(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 modifying such authorisation.

(2)

Commission Implementing Regulation (EU) No 684/2014 (2) authorised the use of a preparation of canthaxanthin as a feed additive for breeder hens for a 10-year period.

(3)

In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted on 4 February 2021 for the modification of the terms of the authorisation of the preparation of canthaxanthin as a feed additive for breeder hens. The application concerned the addition of a new production route by fermentation with Yarrowia lipolytica CBS 146148 and the modification of the additive specifications by substituting ethoxyquin by 4,4 % butylated hydroxytoluene and increasing the limit of the impurity dichloromethane from 10 to 80 mg/kg additive. The request was accompanied by the relevant supporting data.

(4)

The European Food Safety Authority (‘the Authority’) indicated in its opinion of 26 November 2024 (3) that the conclusions previously reached for synthetic canthaxanthin, in its opinion of 12 December 2012 (4), with regards to target animals, consumers and environment, also apply to canthaxanthin produced by fermentation with Yarrowia lipolytica CBS 146148. The Authority therefore concluded that using canthaxanthin produced with Yarrowia lipolytica CBS 146148 in the formulation of the preparation of canthaxanthin is considered safe for the target species, consumer and environment under the current authorized conditions of use for synthetic canthaxanthin. Regarding user safety, it also concluded that canthaxanthin is not irritant to skin and eyes and unlikely to be a skin sensitiser, that no conclusion can be reached on the respiratory sensitisation of canthaxanthin, and that, in the absence of data with the preparation of canthaxanthin, no conclusions can be reached regarding the safety of that preparation for the user. The Authority further indicated that canthaxanthin produced by fermentation with Yarrowia lipolytica CBS 146148 has been shown to have the same purity as canthaxanthin produced by chemical synthesis, and that it is considered as equivalent. Consequently, the conclusions reached in the opinion of 12 December 2012 on the preparation containing synthetic canthaxanthin are considered also applicable to the preparation containing canthaxanthin produced by fermentation with Yarrowia lipolytica CBS 146148, without the need for additional studies, and the Authority concluded that the additive is efficacious in breeder hens at 6 mg/kg complete feed. The Authority did not express concerns on the new specifications of the preparation of canthaxanthin. Finally, it recommended adjusting the wording of two provisions of the Annex to Implementing Regulation (EU) No 684/2014 regarding the mixture of different sources of canthaxanthin and regarding the mixture of the preparation of canthaxanthin with other carotenoids.

(5)

An application for the renewal of the authorisation of the preparation of canthaxanthin was sent to the Commission on 10 July 2023, in accordance with the first paragraph of Article 14(1) of Regulation (EC) No 1831/2003. As for reasons beyond the control of the applicant no decision on the renewal of the authorisation had been taken before the expiry of the authorisation, the period of authorisation has automatically been extended in accordance with Article 14(4) of Regulation (EC) No 1831/2003.

(6)

In view of the above, the Commission considers that the preparation of canthaxanthin still satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 when modifying the terms of the authorisation with the addition of a new production route by fermentation with Yarrowia lipolytica CBS 146148, the substitution of ethoxyquin by 4,4 % butylated hydroxytoluene and the increase the limit of the impurity dichloromethane from 10 to 80 mg/kg additive. In addition, certain provisions of the Annex to Implementing Regulation (EU) No 684/2014 should be adjusted in accordance with the recommendations of the Authority.

(7)

Implementing Regulation (EU) No 684/2014 should therefore be amended accordingly.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of canthaxanthin, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the modification of the terms of the authorisation.

(9)

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