Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2025/2200 30.10.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2200 of 21 October 2025 amending Implementing Regulation (EU) 2022/1186 as regards administrative changes to the Union authorisation of the biocidal product family ‘L+R Propanol PT1 Family’ (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the...
Official Journal EN of the European Union L series 2025/2200 30.10.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2200 of 21 October 2025 amending Implementing Regulation (EU) 2022/1186 as regards administrative changes to the Union authorisation of the biocidal product family ‘L+R Propanol PT1 Family’ (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 50(2) thereof,
Whereas:
(1) On 8 July 2022, Commission Implementing Regulation (EU) 2022/1186(2) granted a Union authorisation with authorisation number EU-0027466-0000, to Lohmann & Rauscher International GmbH&Co.KG for the making available on the market and use of the biocidal product family ‘L+R Propanol PT1 Family’. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.
(2) On 2 June 2025, Lohmann & Rauscher International GmbH&Co.KG submitted to the European Chemicals Agency (‘the Agency’) a notification in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013(3)of administrative changes to the Union authorisation for the biocidal product family ‘L+R Propanol PT1 Family’, as referred to in Title 1, Sections 1 and 2, of the Annex to that Implementing Regulation. The
notification was recorded in the Register for Biocidal Products under case number BC-XW106193-09.
(3) The notified proposed changes to the authorisation concern the transfer of the authorisation to a new holder established in the European Economic Area, a change in the family name and product names, the addition and deletion of trade names, the addition and deletion of product manufacturers and the addition of new active substance manufacturers.
(4) On 30 June 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, an opinion(4)on the notified administrative changes to the Union authorisation for the biocidal product family ‘L+R Propanol PT1 Family’, together with a revised summary of the biocidal product characteristics. In the opinion, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Sections 1 and 2, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.
(5) On 30 June 2025, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the biocidal product family ‘L+R Propanol PT1 Family’ in all official languages of the Union, covering all the administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2022/1186 of 8 July 2022 granting a Union authorisation for the biocidal product family ‘L+R Propanol PT1 Family’ (OJ L 184, 11.7.2022, p. 41, ELI: http://data.europa.eu/eli/reg_impl/2022/1186/oj).
(3) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p.4, ELI: http://data.europa.
eu/eli/reg_impl/2013/354/oj).
(4) ECHA Opinion No UTR-C_1835532-78-00/F of 30 June 2025 on the administrative change of the Union authorisation of the biocidal product family ‘L+R Propanol PT1 Family’, https://echa.europa.eu/opinions-on-union-authorisation.
ELI: http://data.europa.eu/eli/reg_impl/2025/2200/oj 1/17EN OJ L, 30.10.2025
(6) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘L+R Propanol PT1 Family’ to transfer the authorisation to Schuelke & Mayr GmbH and to introduce the other administrative changes requested.
(7) Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of ‘L+R Propanol PT1 Family’ as set out in Annex to Implementing Regulation
(EU) 2022/1186 remains unchanged.
(8) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2022/1186 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the Register for Biocidal Products in February 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes.
(9) Implementing Regulation (EU) 2022/1186 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1 The Annex to Implementing Regulation (EU) 2022/1186 is replaced by the text in the Annex to this Regulation.
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, 21 October 2025.
