G/SPS/N/EU/325  
 
5 June 2019  
(19-3855) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION OF EMERGENCY MEASURES  
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):  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:  Commission Regulation (EU) 2019/799 amending 
Annex I to Regulation (EC ) No 1334/2008 of the European Parliament and of the Council 
as regards removal from the Union list of the flavouring substance furan - 2(5H) -one (FL -
no 10.066) (Text with EEA relevance) . Language(s): English, French and Spanish . 
Number of pages: 3 
https://members.wto.org/crnattachments/2019/SPS/EEC/19_3290_00_e.pdf  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_3290_00_f.pdf  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_3290_00_s.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 n otified in G/SPS/N/EU/13/Add.1 (12 October 2012) which is now 
amended by this Regulation.  
This addendum concerns the removal of the flavouring substance furan -2(5H) -one (FL -
no 10.066) from the European Union list of flavourings following the European Food Safety 
Authority opinion published at the end of January 2019 which concluded that this 
substance is genotoxic in vivo and therefore its use as a flavouring substance raises a 
safety concern.  
The measure has been taken in urgency in view of this EFSA asses sment indicating a 
serious risk (genotoxicity) of this flavouring substance FL 10.066 on the basis of new 
scientific data. Therefore, its addition to foods should be stopped swiftly. It has not been 
possible to notify the draft measure in view of the natur e of the risk involved.  
According to the European Association of producers of flavourings (EFFA) as reported in 
the opinion by EFSA, the poundage for this substance in Europe is very low (zero in 2017).  
This substance furan -2(5H) -one (FL No 10.066) can als o be identified with CAS No. 497 -
23-4, JECFA No 2000 and JECFA name "4 -hydroxy -2-butenoic acid gamma lactone".  
The EFSA opinion is available as EFSA Scientific Opinion on Flavouring Group Evaluation 
217 Revision 2 (FGE.217Rev2), consideration of genotoxici ty potential for alpha, beta G/SPS/N/EU/325  
 
- 2 - 
 
  unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones; 
EFSA Journal 2019;17(1):5568.  
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.  
8. Nature of the urgent problem(s) and reason for urgent action:  The flavouring 
substance FL 10.066 is genotoxic and therefore this substance should not be added to 
foods. Thi s substance could be used as a flavouring substance in food before the adoption  
of the new measure and consumers should not be exposed to genotoxic substances added 
to food.  
9. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] 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 standa rd:  
10. Other relevant documents and language(s) in which these are available:    
11. Date of entry into force ( dd/mm/yy )/period of application (as applicable):  
21 May 2019  
[ ] Trade facilitating measure   
12. 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