LegalizeCommission Implementing Regulation (EU) 2018/1853 of 27 November 2018 granting a Union authorisation for the biocidal product family Teat disinfectants biocidal product family of CVAS (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 Yeasts |
| Field(s) of use | Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
| Application method(s) | Automated foaming |
| Application rate(s) and frequency | Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg |
4.6.1. Use-specific instructions for use
The product must be brought to a temperature above 20 °C before use.
Open a can containing the RTU product and insert a suction tube of the automated foaming-system. Avoid discharge of surplus fluids.
After milking, the vacuum is shut off and the teat disinfectant is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of foam when the teat foam cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated foaming-system is thoroughly rinsed with water and blown out with compressed air.
In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
Afterwards, the milking system is ready for the next milking event.
The whole process is automated.
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 36. Use # 7 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated spraying by robot
| 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 milkable animals (dairy cows) for use after milking |
| Application method(s) | Automated spraying by robot |
| Application rate(s) and frequency | Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg |
4.7.1. Use-specific instructions for use
The product must be brought to a temperature above 20 °C before use.
Open a can containing the RTU product and insert a suction tube of the robotic milking device. Avoid discharge of surplus fluids.
The teats are cleaned by robot with automatic brushes.
After robotic milking, the disinfectant is sprayed automatically onto teats from a cluster arm.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
Rinsing of the sprayer is automatic.
4.7.2. 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.
4.7.3. 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.
5. GENERAL DIRECTIONS FOR USE 12 OF THE META SPC 9
5.1. Instructions for use
See use specific instructions for use.
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
Mentioned in the MSDS
Description of first aid measures
After inhalation: Supply fresh air; consult doctor in case of symptoms.
After skin contact: Wash with water and soap.
After eye contact: Rinse opened eye for several minutes under running water. Then consult doctor.
After swallowing: Rinse out mouth and then drink plenty of water. Seek immediate medical advice.
Stability and reactivity
Possibility of hazardous reactions: Reaction with oxidant- and reducing agent.
Conditions to avoid: No further relevant information available.
Incompatible materials: No further relevant information available.
Hazardous decomposition products: iodine (when warming up).
Accidental release measures
Personal precautions, protective equipment and emergency procedures: No special measures required.
Environmental precautions: Do not allow product to reach sewage systems or water bodies in great quantities.
Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.
5.4. Instructions for safe disposal of the product and its packaging
Mentioned in the MSDS
Waste treatment methods
Recommendation: Must be specially treated with regard to official regulations.
Waste disposal key number: Corresponding to the regulation of the European Waste catalogue the relation of the waste key numbers has to be made specific to industry and process.
European waste catalogue: Corresponding to the regulation of the EWC the relation of the waste key numbers has to be made specific to industry and process.
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.
Recommended cleaning agent: Water, if necessary with cleaning agent.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.
6. OTHER INFORMATION
—
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | calgodip D 3000 Jod-Dip S 30 Bestfarm Dip Premium Jod 30 Universal (Iwetec) Jod-Dipp 30 (Technolit) Dip es SF 3000 Lerapur Jod SP 30 | calgodip D 3000 Jod-Dip S 30 Bestfarm Dip Premium Jod 30 Universal (Iwetec) Jod-Dipp 30 (Technolit) Dip es SF 3000 Lerapur Jod SP 30 | calgodip D 3000 Jod-Dip S 30 Bestfarm Dip Premium Jod 30 Universal (Iwetec) Jod-Dipp 30 (Technolit) Dip es SF 3000 Lerapur Jod SP 30 | calgodip D 3000 Jod-Dip S 30 Bestfarm Dip Premium Jod 30 Universal (Iwetec) Jod-Dipp 30 (Technolit) Dip es SF 3000 Lerapur Jod SP 30 | calgodip D 3000 Jod-Dip S 30 Bestfarm Dip Premium Jod 30 Universal (Iwetec) Jod-Dipp 30 (Technolit) Dip es SF 3000 Lerapur Jod SP 30 |
| Authorisation number | EU-0018724-0011 1-9 | EU-0018724-0011 1-9 | EU-0018724-0011 1-9 | EU-0018724-0011 1-9 | EU-0018724-0011 1-9 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | Active Substance | 7553-56-2 | 231-442-4 | 0,34 | |
| Polyvinylpyrrolidone iodine | Active Substance | 25655-41-8 | 0 | ||
| Acetic acid | Acetic acid | Non active substance | 64-19-7 | 200-580-7 | 0,26 |
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC6.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC7.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC8.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC9.
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.