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Commission Implementing Regulation (EU) 2023/2384 of 29 September 2023 amending Implementing Regulation (EU) 2018/1287 to make an administrative change to the Union authorisation of the biocidal product family Quat-Chem’s iodine based products

Commission Implementing Regulation (EU) 2023/2384of 29 September 2023amending Implementing Regulation (EU) 2018/1287 to make an administrative change to the Union authorisation of the biocidal product family Quat-Chem’s iodine based products(Text with EEA relevance) THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal productsOJ L 167, 27.6.2012, p. 1., and in particular Article 50(2) thereof,Whereas:(1)On 24 September 2018, Commission Implementing Regulation (EU) 2018/1287Commission Implementing Regulation (EU) 2018/1287 of 24 September 2018 granting a Union authorisation for the biocidal product family Quat-Chem’s iodine based products (OJ L 240, 25.9.2018, p. 10). granted a Union authorisation with authorisation number EU-0018496-0000 to Quatchem Ltd for the making available on the market and use of the biocidal product family "Quat-Chem’s iodine based products".(2)On 14 December 2020, Quatchem Ltd submitted a notification to the European Chemicals Agency ("the Agency"), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013Commission 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)., regarding an administrative change to the Union authorisation for the biocidal product family "Quat-Chem’s iodine based products" referred to in Title 1, Section 1, of the Annex to that Regulation.(3)Quatchem Ltd proposed to transfer the authorisation to a new holder established in the European Economic Area as set out in Title 1, Section 1, point 3, of the Annex to Implementing Regulation (EU) No 354/2013. The notification was recorded under case number BC-VP063434-15 in the Register for Biocidal Products.(4)On 29 April 2022, the Agency submitted an opinionECHA opinion on an administrative change of the Union authorisation of QUAT-CHEM’s iodine based products of 13 August 2021, Opinion No UTR-C-1527940-77-00/F, https://echa.europa.eu/opinions-on-union-authorisation to the Commission on the proposed change, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013. The opinion concludes that the amendment to the existing authorisation sought by the authorisation holder falls under Article 50(3), point (a), of Regulation (EU) No 528/2012, that the parties have agreed to the transfer of the authorisation, that the prospective new authorisation holder is established in the Union, and that after the implementation of the changes, the conditions of Article 19 of that Regulation are still met. On the same date, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics in all the official languages of the Union in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.(5)The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the biocidal product family "Quat-Chem’s iodine based products".(6)Save for the amendment regarding the transfer of the authorisation to a new holder, all other information included in the summary of the biocidal product characteristics of "Quat-Chem’s iodine based products" as set out in the Annex to Implementing Regulation (EU) 2018/1287 remains unchanged,HAS ADOPTED THIS REGULATION:

Article 1Implementing Regulation (EU) 2018/1287 is amended as follows:(1)in Article 1, first paragraph, the name "Quatchem Ltd" is replaced by the name "Neogen Italia S.r.l.";(2)the Annex is replaced by the text set out in the Annex to this Regulation.

Article 2This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 29 September 2023.For the CommissionThe PresidentUrsula von der LeyenANNEXSummary of product characteristics for a biocidal product familyQUAT-CHEM’s iodine based productsProduct type 3 – Veterinary hygiene (Disinfectants)Authorisation number: EU-0018496-0000R4BP asset number: EU-0018496-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.Family name

Name	QUAT-CHEM’s iodine based products

1.2.Product type(s)

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

1.3.Authorisation holder

Name and address of the authorisation holder	Name	Neogen Italia S.r.l.
	Address	Via Agnello 8, 20121 Milano, Italy
Authorisation number	EU-0018496-0000
R4BP asset number	EU-0018496-0000
Date of the authorisation	15 October 2018
Expiry date of the authorisation	30 September 2028

1.4.Manufacturer(s) of the biocidal products

Name of manufacturer	QUAT-CHEM LTD
Address of manufacturer	Charter House 33 – Greek Street, SK3 8AX Stockport United Kingdom
Location of manufacturing sites	QUAT-CHEM LTD – Charter House 33 – Greek Street, SK3 8AX Stockport United Kingdom

