Commission Implementing Regulation (EU) 2015/1399
of 17 August 2015
concerning the denial of authorisation of the preparation of Bacillus toyonensis (NCIMB 14858T) (formerly Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012) as a feed additive for cattle for fattening, rabbits for fattening, chickens for fattening, piglets (weaned), pigs for fattening, sows for reproduction and calves for rearing and the revocation of the authorisations of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as a feed additive for turkeys 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 EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as a feed additive for cattle for fattening, rabbits for fattening, chickens 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 rearing, both applications requesting the additive to be classified in the additive category ‘zootechnical additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
Implementing Regulation (EU) No 288/2013 refers to the possibility that supplementary data concerning the safety of use of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012), to be submitted 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.
On 6 December 2013, the applicant submitted supplementary data to the Commission, which were subsequently forwarded to the Authority with a request to evaluate them in order to receive a new opinion on the safety and efficacy of the additive.
In addition, the applicant, on his own initiative, submitted to the Authority additional documentation on 24 April 2014, on 14 May 2014 and on 17 June 2014.
Consequently, it has not been established that the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012), which has been re-classified 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.
The conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are therefore not satisfied.
Accordingly, the authorisation of the preparation of Bacillus toyonensis (NCIMB 14858T) as a feed additive for cattle for fattening, rabbits for fattening, chickens for fattening, piglets (weaned), pigs for fattening, sows for reproduction and calves for rearing should be denied.
For the same reasons, the conditions for authorisation of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as a feed additive for use for turkeys for fattening and for rabbit breeding does are no longer fulfilled and those authorisations should be revoked.
Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005 and (EC) No 1200/2005 should be amended accordingly, and Regulations (EC) No 166/2008 and (EC) No 378/2009 should be repealed.
Implementing Regulation (EU) No 288/2013 should also be repealed.
Since existing stocks of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012), of premixtures containing that preparation and of feed materials and compound feed produced from that preparation were already to be withdrawn from the market according to Article 7 of Implementing Regulation (EU) No 288/2013, no transitional measures should be provided for.
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 1Denial of authorisation
Authorisation of Bacillus toyonensis (NCIMB 14858T) as an additive in animal nutrition for use for cattle for fattening, rabbits for fattening, chickens for fattening, piglets (weaned), pigs for fattening, sows for reproduction and calves for rearing is denied.
Article 2Revocation of authorisation
Authorisation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as an additive in animal nutrition for use for turkeys for fattening and rabbit breeding does is revoked.
Article 3Amendment to Regulation (EC) No 256/2002
Article 3 of Regulation (EC) No 256/2002 and Annex III to that Regulation are deleted.
Article 4Amendment to Regulation (EC) No 1453/2004
In Annex I to Regulation (EC) No 1453/2004, the entry E 1701, Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012, is deleted.
Article 5Amendment to Regulation (EC) No 255/2005
In Annex I to Regulation (EC) No 255/2005, the entry E 1701, Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012, is deleted.
Article 6Amendment to Regulation (EC) No 1200/2005
In Annex II to Regulation (EC) No 1200/2005, the entry E 1701, Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012, is deleted.
Article 7Repeal of Regulation (EC) No 166/2008
Regulation (EC) No 166/2008 is repealed.
Article 8Repeal of Regulation (EC) No 378/2009
Regulation (EC) No 378/2009 is repealed.
Article 9Repeal of Implementing Regulation (EU) No 288/2013
Implementing Regulation (EU) No 288/2013 is repealed.
Article 10Entry 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, 17 August 2015.
For the Commission
The President
Jean-Claude Juncker