. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/165 
6 January 2006 
 (06-0030) 
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) (174) 
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):    
Barley and barley-containing foods (HS:  1101, 1102, 1103, 1104;  ICS: 67) 
5. Title, number of pages and language(s) of the notified document:   Food Labeling: 
Health Claims; Soluble dietary fiber from certain foods and coronary heart disease; Interim 
final rule (12 pages, in English) 
6. Description of content:   The Food and Drug Administration (FDA) is amending the 
existing regulation authorizing the use on food la bels of a health claim about beta-glucan 
soluble fiber from whole oat foods and risk of heart disease, to include whole grain barley and dry milled barley products as additional e ligible sources of beta-glucan soluble fiber. 
Based on the totality of publicly available sci entific evidence, FDA has determined that 
blood cholesterol-lowering effects of oats and barley are equivalent.  Therefore, FDA has 
concluded that consuming beta -glucan-containing whole grain barley or certain dry milled 
barley products may help reduce blood c holesterol levels, and FDA is amending 
21 CFR 101.81 to include whole grain barley and certain dry milled barley products as 
substances eligible for the soluble dietary fiber- heart disease risk health claim.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
To protect human health (provide for food labeling statements regarding usefulness of 
consuming beta-glucan-containing oats and barley foods in helping to reduce heart disease 
risk) 
8. Relevant documents:   70 Federal Register (FR) 76150 23 December 2005; Title 21 Code 
of Federal Regulations (CFR) Part 101.  Will a ppear in the Federal Register when adopted. G/TBT/N/USA/165 
Page 2  
 
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   8 March 2006 
11. Texts available from:  National enquiry point [    ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Complete text can be found on the Internet at: 
http://a257.g.akamaitech.net/7/257/24 22/01jan20051800/edocket.access.gpo.gov/2005/05-
24387.htm 
http://a257.g.akamaitech.net/7/257/24 22/01jan20051800/edocket.access.gpo.gov/2005/pdf/
05-24387.pdf 
http://www.accessdata.fda.gov/scripts/oc/ohrms/i ndex.cfm (by looking under DOCKET No. 
2004P-0512)