COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/2117 
of 16 December 2020 
concer ning the renewal of the author isation of selenomethionine produced by Sacc haromy ces 
cerevisiae CNCM I-3399 with the new name ‘selenised yeast Sacc haromy ces cerevisiae CNCM I-3399’ 
as a feed additiv e for all animal species, and repealing Regulation (EC) No 900/2009 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1) Regulation (EC) No 1831/2003 provid es 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) Selenomethionine produced by Sacchar omyces cerevisiae CNCM I-3399 was author ised for 10 years as a feed additive 
for all animal species by Commission Regulation (EC) No 900/2009 (2). 
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of 
the author isation of selenomethionine produced by Saccharom yces cerevisiae CNCM I-3399 as feed additive for all 
animal species in the additive catego ry ‘nutr itional additives ’. The application was accompan ied by the particulars 
and documents required under Article 14(2) of Regulation (EC) No 1831/2003. 
(4) It results from the opinion of the European Food Safety Author ity (‘the Author ity’) of 7 May 2020 (3) that, under the 
proposed conditions of use, selenomethionine produced by Saccharomy ces cerevisiae CNCM I-3399 does not have an 
adverse effect on animal health, consumer safety or the environment. The Author ity also concluded that the 
additive is a poten tial dermal and respirato ry sensitizer . Theref ore, the Commission considers that appropr iate 
prote ctive measures should be taken to prevent adverse effects on human health, in particular as regar ds the users 
of the additive. The proof of the efficacy of the additive, on which the initial author isation was based, withstands in 
a renewal procedure. Finally , the Auth ority recommended changing the denomination of the additive. The 
Authority also verified the repor t on the method of analysis of the feed additive in feed submitted by the Reference 
Laboratory set up by Regulation (EC) No 1831/2003. 
(5) The assessment of selenomethionine produced by Saccharom yces cerevisiae CNCM I-3399 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 this additive should be renewed. 
(6) As a consequence of the renewal of the author isation of selenomethionine produced by Saccharomy ces cerevisiae 
CNCM I-3399 as feed additive, Regulation (EC) No 900/2009 should be repealed. 
(7) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
for selenomethionine produced by Sacchar omyces cerevisiae CNCM I-3399, it is appropr iate to allow a transitional 
period for interest ed parties to prepare themselves to meet the new requirements resulting from the renewal of the 
author isation. 
(8) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Commission Regulation (EC) No 900/2009 of 25 September 2009 concer ning the author isation of selenomethionine produced by 
Sacc haromy ces cerevisiae CNCM I-3399 as a feed additive (OJ L 256, 29.9.2009, p. 12). 
(3)EFSA Journal 2020;18(5):6144. EN Offi cial Jour nal of the European Union 17.12.2020                                                                                                                                       L 426/11   HAS ADOPTED THIS REGUL ATION: 
Article 1 
The author isation of the additive 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. Selenomethionine produced by Saccharomy ces cerevisiae CNCM I-3399 and premixtures containing this additive, whic h 
are produced and labelled before 6 July 2021 in accordance with the rules applicable before 6 Januar y 2021 may continue 
to be placed on the market and used until the existing stoc ks are exhaust ed. 
2. Feed mater ials and compound feed containing selenomethionine produced by Saccharomy ces cerevisiae CNCM I-3399, 
which are produced and labelled before 6 Januar y 2022 in accordance with the rules applicable before 6 Januar y 2021 
may continue to be placed on the mark et and used until the existing stocks are exhaust ed if they are intended for food- 
producing animals. 
3. Feed mater ials and compound feed containing selenomethionine produced by Saccharomy ces cerevisiae CNCM I-3399, 
which are produced and labelled before 6 Januar y 2023 in accordance with the rules applicable before 6 Januar y 2021 
may continue to be placed on the market and used until the existing stoc ks are exhaust ed if they are intende d for non- 
food-producing animals. 
Article 3 
Regulation (EC) No 900/2009 is 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 States. 
Done at Brussels, 16 December 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 426/12                                                                                                                                       17.12.2020   ANNEX 
Identifica-
tion 
number of 
the additive Name of 
the holder 
of 
author isa-
tion Additive Composition, chemical formula, descr iption, 
analytical method. Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period of 
author isation 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 
3b812 — Selenised yeast 
Saccharomy ces 
cerevisiae CNCM 
I-3399, inactivat ed Additive composition: 
Preparation of organic selenium: 
Content of selenium: 2 000 to 3 500 mg 
Se/kg 
Org anic selenium > 97 to 99 % of total 
selenium 
Selenomethionine > 63 % of total 
selenium All 
species -  0,50 
(total) 1. The additive shall be incor porat ed 
into feed in the form of a 
premixture. 
2. In the directions for use of the 
additive and premixtures, 
indicate the storag e and stability 
conditions. 
3. For users of the additive and 
premixtures, feed business 
operat ors shall establish 
operational procedures and 
organisational measures to 
address poten tial risks by 
inhalation and skin 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 protective equipment. 
4. Maximum supplementation with 
organic selenium: 
0,2 mg Se/kg of complet e feed 
with a moisture content of 12 %. 6 Januar y 2031 
Char acter isation of the active substance: 
Selenomethionine produced by 
Saccharomy ces cerevisiae CNCM I-3399 
Chemical formula: C5H11NO 2Se 
Analytical method (1): 
For the determination of 
selenomethionine in the feed additive: 
— reversed phase high perf ormance 
liquid chromat ography with UV 
detection (RP-HPL C-UV) or 
— high performa nce liquid 
chromatograph y and inductively 
coupled plasma mass spectrometr y 
(HPL C-ICP -MS) after triple 
prote olytic diges tion. 
For the determination of tota l selenium 
in the feed additive: 
— inductively coupled plasma atomi c 
emission spectrometr y (ICP -AES) or 
— inductively coupled plasma mass 
spectrometr y (ICP -MS). 
For the determination of tota l selenium 
in premixtures, compo und feed and feed 
mater ials: EN Offi cial Jour nal of the European Union 17.12.2020                                                                                                                                       L 426/13   — hydride generation atomic  
absor ption spectrometr y (HGAAS) 
after microwa ve digestion (EN 
16159:2012). 
(1) Details of the analytical methods are avail able at the follo wing address of the European Union Reference Laborato ry: https://ec.europa.eu/jrc/en/eurl/feed -additives/evaluation-repor ts   EN Offi cial Jour nal of the European Union L 426/14                                                                                                                                       17.12.2020