LegalizeCommission Implementing Regulation (EU) 2019/403 of 13 March 2019 granting a Union authorisation for the biocidal product family ‘Deosan Activate BPF based on Iodine’
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.
| Trade name(s) | Deosan Activate Pre/Post AG217 Deosan Activate Pre/Post Iodine Plus Pre & Post Deosan D4T Super AG211 Agros Iodo Agros Iodo Multi Poviclyn liquido | Deosan Activate Pre/Post AG217 Deosan Activate Pre/Post Iodine Plus Pre & Post Deosan D4T Super AG211 Agros Iodo Agros Iodo Multi Poviclyn liquido | Deosan Activate Pre/Post AG217 Deosan Activate Pre/Post Iodine Plus Pre & Post Deosan D4T Super AG211 Agros Iodo Agros Iodo Multi Poviclyn liquido | Deosan Activate Pre/Post AG217 Deosan Activate Pre/Post Iodine Plus Pre & Post Deosan D4T Super AG211 Agros Iodo Agros Iodo Multi Poviclyn liquido | Deosan Activate Pre/Post AG217 Deosan Activate Pre/Post Iodine Plus Pre & Post Deosan D4T Super AG211 Agros Iodo Agros Iodo Multi Poviclyn liquido |
| Authorisation number | EU-0019228-0004 1-2 | EU-0019228-0004 1-2 | EU-0019228-0004 1-2 | EU-0019228-0004 1-2 | EU-0019228-0004 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | Active Substance | 7553-56-2 | 231-442-4 | 0,3 |
7.3. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Deosan Activate PVP Plus AG215 Deosan Activate PVP Plus Agros Iodo-Prev POS-Ordenha Deosan Hitech 2 AG214 Iodine Teat Dip Solution | Deosan Activate PVP Plus AG215 Deosan Activate PVP Plus Agros Iodo-Prev POS-Ordenha Deosan Hitech 2 AG214 Iodine Teat Dip Solution | Deosan Activate PVP Plus AG215 Deosan Activate PVP Plus Agros Iodo-Prev POS-Ordenha Deosan Hitech 2 AG214 Iodine Teat Dip Solution | Deosan Activate PVP Plus AG215 Deosan Activate PVP Plus Agros Iodo-Prev POS-Ordenha Deosan Hitech 2 AG214 Iodine Teat Dip Solution | Deosan Activate PVP Plus AG215 Deosan Activate PVP Plus Agros Iodo-Prev POS-Ordenha Deosan Hitech 2 AG214 Iodine Teat Dip Solution |
| Authorisation number | EU-0019228-0005 1-2 | EU-0019228-0005 1-2 | EU-0019228-0005 1-2 | EU-0019228-0005 1-2 | EU-0019228-0005 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | Active Substance | 7553-56-2 | 231-442-4 | 0,3 |
META SPC 3
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
| Identifier | Meta SPC 3 — Deosan Activate BPF – RTU gel |
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 (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| Iodine | Active Substance | 7553-56-2 | 231-442-4 | 0,3 | 0,32 |
2.2. Type(s) of formulation of the meta SPC 3
| Formulation(s) | GW — Water soluble gel |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
| Hazard statements | Harmful to aquatic life with long lasting effects. |
| Precautionary statements | If medical advice is needed, have product container or label at hand. Keep out of reach of children. Avoid release to the environment. Dispose of contents to in accordance with national regulations. Dispose of container to in accordance with national regulations. |
4. AUTHORISED USE(S) OF THE META SPC 3
4.1. Use description
Table 23. Use # 1 – Pre-milking disinfection, manual dipping (RTU gel)
| 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) | Manual dipping Teat disinfectant, for direct application to lactating animals pre milking Applied directly to animal teats pre- milking via manual dipping application method. |
| Application rate(s) and frequency | In use iodine concentration of 3 000 mg/Kg (0,3 % w/w) – Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use. 3 pre milking applications, per animal, per day. Apply a maximum of 10 ml product/animal/application |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1, 5 and 20 litre HDPE or f-HDPE canister 200 litre HDPE or f-HDPE drum 950 litre HDPE or f-HPDE Intermediate Bulk Container (IBC) |
4.1.1. Use-specific instructions for use
Applied directly to animal teats pre- milking via manual dipping application method.
Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.
3 pre milking applications, per animal, per day.
Apply a maximum of 10 ml product/animal/application
4.1.2. Use-specific risk mitigation measures
See section 5 — General Directions for Use
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See section 5 — General Directions for Use
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 5 — General Directions for Use
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See section 5 — General Directions for Use
4.2. Use description
Table 24. Use # 2 – Post-milking disinfection, manual dipping (RTU gel)
| 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) | Manual dipping Teat disinfectant, for direct application to lactating animals post milking Applied directly to animal teats post milking via manual dipping method. |
| Application rate(s) and frequency | In use iodine concentration of 3 000 mg/Kg (0,3 % w/w) – Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use. 3 post milking applications, per animal, per day. apply a maximum of 10 ml product/animal/application |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1, 5 and 20 litre HDPE or f-HDPE canister 200 litre HDPE or f-HDPE drum 950 litre HDPE or f-HPDE Intermediate Bulk Container (IBC) |
4.2.1. Use-specific instructions for use
Applied directly to animal teats post milking via manual dipping method.
Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.
2-3 post milking applications, per animal, per day.
