDPE + PP screw flip top cap — 150 ml bottle – HDPE + PP screw flip top cap — 100 ml bottle – HDPE + PP screw flip top cap

4.3.1. Use-specific instructions for use The product shall be used on visibly clean hands and lower arms. If hands are dirty, wash with soap and water, rinse and dry before applying the product.

Rub undiluted solution on skin to keep hands and lower arms moist for 90 seconds.

Use sufficient product to ensure complete coverage during contact time. This may vary with hand size and skin condition.

Approximately 6-12 ml are needed for 90 seconds contact time.

Refilling/decanting of the product shall only be done under aseptic conditions.

The canister must be equipped with canister pump dispenser or canister valve.

The smaller vessel shall be fitted with a funnel.

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 10/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025 — 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 See general directions for use of Meta SPC 1.

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 See general directions for use of Meta SPC 1.

4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta SPC 1.

4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of Meta SPC 1.

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1. Instructions for use See use-specific instructions for each use.

Comply with the instructions for use.

5.2. Risk mitigation measures All handling shall only take place in well-ventilated areas.

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

Avoid contact with eyes.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment If medical advice is needed, have product container or label at hand.

In case of fire: Use CO , dry chemical, or foam to extinguish.

2 Dispose of contents/container according to local / regional / national / international regulations.

First aid:

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

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.

5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.

Waste disposal code: 070604

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 11/28EN OJ L, 19.9.2025

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep out of reach of children and non-target animals/pets.

Store in the dark. Keep cool. Do not store at temperatures exceeding 35 °C.

Shelf life: 3 years

6. OTHER INFORMATION Please be aware of the European reference value of 129,2 mg/m3 for the active substance propan-2-ol (CAS No:

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

Professionals (including industrial, professionals) mean trained professional if this is required by national legislation.

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) OP Sept Color Market area: EU

Op Sept Blau Market area: EU

Teva Sept Skin Market area: EU poly-alkoholos bőrfertőtlenítő (színezett) Authorisation number EU-0033834-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,14 % (w/w)

7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) OP Sept Market area: EU residue-free

Curacid Market area: EU HD-sept

Manorapid Market area: EU pure

Op Sept pur Market area: EU

Op Sept pure Market area: EU Authorisation number EU-0033834-0002 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,14 % (w/w) 12/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025

7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) OP Sept Market area: EU Classic

Camed Market area: EU HD-Plus

Curacid Poly Market area: EU

Dezodent HW Market area: EU Dr. Desi Market area: EU Händedesin­ fektion Kühn Market area: EU Händedesin­ fektion Kühn Market area: EU Händedesin­ fektion

Maimed Clean Market area: EU

Manorapid Market area: EU Basic

Manorapid Market area: EU r.f.u.

Op Derm Market area: EU

Op Derm Market area: EU Medical

Op Sept Market area: EU

OPSept Market area: EU OP-Sept Market area: EU

Septomed Market area: EU

Teva Sept Market area: EU Hand

Teva Sept Market area: EU Hand

Teva Sept Skin Market area: EU poly-alkoholos bőrfertőtlenítő és sebészi bemosakodó (színezetlen)

Alcoman Market area: EU Alcoman + Market area: EU

Alcoman Market area: EU Optima

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 13/28EN OJ L, 19.9.2025

Alcoman Plus Market area: EU

Hand Market area: EU Antiseptic

Hand Market area: EU Disinfection Hände Market area: EU Antiseptikum Händedesin­ Market area: EU fektion

MyClean Market area: EU IP-Sept

MyClean Market area: EU OP-Sept

Sicu Sept Market area: EU

Actoderm Market area: EU

OP Sept Market area: EU perfume-free

OpSeptClassic Market area: EU - parfumfrei Authorisation number EU-0033834-0003 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,14 % (w/w)

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 2 identifier

Identifier Meta SPC: meta SPC 2

1.2. Suffix to the authorisation number Number 1-2

1.3. Product type(s) Product type(s) PT01: Human hygiene 14/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025

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 Active 67-63-0 200-661-7 63,14-64 % (w/w) substance

2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) XX: wipes impregnated with liquid, ready-to-use

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.

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.

P233: Keep container tightly closed.

P240: Ground and bond container and receiving equipment.

P241: Use explosion-proof electrical, ventilating, lighting equipment.

P243: Take actions to prevent static discharges.

P261: Avoid breathing vapours.

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 / doctor if you feel unwell.

