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)

ANNEX
ANNEX
Summary of product characteristics for a biocidal product family
Iodine Teat dip products
Product type 3 — Veterinary hygiene (Disinfectants)
Authorisation number: EU-0020125-0000
R4BP asset number: EU-0020125-0000
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
Table 1
Use # 1 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Dipping
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:
—
cows and buffaloes: 3 to 10 ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Dip at least 2/3 of the teat length with diluted product immediately after milking
4.1.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves and eye protection when handling the concentrate
(glove material to be specified by the authorisation holder within the product information).
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection
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
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2.    Use description
Table 2
Use # 2 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Spraying
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Spray at least 2/3 of the teat length with diluted product immediately after milking
4.2.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves and eye protection when handling the concentrate
(glove material to be specified by the authorisation holder within the product information).
Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
A protective coverall (at least type 6, EN 13034) shall be worn.
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection
4.2.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.3.    Use description
Table 3
Use # 3 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Foaming
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Dip at least 2/3 of the teat length with diluted product immediately after milking
4.3.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves and eye protection when handling the concentrate
(glove material to be specified by the authorisation holder within the product information).
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection
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
See general directions for use.
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.3.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5.   GENERAL DIRECTIONS FOR USE  ( 1 ) OF THE META SPC 1
5.1.    Instructions for use
Keep out of reach of children
Always read the label or leaflet before use and follow all the instructions provided.
The product must be brought to a temperature above 20 °C before use.
Dilute product before application according to the ratio specified on the product label
Formanual dilution of the concentrate; Add the ratio of concentrate and water, specified on the product label, to a suitably sized container to achieve the required dilution rate. Mix to a uniform solution.
Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow
For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
Product can be used during the entire lactation period
5.2.    Risk mitigation measures
See use specific risk mitigation measures
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Remove and wash contaminated clothing before re-use.
After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.
If you feel unwell, seek medical advice.
After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.
After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.
After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.
Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual farm based waste water treatment plant.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost
Do not store at temperatures above 30 °C
Shelf life 12 months.
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
Table 4
Use # 1 – RTU Products — Professional RTU Liquid, for application pre-milking — Dipping
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for post milking disinfection
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
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2.    Use description
Table 5
Use # 2 – RTU Products — Professional RTU Liquid, for application pre milking — Spraying
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
See general directions for use.
4.2.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for post milking disinfection
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
See general directions for use.
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.3.    Use description
Table 6
Use # 3 – RTU Products — Professional RTU Liquid, for application pre milking – Foaming
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
See general directions for use.
4.3.2.    Use-specific risk mitigation measures
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for post milking disinfection
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
See general directions for use.
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.3.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.4.    Use description
Table 7
Use # 4 – RTU Products — Professional RTU Liquid, for application post milking – Dipping
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Dip at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.4.2.    Use-specific risk mitigation measures
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre milking disinfection
4.4.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.4.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.4.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.5.    Use description
Table 8
Use # 5 – RTU Products — Professional RTU Liquid, for application post milking – Spraying
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Spray at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.5.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
A protective coverall (at least type 6, EN 13034) shall be worn
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre milking disinfection
4.5.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.5.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.5.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.6.    Use description
Table 9
Use # 6 – RTU Products — Professional RTU Liquid, for application post milking – Foaming
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Dip at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.6.2.    Use-specific risk mitigation measures
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre milking disinfection
4.6.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.6.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.6.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.7.    Use description
Table 10
Use # 7 – RTU Products — Professional RTU Liquid, for application pre and post milking-Dipping
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Post milking:
Dip at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.7.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves when applying the product by dipping (glove material to be specified by the authorisation holder within the product information).
This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
4.7.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.7.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.7.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.8.    Use description
Table 11
Use # 8 – RTU Products — Professional RTU Liquid, for application pre and post milking- Spraying
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended) –
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
Post milking:
Spray at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.8.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
A protective coverall (at least type 6, EN 13034) shall be worn
This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
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
See general directions for use.
4.8.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.8.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.9.    Use description
Table 12
Use # 9 – RTU Products — Professional RTU Liquid, for application pre and post milking — Foaming
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1.5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Post milking:
