G/SPS/N/USA/2534/Add.1  
 
29 June 2015  
(15-3320)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 25 June 2015, is being circulated at the request of the 
Delegation of the United States of America. 
 
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 Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and 
Related Labelling Requirements, Final Rule 
The Food and Drug Administration (FDA or we) is amending the regulations on nutrient specifications and labelling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula. This final 
rule is effective 22 June 2016. 
The notice published in the Federal Register (FR 80 35834) on 23 June 2015, and can be found at: 
http://www.regulations.gov/#!docu mentDetail;D=FDA-2013-N-0067-0007 . 
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 
[X] Other: This final rule is effective 22 June 2016 
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) : 23 July 2015 
You may submit either electronic or written objections and/or requests for a hearing by 
23 July 2015, identified by Docket No. FDA-2013- N-0067, 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. 
Written Submissions 
Submit written objections in the following ways: Mail/Hand delivery/Courier (for paper submissi ons): Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. G/SPS/N/USA/2534/Add.1 
 
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  Instructions: All submissions received must include the Docket No. FDA-2013-N-0067 for 
this rulemaking. All objections received may be posted without change to http://www.regulations.gov/ , including any personal information provided. For additional 
information on submitting objections, see the "Objections" heading of the SUPPLEMENTARY 
INFORMATION section of this document. 
Docket: For access to the docket to read background documents, comments, or objections 
received, go to http://www.regulations.gov/  and insert the docket number, 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 Mana gement, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. 
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: 
For further information contact: Leila Beker, Cent er for Food Safety and Applied Nutrition (HFS-
850), Food and Drug Administration, 5100 Pain t Branch Pkwy., College Park, MD 20740, 
Tel: +(1 240) 402 1451  
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 be found in the Federal Register at http://www.regulations.gov/ #!documentDetail;D=FDA
-2013-N-0067-0007 .  
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