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) Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) 2016/348of 10 March 2016amending 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), 32016R0348, March 11, 2016
Commission Implementing Regulation (EU) No 98/2012of 7 February 2012concerning 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)(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 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036). The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(3)The application concerns 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, to be classified in the additive category "zootechnical additives".(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 11 October 2011EFSA Journal 2011; 9(11):2414. that, under the proposed conditions of use, 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) does not have an adverse effect on animal health, human health or the environment, and that its use can improve the phosphorus digestibility in all target species and performance parameters in avian species. 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.(5)The assessment of 6-phytase (EC 3.1.3.26) produced by Pichia 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 this preparation should be authorised as specified in the Annex to this Regulation.(6)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,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 20th day following 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.ANNEX
1 OTU is the amount of enzyme that catalyzes 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 color at 820 nm.Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspxCategory 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 methodColorimetric method based on the quantification of the inorganic phosphate released by the enzyme from the sodium phytateChickens for fattening, chickens reared for laying, laying hens, other avian species other than turkeys for fattening and turkeys reared for breeding, pigs for fattening, sows.—125 OTU—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended maximum dose for all authorised species: 500 OTU/Kg of complete feedingstuff.3.For use in feed containing more than 0,23 % phytin-bound phosphorus.4.For safety: breathing protection, glasses and gloves shall be used during handling.28 February 2022
Turkeys for fattening, turkeys reared for breeding, piglets (weaned)250 OUT