2025/1171

17.6.2025

COMMISSION IMPLEMENTING REGULATION (EU) 2025/1171

of 16 June 2025

granting a Union authorisation for the biocidal product family ‘PRODHYNET’s Lactic acid based products’ 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 26 April 2019, PRODHYNET SA 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 biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘PRODHYNET's Lactic acid based products’, of product-type 3, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-XX051283-02 in the Register for Biocidal Products. The application also indicated the case number of the related reference biocidal product family ‘Kersia’s Lactic acid based products’ later authorised by Commission Implementing Regulation (EU) 2024/2188 (3), with authorisation number EU-0031195-0000.

(2) The biocidal product family ‘PRODHYNET's Lactic acid based 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 24 April 2024, the Agency submitted to the Commission its opinion (4) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘PRODHYNET's Lactic acid based products’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.

(4) In its opinion, the Agency concludes that the proposed differences between the biocidal product family ‘PRODHYNET’s Lactic acid based products’ and the related reference biocidal product family ‘Kersia’s Lactic acid based products’, 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 ‘Kersia’s Lactic acid based products’ and subject to compliance with the draft SPC, the same biocidal product family ‘PRODHYNET’s Lactic acid based products’ meets the conditions laid down in Article 19(6) of Regulation (EU) No 528/2012.

(5) On 22 May 2024, the Agency also transmitted to the Commission the draft SPC of ‘PRODHYNET’s Lactic acid based products’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(6) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family ‘PRODHYNET’s Lactic acid based products’.

(7) The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family ‘Kersia’s Lactic acid based 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-0033504-0000 is hereby granted to PRODHYNET SA for the making available on the market and use of the same biocidal product family ‘PRODHYNET’s Lactic acid based products’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 7 July 2025 until 31 August 2034.

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, 16 June 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) 2024/2188 of 3 September 2024 granting a Union authorisation for the biocidal product family ‘Kersia’s Lactic acid based products’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (

OJ L, 2024/2188, 4.9.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2188/oj

).

(4)  European Chemicals Agency opinion of 24 April 2024 on the Union authorisation of the same biocidal product family ‘PRODHYNET's Lactic acid based products’, UBP-C-1719023-18-00/F,

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 family

PRODHYNET’s Lactic acid based products

Product type(s)

PT03: Veterinary hygiene

Authorisation number

EU-0032621-0000

R4BP asset number

EU-0032621-0000

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

Disinfection of teats of milk producing animals by manual or automated dipping, foaming or spraying after milking

4.1.1.   

Use-specific instructions

See general directions for use of meta SPC 1

4.1.2.   

Use-specific risk mitigation measures

See general directions for use of meta SPC 1

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 of meta SPC 1

4.1.4.   

Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1

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 of meta SPC 1

5.   

GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   

Instructions for use

Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Manual or automatic dipping/foaming/spraying on animal’s teats on the full length of the teat after milking.

Make sure that the teats are fully covered with disinfectant.

Leave the product until next milking.

Keep the animals standing for at least 5 minutes until the product has dried.

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

Avoid contact with eyes.

Wash hands after work.

Product must be brought to a temperature between 20°C and 30°C before use.

5.2.   

Risk mitigation measures

Wear chemical goggles or face protection consistent with European Standard EN ISO 16321 or equivalent.

For manual application by spraying: Wear protective chemical resistant gloves consistent with European Standard EN ISO 374 during product handling phase.

Keep out of reach of children.

5.3.   

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

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

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, soak up with an inert absorbant and pump in an emergency tank. Never return spills in original containers for re-use. Keep in suitable, properly labelled and closed containers for disposal.

5.4.   

Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose 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 waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal domestic waste.

5.5.   

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

Shelf life: 2 years in HDPE

6.   

OTHER INFORMATION

Full titles of EN standards and legislation referred to in section 5.2:

 

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

 

EN ISO 16321 – Eye and face protection for occupational use.

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

Disinfection of teats of milk producing animals by manual or automated dipping after milking

4.1.1.   

Use-specific instructions

See general directions for use of meta SPC 2

4.1.2.   

Use-specific risk mitigation measures

See general directions for use of meta SPC 2

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 of meta SPC 2

4.1.4.   

Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2

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 of meta SPC 2

5.   

GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   

Instructions for use

Fill the dipping cup manually or automatically with the ready to use product.

Apply by dipping manually or automatically on animal’s teats on the full length of the teat after milking.

Make sure that the teats are fully covered with disinfectant.

Leave the product until next milking. Keep the animals standing for at least 5 minutes until the product has dried.

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

Avoid contact with eyes.

Wash hands after work.

Product must be brought to a temperature between 20°C and 30°C before use.

5.2.   

Risk mitigation measures

Wear chemical goggles or face protection consistent with European Standard EN ISO 16321 or equivalent.

Keep out of reach of children.

5.3.   

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

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

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, soak up with an inert absorbant and pump in an emergency tank. Never return spills in original containers for re-use. Keep in suitable, properly labelled and closed containers for disposal.

5.4.   

Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose 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 waste water treatment plant.

The paper towels used for removing the product and drying the teats are disposed in the normal domestic waste.

5.5.   

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

Shelf life: 2 years in HDPE

Store below 30°C

6.   

OTHER INFORMATION

Full titles of EN standards and legislation referred to in section 5.2:

EN ISO 16321 – Eye and face protection for occupational use.

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

ELI: http://data.europa.eu/eli/reg_impl/2025/1171/oj

ISSN 1977-0677 (electronic edition)