(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)    The substances clove bud essential oil and clove leaf essential oil from Syzygium aromaticum (L.) Merr. & L.M. Perry were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These 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 authorisation of clove bud essential oil, clove leaf essential oil and beta-caryophyllene-rich fraction of clove leaf essential oil (the latter previously included in the entry of clove leaf essential oil) from Syzygium aromaticum (L.) Merr. & L.M. Perry as feed additives for all animal species, requesting the additives 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 additives to be authorised also for use 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 these additives in water for drinking should not be allowed. 

(5)    The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 July 2023  that clove bud essential oil, clove leaf essential oil and beta-caryophyllene-rich fraction of clove leaf essential oil from Syzygium aromaticum (L.) Merr. & L.M. Perry are of no concern for target species for fattening and are considered very unlikely to induce adverse effects in any other species and in long-living and reproductive animals at certain maximum concentrations further specified for each species. Furthermore, the Authority concluded that no concerns for consumers were identified following the use of clove bud essential oil, clove leaf essential oil and beta-caryophyllene-rich fraction of clove leaf essential oil from Syzygium aromaticum (L.) Merr. & L.M. Perry, under the proposed conditions, and that their use, under the proposed conditions, is not expected to pose a risk to the environment. The Authority concluded that clove bud essential oil, clove leaf essential oil and beta-caryophyllene-rich fraction of clove leaf essential oil from Syzygium aromaticum (L.) Merr. & L.M. Perry should be considered as irritants to skin and eyes and as skin and respiratory sensitisers. The Authority indicated that unprotected users may be exposed to methyleugenol when handling the additives and that the exposure of the users should therefore be minimised to reduce that risk. The Authority further concluded that since clove bud essential oil, clove leaf essential oil and beta-caryophyllene-rich fraction of clove leaf essential oil from Syzygium aromaticum (L.) Merr. & L.M. Perry 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. The Authority also verified the report on the method of analysis of the feed additives 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 bud essential oil, clove leaf essential oil and beta-caryophyllene-rich fraction of clove leaf essential oil from Syzygium aromaticum (L.) Merr. & L.M. Perry satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of these substances should be authorised as specified in the Annex to this Regulation. The Commission considers that the presence of methyleugenol, a substance of concern belonging to the group of p-allylalkoxybenzenes, in clove bud essential oil, clove leaf essential oil and beta-caryophyllene-rich fraction of clove leaf essential oil from Syzygium aromaticum (L.) Merr. & L.M. Perry, requires the setting of maximum content for these feed additives in complete feed. It also considers that the simultaneous use of clove bud essential oil, clove leaf essential oil and beta-caryophyllene-rich fraction of clove leaf essential oil from Syzygium aromaticum (L.) Merr. & L.M. Perry with other feed additives is permitted provided that the combined content of p-allylalkoxybenzenes (methyleugenol, estragole, elemicin, safrole, myristicin, dillapiole, and apiole) in feed materials and compound feed remains below the content that would result from using the authorised feed additive with the highest content of those substances at its maximum or recommended maximum content for the relevant animal species or  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,