Commission Implementing Regulation (EU) 2018/1261 of 20 September 2018 granting a Union authorisation for the biocidal product family Hypred's iodine based productsText with EEA relevance.

Commission Implementing Regulation (EU) 2018/1261 of 20 September 2018 granting a Union authorisation for the biocidal product family Hypred's iodine based products (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products OJ L 167, 27.6.2012, p. 1. , and in particular Article 44(5) thereof, Whereas: (1) On 16 July 2015, Hypred SAS submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Hypred's iodine based products (the product family) of product-type 3, as defined in Annex V to that Regulation. The Netherlands agreed that their competent authority referred to in Article 43(1) of Regulation (EU) No 528/2012 evaluate this application. The application was recorded under the case number BC-LC018584-49 in the Register for Biocidal Products (the Register). (2) The biocidal product family contains iodine as active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, once the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 Commission delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1). will become applicable, the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012. (3) On 6 June 2017 the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (the Agency). (4) On 12 January 2018, the Agency submitted to the Commission an opinion ECHA opinion of 12 December 2017 on the Union authorisation of Hypred's iodine based products (ECHA/BPC/178/2017). , including the draft summary of the biocidal product characteristics (hereinafter SPC) and the final product assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concluded that the product family falls within the definition of biocidal product family laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that it was found eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(5) On 26 February 2018, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. (6) The Commission concurs with the opinion of the Agency and considers therefore appropriate to grant a Union authorisation for the biocidal product family, and to record the SPC and the product assessment report on the product family in the Register in accordance with Article 71(6) of Regulation (EU) No 528/2012. (7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation is granted to Hypred SAS for the biocidal product family Hypred's iodine based products with authorisation number EU-0018397-0000. The Union authorisation is valid from 11 October 2018 until 30 September 2028. The Union authorisation is subject to compliance with the SPC set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 September 2018. For the Commission The President Jean-Claude Juncker

Annex

ANNEX Summary of product characteristics for a biocidal product family HYPRED's iodine based products Product type 3 — Veterinary hygiene (Disinfectants) Authorisation number: EU-0018397-0000 R4BP asset number: EU-0018397-0000 PART I FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION 1.1. Family name NameHYPRED'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 holderNameHypred SASAddress55, Boulevard Jules Verger - BP10180 35803 DINARD Cedex FranceAuthorisation numberEU-0018397-0000R4BP asset numberEU-0018397-0000Date of the authorisation11 October 2018Expiry date of the authorisation30 September 2028 1.4. Manufacturer(s) of the biocidal products Name of manufacturerHYPRED SASAddress of manufacturer55, Boulevard Jules Verger - BP10180 35803 DINARD FranceLocation of manufacturing sites HYPRED SAS - 55, Boulevard Jules Verger - BP10180 35803 DINARD France HYPRED POLSKA SP. Z O.O. NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland HYPRED IBERICA S.L Pol. Ind. Arazuri-Orcoyen C/C no 32 31160 Orcoyen – NAVARRA Spain HYPRED GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany HYPRED Italia s.r.l. Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy 1.5. Manufacturer(s) of the active substance(s) Active substanceIodineName of manufacturerCOSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. N°96.625.710-5Address of manufacturerTerrenos de Elena S/N Terrenos de Elena S/N Huara, Región de Tarapacá ChileLocation of manufacturing sites Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad. Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile

Active substanceIodineName of manufacturerACF MINERA SAAddress of manufacturerSan Martín 499 Iquique ChileLocation of manufacturing sitesFaena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte ChileActive substanceIodineName of manufacturerSOCIEDAD QUIMICA y MINERA SAAddress of manufacturerLos Militares 4290 SANTIAGO DE CHILE ChileLocation of manufacturing sites Pedro de Valdivia (PV) Route B 180 Antofagasta Chile Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxIodineActive substance7553-56-2231-442-40,252,5Alcohols, 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 liquid SL - Soluble concentrate PART II SECOND INFORMATION LEVEL - META SPC(S) META SPC 1

1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. 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 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxIodineActive substance7553-56-2231-442-40,250,49Alcohols, 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 FormulationAL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
4. AUTHORISED USE(S) OF THE META SPC 1 4.1. Use description Table 1. Use # 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) Bacteria Yeasts Algae Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping after milking Application method(s) Dipping - Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine. Application rate(s) and frequency 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) Frequency: 2 to 3 times per day Category(ies) of usersProfessionalPack sizes and packaging material

HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000 L 4.1.1. Use-specific instructions for use See general directions for use of meta SPC 1 4.1.2. Use-specific risk mitigation measures See general directions for use of meta SPC 1 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use of meta SPC 1 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging None: See general directions for use of meta SPC 1 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 1 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1. OF THE META SPC 1 5.1. Instructions for 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 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 measures Wear 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 environment Take the contaminated clothes and shoes off immediately. Wash them before wearing them again. FIRST AID INSTRUCTIONS In 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 packaging At 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 storage Shelf life: 2 years in HDPE Do not store at a temperature higher than 30 °C. 6. OTHER INFORMATION 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Dip-io 2500 JOD DIP IODERM PSP DERMINO FR Iododip IODEX EXTRA Iodystrong DERMIODE INO IODE EPAIS INO STAR + IODACTIV 2500 IODIUM BX2500 Usual Iod Post ASiRAL Dip Coat IODOCAN EXTRA UDDER PLUS PRIMADIODE CERTIODE EPAIS IODIPACK GEL HELIO IODE EPAIS VAGEL GELAPIS ACTIV IOSAPIS GEL ZENCARE FLASH REPROGEL DERMADINE + KRONI Jod Dipp 2500 WÜBBELMANN JOD DIP Iodine Cleaner&Sanitizer MUNGIFILM ZEP FS FILMIODINE NIPPLE NP Authorisation numberEU-0018397-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,25Alcohols, 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 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Dip-io YB MAX INO Io Dip MAX JOD DIP YB MAX IodoDip YB MAX Iodium Dip YB MAX JodyDip YB MAX Delta IoDip YB MAX Authorisation numberEU-0018397-0002 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,49Alcohols, 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 2

1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. 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 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxIodineActive substance7553-56-2231-442-40,250,49Alcohols, 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 FormulationAL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children.

Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. 4. AUTHORISED USE(S) OF THE META SPC 2 4.1. Use description Table 2. Use # 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) Bacteria Yeasts Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking Application method(s) Dipping, foaming or spraying before milking - Manual or automated disinfection of teats by dipping, foaming or spraying before milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency 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) Frequency: 2 to 3 times per day Category(ies) of usersProfessionalPack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000 L 4.1.1. Use-specific instructions for use 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 SPC 2. 4.1.2. Use-specific risk mitigation measures For 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 environment See general directions for use of meta SPC 2 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 2 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 2 4.2. Use description Table 3. Use # 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) Bacteria Yeasts Algae Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking Application method(s) Dipping, foaming, spraying after milking - Manual or automated disinfection of teats by dipping, foaming or spraying after milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency 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) Frequency: 2 to 3 times per day Category(ies) of usersProfessionalPack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000 L 4.2.1. Use-specific instructions for use 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 2. 4.2.2. Use-specific risk mitigation measures 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 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 environment See general directions for use of meta SPC 2 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 2 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 2 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2. OF THE META SPC 2 5.1. Instructions for use See 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 milking Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures See 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 environment Take the contaminated clothes and shoes off immediately. Wash them before wearing them again. FIRST AID INSTRUCTIONS In 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 packaging At 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 storage Shelf life: 2 years in HDPE Do not store at a temperature higher than 30 °C. 6. OTHER INFORMATION 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Liq-io 2500 JOD SPRAY IODINE 3000 RTU IODEX 2500 Usual Iod Liquid Iodoliquid Iodospray DESINTEAT IODYSPRAY RBT 2500 IODY'FLASH INO IODE SPRAY IODYPRO 2500 IODYPRO BL2500 Robot Liq-io 25 ADF iDip+ ASiRAL Dip Spray J IODIPACK HELIO IODE LIQUIDE POLY-IODE CERTIODE LIQUIDE IOSAPIS FLUID GELAPIS ROBOT ZENCARE SPRAY HELIO IODE SPRAY + IODIP + KRONI Jod Spray 2500 WÜBBELMANN JOD LIQUID Authorisation numberEU-0018397-0003 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,25Alcohols, 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 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Liq-io YB MAX INO Io Liquid Max Iodoliquid YB MAX Iodospray YB MAX Desinteat YB MAX Iodium Spray YB MAX JodySpray YB MAX Delta IoSpray YB MAX Authorisation numberEU-0018397-0004 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,49Alcohols, 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

