G/SPS/N/USA/2337/Add.1  
 
14 August 2014  
(14-4733)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 14 August 2014, is being circulated at the request of the 
Delegation of the United States of America. 
 
_______________ 
 
 Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D
3; Final 
Rule 
The Food and Drug Administration is amending the food additive regulations to provide for the safe use of vitamin D
3 as a nutrient supplement in meal replacement beverages that are not intended 
for special dietary use in reducing or maintaining body weight and for use in foods that are sole 
sources of nutrition for enteral feedings. FDA is taking this action in response to a petition filed by 
Abbott Laboratories. 
This rule is effective 12 August 2014. 
http://members.wto.org/crnattachments/2014/sps/USA/14_3684_00_e.pdf  
This addendum concerns a: 
[ ] Modification of final date for comments 
[X] Notification of adoption, publication or entry into force of regulation 
[ ] Modification of content and/or scope of  previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[ ] Other:   
Comment period: (If the addendum extends the scope of the previously notified 
measure in terms of products and/or potent ially affected Members, a new deadline for 
receipt of comments should be provided, norm ally of at least 60 calendar days. Under 
other circumstances, such as extension of or iginally announced final date for comments, 
the comment period provided in the addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) : Submit either electronic or written objections and requests for a 
hearing by 11 September 2014. 
Agency or authority designated to handle co mments: [ ] National Notification Authority, 
[ ] National Enquiry Point. Address, fax nu mber and e-mail address (if available) of 
other body: 
You may submit either electronic or written objections and requests for a hearing identified by 
Docket No. FDA-2012-F-0138, by any of the following methods: 
Electronic Submissions 
Submit electronic objections in the following way: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting 
comments. G/SPS/N/USA/2337/Add.1 
 
- 2 - 
 
  Written Submissions 
Submit written objections in the following ways: Mail/Hand delivery/Courier (for paper submission s): Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Instructions: All submissions received must incl ude the Agency name and Docket No. FDA-2012-F-
0138 for this rulemaking. All objections received will be posted without change to http://www.regulations.gov , including any personal information provided. For detailed instructions 
on submitting objections, see the ''Objection s'' heading of the SUPPLEMENTARY INFORMATION 
section.  
Text available from: [X] National Notificati on Authority, [ ] National Enquiry Point. 
Address, fax number and e-mail addre ss (if available) of other body: 
United States SPS National Notification Authority, USDA Foreign 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.spsenquirypoint@fas.usda.gov 
Text can be also be found in the Federal Register, Vol. 49, No. 155, Page 46993 and on the 
Internet at: http://www.gpo.gov/fdsys/pkg/FR- 2014-08-12/pdf/ 2014-18969.pdf .  
 
__________