G/SPS/N/USA/2577/Add.1  
 
25 July 2016  
(16-3935)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 22 July 2016, 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 D2 and 
Vitamin D3; Final Rule 
The Food and Drug Administration is amending the food additive regulations to expand the safe uses of vitamin D2 as a nutrient supplement in edible plant-based beverages intended for use as milk alternatives and in edible plant-based yogurt alternatives and vitamin D3 as a nutrient 
supplement in milk at levels higher than those currently permitted. It is taking this action in 
response to a food additive petition filed by  Dean Foods Company and WhiteWave Foods Company.
 
This rule is effective 18 July 2016. 
The text is available at https://www.gpo.gov/fdsys/pkg/F R-2016-07-18/pdf/2016-16738.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 17 August 2016. G/SPS/N/USA/2577/Add.1 
 
- 2 - 
 
  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 objections and requests for a hearing as follows: 
Electronic Submissions 
Submit electronic objections in the following way: 
Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting 
comments. Objections submitted electronically, including attachments, to 
http://www.regulations.gov  will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your objection does not include any 
confidential information that you or a third part y may not wish to be posted, such as medical 
information, your or anyone else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be 
posted on http://www.regulations.gov . 
If you want to submit an objection with confidential information that you do not wish to be made 
available to the public, submit the objection as  a written/paper submission and in the manner 
detailed (see "Written/Paper Submissions" and "Instructions"). 
Written/Paper Submissions 
Submit written/paper submissions as follows: 
Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For 
written/paper objections submitted to the Division of Dockets Management, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as 
confidential, if submitted as detailed in "Instructions". 
Instructions: All submissions received must include the Docket No. FDA-2013-N-0888 for "Food 
Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 and Vitamin 
D3 Final Rule". Received objections will be placed in the docket and, except for those submitted as 
"Confidential Submissions", publicly viewable at http://www.regulations.gov  or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. 
Confidential Submissions--To submit an objection with confidential information that you do not 
wish to be made publicly available, submit your objections only as a written/paper submission. You 
should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that stat es "THIS DOCUMENT CONTAINS CONFIDENTIAL 
INFORMATION". The Agency will review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 
http://www.regulations.gov . Submit both copies to the Division of Dockets Management. If you do 
not wish your name and contact information to be made publicly available, you can provide this 
information on the cover sheet and not in the body  of your comments and you must identify this 
information as "confidential". Any information marked as "confidential" will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, see 80 FR 56469, 
18 September 2015, or access the information at: 
http://www.fda.gov/regulatoryinformation/dockets/default.htm . 
Text(s) 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 also be found in the Federal Register, Vol. 81, No. 137, page 46578 or on the internet at: 
https://www.gpo.gov/fdsys/pkg/F R-2016-07-18/pdf /2016-16738.pdf .  
 
__________