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Commission Implementing Regulation (EU) 2026/473of 14 October 2025amending Implementing Regulation (EU) 2020/1187 granting a Union authorisation for the biocidal product family Iodine based products – CID LINES NV(Text with EEA relevance)

Den Europæiske UnionForordning2026

European Union

Commission Implementing Regulation (EU) 2026/473 of 14 October 2025 amending Implementing Regulation (EU) 2020/1187 granting a Union authorisation for the biocidal product family Iodine based products – CID LINES NV (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, ELI: http://data.europa.eu/eli/reg/2012/528/oj. , and in particular Article 48(1), point (a), thereof, Whereas: (1) On 7 August 2020, a Union authorisation was granted to CID Lines NV for the making available on the market and use of the biocidal product family Iodine based products – CID LINES NV (biocidal product family) by Commission Implementing Regulation (EU) 2020/1187 Commission Implementing Regulation (EU) 2020/1187 of 7 August 2020 granting a Union authorisation for the biocidal product family Iodine based products – CID LINES NV (OJ L 268, 14.8.2020, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2020/1187/oj). for use of the products in product-types 3 and 4 as specified in the summary of product characteristics (SPC) in the Annex to that Regulation. (2) The biocidal product family contains the active substances iodine and polyvinylpyrrolidone iodine. Both active substances were approved, among others, for product-types 3 and 4 by Commission Implementing Regulation (EU) No 94/2014 Commission Implementing Regulation (EU) No 94/2014 of 31 January 2014 approving iodine, including polyvinylpyrrolidone iodine, as an existing active substance for use in biocidal products for product-types 1, 3, 4 and 22 (OJ L 32, 1.2.2014, p. 23, ELI: http://data.europa.eu/eli/reg_impl/2014/94/oj). which provided the expiry date of approval of 31 August 2025. (3) For iodine and polyvinylpyrrolidone iodine, for product-type 4, no applications for renewal were submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 by the deadline. Therefore, the approval of both active substances for use in products for product-type 4 will expire on 31 August 2025. (4) Consequently, for the uses of the biocidal product family belonging to product-type 4 the condition for authorisation of Article 19(1), point (a), of Regulation (EU) No 528/2012 requiring that the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met, will not be fulfilled as of 1 September 2025. (5) All the indications of product-type 4, including the related uses and the related information should therefore be removed from the SPC in initial meta SPCs 7 and 8, and the initial meta SPC 9 should be removed completely. The Union authorisation should be amended accordingly. (6) On 2 April 2025, the Commission informed CID Lines NV of its intention to amend the Union authorisation for the biocidal product family and gave it the opportunity to submit comments or additional information in accordance with Article 48(2) of Regulation (EU) No 528/2012. On 16 April 2025, CID Lines NV responded that it takes note of the information and does not have comments.

(7) It is therefore appropriate to grant a period of grace for the making available on the market and the use of the existing stocks in accordance with Article 52 of Regulation (EU) No 528/2012. (8) In order to enhance clarity and ease the access of users and interested parties to the final version of the SPC which is to be published in the register of biocidal products, the Annex to Implementing Regulation (EU) 2020/1187 should be replaced in its entirety. (9) Implementing Regulation (EU) 2020/1187 should therefore be amended accordingly, HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2020/1187 is replaced by the text set out in the Annex to this Regulation.

Article 2

Biocidal products of the biocidal product family Iodine based products – CID LINES NV may be made available on the market for uses belonging to product-type 4 until 27 February 2026 and such biocidal products may be used until 26 August 2026.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 September 2025. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 14 October 2025. For the Commission The President Ursula von der Leyen

Annex

ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY Iodine based products – CID LINES NV Product type(s) PT03: Veterinary hygiene Authorisation number: EU-0022265-0000 R4BP asset number: EU-0022265-0000 PART I FIRST INFORMATION LEVEL