For the Commission The President Ursula VON DER LEYEN 2/17 ELI: http://data.europa.eu/eli/reg_impl/2025/2200/ojEN OJ L, 30.10.2025 ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY Propanol PT1 Family Product type(s) PT01: Human hygiene
Authorisation number: EU-0027466-00 R4BP asset number: EU-0027466-0000 PART I FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name Name Propanol PT1 Family
1.2. Product type(s) Product type(s) PT01: Human hygiene
1.3. Authorisation holder
1.4. Manufacturer(s) of the product Name Schülke & Mayr GmbH Name and address of the authorisation holder Address Robert-Koch-Str. 2 22851 Norderstedt Germany Authorisation number EU-0027466-00 R4BP asset number EU-0027466-0000 Date of the authorisation 31.7.2022 Expiry date of the authorisation 30.6.2032 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 A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH Address of manufacturer Otto-Brenner-Straße 16 21337 Lüneburg Germany
ELI: http://data.europa.eu/eli/reg_impl/2025/2200/oj 3/17EN OJ L, 30.10.2025 Location of manufacturing sites A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH site 1 Otto-Brenner- Straße 16 21337 Lüneburg Germany
1.5. Manufacturer(s) of the active substance(s) Active substance Propan-2-ol Name of manufacturer INEOS Solvent Germany GmbH Address of manufacturer Römerstrasse 733 47443 Moers Germany Location of manufacturing sites INEOS Solvent Germany GmbH site 1 INEOS Solvent Germany GmbH, Römerstrasse 733 47443 Moers Germany 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 2 Shamrockstr. 88 44623 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) Active substance Propan-1-ol Name of manufacturer OQ Chemicals GmbH (formerly OXEA) Address of manufacturer Rheinpromenade 4a 40789 Monheim am Rhein Germany Location of manufacturing sites OQ Chemicals GmbH (formerly OXEA) site 1 OQ Chemicals Corporation, 2001 FM 3057 (formerly OXEA Corporation) TX 77414-2968 Bay City United States (the) Active substance Propan-1-ol Name of manufacturer Sasol Chemie GmbH & Co. KG 4/17 ELI: http://data.europa.eu/eli/reg_impl/2025/2200/ojEN OJ L, 30.10.2025 Address of manufacturer Secunda Chemical Operations, Sasol Place, 50 Katherine Street 2090 Sandton South Africa Location of manufacturing sites Sasol Chemie GmbH & Co. KG site 1 Secunda Chemical Operations, PDP Kruger Street 2302 Secunda South Africa Active substance Propan-1-ol Name of manufacturer BASF SE Address of manufacturer Carl-Bosch-Str. 38 67056 Ludwigshafen Germany Location of manufacturing sites BASF SE site 1 BASF SE, Carl-Bosch-Str. 38 67056 Ludwigshafen Germany
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 45 - 45 % (w/w) substance Propan-1-ol Active 71-23-8 200-746-9 30 - 30 % (w/w) substance Tetradecanol Myristil Non-active 112-72-1 204-000-3 0 - 0,95 % (w/w) alcohol 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 Meta SPC: meta SPC 1
1.2. Suffix to the authorisation number Number 1-1
ELI: http://data.europa.eu/eli/reg_impl/2025/2200/oj 5/17EN OJ L, 30.10.2025
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 Active 67-63-0 200-661-7 45 - 45 % (w/w) substance Propan-1-ol Active 71-23-8 200-746-9 30 - 30 % (w/w) substance Tetradecanol Myristil Non-active 112-72-1 204-000-3 0,95 - 0,95 % (w/w) alcohol 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 H226: Flammable liquid and vapour.
H318: Causes serious eye damage.
H412: Harmful to aquatic life with long lasting effects.
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.
P233: Keep container tightly closed.
P261: Avoid breathing vapours.
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.
P310: Immediately call a POISON CENTER / doctor.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of container to an approved waste disposal plant.
6/17 ELI: http://data.europa.eu/eli/reg_impl/2025/2200/ojEN OJ L, 30.10.2025
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description Table 1 Hygienic handrub Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant. authorised use Target organism(s) (including development Scientific name: other stage) Common name: Bacteria
Development stage: no data
Scientific name: other
Common name: Yeasts
Development stage: no data
Scientific name: other
Common name: Mycobacteria
Development stage: no data
Scientific name: other
Common name: viruses (limited spectrum of virucidal activity)
Development stage: no data Field(s) of use indoor use — hospitals and other health care institutions, ambulances, surgeries, nursing homes (including home-care of patients), — hospital canteens, large kitchens, pharmaceutical industries, production sites, laboratories: hygienic handrub onto visibly clean and dry hands.
— for professional use only.
Application method(s) Method: manual application
Detailed description:
Rubbing Application rate(s) and frequency Application Rate:
Dosage: At least 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Minimum contact time: 30 sec ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications.
No safety intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users industrial professional Pack sizes and packaging material 100 ml, 500 ml and 1 000 ml in transparent HDPE bottles with PP flip top cap.
