
Article 1 
The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘substances for the reduction of the contamination of feed by mycotoxins’, is authorised as an additive in animal nutrition subject to the conditions laid down in the Annex.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 18 October 2018.
For the Commission
The President
Jean-Claude JUNCKER
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 %
Technological additives: substances for reduction of the contamination of feed by mycotoxins: fumonisins
1m03i — Fumonisin esterase EC 3.1.1.87 
Preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159) containing a minimum of 3 000 U/g.

Preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159)

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.
 All pigsAll poultry species — 10  
1. In the directions for use of the additive and premixtures, the storage conditions and stability to pelleting shall be indicated.

2. Recommended maximum dose: 300 U/kg of complete feedingstuff.

3. The use of the additive is allowed in feedingstuffs complying with the European Union legislation on undesirable substances in animal feed.

4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their 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.
 8 November 2028


