COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/804 
of 17 May 2019 
concer ning the renewal of the author isation of organic form of selenium produced by 
Sacc haromy ces cerevisiae CNCM I-3060 and of selenomethionine produced by Sacchar omy ces 
cerevisiae NCY C R397 as feed additiv es for all animal species and repealing Regulations (EC) 
No 1750/2006 and (EC) No 634/2007 
(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 and renewing such author isation. 
(2)  The orga nic form of selenium produced by Sacchar omyces cerevisiae CNCM I-3060 was author ised for 10 years as 
a feed additive for all animal species by Commission Regulation (EC) No 1750/2006 (2). Selenomethionine 
produced by Saccharomy ces cerevisiae NCY C R397 was author ised for 10 years as a feed additive for all animal 
species by Commission Regulation (EC) No 634/2007 (3). 
(3)  In accordance with Article 14 of Regulation (EC) No 1831/2003, applications were submitted for the renewal of 
the author isation of the organic form of selenium produced by Saccharomy ces cerevisiae CNCM I-3060 and of 
selenomethionine produced by Saccharomy ces cerevisiae NCY C R397 as feed additives for all animal species, 
requesting those additives to be classif ied in the additive catego ry ‘nutr itional additives ’. Those applications were 
accompan ied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. 
(4)  The European Food Safet y Author ity (‘the Author ity’) concluded in its opinions of 5 July 2018 (4) and 
28 November 2018 (5) that the applicants have provid ed data demonstrating that the additives compl y with the 
conditions of author isation under the proposed conditions of use. The Author ity confir med its previous 
conclusions that the organic form of selenium produced by Sacchar omyces cerevisiae CNCM I-3060 and the seleno ­
methionine produced by Saccharomy ces cerevisiae NCY C R397 do not have adverse effects on animal health, 
consumer safety or the envi ronment. It also state d for the organic form of selenium produced by Saccharom yces 
cerevisiae CNCM I-3060 capacities to be a respirator y sensitizer and hazardous upon inhalation, and for seleno ­
methionine produced by Saccharomy ces cerevisiae NCY C R397 capacities to be an eye and mucosae irritant, and 
a skin and respirato ry sensitizer . Theref ore, the Commission considers that appropr iate protective measures 
should be taken to prevent adverse effects on human health, in particular as regar ds the users of the additive. 
Finally , the Auth ority recommends changing the denomination of the additives. 
(5)  It is appropr iate to updat e the methods of analysis for selenium and selenomethionine based on the respective 
recent repor ts of the Reference Laboratory set up by Regulation (EC) No 1831/2003. 
(6) The assessment of the organic form of selenium produced by Saccharom yces cerevisiae CNCM I-3060 and of seleno ­
methionine produced by Saccharom yces cerevisiae NCY C R397 shows that the conditions for author isation, as 
provid ed for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the author isation of those 
additives should be renewed as specifi ed in the Annex to this Regulation. 20.5.2019 L 132/28 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Commission Regulation (EC) No 1750/2006 of 27 November 2006 concer ning the author isation of selenomethionine as a feed additive 
(OJ L 330, 28.11.2006, p. 9). 
(3)Commission Regulation (EC) No 634/2007 of 7 June 2007 concer ning the author isation of selenomethionine produced by Saccharomy ces 
cerevisiae NCY C R397 as a feed additive (OJ L 146, 8.6.2007, p. 14). 
(4)EFSA Jour nal 2018;16(7):5386. 
(5)EFSA Jour nal 2019;17(1):5539. (7)  As a consequence of the renewal of the author isations of the organic form of selenium produced by Saccharom yces 
cerevisiae CNCM I-3060 and of selenomethionine produced by Sacchar omyces cerevisiae NCY C R397 as feed 
additives under the conditions laid down in the Annex to this Regulation, Regulations (EC) No 1750/2006 and 
(EC) No 634/2007 should be repealed. 
(8) Since safety reasons do not require the immediate application of the modifi cations to the conditions of author isa­
tion for the organic form of selenium produced by Saccharom yces cerevisiae CNCM I-3060 and for seleno ­
methionine produced by Saccharomy ces cerevisiae NCY C R397, it is appropr iate to allow a transitional period for 
inter ested parties to prepare themselves to meet the new requirements resulting from the renewal of the 
author isation. 
(9)  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 author isation of the additives specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives’ and to 
the functional group ‘compounds of trace elements’, is renewed subject to the conditions laid down in that Annex. 
Article 2 
1. The organic form of selenium produced by Saccharom yces cerevisiae CNCM I-3060, selenomethionine produced by 
Saccharom yces cerevisiae NCY C R397 and premixtures containing these substances, which are produced and labelled before 
9 December 2019 in accordance with the rules applicable before 9 June 2019 may continue to be placed on the mark et 
and used until the existing stocks are exhausted. 
2. Feed mater ials and compo und feed containing the substances refer red to in point 1, whic h are produced and 
labelled before 9 June 2020 in accordance with the rules applicable before 9 June 2019 may continue to be placed on 
the mark et and used until the existing stoc ks are exhaust ed if they are intended for food-producing animals. 
