Commission Implementing Regulation (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family BPF_Iodine_VET (Text with EEA relevance)

ANNEXSummary of product characteristics for a biocidal product family
ANNEX
Summary of product characteristics for a biocidal product family
BPF_Iodine_VET
Product type 3 - Veterinary hygiene (Disinfectants)
Authorisation number: EU-0020540-0000
R4BP asset number: EU-0020540-0000
PART I
FIRST INFORMATION LEVEL
1.   ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
BPF_Iodine_VET
1.2.    Product type(s)
Product type(s)
PT03 — Veterinary hygiene (Disinfectants)
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
Applied Biocide GmbH
Address
Sprl 31, Rue Jules Melotte, 4350, Remicourt, Belgium
Authorisation number
EU-0020540-0000
R4BP asset number
EU-0020540-0000
Date of the authorisation
25 November 2019
Expiry date of the authorisation
31 October 2029
1.4.    Manufacturer(s) of the biocidal products
Name of manufacturer
Ewabo Chemikalien GmbH & Co KG
Address of manufacturer
Kolpingstrasse 4, 49835 Wietmarschen Germany
Location of manufacturing sites
Kolpingstrasse 4, 49835 Wietmarschen Germany
Name of manufacturer
FINK TEC GmbH
Address of manufacturer
Oberster Kamp 23, 59069 Hamm Germany
Location of manufacturing sites
Oberster Kamp 23, 59069 Hamm Germany
Name of manufacturer
IRCASERVICE
Address of manufacturer
S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy
Location of manufacturing sites
S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy
Name of manufacturer
Laboratorios Maymo SA
Address of manufacturer
Via Augusta, 302, 08017 Barcelona Spain
Location of manufacturing sites
Via Augusta, 302, 08017 Barcelona Spain
1.5.    Manufacturer(s) of the active substance(s)
Active substance
Iodine
Name of manufacturer
Cosayach S.A. Compania de Salitre y Yodo
Address of manufacturer
Amunátegui 178, 7th Floor, 8320000 Santiago Chile
Location of manufacturing sites
S.C.M. Cosayach Cala, 1180000 Pozo Almonte Chile Chile
Active substance
Iodine
Name of manufacturer
ACF Minera S.A.
Address of manufacturer
San Martin 499, 1100000 Iquique Chile
Location of manufacturing sites
Lagunas mine, 1180000 Pozo Almonte Chile
Active substance
Iodine
Name of manufacturer
Sociedad Quimica y Minera SA
Address of manufacturer
Los Militares 4290, 7550000 Las Condes Chile
Location of manufacturing sites
Nueva Victoria, 1180000 Pozo Almonte Chile
Pedro de Valdivia, 1240000 Antofagasta 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
0,1
3,0
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
0,0
10,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
0,0
31,8
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Non-active substance
68439-46-3
614-482-0
0,0
31,8
2.2.    Type(s) of formulation
Formulation(s)
meta SPC 1-5: AL — any other liquid
meta SPC 6-8: 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
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
0,15
0,15
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
0,0
0,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
0,0
0,0
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Non-active substance
68439-46-3
614-482-0
0,0
0,0
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
May be corrosive to metals.
Precautionary statements
Keep only in original packaging.
Absorb spillage to prevent material damage.
Store in corrosive resistant container with a resistant inner liner.
4.   AUTHORISED USE(S) OF THE META SPC 1
4.1.    Use description
Table 1
Use # 1 — Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — spraying (post milking)
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
Application method(s)
Open system: spray treatment
Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking)
Application rate(s) and frequency
Application rate: 10-15 ml per cow
Application frequency:
During lactation period:
—
manual: 2 applications per day (post-milking)
—
automated: 3 applications per day (post-milking)
During dry period: 1 application per day
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle high-density polyethylene (HDPE): 1 liter, cap is made of PP
Jerry can HDPE: 5-60 liters
Drum HDPE: 200 liters
IBC HDPE: 600-1 000 liters
4.1.1.    Use-specific instructions for use
---
4.1.2.    Use-specific risk mitigation measures
---
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
---
5.   GENERAL DIRECTIONS FOR USE  ( 1 ) OF THE META SPC 1
5.1.    Instructions for use
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.
The use of a dosing pump for filling the product into the application equipment is recommended.
Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.
