G/SPS/N/EU/399  
21 July 2020  
(20-4990) 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 Consumers 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:  Draft Commission Regulation 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 (Text with EEA relevance) . Language(s):  
English . Number of pages:  Act (5 pages) + Annex (2 pages)  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_4376_00_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_4376_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 estab lished 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 
amended by the draft "Commission Regulation (EU) amending Annex I  to Regulation (EC) 
No 1334/2008 of the European Parliament and of the Council 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 add endum concerns the withdrawal of the following 5 substances: alpha -damascone 
(Fl no 07.134) (representative substance of the group), delta -damascone (Fl no. 07.130), 
cis-1-(2,6,6 -trimethyl -2-cyclohexen -1-yl)but -2-en-1-one (Fl no. 07.225), trans -1-(2,6,6 -
trimethyl -2-cyclohexen -1-yl)but -2-en-1-one (Fl no. 07.226) and alpha -damascenone (Fl 
no. 07.231) from the list of authorised flavouring substances in the European Union.  
The European Food Safety Authority (EFSA) has evaluated these substances in the 
framewor k of the completion of their evaluation as flavourings substances. EFSA concluded 
that the concern for genotoxicity cannot be ruled out for the five concerned substances. It 
is therefore not established that the concerned substances do not pose a safety ri sk to the 
health of the consumer. On the basis of the scientific evidence submitted within the 
framework set out for the substances pending the completion of their evaluation, the use 
of the concerned substances does not comply with the general conditions of use for 
flavourings set out in Article 4 of Regulation (EC) No 1334/2008.  
The measure includes transitional measures for food to which any of these substances has 
been added.  G/SPS/N/EU/399  
 
- 2 - 
 
  7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant pro tection, 
[ ] 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 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) : September 2020  
Proposed date of publication (dd/mm/yy) : September 2020  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : October 2020  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 18 September 2020  
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 G6 -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 G6 -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