COMMISSION IMPLEMENTING REGULATION (EU) No 840/2012

19.9.2012 | EN | Official Journal of the European Union | L 252/14 ---|---|---|--- * * * COMMISSION IMPLEMENTING REGULATION (EU) No 840/2012 of 18 September 2012 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Schizosaccharomyces pombe (ATCC 5233) as a feed additive for all avian species for fattening other than chickens for fattening, turkeys for fattening and ducks for fattening and all avian species for laying other than laying hens (holder of authorisation Danisco Animal Nutrition) (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. ---|--- (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 Schizosaccharomyces pombe (ATCC 5233). 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 Schizosaccharomyces pombe (ATCC 5233) as a feed additive for all avian species for fattening other than chickens for fattening, turkeys for fattening and ducks for fattening and all avian species for laying other than laying hens, to be classified in the additive category ‘zootechnical additives’. ---|--- (4) | The use of preparations of 6-phytase EC 3.1.3.26 was authorised for 10 years for chickens for fattening, turkeys for fattening, laying hens, piglets (weaned), ducks for fattening, pigs for fattening and sows by Commission Regulations (EC) No 785/2007 (2) and (EC) No 379/2009 (3). ---|--- (5) | New data were submitted in support of the application for the authorisation of 6-phytase (EC 3.1.3.26) produced by Schizosaccharomyces pombe (ATCC 5233) for use as feed additive to all avian species for fattening other than chickens for fattening, turkeys for fattening and ducks for fattening and all avian species for laying other than laying hens. The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 March 2012 (4) that, under the proposed conditions of use, 6-phytase (EC 3.1.3.26) produced by Schizosaccharomyces pombe (ATCC 5233) does not have an adverse effect on animal health, human health or the environment, and that its use can improve the phosphorus utilisation in all target 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. ---|--- (6) | The assessment of 6-phytase (EC 3.1.3.26) produced by Schizosaccharomyces pombe (ATCC 5233) 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. ---|--- (7) | 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 1 The 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 2 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, 18 September 2012. For the Commission The President José Manuel BARROSO * * * (1) OJ L 268, 18.10.2003, p. 29. (2) OJ L 175, 5.7.2007, p. 5. (3) OJ L 116, 9.5.2009, p. 6. (4) EFSA Journal 2012; 10(3):2619. * * * ANNEX 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 4a1640 | Danisco Animal Nutrition (legal entity Danisco (UK) Limited) | 6-phytase EC 3.1.3.26 | | | Additive composition Preparation of 6-phytase (EC 3.1.3.26) produced by Schizosaccharomyces pombe (ATCC 5233) having a minimum activity of: Liquid and solid form: 5 000 FTU (1)/g ---|--- | Characterisation of the active substance 6-phytase (EC 3.1.3.26) produced by Schizosaccharomyces pombe (ATCC 5233) ---|--- | Analytical method (2) | | Determination of 6-phytase EC 3.1.3.26 in feed additive: colorimetric method based on the quantification of inorganic phosphate released by the enzyme from sodium phytate. ---|--- | Determination of 6-phytase EC 3.1.3.26 in feed premixtures and feedingstuff: EN ISO 30024: colorimetric method based on the quantification of inorganic phosphate released by the enzyme from sodium phytate (after dilution with heat-treated whole grain flour). ---|--- All avian species for fattening other than chickens for fattening, turkeys for fattening and ducks for fattening | — | 250 FTU | | | 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. ---|--- 2. | For use in compound feed containing more than 0,23 % phytin-bound phosphorus. ---|--- 3. | Maximum recommended dose: 1 000 FTU/kg of complete feedingstuff. ---|--- 4. | For safety: breathing protection glasses and gloves shall be used during handling. ---|--- 9 October 2022 All avian species for laying other than laying hens | 150 FTU * * * (1) 1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from a sodium phytate substrate at pH 5,5 and 37 °C. (2) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx * * *