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 an authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of thyme oil, star anise oil and quillaja bark powder as a feed additive. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of a preparation of thyme oil, star anise oil and quillaja bark powder as a feed additive for all avian species, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional groups ‘digestibility enhancers’ and ‘other zootechnical additives’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 21 March 2023 (2) that, under the proposed conditions of use, the preparation of thyme oil, star anise oil and quillaja bark powder is safe for chickens for fattening and other poultry species for fattening, consumers and the environment. For long-living animals, the use of that additive was considered of concern owing to the presence of estragole. It also concluded that the preparation of thyme oil, star anise oil and quillaja bark powder is corrosive to the eyes but not irritant to skin, and may be a respiratory irritant or dermal or respiratory sensitiser. The Authority further concluded that the preparation of thyme oil, star anise oil and quillaja bark powder, under the proposed conditions of use, has the potential to be efficacious in improving the zootechnical performance of chickens for fattening. This conclusion was extrapolated to all poultry species for fattening, reared for laying or reared for breeding. Due to the lack of sufficient data, the Authority could not conclude on the efficacy of the preparation of thyme oil, star anise oil and quillaja bark powder as a zootechnical additive for laying hens and, consequently, for other laying poultry species. It did not consider that there is a need for specific requirements of post-market monitoring. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005 (3), the Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the previous assessment regarding the methods used for the control of the active substance thymol in animal feed (4) are valid and applicable for the current application.

(5) The applicant withdrew the application on 17 July 2023 for the authorisation of the preparation of thyme oil, star anise oil and quillaja bark powder for all poultry species for breeding and laying, reared for laying and reared for breeding, and for ornamental birds, and on 19 October 2023 as regards the authorisation of that preparation in the functional group ‘digestibility enhancers’.

(6) In view of the above, the Commission considers that the preparation of thyme oil, star anise oil and quillaja bark powder satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for all poultry species for fattening. 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) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,