Commission Implementing Regulation (EU) 2025/1887 of 17 September 2025 granting a Union authorisation for the single biocidal product CLARMARIN® 350 LD in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journal EN of the European Union L series 2025/1887 18.9.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1887 of 17 September 2025 granting a Union authorisation for the single biocidal product ‘CLARMARIN® 350 LD’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products(1), and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) On 30 July 2024, Evonik Operations GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013(2)for Union authorisation of the same single biocidal, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘CLARMARIN® 350 LD’, of product-type 2, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-KL099229-17 in the Register for Biocidal Products. The application referred to the single biocidal product ‘CLARMARIN® 350’ (authorisation number EU-0028964-0005), which is a part of the related reference biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’. The application also indicated the authorisation number of the related reference biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ authorised by Commission Implementing Regulation (EU) 2023/2183(3), with authorisation number EU-0028964-0000. (2) The single biocidal product ‘CLARMARIN® 350 LD’ contains hydrogen peroxide 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 2. (3) On 30 October 2024, the Agency submitted to the Commission its opinion(4), in accordance with Article 6 of Implementing Regulation (EU) No 414/2013. (4) In its opinion, the Agency concludes that the proposed differences between the single biocidal product ‘CLARMARIN® 350 LD’ and the related single reference biocidal product ‘CLARMARIN® 350’, which is a part of the related reference biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013(5), and that based on the assessment of the related reference biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ and subject to compliance with the draft SPC, the same single biocidal product ‘CLARMARIN® 350 LD’ meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012. (1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. (2) Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj). (3) Commission Implementing Regulation (EU) 2023/2183 of 18 October 2023 granting a Union authorisation for the biocidal product family Evonik’s Hydrogen Peroxide Product Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2023/2183, 19.10.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2183/oj). (4) European Chemicals Agency opinion of 30 October 2024 on the Union authorisation of the same single biocidal product ‘CLARMARIN® 350 LD’, https://echa.europa.eu/opinions-on-union-authorisation. (5) 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). ELI: http://data.europa.eu/eli/reg_impl/2025/1887/oj 1/9EN OJ L, 18.9.2025 (5) On 24 September 2024, the Agency transmitted to the Commission the draft SPC of ‘CLARMARIN® 350 LD’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. (6) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘CLARMARIN® 350 LD’. (7) The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’. (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-0033557-0000 is hereby granted to Evonik Operations GmbH for the making available on the market and use of the same single biocidal product ‘CLARMARIN® 350 LD’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 8 October 2025 until 31 October 2033. 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, 17 September 2025. For the Commission The President Ursula VON DER LEYEN 2/9 ELI: http://data.europa.eu/eli/reg_impl/2025/1887/ojEN OJ L, 18.9.2025 ANNEX Summary of product characteristics for a biocidal product CLARMARIN® 350 LD Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals Authorisation number: EU-0033557-0000 R4BP asset number: EU-0033557-0000 1. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s) CLARMARIN® 350 LD BEIBLEACH WP 35 1.2. Authorisation holder Name Evonik Operations GmbH Name and address of the authorisation holder Address Rellinghauser Straße 1 - 11 45128 Essen DE Authorisation number EU-0033557-0000 R4BP asset number EU-0033557-0000 Date of the authorisation 8 October 2025 Expiry date of the authorisation 31 October 2033 1.3. Manufacturer(s) of the product Name of manufacturer Evonik Antwerpen NV Address of manufacturer Tijsmanstunnel West 2040 Antwerpen Belgium Location of manufacturing sites Evonik Antwerpen NV Tijsmanstunnel West 2040 Antwerpen Belgium Name of manufacturer Evonik Operations GmbH Address of manufacturer Rellinghauser Straße 1-11 45128 Essen Germany Location of manufacturing sites Evonik Operations GmbH Untere Kanalstr. 