2024/2188

4.9.2024

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

(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, HYPRED SAS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named ‘Kersia’s Lactic acid based 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-CH051281-59 in the Register for Biocidal Products.

(2) ‘Kersia’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 30 November 2022, 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 30 June 2023, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Kersia’s Lactic acid based 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 ‘Kersia’s Lactic acid based 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(1) and (6) of that Regulation. The opinion does not recommend the authorisation of the use of the products as teat disinfectants applied prior to milking, due to an exceedance of the acceptable daily intake of a co-formulant contained in all products of the biocidal product family ‘Kersia’s Lactic acid based products’.

(6) On 13 July 2023, 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 ‘Kersia’s Lactic acid based products’ in accordance with the recommendations in that opinion.

(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-0031195-0000 is hereby granted to HYPRED SAS for the making available on the market and use of the biocidal product family ‘Kersia’s Lactic acid based products’ subject to compliance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 24 September 2024 to 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, 3 September 2024.

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 the Biocidal Products Committee of 6 June 2023 on the Union authorisation of ‘Kersia’s Lactic acid based products’ (ECHA/BPC/381/2023),

https://echa.europa.eu/opinions-on-union-authorisation

ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

Kersia’s Lactic acid based products

Product type(s)

: PT03: Veterinary hygiene

Authorisation number

: EU-0031195-0000

R4BP asset number

: EU-0031195-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name

Name	Kersia’s Lactic acid based products

1.2. Product type(s)

PT03: Veterinary hygiene

1.3. Authorisation holder

Name and address of the authorisation holder	Name	HYPRED SAS
Name and address of the authorisation holder	Address	55, boulevard Jules Verger 35803 DINARD FR
Authorisation number		EU-0031195-0000
R4BP asset number		EU-0031195-0000
Date of the authorisation		24 September 2024
Expiry date of the authorisation		31 August 2034

1.4. Manufacturer(s) of the product

Name of manufacturer

HYPRED SAS - KERSIA Group

Address of manufacturer

55, Boulevard Jules Verger BP10180 35803 DINARD France

Location of manufacturing sites

HYPRED SAS - KERSIA Group 55, Boulevard Jules Verger; BP 10180 35803 DINARD Cedex France

HYPRED SAS - KERSIA Group Zone Industrielle Le Roineau 72500 VAAS France

Medentech Ltd – KERSIA Group Clonard Road Y35Y7WY WEXFORD Ireland

SOPURA – KERSIA Group Parc Paysager de Tyberchamps 14 7180 SENEFFE Belgium

KERSIA DEUTSCHLAND GmbH Marie-Curie-Straße 23 53332 BORNHEIM – SECHTEM Germany

Holchem Laboratories Ltd – KERSIA Group Gateway House, Pilsworth Road, Pilsworth Industrial Estate BL9 8RD Bury United Kingdom of Great Britain and Northern Ireland (the)

KERSIA AUSTRIA GmbH PFONGAUERSTRAßE 17 5202 NEUMARKT AM WALLERSEE Austria

KERSIA POLSKA Sp.z.o.o Niepruszewo, ul. Kasztanowa 4 64-320 BUK Poland

KERSIA ITALIA S.r.l Strada Montodine – Gombito; Loc. Cà Nova 26010 RIPALTA ARPINA (CR) Italy

KERSIA IBERICA SL Pol. Miguel Eguía C/Zarapuz s/n 31200 ESTELLA (NAVARRA) Spain

Kilco Holdings Ltd – KERSIA Group Broomhouses 2 Industrial Estate; Old Glasgow Road DG11 2SD LOCKERBIE United Kingdom of Great Britain and Northern Ireland (the)

Kilco (International) Ltd – KERSIA Group 1A Trench Road Mallusk; Newtownabbey BT36 4TY CO ANTRIM Ireland

SOPURA Quimica – KERSIA Group Pol. Ind. “La Canaleta“; Avinguda Júpiter n° 7 25300 TARREGA (LLEIDA) Spain

KERSIA DEUTSCHLAND GmbH Oberbrühlstraße 16-18 87700 Memmingen Germany

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

Active substance	L-(+)-lactic acid
Name of manufacturer	PURAC Bioquimica SA
Address of manufacturer	Gran Vial 19-25 8160 Montmelo - Barcelona Spain
Location of manufacturing sites	PURAC Bioquimica SA Gran Vial 19-25 8160 Montmelo - Barcelona Spain PURAC BIOCHEM BV Arkelsedijk 46 4206 AC Gorinchem Netherlands (the) Purac Sínteses Ltda Av. Rui Barbosa, 521 CEP 28015-520 Campos dos Goytacazes - RJ Brazil Purac America Inc. 650 Industrial Park Drive, P.O. Box 38 NE 68008 Blair United States (the) Purac (Corbion) Thailand Ltd Tambol Huay Pong, Amphoe Muang 21150 Rayong Thailand

Active substance	L-(+)-lactic acid
Name of manufacturer	Jungbunzlauer S.A.
Address of manufacturer	Z.I. Portuaire BP 32 67390 Marckolsheim France
Location of manufacturing sites	Z.I. Portuaire BP 32 67390 Marckolsheim France

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
L-(+)-lactic acid		active substance	79-33-4	201-196-2	8,4 - 8,4 % (w/w)
Sodium p-cumenesulphonate		Non-active substance	15763-76-5	239-854-6	1,32 - 1,32 % (w/w)
Sodium 2-ethylhexyl sulfate		Non-active substance	126-92-1	204-812-8	0 - 2,1 % (w/w)
Diethanolamine		Non-active substance	111-42-2	203-868-0	3,92 - 4,234 % (w/w)

2.2. Type(s) of formulation

Formulation type(s)

AL Any other liquid

PART II

SECOND INFORMATION LEVEL - META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier

Identifier

Meta SPC: meta SPC 1 - Dipping, foaming, spraying ready to use products

1.2. Suffix to the authorisation number

Number

1-1

1.3. Product type(s)

PT03: Veterinary hygiene

2. META SPC 1 COMPOSITION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
L-(+)-lactic acid		active substance	79-33-4	201-196-2	8,4 - 8,4 % (w/w)
Sodium p-cumenesulphonate		Non-active substance	15763-76-5	239-854-6	1,32 - 1,32 % (w/w)
Diethanolamine		Non-active substance	111-42-2	203-868-0	4,234 - 4,234 % (w/w)

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

Formulation type(s)

AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

H319: Causes serious eye irritation.

Precautionary statements

P264: Wash hands thoroughly after handling.

P280: Wear eye protection.

P280: Wear face protection.

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P337+P313: If eye irritation persists: Get medical attention.

P337+P313: If eye irritation persists: Get medical advice.

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

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data
Field(s) of use	indoor use Manual or automated disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Method: Dipping, foaming or spraying Detailed description: Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine.
Application rate(s) and frequency	Application rate: application rate per animal: - cows and buffaloes 3 to 10 ml (5 to 8 ml recommended) - sheep 1,5 to 5 ml (1,5 to 3 ml recommended) - goats 2,5 to 6 ml (2,5 to 4 ml recommended) Dilution (%): Ready to use product Number and timing of application: Contact time : 5 minutes Frequency: 2 to 3 times per day
Category(ies) of users	professional
Pack sizes and packaging material	HDPE (High Density Polyethylene) jerrycans 5, 10, 22, 25 and 30 litre HDPE barrel 60 litre HDPE drums 120 and 220 litre HDPE container 640 and 1000 litre