  1. ADMINISTRATIVE INFORMATION 1.1. Family name NameIodine based products – CID LINES NV 1.2. Product type(s) Product type(s)PT03: Veterinary hygiene 1.3. Authorisation holder Name and address of the authorisation holderNameCID LINES NVAddressWaterpoortstraat 2 8900 Ieper BelgiumAuthorisation numberEU-0022265-0000R4BP asset numberEU-0022265-0000Date of the authorisation3 September 2020Expiry date of the authorisation31 August 2030 1.4. Manufacturer(s) of the product Name of manufacturerCID LINES NVAddress of manufacturerWaterpoortstraat 2 8900 Ieper BelgiumLocation of manufacturing sitesCID LINES NV site 1 Waterpoortstraat 2 8900 Ieper Belgium 1.5. Manufacturer(s) of the active substance(s) Active substanceIodineName of manufacturerSQM S.A.Address of manufacturerLos Militares, Piso 4 4290 Santiago Chile Location of manufacturing sitesSQM S.A. site 1 Nueva Victoria plant 00 Pedro de Valdivia ChileActive substanceIodineName of manufacturerCosayach Nitratos S.A.Address of manufacturerAmunategui 178 00 Santiago ChileLocation of manufacturing sitesCosayach Nitratos S.A. site 1 Cala Cala 00 Pozo Almonte ChileActive substanceIodineName of manufacturerACF Minera S.A.Address of manufacturerSan Martin No 499 00 Iquique ChileLocation of manufacturing sitesACF Minera S.A. site 1 Lagunas mine 00 Pozo Almonte ChileActive substanceIodineName of manufacturerISE Chemicals CorporationAddress of manufacturer3-1, Kyobashi 1-Chome 104-0031 Tokyo JapanLocation of manufacturing sitesISE Chemicals Corporation site 1 3695 Kitaimaizumi 299-3201 Oamishirasato city JapanActive substancePolyvinylpyrrolidone iodineName of manufacturerISP Chemicals LLC, Afiliate of Ashland IncAddress of manufacturer455 N. main st (HWY 95) KY 42029 Calvert City United States (the)Location of manufacturing sitesISP Chemicals LLC, Afiliate of Ashland Inc site 1 455 N. main st (HWY 95) KY 42029 Calvert City United States (the)Active substancePolyvinylpyrrolidone iodineName of manufacturerPantheon FZE (DMCC branch)Address of manufacturer403, Reef Tower, Jumeira Lake Tower Shaikh Zayed Road 00 Dubai United Arab Emirates (the)Location of manufacturing sitesPantheon FZE (DMCC branch) site 1 Cala Cala 00 Pozo Almonte Chile
  1. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40-3 % (w/w)Polyvinylpyrrolidone iodineActive substance25655-41-80-10 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylated láiteNon-active substance68131-39-5500-195-70-21 % (w/w)Phosphoric acidPhosphoric acidNon-active substance7664-38-2231-633-20-30 % (w/w)Alcohol C9-11 +6 EOAlcohol C9-11 +6 EONon-active substance68439-46-30-12,5 % (w/w) 2.2. Type(s) of formulation Formulation type(s) AL Any other liquid SL Soluble concentrate PART II SECOND INFORMATION LEVEL META SPC(S)
  2. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier IdentifierMeta SPC: metaSPC 1: PT3 – Concentrated teat disinfectants Iodine 1.2. Suffix to the authorisation number Number1-1 1.3. Product type(s) Product type(s)PT03: Veterinary hygiene
  3. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-41,5-1,5 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-712,05-12,05 % (w/w) 2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s)SL Soluble concentrate
  4. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements H318: Causes serious eye damage. H412: Harmful to aquatic life with long lasting effects. H373: May cause damage to organs (thyroid) through prolonged or repeated exposure (oral). Precautionary statements P280: Wear eye protection. P280: Wear protective clothing. P280: Wear protective gloves. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a doctor, a poison center. P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  5. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3 – Concentrated Teat disinfectant, post-milking, Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use– Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use Indoor use Post-milking teat disinfection of milk producing animals Application method(s) Method: Manual or automatic spraying on teats Detailed description: – Application rate(s) and frequency

Application Rate: Dilute the product to a final concentration of 0,3% (w/w) available iodine. Number and timing of application: Apply 2 times per day with manual sprayer and 3 times per day with a robot. Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE (High Density Polyethylene) 4.1.1. Use-specific instructions for use See general directions for use. 4.1.2. Use-specific risk mitigation measures See general directions for use. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use The product must be diluted before use with clean potable water to allow a final concentration of iodine of 0,3 % (200 ml product, add water up to 1 l). The diluted product must be brought to a temperature above 20 °C before use. Assume 5 ml diluted product per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended. Use gloves and eye protection during the dilution step. The diluted product can be kept and used during 1 week but do not prepare more fluid than necessary. Apply the diluted product on the teats with a manual sprayer or with an automatic sprayer. The product should be used directly after milking 2 times per day by using a manual sprayer and 3 times per day when using a robot (automatic sprayer). Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). Do not mix with other chemicals. 5.2. Risk mitigation measures For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection. For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information). If a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection. Keep out of reach of children. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand. After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice. Have product container or label at hand. 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. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. Protect from frost. Do not expose to temperatures > 40 °C. The shelf-life of the products is 2 years. 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)Kenodin SD 400Market area: EUIodoSD 400Market area: EUVelvet ConcentrateMarket area: EUWynnsan Iodine 3 - 1 concMarket area: EUIodin Teat Spray 400Market area: EUAuthorisation numberEU-0022265-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-41,5 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-712,05 % (w/w)

  1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier IdentifierMeta SPC: metaSPC 2: PT3 – Ready to Use (RTU) Teat disinfectants Iodine 1.2. Suffix to the authorisation number Number1-2 1.3. Product type(s) Product type(s)PT03: Veterinary hygiene
  2. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,3-0,3 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,1-2,9 % (w/w) 2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s)AL Any other liquid
  3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statementsH412: Harmful to aquatic life with long lasting effects.Precautionary statements P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3– RTU Teat disinfectant, post-milking, Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use–Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data

Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use Indoor use Post-milking teat disinfection of milk producing animals Application method(s) Method: By dipping or spraying on teats Detailed description: – Application rate(s) and frequency Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE 4.1.1. Use-specific instructions for use See general directions for use. 4.1.2. Use-specific risk mitigation measures See general directions for use. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1. Instructions for use The product must be brought to a temperature above 20 °C before use. Apply the product by dipping or by spraying: By dipping: Apply the product with a dip cup. Wash the dip cup with water after use. By spraying: Apply the product with a manual sprayer or with an automatic sprayer. Do not prepare more fluid than necessary; assume 5 ml solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended. The product should be used immediately after each milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). Do not mix with other chemicals. 5.2. Risk mitigation measures For manual dipping application: No special protection equipment is recommended under normal conditions of use. For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information. If 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. Keep out of reach of children. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment After eye contact: Rinse immediately with water. After ingestion: Rinse mouth. Spit. 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. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use. Protect from frost. Do not expose to temperatures > 40 °C. The shelf-life of the products is 2 years. 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)IodoDip 3000Market area: EUBio Tec Jodip 3000Market area: EURecoïodeMarket area: EUStalosan Io DipMarket area: EUStalosan Super DipMarket area: EUVelvet High ViscoMarket area: EUBühning Joddip 3000Market area: EUKenodinMarket area: EU Wynnsan trikill RTUMarket area: EUWynnsan Iodine RTU teat dipMarket area: EUWynnsan Iodine dip RTUMarket area: EUIocidMarket area: EUIodip+Market area: EUWynngold Iodine DipMarket area: EUPezerk iv plusMarket area: EUIod protect 3000 FilmMarket area: EUSeivit® Iode 3000Market area: EUKenostartMarket area: EUGAHERYODMarket area: EUKenodin 3000Market area: EUIodin Teat Dip 3000Market area: EUIod 3000 dipMarket area: EUIodoschutz dipMarket area: EUIoschutz dipMarket area: EUIodocoop dipMarket area: EUIodotech dipMarket area: EUIodactiv’ dipMarket area: EUIododipMarket area: EUMIROX Dip JodMarket area: EUHCP Iodine DipMarket area: EUAgib Jodium DipMarket area: EUJod 3000Market area: EUIod dipMarket area: EUIode 3000Market area: EU IodoschutzMarket area: EUCoopjodMarket area: EUCoopiodeMarket area: EUCoopiode épaisMarket area: EUSemex jodMarket area: EUIodotechMarket area: EUIododip greenMarket area: EUIodip bioMarket area: EUIododip bioMarket area: EUIodactive épaisMarket area: EUIodactivMarket area: EUIodoactiv’Market area: EUBayley’s Premier Iodine Teat DipMarket area: EUPearce Premier Iodine Teat DipMarket area: EUDiamond 1:3 Concentrate Iodine Post Dip SprayMarket area: EUJODOCAREMarket area: EUKENOSTART DYPMarket area: EUSTREPTOFITMarket area: EUIodall FilmMarket area: EUAuthorisation numberEU-0022265-0002 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,3 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,17 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Kenodin FilmMarket area: EUIodoFilmMarket area: EUWynnsan Iofilm teat dipMarket area: EUKenodin Film ExtraMarket area: EUWynngold FilmMarket area: EUWynnsan trikill film teat dipMarket area: EUKenodin Film SoftMarket area: EUIocid FilmMarket area: EUTOP FilmMarket area: EUSeivit® Iode GelMarket area: EUIOD protect 3000 FilmMarket area: EUIodin Film Teat Dip 3000Market area: EUIodin Barrier Teat Dip 3000Market area: EUIodin Film Teat DipMarket area: EUIodin Barrier Teat DipMarket area: EUIod 3000 filmMarket area: EUIodoschutz filmMarket area: EUIoschutz filmMarket area: EUIodocoop filmMarket area: EUIodotech filmMarket area: EUIodactiv’ filmMarket area: EUIodofilmMarket area: EUHCP Iodine FilmMarket area: EU

Iod 3000 filmMarket area: EUCoopjod filmMarket area: EUCoopiode filmMarket area: EUIodocoop filmMarket area: EUSemex jod filmMarket area: EUIodofilmMarket area: EUIodofilm bioMarket area: EUIofilm bioMarket area: EUIodactive filmMarket area: EUIodactiv filmMarket area: EUIodactiv’ filmMarket area: EUSCUDO 3000Market area: EUAuthorisation numberEU-0022265-0003 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,3 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,9 % (w/w)

  1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier IdentifierMeta SPC: metaSPC 3: PT3 – RTU Udder disinfectant Iodine 1.2. Suffix to the authorisation number Number1-3 1.3. Product type(s) Product type(s)PT03: Veterinary hygiene
  2. META SPC 3 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,3-0,99 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,17-2,95 % (w/w) 2.2. Type(s) of formulation of the meta SPC 3 Formulation type(s)AL Any other liquid
  3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statementsH412: Harmful to aquatic life with long lasting effects.Precautionary statements P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3 – RTU Udder disinfectants, Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use–Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Field(s) of use Indoor use Skin disinfection only for use on intact skin of: the udder of dairy and beef cattle before calving the udder of sows before farrowing Application method(s) Method: spraying Detailed description: – Application rate(s) and frequency Application Rate: The product is ready to use. Number and timing of application: Apply to: the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 ml per application) the udder of sows: 15 to 20 ml per animal Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE 4.1.1. Use-specific instructions for use See general directions for use. 4.1.2. Use-specific risk mitigation measures See general directions for use. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3 5.1. Instructions for use For disinfection of the skin: 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. Apply by spraying on the animals’ intact skin for a topical disinfection: on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 ml per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing at least 5 minutes); on the udder of sows before farrowing: Assume 15 to 20 ml per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). Only for use on intact skin. Do not mix with other chemicals. 5.2. Risk mitigation measures For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information). In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections. Keep out of reach of children. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment After eye contact: Rinse immediately with water. After ingestion: Rinse mouth. Spit 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. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use. Protect from frost. Do not expose to temperatures > 40 °C. The shelf-life of the products is 2 years. 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)Animal Skin DisinfectantMarket area: EUDermades 3000Market area: EUIodin Skin DisinfectantMarket area: EUAuthorisation numberEU-0022265-0004 1-3Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,3 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,17 % (w/w)

