COMMISSION 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)
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 CVAS |
|
|
1.2.
Product type(s)
Product type(s) |
PT03 — Veterinary hygiene (Disinfectants) |
|
|
1.3.
Authorisation holder
Name and address of the authorisation holder |
Name |
CVAS Development GmbH |
Address |
Dr Albert Reimann Str. 16a, 68526 Ladenburg, Germany |
|
Authorisation number |
EU-0018724-0000 |
|
R4BP asset number |
EU-0018724-0000 |
|
Date of the authorisation |
18 December 2018 |
|
Expiry date of the authorisation |
30 November 2028 |
1.4.
Manufacturer(s) of the biocidal products
Name of manufacturer |
Calvatis GmbH |
Address of manufacturer |
Dr Albert Reimann Str. 16a, 68526 Ladenburg, Germany |
Location of manufacturing sites |
Dr Albert Reimann Str. 16a, 68526 Ladenburg, Germany |
Name of manufacturer |
Arthur Schopf Hygiene GmbH & Co. KG |
Address of manufacturer |
Pfaffensteinstr. 1, 83115 Neubeuern, Germany |
Location of manufacturing sites |
Pfaffensteinstr. 1, 83115 Neubeuern, Germany |
1.5.
Manufacturer(s) of the active substance(s)
Active substance |
Iodine |
Name of manufacturer |
Cosayach Nitratos S.A. |
Address of manufacturer |
Amunategui 178 Santiago Chile |
Location of manufacturing sites |
S.C.M. Cosayach Cala Cala Pozo Almonte Chile |
Active substance |
Iodine |
Name of manufacturer |
ACF Minera S.A. |
Address of manufacturer |
San Martín No 499 Iquique Chile |
Location of manufacturing sites |
Lagunas mine Pozo Almonte Chile |
Active substance |
Iodine |
Name of manufacturer |
SQM S.A. |
Address of manufacturer |
Los Militares 4290, Piso 4 Las Condes Chile |
Location of manufacturing sites |
Nueva Victoria plant Pedro de Valdivia plant Chile |
Active substance |
Iodine |
Name of manufacturer |
Nihon Tennen Gas Co., Ltd/Kanto Natural Gas Development Co., Ltd |
Address of manufacturer |
661 Mobara 297-8550 Mobara City, Chiba Japan |
Location of manufacturing sites |
Chiba Plant, 2508 Minami-Hinata 299-4205 Shirako-Machi, Chosei-Gun, Chiba Japan |
Active substance |
Polyvinylpyrrolidone iodine |
Name of manufacturer |
Norkem Limited (manufacturer of PVP-iodine) |
Address of manufacturer |
Norkem House, Bexton Lane WA 16 9FB Knutsford, Cheshire United Kingdom |
Location of manufacturing sites |
Norkem House, Bexton Lane WA 16 9FB Knutsford, Cheshire United Kingdom |
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 |
|||||
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
0,54 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
0 |
4,16 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
0,33 |
2.2.
Type(s) of formulation
Formulation(s) |
AL — Any other liquid |
|
|
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 |
|||||
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,16 |
1,5 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
0 |
2.2.
Type(s) of formulation of the meta SPC 1
Formulation |
AL — Any other liquid |
|
|
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements |
|
Precautionary statements |
If medical advice is needed, have product container or label at hand. Keep out of reach of children. |
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual dipping using a dip cup |
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 |
4.1.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Automated dipping |
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 |
4.2.1.
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 (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
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) |
Dip es barriere Dip es barriere 1.4 Iod Dip F 14 P |
||||
Authorisation number |
EU-0018724-0001 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,16 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
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 |
|||||
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,56 |
2,5 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
0 |
2.2.
Type(s) of formulation of the meta SPC 2
Formulation |
AL — Any other liquid |
|
|
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements |
Harmful to aquatic life with long lasting effects. |
Precautionary statements |
If medical advice is needed, have product container or label at hand. Keep out of reach of children. Avoid release to the environment. Dispose of contents to local/regional/national/international regulation. Dispose of container to 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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual dipping using a dip cup |
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 |
4.1.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Automated dipping |
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 |
4.2.1.
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
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) |
Dip es Io-film Dip es Io-film 3.0 Iod-Dip Io-film 30 |
||||
Authorisation number |
EU-0018724-0002 1-2 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
2,5 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
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 |
|||||
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,56 |
4,16 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
0 |
2.2.
