. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/358 
6 October 2009 
 (09-4792) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  EUROPEAN COMMUNITIES
 
If applicable, name of local government involved:    
2. Agency responsible:  Commission of the European Communities. 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):  Several foodstuffs e.g.:  (non-al coholic drinks HS Code - 2206), 
(confectionery HS Code - 17040), (chewing gum HS Code - 17041), (edible ices HS Code - 
2105) 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[ ] All trading partners 
[X] Specific regions or countries:  EC member States and third countries exporting 
these products to the European Communities  
5. Title of the notified document:  "Draft Commission Directive of *** amending Directive 
94/35/EC of the European Parliament and of the Council on sweeteners for use in 
foodstuffs with regard to neotame"  Language:  English  Number of pages:  7  
http://members.wto.org/crnattach ments/2009/sps/EEC/09_3467_00_e.pdf  
6. Description of content:  The European Food Safety Authority (EFSA) evaluated the safety 
of neotame as a sweetener and flavour enhan cer and expressed its opinion of 27 September 
2007.1  EFSA concluded that neotame is not of safety concern with respect to the proposed 
uses as a sweetener and flavour enhancer and established an Acceptable Daily Intake (ADI) 
of 0-2 mg/kg bw/day.  The objective of this draft Directive is to amend the Annex of 
Directive 94/35/EC on sweeteners for use in f oodstuffs in order to permit the use of 
neotame in the same food applications as the other currently permitted intense sweeteners. 
Neotame is assigned a new E number, namely E 961. 
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 Scientific Opinion of the Panel on Food Additiv es, Flavourings, Processing Aids and Materials in 
Contact with Food on a request fro m European Commission on Neotame as a sweetener and flavour enhancer 
(EFSA Journal (2007) 581, 1-43). G/SPS/N/EEC/358 
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) GSFA Provisions for Neotame 
[ ] 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:  Some maximum levels are different from GSFA provisions 
following discussions with the industry, manuf acturers and the EC member States, in 
particular taking into consid eration technological needs. 
9. Other relevant documents and language (s) in which these are available:  European 
Commission Document SANCO/2009/6358 (available in English).  When adopted it will be published at the Official Journal available at:  http://eur-lex.europa.eu
  
Further to Document SANCO/2009/6358, informa tion relevant to this proposal can be 
found on the website of DG Health and Consumers at 
http://ec.europa.eu/food/food/chemicalsafety/additives/index_en.htm    
10. Proposed date of adoption (dd/mm/yy) :  December 2009 
Proposed date of publication (dd/mm/yy) :      
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :    20 days after publication 
[ ] Trade facilitating measure 
12. Final date for comments:  [X] Sixty days  from the date of circulation of the 
notification and/or (dd/mm/yy) :  5 December 2009 
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:  sps@ec.europa.eu 
13. Texts available from:  [X] National Notification Authority, [X] National Enquiry 
Point.  Address, fax number and e-mail address (if available) of other body:  
sps@ec.europa.eu