Introductory text

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^f1 and in particular Article 13(1), (2) and (3) thereof,

Whereas:

The use of Saccharomyces cerevisiae NCYC Sc 47 belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’ was authorised for 10 years by Commission Regulation (EC) No 232/2009^f2 for dairy buffaloes, by Commission Regulation (EC) No 1447/2006^f3 for lambs for fattening, by Commission Regulation (EC) No 188/2007^f4 for dairy goats and dairy sheep, by Commission Regulation (EC) No 186/2007^f5 for horses, and by Commission Regulation (EC) No 209/2008^f6 for pigs for fattening. It was authorised without a time limit by Commission Regulation (EC) No 316/2003^f7 for cattle for fattening, by Commission Regulation (EC) No 1811/2005^f8 for dairy cows, by Commission Regulation (EC) No 1288/2004^f9 for sows, and by Commission Regulation (EC) No 2148/2004^f10 for weaned piglets.

In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisations has proposed changing the terms of the authorisations of Saccharomyces cerevisiae NCYC Sc 47 as set out in the Regulations referred to in recital 1.

The use of Bacillus subtilis DSM 17299 belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’ was authorised for 10 years by Commission Regulation (EC) No 1137/2007^f11 for chickens for fattening.

In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation of Bacillus subtilis DSM 17299 as set out in the Regulation referred to in recital 3.

The opinions adopted by the European Food Safety Authority (‘the Authority’) on the use of certain micro-organisms in feed were based on the Qualified Presumption of Safety (QPS) status of the micro-organisms concerned (‘Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2011 update)’^f12). The holders of the authorisations have proposed to delete the limitation concerning the maximum content of the micro-organisms Saccharomyces cerevisiae NCYC Sc 47 and Bacillus subtilis DSM 17299 in complete feedingstuffs, on the basis that the maximum doses were not consistent with the QPS approach.

In order to avoid market distortions it is appropriate to delete the limitation concerning the maximum content also as regards authorisations of other micro-organisms having the same QPS status.

In accordance with Article 13(1) the Authority was requested to provide an opinion on the possibility to delete the maximum content for other micro-organisms having the same QPS status: Saccharomyces cerevisiae CNCM I-1077 authorised for 10 years by Commission Regulation (EC) No 1293/2008^f13 for lambs, by Commission Regulation (EC) No 226/2007^f14 for dairy goats and dairy sheep and without a time limit by Commission Regulation (EC) No 1200/2005^f15 for dairy cows and cattle for fattening; Saccharomyces cerevisiae CNCM I-1079 authorised without a time limit by Commission Regulation (EC) No 1847/2003^f16 for piglets and by Commission Regulation (EC) No 2036/2005^f17 for sows; Saccharomyces cerevisiae CBS 493.94 authorised without a time limit by Commission Regulation (EC) No 1288/2004 for cattle for fattening and calves and by Commission Regulation (EC) No 1811/2005^f18 for dairy cows; Saccharomyces cerevisiae MUCL 39885 authorised without a time limit by Commission Regulation (EC) No 492/2006^f19 for cattle for fattening; Bacillus amyloliquefaciens CECT 5940 authorised for 10 years by Commission Regulation (EC) No 1292/2008^f20 for chickens for fattening; Lactobacillus farciminis CNCM MA 67/4R authorised for four years by Commission Regulation (EC) No 1876/2006^f21 for chickens and turkeys for fattening and laying hens and without a time limit by Commission Regulation (EC) No 492/2006 for weaned piglets; Pediococcus acidilactici CNCM MA18/5M authorised without a time limit by Commission Regulation (EC) No 1200/2005 for chickens for fattening and by Commission Regulation (EC) No 2036/2005 for pigs for fattening; Lactobacillus acidophilus D2/CSL CECT4529 authorised without a time limit by Commission Regulation (EC) No 1520/2007^f22 for laying hens; Bacillus subtilis C-3102 (DSM 15544) authorised for 10 years by Commission Regulation (EC) No 1444/2006^f23 for chickens for fattening.

The Authority concluded in its opinion of 24 April 2012^f24 that the setting of a maximum content of Saccharomyces cerevisiae NCYC Sc 47, Bacillus subtilis DSM 17299, Saccharomyces cerevisiae CNCM I-1077, Saccharomyces cerevisiae CNCM I-1079, Saccharomyces cerevisiae CBS 493.94, Saccharomyces cerevisiae MUCL 39885, Bacillus amyloliquefaciens CECT 5940, Lactobacillus farciminis CNCM MA 67/4R, Pediococcus acidilactici CNCM MA18/5M, Lactobacillus acidophilus D2/CSL CECT4529, and Bacillus subtilis C-3102 (DSM 15544) in complete feedingstuff does not offer any additional degree of safety for the target animals and consumers. Therefore, there are no reasons to maintain the maximum content for them.

The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.

Regulations (EC) No 232/2009, (EC) No 188/2007, (EC) No 186/2007, (EC) No 209/2008, (EC) No 1447/2006, (EC) No 316/2003, (EC) No 1811/2005, (EC) No 1288/2004, (EC) No 2148/2004, (EC) No 1137/2007, (EC) No 1293/2008, (EC) No 226/2007, (EC) No 1444/2006, (EC) No 1876/2006, (EC) No 1847/2003, (EC) No 2036/2005, (EC) No 492/2006, (EC) No 1200/2005, and (EC) No 1520/2007 should therefore be amended accordingly.

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: