G/SPS/N/EU/496  
 
17 June 2021  
(21-4974) 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) 2021/969 
concerning the authorisation of L -threonine produced by Escherichia coli  CGMCC 13325 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_4209_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_4209_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_4209_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 -threonine produced by Escherichia coli  
CGMCC 13325 as a feed additive for use in feed for all animal species. That applicat ion was 
accompanied by the particulars and documents required under Article 7(3) of that 
Regulation.  The application concerns the authorisation of L -threonine produced by 
Escherichia coli  CGMCC 13325 as a feed additive for all animal species to be classifi ed in 
the additive category 'nutritional additives '. The European Food Safety Authority ( 'the 
Authority') concluded in its opinion of 18 November 2020  that, under the proposed 
conditions of use, L -threonine produced by Escherichia coli  CGMCC 13325 does not  have 
an adverse effect on animal health, consumer health or the environment. It could not 
conclude on the potential of L -threonine produced by Escherichia coli  CGMCC 13325 to be 
a skin sensitiser and irritant to the skin and eyes, and stated an inhalation  risk to 
endotoxins for the users of the additive. Therefore, appropriate protective measures 
should be taken to prevent adverse effects on human health, in particular as regards the 
users of the additive. The Authority also concluded that the additive is an efficacious 
source of the amino acid L -threonine for all animal species and that in order to be as 
efficacious in ruminants as in non -ruminant species, the additive needs to 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 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 L -threonine produced by 
Escherichia  coli CGMCC 13325 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 
additive should be authorised as specified in the Anne x to this Regulation.  G/SPS/N/EU/496  
 
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  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 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, descr ibe, 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 June 2021  
Proposed date of publication (dd/mm/yy) : 17 June 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 O fficial 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