WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1499 
30 January 2007 
 (07-0414) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
 
NOTIFICATION 
 
1. Member to Agreement notifying:  UNITED STATES
 
If applicable, name of local government involved:   
2. Agency responsible:  Food and Drug Administration (FDA) 
3. Products covered (provide tariff item number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):   All foods regulated by FDA that are marketed in the US, which exclude meat, 
poultry and certain egg products that are regulated  by the US Department of Agriculture and 
which exclude all distilled spirits  and malt beverages, irrespective of their alcohol content, 
and wines with 7% or more alcohol by volume that are regulated by the US Alcohol and 
Tobacco Tax and Trade Bureau.  
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Trading partners. 
5. Title, language and number of pages of the notified document:  Food Labeling;  Gluten-
Free Labeling of Foods (Available in English;  23 pages in PDF format). 
6. Description of content:  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 conditions for use of the food labeling term 
"gluten-free".  The proposed provisions would ap ply to all foods regulated by FDA that are 
marketed in the US, including those domestically produced and imported.  The proposed 
rule provides that a food bearing a "gluten-fr ee" or similar labeling claim (e.g. "free of 
gluten", "without gluten", or "no gluten") ca nnot 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 
(ppm) or more gluten.  The proposal also sp ecifies how a "gluten-free" labeling claim for a 
food that inherently does not contain gluten could be stated. 
7. Objective and rationale: [ X ] food safety,  [   ] animal health,  [   ] plant protection, 
[   ] protect humans from animal/plant pest or disease, [   ] protect territory from 
other damage from pests   G/SPS/N/USA/1499 
Page 2  
 
  8. International standard, guideline or recommendation: 
[ X ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [   ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
Codex Standard for "Gluten-Fr ee Foods" (Codex Stan 118-1981) 
(http://www.codexalimentarius.ne t/web/standard_list.do?lang=en ), which was established in 
1981 and amended (labeling provisions only) in 1983.  (Note:  For the past several years, the Codex Committee on Nutrition and Foods fo r Special Dietary Uses has considered 
revisions to this existing standard.  Th e Committee will continue to discuss proposed 
revisions at its next session in November 2007.) 
Some major differences between the proposed FDA definition of gluten-free foods and the 
existing Codex standard for gluten-free foods are: 
• FDA's proposed definition of "gluten-free" rule includes the criterion that a food so 
labeled cannot contain 20 ppm or more gl uten.  In comparison, the existing Codex 
standard defines the term "gluten-free" to mean the total nitrogen content of gluten-
containing cereal grains used in the food so labeled cannot exceed 0.05 grams (g) per 
100 g of these grains on a dry weight basis. 
• FDA's proposed rule defines "gluten" to mean  the proteins that naturally occur in a 
prohibited grain and that may cause adverse hea lth effects in persons with celiac disease.  
The proposal also defines "prohibited grain" to mean any species of wheat, rye or barley 
or their crossbred hybrids (e.g. triticale).  The proposal does not identify oats as a 
prohibited grain or source of gluten.  In co mparison, the existing Codex standard defines 
"gluten" to mean those proteins commonly fou nd in wheat, triticale, rye, barley or oats to 
which some persons are intolerant. 
• FDA's proposed rule would allow a food la beled gluten-free to contain ingredients 
derived from wheat, rye, barley or their crossb red hybrids only if such ingredients were 
processed to remove gluten and the finished f ood did not contain 20 ppm or more gluten.  
In addition, FDA's proposal would allow foods  labeled gluten-free to contain oats and 
their derivatives, provided that the finished food did not contain 20 ppm or more gluten.  
In comparison, the Codex standard permits a food labeled gluten-free to contain wheat, 
triticale, rye, barley or oats
 and their constituents only if th ey have been rendered gluten-
free (i.e., total nitrogen content of gluten-containing cereal grains does not exceed 0.05 g/100 g dry grain).   
• FDA's proposed definition of gluten-free app lies to all foods, including those specially 
formulated by substituting ingredients that do not contain gluten for ingredients that do, those made with ingredients specifically pro cessed to remove gluten, and those in their 
unprocessed or natural form which inherently do  not contain gluten.  In comparison, the 
Codex standard applies only to foods whic h have been specially formulated by 
substituting ingredients that do not contain glut en for ingredients that do and foods made 
with ingredients specifically processed to not contain gluten and foods specifically 
processed to remove gluten, but the standard  does not apply to foods in their unprocessed 
or normal form which inherently do not contain gluten. 
9. Relevant documents and language(s) in which these are available:  The proposed rule 
was published in the Federal Register:  23 January 2007 (Volume 72, Number 14), 
Page 2795-2817 and can be electronically accessed at  http://a257.g.akamaitech.net/7/257/24 22/01jan20071800/edocket.access.gpo.gov/2007/E7-
843.htm .  Available only in English.  G/SPS/N/USA/1499 
 Page 3 
 
 
  10. Proposed date of adoption:  Not yet determined.  A final rule is expected to be published 
in 2008 which will specify the effective date of implementation. 
11. Proposed date of entry into force:  Not yet determined.  A final rule is expected to be 
published in 2008 which will specify th e effective date of implementation.  
12. Final date for comments:  23 April 2007. 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or address, fax number and E-mail address (if 
available) of other body:   
Submit comments, referencing the docket number 2005N-0279, either electronically at 
http://www.regulations.gov  or http://www.fda.gov/dockets/ecomments  by following the 
instructions at the selected website, or in writing to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5 630 Fishers Lane, room 1061, Rockville, 
MD 20852.  Fax:  301-827-6870.  
13. Texts available from:  [   ] National noti fication authority, [ X ] National enquiry 
point, or address, fax number and E-mail address (if available) of other body:  
United States SPS National Notification Authority, USDA Foreign Agricultural Service, 
International Regulations and Standards Di vision (IRSD), Stop 1027, Washington D.C. 
20250.  Tel:  202-720-1301;  Fa x:  202-690-0677;  Email:  fstsd@fas.usda.gov  
The complete text for the proposed rule is found at 
http://a257.g.akamaitech.net/7/257/24 22/01jan20071800/edocket.access.gpo.gov/2007/E7-
843.htm .  Some documents filed in docket numbe r 2005N-0279 related to this rulemaking 
can be viewed at http://www.fda.gov/ohrms/dockets /dockets/05n0279/05n0279.htm .  
Copies of other such documents may be request ed under the Freedom of Information Act or 
can only be viewed onsite between the hours of 9:00 a.m. and 4:00 p.m. Monday through 
Friday at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061, Rockville, MD 20852.  Tel:  (301)827-6860;  Fax:  301-
827- 687;  TTY/TDD users:  1-800-735-2258.