Commission Implementing Regulation (EU) 2018/1287 of 24 September 2018 granting a Union authorisation for the biocidal product family Quat-Chem's iodine based products (Text with EEA relevance.)
Modified by
  • 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), 32023R2384, October 6, 2023
Commission Implementing Regulation (EU) 2018/1287of 24 September 2018granting a Union authorisation for the biocidal product family Quat-Chem's iodine based products(Text with EEA relevance)
Article 1A Union authorisation is granted to Neogen Italia S.r.l. for the same biocidal product family Quat-chem's iodine based products with authorisation number EU-0018496-0000.The Union authorisation is valid from 15 October 2018 until 30 September 2028.The Union authorisation is subject to compliance with the SPC set out in the Annex.
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 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
NameQUAT-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 holderNameNeogen Italia S.r.l.
AddressVia Agnello 8, 20121 Milano, Italy
Authorisation numberEU-0018496-0000
R4BP asset numberEU-0018496-0000
Date of the authorisation15 October 2018
Expiry date of the authorisation30 September 2028
1.4.Manufacturer(s) of the biocidal products
Name of manufacturerQUAT-CHEM LTD
Address of manufacturerCharter House 33 – Greek Street, SK3 8AX Stockport United Kingdom
Location of manufacturing sitesQUAT-CHEM LTD – Charter House 33 – Greek Street, SK3 8AX Stockport United Kingdom
1.5.Manufacturer(s) of the active substance(s)
Active substanceIodine
Name of manufacturerCOSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. No 96.625.710-5
Address of manufacturerTerrenos de Elena S/N, Terrenos de Elena S/N Huara, Región de Tarapacá Chile
Location of manufacturing sitesMined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad., Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile
Active substanceIodine
Name of manufacturerACF MINERA SA
Address of manufacturerSan Martín, 499 Iquique Chile
Location of manufacturing sitesFaena Lagunas, KM. 1.722 Ruta A-5, Pozo Almonte Chile
Active substanceIodine
Name of manufacturerSOCIEDAD QUIMICA y MINERA SA
Address of manufacturerLos Militares, 4290 SANTIAGO DE CHILE Chile
Location of manufacturing sitesPedro 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 nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-40,252,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-92,69724,199
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
Identifiermeta SPC 1: Dipping products – ready to use
1.2.Suffix to the authorisation number
Number1-1
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 nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-40,250,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-92,6974,993
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 statementsCauses serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statementsKeep 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 2500Market area: EU
IODO GUARD 2500Market area: EU
Authorisation numberEU-0018496-0001 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive Substance7553-56-2231-442-40,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-92,697
META SPC 21.META SPC 2 ADMINISTRATIVE INFORMATION1.1.Meta SPC 2 identifier
Identifiermeta SPC 2: Dipping, foaming, spraying products – Ready to use
1.2.Suffix to the authorisation number
Number1-2
1.3.Product type(s)
Product type(s)PT03 – Veterinary hygiene (Disinfectants)
2.META SPC 2 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-40,250,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-92,6974,69
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 statementsCauses serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statementsKeep 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 2500Market area: EU
IODO SPRAY 2500Market area: EU
Authorisation numberEU-0018496-0002 1-2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive Substance7553-56-2231-442-40,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-92,697
META SPC 31.META SPC 3 ADMINISTRATIVE INFORMATION1.1.Meta SPC 3 identifier
Identifiermeta SPC 3: Dipping, foaming, spraying concentrated products
1.2.Suffix to the authorisation number
Number1-3
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 nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-42,52,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-924,19924,199
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 statementsCauses 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 statementsKeep 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 1:4Market area: EU
IODO GUARD CONCENTRATE 1:4Market area: EU
Authorisation numberEU-0018496-0003 1-3
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive Substance7553-56-2231-442-42,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-924,199
META SPC 41.META SPC 4 ADMINISTRATIVE INFORMATION1.1.Meta SPC 4 identifier
Identifiermeta SPC 4: Dipping products reaching virucidal activity – Ready to use
1.2.Suffix to the authorisation number
Number1-4
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 nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-40,50,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-94,9934,993
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 statementsCauses serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statementsKeep 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 5000Market area: EU
IODO GUARD 5000Market area: EU
Authorisation numberEU-0018496-0004 1-4
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive Substance7553-56-2231-442-40,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-94,993
META SPC 51.META SPC 5 ADMINISTRATIVE INFORMATION1.1.Meta SPC 5 identifier
Identifiermeta SPC 5: Dipping, foaming, spraying products 5500 ppm – Ready to use
1.2.Suffix to the authorisation number
Number1-5
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 nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-40,550,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-94,694,69
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 statementsCauses serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statementsKeep 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 5500Market area: EU
IODO SPRAY 5500Market area: EU
Authorisation numberEU-0018496-0005 1-5
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive Substance7553-56-2231-442-40,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-94,69
Article 1A Union authorisation is granted to Neogen Italia S.r.l. for the same biocidal product family Quat-chem's iodine based products with authorisation number EU-0018496-0000.The Union authorisation is valid from 15 October 2018 until 30 September 2028.The Union authorisation is subject to compliance with the SPC set out in the Annex.
