Commission Implementing Regulation (EU) 2023/1764 of 12 September 2023 granting a... (32023R1764)
INHALT
Commission Implementing Regulation (EU) 2023/1764 of 12 September 2023 granting a Union authorisation for the biocidal product family ‘Oxy’Pharm H2O2’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
- COMMISSION IMPLEMENTING REGULATION (EU) 2023/1764
- of 12 September 2023
- granting a Union authorisation for the biocidal product family ‘Oxy’Pharm H
- 2
- O
- 2
- ’ 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
- Oxy'Pharm H
- 2
- O
- 2
- 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-0029752-0000
- R4BP asset number: EU-0029752-0000
- 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
- First aid
- Likely direct or indirect effects
- 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
- 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 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
- First aid
- Likely direct or indirect effects
- 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
- 7.3.
- 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
- First aid
- Likely direct or indirect effects
- 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
- First aid
- Likely direct or indirect effects
- 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
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