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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

Commission Implementing Regulation (EU) 2024/2188of 3 September 2024granting 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 productsOJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj., 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 opinionOpinion 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., 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 1A 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 2This 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 CommissionThe PresidentUrsula von der LeyenANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILYKersia’s Lactic acid based productsProduct type(s)PT03: Veterinary hygieneAuthorisation numberEU-0031195-0000R4BP asset numberEU-0031195-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.Family name

Name	Kersia’s Lactic acid based products

1.2.Product type(s)

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 FranceHYPRED SAS - KERSIA Group Zone Industrielle Le Roineau 72500 VAAS FranceMedentech Ltd – KERSIA Group Clonard Road Y35Y7WY WEXFORD IrelandSOPURA – KERSIA Group Parc Paysager de Tyberchamps 14 7180 SENEFFE BelgiumKERSIA DEUTSCHLAND GmbH Marie-Curie-Straße 23 53332 BORNHEIM – SECHTEM GermanyHolchem 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 AustriaKERSIA POLSKA Sp.z.o.o Niepruszewo, ul. Kasztanowa 4 64-320 BUK PolandKERSIA ITALIA S.r.l Strada Montodine – Gombito; Loc. Cà Nova 26010 RIPALTA ARPINA (CR) ItalyKERSIA IBERICA SL Pol. Miguel Eguía C/Zarapuz s/n 31200 ESTELLA (NAVARRA) SpainKilco 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 IrelandSOPURA Quimica – KERSIA Group Pol. Ind. "La Canaleta"; Avinguda Júpiter n° 7 25300 TARREGA (LLEIDA) SpainKERSIA 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 SpainPURAC BIOCHEM BV Arkelsedijk 46 4206 AC Gorinchem Netherlands (the)Purac Sínteses Ltda Av. Rui Barbosa, 521 CEP 28015-520 Campos dos Goytacazes - RJ BrazilPurac 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 FORMULATION2.1.Qualitative and quantitative information on the composition of the family

Common 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 IISECOND INFORMATION LEVEL - META SPC(S)1.META SPC 1 ADMINISTRATIVE INFORMATION1.1.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)

Product type(s)

PT03: Veterinary hygiene

2.META SPC 1 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 1

Common 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 SPC4.1.Use description

Table 1Disinfection 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 dataCommon name: BacteriaDevelopment stage: no dataScientific name: no dataCommon name: YeastsDevelopment stage: no data
Field(s) of use	indoor useManual or automated disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Method: Dipping, foaming or sprayingDetailed 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 productNumber and timing of application:Contact time : 5 minutesFrequency: 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 litreHDPE barrel 60 litreHDPE drums 120 and 220 litreHDPE container 640 and 1000 litre

4.1.1.Use-specific instructionsSee general directions for use of meta SPC 14.1.2.Use-specific risk mitigation measuresSee general directions for use of meta SPC 14.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use of meta SPC 14.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 14.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 15.GENERAL DIRECTIONS FOR USE OF THE META SPC 15.1.Instructions for useFill 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 measuresWear 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 environmentIF 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 packagingAt 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 storageShelf life: 2 years in HDPE6.OTHER INFORMATIONFull 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 17.1.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)			NATIDINE		Market area: EU
			Bonimal H Lactiliquid		Market area: EU
			LACTILIQ		Market area: EU
			MilchsäureDip-Spray		Market area: EU
			NATILAC		Market area: EU
			PRIMAMO		Market area: EU
			RBT LACTIC		Market area: EU
			ROBOSPRAY LACTIC		Market area: EU
			SPRAYLAC		Market area: EU
			Bonimal CARE LactiLiquid		Market area: EU
Authorisation number					EU-0031195-0001 1-1
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
L-(+)-lactic acid		active substance		79-33-4		201-196-2	8,4
Sodium p-cumenesulphonate		Non-active substance		15763-76-5		239-854-6	1,32
Diethanolamine		Non-active substance		111-42-2		203-868-0	4,234

1.META SPC 2 ADMINISTRATIVE INFORMATION1.1.Meta SPC 2 identifier

Identifier

Meta SPC: meta SPC 2 - Dipping ready to use products

1.2.Suffix to the authorisation number

Number

1-2

1.3.Product type(s)

Product type(s)

PT03: Veterinary hygiene

2.META SPC 2 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 2

Common 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 - 3,92 % (w/w)

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

Formulation type(s)

