LegalizeCommission Implementing Regulation (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family BPF_Iodine_VET (Text with EEA relevance)
| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria Yeasts Viruses |
| Field(s) of use | Indoor |
| Application method(s) | Open system: spray treatment Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar) |
| Application rate(s) and frequency | 100 mL/m2 – Concentration of Iodine in application solution: 750 ppm (0,075 %w/w). Application frequency per year: Dairy cows: 1 Beef cattle: 1 Veal calves: 4 Sows, in individual pens: 5 Sows in groups: 5 Fattening pigs: 3 Laying hens in battery cages without treatment: 1 Laying hens in battery cages with aeration (belt drying): 1 Laying hens in battery cages with forced drying (deep pit, high rise): 1 Laying hens in compact battery cages: 1 Laying hens in free range with litter floor (partly litter floor, partly slatted): 1 Broilers in free range with litter floor: 7 Laying hens in free range with grating floor (aviery system): 1 Parent broilers in free range with grating floor: 1 Parent broilers in rearing with grating floor: 3 Turkeys in free range with litter floor: 2 Ducks in free range with litter floor: 13 Geese in free range with litter floor: 6 |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Bottle HDPE: 1 liter, cap is made of PP Jerry can HDPE: 5 – 60 liters Drum HDPE: 200 liters IBC HDPE: 600 – 1000 liters |
4.1.1. Use-specific instructions for use
Iodosan 15: Mix 46 mL product with 954 mL water to obtain 1 L application solution.
4.1.2. Use-specific risk mitigation measures
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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
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4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
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4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
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5. GENERAL DIRECTIONS FOR USE ([^E0008])OF THE META SPC 8
5.1. Instructions for use
Always read the label or leaflet before use and follow all the instructions provided.
To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product.
Use max. 100 mL application solution per m2 treated area. Do not prepare more fluid than strictly necessary.
The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner.
Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off.
5.2. Risk mitigation measures
Keep out of reach of children.
The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product.
During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory.
During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift.
Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes.
Only use one kind of Iodine-containing product per day.
Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Immediately take off contaminated clothing and wash skin thoroughly.
After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
Methods and material for containment and cleaning up:
Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local/national regulations.
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.
European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Store the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 24 months in HDPE
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | IODOSAN 15 | IODOSAN 15 | IODOSAN 15 | IODOSAN 15 | IODOSAN 15 |
| Authorisation number | EU-0020540-0012 1-8 | EU-0020540-0012 1-8 | EU-0020540-0012 1-8 | EU-0020540-0012 1-8 | EU-0020540-0012 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | Active Substance | 7553-56-2 | 231-442-4 | 1,5 | |
| Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 3,0 |
| Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 18,0 |
[^E0001]: 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.
[^E0002]: 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.
[^E0003]: 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.
[^E0004]: Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.
[^E0005]: Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.
[^E0006]: Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.
[^E0007]: Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.
[^E0008]: Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.
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