COMMISSION IMPLEMENTING REGULATION (EU) 2020/202
of 4 October 2019
granting a Union authorisation for the biocidal product family ‘Iodine Teat Dip Products’
(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 |
Iodine Teat dip products |
1.2.
Product type(s)
Product type(s) |
PT03 — Veterinary hygiene (Disinfectants) |
1.3.
Authorisation holder
Name and address of the authorisation holder |
Name |
GEA Farm Technologies GmbH |
Address |
Siemensstraße 25-27, 59199, Bönen, Germany |
|
Authorisation number |
EU-0020125-0000 |
|
R4BP asset number |
EU-0020125-0000 |
|
Date of the authorisation |
19 November 2019 |
|
Expiry date of the authorisation |
31 October 2029 |
1.4.
Manufacturer(s) of the biocidal products
Name of manufacturer |
GEA Farm Technologies |
Address of manufacturer |
Wylye Works, BA12 9HT Warminster United Kingdom |
Location of manufacturing sites |
Wylye Works, Watery Lane, BA12 9HT Warminster United Kingdom Gewerbestraße 5, 5325 Plainfeld Austria ul. Olowiana 10, 85-461 Bydgoszcz Poland |
1.5.
Manufacturer(s) of the active substance(s)
Active substance |
Iodine |
Name of manufacturer |
SQM Europe N.V. |
Address of manufacturer |
St Pietersvliet 7„ bus 8 2000 Antwerp Belgium |
Location of manufacturing sites |
Sociedad Quimica y Minera SA, Los Militares, Las Condes, 4290 Piso 4 Santiago Chile |
Active substance |
Iodine |
Name of manufacturer |
Nihon Tennen Gas Co., Ltd (Via Mitsui & Co Europe PLC) |
Address of manufacturer |
Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun„ 299-4205 Chosei-Gun Japan |
Location of manufacturing sites |
Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun„ 299-4205 Chosei-Gun Japan |
Active substance |
Iodine |
Name of manufacturer |
Norkem Ltd |
Address of manufacturer |
Norkem House, Bexton Lane„ WA16 9FB Knutsford United Kingdom |
Location of manufacturing sites |
OFICINA CALA CALA S/N, Unknown POZO ALMONTE 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 |
|||||
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,16 |
2,47 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
0,0 |
2,35 |
2.2.
Type(s) of formulation
Formulation(s) |
AL — Any other liquid SL — Soluble concentrate |
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 — Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates |
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 |
1,58 |
2,47 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
1,51 |
2,35 |
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 |
Causes serious eye irritation. May cause damage to thyroid gland through prolonged or repeated exposure. May be corrosive to metals. Toxic to aquatic life with long lasting effects. |
Precautionary statements |
Do not breathe vapours. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if you feel unwell. If eye irritation persists: Get medical advice. Collect spillage. Dispose of container according to local regulations. Dispose of contents according to local regulations. |
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 |
||||||
Application method(s) |
Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense diluted product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. Cups should be refilled with fresh solution before starting new milking session |
||||||
Application rate(s) and frequency |
Quantity of diluted product to be applied per application:
Product to be diluted by the relevant rate stated on the label. Either: 25 % (1 part product to 3 parts water) 20 % (1 part product to 4 parts water) 12,5 % (1 part product to 7 parts water) In use concentration of products between 0,29 and 0,52 % (w/w) iodine. 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 |
||||||
Application method(s) |
Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the diluted product. The diluted product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the diluted product Application via manual trigger spray: Fill trigger spray bottle with diluted product. Use trigger spray to cover the bottom two thirds of each teat with diluted product |
||||||
Application rate(s) and frequency |
Quantity of diluted product to be applied per application:
Product to be diluted by the relevant rate stated on the label. Either: 25 % (1 part product to 3 parts water) 20 % (1 part product to 4 parts water) 12,5 % (1 part product to 7 parts water) In use concentration of products between 0,29 and 0,52 % (w/w) iodine. 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 |
||||||
Application method(s) |
Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of diluted product to be applied per application:
Product to be diluted by the relevant rate stated on the label. Either: 25 % (1 part product to 3 parts water) 20 % (1 part product to 4 parts water) 12,5 % (1 part product to 7 parts water) In use concentration of products between 0,29 and 0,52 % (w/w) iodine. 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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
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) |
Ioklene Concentrate. Coars Dual |
||||
Authorisation number |
EU-0020125-0001 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
1,58 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
1,51 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
Clinidip L Concentrate, Maxadine C, Diamond 3:1 Concentrate, Kristal 321, IO Spray 3:1 Concentrate, Coars Shield |
||||
Authorisation number |
EU-0020125-0002 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
2,06 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
1,96 |
7.3.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
Clinidip Superconcentrate, Dunglinson Super IO 421 Concentrate, Ceanodine 4:1, Iodosan |
||||
Authorisation number |
EU-0020125-0003 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
2,47 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
2,35 |
7.4.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
Priodine, Diamond Predip |
||||
Authorisation number |
EU-0020125-0004 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
2,32 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
2,21 |
META SPC 2
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 2 identifier
Identifier |
Meta SPC 2 — RTU Products — Professional RTU Liquid for application pre and post milking |
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 |
0,16 |
0,5 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
0,0 |
0,56 |
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 |
May be corrosive to metals. Harmful to aquatic life with long lasting effects. |
Precautionary statements |
Avoid release to the environment. Collect spillage. Dispose of contents in accordance with local regulations. Dispose of container in accordance with local regulations. |
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 |
||||||
Application method(s) |
Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation in use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 All |
||||||
Field(s) of use |
Indoor |
||||||
Application method(s) |
Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 All |
||||||
Field(s) of use |
Indoor |
||||||
Application method(s) |
Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation. In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 |
||||||
Application method(s) |
Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation. In use concentration 0,16-0,50 % (w/w) iodine. 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 |
||||||
Application method(s) |
Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation. In use concentration 0,16-0,50 % (w/w) iodine. 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 Yeast |
||||||
Field(s) of use |
Indoor |
||||||
Application method(s) |
Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16-0,50 % (w/w) iodine. 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 Yeast |
||||||
Field(s) of use |
Indoor |
||||||
Application method(s) |
Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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
4.8.