4.1.1. Use-specific instructions for use The products can be applied directly, or the products can be used in a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
ELI: http://data.europa.eu/eli/reg_impl/2025/2200/oj 7/17EN OJ L, 30.10.2025
4.1.2. Use-specific risk mitigation measures See general directions for use of meta SPC 1
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
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 Surgical handrub Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant. authorised use Target organism(s) (including development Scientific name: other stage) Common name: Bacteria
Development stage: no data
Scientific name: other
Common name: Yeasts
Development stage: no data
Scientific name: other
Common name: Mycobacteria
Development stage: no data
Scientific name: other
Common name: viruses (limited spectrum of virucidal activity)
Development stage: no data Field(s) of use indoor use
hospitals and other health care institutions: surgical handrub onto visibly clean and dry hands and forearms.
For professional use only.
Application method(s) Method: manual application
Detailed description:
Rubbing Application rate(s) and frequency Application Rate:
Dosage: in portions of 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Minimum exposure time:
90s ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications.
No safety intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users professional Pack sizes and packaging material 100 ml, 500 ml and 1 000 ml in transparent HDPE bottles with PP flip top cap.
8/17 ELI: http://data.europa.eu/eli/reg_impl/2025/2200/ojEN OJ L, 30.10.2025
4.2.1. Use-specific instructions for use The products can be applied directly or the products can be used in a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
4.2.2. Use-specific risk mitigation measures See general directions for use of meta SPC 1
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
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1. Instructions for use For professional use only.
5.2. Risk mitigation measures Avoid contact with eyes.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water. for 15 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 IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
After spilling: Take up with absorbent material (for example sand, kieselgur, universal binder). When picked up, treat material as prescribed under “Disposal considerations”.
ELI: http://data.europa.eu/eli/reg_impl/2025/2200/oj 9/17EN OJ L, 30.10.2025
5.4. Instructions for safe disposal of the product and its packaging Residuals must be removed from packaging and when emptied completely disposed of in accordance with the regulations for waste removal.
Incompletely emptied packaging must be disposed of in the form of disposal specified by the regional disposer.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Technical measures and storage conditions:
Shelf-life: 36 months Keep container tightly closed and dry in a cool, well-ventilated place. Protect from direct sunlight.
Recommended storage temperature: 0-30°C
Requirements for storage rooms and vessels:
Containers which are opened must be carefully closed and kept upright to prevent leakage. Always keep in containers of same material as the original one.
Advice on storage assembly:
Do not store together with: oxidizing substances; spontaneously combusting substances.
6. OTHER INFORMATION
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 protect
desmanol Market area: EU plus
desmanol Market area: EU pro
desmanol Market area: EU ultra
desmanol Market area: EU clinpure
desmanol Market area: EU advanced
desmanol Market area: EU ethanolfree
desmanol Market area: EU pro pure
sensiva Market area: EU protect
virusept Market area: EU protect 10/17 ELI: http://data.europa.eu/eli/reg_impl/2025/2200/ojEN OJ L, 30.10.2025
septoderm Market area: EU micro Market area: EU shield
Halasept Market area: EU 710 Authorisation number EU-0027466-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 45 % (w/w) substance Propan-1-ol Active 71-23-8 200-746-9 30 % (w/w) substance Tetradecanol Myristil alcohol Non-active 112-72-1 204-000-3 0,95 % (w/w) substance
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
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 45 - 45 % (w/w) substance Propan-1-ol Active 71-23-8 200-746-9 30 - 30 % (w/w) substance
2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) AL Any other liquid
ELI: http://data.europa.eu/eli/reg_impl/2025/2200/oj 11/17EN OJ L, 30.10.2025
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements H226: Flammable liquid and vapour.
H318: Causes serious eye damage.
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.
P233: Keep container tightly closed.
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.
P310: Immediately call a POISON CENTER/doctor.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of container to an approved waste disposal plant.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description Table 1 Hygienic handrub Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant authorised use Target organism(s) (including development Scientific name: other stage) Common name: Bacteria
Development stage: no data
Scientific name: other
Common name: Yeasts
Development stage: no data
Scientific name: other
Common name: Mycobacteria
Development stage: no data
Scientific name: other
Common name: viruses (limited spectrum of virucidal activity)
Development stage: no data Field(s) of use indoor use — hospitals and other health care institutions, ambulances, surgeries, nursing homes (including home-care of patients), — hospital canteens, large kitchens, pharmaceutical industries, production sites, laboratories: hygienic handrub onto visibly clean and dry hands.
— for professional use only.