Keep the cows standing until the product has dried (at least 5 minutes).
Product can be applied manually or by means of automatic teat sprayer.
Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).
5.2.    Risk mitigation measures
Keep out of reach of children.
Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in 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.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
Environmental emergency measures:
Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
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.
European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE.
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)
FINK — Io Spray 15
FINK — Euter-DIP PVP-S
FINK Pattedyp PVP
IOSpray 15 PVP
Authorisation number
EU-0020540-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,15
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
0,3
0,5
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
0,0
0,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
0,0
0,0
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Non-active substance
68439-46-3
614-482-0
0,0
0,0
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
Keep only in original packaging.
Avoid release to the environment.
Absorb spillage to prevent material damage.
Store in corrosive resistant container with a resistant inner liner.
Dispose of contents to/container in accordance with the local/national regulations.
4.   AUTHORISED USE(S) OF THE META SPC 2
4.1.    Use description
Table 2
Use # 1 — Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — spraying (post milking)
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
Application method(s)
Open system: spray treatment
Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking)
Application rate(s) and frequency
Application rate: 10-15 ml per cow
Application frequency:
During lactation period:
—
manual: 2 applications per day (post-milking)
—
automated: 3 applications per day (post-milking)
During dry period: 1 application per day
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5-60 liters
Drum HDPE: 200 liters
IBC HDPE: 600-1 000 liters
4.1.1.    Use-specific instructions for use
--
4.1.2.    Use-specific risk mitigation measures
--
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
--
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
--
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
--
5.   GENERAL DIRECTIONS FOR USE  ( 2 ) OF THE META SPC 2
5.1.    Instructions for use
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.
The use of a dosing pump for filling the product into the application equipment is recommended.
Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.
Keep the cows standing until the product has dried (at least 5 minutes).
Product can be applied manually or by means of automatic teat sprayer.
Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).
5.2.    Risk mitigation measures
Keep out of reach of children.
Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in 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.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
Environmental emergency measures:
Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
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.
European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE.
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)
Fink Io Spray - 30
ST-Io Spray
DESINTEC MH Iodine S
DESINTEC MH Raidip plus
Iodine Spray 3000
Iodine Spray
Authorisation number
EU-0020540-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,3
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Fink — Io Spray 50
DESINTEC MH Raidip 5000
Iodine Spray 5000
Authorisation number
EU-0020540-0003 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,5
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
0,5
0,5
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
0,0
0,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
0,0
0,0
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Non-active substance
68439-46-3
614-482-0
0,0
0,0
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.
Harmful to aquatic life with long lasting effects.
Precautionary statements
Keep only in original packaging.
Avoid release to the environment.
Absorb spillage to prevent material damage.
Store in corrosive resistant container with a resistant inner liner.
Dispose of contents to/container in accordance with the local/national regulations.
4.   AUTHORISED USE(S) OF THE META SPC 3
4.1.    Use description
Table 3
Use # 1 – Veterinary hygiene - animal husbandry - teat disinfectant - professional - indoors – spraying (post milking)
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
Application method(s)
Open system: spray treatment
Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking)
Application rate(s) and frequency
Application rate: 10-15 ml per cow
Application frequency:
During lactation period:
—
manual: 2 applications per day (post-milking)
—
automated: 3 applications per day (post-milking)
During dry period: 1 application per day
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5-60 liters
Drum HDPE: 200 liters
IBC HDPE: 600-1 000 liters
4.1.1.    Use-specific instructions for use
--
4.1.2.    Use-specific risk mitigation measures
---
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
--
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
---
5.   GENERAL DIRECTIONS FOR USE  ( 3 ) OF THE META SPC 3
5.1.    Instructions for use
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.
The use of a dosing pump for filling the product into the application equipment is recommended.
Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.
Keep the cows standing until the product has dried (at least 5 minutes).
Product can be applied manually or by means of automatic teat sprayer.
Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).
5.2.    Risk mitigation measures
Keep out of reach of children.
Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in 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.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
Environmental emergency measures:
Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
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.
European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE.