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 |
||||||
Application method(s) |
Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
4.8.1.
Use-specific instructions for use
4.8.2.
Use-specific risk mitigation measures
4.8.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.8.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.8.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.9.
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 |
||||||
Application method(s) |
Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
4.9.1.
Use-specific instructions for use
4.9.2.
Use-specific risk mitigation measures
4.9.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.9.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.9.5.
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) |
LuxSpray 30, Ioklene RTU, Corston Pre/Post Sprayable, Kristal Iocare Plus, PrePost, Autodine, Coars Super Pre |
||||
Authorisation number |
EU-0020125-0005 1-2 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,3 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
0,305 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
LuxSpray 50, Silkidip, Ceanodine, IoSpray 10, Maxadine RTU, Diamond Superdip, Kristal Iocare Post, KiwiDip, Superdip Excel, Ioguard RTU, Shepherd’s IoSpray 50 |
||||
Authorisation number |
EU-0020125-0006 1-2 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,5 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
0,56 |
7.3.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
LuxDip 50B, Postguard |
||||
Authorisation number |
EU-0020125-0007 1-2 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,5 |
7.4.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
LuxDip 25, Kote It, Corston Barracide Post Film Forming Dip, Pro-Tect, Kristal Iocare Film, Coars Iodinegel, Coars Iodogel, LuxDip 20B |
||||
Authorisation number |
EU-0020125-0008 1-2 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,25 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
0,5 |
META SPC 3
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 3 identifier
Identifier |
Meta SPC 3 — RTU Products — Professiona RTU Liquid for application pre and post milking (LuxSpray 15) |
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 |
0,16 |
0,16 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
0.166 |
0.166 |
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 |
May be corrosive to metals. |
Precautionary statements |
Avoid release to the environment. Collect spillage. Dispose of contents in accordance with local regulations. Dispose of container in accordance with local regulations. |
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 |
||||||
Application method(s) |
Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation. In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 |
||||||
Application method(s) |
Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 |
||||||
Application method(s) |
Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 |
||||||
Application method(s) |
Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 All |
||||||
Field(s) of use |
Indoor |
||||||
Application method(s) |
Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 Yeast |
||||||
Field(s) of use |
Indoor |
||||||
Application method(s) |
Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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 Yeast |
||||||
Field(s) of use |
Indoor |
||||||
Application method(s) |
Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
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
4.8.
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 |
||||||
Application method(s) |
Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product |
||||||
Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day |
||||||
Category(ies) of users |
Trained professional Professional |
||||||
Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
4.8.1.
Use-specific instructions for use
4.8.2.
Use-specific risk mitigation measures
4.8.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.8.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.8.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.9.
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 |
||||||
Application method(s) |
Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. |
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Application rate(s) and frequency |
Quantity of RTU product to be applied per application:
Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day |
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Category(ies) of users |
Trained professional Professional |
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Pack sizes and packaging material |
Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified. |
4.9.1.
Use-specific instructions for use
4.9.2.
Use-specific risk mitigation measures
4.9.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.9.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.9.5.
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) |
LuxSpray 15 — Priodine RTU/Kristal Iocare Pre/Super Pre |
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Authorisation number |
EU-0020125-0009 1-3 |
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Iodine |
|
Active Substance |
7553-56-2 |
231-442-4 |
0,16 |
C9-11 Alcohol Ethoxylate |
C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 |
Non-active substance |
68439-46-3 |
614-482-0 |
0,166 |