(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) Two forms of a preparation of monensin sodium (Coxidin) (‘the preparation’), with wheat bran or with calcium carbonate, were authorised for 10 years as a feed additive for use in chickens for fattening and turkeys up to 16 weeks of age by Commission Regulation (EC) No 109/2007 (2). The form of the preparation with calcium carbonate was authorised also for use in chickens reared for laying by Commission Implementing Regulation (EU) No 140/2012 (3).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, two applications were submitted for the renewal of the authorisation of the preparation as a feed additive for chickens for fattening and turkeys for fattening (both forms) and for chickens reared for laying (form with calcium carbonate), requesting the additive to be classified in the additive category coccidiostats and histomonostats. Those applications were accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(4) In parallel, two applications were submitted in accordance with Article 7 of Regulation (EC) No 1831/2003 for the authorisation of new uses of the preparation. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(5) The applications submitted in accordance with Article 7 of Regulation (EC) No 1831/2003 concern the authorisation of the preparation as a feed additive for chickens reared for laying (form with wheat bran) and turkeys reared for reproduction (both forms), requesting that additive to be classified in the category coccidiostats and histomonostats.

(6) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 31 January 2024 (4) and 24 June 2025 (5) that the applicant had provided evidence that the preparation remains safe for turkeys for fattening (up to 16 weeks) at the current maximum authorised level of 100 mg monensin sodium/kg complete feed and extended this conclusion to turkeys reared for reproduction (up to 16 weeks). It further concluded that the use of the preparation is safe up to the newly proposed maximum recommended level of 120 mg monensin sodium/kg complete feed for chickens for fattening and chickens reared for laying. Additionally, the Authority concluded that the use of the preparation remains safe for consumers – the existing maximum residue levels (MRLs) for poultry tissues ensuring consumer safety with no withdrawal time being necessary – and the environment. It also concluded that both formulations of the preparation pose a risk by inhalation and are not irritant to the skin. The Authority specified further that the formulation with wheat bran is not a skin sensitiser but is irritant to the eyes, and the formulation with calcium carbonate is to be considered as a skin and respiratory sensitiser, while no conclusions can be reached on its eye irritation potential. The Authority further concluded that the preparation is efficacious in controlling coccidiosis at a level of 100 mg monensin sodium/kg complete feed for chickens for fattening and at 60 mg monensin sodium/kg complete feed for turkeys for fattening. These conclusions were extended by the Authority to chickens reared for laying and turkeys reared for reproduction. It noted that there are signs of development of resistance of Eimeria spp. to monensin sodium and considered that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003, resulting from the amendment/supplementation of the conditions of the previous authorisation.

(7) 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 authorisation of both forms of that preparation for use in chickens for fattening and turkeys for fattening, and of the form with calcium carbonate for use in chickens reared for laying, should be renewed. In addition, that preparation should be authorised for the new uses applied for, namely for chickens reared for laying (form with wheat bran) and turkeys reared for reproduction (both forms). It is appropriate to provide for a post-market monitoring programme, starting five years after the entry into force of this Implementing Regulation, in order to trace and document any sign of resistance to monensin sodium resulting from the use of the preparation. Finally, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(8) As a consequence of the renewal of the authorisation of both forms of the preparation for use in chickens for fattening and turkeys for fattening, and of the form with calcium carbonate for use in chickens reared for laying, Regulation (EC) No 109/2007 and Implementing Regulation (EU) No 140/2012 should be repealed.

(9) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of both forms of the preparation for use in chickens for fattening and turkeys for fattening, and of the form with calcium carbonate for use in chickens reared for laying, 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.

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