. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/USA/237/Add.1 
12 August 2011  
 (11-4039) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION  
 
Addendum 
  
 The following communication, dated 3 August 2011, is being circulated at the request of the 
delegation of the United States.  
 
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TITLE:  Food Labelling; Gluten-Free Labelling of Foods; Reopening of the Comment Period. 
 AGENCY:  Food and Drug Administration (FDA), Depa rtment of Health and Human Services (HHS) 
 ACTION:  Reopening of Comment Period 
 
SUMMARY:  The Food and Drug Administration (F DA) is reopening the comment period for the 
proposed rule on the "gluten-free" labelling of foods, published in the Federal Register of 
23 January 2007 (72 FR 2795). In th at document, FDA proposed to define the term "gluten-free", for 
voluntary use in the labelling of foods, to mean that the food does not contain an ingredient that is any 
species of wheat, rye, barley, or a crossbred hybr id of these grains (collectively referred to 
as" prohibited grains"); an ingredient that is de rived from a prohibited grain and that has not been 
processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited grain 
and that has been processed to remove gluten (e.g., wh eat starch), if the use of that ingredient results 
in the presence of 20 parts per million (ppm) or more gluten in the food; or 20 ppm or more gluten. FDA also announced in the proposed rule that we intended to conduct a safety assessment for gluten 
exposure and seek comments on the safety assessment and its potential use in defining the term 
gluten-free” in the final rule. A report by FDA di scussing a health hazard assessment we conducted, 
which included a safety assessment for gluten exposur e in individuals with celiac disease, has been 
peer reviewed by an external group of scientif ic experts, and we revised the assessment, as 
appropriate, based upon expert comments. FDA is  reopening the comment period for the proposed 
rule on the “gluten-free labelling of foods to, in  part, announce the availability of and solicit 
comments on the report entitled "Health Hazard Assess ment for Effects of Gluten Exposure in 
Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of 
Concern for Gluten" ("Gluten Report"), which discusses the Agency's gluten safety assessment. The 
Agency also seeks comments on whether and, if so, how, the safety assessment should affect FDA's 
proposed definition of "gluten-free" in the final rule , and on a number of related issues. Finally, FDA 
seeks comments on the Agency's tentative conclusi ons that the safety assessment-based approach may 
lead to a conservative, highly uncertain estimation of  risk to individuals with celiac disease associated 
with very low levels of gluten exposure; and that  the final rule should adopt the proposed rule's 
approach to defining the term "gluten-free", because that approach takes into account the availability 
of reliable analytical methods and also considers other practical factors related to the needs of 
individuals with celiac disease and their food consumption. 
 G/TBT/N/USA/237/Add.1 
Page 2  
 
  DATES:  Submit electronic or written comments by 3 October 2011. 
 
FULL TEXT URLs:   http://www.gpo.gov/fdsys/pkg/FR-2011-08-03/html/2011-19620.htm  
http://www.gpo.gov/fdsys/pkg/FR -2011-08-03/pdf/2011-19620.pdf  
 
   
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