Commission Implementing Regulation (EU) 2025/1019 of 26 May 2025 granting a Union authorisation for the biocidal product family Lactic Acid Teatdip Products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

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 26 April 2019, GEA Farm Technologies GmbH 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 ‘Lactic Acid Teatdip Products’ of product-type 3 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-KN051277-28 in the Register for Biocidal Products.

• (2) ‘Lactic Acid Teatdip Products’ contains L-(+)-lactic acid 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-type 3.

• (3) On 19 March 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 10 October 2024, the Agency submitted to the Commission its opinion ², the draft summary of the biocidal product characteristics (‘SPC’) of ‘Lactic Acid Teatdip 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 ‘Lactic Acid Teatdip 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 25 October 2024, 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 ‘Lactic Acid Teatdip 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-0033409-0000 is hereby granted to GEA Farm Technologies GmbH for the making available on the market and use of the biocidal product family ‘Lactic Acid Teatdip Products’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 16 June 2025 until 31 May 2035.

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, 26 May 2025.

For the Commission

The President

Ursula VON DER LEYEN

ANNEX

Summary of product characteristics for a biocidal product family

Lactic Acid Teatdip Products

Product type(s)

PT03: Veterinary hygiene

Authorisation number EU-0033409-0000

R4BP asset number EU-0033409-0000

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 # 2.8 – RTU Products – Professional RTU Liquid, for application post-milking – Automated in-liner dipping

4.1.1.   Use-specific instructions

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animals standing at least 5 minutes).

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 # 2.9 – RTU Products – Professional RTU Liquid, for application post milking – via automatic spray system

4.2.1.   Use-specific instructions

Cover at least 2/3 of the teat length by automatically spraying RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animals standing at least 5 minutes).

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 1

5.1.   Instructions for use

Ready to use product

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

Product can be used during the entire lactation period

5.2.   Risk mitigation measures

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.

During mixing and loading: Wear protective gloves consistent with the European Standard EN 374 or equivalent and safety glasses with side shield or face protection consistent with the European Standard EN 166 or equivalent.

See section 6 for the full reference to this act and the European Standards

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

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.

Large Spills: Contain and collect for disposal. Large spills should 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 wastewater treatment plant to prevent malfunctioning.

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

Protect from frost.

Store in a cool dry place away from direct sunlight.

Shelf life 12 months.

6. OTHER INFORMATION

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. 11–23 ELI: http://data.europa.eu/eli/dir/1998/24/oj

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

EN 166 – Eye protection against chemicals

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 1

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

ELI: http://data.europa.eu/eli/reg_impl/2025/1019/oj

ISSN 1977-0677 (electronic edition)