G/SPS/N/EU/521  
 
1 December 2021  
(21-9063) 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) 2021/2080 
of 26 November 2021 concerning the authorisation of L -histidine monohydrochloride 
monohydrate produced by fermentation with Escherichia coli  NITE SD 00268 as a feed 
additive for all animal species except f infish (Text with EEA relevance) . Language(s):  
English, French and Spanish . Number of pages:  5 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7475_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7475_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7475_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 the extension of use of L -histid ine 
monohydrochloride monohydrate produced by fermentation with Escherichia coli  NITE 
SD 00268 as a feed additive from finfish to all animal species. That application was 
accompanied by the particulars and documents required under Article 7(3) of Regulatio n 
(EC) No 1831/2003. The application concerns the authorisation of the extension of use of 
L-histidine monohydrochloride monohydrate produced by fermentation with 
Escherichia  coli NITE SD 00268 as a feed additive from finfish to all animal species to be 
classified in the additive category 'nutritional additives', functional group 'amino acids, 
their salts and analogues', and in the additive category 'sensory additives', functional 
group 'flavouring compounds'. The European Food Safety Authority ('the Author ity') 
concluded in its opinion of 5 May 2021 that, under the proposed conditions of use, 
L-histidine monohydrochloride monohydrate produced by fermentation with 
Escherichia  coli NITE SD 00268 does not have an adverse effect on animal health, 
consumers safe ty or the environment. The Authority also concluded for the additive in 
question that 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 th at 
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 essential amino acid histidine  and efficacious as 
a flavouring compound.  G/SPS/N/EU/521  
 
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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 rele vant 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) : 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 
public ation 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 co mments: [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