Commission Implementing Regulation (EU) 2017/1006 of 15 June 2017 amending Implementing Regulation (EU) No 1206/2012 as regards the change of the production strain of the preparation of endo-1,4-beta-xylanase, produced by Aspergillus oryzae (DSM 10287) as feed additive for poultry for fattening, weaned piglets and pigs for fattening (holder of authorisation DSM Nutritional Products Ltd) (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2017/1006@2017-06-15/en
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, and in particular Article 13(3) thereof,
Whereas:
(1) The use of the preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287), belonging to the additive category of zootechnical additives, was authorised for 10 years as a feed additive for poultry for fattening, weaned piglets and pigs for fattening by Commission Implementing Regulation (EU) No 1206/2012.
(2) In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation of the preparation concerned by requesting for a change in the production strain, from Aspergillus oryzae (DSM 10287) to Aspergillus oryzae (DSM 26372). The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (hereinafter the Authority).
(3) The Authority concluded in its opinion of 14 July 2016 that the preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) does not have any adverse effects on animal health, human health and the environment. The Authority further concluded that the additive has the potential to be efficacious as a zootechnical additive in poultry species for fattening, weaned piglets and 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.
(4) The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.
(5) Implementing Regulation (EU) No 1206/2012 should therefore be amended accordingly.
(6) 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.
(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 Annex to Implementing Regulation (EU) No 1206/2012 is replaced by the text set out in the Annex to this Regulation.
Article 2
The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 6 January 2018 in accordance with the rules applicable before 6 July 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 3
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 June 2017. For the Commission The President Jean-Claude Juncker
ANNEX
ANNEX
ANNEX 1.2.3.4.
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 Units of activity/kg of complete feedingstuff with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers 4a1607i DSM Nutritional Products Ltd Endo-1,4-beta-xylanase EC 3.2.1.8 Poultry for fattening — 100FXU — In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. Recommended maximum dose per kilogram of complete feedingstuff for: For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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, including breathing protection and skin protection. For use in weaned piglets up to approximately 35 kg. 4 January 2023 Weaned piglets 200FXU Pigs for fattening 200FXU
ANNEX Additive composition
Preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) having a minimum activity of:
Solid form: 1000 FXU /g
Liquid form: 650 FXU/ml
Characterisation of the active substance
endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372)
Analytical method
For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) in a feed additive: For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM26372) in premixtures and feedingstuffs:
colorimetric method measuring coloured compound produced by the dinitro salicylic acid (DNSA) and the xylosylic moieties released by the action of xylanase on arabinoxylan.
colorimetric method measuring water soluble dye released by action of xylanase from dye-labelled oat spelt azo-xylan.
poultry for fattening: 200 FXU;
piglets (weaned): 400 FXU;
pigs for fattening: 400 FXU.