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)
Fink — Io Spray 50 (Jodophor)
Fink — Io Spray 50 (Iodophor)
Authorisation number
EU-0020540-0004 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,5
META SPC 4
1.   META SPC 4 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 4 identifier
Identifier
Meta SPC 4
1.2.    Suffix to the authorisation number
Number
1-4
1.3.    Product type(s)
Product type(s)
PT03 — Veterinary hygiene (Disinfectants)
2.   META SPC 4 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Iodine
Active Substance
7553-56-2
231-442-4
0,1
0,15
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
0,0
0,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
0,0
0,0
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Non-active substance
68439-46-3
614-482-0
0,0
0,0
2.2.    Type(s) of formulation of the meta SPC 4
Formulation(s)
AL — any other liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements
May be corrosive to metals.
Precautionary statements
Keep only in original packaging.
Absorb spillage to prevent material damage.
Store in corrosive resistant container with a resistant inner liner.
4.   AUTHORISED USE(S) OF THE META SPC 4
4.1.    Use description
Table 4
Use # 1 – Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — dipping (post milking)
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
Application method(s)
Open system: dip treatment
Teat-dipping: Manual non-medical disinfection of teats with a ready-to-use liquid (on cows, post-milking)
Application rate(s) and frequency
Application rate: 5-10 ml per cow
Application frequency:
During lactation period: 2 applications per day (post-milking)
During dry period: 1 application per day
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5-60 liters
Drum HDPE: 200 liters
IBC HDPE: 600-1 000 liters
4.1.1.    Use-specific instructions for use
---
4.1.2.    Use-specific risk mitigation measures
---
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
---
5.   GENERAL DIRECTIONS FOR USE  ( 4 ) OF THE META SPC 4
5.1.    Instructions for use
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.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill up a teat dipping cup with 2/3 of product. Immediately after each cow has been milked, dip each teat manually in the solution. Ensure that at least two thirds of the teats, preferably the entire teats, come in contact with the solution.
Do not clean the teats directly after disinfection. Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).
Refill the cup as necessary.
Teat dipping cups should be emptied after milking and washed before re-use. Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day (post-milking).
5.2.    Risk mitigation measures
Keep out of reach of children.
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.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
Environmental emergency measures:
Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
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.
European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE.
6.   OTHER INFORMATION
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
FINK — Io Dip 10
IODip 10 PVP
Authorisation number
EU-0020540-0005 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,1
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
FINK — Io Dip Protect
DESINTEC MH Iodine Barrier
TvP — Barrier Dip
Authorisation number
EU-0020540-0006 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,15
META SPC 5
1.   META SPC 5 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 5 identifier
Identifier
Meta SPC 5
1.2.    Suffix to the authorisation number
Number
1-5
1.3.    Product type(s)
Product type(s)
PT03 — Veterinary hygiene (Disinfectants)
2.   META SPC 5 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 5
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Iodine
Active Substance
7553-56-2
231-442-4
0,3
0,45
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
0,35
0,4
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
0,0
0,0
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Non-active substance
68439-46-3
614-482-0
0,0
0,0
2.2.    Type(s) of formulation of the meta SPC 5
Formulation(s)
AL — any other liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
Hazard statements
May be corrosive to metals.
Harmful to aquatic life with long lasting effects.
Precautionary statements
Keep only in original packaging.
Avoid release to the environment.
Absorb spillage to prevent material damage.
Store in corrosive resistant container with a resistant inner liner.
Dispose of contents to / container in accordance with the local/national regulations.
4.   AUTHORISED USE(S) OF THE META SPC 5
4.1.    Use description
Table 5
Use # 1 — Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — dipping (post milking)
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
Application method(s)
Open system: dip treatment
Teat-dipping: Manual non-medical disinfection of teats with a ready-to-use liquid (on cows, post-milking)
Application rate(s) and frequency
Application rate: 5-10 ml per cow
Application frequency:
During lactation period: 2 applications per day (post-milking)
During dry period: 1 application per day
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5-60 liters
Drum HDPE: 200 liters
IBC HDPE: 600-1 000 liters
4.1.1.   Use-specific instructions for use
---
4.1.2.    Use-specific risk mitigation measures
---
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
---
5.   GENERAL DIRECTIONS FOR USE  ( 5 ) OF THE META SPC 5
5.1.    Instructions for use
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.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill up a teat dipping cup with 2/3 of product. Immediately after each cow has been milked, dip each teat manually in the solution. Ensure that at least two thirds of the teats, preferably the entire teats, come in contact with the solution.
