INHALT

Commission Implementing Regulation (EU) 2023/2183 of 18 October 2023 granting a Union authorisation for the biocidal product family Evonik’s Hydrogen Peroxide Product Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

COMMISSION IMPLEMENTING REGULATION (EU) 2023/2183
of 18 October 2023
granting a Union authorisation for the biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product family
Evonik’s Hydrogen Peroxide Product Family
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 – Food and feed area (Disinfectants)
Authorisation number: EU-0028964-0000
R4BP asset number: EU-0028964-0000
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
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
4.3.
Use description
4.3.1.
Use-specific instructions for use
4.3.2.
Use-specific risk mitigation measures
4.3.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
4.4.1.
Use-specific instructions for use
4.4.2.
Use-specific risk mitigation measures
4.4.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.4.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.5.
Use description
4.5.1.
Use-specific instructions for use
4.5.2.
Use-specific risk mitigation measures
4.5.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.5.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.5.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.6.
Use description
4.6.1.
Use-specific instructions for use
4.6.2.
Use-specific risk mitigation measures
4.6.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.6.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.6.5.
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
Accidental release measures
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
7.2.
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
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
4.3.
Use description
4.3.1.
Use-specific instructions for use
4.3.2.
Use-specific risk mitigation measures
4.3.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
4.4.1.
Use-specific instructions for use
4.4.2.
Use-specific risk mitigation measures
4.4.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.4.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5.
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
See use specific instructions for each 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
First aid instructions
Accidental release measures
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
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
4.3.
Use description
4.3.1.
Use-specific instructions for use
4.3.2.
Use-specific risk mitigation measures
4.3.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
4.4.1.
Use-specific instructions for use
4.4.2.
Use-specific risk mitigation measures
4.4.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.4.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5.
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
First aid instructions
Accidental release measures
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
Advice on protection against fire and explosion
Storage
Advice on common storage
Shelf-life:
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