Commission Implementing Regulation (EU) 2021/363 of 26 February 2021 concerning the authorisation of a preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159 as a feed additive for all animal species (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 ‘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.
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 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 fresh material Category of technological additives. Functional group: substances for reduction of the contamination of feed by mycotoxins: fumonisins 1m03i Fumonisin esterase EC 3.1.1.87 Additive composition Preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159 containing a minimum of 3 000 U/g ( 1 ) All animal species - 40 - 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated. 2. The use of the additive is only allowed in maize based silages. 3. Recommended maximum dose: 300 U/kg of fresh material. 4. The use of the additive is allowed in feedingstuffs complying with European Union legislation on undesirable substances in animal feed ( 3 ) 5. 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. 21.3.2031 Characterisation of the active substance Preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159. Analytical method ( 2 ) — For the determination of fumonisin esterase activity: High Performance Liquid Chromatography coupled with a tandem mass spectrometry. (HPLC-MS/MS) method based on the quantification of the tricarballylic acid released from the action of the enzyme on fumonisin B1 at pH 8,0 and 30 °C. ( 1 ) 1 U is the enzymatic activity that releases 1 μmol tricarballylic acid per minute from 100 μΜ fumonisin B1 in 20 mM Tris-Cl buffer pH 8,0 with 0,1 mg/ml bovine serum albumin at 30 °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 ( 3 ) Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed ( OJ L 140, 30.5.2002, p. 10 ).
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