Commission Implementing Regulation (EU) 2025/1885of 11 September 2025granting 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)

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

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

Annex

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 NameBPF Propan-2-ol Dr Deppe 1.2. Product type(s) Product type(s)PT01: Human hygiene 1.3. Authorisation holder Name and address of the authorisation holderNameLaboratorium Dr. Deppe GmbHAddressHooghe Weg 35 47906 Kempen DEAuthorisation numberEU-0033834-0000R4BP asset numberEU-0033834-0000Date of the authorisation9 October 2025Expiry date of the authorisation30 September 2035 1.4. Manufacturer(s) of the product Name of manufacturerLaboratorium Dr. Deppe GmbHAddress of manufacturerHooghe Weg 35 47906 Kempen GermanyLocation 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 1.5. Manufacturer(s) of the active substance(s) Active substancePropan-2-olName of manufacturerBrenntag GmbHAddress of manufacturerStinnes-Platz 1 45472 Muelheim an der Ruhr GermanyLocation 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 nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-763,14-64 % (w/w) 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)
3. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier IdentifierMeta SPC: meta SPC 1 1.2. Suffix to the authorisation number Number1-1 1.3. Product type(s) Product type(s)PT01: Human hygiene
4. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-763,14-64 % (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 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 CO2, dry chemical, or 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 # 1.1 – Hygienic Handrub, General – BP01 Product typePT01: Human hygieneWhere relevant, an exact description of the authorised usen/aTarget organism(s) (including development stage) Common name: Bacteria 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 usersGeneral public (non-professional) Pack sizes and packaging material 1000 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. 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 typePT01: Human hygieneWhere relevant, an exact description of the authorised usen/aTarget organism(s) (including development stage) Common name: Bacteria 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 usersProfessionalPack sizes and packaging material 5000 ml canister - HDPE + HDPE screw cap 1000 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. 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.

4.3. Use description Table 3 Use #1.3 – Surgical Handrub – BP01 Product typePT01: Human hygieneWhere relevant, an exact description of the authorised usen/aTarget organism(s) (including development stage) Common name: Bacteria 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 usersProfessionalPack sizes and packaging material 5000 ml canister – HDPE + HDPE screw cap 1000 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 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 CO2, dry chemical, or foam to extinguish. 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 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 ColorMarket area: EUOp Sept BlauMarket area: EUTeva Sept Skin poly-alkoholos bőrfertőtlenítő (színezett)Market area: EUAuthorisation numberEU-0033834-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-763,14 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)OP Sept residue-freeMarket area: EUCuracid HD-septMarket area: EUManorapid pureMarket area: EUOp Sept purMarket area: EUOp Sept pureMarket area: EUAuthorisation numberEU-0033834-0002 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-763,14 % (w/w) 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)OP Sept ClassicMarket area: EUCamed HD-PlusMarket area: EUCuracid PolyMarket area: EUDezodent HWMarket area: EUDr. Desi HändedesinfektionMarket area: EUKühn HändedesinfektionMarket area: EUKühn HändedesinfektionMarket area: EUMaimed CleanMarket area: EUManorapid BasicMarket area: EUManorapid r.f.u.Market area: EUOp DermMarket area: EUOp Derm MedicalMarket area: EUOp SeptMarket area: EUOPSeptMarket area: EUOP-SeptMarket area: EUSeptomedMarket area: EUTeva Sept HandMarket area: EUTeva Sept HandMarket area: EUTeva Sept Skin poly-alkoholos bőrfertőtlenítő és sebészi bemosakodó (színezetlen)Market area: EUAlcomanMarket area: EUAlcoman +Market area: EUAlcoman OptimaMarket area: EU

Alcoman PlusMarket area: EUHand AntisepticMarket area: EUHand DisinfectionMarket area: EUHände AntiseptikumMarket area: EUHändedesinfektionMarket area: EUMyClean IP-SeptMarket area: EUMyClean OP-SeptMarket area: EUSicu SeptMarket area: EUActodermMarket area: EUOP Sept perfume-freeMarket area: EUOpSeptClassic - parfumfreiMarket area: EUAuthorisation numberEU-0033834-0003 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-763,14 % (w/w)

1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier IdentifierMeta SPC: meta SPC 2 1.2. Suffix to the authorisation number Number1-2 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 nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-763,14-64 % (w/w) 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. P370+P378: In case of fire: Use CO2, dry chemical, or 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 typePT01: Human hygieneWhere relevant, an exact description of the authorised usen/aTarget organism(s) (including development stage) Common name: Bacteria 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 usersGeneral 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) Large wipes: Pack sizes: 30 / 42 / 60 / 80 or 84 wipes per package Total volume of biocide in package: 513,76 / 719,26 / 1027,51 / 1370,02 or 1438,52 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 typePT01: Human hygieneWhere relevant, an exact description of the authorised usen/aTarget organism(s) (including development stage) Common name: Bacteria 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. 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 usersProfessionalPack 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 / 1027,51 / 1370,02 / or 1438,52 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. 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 CO2, dry chemical, or foam to extinguish. 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 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 MedicalMarket area: EUAlcohol WipesMarket area: EUAlcoman TücherMarket area: EUAlcoman WipesMarket area: EUChucky WipesMarket area: EUDeppe WipesMarket area: EUDesi WipesMarket area: EUIP-WipesMarket area: EUOp Sept MedicalMarket area: EUOp Sept WipesMarket area: EUOPSept medical perfume-freeMarket area: EUAuthorisation numberEU-0033834-0004 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-763,14 % (w/w)

1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier IdentifierMeta SPC: meta SPC 3 1.2. Suffix to the authorisation number Number1-3 1.3. Product type(s) Product type(s)PT01: Human hygiene
2. META SPC 3 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-764-64 % (w/w) 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. 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 CO2, dry chemical, or 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 typePT01: Human hygieneWhere relevant, an exact description of the authorised usen/aTarget organism(s) (including development stage) Common name: 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), 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 usersGeneral public (non-professional) Pack sizes and packaging material 1000 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle) 1000 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. 4.2. Use description Table 2 Use #3.2 – Hygienic Handrub, Professional – BP03 Product typePT01: Human hygieneWhere relevant, an exact description of the authorised usen/aTarget organism(s) (including development stage) Common name: 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), 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 usersProfessionalPack sizes and packaging material 1000 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle) 1000 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. 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 CO2, dry chemical, or foam to extinguish. 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. 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 GelMarket area: EUAlco GelMarket area: EUCare Sept GelMarket area: EULotio-Sept-GelMarket area: EUManorapid gelMarket area: EUOp Sept GelMarket area: EUSeptoMed GelMarket area: EUSicu GelMarket area: EUSicu Sept GelMarket area: EUTeva Lotio Sept GelMarket area: EU Tork Alcohol GelMarket area: EUAlcohol GelMarket area: EUAlcoman-GelMarket area: EUAlkohol GelMarket area: EUantiseptic gelMarket area: EUDeppe GelMarket area: EUDesinfektionsgelMarket area: EUdesinfizierendes HandgelMarket area: EUHändedesinfektionsgelMarket area: EUHandgelMarket area: EUHygienegelMarket area: EUHygienic Hand GelMarket area: EUActoderm GelMarket area: EULotio Sept Gel perfume-freeMarket area: EULotio Sept Gel purMarket area: EULotio Sept Gel pureMarket area: EUManorapid gel pureMarket area: EUAuthorisation numberEU-0033834-0005 1-3Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-764 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Lotio Sept Gel ColorMarket area: EULotio Sept Gel blauMarket area: EULotio Sept Gel blueMarket area: EUOP Sept Gel ColorMarket area: EUAuthorisation numberEU-0033834-0006 1-3Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-764 % (w/w)