Commission Implementing Regulation (EU) 2023/364 of 16 February 2023 granting a U... (32023R0364)
Commission Implementing Regulation (EU) 2023/364 of 16 February 2023 granting a Union authorisation for the biocidal product family ‘IPA Family 1’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
- COMMISSION IMPLEMENTING REGULATION (EU) 2023/364
- of 16 February 2023
- granting a Union authorisation for the biocidal product family ‘IPA Family 1’ 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 I
- Terms and conditions (EU-0028425-0000)
- ANNEX II
- 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
- Potential Health Effects
- First Aid Measures
- 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
- Product
- Contaminated packaging
- Product residues
- 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
- Potential Health Effects
- First Aid Measures
- 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
- Product
- Contaminated packaging
- Product residues
- 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
- 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
- Potential Health Effects
- First Aid Measures
- 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
- Product
- Contaminated packaging
- Product residues
- 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
- 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
- Potential Health Effects
- First Aid Measures
- 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
- Product
- Contaminated packaging
- Product residues
- 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
- Potential Health Effects
- First Aid Measures
- 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
- Product
- Contaminated packaging
- Product residues
- 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
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