II 
(Non-legislative acts) 
REGUL ATIONS 
COMMI SSION IMPLEMENTING REGUL ATION (EU) 2015/1399 
of 17 August 2015 
concer ning the denial of author isation of the preparation of Bacillus toyonensis (NCIMB 14858T) 
(for merly Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012) as a feed additiv e for cattle for 
fattening, rabbits for fattening, chickens for fattening, piglets (weaned), pigs for fattening, sows for 
reproduction and calv es for rear ing and the revocation of the author isations of the preparation 
of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as a feed additiv e for turke ys for 
fattening and rabbit breeding does, amending Regulations (EC) No 256/2002, (EC) No 1453/2004, 
(EC) No 255/2005 and (EC) No 1200/2005 and repealing Regulations (EC) No 166/2008, (EC) 
No 378/2009 and Implementing Regulation (EU) No 288/2013 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Articles 9(2) and 13(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provides for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting, deny ing or revoki ng such author isation. Article 10 of that Regulation 
provides for the re-evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2). 
(2)  The preparation of Bacillus cereu s var. toyoi (NCIMB 40112/CNCM I-1012) was author ised without a time limit in 
accordance with Directive 70/524/EEC as a feed additive for piglets under 2 months and sows by Commission 
Regulation (EC) No 256/2002 (3), for piglets from 2 to 4 months and pigs for fattening by Commission 
Regulation (EC) No 1453/2004 (4), for cattle for fattening by Commission Regulation (EC) No 255/2005 (5) and 
for rabbits for fattening and chickens for fattening by Commission Regulation (EC) No 1200/2005 (6). The 
preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with 
Article 10(1) of Regulation (EC) No 1831/2003. 18.8.2015 L 217/1 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Council Directive 70/524/EEC of 23 November 1970 concer ning additives in feed ingstuffs (OJ L 270, 14.12.1970, p. 1). 
(3)Commission Regulation (EC) No 256/2002 of 12 Febr uary 2002 concer ning the provisional author isation of new additives, the 
prolong ation of provisional author isation of an additive and the permanent author isation of an additive in feedingstuffs (OJ L 41, 
13.2.2002, p. 6). 
(4)Commission Regulation (EC) No 1453/2004 of 16 August 2004 concer ning the permanent author isation of certain additives in feed ing­
stuffs (OJ L 269, 17.8.2004, p. 3). 
(5)Commission Regulation (EC) No 255/2005 of 15 Febr uary 2005 concer ning the permanent author isations of certain additives in 
feed ingstuffs (OJ L 45, 16.2.2005, p. 3). 
(6)Commission Regulation (EC) No 1200/2005 of 26 July 2005 concer ning the permanent author isation of certain additives in feeding ­
stuffs and the provisional author isation of a new use of an additive already author ised in feed ingstuffs (OJ L 195, 27.7.2005, p. 6). (3)  That preparation was also author ised in accordance with Regulation (EC) No 1831/2003 for 10 years for turke ys 
for fattening by Commission Regulation (EC) No 166/2008 (1) and for rabbit breeding does by Commission 
Regulation (EC) No 378/2009 (2). 
(4)  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, 
an application was submitted for the author isation of the preparation of Bacillus cereus var. toyoi 
(NCIMB 40112/CNCM I-1012) as a feed additive for cattle for fattening, rabbits for fattening, chick ens for 
fattening, piglets (weaned), pigs for fattening and sows for reproduction and, in accordance with Article 7 of that 
Regulation, an application was submitted for a new use of that preparation for calves for rear ing, both 
applications requesting the additive to be classified in the additive catego ry ‘zootec hnical additives ’. Those 
applications were accompan ied by the particulars and documents required under Article 7(3) of Regulation (EC) 
No 1831/2003. 
(5)  On the basis of the opinion of 16 Octobe r 2012 of the European Food Safet y Author ity (‘the Author ity’) (3), 
Commission Implementing Regulation (EU) No 288/2013 (4) suspended the existing author isations of the 
preparation of Bacillus cereu s var. toyoi (NCIMB 40112/CNCM I-1012). 
(6)  Implementing Regulation (EU) No 288/2013 refers to the possibility that supplementar y data concer ning the 
safety of use of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012), to be submitt ed by the 
applicant, may bring new elements which would allow a re-consideration of the assessment carried out for that 
additive. That Regulation further provides for the review of the suspension measure. 
(7)  On 6 December 2013, the applicant submitted supplementar y data to the Commission, whic h were subsequently 
forwarded to the Author ity with a request to evaluate them in order to receive a new opinion on the safety and 
efficacy of the additive. 
(8)  In addition, the applicant, on his own initiative, submitt ed to the Author ity additional documentation on 
24 Apr il 2014, on 14 May 2014 and on 17 June 2014. 
(9)  On 1 July 2014, the Authority adop ted an opinion following the assessment of the supplementar y data 
submitte d by the applicant (5). In its opinion, the Author ity considered that the taxonomic re-classification of the 
strain of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as a new species named Bacillus toyonensis had no 
impact on the assessment thereof, as it still belongs to the Bacillus cereu s group. As regar ds the antibiotic suscept ­
ibility of the Bacillus toyonensis strain, the Authority concluded that the supplementar y data provided do not alter 
the previous conclusion that the strain poses a risk for the spread of genes coding for resistance to tetracy cline 
and chloram phenicol, whic h are antibiotics of human and veteri nary impor tance. On the toxigenic poten tial of 
the Bacillus toyonensis strain, the Author ity concluded that it has the capacity to elaborat e functional toxins and, 
thus, to pose a risk to those exposed to the organism, including those handling the additive and consumers 
exposed to contaminate d animal products. 
