G/SPS/N/EU/522  
 
1 December 2021  
(21-9064) 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) 2021/2076 
of 26  November 2021 concerning the authorisation of L -tryptophan produced by 
Escherichia coli  KCCM 80210 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_7476_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7476_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7476_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 -tryptophan produced by Escherichia  coli 
KCCM  80210. The application was accompanied by the particulars and documents required 
under Article 7 of that Regulation. The application concerns the authorisation of 
L-tryptophan produced by Escherichia coli  KCCM 80210 as a feed additive for all an imal 
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 27 January 2021 that, under the pro posed 
conditions of use, L -tryptophan produced by Escherichia coli  KCCM 80210 does not have 
an adverse effect on the health of non -ruminant animals, consumer safety or the 
environment. To be safe for ruminants, the L -tryptophan should be protected against 
degradation in the rumen. The Authority stated that the additive under assessment is 
considered a mild eye irritant. The endotoxin activity of the additive and its dusting 
potential indicate a risk by inhalation. Therefore, the Commission considers that 
appropriate protective measures should be taken to prevent adverse effects on human 
health, in particular as regards the users of the additive.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from ani mal/plant pest or disease, [  ] protect territory from 
other damage from pests.   G/SPS/N/EU/522  
 
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  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, 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) : 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 the 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