Commission Implementing Regulation (EU) 2023/1758 of 11 September 2023 granting a... (32023R1758)
INHALT
Commission Implementing Regulation (EU) 2023/1758 of 11 September 2023 granting a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
- COMMISSION IMPLEMENTING REGULATION (EU) 2023/1758
- of 11 September 2023
- granting a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ 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
- SALVECO SALVESAFE PRODUCTS
- Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
- Product type 3 - Veterinary hygiene (Disinfectants)
- Product type 4 - Food and feed area (Disinfectants)
- Authorisation number: EU-0028967-0000
- R4BP asset number: EU-0028967-0000
- 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
- 5.
- GENERAL DIRECTIONS FOR USE
- (1)
- OF THE META SPC 1
- 5.1.
- Instructions for use
- 5.2.
- Risk mitigation measures
- For professional use only:
- For non-professional use only:
- 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
- 7.2.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.3.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.4.
- 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
- 5.
- GENERAL DIRECTIONS FOR USE
- (2)
- OF THE META SPC 2
- 5.1.
- Instructions for use
- 5.2.
- Risk mitigation measures
- For professional use only:
- For non-professional use only:
- 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
- 7.3.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.4.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.5.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.6.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.7.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.8.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.9.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.10.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.11.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.12.
- 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
- 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
- 7.2.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.3.
- 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
- 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
- (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
- 7.2.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.3.
- 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
- 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
- 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
- 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
- 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
- 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
- 7.2.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.3.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.4.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.5.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.6.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.7.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.8.
- 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
- 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
- (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
- 7.2.
- Trade name(s), authorisation number and specific composition of each individual product
- 7.3.
- Trade name(s), authorisation number and specific composition of each individual product
Feedback