Commission Implementing Regulation (EU) 2026/891 of 23 April 2026 granting a Union authorisation for the biocidal product family Hydrogen Peroxide Products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

of 23 April 2026

granting a Union authorisation for the biocidal product family ‘Hydrogen Peroxide Products’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(Text with EEA relevance)

Preamble

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 14 February 2017, GEA Farm Technologies submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Hydrogen Peroxide Products’ of product-types 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-KD029460-57 in the Register for Biocidal Products.

(2) ‘Hydrogen Peroxide Products’ 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 3 and 4.

(3) On 13 November 2024, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

(4) On 5 June 2025, the Agency submitted to the Commission its opinion ² , the draft summary of the biocidal product characteristics (‘SPC’) of ‘Hydrogen Peroxide Products’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ‘Hydrogen Peroxide Products’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(6) of that Regulation.

(6) On 23 June 2025, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘Hydrogen Peroxide Products’.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0035038-0000 is hereby granted to GEA Farm Technologies for the making available on the market and use of the biocidal product family ‘Hydrogen Peroxide Products’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 14 May 2026 until 30 April 2036.

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 .

Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 23 April 2026. 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 Opinion of 15 May 2025 on the Union authorisation of the biocidal product family ‘Hydrogen Peroxide Products’ (ECHA/BPC/479/2025), https://echa.europa.eu/opinions-on-union-authorisation .

Hydrogen Peroxide Products

Product type(s)

PT03: Veterinary hygiene

PT04: Food and feed area

Authorisation number EU-0035038-0000

R4BP asset number EU-0035038-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name

1.2. Product type(s)

1.3. Authorisation holder

1.4. Manufacturer(s) of the product

1.5. Manufacturer(s) of the active substance(s)

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1. Qualitative and quantitative information on the composition of the family

2.2. Type(s) of formulation

PART II

SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier

1.2. Suffix to the authorisation number

1.3. Product type(s)

2. META SPC 1 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 1

2.2. Type(s) of formulation of the meta SPC 1

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description

Table 1

Use # 1.1 – RTU Products – Professional RTU Liquid, for application pre milking – teat spraying

4.1.1. Use-specific instructions for use

Before attaching the milking cluster, all teat-dip residues shall be removed from teats with either a single use towel or re-usable cloth. One cloth shall be used per animal.

The product must be brought to a temperature above 20°C before use.

Always read the label or leaflet before use and follow all the instructions provided.

Product can be used during the entire lactation period.

4.1.2. Use-specific risk mitigation measures

See General directions for use

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

See General directions for use

4.1.4. Where specific to the use, the 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

See General directions for use

4.2. Use description

Table 2

Use # 1.2 – RTU Products – Professional RTU Liquid, for application pre milking –teat foaming

4.2.1. Use-specific instructions for use

Before attaching the milking cluster, all teat-dip residues shall be removed from teats with either a single use towel or re-usable cloth. One cloth shall be used per animal.

The product must be brought to a temperature above 20°C before use.

Cups shall be refilled with fresh solution before starting new milking session.

Dispose of unused product after each milking session.

Always read the label or leaflet before use and follow all the instructions provided.

Product can be used during the entire lactation period.

4.2.2. Use-specific risk mitigation measures

See General directions for use

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

See General directions for use

4.2.4. Where specific to the use, the 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

See General directions for use

4.3. Use description

Table 3

Use # 1.3 – RTU Products – Professional RTU Liquid, for application pre milking – teat dipping

4.3.1. Use-specific instructions for use

Before attaching the milking cluster, all teat-dip residues shall be removed from teats with either a single use towel or re-usable cloth. One cloth shall be used per animal.

The product must be brought to a temperature above 20°C before use.

Dispose of unused product after each milking session.

Always read the label or leaflet before use and follow all the instructions provided.

Product can be used during the entire lactation period.

4.3.2. Use-specific risk mitigation measures

See General directions for use

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

See General directions for use

4.3.4. Where specific to the use, the 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

See General directions for use

4.4. Use description

Table 4

Use # 1.4 – RTU Products – Professional RTU Liquid, for application pre milking – teat dipping via automated In-liner dipping

4.4.1. Use-specific instructions for use

The product must be brought to a temperature above 20°C before use.

Always read the label or leaflet before use and follow all the instructions provided.

Product can be used during the entire lactation period.

4.4.2. Use-specific risk mitigation measures

See General directions for use

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

See General directions for use

4.4.4. Where specific to the use, the 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

See General directions for use

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1. Instructions for use

See Use specific instructions

5.2. Risk mitigation measures

See Use specific instructions

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Remove and wash contaminated clothing before re-use.

