COMMISSION IMPLEMENTING REGULATION (EU) 2019/423
of 13 March 2019
granting a Union authorisation for the biocidal product family ‘Teat disinfectants biocidal product family of Novadan’
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product family
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1.
Family name
Name |
Teat disinfectants biocidal product family of Novadan |
1.2.
Product type(s)
Product type(s) |
PT03 — Veterinary hygiene (Disinfectants) |
1.3.
Authorisation holder
Name and address of the authorisation holder |
Name |
Novadan ApS |
Address |
Platinvej 21, 6000 Kolding, Denmark |
|
Authorisation number |
EU-0019757-0000 |
|
R4BP asset number |
EU-0019757-0000 |
|
Date of the authorisation |
7 April 2019 |
|
Expiry date of the authorisation |
31 March 2029 |
1.4.
Manufacturer(s) of the biocidal products
Name of manufacturer |
Novadan ApS |
Address of manufacturer |
Platinvej 21, 6000 Kolding Denmark |
Location of manufacturing sites |
Platinvej 21, 6000 Kolding Denmark |
1.5.
Manufacturer(s) of the active substance(s)
Active substance |
Polyvinylpyrrolidone iodine |
Name of manufacturer |
Marcus Research Laboratory, Inc. |
Address of manufacturer |
Delmar Blvd., 63103-1789 Saint Louis, Missouri United States |
Location of manufacturing sites |
Delmar Blvd., 63103-1789 Saint Louis, Missouri United States |
Active substance |
Iodine |
Name of manufacturer |
Cosayach Nitratos S.A. |
Address of manufacturer |
Hnos Amunátegui 178, 8320000 Santiago Chile |
Location of manufacturing sites |
S.C.M. Cosayach Cala Cala, 1180000 Pozo Almonte Chile |
Active substance |
Iodine |
Name of manufacturer |
ACF Minera S.A. |
Address of manufacturer |
San Martin No 499, 11 00000 Iquique Chile |
Location of manufacturing sites |
Lagunas mine, 1180000 Pozo Almonte Chile |
Active substance |
Iodine |
Name of manufacturer |
Sociedad Quimica y Minera (SQM) S.A. |
Address of manufacturer |
Los Militares 4290, Piso 4, Las Condes, 8320000 Santiago Chile |
Location of manufacturing sites |
Nueva Victoria plant, 5090000 Pedro de Valdivia plant Chile |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1.
Qualitative and quantitative information on the composition of the family
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
0,714 |
3,57 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,15 |
0,75 |
2.2.
Type(s) of formulation
Formulation(s) |
SL — Soluble concentrate AL — Any other liquid EW — Emulsion, oil in water |
PART II
SECOND INFORMATION LEVEL — META SPC(S)
META SPC 1
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 1 identifier
Identifier |
meta-SPC 1 |
1.2.
Suffix to the authorisation number
Number |
1-1 |
1.3.
Product type(s)
Product type(s) |
PT03 — Veterinary hygiene (Disinfectants) |
2. META SPC 1 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 1
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
3,57 |
3,57 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,75 |
0,75 |
2.2.
Type(s) of formulation of the meta SPC 1
Formulation(s) |
SL — Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements |
May be corrosive to metals. Harmful to aquatic life with long lasting effects. Safety data sheet available on request. |
Precautionary statements |
Keep out of reach of children. Keep only in original packaging. Avoid release to the environment. Absorb spillage to prevent material damage. Dispose of contents in accordance with local/regional/national/international regulation. Dispose of container in accordance with local/regional/national/international regulation. |
4. AUTHORISED USE(S) OF THE META SPC 1
4.1.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual dipping (concentrate) Fill the reservoir with the diluted concentrate and screw the dip cup on top. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water. |
Application rate(s) and frequency |
Dilution: 20 % Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual spraying, trigger sprayer (concentrate) Fill the reservoir with the diluted concentrate and screw the top of the trigger sprayer on it. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, spray the disinfectant on the teats using the trigger sprayer making sure that each teat is covered with the disinfectant. Top up the reservoir with fresh disinfectant as needed. After disinfection, empty the reservoir and clean reservoir and sprayer by rinsing with water. |
Application rate(s) and frequency |
Dilution: 20 % Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.3.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual spraying, electronic sprayer (concentrate) Open a can containing the diluted concentrate and insert the suction tube of the electronic sprayer. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, spray the disinfectant on the teats using the electronic sprayer making sure that each teat is covered with the disinfectant. Replace the empty can by a new can as needed. After disinfection, put the suction tube system into a bucket of water and rinse the sprayer by pumping the water through the sprayer. |
Application rate(s) and frequency |
Dilution: 20 % Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.3.1.
