. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1902 
25 March 2009  
 (09-1479) 
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):  Soy beverages, soy beverage products, soy-based butter substitute spreads, 
soy-based cheese substitutes and soy- based cheese substitute products 
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:  Food Additives Permitted for Direct Addition to Food for 
Human Consumption; Vitamin D 2; Final Rule  Language:  English  Number of pages:  4 
6. Description of content:  The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of vitamin D 2 as a nutrient supplement in 
soy-based food products.  This action is in response to a petition filed by Dean Foods Co. 
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 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:    G/SPS/N/USA/1902 
Page 2  
 
  9. Other relevant documents and language(s) in which these are available:  Federal 
Register:  16 March 2009 (Volume 74, Number 49); Notices Pages 11019-11022.  Available online at http://edocket.access.gpo. gov/2009/E9-5549.htm
 
Federal Register:  4 October 2007 (Vol ume 72, Number 192); Notices Page 56768.  
Available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-19576.pdf  
10. Proposed date of adoption (dd/mm/yy) :  16 March 2009 
Propose date of publication ( dd/mm/yy) :  16 March 2009 
11. Proposed date of entry into force:  [   ] Six months from date of publication , and/or  
(dd/mm/yy) :  16 March 2009 
[ X ] Trade facilitating measure  
12. Final date for comments: [   ] Sixty days from the date of circulation of the 
notification and/or ( dd/mm/yy ):  Objections and requests for a hearing by 15 April 2009 
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:    
Written or electronic objections and requests for a hearing, identified by Docket No. FDA-
2007-F-0274 (formerly Docket No. 2007F-0355), may be submitted by any of the following methods: 
• Federal eRulemaking Portal:  http://www.regulations.gov
.  Follow the instructions 
for submitting comments. 
• Fax:  301-827-6870 
• Mail/Hand delivery/Courier [For paper, disk , or CD-ROM submissions]:  Division 
of Dockets Management (HFA-305), Food and Drug 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.regulations.gov
, including any personal information provided. 
 For access to the docket [FDA-2007-F-0274] to read background documents or comments received, go to http://www.regulations.gov
 and insert the docket number [FDA-2007-F-
0274], found in brackets in the heading of this  document, into the "Search" box and follow 
the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. 
13. Texts available from:  [   ] National Notification Authority, [ X ] National Enquiry 
Point.  Address, fax number and E-mail address (if available) of other body:    
United States SPS National Notification Aut hority, 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