COMMI SSION IMPLEMENTING REGUL ATION (EU) 2017/913 
of 29 May 2017 
concer ning the author isation of a preparation of fumonisin esterase produced by Komag ataella 
pastor is (DSM 26643) as a feed additiv e for all avian species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provides 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 submitt ed for the author is­
ation of a preparation of fumonisin esterase produced by Komag ataella pastor is (DSM 26643). That application 
was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) 
No 1831/2003. 
(3)  That application concer ns the author isation of a new use of a preparation of fumonisin esterase produced by 
Komag ataella pastor is (DSM 26643) as a feed additive for all avian species, to be classifie d in the additive catego ry 
‘technological additives’. 
(4)  That additive was already author ised as feed additive for 10 years by Commission Implementing Regulation (EU) 
No 1115/2014 (2) for pigs. 
(5)  The European Food Safety Auth ority (‘the Author ity’) in its opinion of 18 October 2016 (3) concluded that, 
under the proposed conditions of use, the preparation of fumonisin esterase produced by Komag ataella pastor is 
(DSM 26643) does not have adverse effect on animal health, human health or the environment. It also concluded 
that it has the capacity to degrade fumonisins in contaminated feed for chick ens for fattening, turke ys for 
fattening and laying hens. This conclusion can be extrapolat ed to all avian species. The Authority does not 
consider that there is a need for specifi c requirements of post-market monitori ng. It also verified the repor t on 
the method of analysis of the feed additive in feed submitte d by the Reference Laboratory set up by Regulation 
(EC) No 1831/2003. 
(6)  The assessment of the preparation of fumonisin esterase produced by Komag ataella pastor is (DSM 26643) shows 
that the conditions for author isation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. 
According ly, the use of that preparation should be author ised as specifi ed in the Annex to this Regulation. 
(7)  The measures provided 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 ‘technological additives ’ and to the functional 
group ‘substances for the 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. 30.5.2017 L 139/33 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Commission Implementing Regulation (EU) No 1115/2014 of 21 October 2014 concer ning the author isation of a preparation of 
fumonisin esterase produced by Komag ataella pastor is (DSM 26643) as a feed additive for pigs (OJ L 302, 22.10.2014, p. 51). 
(3)EFSA Journal 2016; 14(11):4617. 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 State s. 
Done at Brussels, 29 May 2017. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  30.5.2017 L 139/34 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author is­
ation Additive Compo sition, chemi cal formula, 
descr iption, analytical method Species or cat­
egor y of animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of period 
of author is­
ation Units of activity/kg of 
compl ete feedingstuff with 
a moisture content of 12 % 
Technological additiv es: subst ances for reduction of the contamination of feed by mycotoxins: fumonisins 
1m03 — Fumonisin 
esterase 
EC 3.1.1.87 Additive composition 
Preparation of fumonisin esterase 
produced by Komag ataella pastor is 
(DSM 26643) containing a mini ­
mum of 3 000 U(1)/g. 
Char acter isation of the active sub­
stance 
Preparation of fumonisin esterase 
produced by Komag ataella pastor is 
(DSM 26643). 
Analytical method (2) 
For the determination of fumoni ­
sin esterase activity: High Perform­
ance Liquid Chromat ography 
coupled to a tandem mass spec ­
trometr y. 
(HPLC-MS/MS) method based on 
the quantific ation of the tricar­
ballylic acid released from the ac­
tion of the enzyme on fumonisin 
B1 at pH 8,0 and 30 °C.  All avian spe­
cies — 15 U —  1. In the directions for use of the 
additive and premixtures, the 
storage conditions and stability 
to heat treatment shall be indi ­
cated .  
2. Recommended maximum 
dose: 300 U/kg of compl ete 
feedingstuff. 
3.The use of the additive is al­
lowed in feedingstuffs compl y­
ing with the European Union 
legislation on undesirable sub­
stances in animal feed (3).  
4. For users of the additive and 
premixtures, feed business op­
erators shall establish opera ­
tional procedures and organisa ­
tional measures to address 
poten tial risks resulting from 
their use. Where those risks 
cannot be eliminated or re­
duced to a minimum by such 
procedures and measures, the 
additive and premixtures shall 
be used with personal prote c­
tive equipment, including 
breathing prot ection. 19 June 
2027 
(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 for Feed Additives: 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).   30.5.2017 L 139/35 Official Jour nal of the European Union EN