Do not clean the teats directly after disinfection. Leave the product until next milking.
Keep the cows standing until the product has dried (at least 5 minutes).
Refill the cup as necessary.
Teat dipping cups should be emptied after milking and washed before re-use. Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
Application frequency must not exceed two applications per cow and day (post-milking).
5.2.    Risk mitigation measures
Keep out of reach of children.
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.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Wash skin thoroughly.
After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
Environmental emergency measures:
Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
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.
European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 12 months in HDPE.
6.   OTHER INFORMATION
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Jodofilm 75/5 4 500 ppm
Authorisation number
EU-0020540-0007 1-5
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,45
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
0,4
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Jodofilm 75/5 3 000 ppm
Authorisation number
EU-0020540-0008 1-5
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
0,3
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
0,35
META SPC 6
1.   META SPC 6 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 6 identifier
Identifier
Meta SPC 6
1.2.    Suffix to the authorisation number
Number
1-6
1.3.    Product type(s)
Product type(s)
PT03 — Veterinary hygiene (Disinfectants)
2.   META SPC 6 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 6
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Iodine
Active Substance
7553-56-2
231-442-4
1,75
2,4
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
3,0
10,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
0,0
25,6
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Non-active substance
68439-46-3
614-482-0
0,0
31,8
2.2.    Type(s) of formulation of the meta SPC 6
Formulation(s)
SL — soluble concentrate
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
Hazard statements
May be corrosive to metals.
Harmful if swallowed.
Causes severe skin burns and eye damage.
Causes serious eye damage.
May cause damage to thyroid gland through prolonged or repeated exposure.
Harmful to aquatic life with long lasting effects.
Precautionary statements
Keep only in original packaging.
Do not breathe mist.
Do not breathe spray.
Avoid release to the environment.
Wear protective gloves.
Wear protective clothing.
Wear face protection.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
Absorb spillage to prevent material damage.
Store locked up.
Keep out of reach of children.
4.   AUTHORISED USE(S) OF THE META SPC 6
4.1.    Use description
Table 6
Use # 1 — Veterinary hygiene — animal husbandry — hard surface disinfectant — professional — indoors — spraying
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Viruses
Field(s) of use
Indoor
Application method(s)
Open system: spray treatment
Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar)
Application rate(s) and frequency
100 ml/m 2 — Concentration of Iodine in application solution: 750 ppm (0,075 % w/w).
Application frequency per year:
Dairy cows: 1
Beef cattle: 1
Veal calves: 4
Sows, in individual pens: 5
Sows in groups: 5
Fattening pigs: 3
Laying hens in battery cages without treatment: 1
Laying hens in battery cages with aeration (belt drying): 1
Laying hens in battery cages with forced drying (deep pit, high rise): 1
Laying hens in compact battery cages: 1
Laying hens in free range with litter floor (partly litter floor, partly slatted): 1
Broilers in free range with litter floor: 7
Laying hens in free range with grating floor (aviery system): 1
Parent broilers in free range with grating floor: 1
Parent broilers in rearing with grating floor: 3
Turkeys in free range with litter floor: 2
Ducks in free range with litter floor: 13
Geese in free range with litter floor: 6
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5-60 liters
Drum HDPE: 200 liters
IBC HDPE: 600-1 000 liters
4.1.1.    Use-specific instructions for use
Iodosan 30: Mix 29 ml product with 971 ml water to obtain 1 l application solution.
Iodosan 18: Mix 40 ml product with 960 ml water to obtain 1 l application solution.
4.1.2.    Use-specific risk mitigation measures
---
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
---
5.   GENERAL DIRECTIONS FOR USE  ( 6 ) OF THE META SPC 6
5.1.    Instructions for use
Always read the label or leaflet before use and follow all the instructions provided.
To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product.
Use max. 100 ml application solution per m 2 treated area. Do not prepare more fluid than strictly necessary.
The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner.
Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36 h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off.
5.2.    Risk mitigation measures
Keep out of reach of children.
The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product.
During the mixing and loading phase : The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory.
During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift.
Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes.
Only use one kind of Iodine-containing product per day.
Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Immediately take off contaminated clothing and wash skin thoroughly.
After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
Environmental emergency measures:
Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
Methods and material for containment and cleaning up:
Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local / national regulations.
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.
