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’ (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
A Union authorisation with authorisation number EU-0022265-0000 is 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’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 3 September 2020 until 31 August 2030.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
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 Name Iodine 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 holder Name CID LINES NV Address Waterpoortstraat 2 8900 Ieper Belgium Authorisation number EU-0022265-0000 R4BP asset number EU-0022265-0000 Date of the authorisation 3 September 2020 Expiry date of the authorisation 31 August 2030 1.4. Manufacturer(s) of the product Name of manufacturer CID LINES NV Address of manufacturer Waterpoortstraat 2 8900 Ieper Belgium Location of manufacturing sites CID LINES NV site 1 Waterpoortstraat 2 8900 Ieper Belgium 1.5. Manufacturer(s) of the active substance(s) Active substance Iodine Name of manufacturer SQM S.A. Address of manufacturer Los Militares, Piso 4 4290 Santiago Chile Location of manufacturing sites SQM S.A. site 1 Nueva Victoria plant 00 Pedro de Valdivia Chile Active substance Iodine Name of manufacturer Cosayach Nitratos S.A. Address of manufacturer Amunategui 178 00 Santiago Chile Location of manufacturing sites Cosayach Nitratos S.A. site 1 Cala Cala 00 Pozo Almonte Chile Active substance Iodine Name of manufacturer ACF Minera S.A. Address of manufacturer San Martin No 499 00 Iquique Chile Location of manufacturing sites ACF Minera S.A. site 1 Lagunas mine 00 Pozo Almonte Chile Active substance Iodine Name of manufacturer ISE Chemicals Corporation Address of manufacturer 3-1, Kyobashi 1-Chome 104-0031 Tokyo Japan Location of manufacturing sites ISE Chemicals Corporation site 1 3695 Kitaimaizumi 299-3201 Oamishirasato city Japan Active substance Polyvinylpyrrolidone iodine Name of manufacturer ISP Chemicals LLC, Afiliate of Ashland Inc Address of manufacturer 455 N. main st (HWY 95) KY 42029 Calvert City United States (the) Location of manufacturing sites ISP Chemicals LLC, Afiliate of Ashland Inc site 1 455 N. main st (HWY 95) KY 42029 Calvert City United States (the) Active substance Polyvinylpyrrolidone iodine Name of manufacturer Pantheon FZE (DMCC branch) Address of manufacturer 403, Reef Tower, Jumeira Lake Tower Shaikh Zayed Road 00 Dubai United Arab Emirates (the) Location of manufacturing sites Pantheon FZE (DMCC branch) site 1 Cala Cala 00 Pozo Almonte Chile 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0 -3 % (w/w) Polyvinylpyrrolidone iodine Active substance 25655-41-8 0 -10 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated láite Non-active substance 68131-39-5 500-195-7 0 -21 % (w/w) Phosphoric acid Phosphoric acid Non-active substance 7664-38-2 231-633-2 0 -30 % (w/w) Alcohol C9-11 +6 EO Alcohol C9-11 +6 EO Non-active substance 68439-46-3 0 -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) 1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier Meta SPC: metaSPC 1: PT3 – Concentrated teat disinfectants Iodine 1.2. Suffix to the authorisation number Number 1-1 1.3. Product type(s) Product type(s) PT03: Veterinary hygiene 2. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 1,5 -1,5 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 12,05 -12,05 % (w/w) 2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s) SL Soluble concentrate 3. 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. 4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 PT3 – Concentrated Teat disinfectant, post-milking, Iodine Product type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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 400 Market area: EU IodoSD 400 Market area: EU Velvet Concentrate Market area: EU Wynnsan Iodine 3 - 1 conc Market area: EU Iodin Teat Spray 400 Market area: EU Authorisation number EU-0022265-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 1,5 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 12,05 % (w/w) 1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier Meta SPC: metaSPC 2: PT3 – Ready to Use (RTU) Teat disinfectants Iodine 1.2. Suffix to the authorisation number Number 1-2 1.3. Product type(s) Product type(s) PT03: Veterinary hygiene 2. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,3 -0,3 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,1 -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 statements H412: 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 type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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 3000 Market area: EU Bio Tec Jodip 3000 Market area: EU Recoïode Market area: EU Stalosan Io Dip Market area: EU Stalosan Super Dip Market area: EU Velvet High Visco Market area: EU Bühning Joddip 3000 Market area: EU Kenodin Market area: EU Wynnsan trikill RTU Market area: EU Wynnsan Iodine RTU teat dip Market area: EU Wynnsan Iodine dip RTU Market area: EU Iocid Market area: EU Iodip+ Market area: EU Wynngold Iodine Dip Market area: EU Pezerk iv plus Market area: EU Iod protect 3000 Film Market area: EU Seivit® Iode 3000 