Commission Implementing Regulation (EU) 2019/1794 of 22 October 2019 granting a Union authorisation for the biocidal product family ‘Boumatic Iodine product family’ (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-0020541-0000 is granted to Boumatic Gascoigne Melotte for the making available on the market and use of the biocidal product family ‘Boumatic Iodine product family’, in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 18 November 2019 until 31 October 2029.
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 Boumatic Iodine product family Product type 3 — Veterinary hygiene (Disinfectants) Authorisation number: EU-0020541-0000 R4BP asset number: EU-0020541-0000 PART I FIRST INFORMATION LEVEL 1. ADMINISTRATIVE INFORMATION 1.1. Family name Name Boumatic Iodine product family 1.2. Product type(s) Product type(s) PT03 — Veterinary hygiene (Disinfectants) 1.3. Authorisation holder Name and address of the authorisation holder Name Boumatic Gascoigne Melotte Address 31, Rue Jules Melotte, 4350, Remicourt, Belgium Authorisation number EU-0020541-0000 R4BP asset number EU-0020541-0000 Date of the authorisation 18 November 2019 Expiry date of the authorisation 31 October 2029 1.4. Manufacturer(s) of the biocidal products Name of manufacturer Christeyns n.v. Address of manufacturer Afrikalaan 182, 9000 Ghent Belgium Location of manufacturing sites Afrikalaan 182, 9000 Ghent Belgium 1.5. Manufacturer(s) of the active substance(s) Active substance Iodine Name of manufacturer Christeyns n.v. Address of manufacturer Afrikalaan 182, 9000 Ghent Belgium Location of manufacturing sites Cosayach Nitratos S.A, Oficina Cala Cala S/N, Pozo Almonte Iquique 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 0,26 0,5 Fatty alcohol ethoxylate Non-active substance 69011-36-5 500-241-6 1,0 2,99 2.2. Type(s) of formulation Formulation(s) AL — Any other liquid 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 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 0,44 0,5 Fatty alcohol ethoxylate Non-active substance 69011-36-5 500-241-6 1,0 2,99 2.2. Type(s) of formulation of the meta SPC 1 Formulation(s) AL — Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Wash hands thoroughly after handling. 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. Avoid release to the environment. 4. AUTHORISED USE(S) OF THE META SPC 1 4.1. Use description Table 1. Use # 1 – Manual dip treatment, pre- or post-milking teat disinfectants 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 Teat disinfectants for pre- or post-milking manual dip treatment of cow teats Application method(s) Open system: dip treatment For pre-milking: min. 1 minute contact time For post-milking min. 5 minutes contact time Application rate(s) and frequency Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per treatment — Product is ready to use Use 2 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg high-density polyethylene (HDPE) drum and 1 000 kg HDPE 4.1.1. Use-specific instructions for use Product for disinfection of cow teat by dipping before or after milking. Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment. Fill the dipping cup with indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup. To reduce dermal exposure, the use of a dosing pump for filling the product into the application equipment is recommended. 4.1.2. Use-specific risk mitigation measures Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information) and eye protection. 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 the meta SPC 1 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 the 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 the meta SPC 1 4.2. Use description Table 2. Use # 2 – Manual spraying treatment pre- or post-milking teat disinfectants 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 Teat disinfectants for pre- or post-milking, manual spray treatment of cow teat Application method(s) Open system: spray treatment or pre-milking: min. 1 minute contact time or post-milking min. 5 minutes contact time Application rate(s) and frequency Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray — Product is ready to use Use 2 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE Intermediate bulk containers (IBC) 4.2.1. Use-specific instructions for use Product for disinfection of cow teat by spraying before or after milking. Apply an amount of product that is sufficient to cover the entire teat at the maximum 15 ml per spray treatment. Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended. 4.2.2. Use-specific risk mitigation measures Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information), protective clothing, chemical resistant boots, and eye protection. 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 the meta SPC 1 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 the meta SPC 1 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 the meta SPC 1 4.3. Use description Table 3. Use # 3 – Automated dip treatment, pre- or post-milking teat disinfectants 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 Teat disinfectants for pre- or post-milking, automated dip treatment of cow teat Application method(s) Open system: dip treatment For pre-milking: min. 1 minute contact time For post-milking min. 5 minutes contact time Application rate(s) and frequency Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip — Product is ready to use Use 3 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC 4.3.1. Use-specific instructions for use Product for disinfection of cow teat by dipping before or after milking. Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment. Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended. 4.3.2. Use-specific risk mitigation measures See general directions for use of the meta SPC 1 4.3.3. 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 the meta SPC 1 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of the meta SPC 1 4.3.5. 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 the meta SPC 1 4.4. Use description Table 4. Use # 4 – Automated spraying treatment, pre- or post-milking teat disinfectants 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 Teat disinfectants for pre- or post-milking, automated spray treatment of cow teat Application method(s) Open system: spray treatment or pre-milking: min. 1 minute contact time or post-milking min. 5 minutes contact time Application rate(s) and frequency Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray — Product is ready to use Use 3 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC 4.4.1. Use-specific instructions for use Product for disinfection of cow teat by spraying before or after milking. Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment. Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended. 4.4.2. Use-specific risk mitigation measures See general directions for use of the meta SPC 1 4.4.3. 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 the meta SPC 1 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of the meta SPC 1 4.4.5. 