Commission Implementing Regulation (EU) 2025/474 of 13 March 2025 granting a Union authorisation for the single biocidal product Büfa-Oxy WS in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
A Union authorisation with authorisation number EU-0033025-0000 is hereby granted to BÜFA Cleaning GmbH & Co. KG for the making available on the market and use of the same single biocidal product ‘Büfa-Oxy WS’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 6 April 2025 until 31 October 2033.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX Summary of product characteristics for a biocidal product Büfa-Oxy WS Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Authorisation number: EU-0033025-0000 R4BP asset number: EU-0033025-0000 1. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s) Büfa-Oxy WS O 33 1.2. Authorisation holder Name and address of the authorisation holder Name BÜFA Cleaning GmbH & Co. KG Address August-Hanken-Straße 30 26125 Oldenburg DE Authorisation number EU-0033025-0000 R4BP asset number EU-0033025-0000 Date of the authorisation 6 April 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 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 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 peroxide active substance 7722-84-1 231-765-0 35 % (w/w) 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. 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 stage) Common name: bacteria 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 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 20m 3 4.1.1. Use-specific instructions 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. 4.2. Use description Table 2 Disinfection of distribution system for drinking water by cleaning in place (CIP) Product type PT04: Food and feed area Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Disinfection of distributing and storing installations for drinking water. Application method(s) Method: CIP (Cleaning in place) in closed systems Detailed description: Disinfecting the interior surfaces of closed systems by CIP Application rate(s) and frequency Application rate: 4,7 % (w/w ) hydrogen peroxide For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7% (w/w) hydrogen peroxide. For example, in the case of a product containing 35% (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7% (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 3 hours Frequency: Daily / if required Temperature: room temperature 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 20m 3 4.2.1. Use-specific instructions CIP (Cleaning in place): Clean prior to disinfection. Circulate the diluted product through the system under conditions of increased turbulence and flow velocity. After 3 hours contact time, pipelines and tanks are rinsed with water before refilled with drinking water. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7% (w/w) hydrogen peroxide. For example, for a product containing 35% (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7% (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. 4.2.2. 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. See section 6 for the full titles of the EN standards. Glove and coverall material to be specified by the authorisation holder within the product information. 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. 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.2.4. 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. 4.2.5. 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. 4.3. Use description Table 3 Disinfection of non-porous hard surfaces and equipment by immersion Product type PT04: Food and feed area Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Equipment in both food and drink industries, large scale catering kitchens and large scale canteens. Application method(s) Method: Open system: immersion Detailed description: Manual immersion of equipment in closed baths. Automated immersion of equipment in closed baths. Application rate(s) and frequency Application rate: 8,1% (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 8,1% (w/w) hydrogen peroxide. For example, for a product containing 35% (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1% (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: 60 minutes Frequency: Daily / if required Temperature: room temperature 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 20m 3 4.3.1. Use-specific instructions For disinfection of bacteria yeasts and fungi the product should be diluted to 8,1% (w/w) hydrogen peroxide. For example, for a product containing 35% (w/w) hydrogen peroxide: add 200 ml product to 738 ml water to achieve a dilution of 8,1% (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Immersion: Equipment in the food and feed industry is disinfected by immersion. Pre-clean the equipment. The disinfection solution should be diluted into vats (i.e. pouring or pumping the product into vats). The equipment to be disinfected is manually or automatically placed into these vats (closed baths) and taken out after a contact time of not less than 60 minutes. After the disinfection procedure is completed, equipment is rinsed with water. The disinfection of the immersion/dipping bath should be replaced after each disinfection cycle. 4.3.2. 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 and application. 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. No access to the room is permitted during disinfection without wearing adequate PPE and RPE as described above. Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Dipping bath has to be placed in a separate room. For use only in areas inaccessible to the general public. Professional users without PPE and RPE (APF=10) are not allowed to enter the disinfection room. Keep the bath closed during disinfection, only open to load and discharge. Observe label instructions. 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 No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.3.4. 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. 4.3.5. 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. 4.4. Use description Table 4 Disinfection of surfaces by cleaning in place (CIP) Product type PT04: Food and feed area Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Common name: bacteria Development stage: - Common name: yeasts Development stage: - Common name: fungi Development stage: - Field(s) of use indoor use Disinfection of food contact inner surfaces of pipe work and tank systems in food and feed industry. Application method(s) Method: CIP in closed systems Detailed description: Disinfecting the interior surfaces of closed systems by Cleaning In Place (CIP). Application rate(s) and frequency Application rate: 4,7% (w/w) hydrogen peroxide. For disinfection of bacteria, yeasts and fungi the product should be diluted to 4,7% (w/w) hydrogen peroxide. For example, for a product containing 35% (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7% (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. Number and timing of application: Contact time: at least 3 hours Frequency: Daily / if required Temperature: room temperature 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 20m 3 4.4.1. Use-specific instructions Clean prior to disinfection. The inner surfaces of pipe work and tank systems are disinfected by CIP process. For disinfection of bacteria yeasts and fungi the product should be diluted to 4,7% (w/w) hydrogen peroxide. For example, for a product containing 35% (w/w) hydrogen peroxide: add 114 ml product to 819 ml water to achieve a dilution of 4,7% (w/w) hydrogen peroxide. For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly. The process is carried out by circulating the disinfection solution through the system under conditions of increased turbulence and flow velocity. The application is automated and a closed process. After 3 hours contact time, pipelines and tanks are rinsed with water under closed system conditions as well. 4.4.2. 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. See section 6 for the full titles of the EN standards. Glove and coverall material to be specified by the authorisation holder within the product information. 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. 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment No use specific first aid instructions and emergency measures to protect the environment. See general directions for use. 4.4.4. 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. 4.4.5. 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. 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. 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). ( 1 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
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