Commission Implementing Regulation (EU) 2023/1763 of 12 September 2023 granting a Union authorisation for the biocidal product family Lactic acid Family – Quatchem in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the CouncilText with EEA relevance.

Commission Implementing Regulation (EU) 2023/1763 of 12 September 2023 granting a Union authorisation for the biocidal product family Lactic acid Family – Quatchem 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. , and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) On 14 April 2019, Arrow Regulatory (Ireland) Limited submitted to the European Chemicals Agency (the Agency) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named Lactic acid Family – Quatchem of product-type 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Latvia had agreed to evaluate the application. The application was recorded under case number BC-WC050857-29 in the Register for Biocidal Products. (2) Lactic acid Family – Quatchem 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 16 May 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 13 December 2022, the Agency submitted to the Commission its opinion ECHA opinion of 24 November 2022 on the Union authorisation of Lactic acid Family – Quatchem (ECHA/BPC/371/2022), https://echa.europa.eu/opinions-on-union-authorisation. , the draft summary of the biocidal product characteristics (SPC) of Lactic acid Family – Quatchem 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 Family – Quatchem 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. (6) On 5 January 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 Lactic acid Family – Quatchem. (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-0030143-0000 is hereby granted to Arrow Regulatory (Ireland) Limited for the making available on the market and use of the biocidal product family Lactic acid Family – Quatchem subject to compliance with the terms and conditions set out in the Annex. The Union authorisation is valid from 3 October 2023 to 30 September 2033.

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, 12 September 2023. For the Commission The President Ursula von der Leyen

Annex

ANNEX Summary of product characteristics for a biocidal product family Lactic acid Family - Quatchem Product type 3 - Veterinary hygiene (Disinfectants) Authorisation number: EU-0030143-0000 R4BP asset number: EU-0030143-0000 PART I FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION 1.1. Family name NameLactic acid Family - Quatchem 1.2. Product type(s) Product type(s)PT03 - Veterinary hygiene (Disinfectants) 1.3. Authorisation holder Name and address of the authorisation holderNameArrow Regulatory (Ireland) LimitedAddressThe Black Church St. Mary's Place, D07 P4AX Dublin IrelandAuthorisation numberEU-0030143-0000R4BP asset numberEU-0030143-0000Date of the authorisation3 October 2023Expiry date of the authorisation30 September 2033 1.4. Manufacturer(s) of the biocidal products Name of manufacturerQuat-Chem Ltd. A Neogen CompanyAddress of manufacturer1-4 Sandfield Industrial Park, Dodgson Street, Rochdale, OL16 5SJ Lancashire United KingdomLocation of manufacturing sites1-4 Sandfield Industrial Park, Dodgson Street, Rochdale, OL16 5SJ Lancashire United Kingdom 1.5. Manufacturer(s) of the active substance(s) Active substanceL-(+)-lactic acidName of manufacturerPurac Biochem bvAddress of manufacturerArkelsedijk 46, 4206 AC Gorinchem NetherlandsLocation of manufacturing sitesArkelsedijk 46, 4206 AC Gorinchem NetherlandsActive substanceL-(+)-lactic acidName of manufacturerJungbunzlauer S. AAddress of manufacturerZ.I. et Portuaire, B.P. 32, FR-67390 Marckolsheim FranceLocation of manufacturing sitesZ.I. et Portuaire, B.P. 32, FR-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 (%)MinMaxL-(+)-lactic acidActive Substance79-33-4201-196-24,04,0 2.2. Type(s) of formulation Formulation(s)AL - Any other liquid PART II SECOND INFORMATION LEVEL - META SPC(S) META SPC 1
3. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifiermeta SPC 1 1.2. Suffix to the authorisation number Number1-1 1.3. Product type(s) Product type(s)PT03 - Veterinary hygiene (Disinfectants)
4. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1

Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxL-(+)-lactic acidActive Substance79-33-4201-196-24,04,0 2.2. Type(s) of formulation of the meta SPC 1 Formulation(s)AL - Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements Causes skin irritation. Causes serious eye damage. Precautionary statements Wear protective gloves. Wear eye protection. Wash hands thoroughly after handling. IF IN EYES:Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. IF ON SKIN:Wash with plenty of water. If skin irritation occurs: Get medical advice. If skin irritation occurs: Get medical attention. Take off contaminated clothing. And wash it before reuse. Dispose of contents to hazardous or special waste collection point in accordance with national regulations. Dispose of container to hazardous or special waste collection point in accordance with national regulations. 4. AUTHORISED USE(S) OF THE META SPC 1 4.1. Use description Table 1. Use # 1 – Use # 1.1 – Post milking teat disinfection – manual dipping Product typePT03 - Veterinary hygiene (Disinfectants)Where relevant, an exact description of the authorised use- Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: - Scientific name: Yeasts Common name: Yeasts Development stage: - Field(s) of use Indoor Teat disinfection post-milking by manual dipping using a dip cup Application method(s) Method: Manual dipping using a dip cup Detailed description: Contact time for dipping at 30 oC in dirty conditions:

