G/SPS/N/EU/96  
 
3 October 2014  
(14-5580)  Page: 1/3  
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; IC S numbers should be provided in 
addition, where applicable): Food, 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: Draft 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: 3+2 
http://members.wto.org/crnattachments/2014/sps/EEC/14_4333_00_e.pdf  
http://members.wto.org/crnattachments/2014/sps/EEC/14_4333_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. 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 proposed to be amended by this notifi ed "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". 
This addendum concerns the removal of the following 5 substances: 
Flavis no. Name of the substance CAS No. JECFA No. CoE 
1. 01.014 1-Methylnaphthalene 90-12-0 1335 11009 
2. 13.052 Furfuryl methyl ether 13679-46-4 1520 10944 
3. 13.056 Difurfuryl sulfide 13678-67-6 1080 11438 
4. 13.061 Difurfuryl ether 4437-22-3 1522 10930 
5. 13.123 Ethyl furfuryl ether 6270-56-0 1521 10940 
The substance 1-Methylnaphthalene, Flavis No. 01.014, was evaluated by the European 
Food Safety Authority (EFSA) in 2008 (EFSA Opinion on Flavouring Group Evaluation 78 
(FGE. 78), http://www.efsa.europa.eu/en/efsajournal/pub/931.htm ) and additional 
toxicity data on it were requested. This was repeated in the revision of this EFSA opinion 
of 2011 (Opinion on Flavouring Group Evaluation 78, Revision 1, FGE.78 Rev.1), 
http://www.efsa.europa.eu/en/ efsajournal/pub/2178.htm . 
The three substances Furfuryl methyl ether, Flavis No. 13.052, Difurfuryl ether, Flavis 
No. 13.061, and Ethyl furfuryl ether, Flavis No. 13.123, were evaluated by EFSA in 2011 (Opinion on Flavouring Group FGE 67 Rev.1), G/SPS/N/EU/96 
 
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  http://www.efsa.europa.eu/en/ efsajournal/pub/2315.htm  and EFSA identified a concern 
for genotoxicity. Therefore genotoxicity data was required to address this concern. 
The substance difurfuryl sulphide, Flavis  No. 13.056, was evaluated by EFSA in 2009 
(opinion on Flavouring Group Evaluation 65 (FGE. 65), 
http://www.efsa.europa.eu /en/scdocs/doc/1406.pdf  and an adequate toxicity study to 
establish a NOAEL was requested. 
The Commission Implementing Regulation (EU) No. 872/2012 laid down in 2012 the 
deadline of 31 December 2013 for the submission of the requested additional scientific data for these five substances. 
This Regulation also indicated that where the necessary information is not provided by 
the time requested, the flavouring substance in question will be removed from the Union list. 
The data requested concerning these five substances has not been submitted by the 
time of the deadline of 31 December2013. These five substances are therefore removed 
from the Union list as sufficient data to support their safety have not been provided. 
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 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 standard:   
9. Other relevant documents and language (s) in which these are available:     
10. Proposed date of adoption (dd/mm/yy) : 27 November 2014 
Proposed date of publication (dd/mm/yy) : January 2015 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : January 2015 
[ ] Trade facilitating measure   
12. Final date for comments: [X] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) :  2 December 2014 
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 Consumers, Unit G6-Multilateral International Relations Rue Froissart 101 
B-1049 Brussels 
Tel: +(32 2) 295 4263 Fax: +(32 2) 299 8090 
E-mail: sps@ec.europa.eu G/SPS/N/EU/96 
 
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  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 Consumers, Unit G6-Multilateral International Relations 
Rue Froissart 101 B-1049 Brussels 
Tel: +(32 2) 295 4263 
Fax: +(32 2) 299 8090 E-mail: sps@ec.europa.eu