12/17 ELI: http://data.europa.eu/eli/reg_impl/2025/2200/ojEN OJ L, 30.10.2025 Application method(s) Method: manual application
Detailed description:
Rubbing Application rate(s) and frequency Application Rate:
Dosage: At least 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per= 3 ml). Minimum exposure time: 30s ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications.
No safety intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users industrial professional Pack sizes and packaging material 100 ml, 500 ml and 1 000 ml in transparent HDPE bottles with PP flip top cap.
4.1.1. Use-specific instructions for use The products can be applied directly or the products can be used with a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
4.1.2. Use-specific risk mitigation measures See general directions for use of meta SPC 2
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 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 Surgical handrub Product type PT01: Human hygiene Where relevant, an exact description of the Not relevant. authorised use Target organism(s) (including development Scientific name: other stage) Common name: Bacteria
Development stage: no data
Scientific name: other
Common name: Yeasts
Development stage: no data
Scientific name: other
Common name: Mycobacteria
Development stage: no data
ELI: http://data.europa.eu/eli/reg_impl/2025/2200/oj 13/17EN OJ L, 30.10.2025
Scientific name: other
Common name: viruses (limited spectrum of virucidal activity)
Development stage: no data Field(s) of use indoor use
Hospitals and other health care institutions: surgical handrub onto visibly clean and dry hands and forearms.
For professional use only.
Application method(s) Method: manual application
Detailed description:
Rubbing Application rate(s) and frequency Application Rate:
Dosage: in portions of 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Minimum exposure time:
90s ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications.
No safety intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users professional Pack sizes and packaging material 100 ml, 500 ml and 1 000 ml in transparent HDPE bottles with PP flip top cap.
4.2.1. Use-specific instructions for use The products can be applied directly or the products can be used with a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
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.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1. Instructions for use For professional use only
5.2. Risk mitigation measures Avoid contact with eyes.
Keep out of reach of children.
14/17 ELI: http://data.europa.eu/eli/reg_impl/2025/2200/ojEN OJ L, 30.10.2025
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water. for 15 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 IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
After spilling: Take up with absorbent material (for example sand, kieselgur, universal binder). When picked up, treat material as prescribed under “Disposal considerations”.
5.4. Instructions for safe disposal of the product and its packaging Residuals must be removed from packaging and when emptied completely disposed of in accordance with the regulations for waste removal.
Incompletely emptied packaging must be disposed of in the form of disposal specified by the regional disposer.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Technical measures and storage conditions:
Shelf-life: 36 months Keep container tightly closed and dry in a cool, well-ventilated place. Protect from direct sunlight.
Recommended storage temperature: 0-30°C
Requirements for storage rooms and vessels:
Containers which are opened must be carefully closed and kept upright to prevent leakage. Always keep in containers of same material as the original one.
Advice on storage assembly:
Do not store together with: oxidizing substances; spontaneously combusting substances
6. OTHER INFORMATION
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 protect
desmanol Market area: EU pure+
ELI: http://data.europa.eu/eli/reg_impl/2025/2200/oj 15/17EN OJ L, 30.10.2025
desmanol Market area: EU pure pro
desmanol Market area: EU pure guard
desmanol Market area: EU expert
desmanol Market area: EU pure ultra
desmanol Market area: EU EF
desmanol Market area: EU clear
sensiva Market area: EU pure
virusept Market area: EU pure
septoderm Market area: EU pure micro Market area: EU shield pure
Halasept Market area: EU 720 Authorisation number EU-0027466-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 45 % (w/w) substance Propan-1-ol Active 71-23-8 200-746-9 30 % (w/w) substance
7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) desmanol Market area: EU pure universal
desmanol Market area: EU pure plus
desmanol Market area: EU pure expert 16/17 ELI: http://data.europa.eu/eli/reg_impl/2025/2200/ojEN OJ L, 30.10.2025
desmanol Market area: EU proshield
desmanol Market area: EU healthcare
desmanol Market area: EU duo
desmanol Market area: EU EtOH-free
desmanol Market area: EU zero
sensiva Market area: EU pure+
virusept Market area: EU expert
septoderm Market area: EU pure+ micro Market area: EU shield pure +
Halasept Market area: EU 740 Authorisation number EU-0027466-0003 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 45 % (w/w) substance Propan-1-ol Active 71-23-8 200-746-9 30 % (w/w) substance
ELI: http://data.europa.eu/eli/reg_impl/2025/2200/oj 17/17