7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)DermadesMarket area: EUAnimal skin disinfectant 1 %Market area: EUDermades StrongMarket area: EUIodin Skin Disinfectant StrongMarket area: EUAuthorisation numberEU-0022265-0005 1-3Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,99 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,95 % (w/w)

  1. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier IdentifierMeta SPC: metaSPC 4: PT3 – RTU Udder and Teat disinfectants Iodine 1.2. Suffix to the authorisation number Number1-4 1.3. Product type(s) Product type(s)PT03: Veterinary hygiene
  2. META SPC 4 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 4 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,3-0,3 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,17-2,17 % (w/w) 2.2. Type(s) of formulation of the meta SPC 4 Formulation type(s)AL Any other liquid
  3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statementsH412: Harmful to aquatic life with long lasting effects.Precautionary statements P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3 – RTU Teat disinfectant, Post-milking, Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use–Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use Indoor use Ready to use teat disinfectant to be used post milking on milk producing animals. Application method(s) Method: Dipping or Spraying Detailed description: – Application rate(s) and frequency Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE 4.1.1. Use-specific instructions for use For disinfection of the teats: The product must be brought to a temperature above 20 °C before use. By dipping: Apply the product on the teats with a dip cup. Wash the dip cup with water after use. By spraying: Apply the product on the teats with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary. Assume 5 ml solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended. The product should be used directly after milking by using a dipping cup or a manual or automatic sprayer. Ensure that the teat is completely covered to three quarters of its length. The product is applied after milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Let the product dry on the teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). Do not mix with other chemicals. 4.1.2. Use-specific risk mitigation measures For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information). For manual dipping application: no Personal Protection Equipment (PPE) is necessary for safe use. If a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection. Keep out of reach of children. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 4.2. Use description Table 2 PT3 – RTU Udder disinfectant, Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use– Target organism(s) (including development stage) Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Bacteria Development stage: no data Field(s) of use Indoor use Ready to use skin disinfectant, only for use on intact skin of: the udder of dairy and beef cattle before calving the udder of sows before farrowing Application method(s) Method: Application on animal skin: by spraying Detailed description: – Application rate(s) and frequency Application Rate: The product is ready to use. Number and timing of application: Apply to: the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 ml per application) the udder of sows: 15 to 20 ml per animal Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE 4.2.1. Use-specific instructions for use For disinfection of the skin: 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. Apply by spraying on the animals’ intact skin for a topical disinfection:

on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 ml per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes); on the udder of sows before farrowing: Assume 15 to 20 ml per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). Let the product dry on skin. Only for use on intact skin. Do not mix with other chemicals. 4.2.2. Use-specific risk mitigation measures For manual spraying application on cows and sows: no PPE is necessary for safe use. Keep out of reach of children. 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4 5.1. Instructions for use See use-specific instructions for use. 5.2. Risk mitigation measures See use-specific risk mitigation measures 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment After eye contact: Rinse immediately with water. After ingestion: Rinse mouth. Spit. 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. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. Protect from frost. Do not expose to temperatures > 40 °C. The shelf-life of the products is 2 years. 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)Kenodin SDMarket area: EUIodoSD 3000Market area: EUBio Tec Jodspray 3000Market area: EUQ Farm Iodine DesMarket area: EUANRO - Euterpflege DipMarket area: EU Stalosan Io SprayMarket area: EUStalosan Super SprayMarket area: EUIDip+Market area: EUBühning Jodspray 3000Market area: EUVelvet RTUMarket area: EUWynnsan trikill sprayMarket area: EUWynnsan Iodine spray RTUMarket area: EUWynngold Iodine Dip and sprayMarket area: EUPezerk ILMarket area: EUIod protect 3000 SprühMarket area: EUSeivit® Iode SprayMarket area: EUIOD protect 3000 SprühMarket area: EUKenodin SprayFilmMarket area: EUIodo SPMarket area: EUKenostart SDMarket area: EUGAHERYOD SPRAYMarket area: EUIodin Teat & Skin 3000Market area: EUIod 3000 sprühMarket area: EUIodoschutz sprühMarket area: EUIoschutz sprühMarket area: EU

