Commission Implementing Regulation (EU) 2025/474 of 13 March 2025 granting a Unio... (32025R0474)
    EU - Rechtsakte: 13 Industrial policy and internal market
    2025/474
    17.3.2025

    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)

    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 29 April 2024, BÜFA Cleaning GmbH & Co. KG 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 product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘Büfa-Oxy WS’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. 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 was recorded under case number BC-AN094539-21 in the Register for Biocidal Products. 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 ‘Büfa-Oxy WS’ 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-types 2 and 4.
    (3) On 29 July 2024, the Agency submitted to the Commission its opinion (4) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Büfa-Oxy WS’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013 and Article 44(4) of Regulation (EU) No 528/2012.
    (4) In its opinion, the Agency concludes that the proposed differences between the single biocidal product ‘Büfa-Oxy WS’ and the related single 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 ‘Büfa-Oxy WS’ meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.
    (5) 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 ‘Büfa-Oxy WS’.
    (6) 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’.
    (7) 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-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.

    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, 13 March 2025.
    For the Commission
    The President
    Ursula VON DER LEYEN
    (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 29 July 2024 on the Union authorisation of the same single biocidal product ‘Büfa-Oxy WS’,
    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
    ).

    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 20m3

    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 20m3

    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 20m3

    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 20m3

    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.
    ELI: http://data.europa.eu/eli/reg_impl/2025/474/oj
    ISSN 1977-0677 (electronic edition)
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