COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/1568 
of 18 Oct ober 2018 
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 pigs and all poultr y 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 provi des 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 phaff ii (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 pigs and poultr y, to be classified in the additive categor y ‘techn ological 
additives’. 
(4)  The European Food Safety Authority (‘the Authority’) in its opinion of 17 Apr il 2018 (2) concluded that, under 
the proposed conditions of use, the preparation of fumonisin esterase produced by Komag ataella phaf fii 
(DSM 32159) does not have adverse effect on animal health, human health or the environment. It also concluded 
that it has the capability to degrade fumonisins in feed. The Auth ority does not consider that there is a need for 
specific 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 Laborat ory 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 provi ded 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. 
(6)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee 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 mycoto xins ’, is author ised as an additive in animal 
nutr ition subject to the conditions laid down in the Annex. 
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. 19.10.2018 L 262/34 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Jour nal 2018; 16(5):5269. This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 18 October 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  19.10.2018 L 262/35 Official Jour nal of the European Union EN     ANNEX 
Identification 
number of 
the additive Name of the 
holder of 
author isation Additive Composition, 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 of 
complet e feed ingstuff 
with a moisture conten t 
of 12 % 
Technological additiv es: subst ances for reduction of the contamination of feed by mycotoxins: fumonisins 
1m03i — Fumonisin 
esterase 
EC 3.1.1.87 Additiv e composition 
Preparation of fumonisin esterase 
produced by Komag ataella phaf fii 
(DSM 32159) containing a minimum 
of 3 000 U/g (1). 
Char acter isation of the activ e substance 
Preparation of fumonisin esterase 
produced by Komag ataella phaf fii 
(DSM 32159) 
Analytical method (2) 
For the determination of fumonisin 
esterase activity: High Performance Li­
quid Chromat ography coupled with 
a tandem mass spectrometr y. 
(HPLC-MS/MS) method based on the 
quantif ication of the tricarballylic acid 
released from the action of the en­
zyme on fumonisin B1 at pH 8,0 and 
30 °C. All pigs 
All poultr y 
species — 10  1.In the directions for use of the ad­
ditive and premixtures, the storage 
conditions and stability to pellet ­
ing shall be indicated . 
2.  Recommended maximum dose: 
300 U/kg of compl ete feedingstuff. 
3.  The use of the additive is allowed 
in feedingstuffs compl ying with 
the European Union legislation on 
undesirable substances in animal 
feed. (3) 
4.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational measures 
to address pote ntial risks concer n­
ing 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, in­
cluding breathing prot ection. 8 November 
2028 
(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 European Union Reference Laborato ry for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additiv es/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).  19.10.2018 L 262/36 Official Jour nal of the European Union EN