6-phytase (EC 3.1.3.26)

In the current application, authorisation of a preparation of 6-phytase (EC 3.1.3.26) is sought under Article 4(1) for avian species under the category/functional group 4 (a) "zootechnical additives"/"digestibility enhancers".

According to the Applicant, the active agent is 6-phytase. The phytase activity is expressed in phytase units (FTU). One FTU unit, as described in EN ISO 30024, is defined as "the amount of enzyme that releases 1 μmol of inorganic phosphate from sodium phytate per minute under reaction conditions of pH 5.5 and 37 °C".

The product is intended to be marketed as solid (Nutrase PD, Nutrase PG and Nutrase PTS) and liquid (Nutrase PL) formulations with a guaranteed minimum 6-phytase activity of 100000 FTU/g for the Nutrase PD and of 10000 FTU/g for the remaining formulations. It is intended to be included through premixtures or directly in feedingstuffs to obtain a minimum recommended activity of 250 FTU/kg feedingstuffs.

For the quantification of the phytase activity the Applicant submitted the ring-trial validated colorimetric standard method ISO 30024 (for the feed additive, premixtures and feedingstuffs). However as the scope of the ISO 30024 is limited to feedingstuffs the EURL requested to the Applicant to apply the ring-trial validated VDLUFA 27.1.4 and VDLUFA 27.1.3 methods to representative feed additive and premixture samples.

Based on the performance characteristics available the EURL recommends for official control the colorimetric ring-trial validated methods mentioned above for the quantification of the phytase activity in the feed additive, premixtures and feedingstuffs.

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.

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2024/1057

For the quantification of 6-phytase activity in the feed additive:

• colorimetric method based on the enzymatic reaction of phytase on phytate – VDLUFA 27.1.4

For the quantification of 6-phytase activity in premixtures:

• colorimetric method based on the enzymatic reaction of phytase on phytate – VDLUFA 27.1.3

For the quantification of 6-phytase activity in compound feed:

• colorimetric method based on the enzymatic reaction of phytase on phytate – EN ISO 30024