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 the meta SPC 1 5. GENERAL DIRECTIONS FOR USE ( 1 ) OF THE META SPC 1 5.1. Instructions for use The products must be brought to temperatures above 20 °C before use. For pre-milking treatment: treat the entire teat with the product, let act 60 seconds and wipe teats dry using single-use towels to avoid any contamination of milk. For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes). 5.2. Risk mitigation measures In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered either for pre- or post-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 First aid: general information: immediately remove any clothing soiled by the product After inhalation: Supply fresh air; consult doctor in case of complaints. After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin. After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing. After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention. If medical advice is needed, have product container or label at hand. Do not allow product to enter sewers surface or ground water. 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 Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach children. Shelf life: 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) Udder Dip Udder Dip Max Udder D Max Udderdine Dip Uddine Dip Udderdine DP Uddine DP Udderdine DS Authorisation number EU-0020541-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0,5 Fatty alcohol ethoxylate Non-active substance 69011-36-5 500-241-6 2,99 META SPC 2 1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier meta SPC 2 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 0,26 0,38 Fatty alcohol ethoxylate Non-active substance 69011-36-5 500-241-6 1,0 2,99 2.2. Type(s) of formulation of the meta SPC 2 Formulation(s) AL — Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Wash hands thoroughly after handling. 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. Avoid release to the environment. 4. AUTHORISED USE(S) OF THE META SPC 2 4.1. Use description Table 5. Use # 1 – Manual dip treatment, post milking teat disinfectants 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 Teat disinfection for post –milking, manual dip treatment of cow teats Application method(s) Open system: dip treatment For post-milking min. 5 minutes contact time Application rate(s) and frequency Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per treatment — Product is ready to use Use 2 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC 4.1.1. Use-specific instructions for use Product for disinfection of cow teat by dipping after milking. Fill the dipping cup with the indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended. 4.1.2. Use-specific risk mitigation measures Wear eye protection. 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 the 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 the 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 the meta SPC 2 4.2. Use description Table 6. Use # 2 – Manual spraying treatment, post milking teat disinfectants 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 Teat disinfection for post – milking, anual spray treatment of cow teats Application method(s) Open system: spray treatment For post-milking min. 5 minutes contact time Application rate(s) and frequency Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray treatment — Product is ready to use Use 2 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC 4.2.1. Use-specific instructions for use Product for disinfection of cow teat by spraying after milking. Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15 ml per spray treatment. Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended. 4.2.2. Use-specific risk mitigation measures Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye protection. 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 the 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 the 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 the meta SPC 2 4.3. Use description Table 7. Use # 3 – Automated dip treatment, post-milking teat disinfectants 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 Teat disinfection for post – milking, utomated dip treatment of cow teats Application method(s) Open system: dip treatment For post-milking min. 5 minutes contact time. Application rate(s) and frequency Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10ml per dip treatment — Product is ready to use. Use 3 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC 4.3.1. Use-specific instructions for use Product for disinfection of cow teat by dipping after milking. Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment. Use the undiluted product straight from the original packaging. To reduce dermal exposure, the use of a dosing pump for filling the product into the application equipment is recommended. 4.3.2. Use-specific risk mitigation measures See general directions for use of the meta SPC 2 4.3.3. 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 the meta SPC 2 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of the meta SPC 2 4.3.5. 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 the meta SPC 2 4.4. Use description Table 8. Use # 4 – Automated spraying treatment, post-milking teat disinfectants 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 Teat disinfection for postmilking, utomated spray treatment of cow teats Application method(s) Open system: spray treatment For post-milking min. 5 minutes contact time Application rate(s) and frequency Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray treatment — Product is ready to use Use 3 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC 4.4.1. Use-specific instructions for use Product for disinfection of cow teat by spraying, after milking. Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended. 4.4.2. Use-specific risk mitigation measures See general directions for use of the meta SPC 2 4.4.3. 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 the meta SPC 2 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of the meta SPC 2 4.4.5. 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 the meta SPC 2 5. GENERAL DIRECTIONS FOR USE ( 2 ) OF THE META SPC 2 5.1. Instructions for use The products must be brought to temperatures above 20 °C before use. For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes). 5.2. Risk mitigation measures In case 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 First aid: general information: immediately remove any clothing soiled by the product After inhalation: Supply fresh air; consult doctor in case of complaints. After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin. After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing. After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention. If medical advice is needed, have product container or label at hand. Do not allow product to enter sewers surface or ground water. 