Commission Implementing Regulation (EU) 2025/2104 of 21 October 2025 amending Implementing Regulation (EU) 2019/2029 as regards administrative changes to the Union authorisation for the single biocidal product CVAS Disinfectant product based on Propan-2-ol

Official Journal EN of the European Union L series 2025/2104 22.10.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2104 of 21 October 2025 amending Implementing Regulation (EU) 2019/2029 as regards administrative changes to the Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’ (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 29 November 2019, Commission Implementing Regulation (EU) 2019/2029(2)granted a Union authorisation, under number EU-0020461-0000, to CVAS Development GmbH for the making available on the market and use of the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’. The Annex to that Implementing Regulation provides a summary of product characteristics for that single biocidal product. (2) On 30 November 2022 and 11 February 2025, CVAS Development GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013(3), notifications of administrative changes to the Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’, as referred to in Title 1 of the Annex to that Regulation. The notifications were recorded in the Register for Biocidal Products (‘Register’) under case numbers BC-QB082302-54 and BC-CC104178-64. The notified proposed changes to that authorisation concern changes to the address of the authorisation holder, changes to the address of one of the manufacturers of the biocidal product and the addition of two production sites. (3) On 10 January 2023 and 18 March 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions(4)on the notified administrative changes to the Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’. In the opinions, 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. (4) On 18 March 2025, the Agency transmitted to the Commission a revised summary of the biocidal product characteristics of the Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’ in all official languages of the Union, covering all 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) 2019/2029 of 29 November 2019 granting a Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’ (OJ L 313, 4.12.2019, p. 41, ELI: http://data.europa.eu/eli/reg_impl/2019/ 2029/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 opinions of 10 January 2023 and 18 March 2025 on administrative changes of the Union authorisation of the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’, Opinions Nos UAD-C-1635714-34-00/F and UAD-C-1810381-35-00/F https://echa.europa.eu/documents/10162/3443008/opinion_for_ua-admin_changes_bc-qb082302-54_en.pdf/4d1b6b3f- e7d9-1891-c6f8-d33708602bd0?t=1686103139710 and https://echa.europa.eu/documents/10162/95571017/ua_adc_echa- opinion_bc-cc104178-64_en.pdf/cbae0e96-6933-67ee-5d70-0da3e1fd6a0e?t=1742289737846. ELI: http://data.europa.eu/eli/reg_impl/2025/2104/oj 1/12EN OJ L, 22.10.2025 (5) The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’ to introduce the administrative changes requested by CVAS Development GmbH. (6) Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of ‘CVAS Disinfectant product based on Propan-2-ol’ as set out in Annex to Implementing Regulation (EU) 2019/2029 remains unchanged. (7) 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) 2019/2029 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 in February 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes. (8) Implementing Regulation (EU) 2019/2029 should therefore be amended accordingly, HAS ADOPTED THIS REGULATION: Article 1 The Annex to Implementing Regulation (EU) 2019/2029 is replaced by the text set out 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 2/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2104/ojEN OJ L, 22.10.2025 ANNEX Summary of product characteristics for a biocidal product CVAS Disinfectant product based on Propan-2-ol Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Authorisation number:EU-0020461-0000 R4BP asset number:EU-0020461-0000 1. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s) CVAS Disinfectant product based on Propan-2-ol calgonit DS 622 R 3000 SCHNELLDESINFEKTION IPADES 70 Alpha Septin Blu-Sept Disinfect home Schnell Des Disinfect Rapid Bakt-Ex Pur Bakt-Ex Rapid ROTIE-DES quick Bactazol I Dezynfektator EOSSAN-Desinfektionsspray-Fluid FS-7-Spray Gartengeräte Hygiene Spray NeudoClean Hygiene Spray 1.2. Authorisation holder Name CVAS Development GmbH Name and address of the authorisation holder Address Am Hafen 16 68526 Ladenburg Germany Authorisation number EU-0020461-0000 R4BP asset number EU-0020461-0000 Date of the authorisation 24 December 2019 Expiry date of the authorisation 30 November 2029 1.3. Manufacturer(s) of the product Name of manufacturer Brenntag GmbH Address of manufacturer Messeallee 11 45131 Essen Germany Location of manufacturing sites Brenntag GmbH Am Nordseekai 22 73207 Plochingen Germany ELI: http://data.europa.eu/eli/reg_impl/2025/2104/oj 3/12EN OJ L, 22.10.2025 Name of manufacturer ACT GmbH Address of manufacturer Weidenweg 12 73087 Bad Boll Germany Location of manufacturing sites ACT GmbH Weidenweg 12 73087 Bad Boll Germany Name of manufacturer Meyer Chemie GmbH & Co. KG Address of manufacturer Werkstr 25 32130 Enger Germany Location of manufacturing sites Meyer Chemie GmbH & Co. KG Werkstr 25 32130 Enger Germany Name of manufacturer Calvatis GmbH Address of manufacturer Am Hafen 16 68526 Ladenburg Germany Location of manufacturing sites Calvatis GmbH Am Hafen 16 68526 Ladenburg Germany Name of manufacturer Arthur Schopf Hygiene GmbH & Co. KG Address of manufacturer Pfaffensteinstr. 1 83115 Neubeuern Germany Location of manufacturing sites Arthur Schopf Hygiene GmbH & Co. KG Pfaffensteinstr. 