. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/606 
17 December 2010  
 (10-6806) 
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 governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Food and Drug Administration (FDA) (623) 
Name and address (including telephone and fax numbers, e-mail and website 
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):  Food (ICS 67.040) 
5. Title, number of pages and langu age(s) of the notified document:  Food Labelling;  Health 
Claim;  Phytosterols and Risk of Coronary Heart Disease (47 pages,  in English).     
6. Description of content:  The Food and Drug Administration (FDA) is proposing to amend 
the regulation authorizing a health claim on the relationship between plan t sterol esters and 
plant stanol esters and reduced risk of coro nary heart disease (CHD) for use on food labels 
and in food labelling.  The agency is taking this action based on evidence previously considered by the agency, and FDA's own review of data on esterified and nonesterified plant 
sterols and stanols (collectively,  phytosterols) published since the agency first authorized the 
health claim by regulation.  FD A is also taking these actions, in  part, in response to a health 
claim petition submitted by Unilever United States , Inc.  The term "phytosterols" is used as a 
collective term for plant sterols and their hydrogenated stanol forms, whether used in the free 
form or esterified with fatty acids.  As discu ssed in more detail elsewhere in this proposal, 
phytosterol is a term commonly used by manufactu rers and distributors of  these substances.  
The proposal would amend the authorized use of  the claim by modifying the nature of the 
substances that may be the subject of th e claim for conventional foods to include 
nonesterified, or free, phy tosterols, by expanding the types of foods that may bear the claim to 
include a broader range of foods, by modifyi ng the daily dietary intake of the substance 
specified in the claim as necessary for the claimed benefit, by adjusting the minimum amount of the substance required for a food to bear th e claim, and by making  other minor changes.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human life and health.  
8. Relevant documents:   75 FR 76526;  8 December 2010;  Title 21 Code of Federal 
Regulations (CFR) Parts 83 and 101.  Will appear in the Federal Register when adopted.   G/TBT/N/USA/606 
Page 2  
 
  9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:  22 February 2011 
11. Text available from: National enquiry point [X], or address, telephone and fax numbers, 
e-mail and website addresses, if available of the other body:  
Complete text can be be found on the Internet  
http://edocket.access.gpo.gov/2010/2010-30386.htm  
http://edocket.access.gpo.gov/2010/pdf/2010-30386.pdf