European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Store the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 24 months in HDPE
6.   OTHER INFORMATION
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
IODOSAN 30
IODOSAN
IODAT
DESINTEC FL-JODES
ROTIE-SOL J
Disinfect Jod
FINK — Jodophos 15
Jod-Reiniger sauer
Tankrein extra
Authorisation number
EU-0020540-0009 1-6
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
2,4
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
10,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
25,6
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
IODOSAN 18
Authorisation number
EU-0020540-0010 1-6
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
1,75
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
3,0
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Non-active substance
68439-46-3
614-482-0
31,8
META SPC 7
1.   META SPC 7 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 7 identifier
Identifier
Meta SPC 7
1.2.    Suffix to the authorisation number
Number
1-7
1.3.    Product type(s)
Product type(s)
PT03 — Veterinary hygiene (Disinfectants)
2.   META SPC 7 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 7
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Iodine
Active Substance
7553-56-2
231-442-4
3,0
3,0
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
10,0
10,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
31,8
31,8
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Non-active substance
68439-46-3
614-482-0
0,0
0,0
2.2.    Type(s) of formulation of the meta SPC 7
Formulation(s)
SL — soluble concentrate
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
Hazard statements
May be corrosive to metals.
Harmful if swallowed.
Causes severe skin burns and eye damage.
Causes serious eye damage.
May cause damage to thyroid gland through prolonged or repeated exposure.
Toxic to aquatic life with long lasting effects.
Precautionary statements
Keep only in original packaging.
Do not breathe mist.
Do not breathe spray.
Avoid release to the environment.
Wear protective gloves.
Wear protective clothing.
Wear face protection.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Absorb spillage to prevent material damage.
Store locked up.
Keep out of reach of children.
4.   AUTHORISED USE(S) OF THE META SPC 7
4.1.    Use description
Table 7
Use # 1 — Veterinary hygiene — animal husbandry — hard surface disinfectant — professional — indoors — spraying
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Viruses
Field(s) of use
Indoor
Application method(s)
Open system: spray treatment
Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar)
Application rate(s) and frequency
100 ml/m 2 - Concentration of Iodine in application solution: 750 ppm (0,075 % w/w).
Application frequency per year:
Dairy cows: 1
Beef cattle: 1
Veal calves: 4
Sows, in individual pens: 5
Sows in groups: 5
Fattening pigs: 3
Laying hens in battery cages without treatment: 1
Laying hens in battery cages with aeration (belt drying): 1
Laying hens in battery cages with forced drying (deep pit, high rise): 1
Laying hens in compact battery cages: 1
Laying hens in free range with litter floor (partly litter floor, partly slatted): 1
Broilers in free range with litter floor: 7
Laying hens in free range with grating floor (aviery system): 1
Parent broilers in free range with grating floor: 1
Parent broilers in rearing with grating floor: 3
Turkeys in free range with litter floor: 2
Ducks in free range with litter floor: 13
Geese in free range with litter floor: 6
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5-60 liters
Drum HDPE: 200 liters
IBC HDPE: 600-1 000 liters
4.1.1.    Use-specific instructions for use
Iodosan 30 plus: Mix 23 ml product with 977 ml water to obtain 1 l application solution.
4.1.2.    Use-specific risk mitigation measures
---
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
---
5.   GENERAL DIRECTIONS FOR USE  ( 7 ) OF THE META SPC 7
5.1.    Instructions for use
Always read the label or leaflet before use and follow all the instructions provided.
To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product.
Use max. 100 ml application solution per m 2 treated area. Do not prepare more fluid than strictly necessary.
The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner.
Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36 h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off.
5.2.    Risk mitigation measures
Keep out of reach of children.
The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product.
During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory.
During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift.
Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes.
Only use one kind of Iodine-containing product per day.
Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Immediately take off contaminated clothing and wash skin thoroughly.
After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
Environmental emergency measures:
Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
Methods and material for containment and cleaning up:
Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local / national regulations.
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.
