. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1940 
30 July 2009  
 (09-3713) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
 
 
 
NOTIFICATION  
 
1. Notifying Member:  UNITED STATES  
If applicable, name of local government involved:    
2. Agency responsible:  US Food and Drug Administration 
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):  N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl- α-aspartyl]-L-phenylalnine 1-
methyl ester, monohydrate (CAS Reg. No. 714229-20-6) (Advantame) 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[ X ] All trading partners, or [   ] Specific regions or countries:    
5. Title of the notified document:  Ajinomoto Co., Inc.; Filing of Food Additive Petition 
Language:  English  Number of pages:   2   
6. Description of content:  Ajinomoto Co., Inc. is petitioning FDA that the food additive 
regulations be amended to provide for the safe use of N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl- α-aspartyl]-L-phenylalanine 1-methyl ester, monohydrate (CAS 
Reg. No. 714229-20-6) for use as a non-nutritive sweetener in tabletop applications and powdered beverage mixes.  Aji nomoto Co. also proposes that this additive be identified as 
advantame. 
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 stan dard?  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 N°)     
[ X ] None Does this proposed regulation conform to the relevant international standard?   
 [   ] Yes   [   ] No G/SPS/N/USA/1940 
Page 2  
 
   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:  Notice of 
Filing in the Federal Register ( 74 FR 35871) (available in English)  
http://edocket.access.gpo.gov/2009/pdf/E9-17250.pdf    
10. Proposed date of adoption (dd/mm/yy) :  To be determined. 
Propose date of publication ( dd/mm/yy) :  To be determined. 
11. Proposed date of entry into force:  [   ] Six months from date of publication , and/or  
(dd/mm/yy) :  To be determined. 
[   ] Trade facilitating measure  
12. Final date for comments: [   ] Sixty days from the date of circulation of the 
notification and/or ( dd/mm/yy ):  Open 
Agency or authority designated to handle comments:  [   ] National Notification 
Authority, [   ] National Enquiry Point.  Address, fax number and E-mail address (if 
available) of other body:   Submit written comments for Docket No. FDA–2009–F–0303 
to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov
.  Cite the when commenting. 
13. Texts available from:  [ X ] National Notification Authority, [   ] National Enquiry 
Point.  Address, fax number and E-mail address (if available) of other body:   United 
States SPS National Notification Authority, USDA Foreign Agricultural Service, 
International Regulations and Standards Division (IRSD), Stop 1027, Washington D.C. 
20250;  Tel:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.spsenquirypoint@fas.usda.gov  
Please use:  Complete text can also be found on the Internet at 
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm
 by looking under Docket No. 
FDA-2009-F-0303.