Commission Implementing Regulation (EU) 2021/330 of 24 February 2021 concerning the authorisation of a preparation of 3-phytase produced by Komagataella phaffii CECT 13094 as a feed additive for pigs for fattening, minor porcine species, turkeys for fattening and reared for breeding (holder of authorisation: Fertinagro Biotech S.L.) (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX Identi-fication 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 feed with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers. 4a25 Fertinagro Biotech S.L. 3-phytase (EC 3.1.3.8) Additive composition: Preparation of 3-phytase (EC 3.1.3.8) produced by Komagataella phaffii (CECT 13094) having a minimum activity of: Solid form: 10 000 FTU ( 1 ) /g Liquid form: 1 000 FTU/ml — Turkeys for fattening — Turkeys reared for breeding purposes — Pigs for fattening — Minor porcine species for fattening - 500 FTU - 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation and dermal contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing protection and gloves. 17.3.2031 Characterisation of the active substance: 3-phytase (EC 3.1.3.8) produced by Komagataella phaffii (CECT 13094) Analytical method ( 2 ) For the quantification of 3-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 3-phytase activity in premixtures: — colorimetric method based on the enzymatic reaction of phytase on phytate – VDLUFA 27.1.3 For the quantification of 3-phytase activity in feed materials and compound feed: — colorimetric method based on the enzymatic reaction of phytase on the phytate – EN ISO 30024 ( 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: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
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