. /. WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/911 
4 June 2004 
 (04-2395) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
1. Member to Agreement notifying:   UNITED STATES 
If applicable, name of local government involved: 
2. Agency responsible:   US Food and Drug Administration (FDA) 
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):  Olestra used in pre-packaged, unpopped p opcorn kernels that are ready-to-heat 
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Trading partners  
5. Title, language and number of pages of the notified document:   Food Additives Permitted 
for Direct Addition to Food for Human Consumption; Olestra (69 Federal Register  
29428-29432) (available in English) 
6. Description of content:   FDA is issuing a final rule am ending the food additive regulations 
to allow the use of olestra in pre-packaged, unpopped popcorn kernels that  are ready-to-heat. 
7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection, 
[   ] protect humans from animal/plant pest or  disease, [   ] protec t territory from other 
damage from pests 
8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [ X ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
9. Relevant documents and language(s) in which these are available:  Food Additives 
Permitted for Direct Addition to Food for Human Consumption; Olestra (69 Federal Register  
29428-29432) (available in Englis h). It can be found at: 
http://www.fda.gov/OHRMS/DOC KETS/98fr/04-11502.html  or  
http://www.fda.gov/OHRMS/ DOCKETS/98fr/04-11502.pdf . 
10. Proposed date of adoption:   24 May 2004 
11. Proposed date of entry into force:   24 May 2004 G/SPS/N/USA/911 
Page 2  
 
 12. Final date for comments:  23 June 2004 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body:    
Submit written comments on the docume nt to the Dockets Management 
Branch (HFA-305), Food and Drug Admini stration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, U.S.A.  
 It is possible to submit electronic comments to:  http://www.fda.gov/dockets/ecomments . 
Submit comments by indicating DOCKET Number 99F-0719 and Food Additives 
Permitted for Direct Addition to F ood for Human Consumption;  Olestra.  
13. Texts available from:  [   ] National notification authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body:    
US Department of Agriculture, Stop 1027, Washington, DC  20250.  Tel (202) 720-4051, 
(202) 720-0677, fstsd@usda.gov .  Complete text can be also be found on the Internet 
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  by looking under DOCKET 
No. 1999F-0719.