Market area: EU Kenostart Market area: EU GAHERYOD Market area: EU Kenodin 3000 Market area: EU Iodin Teat Dip 3000 Market area: EU Iod 3000 dip Market area: EU Iodoschutz dip Market area: EU Ioschutz dip Market area: EU Iodocoop dip Market area: EU Iodotech dip Market area: EU Iodactiv’ dip Market area: EU Iododip Market area: EU MIROX Dip Jod Market area: EU HCP Iodine Dip Market area: EU Agib Jodium Dip Market area: EU Jod 3000 Market area: EU Iod dip Market area: EU Iode 3000 Market area: EU Iodoschutz Market area: EU Coopjod Market area: EU Coopiode Market area: EU Coopiode épais Market area: EU Semex jod Market area: EU Iodotech Market area: EU Iododip green Market area: EU Iodip bio Market area: EU Iododip bio Market area: EU Iodactive épais Market area: EU Iodactiv Market area: EU Iodoactiv’ Market area: EU Bayley’s Premier Iodine Teat Dip Market area: EU Pearce Premier Iodine Teat Dip Market area: EU Diamond 1:3 Concentrate Iodine Post Dip Spray Market area: EU JODOCARE Market area: EU KENOSTART DYP Market area: EU STREPTOFIT Market area: EU Iodall Film Market area: EU Authorisation number EU-0022265-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,3 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,17 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenodin Film Market area: EU IodoFilm Market area: EU Wynnsan Iofilm teat dip Market area: EU Kenodin Film Extra Market area: EU Wynngold Film Market area: EU Wynnsan trikill film teat dip Market area: EU Kenodin Film Soft Market area: EU Iocid Film Market area: EU TOP Film Market area: EU Seivit® Iode Gel Market area: EU IOD protect 3000 Film Market area: EU Iodin Film Teat Dip 3000 Market area: EU Iodin Barrier Teat Dip 3000 Market area: EU Iodin Film Teat Dip Market area: EU Iodin Barrier Teat Dip Market area: EU Iod 3000 film Market area: EU Iodoschutz film Market area: EU Ioschutz film Market area: EU Iodocoop film Market area: EU Iodotech film Market area: EU Iodactiv’ film Market area: EU Iodofilm Market area: EU HCP Iodine Film Market area: EU Iod 3000 film Market area: EU Coopjod film Market area: EU Coopiode film Market area: EU Iodocoop film Market area: EU Semex jod film Market area: EU Iodofilm Market area: EU Iodofilm bio Market area: EU Iofilm bio Market area: EU Iodactive film Market area: EU Iodactiv film Market area: EU Iodactiv’ film Market area: EU SCUDO 3000 Market area: EU Authorisation number EU-0022265-0003 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,3 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,9 % (w/w) 1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier Meta SPC: metaSPC 3: PT3 – RTU Udder disinfectant Iodine 1.2. Suffix to the authorisation number Number 1-3 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 name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,3 -0,99 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,17 -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 statements H412: 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 type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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 Disinfectant Market area: EU Dermades 3000 Market area: EU Iodin Skin Disinfectant Market area: EU Authorisation number EU-0022265-0004 1-3 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,3 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,17 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Dermades Market area: EU Animal skin disinfectant 1 % Market area: EU Dermades Strong Market area: EU Iodin Skin Disinfectant Strong Market area: EU Authorisation number EU-0022265-0005 1-3 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,99 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,95 % (w/w) 1. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier Identifier Meta SPC: metaSPC 4: PT3 – RTU Udder and Teat disinfectants Iodine 1.2. Suffix to the authorisation number Number 1-4 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 name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,3 -0,3 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,17 -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 statements H412: 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 type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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 type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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 SD Market area: EU IodoSD 3000 Market area: EU Bio Tec Jodspray 3000 Market area: EU Q Farm Iodine Des Market area: EU ANRO - Euterpflege Dip Market area: EU Stalosan Io Spray Market area: EU Stalosan Super Spray Market area: EU IDip+ Market area: EU Bühning Jodspray 3000 Market area: EU Velvet RTU Market area: EU Wynnsan trikill spray Market area: EU Wynnsan Iodine spray RTU Market area: EU Wynngold Iodine Dip and spray Market area: EU Pezerk IL Market area: EU Iod protect 3000 Sprüh Market area: EU Seivit® Iode Spray Market area: EU IOD protect 3000 Sprüh Market area: EU Kenodin SprayFilm Market area: EU Iodo SP Market area: EU Kenostart SD Market area: EU GAHERYOD SPRAY Market area: EU Iodin Teat & Skin 3000 Market area: EU