Iodocoop sprühMarket area: EUIodotech sprühMarket area: EUIodactiv’ sprühMarket area: EUIodosprühMarket area: EUMIROX Spray JodMarket area: EUHCP Iodine SDMarket area: EUAgib Jodium SprayMarket area: EUJod 3000 sprayMarket area: EUIod sprühMarket area: EUCoopjodMarket area: EUCoopiode sprayMarket area: EUIodocoop sprayMarket area: EUSemex jod sprayMarket area: EUIododip sprayMarket area: EUIododip spray greenMarket area: EUIodospray BioMarket area: EUIospray bioMarket area: EUIodactive sprayMarket area: EUIodactiv sprayMarket area: EUIodactiv’ sprayMarket area: EUArk Iodine S+DMarket area: EU Agrihealth Iodine SDMarket area: EUAGRO LOGIC JODOCARE SPRAYMarket area: EUIODACTIVEMarket area: EUAuthorisation numberEU-0022265-0006 1-4Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,3 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,17 % (w/w)

  1. META SPC 5 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 5 identifier IdentifierMeta SPC: metaSPC 5: PT3 – RTU Teat disinfectants PVP-Iodine 1.2. Suffix to the authorisation number Number1-5 1.3. Product type(s) Product type(s)PT03: Veterinary hygiene
  2. META SPC 5 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 5 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Polyvinylpyrrolidone iodineActive substance25655-41-83-3 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-71,5-2,9 % (w/w) 2.2. Type(s) of formulation of the meta SPC 5 Formulation type(s)AL Any other liquid
  3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 Hazard statementsH412: Harmful to aquatic life with long lasting effects.Precautionary statements P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3 – RTU Teat disinfectant, post milking, PVP-Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use–Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use Indoor use Post-milking disinfection on teats of milk producing animals Application method(s) Method: Dipping or spraying Detailed description: – Application rate(s) and frequency Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.

Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE 4.1.1. Use-specific instructions for use See general directions for use. 4.1.2. Use-specific risk mitigation measures See general directions for use. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5 5.1. Instructions for use 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. Apply the product by dipping or by spraying: By dipping: Apply the product with a dip cup. Wash the dip cup with water after use. By spraying: Apply the product with a manual sprayer or with an automatic sprayer. Do not prepare more fluid than necessary. Assume 5 ml solution per cow per treatment. The product should be used immediately after each milking, two times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). Do not mix with other chemicals. 5.2. Risk mitigation measures For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information. For manual dipping application: no PPE is necessary for safe use. If 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. Keep out of reach of children. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment After eye contact: Rinse immediately with water. After ingestion: Rinse mouth. Spit. 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. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use. Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 18 months. 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)Iodo PVPMarket area: EUIodin Teat Dip 3000 PVPMarket area: EUAuthorisation numberEU-0022265-0007 1-5Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Polyvinylpyrrolidone iodineActive substance25655-41-83 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,5 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Iodo SD PVPMarket area: EUIodin Teat Spray & Dip 3000 PVPMarket area: EUAuthorisation numberEU-0022265-0008 1-5Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Polyvinylpyrrolidone iodineActive substance25655-41-83 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,5 % (w/w)

  1. META SPC 6 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 6 identifier IdentifierMeta SPC: metaSPC 6: PT3 – RTU Udder disinfectants PVP-Iodine 1.2. Suffix to the authorisation number Number1-6 1.3. Product type(s) Product type(s)PT03: Veterinary hygiene
  2. META SPC 6 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 6 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Polyvinylpyrrolidone iodineActive substance25655-41-810-10 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72-2 % (w/w) 2.2. Type(s) of formulation of the meta SPC 6 Formulation type(s)AL Any other liquid
  3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 Hazard statements H412: Harmful to aquatic life with long lasting effects. H373: May cause damage to organs (thyroid) through prolonged or repeated exposure (oral). Precautionary statements P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P260: Do not breathe spray.
  4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3 – RTU Udder disinfectant PVP-Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use–Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Field(s) of use Indoor use Ready to use skin disinfectant, only for use on intact skin of: the udder of dairy and beef cattle: before calving the udder of sows: before farrowing Application method(s) Method: spraying Detailed description: – Application rate(s) and frequency Application Rate: The product is ready to use.

Number and timing of application: Apply to: The udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 ml per application) The udder of sows: 15 to 20 ml per animal Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE 4.1.1. Use-specific instructions for use 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. Dairy and beef cattle: Apply the product by spraying on the udder before calving (1 spray/teat equivalent to 4,8 ml per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). Sows, on the udder before farrowing: Assume 15 to 20 ml per animal. Disinfection takes place once, one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). Only for use on intact skin. Do not mix with other chemicals. 4.1.2. Use-specific risk mitigation measures For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information). In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections. Keep out of reach of children. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 6 5.1. Instructions for use See use-specific instructions for use. 5.2. Risk mitigation measures See use-specific risk mitigation measures. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment After eye contact: Rinse immediately with water. After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice. Have product container or label at hand. 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.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use. Protect from frost. Do not expose to temperatures > 40 °C. The shelf-life of the products is 2 years. 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Dermades PVPMarket area: EUWynngold 10 % Iodine SolutionMarket area: EUIodin Skin Disinfectant PVPMarket area: EUAuthorisation numberEU-0022265-0009 1-6Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Polyvinylpyrrolidone iodineActive substance25655-41-810 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72 % (w/w)