1.5.Manufacturer(s) of the active substance(s)

Active substance	Iodine
Name of manufacturer	COSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. No 96.625.710-5
Address of manufacturer	Terrenos de Elena S/N, Terrenos de Elena S/N Huara, Región de Tarapacá Chile
Location of manufacturing sites	Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad., Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	ACF MINERA SA
Address of manufacturer	San Martín, 499 Iquique Chile
Location of manufacturing sites	Faena Lagunas, KM. 1.722 Ruta A-5, Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	SOCIEDAD QUIMICA y MINERA SA
Address of manufacturer	Los Militares, 4290 SANTIAGO DE CHILE Chile
Location of manufacturing sites	Pedro de Valdivia (PV), Route B 180 Antofagasta ChileNueva Victoria (NV), Route 5 North, Km 1925 Pozo Almonte Chile

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Iodine		Active Substance	7553-56-2	231-442-4	0,25	2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non-active substance	68439-50-9		2,697	24,199

2.2.Type(s) of formulation

Formulation(s)

AL – Any other liquidSL – Soluble concentrate

PART IISECOND INFORMATION LEVEL – META SPC(S)META SPC 11.META SPC 1 ADMINISTRATIVE INFORMATION1.1.Meta SPC 1 identifier

Identifier

meta SPC 1: Dipping products – ready to use

1.2.Suffix to the authorisation number

Number

1-1

1.3.Product type(s)

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Iodine		Active Substance	7553-56-2	231-442-4	0,25	0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non-active substance	68439-50-9		2,697	4,993

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 serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children.Wash hands thoroughly after handling.Wear protective gloves.Wear protective clothing.Wear eye protection.IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.If eye irritation persists: Get medical advice.Get medical advice.

4.AUTHORISED USE(S) OF THE META SPC 14.1.Use description

Table 1Use # 1 – Use # 1.1 – Manual or automated dipping after milking

Product type	PT03 – Veterinary hygiene (Disinfectants)
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:Scientific name: AlgaeCommon name: AlgaeDevelopment stage:
Field(s) of use	IndoorDisinfection of teats of milk producing animals by dipping after milking
Application method(s)	Method: DippingDetailed description:Manual or automated disinfection of teats by dipping after milking.Dipping cup or automated dipping machine.
Application rate(s) and frequency	Application Rate: – cows and buffaloes (3 to 10 ml: 5 ml recommended) – sheep (1,5 to 5 ml: 1,5 ml recommended) – goats (2,5 to 6 ml: 2,5 ml recommended)Dilution (%):Number and timing of application:Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.1.1.Use-specific instructions for useSee general directions for use of meta SPC 14.1.2.Use-specific risk mitigation measuresSee general directions for use of meta SPC 14.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use of meta SPC 14.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingNone: see directions for use meta SPC 14.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 15.GENERAL DIRECTIONS FOR USEInstructions 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 15.1.Instructions for useAlways read the label or leaflet before use and follow all the instructions provided.The product must be brought to a temperature above 20 °C before use.The use of a dosing pump for filling the product into the application equipment is recommended.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.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)Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.Where necessary, repeat the application after each milking.Clean the application equipment regularly with warm water.5.2.Risk mitigation measuresWear eye protection.In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentTake the contaminated clothes and shoes off immediately. Wash them before wearing them again.FIRST AID INSTRUCTIONSIn the event of inhalation: Bring to fresh air.In the event of contact with the skin: Wash with water.In the event of contact with the eyes:IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.If eye irritation persists: Get medical advice/attention.In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.Refer to the safety data sheet available for professional user: it contains an emergency phone number.Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.5.4.Instructions for safe disposal of the product and its packagingAt the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageShelf life: 2 years in HDPEDo not store at a temperature higher than 30 °C.6.OTHER INFORMATION7.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)	Teatsan 2500		Market area: EU
	IODO GUARD 2500		Market area: EU
Authorisation number	EU-0018496-0001 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	0,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non-active substance	68439-50-9		2,697

