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)

Article 1

A Union authorisation with authorisation number EU-0030143-0000 is hereby granted to  Neogen Italia S.r.l. 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 .

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

ANNEXSupplementary provisions

ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY Lactic acid Family – Quatchem Product type(s) PT03: Veterinary hygiene Authorisation number: EU-0030143-0000 R4BP asset number: EU-0030143-0000 PART I FIRST INFORMATION LEVEL 1.    ADMINISTRATIVE INFORMATION 1.1.    Family name Name Lactic acid Family – Quatchem 1.2.    Product type(s) Product type(s) PT03: Veterinary hygiene 1.3.    Authorisation holder Name and address of the authorisation holder Name Neogen Italia S.r.l. Address c/o REGUS Palazzo Bernini Centro Direzionale Milano Due, Via Fratelli Cervi snc 20054 - Segrate, Milano Italy Authorisation number   EU-0030143-0000 R4BP asset number   EU-0030143-0000 Date of the authorisation   3 October 2023 Expiry date of the authorisation   30 September 2033 1.4.    Manufacturer(s) of the product Name of manufacturer Quat-Chem Ltd. A Neogen Company Address of manufacturer 1-4 Sandfield Industrial Park, Dodgson Street, Rochdale OL16 5SJ Lancashire United Kingdom of Great Britain and Northern Ireland (the) Location of manufacturing sites Quat-Chem Ltd. A Neogen Company site 1 1-4 Sandfield Industrial Park, Dodgson Street, Rochdale OL16 5SJ Lancashire United Kingdom of Great Britain and Northern Ireland (the) 1.5.    Manufacturer(s) of the active substance(s) Active substance L-(+)-lactic acid Name of manufacturer Purac Biochem bv Address of manufacturer Arkelsedijk 46 4206 AC Gorinchem Netherlands (the) Location of manufacturing sites Purac Biochem bv site 1 Arkelsedijk 46 4206 AC Gorinchem Netherlands (the) Active substance L-(+)-lactic acid Name of manufacturer Jungbunzlauer S. A Address of manufacturer Z.I. et Portuaire, B.P. 32 FR-67390 Marckolsheim France Location of manufacturing sites Jungbunzlauer S. A site 1 Z.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 name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid   active substance 79-33-4 201-196-2 4 - 4 % (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 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 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 4 - 4 % (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 H315: Causes skin irritation. H318: Causes serious eye damage. Precautionary statements P280: Wear protective gloves. P280: Wear eye protection. P264: Wash hands thoroughly after handling. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a doctor. P302+P352: IF ON SKIN: Wash with plenty of water. P332+P313: If skin irritation occurs: Get medical advice. P332+P313: If skin irritation occurs: Get medical attention. P362+P364: Take off contaminated clothing and wash it before reuse. P501: Dispose of contents to hazardous or special waste collection point in accordance with national regulations. P501: Dispose of container to hazardous or special waste collection point in accordance with national regulations. 4.    AUTHORISED USE(S) OF THE META SPC 4.1.    Use description 1 Table 1. Use # 1.1 – Post milking teat disinfection – manual dipping Product type PT03: Veterinary hygiene 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 use 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 o C 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 users professional Pack sizes and packaging material 1 000 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 2 Table 2. Use # 1.2 – Post milking teat disinfection - spraying Product type PT03: Veterinary hygiene 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 use 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 o C 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 users professional Pack sizes and packaging material 1 000 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 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) Synodex Market area: EU Lactopost Market area: EU Lactopost Y Market area: EU Lactopost Plus Market area: EU Lactopost Extra Market area: EU Synodex Y Market area: EU Synodex Extra Market area: EU Synodex Plus Market area: EU Udder X Market area: EU Teat Care Market area: EU Lacto Gold Market area: EU Lacto Extra Market area: EU Lactogold Market area: EU Lacto Spray Market area: EU Authorisation number EU-0030143-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid   active substance 79-33-4 201-196-2 4 7.2.    Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Laxsan Market area: EU Hexsan Market area: EU Lactopost R Market area: EU Laxsan R Market area: EU Hexfoam Market area: EU Deosan LA1 Market area: EU Hexsan Extra Market area: EU Hexsan Plus Market area: EU Laxsan Plus Market area: EU Laxsan Extra Market area: EU Hexsan R Market area: EU LA1 Market area: EU Condition Pink Market area: EU Authorisation number EU-0030143-0002 1-1 Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid   active substance 79-33-4 201-196-2 4 1.    META SPC 2 ADMINISTRATIVE INFORMATION 1.1.    Meta SPC 2 identifier Identifier Meta SPC: meta SPC 2 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 COMPOSITION 2.1.    Qualitative and quantitative information on the composition of the meta SPC 2 Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid   active substance 79-33-4 201-196-2 4 - 4 % (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 H315: Causes skin irritation. H318: Causes serious eye damage. EUH208: Contains <name of sensitising substance>. May produce an allergic reaction. Precautionary statements P280: Wear protective gloves. P280: Wear eye protection. P264: Wash hands thoroughly after handling. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a doctor. P302+P352: IF ON SKIN: Wash with plenty of water. P332+P313: If skin irritation occurs: Get medical advice. P332+P313: If skin irritation occurs: Get medical attention. P362+P364: Take off contaminated clothing and wash it before reuse. P501: Dispose of contents to hazardous or special waste collection point in accordance with national regulations. P501: Dispose of container to hazardous or special waste collection point in accordance with national regulations. 4.    AUTHORISED USE(S) OF THE META SPC 4.1.    Use description 1 Table 1. Use # 3.1 – Post milking teat disinfection – manual dipping Product type PT03: Veterinary hygiene 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 use 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 o C 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 users professional Pack sizes and packaging material 1 000 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 2 Table 2. Use # 3.2 – Post milking teat disinfection - spraying Product type PT03: Veterinary hygiene 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 use 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 o C 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 users professional Pack sizes and packaging material 1 000 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 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) Synoshield Market area: EU Lactopost G Market area: EU Synoshield P Market area: EU Lactopost P Market area: EU Synoshield G Market area: EU Lactoshield Market area: EU Lactoshield Plus Market area: EU Lactoshield Extra Market area: EU Synoshield Extra Market area: EU Synoshield Plus Market area: EU Lactopost Protect Market area: EU Udder Shield Market area: EU Teat Care Market area: EU Mint Lacto Plus Market area: EU Lacto Care G Market area: EU Lactosal Market area: EU Lacto Care P Market area: EU Previoshield Market area: EU Authorisation number EU-0030143-0003 1-2 Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid   active substance 79-33-4 201-196-2 4