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Commission Implementing Regulation (EU) 2016/2260 of 15 December 2016 amending Regulations (EC) No 226/2007, (EC) No 1293/2008, (EC) No 910/2009, (EC) No 911/2009, (EU) No 1120/2010, (EU) No 212/2011 and Implementing Regulations (EU) No 95/2013 and (EU) No 413/2013 as regards the name of the holder of the authorisation of Pediococcus acidilactici CNCM MA 18/5M and Saccharomyces cerevisiae CNCM I-1077 (Text with EEA relevance)
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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) Lallemand SAS 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 Regulations (EC) No 226/2007(2), (EC) No 1293/2008(3), (EC) No 910/2009(4), (EC) No 911/2009(5), (EU) No 1120/2010(6), (EU) No 212/2011(7) and Commission Implementing Regulations (EU) No 95/2013(8) and (EU) No 413/2013(9).
(2) The applicant claims that Danstar Ferment AG is the legal owner of the marketing rights for the feed additives Pediococcus acidilactici CNCM MA 18/5M and Saccharomyces cerevisiae CNCM I-1077. The applicant has submitted relevant data supporting its request.
(3) The proposed change of the authorisation holder 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.
(4) To allow Danstar Ferment AG to exploit its marketing rights it is necessary to change the terms of the respective authorisations.
(5) Regulations (EC) No 226/2007, (EC) No 1293/2008, (EC) No 910/2009, (EC) No 911/2009, (EU) No 1120/2010, (EU) No 212/2011 and Implementing Regulations (EU) No 95/2013 and (EU) No 413/2013 should therefore be amended accordingly.
(6) Since safety reasons do not require the immediate application of the amendments made by this Regulation to Regulations (EC) No 226/2007, (EC) No 1293/2008, (EC) No 910/2009, (EC) No 911/2009, (EU) No 1120/2010, (EU) No 212/2011 and Implementing Regulations (EU) No 95/2013 and (EU) No 413/2013, 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 Plant, Animals, Food and Feed.
HAS ADOPTED THIS REGULATION:
In column 2 of the Annex to Regulation (EC) No 226/2007 the term ‘LALLEMAND SAS’ is replaced by the term ‘Danstar Ferment AG represented by Lallemand SAS’.
In column 2 of the Annex to Regulation (EC) No 1293/2008 the term ‘LALLEMAND SAS’ is replaced by the term ‘Danstar Ferment AG represented by Lallemand SAS’.
Regulation (EC) No 910/2009 is amended as follows:
in the title, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG’;
in column 2 of the Annex, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG represented by Lallemand SAS’.
Regulation (EC) No 911/2009 is amended as follows:
in the title, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG’;
in column 2 of the Annex, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG represented by Lallemand SAS’.
Regulation (EU) No 1120/2010 is amended as follows:
in the title, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG’;
in column 2 of the Annex, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG represented by Lallemand SAS’.
Regulation (EU) No 212/2011 is amended as follows:
in the title, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG’;
in column 2 of the Annex, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG represented by Lallemand SAS’.
Implementing Regulation (EU) No 95/2013 is amended as follows:
in the title, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG’;
in column 2 of the Annex, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG represented by Lallemand SAS’.
Implementing Regulation (EU) No 413/2013 is amended as follows:
in the title, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG’;
in column 2 of the Annex, the term ‘Lallemand SAS’ is replaced by the term ‘Danstar Ferment AG represented by Lallemand SAS’.
Existing stocks of the additives 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.
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 is binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 December 2016.
For the Commission
The President
Jean-Claude Juncker
Commission Regulation (EC) No 226/2007 of 1 March 2007 concerning the authorisation of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20 and Levucell SC10 ME) as a feed additive (OJ L 64, 2.3.2007, p. 26).
Commission Regulation (EC) No 1293/2008 of 18 December 2008 concerning the authorisation of a new use of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20 and Levucell SC10 ME) as a feed additive (OJ L 340, 19.12.2008, p. 38).
Commission Regulation (EC) No 910/2009 of 29 September 2009 concerning the authorisation of a new use of the preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for horses (holder of authorisation Lallemand SAS) (OJ L 257, 30.9.2009, p. 7).
Commission Regulation (EC) No 911/2009 of 29 September 2009 concerning the authorisation of a new use of the preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for salmonids and shrimps (holder of authorisation Lallemand SAS) (OJ L 257, 30.9.2009, p. 10).
Commission Regulation (EU) No 1120/2010 of 2 December 2010 concerning the authorisation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for weaned piglets (holder of the authorisation Lallemand SAS) (OJ L 317, 3.12.2010, p. 12).
Commission Regulation (EU) No 212/2011 of 3 March 2011 concerning the authorisation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for laying hens (holder of authorisation Lallemand SAS) (OJ L 59, 4.3.2011, p. 1).
Commission Implementing Regulation (EU) No 95/2013 of 1 February 2013 concerning the authorisation of a preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for all fish other than salmonids (holder of authorisation Lallemand SAS) (OJ L 33, 2.2.2013, p. 19).
Commission Implementing Regulation (EU) No 413/2013 of 6 May 2013 concerning the authorisation of a preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for use in water for drinking for weaned piglets, pigs for fattening, laying hens and chickens for fattening (holder of authorisation Lallemand SAS) (OJ L 125, 7.5.2013, p. 1).
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