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

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 15/28EN OJ L, 19.9.2025 P370+P378: In case of fire: Use CO , dry chemical, or 2 foam to extinguish.

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

P405: Store locked up.

P501: Dispose of contents to conform with local / regional / national / international regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #2.1 – Hygienic Handrub, General – BP02 Product type PT01: Human hygiene Where relevant, an exact description of the n/a authorised use Target organism(s) (including development Common name: Bacteria stage)

Common name: Tuberculosis bacteria

Common name: Yeasts

Common name: Enveloped viruses Field(s) of use Indoor use In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.: — Domestic use (home care etc.); — Recreational areas.

Application method(s) Method: Handrub (hygienic), Wiping

Detailed description:

Ready to use (RTU) wipes.

Application rate(s) and frequency Application Rate:

Use one wipe to disinfect hands.

RTU wipes

Number and timing of application:

Frequency: Up to 9 wipes per day.

Category(ies) of users General public (non-professional)

Pack sizes and packaging material Small wipes:

Pack sizes: 6 / 12 / 15 / 30 / 48 / 60 / 72 / or 84 wipes per package

Total volume of biocide in package: 51,38 / 102,75 / 128,44 / 256,88 / 411,01 / 513,76 / 616,51 / or 719,26 ml

Package material: Polyethylene terephthalate/aluminium/low density polyethylene (PET/Alu/LDPE) laminated foil

Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100 % wood cellulose)

Wipe size: 20 × 15 cm

Wipe weight: 1,5 g (per wipe)

Impregnation liquid weight: 7,5 g (per wipe) 16/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025

Large wipes:

Pack sizes: 30 / 42 / 60 / 80 or 84 wipes per package

Total volume of biocide in package: 513,76 / 719,26 / 1 027,51 / 1 370,02 or 1 438,52 ml

Package material: PET/Alu/LDPE laminated foil

Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100 % wood cellulose)

Wipe size: 20 × 30 cm

Wipe weight: 3 g (per wipe)

Impregnation liquid weight: 15 g (per wipe)

4.1.1. Use-specific instructions for use See general directions for use of Meta SPC 2.

4.1.2. Use-specific risk mitigation measures Use for children (age > 1 year) only under supervision of an adult.

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 See general direction for use of Meta SPC 2.

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta SPC 2.

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of Meta SPC 2.

4.2. Use description Table 2 Use #2.2 – Hygienic Handrub, Professional – BP02 Product type PT01: Human hygiene Where relevant, an exact description of the n/a authorised use Target organism(s) (including development Common name: Bacteria stage)

Common name: Tuberculosis bacteria

Common name: Yeasts

Common name: Enveloped viruses Field(s) of use Indoor use In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.: — Domestic use (home care etc.); — Institutional use (research etc.);

— Industrial applications, e.g. food, cosmetic, pharmaceutical industry etc.; — Restaurants and large-scale/canteen kitchens; — Recreational areas.

Application method(s) Method: Handrub (hygienic), Wiping

Detailed description:

Ready to use (RTU) wipes.

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 17/28EN OJ L, 19.9.2025 Application rate(s) and frequency Application Rate:

Use one wipe to disinfect hands.

RTU wipes

Number and timing of application:

Frequency: Typically 25 applications per day Category(ies) of users Professional

Pack sizes and packaging material Small wipes:

Pack sizes: 6 / 12 / 15 / 30 / 48 / 60 / 72 / or 84 wipes per package

Total volume of biocide in package: 51,38 / 102,75 / 128,44 / 256,88 / 411,01 / 513,76 / 616,51 / or 719,26 ml

Package material: PET/Alu/LDPE laminated foil

Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100 % wood cellulose)

Wipe size: 20 × 15 cm

Wipe weight: 1,5 g (per wipe)

Impregnation liquid weight: 7,5 g (per wipe)

Large wipes:

Pack sizes: 30 / 42 / 60 / 80 / or 84 wipes per package

Total volume of biocide in package: 513,76 / 719,26 / 1 027,51 / 1 370,02 / or 1 438,52 ml

Package material: Polyethylene terephthalate (PET)/Alu/LDPE laminated foil

Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100% wood cellulose)

Wipe size: 20 × 30 cm

Wipe weight: 3 g (per wipe)

Impregnation liquid weight: 15 g (per wipe)

4.2.1. Use-specific instructions for use 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.

See the general use instructions of Meta SPC 2.

4.2.2. Use-specific risk mitigation measures See general directions for use of Meta SPC 2.

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 See general directions for use of Meta SPC 2.

