Commission Implementing Regulation (EU) 2018/1288 of 24 September 2018 granting a Union authorisation for the biocidal product family Prodhynet's iodine based products (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 is granted to Prodhynet SA for the same biocidal product family Prodhynet's iodine based products with authorisation number EU-0018497-0000. The Union authorisation is valid from 15 October 2018 until 30 September 2028. The Union authorisation is subject to compliance with the SPC set out in the Annex.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX Summary of product characteristics for a biocidal product family PRODHYNET's iodine based products Product type 3 - Veterinary hygiene (Disinfectants) Authorisation number: EU-0018497-0000 R4BP asset number: EU-0018497-0000 PART I FIRST INFORMATION LEVEL 1. ADMINISTRATIVE INFORMATION 1.1. Family name Name PRODHYNET's iodine based products 1.2. Product type(s) Product type(s) PT03 - Veterinary hygiene (Disinfectants) 1.3. Authorisation holder Name and address of the authorisation holder Name PRODHYNET SA Address 11 Avenue des châtelets, 22440, PLOUFRAGAN, France Authorisation number EU-0018497-0000 R4BP asset number EU-0018497-0000 Date of the authorisation 15 October 2018 Expiry date of the authorisation 30 September 2028 1.4. Manufacturer(s) of the biocidal products Name of manufacturer PRODHYNET SA Address of manufacturer 11, Avenue des Châtelets 22440 PLOUFRAGAN France Location of manufacturing sites PRODHYNET SA - 11, Avenue des Châtelets 22440 PLOUFRAGAN France 1.5. Manufacturer(s) of the active substance(s) Active substance Iodine Name of manufacturer COSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. N o 96.625.710-5 Address of manufacturer Terrenos de Elena S/N Terrenos de Elena S/N Huara, Región de Tarapacá Chile Location of manufacturing sites Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad. Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile Active substance Iodine Name of manufacturer ACF MINERA SA Address of manufacturer San Martín 499 Iquique Chile Location of manufacturing sites Faena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte Chile Active substance Iodine Name of manufacturer SOCIEDAD QUIMICA y MINERA SA Address of manufacturer Los Militares 4290 SANTIAGO DE CHILE Chile Location of manufacturing sites Pedro de Valdivia (PV) Route B 180 Antofagasta Chile Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common name IUPAC name Function CAS number EC number Content (%) Min Max Iodine Active substance 7553-56-2 231-442-4 0,25 2,5 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy Non active substance 68439-50-9 2,697 24,199 2.2. Type(s) of formulation Formulation(s) AL - Any other liquid SL - Soluble concentrate PART II SECOND INFORMATION LEVEL - META SPC(S) META SPC 1 1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier meta SPC 1: Dipping products - ready to use 1.2. Suffix to the authorisation number Number 1-1 1.3. Product type(s) Product type(s) PT03 - Veterinary hygiene (Disinfectants) 2. META SPC 1 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 (%) Min Max Iodine Active substance 7553-56-2 231-442-4 0,25 0,49 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy Non active substance 68439-50-9 2,697 4,993 2.2. Type(s) of formulation of the meta SPC 1 Formulation AL - Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. 4. AUTHORISED USE(S) OF THE META SPC 1 4.1. Use description Table 1. Use # 1 – Manual or automated dipping after milking Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Algae Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping after milking Application method(s) Dipping - Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine. Application rate(s) and frequency — cows and buffaloes (3 to 10 ml: 5 ml recommended) — sheep (1,5 to 5 ml: 1,5 ml recommended) — goats (2,5 to 6 ml: 2,5 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L 4.1.1. Use-specific instructions for use See general directions for use of meta SPC 1 4.1.2. Use-specific risk mitigation measures See general directions for use of meta SPC 1 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use of meta SPC 1 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging None: see directions for use meta SPC 1 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 1 5. GENERAL DIRECTIONS FOR USE ( 1 ) OF THE META SPC 1 5.1. Instructions for use Always read the label or leaflet before use and follow all the instructions provided. The product must be brought to a temperature above 20 °C before use. The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping cup manually or automatically with the ready to use product. Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking. — cows and buffaloes (3 to 10 ml: 5 ml recommended) — sheep (1,5 to 5 ml: 1,5 ml recommended) — goats (2,5 to 6 ml: 2,5 ml recommended) Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes). At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster. Where necessary, repeat the application after each milking. Clean the application equipment regularly with warm water. 5.2. Risk mitigation measures Wear eye protection. In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Take the contaminated clothes and shoes off immediately. Wash them before wearing them again. FIRST AID INSTRUCTIONS — In the event of inhalation: Bring to fresh air. — In the event of contact with the skin: Wash with water. — In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. — In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice. Refer to the safety data sheet available for professional user: it contains an emergency phone number. Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use. 5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf life: 2 years in HDPE Do not store at a temperature higher than 30 °C. 6. OTHER INFORMATION 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) IODO EP25 IODOGEL PRO TI-N Authorisation number EU-0018497-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,25 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy Non active substance 68439-50-9 2,697 META SPC 2 1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier meta SPC 2: Dipping, foaming, spraying products - Ready to use 1.2. Suffix to the authorisation number Number 1-2 1.3. Product type(s) Product type(s) PT03 - Veterinary hygiene (Disinfectants) 2. META SPC 2 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 (%) Min Max Iodine Active substance 7553-56-2 231-442-4 0,25 0,49 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy Non active substance 68439-50-9 2,697 4,69 2.2. Type(s) of formulation of the meta SPC 2 Formulation AL - Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. 4. AUTHORISED USE(S) OF THE META SPC 2 4.1. Use description Table 2. Use # 1 – Manual or automated dipping, foaming or spraying before milking Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking Application method(s) Dipping, foaming or spraying before milking - Manual or automated disinfection of teats by dipping, foaming or spraying before milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L 4.1.1. Use-specific instructions for use Eliminate all visible dirt before applying the product. Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking. Let the product act at least one minute. Use the teat cleaning and wiping method systematically before attaching the milking cluster. See also general instructions for use of meta SPC 2. 4.1.2. Use-specific risk mitigation measures For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/ eye protection. For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection. In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use of meta SPC 2 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 2 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 2 4.2. Use description Table 3. Use # 2 – Manual or automated dipping, foaming or spraying after milking Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Algae Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking Application method(s) Dipping, foaming, spraying after milking - Manual or automated disinfection of teats by dipping, foaming or spraying after milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L 4.2.1. Use-specific instructions for use Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking. Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes) At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster. See also general instructions for use of meta SPC 2. 4.2.2. Use-specific risk mitigation measures For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection. In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection. 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use of meta SPC 2 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 2 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 2 5. GENERAL DIRECTIONS FOR USE ( 2 ) OF THE META SPC 2 5.1. Instructions for use See use-specific instructions for each use. Always read the label or leaflet before use and follow all the instructions provided. The product must be brought to a temperature above 20 °C before use. The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product. Where necessary repeat the application at each milking Clean the application equipment regularly with warm water. 5.2. Risk mitigation measures See use-specific risk mitigation measures for each use. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Take the contaminated clothes and shoes off immediately. Wash them before wearing them again. FIRST AID INSTRUCTIONS — In the event of inhalation: Bring to fresh air. — In the event of contact with the skin: Wash with water. — In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. — In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice. Refer to the safety data sheet available for professional user: it contains an emergency phone number. Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use. 5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf life: 2 years in HDPE Do not store at a temperature higher than 30 °C. 6. OTHER INFORMATION 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) IODO FL25 PRO ROBO I-N Authorisation number EU-0018497-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,25 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy Non active substance 68439-50-9 2,697 META SPC 3 1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC identifier Identifier meta SPC 3: Dipping, foaming, spraying concentrated products 1.2. Suffix to the authorisation number Number 1-3 1.3. Product type(s) Product type(s) PT03 - Veterinary hygiene (Disinfectants) 2. META SPC 3 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 (%) Min Max Iodine Active substance 7553-56-2 231-442-4 2,5 2,5 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy Non active substance 68439-50-9 24,199 24,199 2.2. Type(s) of formulation of the meta SPC 3 Formulation SL - Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements Causes serious eye damage. May cause damage to organs (thyroid) through prolonged or repeated exposure oral. Toxic to aquatic life with long lasting effects. May be corrosive to metals. Precautionary statements Keep out of reach of children. Do not breathe mist. Do not breathe vapours. Do not breathe spray. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a poison center/doctor. Get medical advice/attention if you feel unwell. Dispose of contents to in accordance with local/ regional/ national/ international regulations. Dispose of container to in accordance with local/ regional/ national/ international regulations. Keep only in original container. Absorb spillage to prevent material damage. 4. AUTHORISED USE(S) OF THE META SPC 3 4.1. Use description Table 4. Use # 1 – Manual or automated dipping, foaming or spraying before milking Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying before milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency A dilution at 10 % (v/v) should be prepared Application rate for the diluted product: — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L 4.1.1. Use-specific instructions for use Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal and yeasticidal activity. Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution. Eliminate all visible dirt before applying the product. Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking. Let the product act at least one minute. Use the teat cleaning and wiping method systematically before attaching the milking cluster. See also general directions for use of meta SPC 3. 4.1.2. Use-specific risk mitigation measures For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection. In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use of meta SPC 3 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 3 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 3 4.2. Use description Table 5 - Use # 2 – Manual or automated dipping, foaming or spraying after milking Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Algae Viruses Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying after milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency For disinfection of bacteria, yeasts and algae a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) should be prepared. For disinfection of viruses a dilution at 20 % (v/v: 20 ml product, add water up to 100 ml) should be prepared Application rate for the diluted product: — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L 4.2.1. Use-specific instructions for use Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal, yeasticidal and algaecidal activity or 20 % (v/v: 20 ml product, add water up to 100 ml) in case virucidal activity is also needed. Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution. Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking. Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes). At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster. See also general directions for use of meta SPC 3. 4.2.2. Use-specific risk mitigation measures For manual spraying applications wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) /protective clothing/eye protection. In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection. 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use of meta SPC 3 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 3 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 3 5. GENERAL DIRECTIONS FOR USE ( 3 ) OF THE META SPC 3 5.1. Instructions for use See use-specific instructions for each use. Always read the label or leaflet before use and follow all the instructions provided. The product must be brought to a temperature above 20 °C before use. The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution. Where necessary, repeat the application at each milking Clean the application equipment regularly with warm water. 5.2. Risk mitigation measures See use-specific risk mitigation measures for each use. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Take the contaminated clothes and shoes off immediately. Wash them before wearing them again. In case of faintness, get medical advice/attention. Show this safety data sheet to the doctor. FIRST AID INSTRUCTIONS — In the event of inhalation: Bring to fresh air. — In the event of contact with the skin: Wash with water. — In the event of contact with the eyes: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician. — In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice. Refer to the safety data sheet available for professional user: it contains an emergency phone number. Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use. 5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf life: 2 years in HDPE Do not store at a temperature higher than 30 °C. 6. OTHER INFORMATION 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) PRMX IODOSE Authorisation number EU-0018497-0003 1-3 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 2,5 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy Non active substance 68439-50-9 24,199 META SPC 4 1. META SPC 4 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 4 identifier Identifier meta SPC 4: Dipping products reaching virucidal activity – Ready to use 1.2. Suffix to the authorisation number Number 1-4 1.3. Product type(s) Product type(s) PT03 - Veterinary hygiene (Disinfectants) 2. META SPC 4 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 (%) Min Max Iodine Active substance 7553-56-2 231-442-4 0,5 0,5 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy Non active substance 68439-50-9 4,993 4,993 2.2. Type(s) of formulation of the meta SPC 4 Formulation AL - Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statements Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. 4. AUTHORISED USE(S) OF THE META SPC 4 4.1. Use description Table 6. Use # 1 – Manual or automated dipping after milking Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Algae Viruses Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping after milking Application method(s) Dipping - Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine. Application rate(s) and frequency — cows and buffaloes (3 to 10 ml: 5 ml recommended) — sheep (1,5 to 5 ml: 1,5 ml recommended) — goats (2,5 to 6 ml: 2,5 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L 4.1.1. Use-specific instructions for use See general directions for use of meta SPC 4 4.1.2. Use-specific risk mitigation measures See general directions for use of meta SPC 4 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use of meta SPC 4 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 4 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 4 5. GENERAL DIRECTIONS FOR USE ( 4 ) OF THE META SPC 4 5.1. Instructions for use Always read the label or leaflet before use and follow all the instructions provided. The product must be brought to a temperature above 20 °C before use. The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping cup manually or automatically with the ready to use product. Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking. — cows and buffaloes (3 to 10 ml: 5 ml recommended) — sheep (1,5 to 5 ml: 1,5 ml recommended) — goats (2,5 to 6 ml: 2,5 ml recommended) Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes). At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster. Where necessary, repeat the application after each milking. Clean the application equipment regularly with warm water. 