G/SPS/N/EU/169  
 
5 August 2016  
(16-4191) Page: 1/3 
Commit tee 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 it em number(s) as specified in national 
schedules deposited with the WTO; ICS 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) 2016/1244 of 28 July 
2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament 
and of the Council as regards certain flav ouring substances from a group related with an 
alpha beta unsaturation structure (Text with EEA relevance)   Language(s): English, 
French and Spanish   Number of pages: 4 
http://members.wto.org/crnattachments/2016/SPS/EEC/16_3126_00_e.pdf  
http://members.wto.org/crnattachments/2016/SPS/EEC/16_3126_00_f.pdf  
http://members.wto.org/crnattachments/2016/SPS/EEC/16_3126_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. The Union list was established by 
Commission Implementing Regulation (EU) No 872/2012 which will be amended by the 
notified measure.  
This amendment concerns the modification of the conditions of use of the following five 
substances belonging to the chemical su bgroup 2.2 of FGE.19 (FGE.208): p-mentha -1,8-
dien-7-ol (FL no. 02.060), myrtenol (FL no. 02.091), myrtenal (FL no. 05.106), 
p-mentha -1,8-dien-7-yl acetate (FL no. 09.278), and myrtenyl acetate (FL no. 09.302).  
The European Food Safety Authority (EFSA) had requested additional scientific data for 
completion of the evaluation as flavouring substances of the group of substances 
FGE.208 composed of ten substances which includes these substances. 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. 
This substance was withdrawn from the Union li st with Commi ssion Regulation 
(EU) 2015/1760  in an urgent procedure. This measure had been notified earlier in 
G/SPS/N/EU/149.  
The EFSA opinion is available as Scientific Opinion on Flavouring Group Evaluation 208 
Revision 1 (FGE.208Rev1): consideration of  genotoxicity data on representatives for 
ten alicyclic aldehydes with the α,β-unsaturation in ring/side -chain and precursors from 
chemical subgroup 2.2 of FGE.19.  G/SPS/N/EU/169  
 
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  EFSA Journal 2015;13(7):4173, 28 pp. doi:10.2903/j.efsa.2015.4173 Online at: 
http:// www.efsa.europa.eu/efsajourna l. 
Four additional substances from this group (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), not 
supported by industr y, were also withdrawn from the Union list in a separate, later, 
measure (Commission Regulation (EU) 2016/637). This measure was notified in 
notification G/SPS/N/EU/157.  
The current measure concerns a modification of the conditions of use of the 
abovementi oned five remaining substances of the group FGE.208 to better reflect the 
current real uses in the food categories specified and not in others, pending the 
evaluation by EFSA of further additional safety studies which were formally requested by 
the Commiss ion to interested parties. Once the process of evaluation of these new data 
is completed (which includes the EFSA risk assessment) these substances will be subject 
of consideration of an appropriate legislative measure taking into account the EFSA 
assessme nt. 
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, id entify 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 Pla nt 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) : 28 July 2016  
Proposed date of publication (dd/mm/yy) : 29 July 2016  
11. Proposed date of entry into force: [ ]  Six months from date of publicat ion, 
and/or  (dd/mm/yy) : 18 August 2016  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 4 October 2016. Comments received will be taken 
into account during the  next revision of the Commission Regulation.  
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 He alth 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/169  
 
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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