G/SPS/N/EU/490  
21 May 2021  
(21-4275) 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 Consumers 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):  Flavourings, food  
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:  Draft Commission Regulation (EU) amending Annex I to 
Regulation (EC) No  1334/2008 of the European Parliament and of the Council as 
regards  the inclusion of 3 -(1-((3,5-dimethylisoxazol -4-yl)methyl) -1H-pyrazol -4-yl)-1-(3-
hydroxybenzyl)imidazolidine -2,4-dione in the Union list of flavouring substances (Text with 
EEA relevance) . Language(s):  English . Number of pages:  Act (5 pages) + Annex (2 
pages)  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3602_01_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3602_00_e.pdf  
6. Description of content:  The Union list of flavourings and source materials is laid down in 
Annex I to Regulation (EC) No 1334/3008. It was established by Commission 
Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of 
flavouring substances notified in G/SPS/N/EU/13/Add.1 (12 October 2012). This list is now 
amended b y the draft "Commission Regulation (EU) amending Annex I to Regulation (EC) 
No 1334/2008 of the European Parliament and of the Council as regards the inclusion of 
3-(1-((3,5-dimethylisoxazol -4-yl)methyl) -1H-pyrazol -4-yl)-1-(3-hydroxybenzyl)  
imidazolidine -2,4-dione in the Union list of flavouring substances".  
This addendum concerns the addition of the substance mentioned above, with 
FL n 16.127, to the list of authorised flavouring substances in the European Union.  
This inclusion follows an application and t he European Food Safety Authority (EFSA) 
evaluation evaluated this substance. The substance mentioned is included with certain 
conditions of use. The substance complies with the general requirements for flavourings 
set out in Article 4 of Regulation (EC) N o 1334/2008.  
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? I f so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  G/SPS/N/EU/490  
 
- 2 - 
 
  [ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] 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) : August 2021  
Proposed date of publication (dd/mm/yy) : August 2021  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : October 2021  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 20 July 2021  
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