Commission Implementing Regulation (EU) 2021/2047 of 23 November 2021 concerning the authorisation of amprolium hydrochloride (COXAM) as a feed additive for chickens for fattening and chickens reared for laying (holder of authorisation: HuvePharma NV) (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/2047of 23 November 2021concerning the authorisation of amprolium hydrochloride (COXAM) as a feed additive for chickens for fattening and chickens reared for laying (holder of authorisation: HuvePharma NV)(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionOJ L 268, 18.10.2003, p. 29., and in particular Article 9(2) thereof,Whereas:(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)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of amprolium hydrochloride (COXAM). That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.(3)The application concerns the authorisation of amprolium hydrochloride (COXAM) as a feed additive for chickens for fattening and chickens reared for laying, to be classified in the additive category "coccidiostats and histomonostats".(4)The European Food Safety Authority ("the Authority") concluded in its opinions of 13 June 2018EFSA Journal 2018;16(7):5338. and 27 January 2021EFSA Journal 2021;19(3):6457. that, under the proposed conditions of use, the amprolium hydrochloride (COXAM) does not have an adverse effect on animal health and the environment. It also concluded that the additive should be considered a potential respiratory and skin sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that it cannot independently evaluate all data relevant to the current application due to the lack of provided data and is therefore unable to conclude on the safety of the additive for the consumer. The Authority further concluded that the additive is efficacious in controlling coccidiosis in chickens for fattening, and that this conclusion is extended to chickens reared for laying. The Authority also concluded that a post-market monitoring plan to monitor the Eimeria spp. resistance should be undertaken. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.(5)Amprolium hydrochloride has already been evaluated by the European Medicines Agency Committee for Medicinal Products for Veterinary Use (EMA CVMP). In its report from January 2001EMA CVMP (European Medicines Agency Committee for Medicinal Products for Veterinary Use), 2001. Amprolium Summary Report (2). EMEA/MRL/767/00-FINAL. January 2001. https://www.ema.europa.eu/en/documents/mrl-report/amprolium-summary-report-2-committee-veterinary-medicinal-products_en.pdf, EMA CVMP concluded that there is no need to establish a maximum residue limit (MRL) for amprolium. Therefore amprolium for poultry is listed in Table 1 of the Annex to Commission Regulation (EC) No 37/2010Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).. On these grounds, the safety of amprolium hydrochloride for the consumer has been sufficiently demonstrated according to Article 8(4)(e) of Regulation (EC) No 1831/2003.(6)The assessment of amprolium hydrochloride (COXAM) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised.(7)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION: