. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/237 
29 January 2007 
 (07-0383) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Food and Drug Administration  (FDA) (244) 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
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 applicable, otherwise national tariff heading.
ICS numbers may be provided in  addition, where applicable):   All foods regulated by 
FDA that are marketed in the U.S., which exclude meat, poultry and certain egg products that 
are regulated by the U.S. Department of Agriculture and which exclude all distilled spirits 
and malt beverages, irrespective of their alc ohol content, and wines with 7% or more 
alcohol by volume that are regulated by the U.S. Alcohol and Tobacco Tax and Trade Bureau (HS:  Chapter 1905;  ICS:  67). 
5. Title, number of pages and langu age(s) of the notified document:   Food Labelling; 
Gluten-Free Labelling of Foods  (23 pages, English) 
6. Description of content:   The Food and Drug Administration (FDA) is proposing to define 
the term "gluten-free" for voluntary use in th e labelling of foods, to mean that the food does 
not contain any of the following: An ingredient  that is any species of the grains wheat, rye, 
barley, or a crossbred hybrid of these grains (a ll noted grains are collectively referred to as 
"prohibited grains"); an ingredient that is derived 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 re move 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; or 20 ppm or more gluten.  A food that bears the claim "gluten -free" or similar claim 
in its labelling and fails to meet the conditio ns specified in the proposed definition of 
"gluten-free" would be deemed misbranded. FDA also is proposing to deem misbranded a 
food bearing a gluten-free claim in its labelling if the food is inherently free of gluten and if 
the claim does not refer to all foods of that sa me type (e.g., "milk, a gluten-free food" or "all 
milk is gluten-free").  In addition, a food made  from oats that bears a gluten-free claim in its 
labelling would be deemed misbranded if the cl aim suggests that all such foods are gluten-
free or if 20 ppm or more gluten is present in th e food.  Establishing a definition of the term 
"gluten-free" and uniform conditions for its use in  the labelling of foods is needed to ensure 
that individuals with celiac disease are not misled and are provided with truthful and 
accurate information with respect to foods so labelled.  This proposed action is in response 
to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). G/TBT/N/USA/237 
Page 2  
 
  FDA issued a proposed rule at :  
http://a257.g.akamaitech.net/7/257/24 22/01jan20071800/edocket.access.gpo.gov/2007/E7-
843.htm to amend its regulations  by adding a new section 101.91 to Title 21 of the Code of 
Federal Regulations to define and establish c onditions for use of the food labelling term 
"gluten-free".  The proposed provisions would ap ply to all foods regulated by FDA that are 
marketed in the U.S., including those domes tically produced and imported.  The proposed 
rule provides that a food bearing a "gluten-free"  or similar labelling claim (e.g., "free of 
gluten", "without gluten", or "no gluten") cannot contain specified prohibited grains (i.e., any species of wheat, rye, barley or their cro ssbred hybrids like triticale), other ingredients 
derived from those grains that have not been rendered gluten-free, or 20 parts per million or 
more gluten.  The proposal also specifies how a "gluten-free" labelling claim for a food that 
inherently does not contain gluten could be stated.   
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human life and health; The action r esponds to a directive of the Food Allergen 
Labelling and Consumer Protection Act of 2004 th at the Secretary of U.S. Department of 
Health and Human Services issue a proposed rule  in 2006 and a final rule in 2008 to define 
and permit use of the term “gluten-free” in th e labelling of foods.  This rulemaking will 
assist persons who have celiac disease, al so known as celiac sprue and gluten-sensitive 
enteropathy, identify packaged foods that do not  contain certain proteins naturally occurring 
in grains, commonly called “gluten,” that cause damage to their small intestine.  Celiac 
disease has no cure, but avoiding the consumption of gluten can resolve its symptoms, mitigate and possibly reverse the damage, and reduce the associated health risks.  FDA 
believes that establishing a definition for the term “gluten-free” and uniform conditions for 
its use in food labelling will ensure that pers ons with celiac disease are not mislead and are 
provided with truthful and accurate information with respect to foods so labelled that are 
appropriate for them to eat. 
8. Relevant documents:   72 Federal Register (FR) 2795 23 January 2007; Title 21 Code of 
Federal Regulations (CFR) Part 101.  Will app ear in the Federal Register when adopted.  
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   23 April 2007 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Internet URLs:   
http://a257.g.akamaitech.net/7/257/24 22/01jan20071800/edocket.access.gpo.gov/2007/E7-
843.htm 
http://a257.g.akamaitech.net/7/257/24 22/01jan20071800/edocket.access.gpo.gov/2007/pdf/
E7-843.pdf