Commission Implementing Regulation (EU) 2024/2184 of 3 September 2024 concerning the authorisation of a preparation of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 as a feed additive for piglets and pigs for fattening of all Suidae species
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 ↗
Authorisation
The substance specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘substances for reduction of the contamination of feed by mycotoxins’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX Identification number of the feed additive 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 complete feedingstuff with 12 % moisture content Category: technological additives. Functional group: substances for reduction of the contamination of feed by mycotoxins: fumonisins 1m04 Fumonisin esterase EC 3.1.1.87 Additive composition Preparation of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 containing a minimum of 1 200 U ( 1 ) /g. Solid form Characterisation of the active substance Fumonisin esterase (EC 3.1.1.87) produced with Komagataella phaffii NCAIM (P) Y001485 Analytical method ( 2 ) For the determination of fumonisin B1 esterase activity in the feed additive, premixtures and compound feed: High Performance Liquid Chromatography coupled to fluorescence detection (HPLC-FLD) based on the quantification of hydrolysed fumonisin B1 released from the action of the enzyme on fumonisin B1 at pH 6,0 and 37 °C. Piglets of all Suidae species Pigs for fattening of all Suidae species — 60 60 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. The additive shall only be used in feed which is already compliant with the rules established for mycotoxins in Union law on undesirable substances in animal feed. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin and breathing protective equipment. 24 September 2034 ( 1 ) One unit (U) is the amount of enzyme that releases one μmol of HFB1 per minute from 100 μM of FB1 in 50 mM phosphate buffer pH 6,0 at 37 °C. ( 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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