Commission Implementing Regulation (EU) 2025/1171of 16 June 2025granting 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)

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 OJ 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, 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 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). 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 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). , 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 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. 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

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). , 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

Annex

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 NamePRODHYNET’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 holderNamePRODHYNET SAAddress11 avenue des châtelets 22440 PLOUFRAGAN FRAuthorisation numberEU-0032621-0000R4BP asset numberEU-0032621-0000Date of the authorisation7 July 2025Expiry date of the authorisation31 August 2034 1.4. Manufacturer(s) of the product Name of manufacturerHYPRED SAS - KERSIA GroupAddress of manufacturer55, Boulevard Jules Verger - BP10180 35803 DINARD FranceLocation of manufacturing sites

HYPRED SAS - KERSIA Group / Dinard 55, Boulevard Jules Verger; BP 10180 35803 DINARD Cedex France HYPRED SAS - KERSIA Group / Vaas 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 / Estella 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 substanceL-(+)-lactic acidName of manufacturerPURAC Bioquimica SAAddress of manufacturerGran Vial 19-25 8160 Montmelo - Barcelona SpainLocation 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 substanceL-(+)-lactic acidName of manufacturerJungbunzlauer S.A.Address of manufacturerZ.I. Portuaire BP 32 67390 Marckolsheim FranceLocation of manufacturing sites Jungbunzlauer S.A. 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 nameIUPAC nameFunctionCAS numberEC numberContent (%)L-(+)-lactic acidactive substance79-33-4201-196-28,4 - 8,4 % (w/w)Sodium p-cumenesulphonateNon-Active substance15763-76-5239-854-61,32 - 1,32 % (w/w)Sodium 2-ethylhexyl sulfateNon-Active substance126-92-1204-812-80 - 2,1 % (w/w)DiethanolamineNon-Active substance111-42-2203-868-03,92 - 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 IdentifierMeta SPC: meta SPC 1 - Dipping, foaming, spraying ready to use products 1.2. Suffix to the authorisation number Number1-1 1.3. Product type(s)

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 nameIUPAC nameFunctionCAS numberEC numberContent (%)L-(+)-lactic acidactive substance79-33-4201-196-28,4 - 8,4 % (w/w)Sodium p-cumenesulphonateNon-Active substance15763-76-5239-854-61,32 - 1,32 % (w/w)DiethanolamineNon-Active substance111-42-2203-868-04,234 - 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 statementsH319: 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 typePT03: Veterinary hygieneWhere 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) Ready to use product Number and timing of application: Contact time : 5 minutes Frequency: 2 to 3 times per day Category(ies) of usersprofessionalPack 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 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 Trade name(s)DOUPIS FLUIDEMarket area: EUPRO AL SPRAYMarket area: EUGALACTIK FLMarket area: EUSpray GuardMarket area: EUExtraGuard SprayMarket area: EUROBOLAK FLMarket area: EU

GALACTIK PULVEMarket area: EULACTI FLUIDEMarket area: EUAGRILAC FLUIDEMarket area: EULACTI SPRAY FLUIDEMarket area: EUHYGIALAC FLUIDEMarket area: EUBRETALAC FLUIDEMarket area: EUAuthorisation numberEU-0032621-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)L-(+)-lactic acidactive substance79-33-4201-196-28,4 % (w/w)Sodium p-cumenesulphonateNon-Active substance15763-76-5239-854-61,32 % (w/w)DiethanolamineNon-Active substance111-42-2203-868-04,234 % (w/w)

1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier IdentifierMeta SPC: meta SPC 2 - Dipping ready to use products 1.2. Suffix to the authorisation number Number1-2 1.3. Product type(s) Product type(s)PT03: Veterinary hygiene
2. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)L-(+)-lactic acidactive substance79-33-4201-196-28,4 - 8,4 % (w/w)Sodium p-cumenesulphonateNon-Active substance15763-76-5239-854-61,32 - 1,32 % (w/w)Sodium 2-ethylhexyl sulfateNon-Active substance126-92-1204-812-80 - 2,1 % (w/w)DiethanolamineNon-Active substance111-42-2203-868-03,92 - 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 statementsH319: 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 after milking Product typePT03: Veterinary hygieneWhere 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 after milking Application method(s) Method: Dipping Detailed 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) Ready to use product Number and timing of application: Contact time : 5 minutes Frequency: 2 to 3 times per day Category(ies) of usersprofessionalPack 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 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 Trade name(s)EDDAR FILMMarket area: EUDOUPIS FILMMarket area: EUGALACTIK EPMarket area: EUXtrem GuardMarket area: EUExtraGuard XtremMarket area: EULACTI EPAISMarket area: EUHYGIALAC EPAISMarket area: EUTREMPAGE EPAIS LACTIMarket area: EUAGRILAC EPAISMarket area: EUFILMOGENEMarket area: EUAGRIFILMMarket area: EUBRETADINEMarket area: EUBRETALAC FILMMarket area: EUGEL TRAYONMarket area: EUAPROMADINEMarket area: EU CELTADINEMarket area: EUDALFILMMarket area: EUFILM-AGRIMarket area: EUHYGIA’TREMPMarket area: EUHYGIAFILMMarket area: EUPRODINEMarket area: EUPRO ALMarket area: EUADIEL FILMMarket area: EUCORIAFILMMarket area: EUGANAFILMMarket area: EUMAGDINEMarket area: EUNUTRIDINEMarket area: EUPLUSAFILMMarket area: EUPROXAFILMMarket area: EUAuthorisation numberEU-0032621-0002 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)L-(+)-lactic acidactive substance79-33-4201-196-28,4 % (w/w)Sodium p-cumenesulphonateNon-Active substance15763-76-5239-854-61,32 % (w/w)Sodium 2-ethylhexyl sulfateNon-Active substance126-92-1204-812-82,1 % (w/w)DiethanolamineNon-Active substance111-42-2203-868-03,92 % (w/w)