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Commission Implementing Regulation (EU) 2015/2305Dangos y teitl llawn
Commission Implementing Regulation (EU) 2015/2305 of 10 December 2015 concerning the authorisation of a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, and amending Regulations (EC) No 2148/2004 and (EC) No 1520/2007 (holder of authorisation Huvepharma NV) (Text with EEA relevance)
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- Rheoliadau yn deillio o’r UE
- 2015 No. 2305
- Introduction
Pa Fersiwn
Nodweddion Uwch
- Dangos Graddfa Ddaearyddol(e.e. Lloegr, Cymru, Yr Alban aca Gogledd Iwerddon)
- Dangos Llinell Amser Newidiadau
Rhagor o Adnoddau
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Commission Implementing Regulation (EU) 2015/2305
of 10 December 2015
concerning the authorisation of a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, and amending Regulations (EC) No 2148/2004 and (EC) No 1520/2007 (holder of authorisation Huvepharma NV)
(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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2).
(2) The preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) (formerly Trichoderma longibrachiatum) hereinafter referred to as ‘the preparation specified in the Annex’ was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commission Regulation (EC) No 2148/2004(3) and for weaned piglets by Commission Regulation (EC) No 1520/2007(4). That 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.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) (formerly Trichoderma longibrachiatum) as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 17 April 2013(5) and 10 March 2015(6) that, under the proposed conditions of use, the preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) (formerly Trichoderma longibrachiatum) does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the use of that preparation has the potential to be efficacious in chickens for fattening and weaned piglets. The Authority further considered that the conclusions on the efficacy can be extrapolated to minor poultry species for fattening. It 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.
(5) The assessment of the preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) (formerly Trichoderma longibrachiatum) 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.
(6) Regulations (EC) No 2148/2004 and (EC) No 1520/2007 should be amended accordingly.
(7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
(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:
(2)
Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3)
Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs (OJ L 370, 17.12.2004, p. 24).
(4)
Commission Regulation (EC) No 1520/2007 of 19 December 2007 concerning the permanent authorisations of certain additives in feedingstuffs (OJ L 335, 20.12.2007, p. 17).
(5)
EFSA Journal 2013; 11(7):3207.
(6)
EFSA Journal 2015; 13(3):4054.
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