(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 substance star anise essential oil, previously identified as anise star oil, 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. 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 star anise essential oil from Illicium verum Hook.f. 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 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 this additive 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, under the proposed conditions of use, star anise essential oil from Illicium verum Hook.f. is considered of no safety concern for target short-living animals and is considered very unlikely to induce adverse effects for target long-living and reproductive animals and for any other animal species at certain maximum concentrations. Furthermore, it concluded that no safety concern would be expected for consumers from the use of star anise essential oil from Illicium verum Hook.f., up to the highest proposed use level in feed, and that its use, under the proposed conditions, is not expected to pose a risk to the environment. The Authority concluded that star anise essential oil from Illicium verum Hook.f. should be considered as irritant to skin and eyes, as skin and respiratory sensitiser. It also stated that, based on the presence of estragole (≥ 1%), star anise essential oil from Illicium verum Hook.f. is classified as suspected of causing genetic defects and of causing cancer and exposure by any route should be minimised. The Authority further concluded that since star anise essential oil from Illicium verum Hook.f. is recognised to flavour food and its 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 star anise essential oil from Illicium verum Hook.f. 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 estragole (substance of concern belonging to a group of p-allylalkoxybenzenes, compounds, which are genotoxic and carcinogenic) requires the setting of maximum content for this feed additive in complete feed. Furthermore, the Commission considers that a simultaneous use of  star anise essential oil from Illicium verum Hook.f. 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,