(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 authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

The substance halofuginone hydrobromide was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That substance was subsequently entered in the Register of feed additives as an existing product belonging to the additive category ‘coccidiostats and histomonostats’, 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 a preparation of halofuginone hydrobromide (Stenorol) as a feed additive for chickens for fattening and turkeys. The applicant requested the additive to be classified in the additive category ‘coccidiostats and histomonostats’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 30 September 2020 (3), 23 November 2022 (4) and 12 March 2023 (5) that, under the proposed conditions of use, the preparation of halofuginone hydrobromide (Stenorol) is safe for chickens for fattening and for turkeys up to a maximum of 12 weeks of age. It is safe for consumers provided a withdrawal period of three days before slaughter is applied and the recommended maximum residue limits (MRLs) are not exceeded, and for the environment. It also concluded that the preparation of halofuginone hydrobromide (Stenorol) is toxic by inhalation, dermal and ocular routes, is very irritant to both the eye and the skin, and is also a skin sensitiser. The Authority further concluded that the preparation of halofuginone hydrobromide (Stenorol) has the potential to control coccidiosis at the proposed conditions of use. It considered that there is a need for specific requirements of post-market monitoring and recommended that field monitoring of Eimeria spp. resistance to halofuginone hydrobromide in chickens for fattening and turkeys be undertaken, preferably during the latter part of the period of authorisation. The Authority also verified the report on the methods of analysis of the feed additive in feed and tissues submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

In view of the above the Commission considers that the preparation of halofuginone hydrobromide (Stenorol) 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 chickens for fattening, turkeys for fattening and turkeys reared for breeding. It is appropriate to provide for a withdrawal period of three days before slaughter, the maximum residue limits recommended by the Authority and post-market monitoring on the resistance of Eimeria spp. to halofuginone hydrobromide. 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.

(6)

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

(7)

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