G/SPS/N/EU/456  
 
12 January 2021  
(21-0390) 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) 2020/2116 
of 16 December 2020 concerning the renewal of the authorisation of L -histidine 
monohydrochloride monohydrate produced by Escherichia coli  ATCC 9637 as a feed 
additive for salmonids and its extension of use  to other finfish, and repealing Regulation 
(EC) No 244/2007 (Text with EEA relevance) . Language(s):  English, French and 
Spanish . Number of pages:  4 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0373_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0373_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0373_00_s.pdf  
6. Description of content:  L-histidine monohydrochloride monohydrate produced by 
Escherichi a coli  ATCC 9637 was authorised for 10 years as a feed additive for salmonids 
by Commission Regulation (EC) No 244/2007. In accordance with Article 14 of Regulation 
(EC) No 1831/2003, an application was submitted for the renewal of the authorisation of 
L-histidine monohydrochloride monohydrate produced by Escherichia coli  ATCC 9637 as 
a feed additive for salmonids. The application included a request to change the strain 
designation to Escherichia coli  NITE SD 00268 and was accompanied by the particulars 
and documents required under Article 14 of that Regulation. In addition, in accordance 
with Article 7 of that Regulation, the application requested an extension of use to other 
finfish. The application was accompanied by the particulars and documents required  under 
Article 7 of Regulation (EC) No 1831/2003. The European Food Safety Authority 
('the Authority') concluded in its opinion of 18 March 2020 that, under the proposed 
conditions of use, L -histidine monohydrochloride monohydrate produced by Escherichia 
coli NITE SD  00268, when supplemented at levels appropriate to the requirements of the 
target species, does not have an adverse effect on animal health, consumer health or the 
environment. The Authority also concluded that while the additive in question is not a 
skin irritant, it was not possible to conclude on the potential for the additive to be toxic if 
inhaled, an irritant to eyes or a skin sensitiser. Therefore, the Commission considers that 
appropriate protective measures should be taken to prevent adv erse 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 histidine for fish species. 
The Authority does not consider that there is a need for  specific requirements of post -G/SPS/N/EU/456  
 
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  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 -histidine monohydrochlor ide monohydrate 
produced by Escherichia coli NITE SD 00268 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 Annex to this Regulation. 
As a consequence of the renewal of the authorisation of L -histidine monohydrochloride 
monohydrate produced by Escherichia coli  ATCC 9637 as a feed additive under the 
conditions laid down in the Annex to this Regulation, Regula tion (EC)  No 244/2007 should 
be repeale d. 
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 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 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  G/SPS/N/EU/456  
 
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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