COMMISSION IMPLEMENTING REGULATION (EU) No 1083/2014
concerning the authorisation of a preparation of
DSM 7134 (Bonvital) as a feed additive for sows
(Text with EEA relevance)
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,
(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 the authorisation of the preparation of
DSM 7134 (Bonvital). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) That application concerns the authorisation of the preparation of
DSM 7134 (Bonvital) as a feed additive for sows to be used for the duration of the entire reproductive cycle, to be classified in the additive category ‘zootechnical additives’.
(4) The use of the preparation of
DSM 7134 was authorised provisionally for piglets and pigs for fattening by Commission Regulation (EC) No 666/2003(2), provisionally for sows by Commission Regulation (EC) No 2154/2003(3), provisionally for chickens for fattening by Commission Regulation (EC) No 521/2005(4), for 10 years for weaned piglets and pigs for fattening by Commission Regulation (EC) No 538/2007(5) and for 10 years for sows from day 90 of pregnancy to the end of lactation by Commission Regulation (EC) No 1521/2007(6).
(5) The European Food Safety Authority (the Authority) concluded in its opinion of 18 February 2014(7) that, under the proposed conditions of use, the preparation of
DSM 7134 (Bonvital) does not have an adverse effect on animal health, human health or the environment. It also concluded that the additive has the potential to increase litter weight gain or maintain sow condition. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6) The assessment of the preparation of
DSM 7134 (Bonvital) 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) As a consequence of the authorisation being granted by this Implementing Regulation, Regulation (EC) No 1521/2007 should be repealed.
(8) 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:
The preparation specified in the Annex, belonging to the category ‘zootechnical additives’ and the functional group ‘gut flora stabilisers’ is authorised as an additive in animal nutrition subject to the conditions laid down in this Annex.
Regulation (EC) No 1521/2007 is repealed.
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, 15 October 2014.
OJ L 268, 18.10.2003, p. 29
(2) Commission Regulation (EC) No 666/2003 of 11 April 2003 provisionally authorising the use of certain micro-organisms in feedingstuffs (
OJ L 96, 12.4.2003, p. 11
(3) Commission Regulation (EC) No 2154/2003 of 10 December 2003 provisionally authorising certain micro-organisms in feedingstuffs (
Lactobacillus acidophilus
OJ L 324, 11.12.2003, p. 11
(4) Commission Regulation (EC) No 521/2005 of 1 April 2005 concerning the permanent authorisation of an additive and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (
(5) Commission Regulation (EC) No 538/2007 of 15 May 2007 concerning the authorisation of a new use of
DSM 7134 (Bonvital) as a feed additive (
OJ L 128, 16.5.2007, p. 16
(6) Commission Regulation (EC) No 1521/2007 of 19 December 2007 concerning the authorisation of a new use of
DSM 7134 (Bonvital) as a feed additive (
OJ L 335, 20.12.2007, p. 24
(7) EFSA Journal 2014; 12(2):3565
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