G/SPS/N/EU/177  
 
20 December 2016  
(16-6955) 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 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) amending Annex I to 
Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards 
certain flavouring substances (Text wi th EEA relevance) . Language(s): English . 
Number of pages: 37 
http://members.wto.org/crnattachments/2016/SPS/EEC/16_5226_00_e.pdf  
http://members.wto.org/crnattachments/2016/SPS/EEC/16_5226_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. This list will be amended by 
the notified measure.  
This amendment concerns the modification of the conditions of use of the twenty 
flavouring substances mentioned in the annex of  the measure.  
The European Food Safety Authority (EFSA) evaluated the genotoxicity of these 
substances taking into account the data on the following two substances selected as 
representative of the group, hexa -2(trans),4(trans) -dienal (FL -no: 05.057), and deca-
2(trans),4(trans) -dienal (FL -no: 05.140) in its scientific opinion of 26 March 2014. 
Overall, EFSA concluded that the safety concern regarding genotoxicity cannot be ruled 
out for both representative substances of the group and that this conclusion is  likewise 
applicable to the other substances of this FGE group 203.  
The current measure concerns a modification of the conditions of use of the 
abovementioned substances of group FGE.203 to prevent the further extension of their 
uses to other food categori es where currently there is no use and to more closely reflect 
the current real uses in the food categories specified by establishing maximum levels for 
the food categories where they are used in order to contain  the consumer exposure to 
these substances.  
The measure takes into account the current uses reported by industry and therefore it is 
unlikely that international trade in foods containing these flavourings, flavourings or 
mixtures of flavourings containing these flavourings will be affected. Neverth eless, 
transitional measures will apply for products en route to the European Union and here 
will be a period of 20 days after the publication before entry into force.  G/SPS/N/EU/177  
 
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  EFSA will evaluate further data on the genotoxicity of these substances. However, it is 
anticipated that the complete evaluation of first the genotoxicity and subsequently, if 
appropriate, the complete evaluation of each of the twenty substances will take well 
beyond a year. Therefore, it is appropriate to adopt this measure at this stage.  
The provisions of Article 15 g of Regulation 1334/2008 on flavourings will also be 
applicable to these flavourings as it is the case for all flavourings with maximum levels in 
foods.  
The draft measure has been the object of a public request for comments unde r the 
Better Regulation approach established by the Commission. The operators have had 
therefore additional time to consider any adjustment in their practices if necessary 
before the measure enters into force.  
Any follow -up measure regarding these substanc es will also be notified under this 
mechanism.  
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, 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 C ode, 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 deviate s from the 
international standard:   
9. Other relevant documents and language(s) in which these are available: 
Scientific Opinion on Flavouring Group Evaluation 203 Rev 1 (FGE.203 Rev1): 
alpha,betaunsaturated aliphatic aldehydes and precursors from chemic al subgroup 1.1.4 
of FGE.19 with two or more conjugated double -bonds and with or without additional 
non-conjugated double -bonds. EFSA Journal 2014;12(4):3626, 31 pp. 
doi:10.2903/j.efsa.2014.3626. Available online: http://www.efsa.europa.eu/efsajournal . 
10. Proposed date of adoption (dd/mm/yy) : February 2017  
Proposed date of publication (dd/mm/yy) : March 2017  
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   G/SPS/N/EU/177  
 
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  12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 18 February 2017  
Agency or aut hority 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 R elations  
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 availab le) 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