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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)

Modified by

Commission Implementing Regulation (EU) 2024/1990of 22 July 2024amending Implementing Regulation (EU) 2023/1763 as regards an administrative change to the Union authorisation of the biocidal product family Lactic acid Family – Quatchem(Text with EEA relevance), 32024R1990, July 23, 2024

Commission Implementing Regulation (EU) 2023/1763of 12 September 2023granting 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 1A 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 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.ANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILYLactic acid Family – QuatchemProduct type(s)PT03: Veterinary hygieneAuthorisation number: EU-0030143-0000R4BP asset number: EU-0030143-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.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.
Name and address of the authorisation holder	Address	c/o REGUS Palazzo BerniniCentro Direzionale Milano Due, Via Fratelli Cervi snc20054 - Segrate, MilanoItaly
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 11-4 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 1Arkelsedijk 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 1Z.I. et Portuaire, B.P. 32 FR-67390 Marckolsheim France

2.PRODUCT FAMILY COMPOSITION AND FORMULATION2.1.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 IISECOND INFORMATION LEVEL - META SPC(S)1.META SPC 1 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.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 SPC4.1.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: BacteriaCommon name: BacteriaDevelopment stage: -Scientific name: YeastsCommon name: YeastsDevelopment stage: -
Field(s) of use	indoor useTeat disinfection post-milking by manual dipping using a dip cup
Application method(s)	Method: Manual dipping using a dip cupDetailed 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 teatDilution (%): RTU (Ready-to-use) productNumber and timing of application:up to twice per day
Category(ies) of users	professional
Pack 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 useSee 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 measuresSee 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 environmentSee general directions for use.4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee 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 storageSee 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: BacteriaCommon name: BacteriaDevelopment stage: -Scientific name: YeastsCommon name: YeastsDevelopment stage: -
Field(s) of use	indoor useTeat disinfection post-milking by using hand-held sprayer
Application method(s)	Method: Manual spraying using hand-held sprayerDetailed 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 teatDilution (%): RTU productNumber and timing of application:up to twice per day
Category(ies) of users	professional
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 useSee 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 measuresSee 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 environmentSee general directions for use.4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee 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 storageSee general directions for use.5.GENERAL DIRECTIONS FOR USE OF THE META SPC 15.1.Instructions for useSee 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 measuresThe 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 environmentIF 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 packagingAt 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 storageKeep out of reach of children.Store in original container tightly closed.Store between 0 °C and + 30 °C.Shelf life: 24 months6.OTHER INFORMATIONThe full titles of the European standards referenced in section 5.2 "Risk mitigation measures" are :EN ISO 16321 - Eye and face protection for occupational useEN ISO 374 – Protective gloves against dangerous chemicals and microorganismsEN 455 - Medical gloves for single use7.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)			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 INFORMATION1.1.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 COMPOSITION2.1.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

4.AUTHORISED USE(S) OF THE META SPC4.1.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: BacteriaCommon name: BacteriaDevelopment stage: -Scientific name: YeastsCommon name: YeastsDevelopment stage: -
Field(s) of use	indoor useTeat disinfection post-milking by manual dipping using a dip cup
Application method(s)	Method: Manual dipping using a dip cupDetailed 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 teatDilution (%): RTU productNumber and timing of application:up to twice per day
Category(ies) of users	professional
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.

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: BacteriaCommon name: BacteriaDevelopment stage: -Scientific name: YeastsCommon name: YeastsDevelopment stage: -
Field(s) of use	indoor useTeat disinfection post-milking by using hand-held sprayer
Application method(s)	Method: Manual spraying using hand-held sprayerDetailed 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 teatDilution (%): RTU productNumber and timing of application:up to twice per day
Category(ies) of users	professional
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 useSee 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 measuresSee 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 environmentSee general directions for use.4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee 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 storageSee general directions for use.5.GENERAL DIRECTIONS FOR USE OF THE META SPC 25.1.Instructions for useSee 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 measuresThe 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 environmentIF 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 packagingAt 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 storageKeep out of reach of children.Store in original container tightly closed.Store between 0 °C and + 30 °C.Shelf life: 24 months6.OTHER INFORMATIONThe full titles of the EN standards referred to in section 5.2 are the following:EN ISO 16321 - Eye and face protection for occupational useEN ISO 374 – Protective gloves against dangerous chemicals and micro-organismsEN 455 - Medical gloves for single use7.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)			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

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