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

ANNEX
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.
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

Schedules & Appendices

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