Apply a maximum of 10 ml product/animal/application
4.2.2. Use-specific risk mitigation measures
See section 5 — General Directions for Use
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 section 5 — General Directions for Use
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 5 — General Directions for Use
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See section 5 — General Directions for Use
4.3. Use description
Table 25. Use # 3 – Post-milking disinfection, semi-automatic dipping (RTU gel)
| 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) | Semi-automatic dipping Teat disinfectant, for direct application to lactating animals post milking Applied directly to animal teats post milking via semi-automatic dipping method. |
| Application rate(s) and frequency | In use iodine concentration of 3 000 mg/Kg (0,3 % w/w) – Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use. 3 post milking applications, per animal per day. Apply a maximum of 10 ml product/animal/application. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1, 5 and 20 litre HDPE or f-HDPE canister 200 litre HDPE or f-HDPE drum 950 litre HDPE or f-HPDE Intermediate Bulk Container (IBC) |
4.3.1. Use-specific instructions for use
Applied directly to animal teats post milking via semi-automatic dipping method.
Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.
3 post milking applications, per animal, per day.
Apply a maximum of 10 ml product/animal/application
4.3.2. Use-specific risk mitigation measures
See section 5 — General Directions for Use
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 section 5 — General Directions for Use
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 5 — General Directions for Use
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See section 5 — General Directions for Use
4.4. Use description
Table 26. Use # 4 – Pre and post-milking disinfection, manual dipping (RTU gel)
| 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) | Manual dipping Teat disinfectant, for direct application to lactating animals pre and post milking Applied directly to animal teats pre and post milking via manual dipping application method. |
| Application rate(s) and frequency | In use iodine concentration of 3 000 mg/Kg (0,3 % w/w) – Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use. 3 pre and 3 post milking applications, per animal, per day (up to 5 applications in total) Apply a maximum of 10 ml product/animal/application |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1, 5 and 20 litre HDPE or f-HDPE canister 200 litre HDPE or f-HDPE drum 950 litre HDPE or f-HPDE Intermediate Bulk Container (IBC) |
4.4.1. Use-specific instructions for use
Applied directly to animal teats pre and post milking via manual dipping application method.
Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.
3 pre and 3 post milking applications, per animal, per day (up to 5 applications in total)
Apply a maximum of 10 ml product/animal/application
4.4.2. 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)
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 section 5 — General Directions for Use
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 5 — 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 section 5 — General Directions for Use
5. GENERAL DIRECTIONS FOR USE 6 OF THE META SPC 3
5.1. Instructions for use
The product must be brought to temperature > 20 °C before use
Pre milking:
Apply product to full length of each teat.
For effective use against bacteria and yeast, product must be left in contact with the skin for at least 30 seconds.
After the appropriate contact time, thoroughly remove the product, using a single service paper towel/cloth to ensure teats are clean and dry.
In use iodine concentration of 3 000 mg/Kg (0,3 % w/w)
Post milking:
Cover the full length of each teat with the 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)
In use iodine concentration of 3 000 mg/Kg (0,3 % w/w)
5.2. Risk mitigation measures
This product can be used for pre- and post-milking disinfection in combination (up to 5 applications in total per animal per day). However, it should not be used in combination with a different iodine-based product
The use of a dosing pump for filling the product into the application equipment is recommended.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Inhalation: No known effects or symptoms in normal use.
Skin contact: No known effects or symptoms in normal use.
Eye contact: No known effects or symptoms in normal use.
Ingestion: No known effects or symptoms in normal use
After inhalation: Supply fresh air; consult doctor in case of symptoms.
After skin contact: Instantly wash with water and soap and rinse thoroughly.
After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).
After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.
If medical advice is needed, have product container or label at hand
Stability and reactivity:
Reactivity: No reactivity hazards known under normal storage and use conditions.
Chemical stability: Stable under normal storage and use conditions.
Possibility of hazardous reactions: No hazardous reactions known under normal storage and use conditions.
Conditions to avoid: None known under normal storage and use conditions.
Hazardous decomposition products: None known under normal storage and use conditions.
Environmental precautions:
Dike to collect larger liquid spills.
Contain and/or absorb spill with inert material, then place in suitable container.
Prevent run-off from entering drains, sewers or waterways.
Collect in closed and suitable containers for disposal.
Do not place spilled materials back into the original container.
5.4. Instructions for safe disposal of the product and its packaging
Empty containers must be tripled rinsed prior to disposal
Paper towels used to dry animal teats and remove the product from them should be disposed of as normal/domestic waste.
Do not discharge undiluted product to sewers.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Store only in original, closed container
Protect from frost
Do not store at temperatures above 30 °C
Shelf life 18 months
6. OTHER INFORMATION
None
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) | Deosan Activate Barrier AG216 Agros Iodo Pós Povisyl espeso | Deosan Activate Barrier AG216 Agros Iodo Pós Povisyl espeso | Deosan Activate Barrier AG216 Agros Iodo Pós Povisyl espeso | Deosan Activate Barrier AG216 Agros Iodo Pós Povisyl espeso | Deosan Activate Barrier AG216 Agros Iodo Pós Povisyl espeso |
| Authorisation number | EU-0019228-0006 1-3 | EU-0019228-0006 1-3 | EU-0019228-0006 1-3 | EU-0019228-0006 1-3 | EU-0019228-0006 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | Active Substance | 7553-56-2 | 231-442-4 | 0,3 |
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 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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