Preparation of 6-phytase (EC 3.1.3.26)

In the current application, an authorisation of a preparation of 6-phytase (EC 3.1.3.26) is sought under Article 4(1) for all growing poultry species and all growing pig species under the category/functional group 4 (a) "zootechnical additives"/"digestibility enhancers" according to Annex I of Regulation (EC) No 1831/2003. According to the Applicant, the active agent of the product (ROVABIO® PHYPLUS) is a 6-phytase, obtained from a fermentation broth of Trichoderma reesei CBS 148412. The product is intended to be marketed as solid and liquid formulations with a guaranteed minimum 6-phytase activity of 20000 and 5000 FTU / g depending on the formulation. According to the Applicant, both formulations are intended to be included through premixtures or directly in compound feed to obtain a minimum activity of 500 FTU / kg compound feed. The activity of 6-phytase is expressed in phytase units (FTU). According to the EN ISO 30024, one phytase activity unit, determined by the reaction conditions specified in that standard, is defined as “the amount of enzyme that releases one micromole of inorganic phosphate from phytate per minute in acetate buffer at pH 5.5 and 37 °C”. For the quantification of the phytase activity in compound feed the Applicant submitted the ring-trial validated colorimetric standard method EN ISO 30024 while for the quantification of the phytase activity in the feed additive, the Applicant proposed an internal single-laboratory validated and further verified method. Upon EURL request, the Applicant demonstrated the equivalence of its internal method to the protocol for feed additives recently included in the revised EN ISO 30024 standard method. Based on the performance characteristics available, the EURL recommends for official control the ring-trial validated EN ISO 30024 standard method for the quantification of the 6-phytase activity in the feed additive, premixtures and compound feed. Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.