(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) Propyl gallate was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That substance was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(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 propyl gallate as a feed additive for all animal species. The applicant requested the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘antioxidants’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4) The applicant requested the additive to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of technological additives for use in water for drinking. Therefore, the use of the additive in water for drinking should not be allowed.

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 17 March 2020 (3) and 31 January 2024 (4) (as readopted on 26 June 2024) that propyl gallate is safe for all animal species and for consumers at certain maximum concentrations further specified in the opinions and for the environment. The Authority also concluded that propyl gallate is irritant to skin and eyes, it is a dermal sensitiser and that exposure via inhalation is possible and it is considered a hazard. The Authority further concluded that the additive has the potential to act as an antioxidant in feedingstuffs for all animal species. The Authority 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.

(6) In view of the above, the Commission considers that propyl gallate satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance 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 additive.

(7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance 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.

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