G/SPS/N/EU/157  
 
22 February 2016  
(16-1077)  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; IC S numbers should be provided in 
addition, where applicable): Foods, flavourings 
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) 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 certain flavouring substances (Text with EEA relevance)  
Language(s): English  Number of pages: 6 
http://members.wto.org/crnattachments/2016/SPS/EEC/16_0730_00_e.pdf  
http://members.wto.org/crnattachments/2016/SPS/EEC/16_0730_01_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. The Union list was established by 
Commission Implementing Regulation (EU) No 872/2012 which is now amended by the 
notified measure. 
This amendment concerns the withdrawal of the following four substances belonging to 
chemical subgroup 2.2 of FGE.19: 2,6,6- trimethyl-1-cyclohexen-1-carboxaldehyde 
(FL no. 05.121), myrtenyl formate (FL no. 09.272), myrtenyl-2-methylbutyrate (FL no. 09.899), and myrtenyl-3-methylbutyrate (FL no. 09.900). 
The European Food Safety Authority (EFSA)  requested additional scientific data for 
completion of their evaluation as flavouring substances, which are part of group 
FGE.208. EFSA evaluated the data on this group of substances in its opinion of 24 June 2015 and concluded that the representative substance of the group p-mentha-1,8-dien-
7-al (FL-no 05.117) is genotoxic in vivo  and therefore its use as a flavouring substance 
raises a safety concern. 
The EFSA opinion is available as Scientific Opinion on Flavouring Group Evaluation 208 
Revision 1 (FGE.208Rev1): Consideration of genotoxicity data on representatives for 10 
alicyclic aldehydes with the α,β-unsaturation in ring/side-chain and precursors from 
chemical subgroup 2.2 of FGE.19. EFSA Journal 2015;13(7):4173, 28 pp. doi:10.2903/j.efsa.2015.4173 Online at: 
http://www.efsa.europa.eu/efsajournal . 
No support has been expressed for the four substances 2,6,6-trimethyl-1-cyclohexen-1-
carboxaldehyde (FL no. 05.121), myrtenyl formate (FL no. 09.272), myrtenyl-2-
methylbutyrate (FL no. 09.899) and myrtenyl-3-methylbutyrate (FL no. 09.900). G/SPS/N/EU/157 
 
- 2 - 
 
  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 st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
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 standard:   
9. Other relevant documents and language (s) in which these are available:     
10. Proposed date of adoption (dd/mm/yy) : December 2015 
Proposed date of publication (dd/mm/yy) : April 2016 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : 20 days after its publication in the Official Journal of the 
European Union. 
[ ] Trade facilitating measure   
12. Final date for comments: [X] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 22 April 2016 
Agency or authority designated to hand le 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 Notifi cation 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