Synthesis of Phytase Enzyme (EC 3.1.3.26)
The European Union is considering a new 6-phytase preparation, ROVABIO® PHYPLUS, for approval in growing poultry and pig species. This product, developed by an unidentified manufacturer, comes in both liquid and solid formulations.
The liquid formulation guarantees a minimum 6-phytase activity of 5,000 FTU/g, while the solid formulation promises a minimum of 20,000 FTU/g. The intended use of both formulations is to be included in compound feed to achieve a minimum activity of 500 FTU/kg compound feed.
The Applicant has proposed an internal single-laboratory validated method for the quantification of 6-phytase activity in the feed additive, but this method has not been validated through a ring-trial. The proposed method's activity of 6-phytase has not been defined according to EN ISO 30024, and the EURL does not recommend its use for the quantification of 6-phytase activity in the feed additive, premixtures, or compound feed.
Instead, the EURL recommends the use of the ring-trial validated EN ISO 30024 standard method, which measures 6-phytase activity in phytase units (FTU). According to this standard, one FTU is the amount of enzyme that releases one micromole of inorganic phosphate from phytate per minute in specific reaction conditions.
The Applicant has submitted this standard method for the quantification of 6-phytase activity in compound feed. However, they have not proposed a specific minimum activity for the solid and liquid formulations of ROVABIO® PHYPLUS when included in compound feed, nor have they submitted their proposed internal method for validation as a standard method.
Further testing or validation of methods is not considered necessary by the EURL, as they believe the current standard method, EN ISO 30024, is sufficient. It's important to note that the EURL does not find it necessary to conduct further testing or validation of methods for the quantification of 6-phytase activity in the feed additive, beyond the EN ISO 30023 and EN ISO 30024 standard methods.
ROVABIO® PHYPLUS is a 6-phytase obtained from Trichoderma reesei CBS 148412 fermentation broth. The application seeks authorization for this 6-phytase preparation under Article 4(1) for growing poultry and pig species.
As the approval process continues, it remains to be seen whether ROVABIO® PHYPLUS will join the ranks of approved 6-phytase preparations in the EU.
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