META SPC 21.META SPC 2 ADMINISTRATIVE INFORMATION1.1.Meta SPC 2 identifier

Identifier

meta SPC 2: Dipping, foaming, spraying products – Ready to use

1.2.Suffix to the authorisation number

Number

1-2

1.3.Product type(s)

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Iodine		Active Substance	7553-56-2	231-442-4	0,25	0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non-active substance	68439-50-9		2,697	4,69

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 serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children.Wash hands thoroughly after handling.Wear protective gloves.Wear protective clothing.Wear eye protection.IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.If eye irritation persists: Get medical advice.Get medical advice.

4.AUTHORISED USE(S) OF THE META SPC 24.1.Use description

Table 2Use # 1 – Use # 2.1 – Manual or automated dipping, foaming or spraying before milking

Product type	PT03 – Veterinary hygiene (Disinfectants)
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	IndoorDisinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s)	Method: Dipping, foaming or spraying before milkingDetailed description:Manual or automated disinfection of teats by dipping, foaming or spraying before milkingDipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	Application Rate: – cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) – sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) – goats (2,5 to 6 ml: 2,5 to 4 ml recommended)Dilution (%):Number and timing of application:Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.1.1.Use-specific instructions for useEliminate all visible dirt before applying the product.Manual or automatic dipping/foaming/spraying on animal’s teats on the full length of the teat before milking.Let the product act at least one minute.Use the teat cleaning and wiping method systematically before attaching the milking cluster.See also general instructions for use of meta SPC 2.4.1.2.Use-specific risk mitigation measuresFor manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) / eye protection.For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) / protective clothing / eye protection.In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.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 of meta SPC 24.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 24.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 24.2.Use description

Table 3Use # 2 – Use # 2.2 – Manual or automated dipping, foaming or spraying after milking

Product type	PT03 – Veterinary hygiene (Disinfectants)
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:Scientific name: AlgaeCommon name: AlgaeDevelopment stage:
Field(s) of use	IndoorDisinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Method: Dipping, foaming, spraying after milkingDetailed description:Manual or automated disinfection of teats by dipping, foaming or spraying after milkingDipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	Application Rate: – cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) – sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) – goats (2,5 to 6 ml: 2,5 to 4 ml recommended)Dilution (%):Number and timing of application:Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.2.1.Use-specific instructions for useManual or automatic dipping/foaming/spraying on animal’s teats on the full length of the teat after milking.Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.See also general instructions for use of meta SPC 2.4.2.2.Use-specific risk mitigation measuresFor manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) / protective clothing / eye protection.In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.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 of meta SPC 24.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 24.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 25.GENERAL DIRECTIONS FOR USEInstructions 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 25.1.Instructions for useSee use-specific instructions for each use.Always read the label or leaflet before use and follow all the instructions provided.The product must be brought to a temperature above 20 °C before use.The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.Where necessary repeat the application at each milkingClean the application equipment regularly with warm water.5.2.Risk mitigation measuresSee use-specific risk mitigation measures for each use.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentTake the contaminated clothes and shoes off immediately. Wash them before wearing them again.FIRST AID INSTRUCTIONSIn the event of inhalation: Bring to fresh air.In the event of contact with the skin: Wash with water.In the event of contact with the eyes:IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.If eye irritation persists: Get medical advice/attention.In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.Refer to the safety data sheet available for professional user: it contains an emergency phone number.Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.5.4.Instructions for safe disposal of the product and its packagingAt the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageShelf life: 2 years in HDPEDo not store at a temperature higher than 30 °C.6.OTHER INFORMATION7.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)	Teat Guard 2500		Market area: EU
	IODO SPRAY 2500		Market area: EU
Authorisation number	EU-0018496-0002 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	0,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non-active substance	68439-50-9		2,697

META SPC 31.META SPC 3 ADMINISTRATIVE INFORMATION1.1.Meta SPC 3 identifier

Identifier

meta SPC 3: Dipping, foaming, spraying concentrated products

1.2.Suffix to the authorisation number

Number

1-3

1.3.Product type(s)

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.META SPC 3 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 3

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Iodine		Active Substance	7553-56-2	231-442-4	2,5	2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non-active substance	68439-50-9		24,199	24,199

2.2.Type(s) of formulation of the meta SPC 3

Formulation(s)

SL – Soluble concentrate

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements

Causes serious eye damage.May cause damage to organs (thyroid) through prolonged or repeated exposure oral.Toxic to aquatic life with long lasting effects.May be corrosive to metals.