Dip at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.9.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves when applying the product by foaming application method (glove material to be specified by the authorisation holder within the product information).
This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
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
See general directions for use.
4.9.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.9.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5.   GENERAL DIRECTIONS FOR USE  ( 2 ) OF THE META SPC 2
5.1.    Instructions for use
Keep out of reach of children
Always read the label or leaflet before use and follow all the instructions provided.
The product must be brought to a temperature above 20 °C before use.
Product can be used during the entire lactation period
Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow
For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds
5.2.    Risk mitigation measures
See use specific risk mitigation measures.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Remove and wash contaminated clothing before re-use.
After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.
If you feel unwell, seek medical advice.
After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.
After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.
After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.
Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual farm based waste water treatment plant.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost
Do not store at temperatures above 30 °C
Shelf life 12 months
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
Table 13
Use # 1 – RTU Products — Professional RTU Liquid, for application pre-milking — Dipping
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for post milking disinfection
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
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2.    Use description
Table 14
Use # 2 – RTU Products — Professional RTU Liquid, for application pre milking — spraying
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
See general directions for use.
4.2.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for post milking disinfection
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
See general directions for use.
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.3.    Use description
Table 15
Use # 3 – RTU Products — Professional RTU Liquid, for application pre milking – Foaming
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
See general directions for use.
4.3.2.    Use-specific risk mitigation measures
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for post milking disinfection
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
See general directions for use.
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.3.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.4.    Use description
Table 16
Use # 4 – RTU Products — Professional RTU Liquid, for application post milking – Dipping
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Dip at least 2/3 of the teat length with diluted product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.4.2.    Use-specific risk mitigation measures
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre milking disinfection
4.4.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.4.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.4.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.5.    Use description
Table 17
Use # 5 – RTU Products — Professional RTU Liquid, for application post milking – Spraying
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Spray at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.5.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
A protective coverall (at least type 6, EN 13034) shall be worn
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre milking disinfection
4.5.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.5.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.5.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.6.    Use description
Table 18
Use # 6 – RTU Products — Professional RTU Liquid, for application post milking – Foaming
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Dip at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.6.2.    Use-specific risk mitigation measures
In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre milking disinfection
4.6.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.6.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.6.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.7.    Use description
Table 19
Use # 7 – Use # 3.7 – RTU Products — Professional RTU Liquid, for application pre and post milking-Dipping
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Post milking:
Dip at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.7.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves when applying the product by dipping (glove material to be specified by the authorisation holder within the product information).
This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
4.7.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.7.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.7.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.8.    Use description
Table 20
Use # 8 – RTU Products — Professional RTU Liquid, for application pre and post milking- Spraying
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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
Post milking:
Spray at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.8.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
A protective coverall (at least type 6, EN 13034) shall be worn
This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
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
See general directions for use.
4.8.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.8.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.9.    Use description
Table 21
Use # 9 – RTU Products — Professional RTU Liquid, for application pre and post milking — Foaming
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:
—
cows and buffaloes: 3 to 10ml (5 ml recommended)
—
sheep 1,5 to 5 ml (1,5 ml recommended)
—
goats 2,5 to 6 ml (2,5 ml recommended)
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.
4.9.1.    Use-specific instructions for use
Post milking:
Dip at least 2/3 of the teat length with RTU product immediately after milking
To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
4.9.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves when applying the product by foaming application method
(glove material to be specified by the authorisation holder within the product information).
This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
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
See general directions for use.
4.9.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.9.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5.   GENERAL DIRECTIONS FOR USE  ( 3 ) OF THE META SPC 3
5.1.    Instructions for use
Keep out of reach of children
Always read the label or leaflet before use and follow all the instructions provided.
The product must be brought to a temperature above 20 °C before use.
Product can be used during the entire lactation period
Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow
For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds
5.2.    Risk mitigation measures
See use specific risk mitigation measures.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Remove and wash contaminated clothing before re-use.
After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.
If you feel unwell, seek medical advice.
After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.
After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.
After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.
Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual farm based waste water treatment plant.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost
Do not store at temperatures above 30 °C
Shelf life 12 months
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
Authorisation number
EU-0020125-0009 1-3
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
( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.
( 2 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.
( 3 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.
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)

Schedules & Appendices

Cite this act
