G/SPS/N/EU/457  
 
12 January 2021  
(21-0394) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -
General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  HS Code 2309 - Preparation of a kind used in animal nutrition  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Commission Implementing Regulation (EU) 2020/2117 
of 16 December 2020 concerning the renewal of the authorisation of selenomethionine 
produced by Saccharomyces cerevisiae  CNCM I -3399 with the new name 'selenised yeast 
Saccharomyces cerevisiae  CNCM I -3399'  as a feed additive for all animal species, and 
repealing Regulation (EC) No 900/2009 (Text with EEA relevance) . Language(s):  
English, French and Spanish . Number of pages:  4 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0374_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0374_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0374_00_s.pdf  
6. Description of content:  Selenomethionine produced by Saccharomyces cerevisiae  
CNCM I -3399 was authorised for 10 years as a feed additive for all animal species by 
Commission Regulation (EC) No 900/2009. In accordance with Article 14 of Regulation 
(EC) No 1831/2003, an application was submitted for the renewal of the authorisation of 
selenomet hionine produced by Saccharomyces cerevisiae  CNCM I -3399 as feed additive 
for all animal species in the additive category 'nutritional additives'. The  application was 
accompanied by the particulars and documents required under Article  14 of Regulation 
(EC) No 1831/2003. It results from the opinion of the European Food Safety Authority 
('the Authority') of 7 May 2020 that, under the proposed conditions of use, 
selenomethionine produced by Saccharomyces cerevisiae  CNCM I -3399 does not have an 
adverse effect o n animal health, consumer safety or the environment. The Authority also 
concluded that the additive is a potential dermal and respiratory sensitizer. Therefore, 
the Commission considers that appropriate protective measures should be taken to 
prevent advers e effects on human health, in particular as regards the users of the 
additive. The  proof of the efficacy of the additive, on which the initial authorisation was 
based, withstands in a renewal procedure. Finally, the Authority recommended changing 
the denom ination of the additive. The Authority also verified the report on the method of 
analysis of the feed additive in feed submitted by the Reference Laboratory set up by 
Regulation (EC) No 1831/2003. The assessment of selenomethionine produced by 
Saccharomyce s cerevisiae  CNCM I -3399 shows that the conditions for authorisation, as 
provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, 
the authorisation of this additive should be renewed. As a consequence of the renewal of G/SPS/N/EU/457  
 
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  the aut horisation of selenomethionine produced by Saccharomyces cerevisiae  CNCM 
I-3399 as feed additive, Regulation (EC) No 900/2009 should be repealed. Since safety 
reasons do not require the immediate application of the modifications to the conditions of 
author isation for selenomethionine produced by Saccharomyces cerevisiae  CNCM I -3399, 
it is appropriate to allow a transitional period for interested parties to prepare themselves 
to meet the new requirements resulting from the renewal of the authorisation.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify th e standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Code of practice on Good Animal Feeding 
CAC/RCP  54-2004 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international st andard?  
[X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 16 December 2020  
Proposed date of publication (dd/mm/yy) : 17 December 2020  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : This Regulation shall enter into force on the twentieth day 
following that of it s publication in the Official Journal of the European Union.  
[X] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if ava ilable) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  G/SPS/N/EU/457  
 
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  13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu