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

(2) A preparation of semduramicin sodium (Aviax 5%) was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1443/2006. 

(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 of semduramicin sodium (Aviax 5%) as a feed additive for chickens for fattening. The applicant requested the additive to be classified in the additive category ‘coccidiostats and histomonostats’. In this context, the applicant also requested a modification of certain conditions of the existing authorisation, consisting of a replacement of crystalline semduramicin by mycelial semduramicin in the additive composition, and of a reduction of the period between cessation of the administration of the additive and slaughter (hereafter referred to as ‘the withdrawal period’). That modification is to be considered within the context of the re-evaluation of the preparation. 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 14 June 2018, 29 June 2022 and 14 November 2023 that, under the proposed conditions of use, the preparation of semduramicin sodium (Aviax 5%) is safe for chickens for fattening up to the maximum recommended level (25 mg/kg complete feed) and the environment. It also concluded that the use of semduramicin sodium (Aviax 5%) at a maximum level of 25 mg/kg complete feed is safe for consumers with no withdrawal period and, that consequently, there is no need to set maximum residue limits for semduramicin sodium in foodstuffs derived from chickens fed with the preparation. The Authority could not conclude on the irritancy of the preparation of semduramicin sodium (Aviax 5%) to skin and eye nor on the potential for dermal and respiratory sensitisation. In this regard it reported that the model calculations on inhalation exposure of persons handling the additive indicated a serious risk. The Authority further concluded that the preparation of semduramicin sodium (Aviax 5%) has the potential to effectively control coccidiosis in chickens for fattening. It considered that there is a need for specific requirements of post-market monitoring and recommended carrying out field monitoring of Eimeria spp. resistance to semduramicin sodium in chickens for fattening, 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 semduramicin sodium (Aviax 5%) 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. It is appropriate to provide for a post-market monitoring on the resistance of Eimeria spp. to semduramicin sodium. 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) As a consequence of the authorisation of the preparation of semduramicin sodium (Aviax 5%) for chickens for fattening, Regulation (EC) No 1443/2006 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,