(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).

(2) A preparation of narasin (Monteban G100) (‘the preparation’) was authorised for 10 years in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commission Regulation (EC) No 1464/2004 (3). That preparation 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 the preparation as a feed additive for chickens for fattening. 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 3 October 2018 (4), 30 January 2024 (5) and 28 January 2026 (6) that the preparation is safe for the target species, as well as for consumers and the environment, when used in chickens for fattening at 70 mg/kg feed. It highlighted that narasin is toxic to horses, turkeys and rabbits at levels below those used in the prevention of coccidiosis in chickens and that the simultaneous use of the preparation and certain antibiotic drugs (e.g. tiamulin) is contraindicated. The Authority also concluded that the preparation is irritant to the eyes but no to the skin, has the potential to induce skin sensitisation and that inhalation exposure would pose a risk to persons handling the additive. The Authority further concluded that the use of the preparation at 60 mg/kg feed is efficacious in controlling coccidiosis in chickens for fattening. It considered that there is a need for specific requirements of post-market monitoring, recommending that field monitoring of Eimeria spp. resistance to narasin 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 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 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for chickens for fattening. It is appropriate to provide for post-market monitoring of the resistance of Eimeria spp. to narasin. It is appropriate to provide for indicating in the directions for use that the additive is dangerous for certain species and that its simultaneous use with certain medicinal substances can be contraindicated. 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, 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) As a consequence of the authorisation of the preparation as a feed additive for chickens for fattening, Regulation (EC) No 1464/2004 should be repealed.

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