G/TBT/N/USA/1050/Add.2  
 
18 August 2020  
(20-5619) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  18 August 2020 , is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title: Food Labeling; Gluten -Free Labeling of Fermented or Hydrolyzed Foods  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[X] Notified measure adopted - date: 13 August 2020  
[  ] Notified measure published - date:  
[X] Notified measure enters into force - date: 13 October 2020  
[X] Text of final measure available from1:  
https://www.govinfo.gov/c ontent/pkg/FR -2020-08-13/html/2020 -17088.htm  
https://www.govinfo.gov/content/pkg/FR -2020-08-13/pdf/2020 -17088.pdf  
https://members.wto.org/crnattachments/2020/TBT/USA/final_measure/20_4958_00_
e.pdf 
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  
New deadline for comments (i f applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  AGENCY: Food and Drug Administration, HHS  
ACTION: Final rule  
SUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule to establish 
requirements concerning "gluten -free" labeling for foods that are fermented or hydrolyzed or that 
contain fermented or hydrolyzed ingredients. These requirements 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." Currently, FDA knows of no 
scientifically valid analytical met hod effective in detecting and quantifying with precision the gluten 
protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten 
proteins. Thus, we plan to evaluate compliance of such fermented or hydrolyzed foods that bear a 
"gluten -free" claim based on records that are made and kept by the manufacturer of the food bearing 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final measure and/or interpretive guidance can be obtained.  G/TBT/N/USA/1050/Add.2  
 
- 2 - 
 
  the "gluten -free" claim and made available to us for inspection and copying. The records need to 
provide adequate assurance that the food or ingredie nts used in the food are "gluten -free" before 
fermentation or hydrolysis. Once we identify that a scientifically valid method has been developed 
that can accurately detect and quantify gluten in fermented or hydrolyzed foods or ingredients, it 
would no lon ger be necessary for the manufacturer of foods bearing the "gluten -free" claim to make 
and keep these records. In addition, because currently there is no scientifically valid analytical 
method effective in detecting and quantifying the gluten protein conte nt in fermented or hydrolyzed 
foods the final rule requires the manufacturer of these kinds of foods bearing the "gluten - free" claim 
to document that it has adequately evaluated the potential for gluten cross -contact and, if identified, 
that the manufactu rer has implemented measures to prevent the introduction of gluten into the food 
during the manufacturing process. Likewise, the final rule requires manufacturers of foods that 
contain fermented or hydrolyzed ingredients and bear the "gluten -free" claim to  make and keep 
records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are 
"gluten -free" in compliance with the 2013 gluten -free food labeling final rule. Finally, this final rule 
states that we will evaluate complianc e 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.  
DATES:  
Effective date: This rule is effective 13 October 20 20. 
Compliance date: The compliance date of this final rule is 13 August 2021.  
This final rule and previous actions notified under the symbol G/TBT/N/USA/1050  are identified by 
Docket Number FDA -2014-N-1021.   The Docket Folder is available on Regulations.gov  at 
https://www.regulations.gov/docket?D=FDA -2014-N-1021 and provides access to primary and 
supporting documents as well as comments received. Documents are also accessible from 
Regulations.gov  by searchin g the Docket Number.  
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