• 5 minutes for bacteria and yeasts. Application rate(s) and frequency Application Rate: 5 to 10 ml per teat Dilution (%): RTU (Ready-to-use) product Number and timing of application: up to twice per day Category(ies) of usersProfessionalPack sizes and packaging material 1000 litre high density polyethylene (HDPE) container with HDPE closure; 200 litre plastic drum with HDPE closure; 25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap; 5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap. 4.1.1. Use-specific instructions for use See general directions for use. Product to be applied post-milking by use of a dipping cup. Pre-clean teat with dry wipe, pour the product into the reservoir of the dip cup. When using a dip cup, the cup is applied to each teat in turn and the operator squeezes the product from the reservoir into the cup. The cup has a non-return value so any residual product cannot go back into the reservoir. 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 – Use # 1.2 – Post milking teat disinfection - spraying Product typePT03 - Veterinary hygiene (Disinfectants)Where relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: - Scientific name: Yeasts Common name: Yeasts Development stage: - Field(s) of use Indoor Teat disinfection post-milking by using hand-held sprayer Application method(s) Method: Manual spraying using hand-held sprayer Detailed description: Contact time for spraying at 30 oC in dirty conditions: 5 minutes for bacteria and yeasts. Application rate(s) and frequency Application Rate: 5 to 10 ml per teat Dilution (%): RTU product Number and timing of application: up to twice per day Category(ies) of usersProfessionalPack sizes and packaging material 1000 litre HDPE container with HDPE closure; 200 litre plastic drum with HDPE closure; 25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap; 5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap. 4.2.1. Use-specific instructions for use See general directions for use. Product to be applied post-milking by use of a hand-held sprayer. Pre-clean teat with dry wipe, pour the product into the reservoir of the sprayer. The operator will spray each animal once after milking. 4.2.2. Use-specific risk mitigation measures See general directions for use. Professional users have to ensure that professional bystanders are not present in the treatment area during disinfection process by spraying. If it is necessary for professional bystanders to be present, professional users have to ensure that those bystanders wear the same type of PPE as the operator. 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 Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. OF THE META SPC 1 5.1. Instructions for use See use-specific instruction for use of meta SPC 1. Always read the label or leaflet before use. The product must be brought to room temperature before use. The amount of product applied per teat is dependent upon the animal being treated. For large mammals (cows, camels) – up to 10 ml per teat, and for small mammals (sheep, goats) – up to 5 ml per teat. Make sure that the teats are fully covered with disinfectant. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing for at least 5 minutes).

5.2. Risk mitigation measures The use of eye protection consistent with European standard EN ISO 16321 or equivalent during handling of the product is mandatory. Avoid hand to eye transfer. Wear protective chemical resistant gloves during product handling phase (nitrile gloves – classified under European standards EN ISO 374 or EN 455 or equivalent). The full titles of the European standards indicated here are available under section 6. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF ON SKIN: Immediately wash 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. 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. 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 waste water treatment plant. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep out of reach of children. Store in original container tightly closed. Store between 0 °C and + 30 °C. Shelf life: 24 months 6. OTHER INFORMATION The full titles of the European standards referenced in section 5.2 Risk mitigation measures are : EN ISO 16321 - Eye and face protection for occupational use EN ISO 374 – Protective gloves against dangerous chemicals and microorganisms EN 455 - Medical gloves for single 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)SynodexMarket area: EULactopostMarket area: EULactopost YMarket area: EULactopost PlusMarket area: EULactopost ExtraMarket area: EUSynodex YMarket area: EUSynodex ExtraMarket area: EUSynodex PlusMarket area: EUUdder XMarket area: EUTeat CareMarket area: EULacto GoldMarket area: EULacto ExtraMarket area: EULactogoldMarket area: EULacto SprayMarket area: EU Authorisation numberEU-0030143-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)L-(+)-lactic acidActive Substance79-33-4201-196-24,0 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)LaxsanMarket area: EUHexsanMarket area: EULactopost RMarket area: EULaxsan RMarket area: EUHexfoamMarket area: EUDeosan LA1Market area: EUHexsan ExtraMarket area: EUHexsan PlusMarket area: EULaxsan PlusMarket area: EULaxsan ExtraMarket area: EUHexsan RMarket area: EULA1Market area: EUCondition PinkMarket area: EUAuthorisation numberEU-0030143-0002 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)L-(+)-lactic acidActive Substance79-33-4201-196-24,0

