. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2337 
8 March 2012  
 (12-1299) 
Committee on Sanitary and 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 (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):  Vitamin D3 as a nutrient supplement in meal replacement beverages and meal 
replacement bars  
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Abbott Laboratories; Filing of Food Additive Petition 
Language(s):  English  Number of pages:  1 
 http://www.gpo.gov/fdsys/pkg/FR-2012-03-06/pdf/2012-5314.pdf  
6. Description of content:  The US Food and Drug Administration is announcing that Abbott 
Laboratories has filed a petition proposing that the food additive regulations be amended to 
provide for the expanded safe use of vitamin D3 as a nutrient supplement in food in 21 
CFR § 172.380. 
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 number)    
[X] None Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [ ] No G/SPS/N/USA/2337 
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:  Published on  
6 March 2012 in  77 Federal Register 13232 and can be found at 
http://www.gpo.gov/fdsys/pkg/FR-2012-03-06/pdf/2012-5314.pdf  (avilable in English) 
10. Proposed date of adoption (dd/mm/yy) :  To be determined. 
Proposed 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) :  Comments will be accepted at any time after publication of the notice 
of filing;  however, if a final rule is pr omulgated, it will address only those comments that 
were received prior to publication of the final rule.   
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:  Judith Kidwell, Center for Food, Safety and Applied Nutrition 
HFS 265, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 3835, (240) 402 1071, Judith.Kidwell@fda.hhs.gov 
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 Fore ign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 20250;  Tel:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.s psenquirypoint@fas.usda.gov  
Text can be also be found on the Internet:  " http://www.gpo.gov/fdsys/pkg/FR-2012-03-
06/pdf/2012-5314.pdf "