COMMISSION IMPLEMENTING REGULATION (EU) 2019/138

of 29 January 2019

amending Regulations (EC) No 1356/2004, (EC) No 1464/2004, (EC) No 786/2007, (EC) No 971/2008, (EU) No 1118/2010, (EU) No 169/2011 and Implementing Regulations (EU) No 888/2011 and (EU) No 667/2013 as regards the name of the holder of the authorisation for feed additives

(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) In accordance with Council Directive 70/524/EEC (2) monensin sodium and narasin, were authorised as feed additives by, respectively, Commission Regulations (EC) No 1356/2004 (3) and (EC) No 1464/2004 (4).

(2) In accordance with Regulation (EC) No 1831/2003, endo-1,4-beta-mannanase and diclazuril were authorised as feed additives by, respectively, Commission Regulations (EC) No 786/2007 (5), (EC) No 971/2008 (6), (EU) No 1118/2010 (7), (EU) No 169/2011 (8) and Commission Implementing Regulations (EU) No 888/2011 (9) and (EU) No 667/2013 (10).

(3) The holder of authorisation, Eli Lilly and Company Ltd, 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 for the feed additives concerned.

(4) The holder of authorisation claims that, with effect from 30 March 2018, Elanco GmbH, a division of Eli Lilly and Company Ltd owns the marketing rights for the additives concerned. The holder of authorisation has submitted relevant data supporting its request.

(5) The proposed change of the terms of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additives concerned. The European Food Safety Authority was informed of the application.

(6) To allow Elanco GmbH to exploit its marketing rights it is necessary to change the terms of the authorisations concerned.

(7) Regulations (EC) No 1356/2004, (EC) No 1464/2004, (EC) No 786/2007, (EC) No 971/2008, (EU) No 1118/2010, (EU) No 169/2011 and Implementing Regulations (EU) No 888/2011 and (EU) No 667/2013, should, therefore, be amended accordingly.

(8) Since safety reasons do not require the immediate application of the amendments made by this Regulation, it is appropriate to allow a transitional period during which existing stocks may be used up.

(9) 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:

Article 1 Amendment to Regulation (EC) No 1356/2004 In the second column of the Annex to Regulation (EC) No 1356/2004, the words ‘Eli Lilly and Company Limited’ are replaced by the words ‘Elanco GmbH’.

Article 2 Amendment to Regulation (EC) No 1464/2004 In the second column of the Annex to Regulation (EC) No 1464/2004, the words ‘Eli Lilly and Company Limited’ are replaced by the words ‘Elanco GmbH’.

Article 3 Amendment to Regulation (EC) No 786/2007 In the second column of the Annex to Regulation (EC) No 786/2007, the words ‘Eli Lilly and Company Ltd’ are replaced by the words ‘Elanco GmbH’.

Article 4 Amendment to Regulation (EC) No 971/2008 In the second column of the Annex to Regulation (EC) No 971/2008, the words ‘Eli Lilly and Company Ltd’ are replaced by the words ‘Elanco GmbH’.

Article 5 Amendment to Regulation (EU) No 1118/2010 In the second column of the Annex to Regulation (EU) No 1118/2010, the words ‘Eli Lilly and Company Ltd’ are replaced by the words ‘Elanco GmbH’.

Article 6 Amendment to Regulation (EU) No 169/2011 In the second column of the Annex to Regulation (EU) No 169/2011, the words ‘Eli Lilly and Company Ltd’ are replaced by the words ‘Elanco GmbH’.

Article 7 Amendment to Regulation (EU) No 888/2011 In the second column of the Annex to Regulation (EU) No 888/2011 the words ‘Eli Lilly and Company Ltd’ are replaced by the words ‘Elanco GmbH’.

Article 8 Amendment to Regulation (EU) No 667/2013 Regulation (EU) No 667/2013 is amended as follows: (1) In the title, the words ‘Eli Lilly and Company Ltd’ are replaced by the words ‘Elanco GmbH’; (2) In the second column of the Annex, the words ‘Eli Lilly and Company Ltd’ are replaced by the words ‘Elanco GmbH’.

Article 9 Transitional measure Monensin sodium, narasin, endo-1,4-beta-mannanase, and diclazuril produced and labelled before the date of entry into force of this Regulation in accordance with the rules applicable before that date may continue to be placed on the market and used until stocks are exhausted.

Article 10 Entry into force 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, 29 January 2019. For the Commission The President Jean-Claude JUNCKER

(1) OJ L 268, 18.10.2003, p. 29.

(2) Council Directive of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

(3) Commission Regulation (EC) No 1356/2004 of 26 July 2004 concerning the authorisation for 10 years of the additive ‘Elancoban’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (OJ L 251, 27.7.2004, p. 6).

(4) Commission Regulation (EC) No 1464/2004 of 17 August 2004 concerning the authorisation for 10 years of the additive ‘Monteban’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (OJ L 270, 18.8.2004, p. 8).

(5) Commission Regulation (EC) No 786/2007 of 4 July 2007 concerning the authorisation of endo-1,4-beta-mannanase EC 3.2.1.78 (Hemicell) as a feed additive (OJ L 175, 5.7.2007, p. 8).

(6) Commission Regulation (EC) No 971/2008 of 3 October 2008 concerning a new use of a coccidiostat as additive in feedingstuffs (OJ L 265, 4.10.2008, p. 3).

(7) Commission Regulation (EU) No 1118/2010 of 2 December 2010 concerning the authorisation of diclazuril as a feed additive for chickens for fattening (holder of authorisation Janssen Pharmaceutica NV) and amending Regulation (EC) No 2430/1999 (OJ L 317, 3.12.2010, p. 5).

(8) Commission Regulation (EU) No 169/2011 of 23 February 2011 concerning the authorisation of diclazuril as a feed additive for guinea fowls (holder of authorisation Janssen Pharmaceutica N.V.) (OJ L 49, 24.2.2011, p. 6).

(9) Commission Implementing Regulation (EU) No 888/2011 of 5 September 2011 concerning the authorisation of diclazuril as a feed additive for turkeys for fattening (holder of authorisation Janssen Pharmaceutica N.V..) and amending Regulation (EC) No 2430/1999 (OJ L 229, 6.9.2011, p. 9).

(10) Commission Implementing Regulation (EU) No 667/2013 of 12 July 2013 concerning the authorisation of diclazuril as a feed additive for chickens reared for laying (holder of authorisation Eli Lilly and Company Ltd) and repealing Regulation (EC) No 162/2003 (OJ L 192, 13.7.2013, p. 35).