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta SPC 2.

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of Meta SPC 2.

18/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1. Instructions for use Comply with the instructions for use.

The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.

The wipes are ready-to-use. Only wet wipes are efficacious, dried wipes are to be discarded. Rub hands evenly with one wipe to keep hands moist for 30 seconds.

Please ensure that also all spaces between the fingers, the fingernail angles and skin folds are moistened completely and over the entire exposure time.

5.2. Risk mitigation measures All handling shall only take place in well-ventilated areas.

Used wipes must be disposed in a closed container.

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

Avoid contact with eyes.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment If medical advice is needed, have product container or label at hand.

In case of fire: Use CO , dry chemical, or foam to extinguish.

2 Dispose of contents/container according to local / regional / national / international regulations.

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

First aid:

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, thereafter call a POISON CENTRE.

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.

5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements

Waste disposal code: 070604

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep out of reach of children and non-target animals/pets.

Store in the dark. Keep cool. Do not store at temperatures exceeding 40 °C.

Shelf life: 1 year

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 19/28EN OJ L, 19.9.2025

6. OTHER INFORMATION Please be aware of the European reference value of 129,2 mg/m3 for the active substance propan-2-ol (CAS No:

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

Professionals (including industrial, professionals) mean trained professional 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) OPSept Market area: EU Medical

Alcohol Wipes Market area: EU

Alcoman Market area: EU Tücher

Alcoman Market area: EU Wipes

Chucky Wipes Market area: EU

Deppe Wipes Market area: EU

Desi Wipes Market area: EU IP-Wipes Market area: EU

Op Sept Market area: EU Medical

Op Sept Wipes Market area: EU

OPSept Market area: EU medical perfume-free Authorisation number EU-0033834-0004 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 63,14 % (w/w)

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 3 identifier

Identifier Meta SPC: meta SPC 3

1.2. Suffix to the authorisation number Number 1-3 20/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025

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 Active 67-63-0 200-661-7 64-64 % (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.

P233: Keep container tightly closed.

P240: Ground and bond container and receiving equipment.

P241: Use explosion-proof electrical, ventilating, lighting equipment.

P243: Take actions to pevent static discharges.

P261: Avoid breathing vapours.

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.

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 21/28EN OJ L, 19.9.2025 P312: Call a POISON CENTER / doctor if you feel unwell.

P337+P313: If eye irritation persists: Get medical POISON CENTER / doctor.

P370+P378: In case of fire: Use CO , dry chemical, or 2 foam to extinguish.

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

P405: Store locked up.

P501: Dispose of contents to conform with local / regional / national / international regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description Table 1 Use #3.1 – Hygienic Handrub, General – BP03 Product type PT01: Human hygiene Where relevant, an exact description of the n/a authorised use Target organism(s) (including development Common name: Bacteria stage)

Common name: Yeasts

Common name: Enveloped viruses Field(s) of use Indoor use In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.: — Domestic use (home care etc.); — Recreational areas.

Application method(s) Method: Handrub (hygienic), gel dispensing onto hands

Detailed description:

The product is ready to use (RTU).

Application rate(s) and frequency Application Rate:

Adults and children of 12 years and above: 3 ml. The amount of gel shall resemble the size of a large-sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).

Children under 12 years: 1,5 ml (The number of pumps with the dosing system equivalent to 1,5 ml of the product to be specified by the authorisation holder within the product information).

RTU

Number and timing of application:

Frequency:

Adults and children of 12 years and above: Up to 10 × per day Children under 12 years: Up to 3 × per day Category(ies) of users General public (non-professional) 22/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025 Pack sizes and packaging material — 1 000 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle) — 1 000 ml bottle – HDPE + PP/PE dosing cap — 500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle) — 150 ml bottle – HDPE + PP screw flip top cap — 100 ml bottle – HDPE+ PP screw flip top cap

4.1.1. Use-specific instructions for use The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.

The product is ready-to-use.

Step 1: Apply the following amount of disinfectant: — Adult and children of 12 years and above: 3 ml — Child under 12 years: 1,5 ml 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.

Keep wet for 30 sec against bacteria, yeast and enveloped viruses.

Do not rinse.

Repeat if renewed hand disinfection is required.

Adults and children of 12 years and above: up to 10 × per day Children under 12 years: up to 3 × per day

4.1.2. Use-specific risk mitigation measures Use for children (age > 1 year) only under supervision of an adult.

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 See general directions for use of Meta SPC 3.