1 83115 Neubeuern Germany 1.4. Manufacturer(s) of the active substance(s) Active substance Propan-2-ol Name of manufacturer Shell Nederland Raffinaderij B.V. Address of manufacturer Vondelingenweg 601 3196 KK, Vodelingenenplaat Rotterdam Netherlands (the) Location of manufacturing sites Shell Nederland Raffinaderij B.V. site 1 Vondelingenweg 601 3196 KK, Vodelingenenplaat Rotterdam Netherlands (the) Active substance Propan-2-ol Name of manufacturer ExxonMobil Address of manufacturer 4999 Scenic Highway LA 70897 Baton Rouge, Louisana United States (the) Location of manufacturing sites ExxonMobil site 1 4999 Scenic Highway LA 70897 Baton Rouge, Louisana United States (the) 4/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2104/ojEN OJ L, 22.10.2025 Active substance Propan-2-ol Name of manufacturer INEOS Solvents Germany GmbH Address of manufacturer Römerstraße 733 47443 Moers Germany Location of manufacturing sites INEOS Solvents Germany GmbH site 1 Römerstraße 733 47443 Moers Germany 2. PRODUCT COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the product Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 61,25 % (w/w) substance 2.2. Type(s) of formulation Any other liquid (ready-to-use) 3. HAZARD AND PRECAUTIONARY STATEMENTS 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. 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. P280: Wear eye protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. ELI: http://data.europa.eu/eli/reg_impl/2025/2104/oj 5/12EN OJ L, 22.10.2025 P501: Dispose of contents /container in accordance with local regulations. P264: Wash hands thoroughly after handling. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P370+P378: In case of fire: Use alcohol-resistant foam to extinguish. 4. AUTHORISED USE(S) 4.1. Use description Table 1 Use 1 – Disinfection of small surfaces in product type 2 by non-professional users Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: Bacteria Development stage: All Scientific name: Yeasts Common name: Yeasts Development stage: All Field(s) of use indoor use Disinfection of non-porous surfaces in domestic areas. Application method(s) Method: Spraying Detailed description: Spraying (with trigger sprayer or pump spray) Method: Spraying and wiping Detailed description: Spraying (with trigger sprayer or pump spray) and wiping Method: Pouring and wiping Detailed description: - Application rate(s) and frequency Application Rate: 40-50 mL/m2 - Number and timing of application: - Category(ies) of users general public (non-professional) 6/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2104/ojEN OJ L, 22.10.2025 Pack sizes and packaging material 1. Bottle: High-density polyethylene (HDPE, 250 - 1000 mL 2. Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL 4.1.1. Use-specific instructions for use The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label: — Trigger spray: Apply 20 spray strokes per 0,5 m2. — Pump spray: Apply 3 jets per 100 cm2. — Bottle: Apply one measuring cup per m2 4.1.2. Use-specific risk mitigation measures See section 5.2. 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 section 5.3. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See section 5.4. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See section 5.5. 4.2. Use description Table 2 Use 2 – Disinfection of small surfaces in product type 2 by professional users Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: Bacteria Development stage: All Scientific name: Yeasts Common name: Yeasts Development stage: All Field(s) of use indoor use Disinfection of non-porous surfaces in industry, small enterprises, institutions and domestic areas. Application method(s) Method: Spraying Detailed description: Spraying (with trigger sprayer or pump spray) Method: Spraying and wiping ELI: http://data.europa.eu/eli/reg_impl/2025/2104/oj 7/12EN OJ L, 22.10.2025 Detailed description: Spraying (with trigger sprayer or pump spray) and wiping Method: Pouring and wiping Detailed description: - Application rate(s) and frequency Application Rate: 40-50 mL/m2 - Number and timing of application: - Category(ies) of users professional Pack sizes and packaging material 1. Bottle: HDPE, 250 - 1000 mL 2. Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL 3. Intermediate bulk containers (IBC): HDPE, 720 L 4. Drum: Steel, zinc coated and painted, 200 - 220 L 5. Canister: HDPE, 5 - 50 L 4.2.1. Use-specific instructions for use See section 5.1. 4.2.2. Use-specific risk mitigation measures 1. The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and / or organisational measures: The use of eye protection during handling of the product is recommended. 2. The product must only be applied for disinfection of small surfaces. 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 section 5.3. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See section 5.4. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See section 5.5. 4.3. Use description Table 3 Use 3 – Disinfection of small surfaces in product type 4 by non-professional users Product type PT04: Food and feed area Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: Bacteria Development stage: All 8/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2104/ojEN OJ L, 22.10.2025 Scientific name: Yeasts Common name: Yeasts Development stage: All Field(s) of use indoor use Disinfection of non-porous surfaces in kitchens. Disinfection of gardening equipment for human hygiene purpose only. Application method(s) Method: Spraying Detailed description: Spraying (with trigger sprayer or pump spray) Method: Spraying and wiping Detailed description: Spraying (with trigger sprayer or pump spray) and wiping Method: Pouring and wiping Detailed description: - Application rate(s) and frequency Application Rate: 40-50 mL/m2 - Number and timing of application: - Category(ies) of users general public (non-professional) Pack sizes and packaging material 1. Bottle: HDPE, 250 - 1000 mL 2. Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL 4.3.1. Use-specific instructions for use 1. For use at room temperature (20±2°C). 2. The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label: — Trigger spray: Apply 20 spray strokes per 0,5 m2. — Pump spray: Apply 3 jets per 100 cm2. — Bottle: Apply one measuring cup per m2 3. Disinfection of gardening equipment for human hygiene purpose only. 4. Disinfect gardening equipment only indoors. 4.3.2. Use-specific risk mitigation measures See section 5.2. 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 section 5.3. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See section 5.4. ELI: http://data.europa.eu/eli/reg_impl/2025/2104/oj 9/12EN OJ L, 22.10.2025 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See section 5.5. 4.4. Use description Table 4 Use 4 – Disinfection of small surfaces in product type 4 by professional users Product type PT04: Food and feed area Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: Bacteria Development stage: All Scientific name: Yeasts Common name: Yeasts Development stage: All Field(s) of use indoor use Disinfection of non-porous surfaces in canteens or kitchens, food processing industry (including breweries). Disinfection of gardening equipment for human hygiene purpose only. Application method(s) Method: Spraying Detailed description: Spraying (with trigger sprayer or pump spray) Method: Spraying and wiping Detailed description: Spraying (with trigger sprayer or pump spray) and wiping Method: Pouring and wiping Detailed description: - Application rate(s) and frequency Application Rate: 40-50 mL/m2 - Number and timing of application: - Category(ies) of users professional Pack sizes and packaging material 1. Bottle: HDPE, 250 - 1000 mL 2. Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL 3. IBC: HDPE, 720 L 4. Drum: Steel, zinc coated and painted, 200 - 220 L 5. Canister: HDPE, 5 - 50 L 4.4.1. Use-specific instructions for use 1. For use at room temperature (20±2°C). 2. Disinfection of gardening equipment for human hygiene purpose only. 3. Disinfect gardening equipment only indoors. 10/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2104/ojEN OJ L, 22.10.2025 4.4.2. Use-specific risk mitigation measures 1. Provide adequate ventilation (industrial ventilation or keeping windows and doors open). 2. The product must only be applied for disinfection of small surfaces. 3. The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and / or organisational measures: The use of eye protection during handling of the product is recommended. 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See section 5.3. 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See section 5.4. 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See section 5.5. 5. GENERAL DIRECTIONS FOR USE(1) 5.1. Instructions for use 1. Clean surfaces before use. 2. Apply the product to the surface undiluted by spraying. Make sure to wet surfaces completely. Allow to take effect for at least 15 minutes. 3. Apply the product to the surface undiluted by spraying / pouring the product and wiping of the surface afterwards. Make sure to wet surfaces completely. Allow to take effect for at least 5 minutes. 4. Do not apply more than 50 mL/m2. 5. Used wipes must be disposed in a closed container. 6. For non-professional users only: Do not use more than 4 applications per day. 5.2. Risk mitigation measures 1. Keep out of reach of children and pets. 2. Avoid contact with eyes. 3. Do not apply in the presence of small children. 4. Keep children and pets away from rooms, where disinfection is taking place. Provide adequate ventilation before children enter treated rooms. 5. For refilling a funnel must be applied. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid: 1. IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. 2. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing. 3. Call a POISON CENTER or doctor/physician if you feel unwell. (1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses. ELI: http://data.europa.eu/eli/reg_impl/2025/2104/oj 11/12EN OJ L, 22.10.2025 4. If eye irritation persists, get medical advice/attention. 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. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Store cool (not above 30°C) and protect from frost. Shelf-life: 24 month. 6. OTHER INFORMATION 1. Please be aware of the European reference value of 129,28 mg/m3for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the product. 2. Information on hazard and precautionary statements: In fact H319 would trigger P280 (Wear eye protection/face protection.). However, for non-professional use correct use of personal protective equipment cannot be assumed. Based on a qualitative risk assessment an additional advice (labelling) with “Avoid contact with eyes” and the other precautionary statements P305 + P351 + P338 and P337 + P313 are considered sufficient to protect the non-professional user from the corresponding risk. H319 also triggers P264 (Wash … thoroughly after handling.). This precautionary statement is also not required since propan-2-ol and the formulated biocidal product is very volatile and will evaporate from contaminated skin rapidly. Thus, washing of hands or other body parts is not necessary. H336 would trigger P304 + P340 (IF INHALED: Remove person to fresh air and keep comfortable for breathing.). According to the Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008 (2016) this precautionary statement is considered as optional. Based on the low hazard from acute inhalation of the biocidal product this precautionary statement is not required. 12/12 ELI: http://data.europa.eu/eli/reg_impl/2025/2104/oj