. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1254 
23 March 2006 
 (06-1325) 
Committee on Sanitary a nd 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  
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):  Vegetable oils as an excipi ent in dietary supplement ta blets, capsules, and liquid 
formulations  HS 1515, 1516, 1302  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Trading 
partners  
5. Title, language and number of p ages of the notified document:  Food Additives 
Permitted for Direct Addition to Food for Huma n Consumption; Glycerides and Polyglycides 
(Available in English, 4 pages).  
6. Description of content:  The U.S. Food and Drug Administration (FDA) issued a final rule 
amending the food additive regula tions under Title 21, Code of Federal Regulations part 172 
for the safe use of a mixture of glycerides and polyethylene glycol monoesters and diesters of 
fatty acids of hydrogenated vege table oils as an excipient in  dietary supplement tablets, 
capsules, and liquid formulations that are intend ed for ingestion in daily quantities measured 
in drops or similar small units of measure.  
FDA had published the food additive petition on 19 December 1991 in 56 FR 65907.  
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. 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:  Final rule published 
in the Federal Register at 71 FR 12618 (availa ble in English).  The notice can be found at 
http://www.fda.gov/OHRMS/DOCKETS/98fr/06-2354.htm   or 
http://a257.g.akamaitech.net/7/257/24 22/01jan20061800/edocket.access.gpo.gov/2006/pdf/
06-2354.pdf  G/SPS/N/USA/1254 
Page 2  
 
  10. Proposed date of adoption:  The rule is effective 13 March 2006.  
11. Proposed date of entry into force:  The rule is effective 13 March 2006.  
12. Final date for comments:  12 April 2006  
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 or electronic comments identified by Docket No. 1991F-0457, by any of the 
following methods: 
• Federal eRulemaking Portal:  http://www.regulations.gov  Follow the instructions 
for submitting comments. 
• Agency Web site:  http://www.fda.gov/dockets/ecomments   Follow the instructions 
for submitting comments on the agency Web site. 
Submit written submissions in the following ways: 
• Fax:  301-827-6870 
• Mail/Hand delivery/Courier [For paper, di sk, or CD-ROM submissions]: Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Instructions: All submissions received must include the agency name and docket number for 
this rulemaking. All objec tions received will be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm . 
13. Texts available from:  [   ] National notification authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body:   
Ms Julie Morin, United States SPS National Notification Authority, USDA Foreign 
Agricultural Service, Food Safety & Technical Services Division, Stop 1027, Washington 
D.C. 20250.  Tel:  202-720-4051;  Fax:  202-690-0677;  E-mail:  fstsd@fas.usda.gov  
Complete text can be also be found on the Internet at  
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  and insert Docket No. 1991F-
0457.  For access to the docket to read bac kground documents or comments received, go to 
http://www.fda.gov/ohrms/dockets/default.htm  and insert the Docket No. 1991F-0457 into 
the "Search" box and follow the prompts.