Precautionary statements

Keep out of reach of children.Do not breathe mist.Do not breathe vapours.Do not breathe spray.Wash hands thoroughly after handling.Wear protective gloves.Wear protective clothing.Wear eye protection.IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.Immediately call a poison center / doctor.Get medical advice if you feel unwell.Get medical attention if you feel unwell.Dispose of contents to in accordance with local/regional/national/international regulations.Dispose of container to in accordance with local/regional/national/international regulations.Keep only in original packaging.Absorb spillage to prevent material damage.

4.AUTHORISED USE(S) OF THE META SPC 34.1.Use description

Table 4Use # 1 – Use # 3.1 – Manual or automated dipping, foaming or spraying before milking

Product type	PT03 – Veterinary hygiene (Disinfectants)
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	IndoorDisinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s)	Method: Dipping, foaming, sprayingDetailed description:Manual or automated disinfection of teats by dipping, foaming or spraying before milking.Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	Application Rate: A dilution at 10 % (v/v) should be prepared Application rate for the diluted product:- cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) – sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) – goats (2,5 to 6 ml: 2,5 to 4 ml recommended)Dilution (%):Number and timing of application:Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.1.1.Use-specific instructions for usePrepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal and yeasticidal activity.Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.Eliminate all visible dirt before applying the product.Manual or automatic dipping/foaming/spraying on animal’s teats on the full length of the teat before milking.Let the product act at least one minute.Use the teat cleaning and wiping method systematically before attaching the milking cluster.See also general directions for use of meta SPC 3.4.1.2.Use-specific risk mitigation measuresFor manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) / protective clothing / eye protection.In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.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 of meta SPC 34.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 34.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 34.2.Use description

Table 5Use # 2 – Use # 3.2 – Manual or automated dipping, foaming or spraying after milking

Product type	PT03 – Veterinary hygiene (Disinfectants)
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:Scientific name: AlgaeCommon name: AlgaeDevelopment stage:Scientific name: VirusesCommon name: VirusesDevelopment stage:
Field(s) of use	IndoorDisinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Method: Dipping, foaming, sprayingDetailed description:Manual or automated disinfection of teats by dipping, foaming or spraying after milking.Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	Application Rate: For disinfection of bacteria, yeasts and algae a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) should be prepared. For disinfection of viruses a dilution at 20 % (v/v: 20 ml product, add water up to 100 ml) should be prepared Application rate for the diluted product:- cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) – sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) – goats (2,5 to 6 ml: 2,5 to 4 ml recommended)Dilution (%):Number and timing of application:Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.2.1.Use-specific instructions for usePrepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal, yeasticidal and algaecidal activity or 20 % (v/v: 20 ml product, add water up to 100 ml) in case virucidal activity is also needed.Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.Manual or automatic dipping/foaming/spraying on animal’s teats on the full length of the teat after milking.Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.See also general directions for use of meta SPC 3.4.2.2.Use-specific risk mitigation measuresFor manual spraying applications wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) /protective clothing / eye protection.In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.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 of meta SPC 34.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 34.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 35.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3. OF THE META SPC 35.1.Instructions for useSee use-specific instructions for each use.Always read the label or leaflet before use and follow all the instructions provided.The product must be brought to a temperature above 20 °C before use.The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.Where necessary, repeat the application at each milking Clean the application equipment regularly with warm water.5.2.Risk mitigation measuresSee use-specific risk mitigation measures for each use.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentTake the contaminated clothes and shoes off immediately. Wash them before wearing them again.In case of faintness, get medical advice/attention. Show this safety data sheet to the doctor.FIRST AID INSTRUCTIONSIn the event of inhalation: Bring to fresh air.In the event of contact with the skin: Wash with water.In the event of contact with the eyes: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open.Remove contact lenses if present and easy to do. Continue rinsing.Immediately call a POISON CENTER or doctor/physician.In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.Refer to the safety data sheet available for professional user: it contains an emergency phone number.Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.5.4.Instructions for safe disposal of the product and its packagingAt the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageShelf life: 2 years in HDPEDo not store at a temperature higher than 30 °C.6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 37.1.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	Teat Guard Concentrate 1:4		Market area: EU
	IODO GUARD CONCENTRATE 1:4		Market area: EU
Authorisation number	EU-0018496-0003 1-3
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non-active substance	68439-50-9		24,199

