COMMISSION IMPLEMENTING REGUL ATION (EU) No 1115/2014 
of 21 Oct ober 2014 
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 pigs 
(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 submitted for the author isa­
tion of a preparation of fumonisin esterase produced by Komag ataella pastor is (DSM 26643). That application was 
accompan ied 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 preparation of fumonisin esterase produced by Komag ataella 
pastor is (DSM 26643)as a feed additive for pigs, to be classified in the additive cate gory ‘technological additives ’. 
(4)  The European Food Safety Author ity (‘the Author ity’) in its opinion of 8 Apr il 2014 (2) 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 biotransf orm fumonisins to less toxic compo unds in contaminated feed for pigs. The 
Author ity does not consider that there is a need for specifi c requirements of post-market monitoring. It also veri­
fied the repor t on the method of analysis of the feed additive in feed submitte d by the Reference Laborator y set 
up by Regulation (EC) No 1831/2003. 
(5)  The assessment of the preparation of a 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. 
(6)  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. 22.10.2014 L 302/51 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Journal 2014; 12(5):3667. 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, 21 October 2014. 
For the Commission 
The Presid ent 
José Manuel BARR OSO  22.10.2014 L 302/52 Official Jour nal of the European Union EN     ANNEX 
Identification 
number of 
the additive Name of the 
holder of 
author isation Additive Composition, chemical formula, descr iption, 
analytical method Species or 
categ ory of 
animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of period 
of author isation Units of activity/kg of 
compl ete feedingstuff with 
a moisture conten t of 12 % 
Technological additiv es: subst ances for reduction of the cont amination 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 minimum of 
3 000 U/g (1). 
Char acter isation of the active substance 
Preparation of fumonisin esterase 
produced by Komag ataella pastor is 
DSM 26643. 
Analytical method (2) 
For the deter mination of fumonisin 
esterase activity: High Performance 
Liquid Chromatograph y coupled to a 
tandem mass spectrometr y. 
(HPL C-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. Pigs — 15 — 1.  In the directions for use of 
the additive and premix ­
tures, indicate the storage 
conditions and stability to 
pelleting. 
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 Euro ­
pean Union legislation on 
undesirable substances in 
animal feed. 
4.For safety: breathing protec ­
tion, glasses and gloves 
shall be used during hand ­
ling. 11 November 
2024 
(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 avail able at the following address of the European Union Reference Laboratory for Feed Additives: http://ir mm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/P ages/ index. 
aspx   22.10.2014 L 302/53 Official Jour nal of the European Union EN