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta SPC 3.

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of Meta SPC 3.

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 23/28EN OJ L, 19.9.2025

4.2. Use description Table 2 Use #3.2 – Hygienic Handrub, Professional – BP03 Product type PT01: Human hygiene Where relevant, an exact description of the n/a authorised use Target organism(s) (including development Common name: Bacteria stage)

Common name: Yeasts

Common name: Enveloped viruses Field(s) of use Indoor use In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.: — Domestic use (home care etc.); — Institutional use (research etc.);

— Industrial applications, e.g. food, cosmetic, pharmaceutical industry etc.; — Restaurants and large-scale/canteen kitchens; — Recreational areas.

Application method(s) Method: Handrub (hygienic), gel dispensing onto hands

Detailed description:

The product is ready to use (RTU).

Application rate(s) and frequency Application Rate:

Adult: 3 ml. The amount of gel shall resemble the size of a large- sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).

RTU

Number and timing of application:

Frequency:

Adult: Typically 25 applications per day.

Category(ies) of users Professional Pack sizes and packaging material — 1 000 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle) — 1 000 ml bottle – HDPE + PP/PE dosing cap — 500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle) — 150 ml bottle – HDPE + PP screw flip top cap — 100 ml bottle – HDPE + PP screw flip top

4.2.1. Use-specific instructions for use The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.

The product is ready-to-use. The product shall be either applied directly or used in a dispenser or with a pump.

Step 1: Apply the following amount of disinfectant: — Adult: 3 ml Rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.

24/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025 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.

Keep wet for 30 sec against bacteria, yeast and enveloped viruses.

Do not rinse.

Repeat if renewed hand disinfection is required.

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.

4.2.2. Use-specific risk mitigation measures See general directions for use of Meta SPC 3.

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 See general directions for use of Meta SPC 3.

4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of Meta SPC 3.

4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of Meta SPC 3.

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3

5.1. Instructions for use See use-specific instructions for each use.

Comply with the instructions for use.

5.2. Risk mitigation measures All handling shall only take place in well-ventilated areas.

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

Avoid contact with eyes.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment If medical advice is needed, have product container or label at hand.

In case of fire: Use CO , dry chemical, or foam to extinguish.

2 Dispose of contents/container according to local / regional / national / international regulations.

First aid:

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, thereafter call a POISON CENTRE.

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 25/28EN OJ L, 19.9.2025

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.

5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements

Waste disposal code: 070604

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep out of reach of children and non-target animals/pets.

Store in the dark. Keep cool. Do not store at temperatures exceeding 35 °C.

Shelf life: 3 years

6. OTHER INFORMATION Please be aware of the European reference value of 129,2 mg/m3 for the active substance propan-2-ol (CAS No:

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

Professionals (including industrial, professionals) mean trained professional 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) Lotio Sept Gel Market area: EU

Alco Gel Market area: EU

Care Sept Gel Market area: EU Lotio-Sept-Gel Market area: EU

Manorapid gel Market area: EU

Op Sept Gel Market area: EU

SeptoMed Gel Market area: EU

Sicu Gel Market area: EU

Sicu Sept Gel Market area: EU

Teva Lotio Market area: EU Sept Gel 26/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/ojEN OJ L, 19.9.2025

Tork Alcohol Market area: EU Gel

Alcohol Gel Market area: EU Alcoman-Gel Market area: EU

Alkohol Gel Market area: EU

antiseptic gel Market area: EU

Deppe Gel Market area: EU Desinfektions­ Market area: EU gel desinfizier­ Market area: EU endes Handgel Händedesin­ Market area: EU fektionsgel

Handgel Market area: EU

Hygienegel Market area: EU

Hygienic Hand Market area: EU Gel

Actoderm Gel Market area: EU

Lotio Sept Gel Market area: EU perfume-free

Lotio Sept Gel Market area: EU pur

Lotio Sept Gel Market area: EU pure

Manorapid gel Market area: EU pure Authorisation number EU-0033834-0005 1-3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 64 % (w/w)

ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj 27/28EN OJ L, 19.9.2025

7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Lotio Sept Gel Market area: EU Color

Lotio Sept Gel Market area: EU blau

Lotio Sept Gel Market area: EU blue

OP Sept Gel Market area: EU Color Authorisation number EU-0033834-0006 1-3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active substance 67-63-0 200-661-7 64 % (w/w) 28/28 ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj