BAKGRUNN (fra kommisjonsforordningen)

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2) The substances acetic acid, calcium acetate and sodium diacetate were authorised without a time limit in accordance with Directive 70/524/EEC, as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.

(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of acetic acid, calcium acetate and sodium diacetate for fish. The applicant requested the additives to be classified in the additive category ‘technological additive’ and in the functional group ‘preservatives’. The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 July 2023 (3) that acetic acid (and its salts) are safe for all fish at the maximum recommended level of 2 500 mg acetic acid/kg complete feed. The Authority concluded in its previous opinions of 1 February 2012 (4) and 6 May 2021 (5) that acetic acid, sodium diacetate and calcium acetate do not have an adverse effect on consumer safety or the environment and that the risks for users handling acetic acid depend on the concentration and include skin, eyes, and respiratory tract irritation (10–25 % solution) and corrosion (> 25 % solution) and that the salts of acetic acid are considered as strongly irritant and a particular risk for the eyes. The Authority further concluded that acetic acid and its salts have the potential to act as preservatives in feedingstuffs. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) In view of the above, the Commission considers that acetic acid, calcium acetate and sodium diacetate satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those substances should be authorised. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives.

(6) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,