3. Feed mater ials and compo und feed containing the substances refer red to in point 1, whic h are produced and 
labelled before 9 June 2021 in accordance with the rules applicable before 9 June 2019 may continue to be placed on 
the mark et and used until the existing stoc ks are exhaust ed if they are intended for non-f ood-producing animals. 
Article 3 
Regulations (EC) No 1750/2006 and (EC) No 634/2007 are repealed. 
Article 4 
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 State s. 
Done at Brussels, 17 May 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  20.5.2019 L 132/29 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
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 
conten t Maximum 
content 
Other provisions End of 
period of 
author isa­
tion Selenium in mg/kg of 
complet e feed with a  
moisture content of 12 % 
Categor y of nutr itional additiv es. Functional group: compounds of trace elements 
3b810 — Selenised yeast 
Saccharom yces 
cerevisiae CNCM 
I-3060, 
inactivat ed Additiv e composition 
Preparation of organic selenium: 
Content of selenium: 2 000 to 
2 400 mg Se/kg 
Org anic selenium > 97 to 99 % of 
total selenium 
Selenomethionine > 63 % of total 
selenium 
Char acter isation of the activ e substance 
Selenomethionine produced by Sac­
charomyces cerevisiae CNCM I-3060 
Chemical formula: C5H11NO2Se 
Analytical method (1) 
For the determi nation of seleno ­
methionine in the feed additive: 
—  reversed phase high performa nce 
liquid chromat ography with UV 
detection (RP-HPLC-UV) or 
—high performa nce liquid chroma ­
tography and inductively coupled 
plasma mass spectrometr y (HPLC- 
ICPMS) after triple proteolytic di­
gestion.  All species —  0,50 (total) 1.The additive shall be incor por­
ated into feed in the form of 
a premixture. 
2.  For users of the additive and 
premixtures, feed business oper ­
ators shall establish operational 
procedures and organisational 
measures to address pote ntial 
risks by inhalation. 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 protective 
equipment, including breathing 
prote ction. 
3.  In the directions for use of the 
additive and premixtures, indi ­
cate the storage and stability 
conditions. 
4.  Maximum supplementation with 
organic selenium: 
0,20 mg Se/kg of compl ete feed 
with a moisture cont ent of 
12 %. 9 June 
2029 20.5.2019 L 132/30 Official Jour nal of the European Union EN     Identifica ­
tion 
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 
conten t Maximum 
content 
Other provisions End of 
period of 
author isa­
tion Selenium in mg/kg of 
complet e feed with a  
moisture content of 12 % 
For the determination of total sele­
nium in the feed additive: 
—  inductively coupled plasma 
atomi c emission spectrometr y 
(ICP -AES) or 
—  inductively coupled plasma mass 
spectrometr y (ICPMS). 
For the determination of total sele­
nium in premixtures, compo und feed 
and feed mater ials: 
—hydride generation atomi c ab­
sorption spectrometr y (HGAAS) 
after microwa ve dige stion (EN 
16159:2012). 
3b811 — Selenised yeast 
Saccharom yces 
cerevisiae 
NCY C R397, 
inactivat ed Additiv e composition 
Preparation of organic selenium: 
Content of selenium: 2 000 to 
3 500 mg Se/kg 
Org anic selenium > 98 % of total 
selenium 
Selenomethionine > 63 % of total 
selenium 
Char acter isation of the activ e substance 
Selenomethionine produced by Sac­
charomyces cerevisiae NCY C R397 
Chemical formula: C5H11NO2Se  All species —  0,50 (total) 1.The additive shall be incor por­
ated into feed in the form of 
a premixture. 
2.  For users of the additive and 
premixtures, feed business oper ­
ators shall establish operational 
procedures and organisational 
measures to address pote ntial 
risks by inhalation, dermal, mu­
cosae or eye contact. 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 pro­
tectiv e equipment, including 
breathing prot ection, safety 
glasses and gloves.  9 June 
2029 20.5.2019 L 132/31 Official Jour nal of the European Union EN     Identifica ­
tion 
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 
conten t Maximum 
content 
Other provisions End of 
period of 
author isa­
tion Selenium in mg/kg of 
complet e feed with a  
moisture content of 12 % 
Analytical method (1) 
For the determi nation of seleno ­
methionine in the feed additive: 
—  reversed phase high performa nce 
liquid chromat ography with UV 
detection (RP-HPLC-UV) or 
—high performa nce liquid chroma ­
tography and inductively coupled 
plasma mass spectrometr y (HPLC- 
ICPMS) after triple proteolytic di­
gestion. 
For the determination of total sele­
nium in the feed additive: 
—  inductively coupled plasma 
atomi c emission spectrometr y 
(ICP -AES) or 
—  inductively coupled plasma mass 
spectrometr y (ICPMS). 
For the determination of total sele­
nium in premixtures, compo und feed 
and feed mater ials: 
—hydride generation atomi c ab­
sorption spectrometr y (HGAAS) 
after microwa ve dige stion (EN 
16159:2012). 3.  In the directions for use of the 
additive and premixtures, indi ­
cate the storage and stability 
conditions. 
4.  Maximum supplementation with 
organic selenium: 
0,20 mg Se/kg of compl ete feed 
with a moisture cont ent of 
12 %. 
(1)  Details of the analytical methods are avai lable 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/Pag es/index.aspx   20.5.2019 L 132/32 Official Jour nal of the European Union EN     