  1. META SPC 7 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 7 identifier IdentifierMeta SPC: metaSPC 7: PT3 – Concentrated Surface disinfectants Iodine 1.2. Suffix to the authorisation number Number1-7 1.3. Product type(s) Product type(s)PT03: Veterinary hygiene
  2. META SPC 7 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 7 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-41,8-2,49 % (w/w) Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-73,15-9,45 % (w/w)Alcohol C9-11 + 6 EOAlcohol C9-11 + 6 EONon-active substance68439-46-32,5-12,5 % (w/w) 2.2. Type(s) of formulation of the meta SPC 7 Formulation type(s)SL Soluble concentrate
  3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 Hazard statements H318: Causes serious eye damage. H373: May cause damage to organs (thyroid) through prolonged or repeated exposure (oral). H290: May be corrosive to metals. H411: Toxic to aquatic life with long lasting effects. Precautionary statements P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a doctor or a POISON CENTER. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P391: Collect spillage. P273: Avoid release to the environment.
  4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3 – Concentrated Surface disinfectant for veterinary use, Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use–Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data

Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use Indoor use Non-porous surface disinfection in veterinary field Application method(s) Method: By spraying with a manual or an automatic sprayer Detailed description: / Application rate(s) and frequency Application Rate: Assume 0,04 l solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,025 % in-use iodine Virucidal activity: 0,035 % in-use iodine Number and timing of application: See use-specific risk mitigation measures Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE 4.1.1. Use-specific instructions for use Use in veterinary field (PT3), surface disinfection: Product should be diluted with water before use (according to table below). Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water. The product is used to disinfect animal housings of pigs, cows and poultry. Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 30 minutes. Animal housing must be empty of animals during application and animals can re-enter 24h after the end of the application. Each product label should give information on how the dilution should be made. Since the concentration iodine in products within this meta SPC can range from 1,8 to 2,49 % it is not possible to indicate all product dilutions here. Example for a product containing 2,49 % iodineDilution of the productContact time Bactericidal and yeasticidal activity Virucidal activity 1 % (10ml product, add water up to 1 l)30 min1,4 % (14ml product, add water up to 1 l)30 min Do not mix with other chemicals. Do not prepare more fluid than necessary. 4.1.2. Use-specific risk mitigation measures During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coated coverall (material to be specified by the authorisation holder within the product information) and eye/face protection. During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information). Only use one kind of Iodine-containing product per day. Due to potential concern for human health, the same professional user shall not carry out animal house disinfection more than 3 times per month and shall not use Iodine products for other purposes during that period. Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application. Keep out of reach of children. The general public and animals should be kept away from treated areas until surfaces are dry.

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 7 5.1. Instructions for use See use-specific instructions for use. 5.2. Risk mitigation measures See use-specific risk mitigation measures. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist. If medical advice is needed, have product container or label at hand. After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice. Have product container or label at hand. 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. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use. Protect from frost. Do not expose to temperatures > 40 °C. The shelf-life of the products is 2 years. 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Dodin 20Market area: EUIodo 20Market area: EUBio Tec JoddesinfektionMarket area: EUDufa dine 1,8 %Market area: EUAlfasan super disinfectantMarket area: EUIodesMarket area: EUStreptocleanMarket area: EUIodin Surface Disinfectant 1,8 %Market area: EUIODINEMarket area: EUAuthorisation numberEU-0022265-0010 1-7 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-41,8 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-75,29 % (w/w)Alcohol C9-11 + 6 EOAlcohol C9-11 + 6 EONon-active substance68439-46-35 % (w/w)

  1. META SPC 8 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 8 identifier IdentifierMeta SPC: metaSPC 8: PT3 – Concentrated Surface disinfectants Iodine 1.2. Suffix to the authorisation number Number1-8 1.3. Product type(s) Product type(s)PT03: Veterinary hygiene
  2. META SPC 8 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 8

Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-42,5-3 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-73,15-9,45 % (w/w)Phosphoric acidPhosphoric acidNon-active substance7664-38-2231-633-25-12 % (w/w)Alcohol C9-11 + 6 EOAlcohol C9-11 + 6 EONon-active substance68439-46-32,5-12,5 % (w/w) 2.2. Type(s) of formulation of the meta SPC 8 Formulation type(s)SL Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8 Hazard statements H290: May be corrosive to metals. H315: Causes skin irritation. H318: Causes serious eye damage. H373: May cause damage to organs (thyroid) through prolonged or repeated exposure (oral). H411: Toxic to aquatic life with long lasting effects. Precautionary statements P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P310: Immediately call a POISON CENTER or doctor/physician. P342+P311: If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. P273: Avoid release to the environment. P391: Collect spillage. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3 – Concentrated Surface disinfectant for veterinary use, Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use– Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use Indoor use Non-porous surface disinfection in veterinary field Application method(s) Method: By spraying with a manual or an automatic sprayer Detailed description: / Application rate(s) and frequency Application Rate: Assume 0,04 l solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,025 % in-use iodine Virucidal activity: 0,035 % in-use iodine Number and timing of application: See use-specific risk mitigation measures. Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE 4.1.1. Use-specific instructions for use Use in veterinary field (PT3), surface disinfection: Product must be diluted with water before use (according to table below).