META SPC 3

1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. 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 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxIodineActive substance7553-56-2231-442-42,52,5Alcohols, 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 FormulationSL - Soluble concentrate
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements Causes serious eye damage. May cause damage to organs (thyroid) through prolonged or repeated exposure oral. Toxic to aquatic life with long lasting effects. May be corrosive to metals. Precautionary statements Keep out of reach of children. Do not breathe mist. Do not breathe vapours. Do not breathe spray. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a poison center/doctor. Get medical advice/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 container. Absorb spillage to prevent material damage.
4. AUTHORISED USE(S) OF THE META SPC 3 4.1. Use description Table 4. Use # 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) Bacteria Yeasts Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying before milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency 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) Frequency: 2 to 3 times per day Category(ies) of usersProfessionalPack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000 L 4.1.1. Use-specific instructions for use Prepare 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 measures 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 environment See general directions for use of meta SPC 3 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 3 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 3 4.2. Use description Table 5. Use # 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) Bacteria Yeasts Algae Viruses Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying after milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency 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) Frequency: 2 to 3 times per day Category(ies) of usersProfessionalPack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000 L 4.2.1. Use-specific instructions for use Prepare 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 measures For 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 environment See general directions for use of meta SPC 3 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 3 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 3 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3. OF THE META SPC 3 5.1. Instructions for use See 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 measures See 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 environment Take 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 INSTRUCTIONS In 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 packaging At 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 storage Shelf life: 2 years in HDPE Do not store at a temperature higher than 30 °C. 6. OTHER INFORMATION 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Liq-io concentrate INO Jod Konzentrat Usual Iod Concent Iodoconcentrat D 10 IODINE D 5 IODINE Liq-io C INO IODE C D 4 IODINE ADF iDip+ concentrate Mammizan Concentré Authorisation numberEU-0018397-0005 1-3Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-42,5Alcohols, 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 4

1. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. 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 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 4 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxIodineActive substance7553-56-2231-442-40,50,5Alcohols, 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 FormulationAL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statements Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
4. AUTHORISED USE(S) OF THE META SPC 4 4.1. Use description Table 6. Use # 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)

Bacteria Yeasts Algae Viruses Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping after milking Application method(s) Dipping - Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine. Application rate(s) and frequency 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) Frequency: 2 to 3 times per day Category(ies) of usersProfessionalPack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000 L 4.1.1. Use-specific instructions for use See general directions for use of meta SPC 4 4.1.2. Use-specific risk mitigation measures See general directions for use of meta SPC 4 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use of meta SPC 4 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 4 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 4 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4. OF THE META SPC 4 5.1. Instructions for 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 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 measures Wear 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 environment Take the contaminated clothes and shoes off immediately. Wash them before wearing them again. FIRST AID INSTRUCTIONS In 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 packaging At 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 storage Shelf life: 2 years in HDPE Do not store at a temperature higher than 30 °C. 6. OTHER INFORMATION 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Dip-io 5000 IODIUM TX INO JOD 50 DIP Usual Iod Post + IODIUM PRO DIP IODERM PSP + IODEX EXTRA + Iododip + IODYSTRONG PLUS INO TREMP INO STAR IODACTIV 5000 DERMINO IODERM 5000 IODIUM BX5000 HOEVE-PLUS DIP TREMPASEPT IODE DERMADINE MAMMO-DERM KRONI Jod Dipp 5000 Authorisation numberEU-0018397-0006 1-4 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,5Alcohols, 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 5

1. META SPC 5 ADMINISTRATIVE INFORMATION 1.1. 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 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 5 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxIodineActive substance7553-56-2231-442-40,550,55Alcohols, 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 FormulationAL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 Hazard statements Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children. Wash hands thoroughly after handling.

Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. 4. AUTHORISED USE(S) OF THE META SPC 5 4.1. Use description Table 7. Use # 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) Bacteria Yeasts Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying before milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency 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) Frequency: 2 to 3 times per day Category(ies) of usersProfessionalPack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000 L 4.1.1. Use-specific instructions for use Fill 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 measures For 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 environment See general directions for use of meta SPC 5 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 5 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 5 4.2. Use description Table 8. Use # 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) Bacteria Yeasts Algae Viruses Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying after milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine. Application rate(s) and frequency 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) Frequency: 2 to 3 times per day Category(ies) of usersProfessionalPack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1000 L 4.2.1. Use-specific instructions for use Fill 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 measures 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 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 environment See general directions for use of meta SPC 5 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 5 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 5 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5. OF THE META SPC 5 5.1. Instructions for use See 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 milking. Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures See 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 environment Take the contaminated clothes and shoes off immediately. Wash them before wearing them again. FIRST AID INSTRUCTIONS In 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 packaging At 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 storage Shelf life: 2 years in HDPE Do not store at a temperature higher than 30 °C. 6. OTHER INFORMATION 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Liq-io 5500 IODYPRO INO JOD 50 Liquid Usual Iod Liquid + IODIUM PRO SPRAY IODEX Iodoliquid + Iodospray Plus DESINTEAT PLUS ROBOSPRAY IODE INOTRAYON IODYPRO 5500 Robot Liq-io 55 IODYPRO BL5500 ADF iDip+ 5500 HOEVE-JODIUM SPRAY GRUPAIODE IODOCAN JOFO JODI PLUS K-AGRO PRODIP ID IODIP HELIO IODE SPRAY MAMMO-JOD KRONI Jod Spray 5500 MUNGI-IOD LELY QUARESS-Iodine Authorisation numberEU-0018397-0007 1-5Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,55Alcohols, 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