European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Store the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 24 months in HDPE
6.   OTHER INFORMATION
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
IODOSAN 30 Plus
YODO CONTROL
YODIVEN
Authorisation number
EU-0020540-0011 1-7
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
3,0
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
10,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
31,8
META SPC 8
1.   META SPC 8 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 8 identifier
Identifier
Meta SPC 8
1.2.    Suffix to the authorisation number
Number
1-8
1.3.    Product type(s)
Product type(s)
PT03 - Veterinary hygiene (Disinfectants)
2.   META SPC 8 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 8
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Iodine
Active Substance
7553-56-2
231-442-4
1,5
1,5
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
3,0
3,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
18,0
18,0
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate
Non-active substance
68439-46-3
614-482-0
0,0
0,0
2.2.    Type(s) of formulation of the meta SPC 8
Formulation(s)
SL - soluble concentrate
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
Hazard statements
May be corrosive to metals.
Causes severe skin burns and eye damage.
Causes serious eye damage.
May cause damage to thyroid gland through prolonged or repeated exposure.
Harmful to aquatic life with long lasting effects.
Precautionary statements
Keep only in original packaging.
Do not breathe mist.
Do not breathe spray.
Avoid release to the environment.
Wear protective gloves.
Wear protective clothing.
Wear face protection.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Absorb spillage to prevent material damage.
Store locked up.
Keep out of reach of children.
4.   AUTHORISED USE(S) OF THE META SPC 8
4.1.    Use description
Table 8
Use # 1 — Veterinary hygiene — animal husbandry — hard surface disinfectant — professional — indoors — spraying
Product type
PT03 — Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
—
Target organism(s) (including development stage)
Bacteria
Yeasts
Viruses
Field(s) of use
Indoor
Application method(s)
Open system: spray treatment
Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar)
Application rate(s) and frequency
100 ml/m 2 — Concentration of Iodine in application solution: 750 ppm (0,075 % w/w).
Application frequency per year:
Dairy cows: 1
Beef cattle: 1
Veal calves: 4
Sows, in individual pens: 5
Sows in groups: 5
Fattening pigs: 3
Laying hens in battery cages without treatment: 1
Laying hens in battery cages with aeration (belt drying): 1
Laying hens in battery cages with forced drying (deep pit, high rise): 1
Laying hens in compact battery cages: 1
Laying hens in free range with litter floor (partly litter floor, partly slatted): 1
Broilers in free range with litter floor: 7
Laying hens in free range with grating floor (aviery system): 1
Parent broilers in free range with grating floor: 1
Parent broilers in rearing with grating floor: 3
Turkeys in free range with litter floor: 2
Ducks in free range with litter floor: 13
Geese in free range with litter floor: 6
Category(ies) of users
Professional
Pack sizes and packaging material
Bottle HDPE: 1 liter, cap is made of PP
Jerry can HDPE: 5-60 liters
Drum HDPE: 200 liters
IBC HDPE: 600-1 000 liters
4.1.1.    Use-specific instructions for use
Iodosan 15: Mix 46 ml product with 954 ml water to obtain 1 l application solution.
4.1.2.    Use-specific risk mitigation measures
---
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
---
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
---
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
---
5.   GENERAL DIRECTIONS FOR USE  ( 8 ) OF THE META SPC 8
5.1.    Instructions for use
Always read the label or leaflet before use and follow all the instructions provided.
To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product.
Use max. 100 ml application solution per m 2 treated area. Do not prepare more fluid than strictly necessary.
The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner.
Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36 h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off.
5.2.    Risk mitigation measures
Keep out of reach of children.
The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product.
During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory.
During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift.
Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes.
Only use one kind of Iodine-containing product per day.
Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
After inhalation: Supply fresh air; consult doctor in case of complaints.
After skin contact: Immediately take off contaminated clothing and wash skin thoroughly.
After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual.
When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
Environmental emergency measures:
Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
Methods and material for containment and cleaning up:
Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local / national regulations.
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.
European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Store the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
Shelf-life: 24 months in HDPE.
6.   OTHER INFORMATION
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
IODOSAN 15
Authorisation number
EU-0020540-0012 1-8
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active Substance
7553-56-2
231-442-4
1,5
Phosphoric Acid
Trihydroxidooxidophosphorus phosphoric acid
Non-active substance
7664-38-2
231-633-2
3,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched
Non-active substance
69011-36-5
500-241-6
18,0
( 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.
( 4 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.
( 5 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.
( 6 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.
( 7 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.
( 8 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.
Commission Implementing Regulation (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family BPF_Iodine_VET (Text with EEA relevance)

Schedules & Appendices

Cite this act