Use-specific instructions for use
4.3.2.
Use-specific risk mitigation measures
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
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Automated dipping (concentrate) Open a can containing the diluted concentrate and insert the suction tube of the automated dipping-system. Before milking clean teats carefully by automatic procedure or manually. After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-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. Afterwards, the milking system is ready for the next milking event. The whole process is automated. |
Application rate(s) and frequency |
Dilution: 20 % Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.4.1.
Use-specific instructions for use
4.4.2.
Use-specific risk mitigation measures
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
4.4.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.5.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Automated spraying by robot (concentrate) Open a can containing the diluted concentrate and insert the suction tube of the robotic milking device. The teats are cleaned by robot with automatic brushes. After robotic milking, 2-4 ml of the disinfectant is sprayed automatically onto teats from a cluster arm. Rinsing of the sprayer is automatic. |
Application rate(s) and frequency |
Dilution: 20 % Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.5.1.
Use-specific instructions for use
4.5.2.
Use-specific risk mitigation measures
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
4.5.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.5.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Description of first aid measures
Environmental emergency measures
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
Nova Dip IO Dip Udder Des 1:4 Jod Ewodip Jodopax vet Fova Dip 1:4 Tehotippi |
||||
Authorisation number |
EU-0019757-0001 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
3,57 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,75 |
META SPC 2
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 2 identifier
Identifier |
meta-SPC 2 |
1.2.
Suffix to the authorisation number
Number |
1-2 |
1.3.
Product type(s)
Product type(s) |
PT03 — Veterinary hygiene (Disinfectants) |
2. META SPC 2 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 2
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,0 |
1,42 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,21 |
0,298 |
2.2.
Type(s) of formulation of the meta SPC 2
Formulation(s) |
AL — Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements |
Harmful to aquatic life with long lasting effects. Safety data sheet available on request. |
Precautionary statements |
Keep out of reach of children. Avoid release to the environment. Dispose of contents in accordance with local/regional/national/international regulation. Dispose of container in accordance with local/regional/national/international regulation. |
4. AUTHORISED USE(S) OF THE META SPC 2
4.1.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual dipping (RTU) Fill the reservoir with the RTU product and screw the dip cup on top. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Automated dipping (RTU) Open a can containing the RTU product and insert the suction tube of the automated dipping-system. Before milking clean teats carefully by automatic procedure or manually. After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-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. Afterwards, the milking system is ready for the next milking event. The whole process is automated. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Description of first aid measures
Environmental emergency measures
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
Jopo Film IO Super Dip Barrera Dip |
||||
Authorisation number |
EU-0019757-0002 1-2 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,42 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,298 |
META SPC 3
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 3 identifier
Identifier |
meta-SPC 3 |
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 (%) |
|
Min |
Max |
|||||
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
0,82 |
0,99 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,172 |
0,208 |
2.2.
Type(s) of formulation of the meta SPC 3
Formulation(s) |
AL — Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
Hazard statements |
Safety data sheet available on request. |
Precautionary statements |
Keep out of reach of children. |
4. AUTHORISED USE(S) OF THE META SPC 3
4.1.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual dipping (RTU) Fill the reservoir with the RTU product and screw the dip cup on top. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment Post-milking application 1-3 times per day (apply after every milking) |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Automated dipping (RTU) Open a can containing the RTU product and insert the suction tube of the automated dipping-system. Before milking clean teats carefully by automatic procedure or manually. After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-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. Afterwards, the milking system is ready for the next milking event. The whole process is automated. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment Post-milking application 1-3 times per day (apply after every milking) |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Description of first aid measures
Environmental emergency measures
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
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) |
Nova Dip Barriere IO Multi Dip |
||||
Authorisation number |
EU-0019757-0003 1-3 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
0,82 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,172 |
META SPC 4
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 4 identifier
Identifier |
meta-SPC 4 |
1.2.
Suffix to the authorisation number
Number |
1-4 |
1.3.
Product type(s)
Product type(s) |
PT03 — Veterinary hygiene (Disinfectants) |
2. META SPC 4 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 4
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
0,714 |
0,99 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,15 |
0,208 |
2.2.
