Commission Implementing Regulation (EU) 2024/2393 of 9 September 2024 concerning the renewal of the authorisation of sodium bisulphate and the authorisation of new uses of that substance as a feed additive for certain animal species

Renewal of authorisation

Article 1

The authorisation of the substance specified in the Annex belonging to the additive category ‘technological additives’ and the functional group ‘preservatives’ for use in feed for all animal species other than aquatic animals, and to the additive category ‘technological additives’ and the functional group ‘acidity regulators’ for use in feed for terrestrial animal species other than pets and other non-food-producing animals, is renewed subject to the conditions laid down in that Annex.

Authorisation

Article 2

The substance specified in the Annex, belonging to the additive category ‘technological additives’ and the functional group ‘acidity regulators’ and to the additive category ‘sensory additives’ and the functional group ‘flavouring compounds’, is authorised as an additive in animal nutrition for pets and other non-food-producing animals other than aquatic animals, subject to the conditions laid down in that Annex.

Repeal

Article 3

Implementing Regulation (EU) 2015/1416 is repealed.

Entry into force

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

ANNEXSupplementary provisions

ANNEX Identification number of the feed additive Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of additive/kg of complete feedingstuff with a moisture content of 12 % Category: technological additives. Functional group: preservatives 1j514ii Sodium bisulphate Additive composition Sodium bisulphate: ≥ 95,2 % Nickel: maximum 1 mg/kg Characterisation of active substance Sodium bisulphate Produced by chemical synthesis Na: 19,15 % SO 4: 80,01 % Chemical formula: NaHSO 4 CAS number: 7681-38-1 Analytical method  ( 1 ) For the determination of sodium bisulphate in the feed additive: Titrimetry – Food Chemical Codex monograph ‘Sodium hydrogen sulfate’. All animal species other than aquatic animals, cats and mink - - 4 000 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated. 2. The total content of sodium bisulphate shall not exceed the maximum permitted levels in complete feedingstuff established for each relevant species. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. 30 September 2034 Cats 20 000 Mink 10 000 Identification number of the feed additive Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of additive/kg of complete feedingstuff with a moisture content of 12 % Category: technological additives. Functional group: acidity regulators 1j514ii Sodium bisulphate Additive composition Sodium bisulphate: ≥ 95,2 % Nickel: maximum 1 mg/kg Characterisation of active substance Sodium bisulphate Produced by chemical synthesis Na: 19,15 % SO 4: 80,01 % Chemical formula: NaHSO 4 CAS number: 7681-38-1 Analytical method  ( 2 ) For the determination of sodium bisulphate in the feed additive: Titrimetry – Food Chemical Codex monograph ‘Sodium hydrogen sulfate’. All animal species other than aquatic animals, cats and mink - - 4 000 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. The total content of sodium bisulphate shall not exceed the maximum permitted levels in complete feedingstuff established for each relevant species. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. 30 September 2034 Cats 20 000 Mink 10 000 Identification number of the feed additive Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of additive/kg of complete feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: flavouring compounds 1j514ii Sodium bisulphate Additive composition Sodium bisulphate: ≥ 95,2 % Nickel: maximum 1 mg/kg Characterisation of active substance Sodium bisulphate Produced by chemical synthesis Na: 19,15 % SO 4: 80,01 % Chemical formula: NaHSO 4 CAS number: 7681-38-1 Analytical method  ( 3 ) For the determination of sodium bisulphate in the feed additive: Titrimetry – Food Chemical Codex monograph ‘Sodium hydrogen sulfate’. Pets and other non-food-producing animals other than aquatic animals, cats and mink - - 4 000 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated. 3. The total content of sodium bisulphate shall not exceed the maximum permitted levels in complete feedingstuff established for each relevant species. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. 30 September 2034 Cats 20 000 Mink 10 000 ( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en . ( 2 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en . ( 3 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .