This Regulation changes the authorisation entry for the additive by replacing the named holder, allows existing compliant stocks to keep being marketed and used until exhausted, and enters into force 20 days after publication.
5.2.2013 | EN | Official Journal of the European Union | L 34/12 ---|---|---|--- * * * COMMISSION IMPLEMENTING REGULATION (EU) No 103/2013 of 4 February 2013 amending Regulation (EC) No 786/2007 as regards the name of the holder of the authorisation of a preparation of endo-1,4-beta-mannanase EC 3.2.1.78 (Hemicell) (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 nutrition (1) and in particular Article 13(3) thereof, Whereas: (1) | ChemGen Corp. has submitted an application under 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 786/2007 (2) concerning the 10 year authorisation of a preparation of endo-1,4-beta-mannanase EC 3.2.1.78 (Hemicell), belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’. ---|--- (2) | The applicant claims that, with effect from 10 February 2012, ChemGen Corp. was acquired by Eli Lilly and Company Ltd which now owns the marketing rights for that additive. The applicant has submitted relevant data supporting its request. ---|--- (3) | The proposed change of the terms of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additive concerned. The European Food Safety Authority was informed of the application. ---|--- (4) | To allow Eli Lilly and Company Ltd to exploit its marketing rights it is necessary to change the terms of the authorisation. ---|--- (5) | Regulation (EC) No 786/2007 should therefore be amended accordingly. ---|--- (6) | Since safety reasons do not require the immediate application of the amendment made by this Regulation to Regulation (EC) No 786/2007, it is appropriate to provide for a transitional period during which existing stocks may be used up. ---|--- (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: Article 1 In column 2 of the Annex to Regulation (EC) No 786/2007 the words ‘ChemGen Corp., represented by Disproquima S.L.’ are replaced by ‘Eli Lilly and Company Ltd’. Article 2 Existing stocks of the additive which are in conformity with the provisions applying before the date of entry into force of this Regulation may continue to be placed on the market and used until they are exhausted. Article 3 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 4 February 2013. For the Commission The President José Manuel BARROSO * * * (1) OJ L 268, 18.10.2003, p. 29. (2) OJ L 175, 5.7.2007, p. 8. * * *