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water. The product is used to disinfect animal housings of pigs, cows and poultry. Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 30 minutes. Animal housing must be empty of animals during application and re-entry of animals can be done 24h after the end of the application. Each product label should give information on how the dilution should be made. Since the concentration iodine in products within this meta SPC can range from 1,8 to 2,49 % it is not possible to indicate all product dilutions here. Example for a product containing 2,5% iodineDilution of the productContact time Bactericidal and yeasticidal activity Virucidal activity 1 % (10ml product, add water up to 1 l)30 min1,4% (14 ml product, add water up to 1L)30 min Do not mix with other chemicals. Do not prepare more fluid than necessary. 4.1.2. Use-specific risk mitigation measures During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coverall (material to be specified by the authorisation holder within the product information)and eye/face protection. During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information). Only use one kind of Iodine-containing product per day. Due to potential concern for human health the same professional user shall not carry out animal house disinfection more than 3 times per month and shall not use Iodine products for other purposes during that period. Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application. Keep out of reach of children. The general public and animals should be kept away from treated areas until surfaces are dry. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 8 5.1. Instructions for use See use-specific instructions for use 5.2. Risk mitigation measures See use-specific risk mitigation measures. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand. After skin (or hair) contact: Remove contaminated clothing and shoes. Wash the affected area thoroughly with plenty of soap and water. Get medical attention if symptoms occur. After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice. Have product container or label at hand. 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. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. Protect from frost. Do not expose to temperatures > 40 °C. The shelf-life of the products is 2 years. 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Iocid 30Market area: EUIodo 30Market area: EUDufa dineMarket area: EUIodin Surface Disinfectant 2,8 %Market area: EUAuthorisation numberEU-0022265-0011 1-8Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-42,8 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-77,93 % (w/w)Phosphoric acidPhosphoric acidNon-active substance7664-38-2231-633-211,25 % (w/w)Alcohol C9-11 + 6 EOAlcohol C9-11 + 6 EONon-active substance68439-46-312,5 % (w/w)

  1. META SPC 9 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 9 identifier IdentifierMeta SPC: metaSPC 10: PT3 – Concentrated teat disinfectants Iodine 1.2. Suffix to the authorisation number Number1-10 1.3. Product type(s) Product type(s)PT03: Veterinary hygien ve
  2. META SPC 9 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 9 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-42,8-2,8 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-721-21 % (w/w) 2.2. Type(s) of formulation of the meta SPC 9 Formulation type(s)SL Soluble concentrate
  3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9 Hazard statements H318: Causes serious eye damage. H411: Toxic to aquatic life with long lasting effects. H373: May cause damage to organs (thyroid) through prolonged or repeated exposure (oral route). Precautionary statements P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a doctor or a poison center.

P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P391: Collect spillage. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3 – Concentrated teat disinfectant, Post-milking, Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use–Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use Indoor use Post-milking teat disinfection of milk producing animals Application method(s) Method: By spraying with a manual sprayer or with an automatic sprayer on teats. Detailed description: / Application rate(s) and frequency Application Rate: The product must be diluted before use in order to allow a final concentration of iodine of 0,3 % Number and timing of application: Apply 2 times per day by using a manual sprayer and 3 times per day when using a robot (or automatic sprayer). Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE 4.1.1. Use-specific instructions for use See general directions for use. 4.1.2. Use-specific risk mitigation measures See general directions for use. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 9 5.1. Instructions for use The product must be diluted before use in order to allow a final concentration of iodine of 0,3 %. The product should be diluted to 11 % (110 ml product, add water up to 1 l). Do not prepare more fluid than necessary. Assume 5 ml solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended. Use gloves and eye protection during the dilution step. The diluted product can be kept and used for 1 week. The product must be brought to a temperature above 20 °C before use. Apply the diluted product on the teats with a manual sprayer or with an automatic sprayer. The product should be used directly after milking 2 times per day by using a manual sprayer and 3 times per day by using a robot (automatic sprayer). Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals. 5.2. Risk mitigation measures For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection. For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection. If a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection. Keep out of reach of children. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist. If medical advice is needed, have product container or label at hand. After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice. Have product container or label at hand. 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. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use. Protect from frost. Do not expose to temperatures > 40 °C. The shelf-life of the products is 2 years. 6. OTHER INFORMATION Dilutions of the product(s) are stable for 1 week. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Kenodin SD 900Market area: EUIodoSD 900Market area: EUIDip+ concentrateMarket area: EUJodkonzentrat 1:9Market area: EUBühning Jodkonzentrat 1:9Market area: EUWynnsan Iodine Conc dip 9-1Market area: EUKenodin 900Market area: EUDufa DipMarket area: EUKenostart 900Market area: EUIodin Teat Spray 900Market area: EUHCP Iodine ConcentrateMarket area: EUMaxi Subliem CPMarket area: EUSubliem Koncentrat PlusMarket area: EUAuthorisation numberEU-0022265-0013 1-10 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-42,8 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-721 % (w/w)

