(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 and renewing such an authorisation.

(2) Eugenol produced by chemical synthesis or by the extraction from cloves or cloves oil and 1-methoxy-4-(prop-1(trans)-enyl)benzene, which is a synonym for trans-anethole, produced by chemical synthesis or by the extraction from pine oil, were authorised for a period of 10 years as feed additives for all animal species except poultry and fish by Commission Implementing Regulation (EU) 2022/1452 (2).

(3) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of eugenol produced by the extraction from dried clove leaves or clove leaf oil and for the authorisation of trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4) The application concerns the authorisation of eugenol produced by the extraction from dried clove leaves or clove leaf oil and of trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise as feed additives for poultry and ornamental birds, requesting those additives to be classified in the category ‘sensory additives’ and in the functional group ‘flavouring compounds.’

(5) However, the Commission considers that the application for the authorisation of trans-anethole produced by chemical synthesis for ornamental birds should be treated as an application for the renewal of the authorisation granted by Implementing Regulation (EU) 2022/1452, as that authorisation concerned the same additive and included the use for ornamental birds. In addition, the Commission considers that trans-anethole produced from pine oil authorised for ornamental birds by Implementing Regulation (EU) 2022/1452 should be authorised with a maximum content as it has the same specifications in terms of composition as the trans-anethole produced by chemical synthesis that is going to be renewed with a maximum content due to the zootechnical effects of this additive for those species. The maximum content will prevent an increase of the zootechnical effects beyond the desired flavouring effect pursued in this authorisation.

(6) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 March 2025 (3) that, under the proposed conditions of use, eugenol produced by the extraction from dried clove leaves or clove leaf oil and trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise are safe for poultry species for fattening (chickens and turkeys) at 25 mg/kg complete feed and are very unlikely to induce adverse effects in long-living and reproductive birds (poultry reared for laying/breeding, laying/breeding hens and ornamental birds) up to 25 mg/kg complete feed. These conclusions can be extrapolated to physiologically-related minor species. The Authority also concluded that eugenol and trans-anethole are safe for consumers and the environment. It also concluded that when handling eugenol produced by extraction from dried clove leaves or clove leaf oil and trans-anethole produced by extraction from leaves or fruit of star anise, exposure of unprotected users to methyleugenol and estragole, respectively, may occur, and that therefore, to reduce the risk, the exposure of the users should be minimised. In addition, the Authority concluded that eugenol produced by the extraction from dried clove leaves or clove leaf oil and trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise are not irritant to skin but are dermal and respiratory sensitisers, that eugenol produced by the extraction from dried clove leaves or clove leaf oil is an eye irritant, but trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise is not, and that any exposure to these additives is considered a risk. The Authority further concluded that since eugenol produced by the extraction from dried clove leaves or clove leaf oil and trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(7) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additives and verified by the Authority in its opinion of 15 November 2011 (4), are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005 (5), an evaluation report by the Reference Laboratory was therefore not required.

(8) In view of the above, the Commission considers that eugenol produced by the extraction from dried clove leaves or clove leaf oil and trans-anethole produced by chemical synthesis and by the extraction from leaves or fruit of star anise satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of eugenol produced by the extraction from dried clove leaves or clove leaf oil should be authorised for poultry and ornamental birds, the use of trans-anethole produced by chemical synthesis should be authorised for poultry and should be renewed for ornamental birds and the use of trans-anethole produced by the extraction from leaves or fruit of star anise should be authorised for poultry and ornamental birds.

(9) Eugenol and trans-anethole are already authorised as zootechnical additives by Commission Implementing Regulation (EU) 2019/898 (6) and Commission Implementing Regulation (EU) 2017/420 (7), respectively to produce zootechnical effects in poultry at levels of use of 5 mg/kg for eugenol and 7,5 mg/kg for trans-anethole. Since ornamental birds are species physiologically related to poultry the same effects are expected in them. In order to prevent the use of the additives for poultry and ornamental birds at higher levels which could potentially increase the zootechnical effects, beyond the desired flavouring effect pursued in this authorisation, it is necessary to establish a maximum content of the additives in complete feed. In addition, the Commission considers that the presence of methyleugenol in eugenol produced by the extraction from dried clove leaves or clove leaf oil and of estragole in trans-anethole produced by the extraction from leaves or fruit of star anise requires the setting of maximum content in complete feed and that a simultaneous use of eugenol or trans-anethole with other additives is permitted provided that the content of methyleugenol or estragole in feed materials and compound feed remains below that which would result from using the additive with the highest content of methyleugenol or estragole, among all authorised feed additives, at their maximum or recommended content for the relevant 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.

(10) As regards trans-anethole, the characterisation of the active substance differs between the additive produced by chemical synthesis and the additive produced by the extraction from leaves or fruit of star anise, with the latter possibly containing estragole. It is therefore appropriate to differentiate between the terms of their authorisation accordingly. In addition, for reasons of clarity and consistency, it is appropriate to reflect the similar differentiation into the existing authorisation of trans-anethole between the additive produced by the extraction from pine oil and the additive produced by chemical synthesis. This differentiation should further allow to remove the use for ornamental birds as regards trans-anethole produced by chemical synthesis as a consequence of the renewal of the authorisation of the additive for ornamental birds and to set a maximum content for ornamental birds for trans-anethole produced from pine oil. Implementing Regulation (EU) 2022/1452 should therefore be amended accordingly.

(11) In addition, to simplify the labelling of trans-anethole and of feed containing it, the Commission considers appropriate to use the name of the additive ‘trans-anethole’ instead of the synonym ‘1-methoxy-4-(prop-1(trans)-enyl)benzene’, which was referred to in Implementing Regulation (EU) 2022/1452. That Implementing Regulation should therefore be amended accordingly.

(12) Since safety reasons do not require the immediate application of the modifications to the conditions of the authorisation of trans-anethole it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from those modifications.

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