3 79618 Rheinfelden Germany Name of manufacturer Evonik Peroxid GmbH Address of manufacturer Industriestraße 1 9721 Weißenstein Austria Location of manufacturing sites Evonik Peroxid GmbH Industriestraße 1 9721 Weißenstein Austria ELI: http://data.europa.eu/eli/reg_impl/2025/1887/oj 3/9EN OJ L, 18.9.2025 Name of manufacturer Evonik Peroxide Netherlands BV Address of manufacturer Hettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands (the) Location of manufacturing sites Evonik Peroxide Netherlands BV Oosterhorn 14 9936 HD Farmsum Netherlands (the) Name of manufacturer Evonik España y Portugal SA Address of manufacturer Afueras s/n 50784 La Zaida Spain Location of manufacturing sites Evonik España y Portugal SA C/ Afueras s/n. 50784 La Zaida Spain 1.4. Manufacturer(s) of the active substance(s) Active substance Hydrogen peroxide Name of manufacturer Evonik Antwerpen NV Address of manufacturer Tijsmanstunnel West 2040 Antwerpen Belgium Location of manufacturing sites Evonik Antwerpen NV Tijsmanstunnel West 2040 Antwerpen Belgium Active substance Hydrogen peroxide Name of manufacturer Evonik Operations GmbH Address of manufacturer Rellinghauser Straße 1-11 45128 Essen Germany Location of manufacturing sites Evonik Operations GmbH Untere Kanalstr. 3 79618 Rheinfelden Germany Active substance Hydrogen peroxide Name of manufacturer Evonik Peroxid GmbH Address of manufacturer Industriestraße 1 9721 Weißenstein Austria Location of manufacturing sites Evonik Peroxid GmbH Industriestraße 1 9721 Weißenstein Austria Active substance Hydrogen peroxide Name of manufacturer Evonik Peroxide Netherlands BV Address of manufacturer Hettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands (the) Location of manufacturing sites Evonik Peroxide Netherlands BV Oosterhorn 14 9936 HD Farmsum Netherlands (the) Active substance Hydrogen peroxide Name of manufacturer Evonik España y Portugal SA Address of manufacturer Afueras s/n 50784 La Zaida Spain Location of manufacturing sites Evonik España y Portugal SA C/ Afueras s/n. 50784 La Zaida Spain 4/9 ELI: http://data.europa.eu/eli/reg_impl/2025/1887/ojEN OJ L, 18.9.2025 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 (%) Hydrogen Active 7722-84-1 231-765-0 35 % (w/w) peroxide substance 2.2. Type(s) of formulation SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS Hazard statements H302: Harmful if swallowed. H315: Causes skin irritation. H318: Causes serious eye damage. H335: May cause respiratory irritation. H412: Harmful to aquatic life with long lasting effects. H272: May intensify fire; oxidiser. Precautionary statements P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective clothing / eye protection / face protection. P301+P312: IF SWALLOWED: Call a POISON CENTER / doctor / physician if you feel unwell. P330: Rinse mouth. P302+P352: IF ON SKIN: Wash with plenty of water/ soap. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER/doctor/physician if you feel unwell. 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. P332+P313: If skin irritation occurs: Get medical advice. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P405: Store locked up. ELI: http://data.europa.eu/eli/reg_impl/2025/1887/oj 5/9EN OJ L, 18.9.2025 P501: Dispose of contents in accordance with local requirements. P501: Dispose of container in accordance with local requirements. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P370+P378: In case of fire: Use water to extinguish. 4. AUTHORISED USE(S) 4.1. Use description Table 1 Laundry disinfection in closed washing machines by dosing 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 Common name: bacteria stage) Development stage: - Common name: yeasts Development stage: - Common name: viruses Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Laundry disinfection in washing machines. Application method(s) Method: Loading (dosing) Detailed description: The product is automatically dosed into the closed washing machine during the washing process (main wash). Application rate(s) and frequency Application Rate: 0,019 – 0,029% (w/w) hydrogen peroxide. The biocidal products are diluted accordingly in order to achieve an in-use concentration in the range of 0,019 – 0,029% (w/w). For example, in the case of 35% (w/w) hydrogen peroxide product: 0,5 ml or 0,75 ml