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 Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach of children. Shelf life: 1 year 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) Gladiator RTU Udder Max Barrier Gladiator Max Barrier Udderdine BARRIER Uddine BARRIER Udderdine RTU Uddine RTU Udderdine BR Authorisation number EU-0020541-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0,26 Fatty alcohol ethoxylate Non-active substance 69011-36-5 500-241-6 1,2 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Udder Star Spray Udder Spray Max Udderdine Spray Uddine Spray Udderdine SP Uddine SP Authorisation number EU-0020541-0003 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0,29 Fatty alcohol ethoxylate Non-active substance 69011-36-5 500-241-6 2,99 META SPC 3 1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier meta SPC 3 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 0,43 0,5 Fatty alcohol ethoxylate Non-active substance 69011-36-5 500-241-6 1,0 2,99 2.2. Type(s) of formulation of the meta SPC 3 Formulation(s) AL — Any other liquid 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Wash hands thoroughly after handling. 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. Avoid release to the environment. 4. AUTHORISED USE(S) OF THE META SPC 3 4.1. Use description Table 9. Use # 1 – Manual dip treatment, post milking teat disinfectants 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 Teat disinfection for post –milking, manual dip treatment of cow teats Application method(s) Open system: dip treatment For post-milking min. 5 minutes contact time Application rate(s) and frequency Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per treatment — Product is ready to use Use 2 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC 4.1.1. Use-specific instructions for use Product for disinfection of cow teat by dipping after milking. Fill the dipping cup with the indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended. 4.1.2. Use-specific risk mitigation measures Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information) and eye protection. 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 the 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 the 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 the meta SPC 3 4.2. Use description Table 10. Use # 2 – Manual spraying treatment, post milking teat disinfectants 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 Teat disinfection for post – milking, manual spray treatment of cow teats Application method(s) Open system: spray treatment For post-milking min. 5 minutes contact time Application rate(s) and frequency Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray treatment — Product is ready to use Use 2 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC 4.2.1. Use-specific instructions for use Product for disinfection of cow teat by spraying after milking. Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15 ml per spray treatment Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended. 4.2.2. Use-specific risk mitigation measures Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information), protective clothing, chemical resistant boots, and eye protection. 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 the 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 the 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 the meta SPC 3 4.3. Use description Table 11. Use # 3 – Automated dip treatment, post-milking teat disinfectants 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 Teat disinfection for post – milking, automated dip treatment of cow teats Application method(s) Open system: dip treatment For post-milking min. 5 minutes contact time. Application rate(s) and frequency Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10ml per dip treatment — Product is ready to use Use 3 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC 4.3.1. Use-specific instructions for use Productfor disinfection of cow teat by dipping after milking. Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment. Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended. 4.3.2. Use-specific risk mitigation measures See general directions for use of the meta SPC 3 4.3.3. 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 the meta SPC 3 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of the meta SPC 3 4.3.5. 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 the meta SPC 3 4.4. Use description Table 12. Use # 4 – Automated spraying treatment, post-milking teat disinfectants 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 Teat disinfection for postmilking, automated spray treatment of cow teats Application method(s) Open system: spray treatment For post-milking min. 5 minutes contact time Application rate(s) and frequency 15 ml per spray treatment — Product is ready to use Use 3 times per day Category(ies) of users Professional Pack sizes and packaging material 20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC 4.4.1. Use-specific instructions for use Product for disinfection of cow teat by spraying after milking. Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment. Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended. 4.4.2. Use-specific risk mitigation measures See general directions for use of the meta SPC 3 4.4.3. 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 the meta SPC 3 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use of the meta SPC 3 4.4.5. 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 the meta SPC 3 5. GENERAL DIRECTIONS FOR USE ( 3 ) OF THE META SPC 3 5.1. Instructions for use The products must be brought to temperatures above 20 °C before use. For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes). 5.2. Risk mitigation measures In case 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 First aid: general information: immediately remove any clothing soiled by the product After inhalation: Supply fresh air; consult doctor in case of complaints. After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin. After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing. After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention. If medical advice is needed, have product container or label at hand. Do not allow product to enter sewers surface or ground water. 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 Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach of children. Shelf life: 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) Udder Star Udder Star Max Udder S Max Udderdine Star Uddine Star Udderdine ST Uddine ST Authorisation number EU-0020541-0004 1-3 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0,5 Fatty alcohol ethoxylate Non-active substance 69011-36-5 500-241-6 2,5 ( 1 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. ( 2 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2. ( 3 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.
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