G/SPS/N/USA/1499/Add.1  
 
8 August 2013  
(13-4227)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 7 August 2013, is being circulated at the request of the 
Delegation of the United States of America. 
 
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 Food Labeling; Gluten-Free Labeling of Foods, Final Rule 
The US Food and Drug Administration is issuing a final rule to define the term "gluten-free" for 
voluntary use in the labeling of foods. The final rule defines the term "gluten-free" to mean that 
the food bearing the claim does not contain an ingredient that is a gluten-containing grain 
(e.g., spelt wheat); an ingredient that is derive d from a gluten-containing grain and that has not 
been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a 
gluten-containing grain and that has been processe d to remove gluten (e.g., wheat starch), if the 
use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the 
food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not 
contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten 
(i.e., below 20 mg gluten per kg of food). A food that bears the claim "no gluten", "free of gluten", or "without gluten" in its labeling and fails to meet the requirements for a "gluten-free" claim will 
be deemed to be misbranded. In addition, a food whose labeling includes the term "wheat" in the 
ingredient list or in a separate "Contains wheat" statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim "gluten-free" will be 
deemed to be misbranded unless its labeling also bears additional language clarifying that the 
wheat has been processed to allow the food to meet FDA requirements for a "gluten-free" claim. Establishing a definition of the term "gluten-free" and uniform conditions for its use in food 
labeling will help ensure that individuals with ce liac disease are not misled and are provided with 
truthful and accurate information with respect to foods so labeled. FDA is issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). 
The final rule becomes effective on 4 September 2013. The compliance date of this final rule is 
5 August 2014. See section II.B.4 (comment 35 and response 35) of the document for an 
additional explanation of the compliance date and implementation of this final rule. 
http://members.wto.org/crnattachments/2013/sps/USA/13_3157_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:   G/SPS/N/USA/1499/Add.1 
 
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  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) : Not applicable 
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: 
Felicia B. Billingslea, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371; Fax: +(301) 436 2636; E-mail: GlutenFreeFinalRuleQuestions@fda.hhs.gov  
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 
The complete text, found in the US Federal Register at 78 FR 47154, can also be obtained online 
at: http://www.gpo.gov/fdsys/pkg/FR-2013-08-05/pdf/2013-18813.pdf . 
 
 
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