WORLD TRADE  
ORGANIZATION   
G/SPS/N/EEC/411 
19 August 2011 
 (11-4144) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  EUROPEAN UNION 
If applicable, name of local government involved:    
2. Agency responsible:  Commission of the European Union - Health & Consumers 
Directorate-General Directorate E - Safety of the food chain 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Food additives (ICS Code 67.220.20);  all foodstuffs 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[ ] All trading partners   
[X] Specific regions or countries:  EU member States and third countries exporting 
these products to the European Union.  
5. Title of the notified document:  Draft Commission Regulation amending Annex II of 
Regulation (EC) No 1333/2008 of the European Pa rliament and of the Council with regard 
to conditions of use and use levels of Qui noline Yellow, Sunset Yellow and Ponceau 4R  
Language(s):  English  Number of pages:  13 
 http://members.wto.org/crnattach ments/2011/sps/EEC/11_2757_00_e.pdf  
6. Description of content:  This Regulation concerns an  amendment to Annex II of 
Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives
1 with regard to revised conditions of use and use levels of Quinoline Yellow, 
Sunset Yellow and Ponceau 4R. 
In its opinions of 23 September 2009, the Eu ropean Food Safety Authority (EFSA) re-
evaluated the safety of Quinoline Yellow (E 104), Sunset Yellow (E 110) and Ponceau 4R (E 124) and recommended to lower down its acceptable daily intake (ADI) to respectively 0.5, 1 and 0.7 mg/kg bw/day.  In addition,  EFSA considered that the refined exposure 
estimates are generally well over the revised ADI's.  It is therefore appropriate to reduce the 
current conditions of use and use levels of these substances to ensure that the new ADI's are 
not exceeded any more. 
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.    
                                                      
1 OJ L 354, 31 December 2008, p.16. G/SPS/N/EEC/411 
Page 2  
 
  8. Is there a relevant international stan dard?  If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text) The General Standard on Food Additives (GSFA) 
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] None 
Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [X] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:  As the proposed regulation takes into account the ADI's 
established by EFSA which are lower than those established by JECFA, the proposed 
conditions of use are stricter than those curre ntly set in Codex General Standards for Food 
Additives. 
9. Other relevant documents and language (s) in which these are available:  When adopted 
it will be published at the Official Journal available in English at:  http://eur-lex.europa.eu .  
10. Proposed date of adoption (dd/mm/yy) :  15 January 2012 
Proposed date of publication (dd/mm/yy) :  16 January 2012 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  20 days after publication 
[X] Trade facilitating measure    
 24-month transitional period afte r entry into force is foreseen.  
12. Final date for comments:  [X] Sixty days  from the date of circulation of the 
notification and/or (dd/mm/yy) :  18 October 2011 
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 Consumers, Unit D3 - In ternational questions (multilateral)  
Rue Froissart 101 
B 1049 Brussels 
Tel:  +(32 2) 29 68185/59922 Fax:  +(32 2) 29 98090 E-mail:  sps@ec.europa.eu  G/SPS/N/EEC/411 
 Page 3 
 
 
  13. Texts 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 Consumers, Unit D3 - In ternational questions (multilateral)  
Rue Froissart 101 B 1049 Brussels 
Tel:  +(32 2) 29 68185/59922 
Fax:  +(32 2) 29 98090 E-mail:  sps@ec.europa.eu 
Information relevant to this proposal can be found on the website of DG Health and 
Consumers at:  http://ec.europa.eu/food/food/chem icalsafety/additives/index_en.htm