META SPC 41.META SPC 4 ADMINISTRATIVE INFORMATION1.1.Meta SPC 4 identifier

Identifier

meta SPC 4: Dipping products reaching virucidal activity – Ready to use

1.2.Suffix to the authorisation number

Number

1-4

1.3.Product type(s)

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.META SPC 4 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 4

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Iodine		Active Substance	7553-56-2	231-442-4	0,5	0,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non-active substance	68439-50-9		4,993	4,993

2.2.Type(s) of formulation of the meta SPC 4

Formulation(s)

AL – Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements	Causes serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children.Wash hands thoroughly after handling.Wear protective gloves.Wear protective clothing.Wear eye protection.IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.If eye irritation persists: Get medical advice.Get medical advice.

4.AUTHORISED USE(S) OF THE META SPC 44.1.Use description

Table 6Use # 1 – Use # 4.1 – Manual or automated dipping after milking

Product type	PT03 – Veterinary hygiene (Disinfectants)
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:Scientific name: AlgaeCommon name: AlgaeDevelopment stage:Scientific name: VirusesCommon name: VirusesDevelopment stage:
Field(s) of use	IndoorDisinfection of teats of milk producing animals by dipping after milking
Application method(s)	Method: DippingDetailed description:Manual or automated disinfection of teats by dipping after milking.Dipping cup or automated dipping machine.
Application rate(s) and frequency	Application Rate: – cows and buffaloes (3 to 10 ml: 5 ml recommended) – sheep (1,5 to 5 ml: 1,5 ml recommended) – goats (2,5 to 6 ml: 2,5 ml recommended)Dilution (%):Number and timing of application:Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.1.1.Use-specific instructions for useSee general directions for use of meta SPC 44.1.2.Use-specific risk mitigation measuresSee general directions for use of meta SPC 44.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use of meta SPC 44.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 44.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 45.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4. OF THE META SPC 45.1.Instructions for useAlways read the label or leaflet before use and follow all the instructions provided.The product must be brought to a temperature above 20 °C before use.The use of a dosing pump for filling the product into the application equipment is recommended. 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.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)Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.Where necessary, repeat the application after each milking.Clean the application equipment regularly with warm water.5.2.Risk mitigation measuresWear eye protection.In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentTake the contaminated clothes and shoes off immediately. Wash them before wearing them again.FIRST AID INSTRUCTIONSIn the event of inhalation: Bring to fresh air.In the event of contact with the skin: Wash with water.In the event of contact with the eyes:IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.If eye irritation persists: Get medical advice/attention.In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.Refer to the safety data sheet available for professional user: it contains an emergency phone number.Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.5.4.Instructions for safe disposal of the product and its packagingAt the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageShelf life: 2 years in HDPEDo not store at a temperature higher than 30 °C.6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 47.1.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	Teatsan 5000		Market area: EU
	IODO GUARD 5000		Market area: EU
Authorisation number	EU-0018496-0004 1-4
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	0,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non-active substance	68439-50-9		4,993

META SPC 51.META SPC 5 ADMINISTRATIVE INFORMATION1.1.Meta SPC 5 identifier

Identifier

meta SPC 5: Dipping, foaming, spraying products 5500 ppm – Ready to use

1.2.Suffix to the authorisation number

Number

1-5

1.3.Product type(s)

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.META SPC 5 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 5

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Iodine		Active Substance	7553-56-2	231-442-4	0,55	0,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non-active substance	68439-50-9		4,69	4,69

2.2.Type(s) of formulation of the meta SPC 5

Formulation(s)

AL – Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements	Causes serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statements	Keep out of reach of children.Wash hands thoroughly after handling.Wear protective gloves.Wear protective clothing.Wear eye protection.IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.If eye irritation persists: Get medical advice.Get medical advice.

