INHALT

Commission Implementing Regulation (EU) 2020/1187 of 7 August 2020 granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’ (Text with EEA relevance)

COMMISSION IMPLEMENTING REGULATION (EU) 2020/1187
of 7 August 2020
granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’
(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
1.2.
Product type(s)
1.3.
Authorisation holder
1.4.
Manufacturer(s) of the biocidal products
1.5.
Manufacturer(s) of the active substance(s)
2.
PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1.
Qualitative and quantitative information on the composition of the family
2.2.
Type(s) of formulation
PART II
SECOND INFORMATION LEVEL – META SPC(S)
META SPC 1
1.
META SPC 1 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 1 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 1 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 1
2.2.
Type(s) of formulation of the meta SPC 1
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
4.
AUTHORISED USE(S) OF THE META SPC 1
4.1.
Use description
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
META SPC 2
1.
META SPC 2 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 2 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 2 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 2
2.2.
Type(s) of formulation of the meta SPC 2
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
4.
AUTHORISED USE(S) OF THE META SPC 2
4.1.
Use description
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
7.2.
Trade name(s), authorisation number and specific composition of each individual product
META SPC 3
1.
META SPC 3 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 3 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 3 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 3
2.2.
Type(s) of formulation of the meta SPC 3
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
4.
AUTHORISED USE(S) OF THE META SPC 3
4.1.
Use description
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
For disinfection of the skin:
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
7.2.
Trade name(s), authorisation number and specific composition of each individual product
META SPC 4
1.
META SPC 4 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 4 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 4 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 4
2.2.
Type(s) of formulation of the meta SPC 4
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
4.
AUTHORISED USE(S) OF THE META SPC 4
4.1.
Use description
4.1.1.
Use-specific instructions for use
For disinfection of the teats:
4.1.2.
Use-specific risk mitigation measures
4.1.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
4.2.1.
Use-specific instructions for use
For disinfection of the skin:
4.2.2.
Use-specific risk mitigation measures
4.2.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
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
META SPC 5
1.
META SPC 5 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 5 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 5 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 5
2.2.
Type(s) of formulation of the meta SPC 5
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
4.
AUTHORISED USE(S) OF THE META SPC 5
4.1.
Use description
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
7.2.
Trade name(s), authorisation number and specific composition of each individual product
META SPC 6
1.
META SPC 6 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 6 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 6 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 6
2.2.
Type(s) of formulation of the meta SPC 6
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
4.
AUTHORISED USE(S) OF THE META SPC 6
4.1.
Use description
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
META SPC 7
1.
META SPC 7 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 7 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 7 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 7
2.2.
Type(s) of formulation of the meta SPC 7
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
4.
AUTHORISED USE(S) OF THE META SPC 7
4.1.
Use description
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
4.1.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
4.2.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
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
META SPC 8
1.
META SPC 8 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 8 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 8 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 8
2.2.
Type(s) of formulation of the meta SPC 8
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
4.
AUTHORISED USE(S) OF THE META SPC 8
4.1.
Use description
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
4.1.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
4.2.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
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
META SPC 9
1.
META SPC 9 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 9 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 9 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 9
2.2.
Type(s) of formulation of the meta SPC 9
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9
4.
AUTHORISED USE(S) OF THE META SPC 9
4.1.
Use description
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
(9)
OF THE META SPC 9
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 9
7.1.
Trade name(s), authorisation number and specific composition of each individual product
META SPC 10
1.
META SPC 10 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 10 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 10 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 10
2.2.
Type(s) of formulation of the meta SPC 10
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10
4.
AUTHORISED USE(S) OF THE META SPC 10
4.1.
Use description
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
(10)
OF THE META SPC 10
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 10
7.1.
Trade name(s), authorisation number and specific composition of each individual product
META SPC 11
1.
META SPC 11 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 11 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 11 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 11
2.2.
Type(s) of formulation of the meta SPC 11
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11
4.
AUTHORISED USE(S) OF THE META SPC 11
4.1.
Use description
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
(11)
OF THE META SPC 11
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 11
7.1.
Trade name(s), authorisation number and specific composition of each individual product
META SPC 12
1.
META SPC 12 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 12 identifier
1.2.
Suffix to the authorisation number
1.3.
Product type(s)
2.
META SPC 12 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 12
2.2.
Type(s) of formulation of the meta SPC 12
3.
HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12
4.
AUTHORISED USE(S) OF THE META SPC 12
4.1.
Use description
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
(12)
OF THE META SPC 12
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 12
7.1.
Trade name(s), authorisation number and specific composition of each individual product
7.2.
Trade name(s), authorisation number and specific composition of each individual product