Type(s) of formulation of the meta SPC 4
Formulation(s) |
AL — Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements |
Safety data sheet available on request. |
Precautionary statements |
Keep out of reach of children. |
4. AUTHORISED USE(S) OF THE META SPC 4
4.1.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual dipping (RTU) Fill the reservoir with the RTU product and screw the dip cup on top. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual spraying, trigger sprayer (RTU) Fill the reservoir with the RTU product and screw the top of the trigger sprayer on it. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, spray the disinfectant on the teats using the trigger sprayer making sure that each teat is covered with the disinfectant. Top up the reservoir with fresh disinfectant as needed. After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.3.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual spraying, electronic sprayer (RTU) Open a can containing the RTU product and insert the suction tube of the electronic sprayer. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, spray the disinfectant on the teats using the electronic sprayer making sure that each teat is covered with the disinfectant. Replace the empty can by a new can as needed. After disinfection, put the suction tube system into a bucket of water and rinse the sprayer by pumping the water through the sprayer. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0.5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.3.1.
Use-specific instructions for use
4.3.2.
Use-specific risk mitigation measures
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
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Automated dipping (RTU) Open a can containing the RTU product and insert the suction tube of the automated dipping-system. Before milking clean teats carefully by automatic procedure or manually. After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-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. Afterwards, the milking system is ready for the next milking event. The whole process is automated. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.4.1.
Use-specific instructions for use
4.4.2.
Use-specific risk mitigation measures
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
4.4.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.5.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Automated spraying by robot (RTU) Open a can containing the RTU product and insert the suction tube of the robotic milking device. The teats are cleaned by robot with automatic brushes. After robotic milking, 2-4 ml of the disinfectant is sprayed automatically onto teats from a cluster arm. Rinsing of the sprayer is automatic. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.5.1.
Use-specific instructions for use
4.5.2.
Use-specific risk mitigation measures
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
4.5.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.5.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Description of first aid measures
Environmental emergency measures
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
Jopo Spray IO Spray Barrera Spray Agro Teat Spray Nova Dip Ready for Use |
||||
Authorisation number |
EU-0019757-0004 1-4 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
0,714 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,15 |
META SPC 5
1. META SPC 5 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 5 identifier
Identifier |
meta-SPC 5 |
1.2.
Suffix to the authorisation number
Number |
1-5 |
1.3.
Product type(s)
Product type(s) |
PT03 — Veterinary hygiene (Disinfectants) |
2. META SPC 5 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 5
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,0 |
1,46 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,21 |
0,307 |
2.2.
Type(s) of formulation of the meta SPC 5
Formulation(s) |
AL — Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
Hazard statements |
Harmful to aquatic life with long lasting effects. Safety data sheet available on request. |
Precautionary statements |
Keep out of reach of children. Avoid release to the environment. Dispose of contents in accordance with local/regional/national/international regulation. Dispose of container in accordance with local/regional/national/international regulation. |
4. AUTHORISED USE(S) OF THE META SPC 5
4.1.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual dipping (RTU) Fill the reservoir with the RTU product and screw the dip cup on top. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed.. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual spraying, trigger sprayer (RTU) Fill the reservoir with the RTU product and screw the top of the trigger sprayer on it. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, spray the disinfectant on the teats using the trigger sprayer making sure that each teat is covered with the disinfectant. Top up the reservoir with fresh disinfectant as needed. After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.3.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual spraying, electronic sprayer (RTU) Open a can containing the RTU product and insert the suction tube of the electronic sprayer. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, spray the disinfectant on the teats using the electronic sprayer making sure that each teat is covered with the disinfectant. Replace the empty can by a new can as needed. After disinfection, put the suction tube system into a bucket of water and rinse the sprayer by pumping the water through the sprayer. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.3.1.
Use-specific instructions for use
4.3.2.
Use-specific risk mitigation measures
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
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Automated dipping (RTU) Open a can containing the RTU product and insert the suction tube of the automated dipping-system. Before milking clean teats carefully by automatic procedure or manually. After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-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. Afterwards, the milking system is ready for the next milking event. The whole process is automated. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0.5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.4.1.
Use-specific instructions for use
4.4.2.