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.

IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.

Large spills shall be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.

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 the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual farm based waste water treatment plant.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 12 months. Do not store above 40°C. Protect from frost and direct sunlight. Keep container tightly closed and do not store together with animal feedstuffs.

6. OTHER INFORMATION

Please be aware of the European reference value of 1,25 mg/m 3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product (please be aware that relevant lower national limit values may apply).

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1. Trade name(s), authorisation number and specific composition of each individual product

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 2 identifier

1.2. Suffix to the authorisation number

1.3. Product type(s)

2. META SPC 2 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 2

2.2. Type(s) of formulation of the meta SPC 2

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description

Table 1

Use # 3.5 – Disinfection and cleaning of inner surfaces in milking machine pipelines by circulation: concentrate

4.1.1. Use-specific instructions for use

Pre-rinse with hand-warm (max 35°C) water.

The product is drawn from its drum via a suction tube into a dilution tank of water. The diluted material is then circulated around the pipe lines. It will be used at a minimum of 50°C (the temperature of water starts at 70-80°C and cools as circulation occurs) and circulated for a minimum of 10 minutes). Rinse off with potable water.

Concentration: product dilution is 0,5% v/v.

Contact time: 10 min.

Circulate for 10 minutes with a 0,5% v/v product dilution in water. The water temperature shall be >50°C at the end of the treatment.

Rinse with cold drinking water.

Always read the label or leaflet before use and follow all the instructions provided.

4.1.2. Use-specific risk mitigation measures

See General directions for use

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

See General directions for use

4.1.4. Where specific to the use, the 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

See General directions for use

4.2. Use description

Table 2

Use # 3.6 – Disinfection and cleaning of milk storage tanks by Circulation: concentrate

4.2.1. Use-specific instructions for use

Pre-rinse with hand-warm (max. 35°C) water.

The product is drawn from its drum via a suction tube into a dilution tank of water. The diluted material is then circulated around the milk storage tanks. It will be used at a minimum of 50°C (the temperature of water starts at 70-80°C and cools as circulation occurs) and circulated for a minimum of 10 minutes). Rinse off with potable water.

Concentration: product dilution is 0,5% v/v.

Contact time: 10 minutes

Circulate for 10 minutes with a 0,5% v/v dilution in water. The water temperature shall be >50°C at the end of the treatment.

Rinse with cold drinking water

Always read the label or leaflet before use and follow all the instructions provided.

4.2.2. Use-specific risk mitigation measures

See General directions for use

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

See General directions for use

4.2.4. Where specific to the use, the 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

See General directions for use

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1. Instructions for use

See Use specific instructions

5.2. Risk mitigation measures

When connecting and disconnecting tubes and during mixing and loading:

— Use of respiratory protective equipment (RPE) according to EN 405 or similar is mandatory.

— Wear gloves according to EN374 or similar (glove material to be specified by the authorisation holder within the product information).

— Wear chemical goggles according to EN166 or similar.

— Wear a protective coverall (at least type 3 or 4, EN 14605 ) which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).

This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.

Product is automatically dosed into the water tank via a suction tube. The diluted material is then circulated around the milking parlour or bulk tank before being discharged to waste water

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Effects:

Causes severe skin burns and eye damage.

Ingestion of aqueous solution causes gastrointestinal burns.

Hazard of gastric perforation.

First aid:

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.

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.

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. Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.

Emergency measures environment:

Do not discharge into the drains/surface waters/ground water.

Cleaning: Take up with absorbent material (e.g. kieselguhr). Shovel into suitable container for disposal.

Avoid release to the environment.

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 the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual farm based waste water treatment plant.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 12 months. Do not store above 25°C.Protect from frost and direct sunlight. Keep container tightly closed and do not store together with animal feedstuffs.

6. OTHER INFORMATION

Please be aware of the European reference value of 1,25 mg/m 3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for the biocidal product (please be aware that relevant lower national limit values may apply).

The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.

EN 166 – Eye protection against chemicals

EN 374 – Protective gloves against dangerous chemicals and micro-organisms

EN 405 - Respiratory protective devices - Valved filtering half masks to protect against gases or gases and particles - Requirements, testing, marking

EN14605 - Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

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, p. 11 ).

With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1. Trade name(s), authorisation number and specific composition of each individual product

Footnotes

1. , ELI: . ↩ ↩²

2. Opinion of 15 May 2025 on the Union authorisation of the biocidal product family ‘Hydrogen Peroxide Products’ (ECHA/BPC/479/2025), . ↩ ↩²