4.AUTHORISED USE(S) OF THE META SPC 54.1.Use description

Table 7Use # 1 – Use # 5.1 – Manual or automated dipping, foaming or spraying before milking

Product type	PT03 – Veterinary hygiene (Disinfectants)
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	IndoorDisinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s)	Method: Dipping, foaming, sprayingDetailed description:Manual or automated disinfection of teats by dipping, foaming or spraying before milkingDipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine
Application rate(s) and frequency	Application Rate: – cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) – sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) – goats (2,5 to 6 ml: 2,5 to 4 ml recommended)Dilution (%):Number and timing of application:Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.1.1.Use-specific instructions for useFill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.Eliminate all visible dirt before applying the product.Manual or automatic dipping/foaming/spraying on animal’s teats on the full length of the teat before milking.Let the product act at least one minute.Use the teat cleaning and wiping method systematically before attaching the milking cluster.See also general instructions for use of meta SPC5.4.1.2.Use-specific risk mitigation measuresFor manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) / eye protection.For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) / protective clothing / eye protection.In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.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 of meta SPC 54.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 54.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 54.2.Use description

Table 8Use # 2 – Use # 5.2 – Manual or automated dipping, foaming or spraying after milking

Product type	PT03 – Veterinary hygiene (Disinfectants)
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:Scientific name: AlgaeCommon name: AlgaeDevelopment stage:Scientific name: VirusesCommon name: VirusesDevelopment stage:
Field(s) of use	IndoorDisinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s)	Method: Dipping, foaming, sprayingDetailed description:Manual or automated disinfection of teats by dipping, foaming or spraying after milking.Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine.
Application rate(s) and frequency	Application Rate: – cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) – sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) – goats (2,5 to 6 ml: 2,5 to 4 ml recommended)Dilution (%):Number and timing of application:Frequency: 2 to 3 times per day
Category(ies) of users	Professional
Pack sizes and packaging material	HDPE JERRYCAN 5, 10, 22 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000L

4.2.1.Use-specific instructions for useFill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.Manual or automatic dipping/foaming/spraying on animal’s teats on the full length of the teat after milking.Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.See also general instructions for use of meta SPC 5.4.2.2.Use-specific risk mitigation measuresFor manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) / protective clothing / eye protection.In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.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 of meta SPC 54.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 54.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 55.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5. OF THE META SPC 55.1.Instructions for useSee use-specific instructions for each use.Always read the label or leaflet before use and follow all the instructions provided.The product must be brought to a temperature above 20 °C before use.The use of a dosing pump for filling the product into the application equipment is recommended.Where necessary repeat the application at each milkingClean the application equipment regularly with warm water.5.2.Risk mitigation measuresSee use-specific risk mitigation measures for each use.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentTake the contaminated clothes and shoes off immediately. Wash them before wearing them again.FIRST AID INSTRUCTIONSIn the event of inhalation: Bring to fresh air.In the event of contact with the skin: Wash with water.In the event of contact with the eyes:IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.If eye irritation persists: Get medical advice/attention.In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.Refer to the safety data sheet available for professional user: it contains an emergency phone number.Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.5.4.Instructions for safe disposal of the product and its packagingAt the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageShelf life: 2 years in HDPEDo not store at a temperature higher than 30 °C.6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 57.1.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	Teat Guard 5500		Market area: EU
	IODO SPRAY 5500		Market area: EU
Authorisation number	EU-0018496-0005 1-5
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active Substance	7553-56-2	231-442-4	0,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)	Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy	Non-active substance	68439-50-9		4,69