LegalizeCommission Implementing Regulation (EU) 2020/202 of 4 October 2019 granting a Union authorisation for the biocidal product family ‘Iodine Teat Dip Products’ (Text with EEA relevance)
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| Product type | PT03 — Veterinary hygiene (Disinfectants) |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria Yeast |
| Field(s) of use | Indoor |
| Application method(s) | Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. |
| Application rate(s) and frequency | Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day |
| Category(ies) of users | Trained professional Professional |
| Pack sizes and packaging material | Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
4.4.1. Use-specific instructions for use
Dip at least 2/3 of the teat length with diluted product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.4.2. Use-specific 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
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.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
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.
4.5. Use description
Table 17
Use # 5 – RTU Products — Professional RTU Liquid, for application post milking – Spraying
| Product type | PT03 — Veterinary hygiene (Disinfectants) |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria Yeast All |
| Field(s) of use | Indoor |
| Application method(s) | Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product |
| Application rate(s) and frequency | Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day |
| Category(ies) of users | Trained professional Professional |
| Pack sizes and packaging material | Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
4.5.1. Use-specific instructions for use
Spray at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.5.2. Use-specific risk mitigation measures
Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
A protective coverall (at least type 6, EN 13034) shall be worn
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
4.5.3. 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.
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.5.5. 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.
4.6. Use description
Table 18
Use # 6 – RTU Products — Professional RTU Liquid, for application post milking – Foaming
| Product type | PT03 — Veterinary hygiene (Disinfectants) |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria Yeast |
| Field(s) of use | Indoor |
| Application method(s) | Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. |
| Application rate(s) and frequency | Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day |
| Category(ies) of users | Trained professional Professional |
| Pack sizes and packaging material | Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
4.6.1. Use-specific instructions for use
Dip at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.6.2. Use-specific 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
4.6.3. 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.
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.6.5. 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.
4.7. Use description
Table 19
Use # 7 – Use # 3.7 – RTU Products — Professional RTU Liquid, for application pre and post milking-Dipping
| Product type | PT03 — Veterinary hygiene (Disinfectants) |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria Yeast |
| Field(s) of use | Indoor |
| Application method(s) | Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. |
| Application rate(s) and frequency | Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day |
| Category(ies) of users | Trained professional Professional |
| Pack sizes and packaging material | Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
4.7.1. Use-specific instructions for use
Post milking:
Dip at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.7.2. Use-specific risk mitigation measures
Wear protective chemical resistant gloves when applying the product by dipping (glove material to be specified by the authorisation holder within the product information).
This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
4.7.3. 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.
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.7.5. 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.
4.8. Use description
Table 20
Use # 8 – RTU Products — Professional RTU Liquid, for application pre and post milking- Spraying
| Product type | PT03 — Veterinary hygiene (Disinfectants) |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria Yeast |
| Field(s) of use | Indoor |
| Application method(s) | Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product |
| Application rate(s) and frequency | Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day |
| Category(ies) of users | Trained professional Professional |
| Pack sizes and packaging material | Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
4.8.1. Use-specific instructions for use
Post milking:
Spray at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.8.2. Use-specific risk mitigation measures
Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
A protective coverall (at least type 6, EN 13034) shall be worn
This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
4.8.3. 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.
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.8.5. 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.
4.9. Use description
Table 21
Use # 9 – RTU Products — Professional RTU Liquid, for application pre and post milking — Foaming
| Product type | PT03 — Veterinary hygiene (Disinfectants) |
| Where relevant, an exact description of the authorised use | — |
| Target organism(s) (including development stage) | Bacteria Yeast |
| Field(s) of use | Indoor |
| Application method(s) | Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. |
| Application rate(s) and frequency | Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day |
| Category(ies) of users | Trained professional Professional |
| Pack sizes and packaging material | Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
4.9.1. Use-specific instructions for use
Post milking:
Dip at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.9.2. Use-specific risk mitigation measures
Wear protective chemical resistant gloves when applying the product by foaming application method
(glove material to be specified by the authorisation holder within the product information).
This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
4.9.3. 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.
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.9.5. 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 6 OF THE META SPC 3
5.1. Instructions for use
Keep out of reach of children
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.
Product can be used during the entire lactation period
Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow
For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds
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
Remove and wash contaminated clothing before re-use.
After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.
If you feel unwell, seek medical advice.
After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.
After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.
After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.
Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.
5.4. Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose of 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 farm based waste water treatment plant.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost
Do not store at temperatures above 30 °C
Shelf life 12 months
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) | LuxSpray 15 — Priodine RTU/Kristal Iocare Pre/Super Pre | LuxSpray 15 — Priodine RTU/Kristal Iocare Pre/Super Pre | LuxSpray 15 — Priodine RTU/Kristal Iocare Pre/Super Pre | LuxSpray 15 — Priodine RTU/Kristal Iocare Pre/Super Pre | LuxSpray 15 — Priodine RTU/Kristal Iocare Pre/Super Pre |
| Authorisation number | EU-0020125-0009 1-3 | EU-0020125-0009 1-3 | EU-0020125-0009 1-3 | EU-0020125-0009 1-3 | EU-0020125-0009 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | Active Substance | 7553-56-2 | 231-442-4 | 0,16 | |
| C9-11 Alcohol Ethoxylate | C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 | Non-active substance | 68439-46-3 | 614-482-0 | 0,166 |
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.
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.
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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