COMMI SSION IMPLEMENTING REGUL ATION (EU) 2015/489 
of 23 March 2015 
concer ning the author isation of selenomethionine produced by Sacchar omy ces cerevisiae NCY C 
R645 as a feed additiv e for all animal 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 submitted for the author i­
sation of selenomethionine produced by Saccharomy ces cerevisiae NCY C R645. 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 preparation of selenomethionine, an organic compo und of 
selenium, as a feed additive for all animal species, to be classifie d in the additive cate gory ‘nutr itional additives ’. 
(4)  The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 3 July 2014 (2) that, under the 
proposed conditions of use, selenomethionine produced by Sacchar omyces cerevisiae NCY C R645 does not have an 
adverse effect on animal health, human health or the environment and that its use may be considered as an 
efficient source of selenium for all animal species. The Auth ority does not consider that there is a need for 
specific requirements of post-market monitor ing. 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 selenomethionine produced by Saccharomy ces cerevisiae NCY C R645 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 specified in the Annex to this Regulation. 
(6)  The Author ity concluded that the limitation of the supplementation with organic selenium established for other 
organic compo unds of selenium should also apply to selenomethionine produced by Saccharomy ces cerevisiae 
NCY C R645. Further more, in case differ ent compo unds of selenium are added to the feed, the supplementation 
with organic selenium should not exceed 0,2 mg per kg complet e feed. 
(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 specified in the Annex, belonging to the additive cate gory ‘nutr itional additives ’ and to the functional 
group ‘compounds of trace elements’, is author ised as an additive in animal nutr ition, subject to the conditions laid 
down in that Annex. 24.3.2015 L 78/5 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Journal 2014; 12(7):3797. 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, 23 Marc h 2015. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  24.3.2015 L 78/6 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author i­
sation Additive Composition, chemical formula, descr iption, analy ­
tical method Species or 
categor y of 
animal Maximum 
age Minimum 
conten t Maximum 
conten t 
Other provisions End of 
period of 
author isa­
tion Selenium in mg/kg of 
compl ete feed with a 
moisture content of 12 % 
Categor y of nutr itional additiv es. Functional group: compounds of trace elements 
3b817 — Selenomethionine 
produced by Sac­
charomyces cerevisiae 
NCY C R645 
(Selenised yeast 
inactivat ed)  Char acter isation of the additive : 
Preparation of organic selenium: 
Content of selenium: 2 000 to 2 400 mg 
Se/kg 
Organic selenium > 98 % of total selenium 
Selenomethionine > 70 % of total selenium 
Char acter isation of the activ e substance: 
Selenomethionine produced by Saccharomy ces 
cerevisiae NCY C R645 
Chemical formula: C5H11NO2Se 
Analytical method (1): 
For the determination of selenomethionine 
in the feed additive: 
—  reversed phase high performa nce liquid 
chromat ography with UV detec tion 
(RP-HPL C-UV), or 
—  high performa nce liquid chromat ography 
and inductively coupled plasma mass 
spectrometr y (HPLC-ICPMS) after triple 
proteolytic digestion. 
For the determination of total selenium in 
the feed additive: 
—  inductively coupled plasma atomi c 
emission spectrometr y (ICP -AES), or 
—inductively coupled plasma mass spectro ­
metr y (ICPMS).  All species —  0,50 
(total) 1.  The additive shall be 
incor porate d into feed 
in the form of a pre­
mixture. 
2.For user safety: breath ­
ing protection, safety 
glasses and gloves shall 
be worn during hand ­
ling. 
3.  Technological additives 
or feed mate rials in­
cluded in the prepar ­
ation of the additive 
shall ensure a dusting 
poten tial < 0,2 mg 
selenium/m3 air. 
4.  In the directions for 
use of the additive and 
premixtures, indicate 
the storag e and stabi ­
lity conditions. 
5.Maximum supplemen ­
tation with organic 
selenium: 
0,20 mg Se/kg of 
compl ete feed with a 
moisture content of 
12 %. 13 Apr il 
2025 24.3.2015 L 78/7 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author i­
sation Additive Composition, chemical formula, descr iption, analy ­
tical method Species or 
categor y of 
animal Maximum 
age Minimum 
conten t Maximum 
conten t 
Other provisions End of 
period of 
author isa­
tion Selenium in mg/kg of 
compl ete feed with a 
moisture content of 12 % 
For the determination of total selenium in 
premixtures, compo und feed and feed mate r­
ials: hydride generation atomi c absor ption 
spectrometr y (HGAAS) after micro wav e di­
gestion (EN 16159:2012).  
(1)  Details of the analytical methods are avail able at the following address of the European Union Reference Laborato ry: http://ir mm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/author isation/evaluation_repor ts/ 
Pages/index.aspx  24.3.2015 L 78/8 Official Jour nal of the European Union EN