G/SPS/N/EU/523  
 
1 December 2021  
(21-9065) 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) 2021/2077 
of 26 November 2021  concerning the authorisation of L -valine produced by 
Corynebacterium glutamicum  CGMCC 7.366 as a feed additive for all animal specie s 
(Text  with EEA relevance) . Language(s):  English, French and Spanish . Number of 
pages:  4 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7477_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7477_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7477_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 
an 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 
accompanied 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 7.366 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 17 March 2021 that, under the proposed conditions of use, L -valine 
produced by Corynebacterium glutamicum  CGMCC 7.366, when supplemented to diets in 
appropriate amounts, does not have an adverse effect on animal health, consumer safety 
or the environment. With respect to the safety of the user of that additive, the Auth ority 
could neither exclude a risk by inhalation, nor that L -valine might be irritant to skin or 
eyes, or a dermal sensitiser. Therefore, the Commission considers that appropriate 
protective measures should be taken to prevent adverse effects on human heal th, in 
particular as regards the users of the additive. Further, the Authority concluded that it is 
considered an efficacious source of the essential amino acid L -valine for animal nutrition 
and that in order to be efficacious in ruminants, the additive sh ould 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 t he Reference Laboratory set up by 
Regulation (EC) No 1831/2003. The assessment of L -valine produced by Corynebacterium 
glutamicum  CGMCC 7.366 shows that the conditions for authorisation, as provided for in G/SPS/N/EU/523  
 
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  Article 5 of Regulation (EC) No 1831/2003, are sat isfied. 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 or related text) : Code of practice on Good An imal 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 standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 26 November 2021  
Proposed date of publication (dd/mm/yy) : 29 November 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 t he twentieth day following its 
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 
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  
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