Commission Implementing Regulation (EU) 2019/1794 of 22 October 2019 granting a Union authorisation for the biocidal product family ‘Boumatic Iodine product family’ (Text with EEA relevance.)

ANNEXSummary of product characteristics for a biocidal product family
ANNEX
Summary of product characteristics for a biocidal product family
Boumatic Iodine product family
Product type 3 — Veterinary hygiene (Disinfectants)
Authorisation number: EU-0020541-0000
R4BP asset number: EU-0020541-0000
PART I
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
Boumatic Iodine product family
1.2.    Product type(s)
Product type(s)
PT03 — Veterinary hygiene (Disinfectants)
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
Boumatic Gascoigne Melotte
Address
31, Rue Jules Melotte, 4350, Remicourt, Belgium
Authorisation number
EU-0020541-0000
R4BP asset number
EU-0020541-0000
Date of the authorisation
18 November 2019
Expiry date of the authorisation
31 October 2029
1.4.    Manufacturer(s) of the biocidal products
Name of manufacturer
Christeyns n.v.
Address of manufacturer
Afrikalaan 182, 9000 Ghent Belgium
Location of manufacturing sites
Afrikalaan 182, 9000 Ghent Belgium
1.5.    Manufacturer(s) of the active substance(s)
Active substance
Iodine
Name of manufacturer
Christeyns n.v.
Address of manufacturer
Afrikalaan 182, 9000 Ghent Belgium
Location of manufacturing sites
Cosayach Nitratos S.A, Oficina Cala Cala S/N, Pozo Almonte Iquique 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
0,26
0,5
Fatty alcohol ethoxylate
Non-active substance
69011-36-5
500-241-6
1,0
2,99
2.2.    Type(s) of formulation
Formulation(s)
AL — Any other liquid
PART II
SECOND INFORMATION LEVEL — META SPC(S)
META SPC 1
1.    META SPC 1 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 1 identifier
Identifier
meta SPC 1
1.2.    Suffix to the authorisation number
Number
1-1
1.3.    Product type(s)
Product type(s)
PT03 — Veterinary hygiene (Disinfectants)
2.    META SPC 1 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Iodine
Active Substance
7553-56-2
231-442-4
0,44
0,5
Fatty alcohol ethoxylate
Non-active substance
69011-36-5
500-241-6
1,0
2,99
2.2.    Type(s) of formulation of the meta SPC 1
Formulation(s)
AL — Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
Causes serious eye irritation.
Harmful to aquatic life with long lasting effects.
Precautionary statements
Wash hands thoroughly after handling.
Wear eye protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice.
Avoid release to the environment.
4.    AUTHORISED USE(S) OF THE META SPC 1
4.1.    Use description
Table 1. Use # 1 – Manual dip treatment, pre- or post-milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfectants for pre- or post-milking manual dip treatment of cow teats
Application method(s)
Open system: dip treatment
For pre-milking: min. 1 minute contact time
For post-milking min. 5 minutes contact time
Application rate(s) and frequency
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per treatment — Product is ready to use
Use 2 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg high-density polyethylene (HDPE) drum and 1 000 kg HDPE
4.1.1.    Use-specific instructions for use
Product for disinfection of cow teat by dipping before or after milking.
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.
Fill the dipping cup with indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup. To reduce dermal exposure, the use of a dosing pump for filling the product into the application equipment is recommended.
4.1.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information) and eye protection.
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 of the meta SPC 1
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 1
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 of the meta SPC 1
4.2.    Use description
Table 2. Use # 2 – Manual spraying treatment pre- or post-milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfectants for pre- or post-milking, manual spray treatment of cow teat
Application method(s)
Open system: spray treatment
or pre-milking: min. 1 minute contact time
or post-milking min. 5 minutes contact time
Application rate(s) and frequency
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray — Product is ready to use
Use 2 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE Intermediate bulk containers (IBC)
4.2.1.    Use-specific instructions for use
Product for disinfection of cow teat by spraying before or after milking.
Apply an amount of product that is sufficient to cover the entire teat at the maximum 15 ml per spray treatment.
Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
4.2.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information), protective clothing, chemical resistant boots, and eye protection.
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 of the meta SPC 1
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 1
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 of the meta SPC 1
4.3.    Use description
Table 3. Use # 3 – Automated dip treatment, pre- or post-milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfectants for pre- or post-milking, automated dip treatment of cow teat
Application method(s)
Open system: dip treatment
For pre-milking: min. 1 minute contact time
For post-milking min. 5 minutes contact time
Application rate(s) and frequency
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip — Product is ready to use
Use 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
4.3.1.    Use-specific instructions for use
Product for disinfection of cow teat by dipping before or after milking.
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.
Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
4.3.2.    Use-specific risk mitigation measures
See general directions for use of the meta SPC 1
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 of the meta SPC 1
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 1
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 of the meta SPC 1
4.4.    Use description
Table 4. Use # 4 – Automated spraying treatment, pre- or post-milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfectants for pre- or post-milking, automated spray treatment of cow teat
Application method(s)
Open system: spray treatment
or pre-milking: min. 1 minute contact time
or post-milking min. 5 minutes contact time
Application rate(s) and frequency
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray — Product is ready to use
Use 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
4.4.1.    Use-specific instructions for use
Product for disinfection of cow teat by spraying before or after milking.
Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment.
Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
4.4.2.    Use-specific risk mitigation measures
See general directions for use of the meta SPC 1
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 of the meta SPC 1
4.4.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 1
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 of the meta SPC 1
5.    GENERAL DIRECTIONS FOR USE   ( 1 )
OF THE META SPC 1
5.1.    Instructions for use
The products must be brought to temperatures above 20 °C before use.
For pre-milking treatment: treat the entire teat with the product, let act 60 seconds and wipe teats dry using single-use towels to avoid any contamination of milk.
For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes).
5.2.    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 either for pre- or post-milking disinfection.
Keep out of reach of children.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid: general information: immediately remove any clothing soiled by the product
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin.
After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing.
After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention.
If medical advice is needed, have product container or label at hand.
Do not allow product to enter sewers surface or ground water.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach children.
Shelf life: 2 years
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)
Udder Dip
Udder Dip Max
Udder D Max
Udderdine Dip
Uddine Dip
Udderdine DP
Uddine DP
Udderdine DS
Authorisation number
EU-0020541-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,5
Fatty alcohol ethoxylate
Non-active substance
69011-36-5
500-241-6
2,99
META SPC 2
1.    META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
meta SPC 2
1.2.    Suffix to the authorisation number
Number
1-2
1.3.    Product type(s)
Product type(s)
PT03 — Veterinary hygiene (Disinfectants)
2.    META SPC 2 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Iodine
Active Substance
7553-56-2
231-442-4
0,26
0,38
Fatty alcohol ethoxylate
Non-active substance
69011-36-5
500-241-6
1,0
2,99
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
Causes serious eye irritation.
Harmful to aquatic life with long lasting effects.
Precautionary statements
Wash hands thoroughly after handling.
Wear eye protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice.
Avoid release to the environment.
4.    AUTHORISED USE(S) OF THE META SPC 2
4.1.    Use description
Table 5. Use # 1 – Manual dip treatment, post milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfection for post –milking, manual dip treatment of cow teats
Application method(s)
Open system: dip treatment
For post-milking min. 5 minutes contact time
Application rate(s) and frequency
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per treatment — Product is ready to use
Use 2 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
4.1.1.    Use-specific instructions for use
Product for disinfection of cow teat by dipping after milking.
Fill the dipping cup with the indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
4.1.2.    Use-specific risk mitigation measures
Wear eye protection.
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 of the meta SPC 2
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 2
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 of the meta SPC 2
4.2.    Use description
Table 6. Use # 2 – Manual spraying treatment, post milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfection for post – milking, anual spray treatment of cow teats
Application method(s)
Open system: spray treatment
For post-milking min. 5 minutes contact time
Application rate(s) and frequency
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray treatment — Product is ready to use
Use 2 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
4.2.1.    Use-specific instructions for use
Product for disinfection of cow teat by spraying after milking.
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15 ml per spray treatment.
Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
4.2.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye protection.
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 of the meta SPC 2
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 2
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 of the meta SPC 2
4.3.    Use description
Table 7. Use # 3 – Automated dip treatment, post-milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfection for post – milking, utomated dip treatment of cow teats
Application method(s)
Open system: dip treatment
For post-milking min. 5 minutes contact time.
Application rate(s) and frequency
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10ml per dip treatment — Product is ready to use.
Use 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
4.3.1.    Use-specific instructions for use
Product for disinfection of cow teat by dipping after milking.
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.
Use the undiluted product straight from the original packaging. To reduce dermal exposure, the use of a dosing pump for filling the product into the application equipment is recommended.
4.3.2.    Use-specific risk mitigation measures
See general directions for use of the meta SPC 2
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 of the meta SPC 2
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 2
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 of the meta SPC 2
4.4.    Use description
Table 8. Use # 4 – Automated spraying treatment, post-milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfection for postmilking, utomated spray treatment of cow teats
Application method(s)
Open system: spray treatment
For post-milking min. 5 minutes contact time
Application rate(s) and frequency
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray treatment — Product is ready to use
Use 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
4.4.1.    Use-specific instructions for use
Product for disinfection of cow teat by spraying, after milking.
Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment
Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
4.4.2.    Use-specific risk mitigation measures
See general directions for use of the meta SPC 2
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 of the meta SPC 2
4.4.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 2
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 of the meta SPC 2
5.    GENERAL DIRECTIONS FOR USE   ( 2 )
OF THE META SPC 2
5.1.    Instructions for use
The products must be brought to temperatures above 20 °C before use.
For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes).
5.2.    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.
Keep out of reach of children.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid: general information: immediately remove any clothing soiled by the product
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin.