Iod 3000 sprüh Market area: EU Iodoschutz sprüh Market area: EU Ioschutz sprüh Market area: EU Iodocoop sprüh Market area: EU Iodotech sprüh Market area: EU Iodactiv’ sprüh Market area: EU Iodosprüh Market area: EU MIROX Spray Jod Market area: EU HCP Iodine SD Market area: EU Agib Jodium Spray Market area: EU Jod 3000 spray Market area: EU Iod sprüh Market area: EU Coopjod Market area: EU Coopiode spray Market area: EU Iodocoop spray Market area: EU Semex jod spray Market area: EU Iododip spray Market area: EU Iododip spray green Market area: EU Iodospray Bio Market area: EU Iospray bio Market area: EU Iodactive spray Market area: EU Iodactiv spray Market area: EU Iodactiv’ spray Market area: EU Ark Iodine S+D Market area: EU Agrihealth Iodine SD Market area: EU AGRO LOGIC JODOCARE SPRAY Market area: EU IODACTIVE Market area: EU Authorisation number EU-0022265-0006 1-4 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,3 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,17 % (w/w) 1. META SPC 5 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 5 identifier Identifier Meta SPC: metaSPC 5: PT3 – RTU Teat disinfectants PVP-Iodine 1.2. Suffix to the authorisation number Number 1-5 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 name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 3 -3 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 1,5 -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 statements H412: 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 type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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 PVP Market area: EU Iodin Teat Dip 3000 PVP Market area: EU Authorisation number EU-0022265-0007 1-5 Common name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 3 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,5 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Iodo SD PVP Market area: EU Iodin Teat Spray & Dip 3000 PVP Market area: EU Authorisation number EU-0022265-0008 1-5 Common name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 3 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,5 % (w/w) 1. META SPC 6 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 6 identifier Identifier Meta SPC: metaSPC 6: PT3 – RTU Udder disinfectants PVP-Iodine 1.2. Suffix to the authorisation number Number 1-6 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 name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 10 -10 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2 -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 type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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 PVP Market area: EU Wynngold 10 % Iodine Solution Market area: EU Iodin Skin Disinfectant PVP Market area: EU Authorisation number EU-0022265-0009 1-6 Common name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 10 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2 % (w/w) 1. META SPC 7 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 7 identifier Identifier Meta SPC: metaSPC 7: PT3 – Concentrated Surface disinfectants Iodine 1.2. Suffix to the authorisation number Number 1-7 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 name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 1,8 -2,49 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 3,15 -9,45 % (w/w) Alcohol C9-11 + 6 EO Alcohol C9-11 + 6 EO Non-active substance 68439-46-3 2,5 -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 type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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. Example for a product containing 2,49 % iodine ( *1 ) Dilution of the product Contact time Bactericidal and yeasticidal activity Virucidal activity 1 % (10ml product, add water up to 1 l) 30 min 1,4 % (14ml product, add water up to 1 l) 30 min ( *1 ) 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. 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 20 Market area: EU Iodo 20 Market area: EU Bio Tec Joddesinfektion Market area: EU Dufa dine 1,8 % Market area: EU Alfasan super disinfectant Market area: EU Iodes Market area: EU Streptoclean Market area: EU Iodin Surface Disinfectant 1,8 % Market area: EU IODINE Market area: EU Authorisation number EU-0022265-0010 1-7 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 1,8 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 5,29 % (w/w) Alcohol C9-11 + 6 EO Alcohol C9-11 + 6 EO Non-active substance 68439-46-3 5 % (w/w) 1. META SPC 8 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 8 identifier Identifier Meta SPC: metaSPC 8: PT3 – Concentrated Surface disinfectants Iodine 1.2. Suffix to the authorisation number Number 1-8 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 name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 2,5 -3 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 3,15 -9,45 % (w/w) Phosphoric acid Phosphoric acid Non-active substance 7664-38-2 231-633-2 5 -12 % (w/w) Alcohol C9-11 + 6 EO Alcohol C9-11 + 6 EO Non-active substance 68439-46-3 2,5 -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 type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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. Example for a product containing 2,5% iodine ( *1 ) Dilution of the product Contact time Bactericidal and yeasticidal activity Virucidal activity 1 % (10ml product, add water up to 1 l) 30 min 1,4% (14 ml product, add water up to 1L) 30 min ( *1 ) 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. 