(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 substance clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. This 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 clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. 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 ‘flavouring compounds’ for use in water for drinking. Therefore, the use of this additive in water for drinking should not be allowed.

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 April 2024 (3) that clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry is very unlikely to be of safety concern for the target species at the proposed use level. Furthermore, it concluded that no safety concern would arise for consumers and the environment from the use of clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry at the proposed use levels in feed. The Authority concluded that clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The Authority further concluded that since the flower buds of Syzygium aromaticum (L.) Merr. & L.M. Perry and their preparations are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary. 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.

(6) In view of the above, the Commission considers that clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. The Commission considers that the presence of the substances of concern, methyleugenol and estragole, requires the setting of maximum content in complete feed and that a mixture of clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry with other botanical additives is permitted provided that the amounts of the same substances of concern in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended content for the species or animal category. 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,