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 authorisation. In particular, Article 10(2) of that Regulation provides rules for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2) The substance star anise terpenes from Illicium verum Hook.f. 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), 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 authorisation of star anise terpenes from Illicium verum Hook.f. as a feed additive for all animal species. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was 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 26 September 2023 (3) that the additive star anise terpenes contains up to 25 % estragole by specification and is obtained by a manufacturing process which results in the enrichment of this genotoxic carcinogen. In this regard, the Authority stated that this does not comply with the principles outlined in the general approach to assess the safety for the target species of botanical preparations which contain compounds that are genotoxic and/or carcinogenic when used as feed additives. Therefore, the Authority considered that it was inappropriate to perform an assessment of the safety and efficacy of star anise terpenes for its use as a feed additive.

(5) The applicant subsequently withdrew the application for authorisation of star anise terpenes from Illicium verum Hook.f. for all animal species.

(6) Article 10(5) of Regulation (EC) No 1831/2003 imposes an obligation on the Commission to adopt a Regulation requiring the withdrawal from the market of feed additives for which no applications as required by Article 10(2) of Regulation (EC) No 1831/2003 were submitted before the deadline provided for in that provision. Similarly, a Regulation should be adopted concerning feed additives for which an application was submitted but subsequently withdrawn.

(7) Therefore, the feed additive star anise terpenes from Illicium verum Hook.f. should be withdrawn from the market.

(8) A transitional period should be allowed for interested parties to comply properly with the withdrawal obligation, providing for a limited period of time within which existing stocks of the additive and feed containing it may be used up. Such period of time should be as short as possible, taking account of the safety concerns raised by the Authority in its opinion of 26 September 2023 concerning the additive.

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