Commission Implementing Regulation (EU) 2024/1755 of 25 June 2024 concerning the authorisation of acetic acid, calcium acetate and sodium diacetate as feed additives for fish

Authorisation

Article 1

The substances specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘preservatives’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.

Transitional measures

Article 2

1.   Acetic acid, calcium acetate and sodium diacetate, as authorised pursuant to Directive 70/524/EEC and premixtures containing these additives, which are produced and labelled before 16 January 2025 in accordance with the rules applicable before 16 July 2024 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for fish. 2.   Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 16 July 2025 in accordance with the rules applicable before 16 July 2024 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing fish. 3.   Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 16 July 2026 in accordance with the rules applicable before 16 July 2024 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing fish.

Entry into force

Article 3

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 Identi-fication 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 1a260 Acetic acid Additive composition Acetic acid ≥ 99,8 % Liquid form Characterisation of the active substance Acetic acid ≥ 99,8 % C 2 H 4 O 2 CAS no 64-19-7 Water ≤ 0,15 % Non volatile matter ≤ 30 mg/kg Formic acid and its salts and other oxidisable material ≤ 0,5 g/kg Produced by chemical synthesis including cellulose production (as a by-product) Method of Analysis  ( 1 ) For the determination of acetic acid as total acetic acid in the feed additive, premixtures and compound feed: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) Fish - - 2 500 1. The mixture of different sources of acetic acid shall not exceed the permitted maximum levels in complete feedingstuffs. 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks resulting from its 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. 3. In the directions for use of the additive, premixture and related feedingstuffs, the following labelling provisions shall be indicated: ‘The simultaneous use of different organic acids is contraindicated where one or more of them is used at or near the maximum permitted content’. 16 July 2034 Identi-fication number of the 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 1a262 Sodium diacetate Additive composition Sodium diacetate ≥ 97 % Solid form Characterisation of the active substance Sodium diacetate (anhydrous and trihydrate) NaC 4 H 7 O 4 CAS no 126-96-5 Sodium acetate ≥ 58 % Acetic acid ≥ 39 % Water ≤ 2 % Formic acid and its salts and other oxidisable material ≤ 1g/kg Produced by chemical synthesis Method of Analysis  ( 2 ) For the determination of sodium in the feed additive: EN ISO 6869: atomic absorption spectrometry (AAS) or EN 15510: inductively coupled plasma-atomic emission spectrometry (ICP-AES) For the determination of sodium diacetate as total acetic acid in the feed additive, premixtures and compound feed: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) Fish - - 2 500 (as acetic acid) 1. The mixture of different sources of acetic acid shall not exceed the permitted maximum levels in complete feedingstuffs. 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks resulting from its 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. 3. In the directions for use of the additive, premixture and related feedingstuffs, the following labelling provisions shall be indicated: ‘The simultaneous use of different organic acids is contraindicated where one or more of them is used at or near the maximum permitted content’. 16 July 2034 Identi-fication number of the 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 1a263 Calcium acetate (anhydrous and monohydrate) Additive composition Calcium acetate ≥ 98,7 % Solid form Characterisation of the active substance Calcium acetate ≥ 98,7 % C 4 H 6 CaO 4 CAS no 62-54-4 Water ≤ 6 % Formic acid and its salts and other oxidisable material ≤ 1g/kg Produced by chemical synthesis Method of Analysis  ( 3 ) For the determination of calcium in the feed additive: EN ISO 6869: atomic absorption spectrometry (AAS) or EN 15510: inductively coupled plasma-atomic emission spectrometry (ICP-AES) For the determination of calcium acetate as total acetic acid in the feed additive, premixtures and compound feed: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) Fish - - 2 500 (as acetic acid) 1. The mixture of different sources of acetic acid shall not exceed the permitted maximum levels in complete feedingstuffs. 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks resulting from its 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. 3. In the directions for use of the additive, premixture and related feedingstuffs, the following labelling provisions shall be indicated: ‘The simultaneous use of different organic acids is contraindicated where one or more of them is used at or near the maximum permitted content’. 16 July 2034 ( 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