Commission Implementing Regulation (EU) 2018/1081 of 30 July 2018 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (Text with EEA relevance.)
Date: 2018-07-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, fattening, food additive, market approval, swine




L_2018194EN.01013701.xml










31.7.2018   


EN


Official Journal of the European Union


L 194/137








            COMMISSION IMPLEMENTING REGULATION (EU) 2018/1081
of 30 July 2018
         
concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office)
(Text with EEA relevance)


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)


The preparation of Bacillus subtilis C-3102 (DSM 15544), belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1444/2006 (2), for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds by Commission Regulation (EU) No 184/2011 (3), for weaned piglets by Commission Regulation (EU) No 333/2010 (4), for laying hens and ornamental fish by Commission Implementing Regulation (EU) 2016/897 (5).for sows, suckling piglets and dogs by Commission Implementing Regulation (EU) 2017/2312 (6).












(3)


In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) for pigs for fattening, requesting that the additive be classified in the additive category ‘zootechnical additives’.












(4)


The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.












(5)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 March 2018 (7) that, under the proposed conditions of use, the preparation of Bacillus subtilis C-3102 (DSM 15544) does not have an adverse effect on animal health, human health and the environment and that it has the potential to improve the zootechnical performance of pigs for fattening. 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 C-3102 (DSM 15544) 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, 30 July 2018.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  Commission Regulation (EC) No 1444/2006 of 29 September 2006 concerning the authorisation of Bacillus subtilis C-3102 (Calsporin) as a feed additive (OJ L 271, 30.9.2006, p. 19).

(3)  Commission Regulation (EU) No 184/2011 of 25 February 2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office) (OJ L 53, 26.2.2011, p. 33).

(4)  Commission Regulation (EU) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office) (OJ L 102, 23.4.2010, p. 19).

(5)  Commission Implementing Regulation (EU) 2016/897 of 8 June 2016 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish (holder of authorisation Asahi Calpis Wellness Co. Ltd) and amending Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 as regards the holder of the authorisation (OJ L 152, 9.6.2016, p. 7).

(6)  Commission Implementing Regulation (EU) 2017/2312 of 13 December 2017 concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (OJ L 331, 14.12.2017, p. 41).

(7)  
            EFSA Journal 2018; 16(3):5219.




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






4b1820


Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office



Bacillus subtilis C-3102 (DSM 15544)



Additive composition


Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g
Solid form

Characterisation of the active substance

Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)

Analytical method
 (1)

Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)
Identification: pulsed-field gel electrophoresis (PFGE).


Pigs for fattening


—


1,5 × 108



—








1.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










2.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks of their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.






20.8.2028






(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: www.irmm.jrc.ec.europa.eu/crl-feed-additives