G/SPS/N/EU/488  
 
6 May 2021  
(21-3881) Page: 1/2 
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):  Preparation of a kind used in animal nutrition (HS Code: 2309)  
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) 2021/719 
concerning the authorisation of L -valine produced by Corynebacterium glutamicum  
CGMCC 7.358 as a feed additive for all animal species (Text with EEA relevance) . 
Language(s):  English, French and Spanish . Number of pages:  4 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3289_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3289_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3289_00_s.pdf  
6. Description of content:  Regulation (EC) No 1831/2003 provides for the authorisation 
of additives for use in animal nutrition and for the grounds and procedures for granting 
such authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003, 
an application was submitted for the authorisation of L -valine. The application was 
accom panied by the particulars and documents required under Article 7(3) of that 
Regulation. The application concerns the authorisation of L -valine produced by 
Corynebacterium glutamicum  CGMCC 7.358 as a feed additive for all animal species, to 
be classified in  the additive category 'nutritional additives', functional group 'amino acids, 
their salts and analogues'.   The European Food Safety Authority ('the Authority') 
concluded in its opinion of 30 September 2020 that, under the proposed conditions of 
use, L -valine produced by Corynebacterium glutamicum  CGMCC 7.358, when 
supplemented to diets in appropriate amounts, does not have an adverse effect on animal 
health, consumer health or the environment. With respect to the safety of the user of 
L-valine produced by Corynebacterium glutamicum  CGMCC 7.358, the Authority could 
neither exclude a risk by inhalation, nor that the substance it is irritant to skin or eyes, 
or a dermal sensitiser. Therefore, appropriate protective measures should be taken for 
this additive to  prevent adverse effects on human health, in particular as regards the 
users of the additive. Furthermore, the Authority concluded that the substance is 
considered an efficacious source of the essential amino acid L -valine for animal nutrition 
and that, in  order to be efficacious in ruminants, it should be protected against 
degradation in the rumen. The Authority does not consider that there is a need for specific 
requirements of post -market monitoring. It also verified the reports 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 L -valine produced by Corynebacterium G/SPS/N/EU/488  
 
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  glutamicum  CGMCC 7.358 shows that the conditions for authorisation, as provided for in 
Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this 
substance should be authorised as specified in the Annex to this Regulation.  
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 the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard o r 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 standard?  
[X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international stand ard:  
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 30 April 2021  
Proposed date of publication (dd/mm/yy) : 3 May 2021  
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 its publication in the Official Journal of the European Union.  
[X] Trade facilitating measure   
12. Final date for comments: [  ] Sixty day s 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 available) o f 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  
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