COMMISSION IMPLEMENTING REGULATION (EU) 2016/348
of 10 March 2016
amending Implementing Regulation (EU) No 98/2012 as regards the minimum content of the
preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed
additive for pigs for fattening (holder of authorisation Huvepharma EOOD)
(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 13(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 and modifying such authorisation.
(2) The use of the preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036), formerly known as Pichia pastoris, was authorised until 28 February 2022 for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows by Commission Implementing Regulation (EU) No 98/2012 ([2]), following an application to that effect in accordance with Article 7 of Regulation (EC) No 1831/2003.
(3) 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 that preparation as a feed additive for pigs for fattening by reducing its minimum recommended content from 250 OTU/kg to 125 OTU/kg. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (hereinafter ‘The Authority’).
(4) The Authority concluded in its opinion of 9 July 2015 ([3]) that, under the new proposed conditions of use, the preparation 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) has the potential to be efficacious at the requested minimum recommended dose of 125 OTU/kg of complete feedingstuff as regards pigs for fattening. The Authority does not consider that there is a need for specific requirements for a postmarket monitoring plan. It also verified the report on the methods 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 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
(6) Implementing Regulation (EU) No 98/2012 should therefore be amended accordingly.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
- ↑ OJ L 268, 18.10.2003, p. 29.
- ↑ Commission Implementing Regulation (EU) No 98/2012 of 7 February 2012 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows (holder of authorisation Huvepharma AD) (OJ L 35, 8.2.2012, p. 6).
- ↑ EFSA Journal 2015; 13(7):4200.
