Commission Implementing Regulation (EU) 2017/2274 of 8 December 2017 concerning the authorisation of a new use of a preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for fish (holder of authorisation Huvepharma EOOD) (Text with EEA relevance. )
Commission Implementing Regulation (EU) 2017/2274of 8 December 2017concerning the authorisation of a new use of a preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for fish (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 nutritionOJ L 268, 18.10.2003, p. 29., 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)In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for fish. 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 a preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for fish to be classified in the additive category "zootechnical additives".(4)The use of that preparation was authorised for 10 years 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 98/2012Commission 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..(5)The European Food Safety Authority ("the Authority") concluded in its opinion of 21 March 2017EFSA Journal 2017;15(4):4763. that, under the proposed conditions of use, preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) does not have an adverse effect on animal health, human health or the environment. It concluded that the additive has the potential to be efficacious in rainbow trout and salmon and this conclusion can be extrapolated to all finfish. 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 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. 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 1The preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "digestibility enhancers", is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2This 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, 8 December 2017.For the CommissionThe PresidentJean-Claude JunckerANNEX
1 OTU is the amount of enzyme that catalyses the release of 1 micromole of inorganic phosphate per minute from 5,1 mM sodium phytate in pH 5,5 citrate buffer at 37 °C, measured as the blue P-molybdate complex colour at 820 nm.Details of the analytical methods are available at the following address of the Reference Laboratory: http://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.Category of zootechnical additives. Functional group: digestibility enhancers.
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
4a16Huvepharma EOOD6-phytase(EC 3.1.3.26)Additive compositionPreparation 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) with a minimum activity of:4000 OTU/g in solid form8000 OTU/g in liquid formCharacterisation of the active substance6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036)Analytical methodFor quantification of 6-phytase in feed:Colorimetric method based on the quantification of the inorganic phosphate released by the enzyme from the sodium phytate.Fish—500 OTU—1.In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2.For use in feed containing more than 0,23 % phytin-bound phosphorus.3.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 protective equipment, including breathing and skin protections.29.12.2027