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

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 .

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

ANNEXSupplementary provisions

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 and address of the authorisation holder Name Schülke & Mayr GmbH 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 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 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 substance 67-63-0 200-661-7 45 - 45 % (w/w) Propan-1-ol   Active substance 71-23-8 200-746-9 30 - 30 % (w/w) Tetradecanol Myristil alcohol Non-active substance 112-72-1 204-000-3 0 - 0,95 % (w/w) 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 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 substance 67-63-0 200-661-7 45 - 45 % (w/w) Propan-1-ol   Active substance 71-23-8 200-746-9 30 - 30 % (w/w) Tetradecanol Myristil alcohol Non-active substance 112-72-1 204-000-3 0,95 - 0,95 % (w/w) 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. 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 authorised use Not relevant. Target organism(s) (including development stage) Scientific name: other 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. 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 authorised use Not relevant. Target organism(s) (including development stage) Scientific name: other 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. 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”. 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 protect Market area: EU desmanol plus Market area: EU desmanol pro Market area: EU desmanol ultra Market area: EU desmanol clinpure Market area: EU desmanol advanced Market area: EU desmanol ethanolfree Market area: EU desmanol pro pure Market area: EU sensiva protect Market area: EU virusept protect Market area: EU septoderm Market area: EU microshield Market area: EU Halasept 710 Market area: EU Authorisation number   EU-0027466-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol   Active substance 67-63-0 200-661-7 45 % (w/w) Propan-1-ol   Active substance 71-23-8 200-746-9 30 % (w/w) Tetradecanol Myristil alcohol Non-active substance 112-72-1 204-000-3 0,95 % (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 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 substance 67-63-0 200-661-7 45 - 45 % (w/w) Propan-1-ol   Active substance 71-23-8 200-746-9 30 - 30 % (w/w) 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 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 authorised use Not relevant Target organism(s) (including development stage) Scientific name: other 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 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 authorised use Not relevant. Target organism(s) (including development stage) Scientific name: other 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. 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. 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 pure protect Market area: EU desmanol pure+ Market area: EU desmanol pure pro Market area: EU desmanol pure guard Market area: EU desmanol expert Market area: EU desmanol pure ultra Market area: EU desmanol EF Market area: EU desmanol clear Market area: EU sensiva pure Market area: EU virusept pure Market area: EU septoderm pure Market area: EU microshield pure Market area: EU Halasept 720 Market area: EU Authorisation number   EU-0027466-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol   Active substance 67-63-0 200-661-7 45 % (w/w) Propan-1-ol   Active substance 71-23-8 200-746-9 30 % (w/w) 7.2.    Trade name(s), authorisation number and specific composition of each individual product Trade name(s) desmanol pure universal Market area: EU desmanol pure plus Market area: EU desmanol pure expert Market area: EU desmanol proshield Market area: EU desmanol healthcare Market area: EU desmanol duo Market area: EU desmanol EtOH-free Market area: EU desmanol zero Market area: EU sensiva pure+ Market area: EU virusept expert Market area: EU septoderm pure+ Market area: EU microshield pure+ Market area: EU Halasept 740 Market area: EU Authorisation number   EU-0027466-0003 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol   Active substance 67-63-0 200-661-7 45 % (w/w) Propan-1-ol   Active substance 71-23-8 200-746-9 30 % (w/w)