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
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product
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 |
|
Name of manufacturer |
Evonik Operations GmbH |
||
Address of manufacturer |
Rellinghauser Straße 1-11 45128 Essen Germany |
||
Location of manufacturing sites |
|
Name of manufacturer |
Evonik Peroxid GmbH |
||
Address of manufacturer |
Industriestraße 1 9721 Weißenstein Austria |
||
Location of manufacturing sites |
|
Name of manufacturer |
Evonik Peroxide Netherlands BV |
||
Address of manufacturer |
Hettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands (the) |
||
Location of manufacturing sites |
|
Name of manufacturer |
Evonik España y Portugal SA |
||
Address of manufacturer |
Afueras s/n 50784 La Zaida Spain |
||
Location of manufacturing sites |
|
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 |
|
Active substance |
Hydrogen peroxide |
||
Name of manufacturer |
Evonik Operations GmbH |
||
Address of manufacturer |
Rellinghauser Straße 1-11 45128 Essen Germany |
||
Location of manufacturing sites |
|
Active substance |
Hydrogen peroxide |
||
Name of manufacturer |
Evonik Peroxid GmbH |
||
Address of manufacturer |
Industriestraße 1 9721 Weißenstein Austria |
||
Location of manufacturing sites |
|
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 |
|
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 |
|
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
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
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 20m3 |
4.1.1.
Use-specific instructions
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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 20m3 |
4.2.1.
Use-specific instructions
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.3.
Use description
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 20m3 |
4.3.1.
Use-specific instructions
4.3.2.
Use-specific risk mitigation measures
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
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
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 20m3 |