Type(s) of formulation of the meta SPC 3
Formulation |
AL — Any other liquid |
|
|
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
Hazard statements |
Harmful to aquatic life with long lasting effects. |
Precautionary statements |
If medical advice is needed, have product container or label at hand. Keep out of reach of children. Avoid release to the environment. Dispose of contents to local/regional/national/international regulation. Dispose of container to local/regional/national/international regulation. |
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual dipping using a dip cup |
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 |
4.1.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Automated dipping |
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 |
4.2.1.
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
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) |
Dip es barriere S Dip es barriere 3.0 Iod-Dip F 30 P Baktostop Barier color |
||||
Authorisation number |
EU-0018724-0003 1-3 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
2,5 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
Dip es barriere RS Dip es barriere 5.0 Iod-Dip F 50 P BaktoStop barier |
||||
Authorisation number |
EU-0018724-0004 1-3 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
4,16 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
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 |
|||||
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,56 |
2,5 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
0 |
2.2.
Type(s) of formulation of the meta SPC 4
Formulation |
AL — Any other liquid |
|
|
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements |
Harmful to aquatic life with long lasting effects. |
Precautionary statements |
If medical advice is needed, have product container or label at hand. Keep out of reach of children. Avoid release to the environment. Dispose of contents to local/regional/national/international regulation. Dispose of container to local/regional/national/international regulation. |
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual dipping using a dip cup |
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 |
4.1.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual spraying using a trigger sprayer |
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 |
4.2.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual spraying using an electronic sprayer |
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 |
4.3.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Automated dipping |
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 |
4.4.1.
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 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 |
4.5.1.
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
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) |
Dip es silver |
||||
Authorisation number |
EU-0018724-0005 1-4 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
2,5 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
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 |
|||||
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,16 |
1,16 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
0 |
2.2.
Type(s) of formulation of the meta SPC 5
Formulation |
AL — Any other liquid |
|
|
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
Hazard statements |
|
Precautionary statements |
If medical advice is needed, have product container or label at hand. Keep out of reach of children. |
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual dipping using a dip cup |
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 |
4.1.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual spraying using a trigger sprayer |
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 |
4.2.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual spraying using an electronic sprayer |
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 |
4.3.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Automated dipping |
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 |
4.4.1.
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 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 |
4.5.1.
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
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) |
Dip es SF Dip es SF 3.0 Iod Dip S 30 P Dip es SF 1.4 Iod-Dip S 14 P EUTADIPP |
||||
Authorisation number |
EU-0018724-0006 1-5 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,16 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
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 |
|||||
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,16 |
1,16 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
0 |
2.2.
Type(s) of formulation of the meta SPC 6
Formulation |
AL — Any other liquid |
|
|
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
Hazard statements |
|
Precautionary statements |
If medical advice is needed, have product container or label at hand. Keep out of reach of children. |
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use before milking |
Application method(s) |
Manual foaming using a foam cup |
Application rate(s) and frequency |
Cows: 5 mL per treatment Pre-milking application: 2-3×/day (before 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 |
4.1.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual foaming using a foam cup |
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 |
4.2.1.
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- 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 |
4.3.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use before and after milking |
Application method(s) |
Manual foaming using a foam cup |
Application rate(s) and frequency |
Cows: 5 mL per treatment Pre- and post-milking application: 4-6 times per day (before and 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 |
4.4.1.
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
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
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) |
Dip es Io-foam Dip es Io-foam 1.4 Iod-Dip Io-foam BaktoStop foam |
||||
Authorisation number |
EU-0018724-0007 1-6 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
1,16 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0 |
META SPC 7
1. META SPC 7 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 7 identifier
Identifier |
meta SPC 7 |
1.2.
Suffix to the authorisation number
Number |
1-7 |
1.3.
Product type(s)
Product type(s) |
PT03 — Veterinary hygiene (Disinfectants) |
|
|
2. META SPC 7 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 7
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,14 |
0,14 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
0 |
0 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0,11 |
0,33 |
2.2.
