G/SPS/N/USA/79/Add.2  
 
18 August 2016  
(16-4440) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
Addendum  
The following communication, received on 18 August 2016, is being circulated at the request of the 
Delegation of  the United States of America . 
 
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Substances Generally Recognized as Safe; Final Rule  
The Food and Drug A dministration (FDA) is issuing a final rule that amends and clarifies the 
criteria in FDA regulations for when the use of a substance in food for humans or animals is not 
subject to the premarket approval requirements of the Federal Food, Drug, and Cosmeti c Act (the 
FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of 
its intended use. FDA is amending its regulations to replace the voluntary GRAS affirmation 
petition process with a voluntary notification procedure u nder which any person may notify FDA of 
a conclusion that a substance is GRAS under the conditions of its intended use. The clarified 
criteria for GRAS status should help stakeholders draw more informed conclusions about whether 
the intended conditions of use of a substance in food for humans or animals complies with the 
FD&C Act, and the notification procedure will enable stakeholders to be aware of whether FDA has 
questioned the basis of a conclusion of GRAS status.  
The notice was published in the Federa l Register on 17 August 2016, 81 FR 54959 and can be 
found at: https://www.gpo.gov/fdsys/pkg/FR -2016-08-17/pdf/2016 -19164.pdf . 
This addendum concerns a:  
[ ] Modification of f inal 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 ado ption, 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 potentially affected Members, a new deadline for 
receipt of comments should be p rovided, normally of at least 60 calendar days. Under 
other circumstances, such as extension of originally announced final date for comments, 
the comment period provided in the addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendu m to the notification and/or 
(dd/mm/yy) : Not applicable  
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:  
Paulette M. G aynor, Center for Food Safety and Applied Nutrition (HFS -255), Food and Drug 
Administration, 5001 Campus Drive, College Park, MD 20740, +(240) 402 1192  G/SPS/N/USA/79/Add.2  
 
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  Text(s) 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 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. 159, page 54959 or on the internet at:  
https://www. gpo.gov/fdsys/pkg/FR -2016-08-17/pdf/2016 -19164.pdf .  
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