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 30 Market area: EU Iodo 30 Market area: EU Dufa dine Market area: EU Iodin Surface Disinfectant 2,8 % Market area: EU Authorisation number EU-0022265-0011 1-8 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 2,8 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 7,93 % (w/w) Phosphoric acid Phosphoric acid Non-active substance 7664-38-2 231-633-2 11,25 % (w/w) Alcohol C9-11 + 6 EO Alcohol C9-11 + 6 EO Non-active substance 68439-46-3 12,5 % (w/w) 1. META SPC 9 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 9 identifier Identifier Meta SPC: metaSPC 10: PT3 – Concentrated teat disinfectants Iodine 1.2. Suffix to the authorisation number Number 1-10 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 name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 2,8 -2,8 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 21 -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 type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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 900 Market area: EU IodoSD 900 Market area: EU IDip+ concentrate Market area: EU Jodkonzentrat 1:9 Market area: EU Bühning Jodkonzentrat 1:9 Market area: EU Wynnsan Iodine Conc dip 9-1 Market area: EU Kenodin 900 Market area: EU Dufa Dip Market area: EU Kenostart 900 Market area: EU Iodin Teat Spray 900 Market area: EU HCP Iodine Concentrate Market area: EU Maxi Subliem CP Market area: EU Subliem Koncentrat Plus Market area: EU Authorisation number EU-0022265-0013 1-10 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 2,8 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 21 % (w/w) 1. META SPC 10 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 10 identifier Identifier Meta SPC: metaSPC 11: PT3 – RTU Teat disinfectants Iodine 1.2. Suffix to the authorisation number Number 1-11 1.3. Product type(s) Product type(s) PT03: Veterinary hygiene 2. META SPC 10 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 10 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,25 -0,25 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,1 -2,1 % (w/w) 2.2. Type(s) of formulation of the meta SPC 10 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10 Hazard statements H412: 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 teats disinfectant, Post-milking, Iodine Product type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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 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 2500 Market area: EU Iodin Teat Dip 2500 Market area: EU Jod 2500 Market area: EU Authorisation number EU-0022265-0014 1-11 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,25 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,1 % (w/w) 1. META SPC 11 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 11 identifier Identifier Meta SPC: meta SPC 12: PT3 – RTU Teat disinfectants Iodine 1.2. Suffix to the authorisation number Number 1-12 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 name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,3 -0,5 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,1 -2,9 % (w/w) 2.2. Type(s) of formulation of the meta SPC 11 Formulation type(s) AL Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11 Hazard statements H412: 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 type PT03: Veterinary hygiene Where 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 users Professional Pack sizes and packaging material 1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000 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 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 5000 Market area: EU IodoDip 5000 Market area: EU JOD 5000 Market area: EU Bio Tec Jodip 5000 Market area: EU Bühning Jodfilmdip-Super Market area: EU Iocid 5000 Market area: EU Iod protect 5000 Film Market area: EU IOD protect 5000 Film Market area: EU Iocid Market area: EU Iodip+ Market area: EU Protetos cua Market area: EU Iodin Teat Dip 5000 Market area: EU Authorisation number EU-0022265-0015 1-12 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,5 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,9 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Kenodin SD 5000 Market area: EU IodoSD 5000 Market area: EU IODOSPRAY 5000 Market area: EU Bio Tec Jodspray 5000 Market area: EU IDip+ 5000 Market area: EU Bühning Jodspray 5000 Market area: EU Iod protect 5000 Sprüh Market area: EU Kenodin Film Spray Market area: EU IOD protect 5000 Sprüh Market area: EU Iodin Spray & Dip 5000 Market area: EU Authorisation number EU-0022265-0016 1-12 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,5 % (w/w) Alcohols, C12-15, ethoxylated Alcohols, C12-15, ethoxylated Non-active substance 68131-39-5 500-195-7 2,9 % (w/w)
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