After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing.
After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention.
If medical advice is needed, have product container or label at hand.
Do not allow product to enter sewers surface or ground water.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach of children.
Shelf life: 1 year
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)
Gladiator RTU
Udder Max Barrier
Gladiator Max Barrier
Udderdine BARRIER
Uddine BARRIER
Udderdine RTU
Uddine RTU
Udderdine BR
Authorisation number
EU-0020541-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,26
Fatty alcohol ethoxylate
Non-active substance
69011-36-5
500-241-6
1,2
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Udder Star Spray
Udder Spray Max
Udderdine Spray
Uddine Spray
Udderdine SP
Uddine SP
Authorisation number
EU-0020541-0003 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,29
Fatty alcohol ethoxylate
Non-active substance
69011-36-5
500-241-6
2,99
META SPC 3
1.    META SPC 3 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 3 identifier
Identifier
meta SPC 3
1.2.    Suffix to the authorisation number
Number
1-3
1.3.    Product type(s)
Product type(s)
PT03 — Veterinary hygiene (Disinfectants)
2.    META SPC 3 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Iodine
Active Substance
7553-56-2
231-442-4
0,43
0,5
Fatty alcohol ethoxylate
Non-active substance
69011-36-5
500-241-6
1,0
2,99
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
Causes serious eye irritation.
Harmful to aquatic life with long lasting effects.
Precautionary statements
Wash hands thoroughly after handling.
Wear eye protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice.
Avoid release to the environment.
4.    AUTHORISED USE(S) OF THE META SPC 3
4.1.    Use description
Table 9. Use # 1 – Manual dip treatment, post milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfection for post –milking, manual dip treatment of cow teats
Application method(s)
Open system: dip treatment
For post-milking min. 5 minutes contact time
Application rate(s) and frequency
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per treatment — Product is ready to use
Use 2 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
4.1.1.    Use-specific instructions for use
Product for disinfection of cow teat by dipping after milking.
Fill the dipping cup with the indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
4.1.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information) and eye protection.
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 of the meta SPC 3
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 3
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 of the meta SPC 3
4.2.    Use description
Table 10. Use # 2 – Manual spraying treatment, post milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfection for post – milking, manual spray treatment of cow teats
Application method(s)
Open system: spray treatment
For post-milking min. 5 minutes contact time
Application rate(s) and frequency
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray treatment — Product is ready to use
Use 2 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
4.2.1.    Use-specific instructions for use
Product for disinfection of cow teat by spraying after milking.
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15 ml per spray treatment
Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
4.2.2.    Use-specific risk mitigation measures
Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information), protective clothing, chemical resistant boots, and eye protection.
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 of the meta SPC 3
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 3
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 of the meta SPC 3
4.3.    Use description
Table 11. Use # 3 – Automated dip treatment, post-milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfection for post – milking, automated dip treatment of cow teats
Application method(s)
Open system: dip treatment
For post-milking min. 5 minutes contact time.
Application rate(s) and frequency
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10ml per dip treatment — Product is ready to use
Use 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
4.3.1.    Use-specific instructions for use
Productfor disinfection of cow teat by dipping after milking.
Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.
Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
4.3.2.    Use-specific risk mitigation measures
See general directions for use of the meta SPC 3
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 of the meta SPC 3
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 3
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 of the meta SPC 3
4.4.    Use description
Table 12. Use # 4 – Automated spraying treatment, post-milking teat disinfectants
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Teat disinfection for postmilking, automated spray treatment of cow teats
Application method(s)
Open system: spray treatment
For post-milking min. 5 minutes contact time
Application rate(s) and frequency
15 ml per spray treatment — Product is ready to use
Use 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
4.4.1.    Use-specific instructions for use
Product for disinfection of cow teat by spraying after milking.
Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment.
Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
4.4.2.    Use-specific risk mitigation measures
See general directions for use of the meta SPC 3
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 of the meta SPC 3
4.4.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of the meta SPC 3
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 of the meta SPC 3
5.    GENERAL DIRECTIONS FOR USE   ( 3 )
OF THE META SPC 3
5.1.    Instructions for use
The products must be brought to temperatures above 20 °C before use.
For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes).
5.2.    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.
Keep out of reach of children.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid: general information: immediately remove any clothing soiled by the product
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin.
After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing.
After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention.
If medical advice is needed, have product container or label at hand.
Do not allow product to enter sewers surface or ground water.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach of children.
Shelf life: 2 years.
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)
Udder Star
Udder Star Max
Udder S Max
Udderdine Star
Uddine Star
Udderdine ST
Uddine ST
Authorisation number
EU-0020541-0004 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,5
Fatty alcohol ethoxylate
Non-active substance
69011-36-5
500-241-6
2,5
( 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) 2019/1794 of 22 October 2019 granting a Union authorisation for the biocidal product family ‘Boumatic Iodine product family’ (Text with EEA relevance.)

Schedules & Appendices

Cite this act
