COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/363 
of 26 Febr uary 2021 
concer ning the author isation of a preparation of fumonisin esterase produced by Komag ataella 
phaffii DSM 32159 as a feed additiv e for all animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of a preparation of fumonisin esterase produced by Komag ataella phaf fii DSM 32159. That application was 
accompan ied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 
(3) The application concer ns the author isation of a preparation of fumonisin esterase produced by Komag ataella phaff ii 
DSM 32159 as a feed additive for all animal species, to be classified in the additive cate gory ‘technological additives ’. 
(4) The European Food Safet y Authority (‘the Author ity’) concluded in its opinion of 1 July 2020 (2) that, under the 
proposed conditions of use, the preparation of fumonisin esterase produced by Komag ataella phaff ii DSM 32159 
does not have an adverse effect on animal health, consumer safet y or the environment. It also concluded that the 
additive is not toxic by inhalation and the respirato ry exposure is likely to be low but a risk of sensitisation via the 
respirato ry rout e could not be excl uded. The additive is non-ir ritant to skin and eyes and is not considered a as a 
dermal sensitiser . Theref ore, the Commission considers that appropr iate protective measures should be taken to 
prevent adverse effects on human health, in particular as regards the users of the additive. The Author ity also 
concluded that the preparation concer ned has the capability to degrade fumonisins in fermenting feed (with a 
fumonisin conte nt within the limits operating in the Union) but only in silages, not in other fermenting feeds. The 
Authority does not consider that there is a need for specific requirements of post-market monitori ng. It also verified 
the repor t on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by 
Regulation (EC) No 1831/2003. 
(5) The assessment of the preparation of fumonisin esterase produced by Komag ataella phaf fii DSM 32159 shows that 
the conditions for author isation, as provid ed for in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. 
According ly, the use of that preparation should be author ised. 
(6) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The preparation specifi ed in the Annex, belonging to the additive catego ry ‘techn ological additives’ and to the functional 
group ‘substances for reduction of the contamination of feed by mycotoxins’, is author ised as an additive in animal 
nutr ition, subject to the conditions laid down in that Annex. 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Journal 2020;18(7):6207 EN Offi cial Jour nal of the European Union 1.3.2021                                                                                                                                             L 70/3   Article 2 
This Regulation shall enter into force on the twentieth day followi ng 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, 26 Febr uary 2021.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 70/4                                                                                                                                              1.3.2021   ANNEX 
Identification 
number of the 
additive Additive Compo sition, chem ical formula, 
descr iption, analytical method Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period of 
author isation Units of activity/kg 
fresh material 
Categor y of technological additiv es. Functional group:subst ances for reduction of the contamination of feed by mycoto xins: fumonisins 
1m03i Fumonisin esterase 
EC 3.1.1.87 Additive composition 
Preparation of fumonisin esterase 
produced by Komag ataella phaf fii 
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 stora ge 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 mate rial. 
4.The use of the additive is allowed in feeding­
stuffs compl ying with European Union legis­
lation on undesirable substances in animal 
feed (3) 
5.For users of the additive and premixtures, 
feed business operat ors shall establish opera­
tional procedures and organisational mea­
sures to address poten tial risks resulting from 
its use. Where those risks cannot be elimi­
nated or reduced to a minimum by such pro­
cedures and measures, the additive and pre­
mixtures shall be used with personal 
prote ctive equipment, including breathing 
prote ction. 21.3.2031 
Char acter isation of the active substance 
Preparation of fumonisin esterase 
produced by Komag ataella phaf fii 
DSM 32159. 
Analytical method (2) 
—For the determination of fumoni­
sin esterase activity: High Perfor ­
mance Liquid Chromat ography 
coupled with a tandem mass 
spectrometr y. (HPLC-MS/MS) 
method based on the quantific a­
tion 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 minut e 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 avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor ts 
(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).   EN Offi cial Jour nal of the European Union 1.3.2021                                                                                                                                             L 70/5