. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1089 
5 July 2005 
 (05-2938) 
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 numbe r(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Vitamin D 3 as a nutrient supplement in meal replacement bars, other-type 
bars, and soy-protein based meal replacement beverages for special dietary use 
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; Vitamin D 3; Final Rule. (4 pages; 
available in English) 
6. Description of content:  FDA is amending the food additive regulations in 21 CFR 
172.380 to provide for the safe use of vitamin D 3 as a nutrient supplement in meal 
replacement bars, other-type bars, and soy-pr otein based meal replacement beverages for 
special dietary use in reducing or maintaining body weight. 
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 thes e are available:  Notice of Filing in the 
Federal Register  (68 FR 50541); Final Rule in Federal Register  ( 70 FR 37255) (Available in 
English) 
10. Proposed date of adoption:   29 June 2005 
11. Proposed date of entry into force:   Same as date of adoption G/SPS/N/USA/1089 
Page 2  
 
 12. Final date for comments:  Any person who will be adversel y affected by this regulation 
may file written or electronic objections and requests for a hearing with the Division of Dockets Management by 29 July 2005. 
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 objections and requests for a hearing identified by Docket No. 2003F-0370, 
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.  • E-mail:  fdadockets@oc.fda.gov
.  Include Docket No. 2003F-0370 in the subject line of 
your e-mail message.   • FAX:  301-827-6870 
• Mail/Hand delivery/Courier [For paper, disk , or CD-ROM submissions]:  Division of 
Dockets Management (HFA-305), Food and Dr ug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD  20852.   
All submissions received must include the agency name and docket number for this 
rulemaking. All objections received will be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm
, including any personal information 
provided. 
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail add ress (if available) of other body:  US Enquiry 
Point, US Department of Agriculture, Stop 1027, Washington, DC  20250.  TEL (202) 720-4051, FAX (202) 690-0677, fstsd@usda.gov
.  Complete text can be also be found on the 
Internet at http://www.fda.gov/OHRMS/DOCKETS/98fr/05-12699.pdf and insert Docket 
No. [2003F-0370].  For access to the docket to read background documents or comments 
received, go to http://www.fda.gov/ohrms/dockets/default.htm  and insert the Docket No. 
[2003F-0370] into the "Search" box and follow the prompts.