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 9(2) thereof,
Whereas:
(1)
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.
(2)
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of the preparation Bacillus subtilis (ATCC PTA-6737). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3)
The application concerns the authorisation of a new use of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for laying hens and minor poultry species for laying, to be classified in the additive category ‘zootechnical additives’.
(4)
The preparation of Bacillus subtilis (ATCC PTA-6737), belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EU) No 107/2010 (2), for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches by Commission Implementing Regulation (EU) No 885/2011 (3), for weaned piglets and weaned Suidae other than Sus scrofa domesticus by Commission Implementing Regulation (EU) No 306/2013 (4) and for turkeys for fattening and turkeys reared for breeding by Commission Implementing Regulation (EU) No 787/2013 (5).
(5)
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 December 2014 (6) that, under the proposed conditions of use, the preparation of Bacillus subtilis (ATCC PTA-6737) does not have an adverse effect on animal health, human health and the environment. It also concluded that the additive has some evidence of beneficial effects on egg production in laying hens. This conclusion can be extended to minor poultry species for laying. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6)
The assessment of the preparation of Bacillus subtilis (ATCC PTA-6737) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.
(7)
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
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2
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 June 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Regulation (EU) No 107/2010 of 8 February 2010 concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV) (OJ L 36, 9.2.2010, p. 1).
(3) Commission Implementing Regulation (EU) No 885/2011 of 5 September 2011 concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of authorisation Kemin Europa N.V.) (OJ L 229, 6.9.2011, p. 3).
(4) Commission Implementing Regulation (EU) No 306/2013 of 2 April 2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) for weaned piglets and weaned Suidae other than Sus scrofa domesticus (holder of authorisation Kemin Europa N.V.) (OJ L 91, 3.4.2013, p. 5).
(5) Commission Implementing Regulation (EU) No 787/2013 of 16 August 2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Kemin Europa N.V.) (OJ L 220, 17.8.2013, p. 15).
(6) EFSA Journal 2015; 13(1):3970.
ANNEX
| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| CFU/kg of complete feedingstuff with a moisture content of 12 % | |||||||||
| Category of zootechnical additives. Functional group: gut flora stabilisers. | |||||||||
| 4b1823 | Kemin Europa NV. | Bacillus subtilisATCC PTA-6737 | Additive composition: Preparation of Bacillus subtilis (ATCC PTA-6737) containing a minimum of 1 × 1010CFU/g additive Solid form Characterisation of the active substance: Viable spores ofBacillus subtilis(ATCC PTA-6737) Analytical method (1) Enumeration: spread plate method using tryptone soya agar with pre heat-treatment of feed samples. Identification: pulsed-field gel electrophoresis (PFGE) method. | Laying hens Minor poultry species for laying | — | 1 × 108 | — | In the directions for use of the additive and premixture indicate the storage conditions and stability to pelleting. | 20.7.2025 |