(10)  On 30 August 2014, the applicant request ed the administrative review of the opinion of the Author ity of 1 July 
2014 and on 17 October 2014 he supplemented his request with additional elements. By Decision of 20 May 
2015 (6), the Commission concluded that there was no reason to require that the Auth ority withdraw that 
opinion. 
(11)  Consequently , it has not been established that the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM 
I-1012), whic h has been re-classifi ed as a new species named Bacillus toyonensis (NCIMB 14858T), does not have 
an adverse effect on animal health or on human health, when used as feed additive. 18.8.2015 L 217/2 Official Jour nal of the European Union EN     
(1)Commission Regulation (EC) No 166/2008 of 22 Febr uary 2008 concer ning the author isation of a new use of the preparation of Bacillus 
cereus var. toyoi (Toyocer in) as a feed additive (OJ L 50, 23.2.2008, p. 11). 
(2)Commission Regulation (EC) No 378/2009 of 8 May 2009 concer ning the author isation of a new use of the preparation of Bacillus cereus 
var. toyoi as a feed additive for rabbit breeding does (holder of the author isation Rubinum S.A.) (OJ L 116, 9.5.2009, p. 3). 
(3)EFSA Journal 2012; 10(10):2924. 
(4)Commission Implementing Regulation (EU) No 288/2013 of 25 March 2013 concer ning the suspension of the author isations of the 
preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as provided for by Regulations (EC) No 256/2002, (EC) 
No 1453/2004, (EC) No 255/2005, (EC) No 1200/2005, (EC) No 166/2008 and (EC) No 378/2009 (OJ L 86, 26.3.2013, p. 15). 
(5)EFSA Journal 2014; 12(7):3766. 
(6)C(2015) 3409 final. (12)  The conditions for author isation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are theref ore not 
satisfied. 
(13)  According ly, the author isation of the preparation of Bacillus toyonensis (NCIMB 14858T) as a feed additive for 
cattle for fattening, rabbits for fattening, chick ens for fattening, piglets (weaned), pigs for fattening, sows for 
reproduction and calves for rear ing should be denied. 
(14)  For the same reasons, the conditions for author isation of the preparation of Bacillus cereus var. toyoi 
(NCIMB 40112/CNCM I-1012) as a feed additive for use for turke ys for fattening and for rabbit breeding does are 
no long er fulfilled and those author isations should be revok ed. 
(15)  Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005 and (EC) No 1200/2005 should be 
amended according ly, and Regulations (EC) No 166/2008 and (EC) No 378/2009 should be repealed. 
(16)  Implementing Regulation (EU) No 288/2013 should also be repealed. 
(17)  Since existing stoc ks of the preparation of Bacillus cereu s var. toyoi (NCIMB 40112/CNCM I-1012), of premixtures 
containing that preparation and of feed mater ials and compound feed produced from that preparation were 
already to be withdra wn from the market according to Article 7 of Implementing Regulation (EU) No 288/2013, 
no transitional measures should be provided for. 
(18)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Denial of author isation 
Author isation of Bacillus toyonensis (NCIMB 14858T) as an additive in animal nutr ition for use for cattle for fattening, 
rabbits for fattening, chick ens for fattening , piglets (weaned), pigs for fattening, sows for reproduction and calves for 
rear ing is denied. 
Article 2 
Rev ocation of author isation 
Author isation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as an additive in animal nutr ition for use for 
turk eys for fattening and rabbit breeding does is revok ed. 
Article 3 
Amendment to Regulation (EC) No 256/2002 
Article 3 of Regulation (EC) No 256/2002 and Annex III to that Regulation are delet ed. 
Article 4 
Amendment to Regulation (EC) No 1453/2004 
In Annex I to Regulation (EC) No 1453/2004, the entr y E 1701, Bacillus cereu s var. toyoi NCIMB 40112/CNCM I-1012, is 
delet ed. 18.8.2015 L 217/3 Official Jour nal of the European Union EN     Article 5 
Amendment to Regulation (EC) No 255/2005 
In Annex I to Regulation (EC) No 255/2005, the entr y E 1701, Bacillus cereu s var. toyoi NCIMB 40112/CNCM I-1012, is 
delet ed. 
Article 6 
Amendment to Regulation (EC) No 1200/2005 
In Annex II to Regulation (EC) No 1200/2005, the entr y E 1701, Bacillus cereu s var. toyoi NCIMB 40112/CNCM I-1012, 
is delet ed. 
Article 7 
Repeal of Regulation (EC) No 166/2008 
Regulation (EC) No 166/2008 is repealed. 
Article 8 
Repeal of Regulation (EC) No 378/2009 
Regulation (EC) No 378/2009 is repealed. 
Article 9 
Repeal of Implementing Regulation (EU) No 288/2013 
Implementing Regulation (EU) No 288/2013 is repealed. 
Article 10 
Entr y 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 State s. 
Done at Brussels, 17 August 2015. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  18.8.2015 L 217/4 Official Jour nal of the European Union EN