concentrate add water up to 1 litre to achieve 0,019% (w/w) or 0,029% (w/w). For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Frequency: Daily / if required Bacteria, yeasts, fungi: In use concentration 0,019% (w/w) hydrogen peroxide in the wash solution. Alkaline buffering agent: 0,6 ml/l BEIPUR ANP. Contact time: 10 minutes Temperature: 70°C 6/9 ELI: http://data.europa.eu/eli/reg_impl/2025/1887/ojEN OJ L, 18.9.2025 Viruses: In use concentration 0,029% (w/w) hydrogen peroxide in the wash solution. Alkaline buffering agent: 0,6 ml/l BEIPUR ANP Contact time: 10 minutes Temperature: 80°C Cloth: liquid ratio = 1:4 Category(ies) of users professional Pack sizes and packaging material HDPE bottle 1, 5 litres HDPE jerry can 10, 20, 30, 60 litres HDPE drum 200 litres HDPE container 1000 litres HDPE ISO tank 20m3 4.1.1. Use-specific instructions for use The product and alkaline buffering agent (BEIPUR ANP) are automatically dosed into the closed washing machine during the washing process. The dosing of both components, i.e. the biocidal product and the alkaline buffering agent BEIPUR ANP, is realised via two separate pipes and dosing stations. Biocidal product and alkaline buffering agent should not be mixed prior the dosing into the washing machine. Treatment Interval - daily / if required (0,5 hours / day). 4.1.2. Use-specific risk mitigation measures Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. Glove and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to Council Directive 98/24/EC. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging No use specific instructions for safe disposal of the product and its packaging. See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use. 5. GENERAL DIRECTIONS FOR USE(1) 5.1. Instructions for use See use specific instructions for each use. (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/2025/1887/oj 7/9EN OJ L, 18.9.2025 5.2. Risk mitigation measures See use specific risk mitigation measures for each use. Observe label instructions. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid instructions 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. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. 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 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. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Accidental release measures Large spillage: Collect product in suitable containers (for example made of plastic) using appropriate equipment (for example liquid pump) for disposal. Never return spills in original containers for re-use. Keep away from flammable and incompatible substances. Rinse away any residue with plenty of water. Dispose of absorbed material in accordance with the applicable environmental regulations. Small spillage: Dilute product with lots of water and rinse away or absorb with liquid-binding material (for example diatomaceous earth or universal binder). Pick up mechanically and collect in suitable containers. Clean contaminated surface thoroughly. Pack and label wastes like the product. Do not detach label from the delivery containers prior to disposal. 5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer depending on local requirements. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Advice on protection against fire and explosion Store away from direct sunlight and heat sources. Store away from sources of ignition - No smoking. Store away from flammable substances. Store away from incompatible substances. Storage Temperature requirement- during storage maximum 40 °C and protect from frost. Store in clean, dry and well- ventilated places. Transport and store container in upright position only. Always close container tightly after removal of product. Avoid leakage and residues of the product on the containers. 8/9 ELI: http://data.europa.eu/eli/reg_impl/2025/1887/ojEN OJ L, 18.9.2025 Advice on common storage Do not store together with alkalis, reductants, metallic salts (risk of decomposition). Do not store together with organic solvents (risk of explosion). Shelf-life 24 months 6. OTHER INFORMATION The full titles of the EN standards referenced in the “Use-specific mitigation measures” sections are: EN 16321 - Eye and face protection for occupational users EN 374 – Protective gloves against chemicals and micro-organisms The Council Directive referenced in the “Use-specific mitigation measures” sections is: Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998[RMJ1], p.11). ELI: http://data.europa.eu/eli/reg_impl/2025/1887/oj 9/9