Commission Implementing Regulation (EU) No 642/2013 of 4 July 2013 concerning the authorisation of niacin and niacinamide as feed additives for all animal species Text with EEA relevance
Commission Implementing Regulation (EU) No 642/2013of 4 July 2013concerning the authorisation of niacin and niacinamide as feed additives for all animal species(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 authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EECOJ L 270, 14.12.1970, p. 1..(2)Niacin (nicotinic acid) and niacinamide (nicotinamide) were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for use on all animal species as part of the group "Vitamins, pro-vitamins and chemically well-defined substances having similar effect". Those feed additives were subsequently entered in the Community Register of feed additives as existing products, in accordance with Article 10(1) 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, five applications were submitted for the re-evaluation of niacin and niacinamide, as a feed additive for all animal species, requesting those additives to be classified in the additive category "nutritional additives". Those applications were 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 22 May 2012EFSA Journal 2012; 10(6):2731., 14 June 2012EFSA Journal 2012; 10(7):2781.EFSA Journal 2012; 10(7):2788.EFSA Journal 2012; 10(7):2789., and 12 September 2012EFSA Journal 2012; 10(10):2885. that, under the proposed conditions of use in feed, niacin and niacinamide do not have an adverse effect on animal and consumer health, and are not expected to pose additional risk for the environment. The Authority does not consider that there is a need for specific requirements of post-market monitoring. The Authority also concluded that no safety concerns would arise for users provided that appropriate protective measures are taken. 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)The assessment of niacin and niacinamide shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those additives should be authorised as specified in the Annex to this Regulation.(6)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for the disposal of existing stocks of the additive, pre-mixtures and compound feed containing it, as authorised by Directive 70/524/EEC.(7)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS REGULATION: