Commission Implementing Regulation (EU) 2016/842 of 27 May 2016 amending Regulation (EC) No 167/2008 as regards the name of the holder of the authorisation and the trade name of a coccidiostat (Text with EEA relevance)
Commission Implementing Regulation (EU) 2016/842of 27 May 2016amending Regulation (EC) No 167/2008 as regards the name of the holder of the authorisation and the trade name of a coccidiostat(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 13(3) thereof,Whereas:(1)KRKA d.d. has submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation as regards Commission Regulation (EC) No 167/2008Commission Regulation (EC) No 167/2008 of 22 February 2008 concerning a new authorisation for ten years of a coccidiostat as an additive in feedingstuffs (OJ L 50, 23.2.2008, p. 14). concerning the authorisation of a coccidiostat (Kokcisan 120G).(2)The applicant claims that, with effect from 5 February 2016, it has transferred the marketing rights of the feed additive Kokcisan 120G to Huvepharma EOOD. Furthermore, Huvepharma EOOD, as the new owner of the marketing rights of the feed additive requests to change the trade name of the feed additive. The applicant has submitted relevant data supporting its request.(3)The proposed changes of the terms of the authorisation are purely administrative in nature and do not entail a fresh assessment of the additive concerned. The European Food Safety Authority was informed of the application.(4)To allow that feed additive to be marketed under the name of Huvepharma EOOD and under the new trade name, it is necessary to change the terms of the authorisation.(5)Regulation (EC) No 167/2008 should therefore be amended accordingly.(6)Since safety reasons do not require the immediate application of the amendments made by this Regulation to Regulation (EC) No 167/2008, it is appropriate to provide for a transitional period during which existing stocks of the additive, premixtures and compound feed containing the additive may be used up.(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: