Article 1
The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed subject to the conditions laid down in that Annex.
Commission Implementing Regulation (EU) 2022/1453 of 1 September 2022 concerning the authorisation of 6-phytase produced by Komagataella pastoris (DSM 23036) as a feed additive for all avian species and for all pigs and repealing Implementing Regulation (EU) No 98/2012 (holder of authorisation Huvepharma EOOD) (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/1453 of 1 September 2022 concerning the authorisation of 6-phytase produced by Komagataella pastoris (DSM 23036) as a feed additive for all avian species and for all pigs and repealing Implementing Regulation (EU) No 98/2012 (holder of authorisation Huvepharma EOOD) (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 ↗
Article 2
Implementing Regulation (EU) No 98/2012 is repealed.
Article 3
The additive, 6-phytase, produced by Komagataella pastoris (DSM 23036), premixtures and compound feed containing that substance, which are produced and labelled before 22 September 2022 in accordance with the rules applicable before 22 September 2022 may continue to be placed on the market and used until the existing stock are exhausted.
Article 4
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Supplementary provisions
ANNEXSupplementary provisions
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. 4a16 Huvepharma EOOD 6-phytase (EC 3.1.3.26) Additive composition Preparation 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) with a minimum activity of: 4 000 OTU ( 1 ) /g in solid form 8 000 OTU/g in liquid form Characterisation of the active substance 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) Analytical method ( 2 ) Colorimetric method based on the quantification of the inorganic phosphate released by the enzyme from the sodium phytate. All avian species other than turkeys All porcine species other than piglets - 125 OTU 1. In the directions for use of the additive and premixture, 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 resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. 22.9.2032 Turkeys Piglets 250 OTU ( 1 ) 1 OTU is the amount of enzyme that catalyses the release of one micromole of inorganic phosphate per minute from 5,1 mM sodium phytate in pH 5,5 citrate buffer at 37 °C, measured as the blue phosphorus-molybdate complex colour at 820 nm. ( 2 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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