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 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
NameQUAT-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 holderNameNeogen Italia S.r.l.
AddressVia Agnello 8, 20121 Milano, Italy
Authorisation numberEU-0018496-0000
R4BP asset numberEU-0018496-0000
Date of the authorisation15 October 2018
Expiry date of the authorisation30 September 2028
1.4.Manufacturer(s) of the biocidal products
Name of manufacturerQUAT-CHEM LTD
Address of manufacturerCharter House 33 – Greek Street, SK3 8AX Stockport United Kingdom
Location of manufacturing sitesQUAT-CHEM LTD – Charter House 33 – Greek Street, SK3 8AX Stockport United Kingdom
1.5.Manufacturer(s) of the active substance(s)
Active substanceIodine
Name of manufacturerCOSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. No 96.625.710-5
Address of manufacturerTerrenos de Elena S/N, Terrenos de Elena S/N Huara, Región de Tarapacá Chile
Location of manufacturing sitesMined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad., Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile
Active substanceIodine
Name of manufacturerACF MINERA SA
Address of manufacturerSan Martín, 499 Iquique Chile
Location of manufacturing sitesFaena Lagunas, KM. 1.722 Ruta A-5, Pozo Almonte Chile
Active substanceIodine
Name of manufacturerSOCIEDAD QUIMICA y MINERA SA
Address of manufacturerLos Militares, 4290 SANTIAGO DE CHILE Chile
Location of manufacturing sitesPedro 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 nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-40,252,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-92,69724,199
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
Identifiermeta SPC 1: Dipping products – ready to use
1.2.Suffix to the authorisation number
Number1-1
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 nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-40,250,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-92,6974,993
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 statementsCauses serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statementsKeep 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 2500Market area: EU
IODO GUARD 2500Market area: EU
Authorisation numberEU-0018496-0001 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive Substance7553-56-2231-442-40,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-92,697
META SPC 21.META SPC 2 ADMINISTRATIVE INFORMATION1.1.Meta SPC 2 identifier
Identifiermeta SPC 2: Dipping, foaming, spraying products – Ready to use
1.2.Suffix to the authorisation number
Number1-2
1.3.Product type(s)
Product type(s)PT03 – Veterinary hygiene (Disinfectants)
2.META SPC 2 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-40,250,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-92,6974,69
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 statementsCauses serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statementsKeep 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 2500Market area: EU
IODO SPRAY 2500Market area: EU
Authorisation numberEU-0018496-0002 1-2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive Substance7553-56-2231-442-40,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-92,697
META SPC 31.META SPC 3 ADMINISTRATIVE INFORMATION1.1.Meta SPC 3 identifier
Identifiermeta SPC 3: Dipping, foaming, spraying concentrated products
1.2.Suffix to the authorisation number
Number1-3
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 nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-42,52,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-924,19924,199
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 statementsCauses 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 statementsKeep 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 1:4Market area: EU
IODO GUARD CONCENTRATE 1:4Market area: EU
Authorisation numberEU-0018496-0003 1-3
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive Substance7553-56-2231-442-42,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-924,199
META SPC 41.META SPC 4 ADMINISTRATIVE INFORMATION1.1.Meta SPC 4 identifier
Identifiermeta SPC 4: Dipping products reaching virucidal activity – Ready to use
1.2.Suffix to the authorisation number
Number1-4
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 nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-40,50,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-94,9934,993
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 statementsCauses serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statementsKeep 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 5000Market area: EU
IODO GUARD 5000Market area: EU
Authorisation numberEU-0018496-0004 1-4
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive Substance7553-56-2231-442-40,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-94,993
META SPC 51.META SPC 5 ADMINISTRATIVE INFORMATION1.1.Meta SPC 5 identifier
Identifiermeta SPC 5: Dipping, foaming, spraying products 5500 ppm – Ready to use
1.2.Suffix to the authorisation number
Number1-5
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 nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-40,550,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-94,694,69
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 statementsCauses serious eye irritation.Harmful to aquatic life with long lasting effects.
Precautionary statementsKeep 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 typePT03 – 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 useIndoorDisinfection 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 frequencyApplication 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 usersProfessional
Pack sizes and packaging materialHDPE 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 5500Market area: EU
IODO SPRAY 5500Market area: EU
Authorisation numberEU-0018496-0005 1-5
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive Substance7553-56-2231-442-40,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon-active substance68439-50-94,69