META SPC 2

1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifiermeta SPC 2 1.2. Suffix to the authorisation number Number1-2 1.3. Product type(s) Product type(s)PT03 - Veterinary hygiene (Disinfectants)
2. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxL-(+)-lactic acidActive Substance79-33-4201-196-24,04,0 2.2. Type(s) of formulation of the meta SPC 2 Formulation(s)AL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements Causes skin irritation. Causes serious eye damage. Contains peppermint oil. May produce an allergic reaction. Precautionary statements Wear protective gloves. Wear eye protection. Wash hands thoroughly after handling. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. IF ON SKIN:Wash with plenty of water. If skin irritation occurs:Get medical advice. If skin irritation occurs:Get medical attention. Take off contaminated clothing.And wash it before reuse. Dispose of contents to hazardous or special waste collection point in accordance with national regulations. Dispose of container to hazardous or special waste collection point in accordance with national regulations.
4. AUTHORISED USE(S) OF THE META SPC 2 4.1. Use description Table 3. Use # 1 – Use # 3.1 – Post milking teat disinfection – manual dipping Product typePT03 - Veterinary hygiene (Disinfectants)Where relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: - Scientific name: Yeasts Common name: Yeasts Development stage: - Field(s) of use Indoor Teat disinfection post-milking by manual dipping using a dip cup Application method(s) Method: Manual dipping using a dip cup Detailed description: Contact time for dipping at 30 oC in dirty conditions: 5 minutes for bacteria and yeasts. Application rate(s) and frequency Application Rate: 5 to 10 ml per teat Dilution (%): RTU product Number and timing of application: up to twice per day Category(ies) of usersProfessionalPack sizes and packaging material 1000 litre HDPE container with HDPE closure; 200 litre plastic drum with HDPE closure; 25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap; 5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap. 4.1.1. Use-specific instructions for use See general directions for use. Product to be applied post-milking by use of a dipping cup. Pre-clean teat with dry wipe, pour the product into the reservoir of the dip cup. When using a dip cup, the cup is applied to each teat in turn and the operator squeezes the product from the reservoir into the cup. The cup has a non-return value so any residual product cannot go back into the reservoir. 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 4. Use # 2 – Use # 3.2 – Post milking teat disinfection - spraying Product typePT03 - Veterinary hygiene (Disinfectants)Where relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: - Scientific name: Yeasts Common name: Yeasts Development stage: - Field(s) of use Indoor Teat disinfection post-milking by using hand-held sprayer Application method(s) Method: Manual spraying using hand-held sprayer Detailed description: Contact time for spraying at 30 oC in dirty conditions: 5 minutes for bacteria and yeasts. Application rate(s) and frequency Application Rate: 5 to 10 ml per teat Dilution (%): RTU product Number and timing of application: up to twice per day Category(ies) of usersProfessional Pack sizes and packaging material 1000 litre HDPE container with HDPE closure; 200 litre plastic drum with HDPE closure; 25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap; 5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap. 4.2.1. Use-specific instructions for use See general directions for use. Product to be applied post-milking by use of a hand-held sprayer. Pre-clean teat with dry wipe, pour the product into the reservoir of the sprayer. The operator will spray each animal once after milking. 4.2.2. Use-specific risk mitigation measures See general directions for use. Professional users have to ensure that professional bystanders are not present in the treatment area during disinfection process by spraying. If it is necessary for professional bystanders to be present, professional users have to ensure that those bystanders wear the same type of PPE as the operators. 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 Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2. OF THE META SPC 2 5.1. Instructions for use See use-specific instruction for use of meta SPC 2. Always read the label or leaflet before use.

The product must be brought to room temperature before use. The amount of product applied per teat is dependent upon the animal being treated. For large mammals (cows, camels) – up to 10 ml per teat, and for small mammals (sheep, goats) – up to 5 ml per teat. Make sure that the teats are fully covered with disinfectant. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing for at least 5 minutes). 5.2. Risk mitigation measures The use of eye protection consistent with European standard EN ISO 16321 or equivalent during handling of the product is mandatory. Avoid hand to eye transfer. Wear protective chemical resistant gloves during product handling phase (nitrile gloves – classified under European standards EN ISO 374 or EN 455 or equivalent). The full titles of the European standards indicated here are available under section 6. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF ON SKIN: Immediately wash 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. 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. 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 waste water treatment plant. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep out of reach of children. Store in original container tightly closed. Store between 0 °C and + 30 °C. Shelf life: 24 months 6. OTHER INFORMATION The full titles of the EN standards referred to in section 5.2 are the following: EN ISO 16321 - Eye and face protection for occupational use EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms EN 455 - Medical gloves for single 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)SynoshieldMarket area: EULactopost GMarket area: EUSynoshield PMarket area: EULactopost PMarket area: EUSynoshield GMarket area: EULactoshieldMarket area: EULactoshield PlusMarket area: EULactoshield ExtraMarket area: EUSynoshield ExtraMarket area: EUSynoshield PlusMarket area: EU