G/TBT/N/USA/1050  
 
20 November 2015  
(15-6155)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: UNITED STATES OF AMERICA 
If applicable, name of local government involved (Article 3.2 and 7.2):  
2. Agency responsible: Food and Drug Administration (FDA), Health and Human Services 
(HHS) [1069] 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above : 
Please submit comments to: USA WTO TBT Enquiry Point 
Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10 .1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: 
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Food labeling. Food 
products in general (ICS: 67.040) 
5. Title, number of pages and language(s) of the notified document: Food Labeling; 
Gluten-Free Labeling of Fermented or Hydrolyzed Foods (17 pages, in English) 
6. Description of content: The Food and Drug Administration (FDA or we) is proposing to 
establish requirements concerning "gluten-fr ee" labeling for foods that are fermented or 
hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional 
requirements for the "gluten- free" labeling rule  are needed to help ensure that individuals 
with celiac disease are not misled and receive truthful and accurate information with 
respect to fermented or hydrolyzed foods labeled as "gluten-free." There is uncertainty in interpreting the results of current gluten te st methods for fermented and hydrolyzed foods 
on a quantitative basis that equates the test results in terms of intact gluten. Thus, we 
propose to evaluate compliance of such fe rmented and hydrolyzed foods that bear a 
"gluten-free" claim with the gluten-free labeling rule based on records that are made and kept by the manufacturer of the food bearing the "gluten-free" claim and made available to 
us for inspection and copying. The records would need to provide adequate assurance that 
the food is "gluten-free" in compliance with the gluten-free food labeling final rule before fermentation or hydrolysis. In addition, the proposed rule would require the manufacturer 
of fermented or hydrolyzed foods bearing the "gluten-free" claim to document that it has 
adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prev ent the introduction of gluten into the 
food during the manufacturing process. Like wise, manufacturers of foods that contain 
fermented or hydrolyzed ingredients and bear the "gluten-free" claim would be required to 
make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are "gluten-free" in co mpliance with the gluten-free food labeling 
final rule. Finally, the proposed rule would state that we would evaluate compliance of 
distilled foods by verifying the absence of protein using scientifically valid analytical 
methods that can reliably detect the presence of protein or protein fragments in the 
distilled food.  G/TBT/N/USA/1050 
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety  
8. Relevant documents: 80 Federal Register (FR) 71990, 18 November 2015; Title 21 Code 
of Federal Regulations (CFR) Part 101. Will a ppear in the Federal Register when adopted. 
9. Proposed date of adoption: To be determined 
Proposed date of entry into force: To be determined 
10. Final date for comments: 16 January 2016 
11. Texts available from: National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
https://members.wto.org/crnattachm ents/2015/TBT/USA/15_4628_00_e.pdf