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)
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product family
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1.
Family name
Name |
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
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:
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
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
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
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:
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
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
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
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:
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
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
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
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
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
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
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
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
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
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/m2— 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
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
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
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
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/m2 - 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
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
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
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
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/m2— 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
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
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
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 |