  1. META SPC 10 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 10 identifier IdentifierMeta SPC: metaSPC 11: PT3 – RTU Teat disinfectants Iodine 1.2. Suffix to the authorisation number Number1-11 1.3. Product type(s) Product type(s)PT03: Veterinary hygiene
  1. META SPC 10 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 10 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,25-0,25 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,1-2,1 % (w/w) 2.2. Type(s) of formulation of the meta SPC 10 Formulation type(s)AL Any other liquid
  2. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10 Hazard statementsH412: Harmful to aquatic life with long lasting effects.Precautionary statements P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  3. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3 – RTU teats disinfectant, Post-milking, Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use–Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Field(s) of use Indoor use Post-milking teat disinfection of milk producing animals Application method(s) Method: By dipping or spraying on teats Detailed description: / Application rate(s) and frequency Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day when using a manual sprayer and 3 times per day when using a dip cup or a robot (automatic sprayer). Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE 4.1.1. Use-specific instructions for use See general directions for use. 4.1.2. Use-specific risk mitigation measures See general directions for use. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use.
  4. GENERAL DIRECTIONS FOR USE OF THE META SPC 10 5.1. Instructions for use Apply the product by dipping or by spraying: By dipping: Apply the product with a dip cup. Wash the dip cup with water after use. By spraying: Apply the product with a manual sprayer or with an automatic sprayer. Do not prepare more fluid than necessary; assume 5 ml solution per cow per treatment. 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.

The product should be used immediately after each milking, two times per day when using a manual sprayer or three times per day when using a dip cup or a robot (automatic sprayer). Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes). Do not mix with other chemicals. 5.2. Risk mitigation measures For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information). For manual dipping application: no PPE is necessary for safe use. If a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection. Keep out of reach of children. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment After eye contact: Rinse immediately with water. After ingestion: Rinse mouth. Spit. 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. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. Protect from frost. Do not expose to temperatures > 40 °C. The shelf-life of the products is 2 years. 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Kenodin 2500Market area: EUIodin Teat Dip 2500Market area: EUJod 2500Market area: EUAuthorisation numberEU-0022265-0014 1-11Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,25 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,1 % (w/w)

  1. META SPC 11 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 11 identifier IdentifierMeta SPC: meta SPC 12: PT3 – RTU Teat disinfectants Iodine 1.2. Suffix to the authorisation number Number1-12 1.3. Product type(s) Product type(s)PT03: Veterinary hygiene
  2. META SPC 11 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 11 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,3-0,5 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,1-2,9 % (w/w) 2.2. Type(s) of formulation of the meta SPC 11 Formulation type(s)AL Any other liquid
  1. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11 Hazard statementsH412: Harmful to aquatic life with long lasting effects.Precautionary statements P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
  2. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3 – RTU Teat disinfectant, Post-milking, Iodine Product typePT03: Veterinary hygieneWhere relevant, an exact description of the authorised use–Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Field(s) of use Indoor use Post-milking teat disinfection of milk producing animals Application method(s) Method: By dipping or spraying on teats Detailed description: / Application rate(s) and frequency Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Category(ies) of usersProfessionalPack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1000 l HDPE 4.1.1. Use-specific instructions for use See general directions for use. 4.1.2. Use-specific risk mitigation measures See general directions for use. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use.
  3. GENERAL DIRECTIONS FOR USE OF THE META SPC 11 5.1. Instructions for use The product must be brought to a temperature above 20 °C before use. Apply the product by dipping or by spraying: By dipping: Apply the product with a dip cup. Wash the dip cup with water after use By spraying: Apply the product with a manual sprayer or with an automatic sprayer. Do not prepare more fluid than necessary; assume 5 ml solution per cow per treatment. The product should be used immediately after each milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals. 5.2. Risk mitigation measures For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information). For manual dipping application: no PPE is necessary for safe use. If a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection. Keep out of reach of children. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment After eye contact: Rinse immediately with water. After ingestion: Rinse mouth. Spit. 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. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use. Protect from frost. Do not expose to temperatures > 40 °C. The shelf-life of the products is 2 years. 6. OTHER INFORMATION / 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Kenodin 5000Market area: EUIodoDip 5000Market area: EUJOD 5000Market area: EUBio Tec Jodip 5000Market area: EUBühning Jodfilmdip-SuperMarket area: EUIocid 5000Market area: EUIod protect 5000 FilmMarket area: EU IOD protect 5000 FilmMarket area: EUIocidMarket area: EUIodip+Market area: EUProtetos cuaMarket area: EUIodin Teat Dip 5000Market area: EUAuthorisation numberEU-0022265-0015 1-12Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,5 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,9 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Kenodin SD 5000Market area: EUIodoSD 5000Market area: EUIODOSPRAY 5000Market area: EUBio Tec Jodspray 5000Market area: EUIDip+ 5000Market area: EUBühning Jodspray 5000Market area: EUIod protect 5000 SprühMarket area: EUKenodin Film SprayMarket area: EUIOD protect 5000 SprühMarket area: EU Iodin Spray & Dip 5000Market area: EUAuthorisation numberEU-0022265-0016 1-12Common nameIUPAC nameFunctionCAS numberEC numberContent (%)IodineActive substance7553-56-2231-442-40,5 % (w/w)Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active substance68131-39-5500-195-72,9 % (w/w)

Metadata

Type
Forordning
År
2026
Ikrafttrædelsesdato
1. januar 1970