Type(s) of formulation of the meta SPC 7
Formulation |
AL — Any other liquid |
|
|
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
Hazard statements |
Harmful to aquatic life with long lasting effects. |
Precautionary statements |
Avoid release to the environment. Dispose of contents to local/regional/national/international regulation. Dispose of container to local/regional/national/international regulation. |
4. AUTHORISED USE(S) OF THE META SPC 7
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual dipping using a dip cup |
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 |
4.1.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual foaming using a foam cup |
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 |
4.2.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual spraying using a trigger sprayer |
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 |
4.3.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual spraying using an electronic sprayer |
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 |
4.4.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Automated dipping |
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 |
4.5.1.
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
4.6.
Use description
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
4.6.2.
Use-specific risk mitigation measures
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
4.6.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.6.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.7.
Use description
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
4.7.2.
Use-specific risk mitigation measures
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
4.7.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.7.5.
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 (7) OF THE META SPC 7
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
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 7
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
calgodip D 1200 Jod-Dip S 12 Dip es SF 1200 |
||||
Authorisation number |
EU-0018724-0008 1-7 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,14 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
0 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0,15 |
META SPC 8
1. META SPC 8 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 8 identifier
Identifier |
meta SPC 8 |
1.2.
Suffix to the authorisation number
Number |
1-8 |
1.3.
Product type(s)
Product type(s) |
PT03 — Veterinary hygiene (Disinfectants) |
|
|
2. META SPC 8 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 8
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,14 |
0,54 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
0 |
0 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0,11 |
0,33 |
2.2.
Type(s) of formulation of the meta SPC 8
Formulation |
AL — Any other liquid |
|
|
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
Hazard statements |
Harmful to aquatic life with long lasting effects. |
Precautionary statements |
Avoid release to the environment. Dispose of contents to local/regional/national/international regulation. Dispose of container to local/regional/national/international regulation. |
4. AUTHORISED USE(S) OF THE META SPC 8
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual dipping using a dip cup |
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 |
4.1.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Automated dipping |
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 |
4.2.1.
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 (8) OF THE META SPC 8
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
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 8
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
calgodip D 3000 Film Jod-Dip F 30 Jod Dipp 30 Film (Technolit) Jod 30 Film (Iwetec) Dip es barriere 3000 Lerapur Dip Jod 30 BaktoStop barrier color 3.0 |
||||
Authorisation number |
EU-0018724-0009 1-8 |
||||
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 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
calgodip D 5000 Jod Dip F 50 Jod Dipp 50 (Iwetec) Jod-Dipp 50 (Technolit) Dip es barriere 5000 BaktoStop barrier 5.0 |
||||
Authorisation number |
EU-0018724-0010 1-8 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,54 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
0 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0,26 |
META SPC 9
1. META SPC 9 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 9 identifier
Identifier |
meta SPC 9 |
1.2.
Suffix to the authorisation number
Number |
1-9 |
1.3.
Product type(s)
Product type(s) |
PT03 — Veterinary hygiene (Disinfectants) |
|
|
2. META SPC 9 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 9
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,34 |
0,34 |
Polyvinylpyrrolidone iodine |
|
Active Substance |
25655-41-8 |
|
0 |
0 |
Acetic acid |
Acetic acid |
Non active substance |
64-19-7 |
200-580-7 |
0,11 |
0,33 |
2.2.
Type(s) of formulation of the meta SPC 9
Formulation |
AL — Any other liquid |
|
|
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9
Hazard statements |
Harmful to aquatic life with long lasting effects. |
Precautionary statements |
Avoid release to the environment. Dispose of contents to local/regional/national/international regulation. Dispose of container to local/regional/national/international regulation. |
4. AUTHORISED USE(S) OF THE META SPC 9
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual dipping using a dip cup |
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 |
4.1.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual foaming using a foam cup |
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 |
4.2.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual spraying using a trigger sprayer |
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 |
4.3.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Manual spraying using an electronic sprayer |
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 |
4.4.1.
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 Yeasts |
Field(s) of use |
Indoor Teat disinfection for milkable animals (dairy cows) for use after milking |
Application method(s) |
Automated dipping |
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 |
4.5.1.
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
4.6.
Use description
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
4.6.2.
Use-specific risk mitigation measures
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
4.6.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.6.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.7.
Use description
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
4.7.2.
Use-specific risk mitigation measures
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
4.7.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.7.5.
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 (9) OF THE META SPC 9
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
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 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 |
||||
Authorisation number |
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 |