5.2. Risk mitigation measures Wear eye protection. In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Take the contaminated clothes and shoes off immediately. Wash them before wearing them again. FIRST AID INSTRUCTIONS — In the event of inhalation: Bring to fresh air. — In the event of contact with the skin: Wash with water. — In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. — In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice. Refer to the safety data sheet available for professional user: it contains an emergency phone number. Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use. 5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf life: 2 years in HDPE Do not store at a temperature higher than 30 °C. 6. OTHER INFORMATION 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) AGRI IODE EPAIS S HYGIA IODE EPAIS S IODE EPAIS NETAIODE EPAIS S TREMPAGE EPAIS IODE S IODO EP50 ADIEL IODE EPAIS LATI IODE PRO TI PROXA IODE EPAIS S BREIZH-IODE EPAIS S BRETAIODE EPAIS DR16 PLUSAIOD EPAIS HELIO FIRST EP TECNO FIRST LACTOIODE EPAIS MAG IODE EPAIS S Authorisation number EU-0018497-0004 1-4 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,5 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy Non active substance 68439-50-9 4,993 META SPC 5 1. META SPC 5 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 5 identifier Identifier meta SPC 5: Dipping, foaming, spraying products 5 500 ppm – Ready to use 1.2. Suffix to the authorisation number Number 1-5 1.3. Product type(s) Product type(s) PT03 - Veterinary hygiene (Disinfectants) 2. META SPC 5 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 (%) Min Max Iodine Active substance 7553-56-2 231-442-4 0,55 0,55 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy Non active substance 68439-50-9 4,69 4,69 2.2. Type(s) of formulation of the meta SPC 5 Formulation AL - Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 Hazard statements Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. 4. AUTHORISED USE(S) OF THE META SPC 5 4.1. Use description Table 7. Use # 1 – Manual or automated dipping, foaming or spraying before milking Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying before milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L 4.1.1. Use-specific instructions for use Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product. Eliminate all visible dirt before applying the product. Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat before milking. Let the product act at least one minute. Use the teat cleaning and wiping method systematically before attaching the milking cluster. See also general instructions for use of meta SPC5. 4.1.2. Use-specific risk mitigation measures For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/ eye protection. For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection. In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use of meta SPC 5 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 5 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 5 4.2. Use description Table 8. Use # 2 – Manual or automated dipping, foaming or spraying after milking Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Algae Viruses Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying after milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine. Application rate(s) and frequency — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L 4.2.1. Use-specific instructions for use Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product. Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking. Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes) At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster. See also general instructions for use of meta SPC 5. 4.2.2. Use-specific risk mitigation measures For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection. In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection. 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use of meta SPC 5 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of meta SPC 5 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use of meta SPC 5 5. GENERAL DIRECTIONS FOR USE ( 5 ) OF THE META SPC 5 5.1. Instructions for use See use-specific instructions for each use. Always read the label or leaflet before use and follow all the instructions provided. The product must be brought to a temperature above 20 °C before use. The use of a dosing pump for filling the product into the application equipment is recommended. Where necessary repeat the application at each milking Clean the application equipment regularly with warm water. 5.2. Risk mitigation measures See use-specific risk mitigation measures for each use. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Take the contaminated clothes and shoes off immediately. Wash them before wearing them again. FIRST AID INSTRUCTIONS — In the event of inhalation: Bring to fresh air. — In the event of contact with the skin: Wash with water. — In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. — In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice. Refer to the safety data sheet available for professional user: it contains an emergency phone number. Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use. 5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf life: 2 years in HDPE Do not store at a temperature higher than 30 °C. 6. OTHER INFORMATION 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) AGRI IODE FLUIDE HYGIA IODE FLUIDE IODE FLUIDE IOSPRAY FLUIDE PULVE IODE IODO FL55 IODOLIN ADIEL IODE FLUIDE BOVI IODE SPRAY PRO ROBO I PROXA IODE FLUIDE HELIODE FLUIDE TECNO FLUIDE DR15 GANAIODE FLUIDE PLUSAIOD PROTECTION FLUIDE IODE BREIZH-IODE FLUIDE BRETAIODE LQ IODE NET FLUIDE LACTOIODE FLUIDE MAG IODE FLUIDE NETAIODE FLUIDE NETAIODE Authorisation number EU-0018497-0005 1-5 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,55 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy Non active substance 68439-50-9 4,69 ( 1 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1. ( 2 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2. ( 3 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3. ( 4 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4. ( 5 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.
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