Use-specific risk mitigation measures
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
4.4.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.5.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Automated spraying by robot (RTU) Open a can containing the RTU product and insert the suction tube of the robotic milking device. The teats are cleaned by robot with automatic brushes. After robotic milking, 2-4 ml of the disinfectant is sprayed automatically onto teats from a cluster arm. Rinsing of the sprayer is automatic. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0.5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.5.1.
Use-specific instructions for use
4.5.2.
Use-specific risk mitigation measures
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
4.5.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.5.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Description of first aid measures
Environmental emergency measures
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
Nova Dip Spray 3000 IO Spray Plus PV-Plus 3000 Tehotippi Soft Plus F 6 Robo V |
||||
Authorisation number |
EU-0019757-0005 1-5 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,46 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,307 |
META SPC 6
1. META SPC 6 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 6 identifier
Identifier |
meta-SPC 6 |
1.2.
Suffix to the authorisation number
Number |
1-6 |
1.3.
Product type(s)
Product type(s) |
PT03 — Veterinary hygiene (Disinfectants) |
2. META SPC 6 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 6
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,0 |
1,43 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,21 |
0,3 |
2.2.
Type(s) of formulation of the meta SPC 6
Formulation(s) |
EW — Emulsion, oil in water |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
Hazard statements |
Harmful to aquatic life with long lasting effects. Safety data sheet available on request. |
Precautionary statements |
Keep out of reach of children. Avoid release to the environment. Dispose of contents in accordance with local/regional/national/international regulation. Dispose of container in accordance with local/regional/national/international regulation. |
4. AUTHORISED USE(S) OF THE META SPC 6
4.1.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual dipping (RTU) Fill the reservoir with the RTU product and screw the dip cup on top. Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that the full length of the teat is immersed into the disinfectant. Top up with fresh disinfectant by squeezing the reservoir as needed. After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual spraying, trigger sprayer (RTU) Fill the reservoir with the RTU product and screw the top of the trigger sprayer on it. Clean carefully the teats by wiping with a single service paper towel/cloth before milking. After milking, spray the disinfectant on the teats using the trigger sprayer making sure that each teat is covered with the disinfectant. Top up the reservoir with fresh disinfectant as needed. After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.3.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Manual spraying, electronic sprayer (RTU) Open a can containing the RTU product and insert the suction tube of the electronic sprayer. Clean carefully the teats by wiping with a single service paper towel/cloth before milking. After milking, spray the disinfectant on the teats using the electronic sprayer making sure that each teat is covered with the disinfectant. Replace the empty can by a new can as needed. After disinfection, put the suction tube system into a bucket of water and rinse the sprayer by pumping the water through the sprayer. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.3.1.
Use-specific instructions for use
4.3.2.
Use-specific risk mitigation measures
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
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Automated dipping (RTU) Open a can containing the RTU product and insert the suction tube of the automated dipping-system. Before milking clean teats carefully by automatic procedure or manually. After milking, the vacuum is shut off and the teat dip is injected into a manifold on the claw piece. The teats are coated with 2-4 ml of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-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. Afterwards, the milking system is ready for the next milking event. The whole process is automated. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.4.1.
Use-specific instructions for use
4.4.2.
Use-specific risk mitigation measures
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
4.4.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.5.
Use description
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 DISINFECTION FOR VETERINARY HYGIENE: Teat disinfection product for milkable animals (cows, buffaloes, sheep, goats) for use after milking. |
Application method(s) |
Automated spraying by robot (RTU) Open a can containing the RTU product and insert the suction tube of the robotic milking device. The teats are cleaned by robot with automatic brushes. After robotic milking, 2-4 ml of the disinfectant is sprayed automatically onto teats from a cluster arm. Rinsing of the sprayer is automatic. |
Application rate(s) and frequency |
Cows and buffaloes: 4 ml/animal per treatment; sheep: 2 ml/animal per treatment; goats: 3 ml/animal per treatment. Post-milking application 1-3 times per day (apply after every milking). |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
Jerry can, HDPE: 0,5 L, 5 L, 10 L, 20 L, 60 L Plastic drum, HDPE: 200 L IBC, HDPE: 1 000 L Opaque containers. |
4.5.1.
Use-specific instructions for use
4.5.2.
Use-specific risk mitigation measures
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
4.5.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.5.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Description of first aid measures
Environmental emergency measures
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
Jopo Winterspray IO Winterspray Jodopax RTU Barrera W |
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Authorisation number |
EU-0019757-0006 1-6 |
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,43 |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,3 |