AL Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

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 SPC4.1.Use description

Table 1Disinfection of teats of milk producing animals by manual or automated dipping 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 dataCommon name: BacteriaDevelopment stage: no dataScientific name: no dataCommon name: YeastsDevelopment stage: no data
Field(s) of use	indoor useManual or automated disinfection of teats of milk producing animals by dipping after milking
Application method(s)	Method: DippingDetailed description: Dipping cup or automated dipping machine.
Application rate(s) and frequency	Application rate: application rate per animal: - cows and buffaloes 3 to 10 ml (5 ml recommended) - sheep 1,5 to 5 ml (1,5 ml recommended) - goats 2,5 to 6 ml (2,5 ml recommended)Dilution (%): Ready to use productNumber and timing of application:Contact time : 5 minutesFrequency: 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 litreHDPE barrel 60 litreHDPE drums 120 and 220 litreHDPE container 640 and 1000 litre

4.1.1.Use-specific instructionsSee general directions for use of meta SPC 24.1.2.Use-specific risk mitigation measuresSee general directions for use of meta SPC 24.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use of meta SPC 24.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 24.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 25.GENERAL DIRECTIONS FOR USE OF THE META SPC 25.1.Instructions for useFill 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 measuresWear 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 environmentIF 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 packagingAt 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 storageShelf life: 2 years in HDPEStore below 30°C6.OTHER INFORMATIONFull 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 27.1.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)			FILMADINE LL		Market area: EU
Authorisation number					EU-0031195-0002 1-2
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
L-(+)-lactic acid		active substance		79-33-4		201-196-2	8,4
Sodium p-cumenesulphonate		Non-active substance		15763-76-5		239-854-6	1,32
Diethanolamine		Non-active substance		111-42-2		203-868-0	3,92

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

Trade name(s)			FILMADINE LC		Market area: EU
			FILMADINE C		Market area: EU
			Bonimal H Lactidip C		Market area: EU
			CERTI CREME C		Market area: EU
			CERTI FILM C		Market area: EU
			COSMADINE C		Market area: EU
			DIPLAC C		Market area: EU
			EQUO LACTO C		Market area: EU
			FILMADIP C		Market area: EU
			FILMALAC C		Market area: EU
			FILMALINE C		Market area: EU
			FILMATREMP C		Market area: EU
			FILMORANGE C		Market area: EU
			FP FILM C		Market area: EU
			HY-COSMETIC C		Market area: EU
			HYPREDIP PLUS C		Market area: EU
			INO EXTRA C		Market area: EU
			INO FILM C		Market area: EU
			LACTIDIP C		Market area: EU
			MilchsäureFilmdip-Super C		Market area: EU
			PRIMASKIN C		Market area: EU
			SUPREMADINE C		Market area: EU
			ZOO FILM RED C		Market area: EU
Authorisation number					EU-0031195-0003 1-2
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
L-(+)-lactic acid		active substance		79-33-4		201-196-2	8,4
Sodium p-cumenesulphonate		Non-active substance		15763-76-5		239-854-6	1,32
Sodium 2-ethylhexyl sulfate		Non-active substance		126-92-1		204-812-8	2,1
Diethanolamine		Non-active substance		111-42-2		203-868-0	3,92

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

Trade name(s)			FILMADINE		Market area: EU
			Bonimal H Lactidip		Market area: EU
			CERTI CREME +		Market area: EU
			CERTI FILM		Market area: EU
			COSMADINE		Market area: EU
			DIPLAC		Market area: EU
			EQUO LACTO		Market area: EU
			FILMADIP		Market area: EU
			FILMALAC		Market area: EU
			FILMALINE		Market area: EU
			FILMATREMP		Market area: EU
			FILMORANGE		Market area: EU
			FP FILM		Market area: EU
			HY-COSMETIC		Market area: EU
			HYPREDIP PLUS		Market area: EU
			INO EXTRA		Market area: EU
			INO FILM		Market area: EU
			LACTIDIP		Market area: EU
			MilchsäureFilmdip-Super		Market area: EU
			PRIMASKIN		Market area: EU
			SUPREMADINE		Market area: EU
			ZOO FILM RED		Market area: EU
			LAURACTIV		Market area: EU
			Salus TOP		Market area: EU
			LAURAFILM		Market area: EU
			Juvelit-extreme		Market area: EU
			Bonimal CARE LactiDip		Market area: EU
Authorisation number					EU-0031195-0004 1-2
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
L-(+)-lactic acid		active substance		79-33-4		201-196-2	8,4
Sodium p-cumenesulphonate		Non-active substance		15763-76-5		239-854-6	1,32
Sodium 2-ethylhexyl sulfate		Non-active substance		126-92-1		204-812-8	2,1
Diethanolamine		Non-active substance		111-42-2		203-868-0	3,92