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)
Article 1
A Union authorisation with authorisation number EU-0020540-0000 is granted to Applied Biocide GmbH for the making available on the market and use of the biocidal product family ‘BPF_Iodine_VET’, in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 25 November 2019 until 31 October 2029.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
Summary of product characteristics for a biocidal product family
BPF_Iodine_VET
Product type 3 – Veterinary hygiene (Disinfectants)
Authorisation number: EU-0020540-0000
R4BP asset number: EU-0020540-0000
PART I
FIRST INFORMATION LEVEL
| Name | BPF_Iodine_VET |
|---|---|
| Product type(s) | PT03 – Veterinary hygiene (Disinfectants) |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Siemensstraße 42, 59199 Bönen, Germany |
| Authorisation number | EU-0020540-0000 |
| R4BP asset number | EU-0020540-0000 |
| Date of the authorisation | 25 November 2019 |
| Expiry date of the authorisation | 31 October 2029 |
| Name of manufacturer | THESEO Deutschland GmbH |
| --- | --- |
| Address of manufacturer | Kolpingstrasse 4, 49835 Wietmarschen Germany |
| Location of manufacturing sites | Kolpingstrasse 4, 49835 Wietmarschen Germany |
| Name of manufacturer | FINK TEC GmbH |
| --- | --- |
| Address of manufacturer | Oberster Kamp 23, 59069 Hamm Germany |
| Location of manufacturing sites | Oberster Kamp 23, 59069 Hamm Germany |
| Name of manufacturer | I.R.C.A. SERVICE S.p.A. |
| --- | --- |
| Address of manufacturer | S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy |
| Location of manufacturing sites | S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy |
| Name of manufacturer | Laboratorios Maymó S.A. |
| --- | --- |
| Address of manufacturer | Via Augusta, 302, 08017 Barcelona Spain |
| Location of manufacturing sites | Via Augusta, 302, 08017 Barcelona Spain |
| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | Cosayach S.A. Compania de Salitre y Yodo |
| Address of manufacturer | Amunátegui 178, 7th Floor, 8320000 Santiago Chile |
| Location of manufacturing sites | S.C.M. Cosayach Cala Cala, 1180000 Pozo Almonte Chile Chile |
| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | ACF Minera S.A. |
| Address of manufacturer | San Martin 499, 1100000 Iquique Chile |
| Location of manufacturing sites | Lagunas mine, 1180000 Pozo Almonte Chile |
| Active substance | Iodine |
| --- | --- |
| Name of manufacturer | Sociedad Quimica y Minera SA |
| Address of manufacturer | Los Militares 4290, 7550000 Las Condes Chile |
| Location of manufacturing sites | Nueva Victoria, 1180000 Pozo Almonte Chile Pedro de Valdivia, 1240000 Antofagasta Chile |
| Common name | IUPAC name |
| --- | --- |
| Min | Max |
| Iodine | |
| Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid |
| Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched |
| Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate |
| Formulation(s) | meta SPC 1-5: AL – any other liquid meta SPC 6-8: SL – soluble concentrate |
| --- | --- |
PART II
SECOND INFORMATION LEVEL – META SPC(S)
| Identifier | Meta SPC 1 |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT03 – Veterinary hygiene (Disinfectants) |
| --- | --- |
| Common name | IUPAC name |
| --- | --- |
| Min | Max |
| Iodine | |
| Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid |
| Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched |
| Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate |
| Formulation(s) | AL – any other liquid |
| --- | --- |
| Hazard statements | May be corrosive to metals. |
| --- | --- |
| Precautionary statements | Keep only in original packaging. Absorb spillage to prevent material damage. Store in corrosive resistant container with a resistant inner liner. |
| 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 |
| Application method(s) | Open system: spray treatment |
| Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking) | |
| Application rate(s) and frequency | Application rate: 10-15 mL per cow |
| Application frequency: During lactation period: manual: 2 applications per day (post-milking) automated: 3 applications per day (post-milking) During dry period: 1 application per day | |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Bottle high-density polyethylene (HDPE): 1 liter, cap is made of PP Jerry can HDPE: 5 – 60 liters Drum HDPE: 200 liters IBC HDPE: 600 – 1000 liters |
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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.
The use of a dosing pump for filling the product into the application equipment is recommended.
Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.
Keep the cows standing until the product has dried (at least 5 minutes).
Product can be applied manually or by means of automatic teat sprayer.
Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).
Keep out of reach of children.
Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information).
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.
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: 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.
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.
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.
Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE
| Trade name(s) | FINK – Io Spray 15 FINK – Euter-DIP PVP-S FINK Pattedyp PVP IOSpray 15 PVP | ||||
|---|---|---|---|---|---|
| Authorisation number | EU-0020540-0001 1-1 | ||||
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | Active Substance | 7553-56-2 | 231-442-4 | 0,15 | |
| Identifier | Meta SPC 2 | ||||
| --- | --- | ||||
| Number | 1-2 | ||||
| --- | --- | ||||
| Product type(s) | PT03 – Veterinary hygiene (Disinfectants) | ||||
| --- | --- | ||||
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max | ||||
| Iodine | Active Substance | 7553-56-2 | 231-442-4 | 0,3 | |
| Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 0,0 |
| 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 | 0,0 |
| Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Non-active substance | 68439-46-3 | 614-482-0 | 0,0 |
| Formulation(s) | AL – any other liquid | ||||
| --- | --- | ||||
| Hazard statements | May be corrosive to metals. Harmful to aquatic life with long lasting effects. | ||||
| --- | --- | ||||
| Precautionary statements | Keep only in original packaging. Avoid release to the environment. Absorb spillage to prevent material damage. Store in corrosive resistant container with a resistant inner liner. Dispose of contents to/container in accordance with the local/national regulations. | ||||
| 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 | ||||
| Application method(s) | Open system: spray treatment Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking) | ||||
| Application rate(s) and frequency | Application rate: 10-15 mL per cow Application frequency: During lactation period: manual: 2 applications per day (post-milking) automated: 3 applications per day (post-milking) During dry period: 1 application per day | ||||
| 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 |
…
…
…
…
…
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.
The use of a dosing pump for filling the product into the application equipment is recommended.
Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.
Keep the cows standing until the product has dried (at least 5 minutes).
Product can be applied manually or by means of automatic teat sprayer.
Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).
Keep out of reach of children.
Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information).
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.
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: 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.
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.
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.
Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE
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.