WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/2125 
22 December 2010  
 (10-6876) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  UNITED STATES
 
If applicable, name of local government involved:    
2. Agency responsible:  US Food and Drug Administration 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Food (ICS Code:  67.040) 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Proposed Rule: Food Labeling; Health Claim; 
Phytosterols and Risk of Coronary Heart Disease  Language:  English  Number of 
pages:  47 
6. Description of content:  The Food and Drug Administration (FDA) is proposing to amend 
the regulation authorizing a health claim on th e relationship between plant sterol esters and 
plant stanol esters and reduced risk of coronary heart disease (CHD) for use on food labels and in food labelling.  The agency is ta king this action based on evidence previously 
considered by the agency, and FDA's own revi ew of data on esterified and nonesterified 
plant sterols and stanols (collectively, phy tosterols) published since the agency first 
authorized the health claim by regulation.  FDA 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 co llective term for plant sterols and their hydrogenated stanol 
forms, whether used in the free form or ester ified with fatty acids.  As discussed in more 
detail elsewhere in this proposal, phytosterol is a term commonly used by manufacturers and distributors of these substances.  The proposal would amend the authorized use of the 
claim by modifying the nature of the substan ces that may be the subject of the claim for 
conventional foods to include nonesterified, or free, phytosterols, by expanding the types of 
foods that may bear the claim to include a br oader range of foods, by modifying the daily 
dietary intake of the substance specified in the claim as necessary for the claimed benefit, 
by adjusting the minimum amount of the substa nce required for a food to bear the claim, 
and by making other minor changes. 
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/2125 
Page 2  
 
  8. Is there a relevant international stan dard?  If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:    
9. Other relevant documents and language(s ) in which these are available:   
United States Federal Register;  8 December 2010; Vol. 75, Page 76526, 
http://edocket.access.gpo.g ov/2010/pdf/2010-30386.pdf  
US Code of Federal Regulations, titl e 21, part 101, secti on 83 (21 CFR 101.83) 
"http://ecfr.gpoaccess.gov/cgi/t/text/text-
idx?c=ecfr&sid=cb9aaedd1754 25012acd99d2da0f890d&rgn=di v8&view=text&node=21:2.
0.1.1.2.5.1.14&idno=21 " 
This document will appear in the Federal Register when adopted. 
10. Proposed date of adoption (dd/mm/yy) :  Not applicable 
Proposed date of publication (dd/mm/yy) :  Not applicable 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  Not applicable 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  22 February 2011 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:   
You may submit comments, identified by Docket Nos. FDA-2000-P-0102, FDA-2000-P-
0133, and FDA-2006-P-0033, by any of the following methods: 
Electronic Submissions  
Submit electronic comments in the following way: 
• Federal eRulemaking Portal:  http://www.regulations.gov .  Follow the instructions 
for submitting comments. 
Written Submissions  
Submit written submissions in the following ways: 
• Fax:  301-827-6870.  G/SPS/N/USA/2125 
 Page 3 
 
 
  • Mail/Hand delivery/Courier (for paper,  disk, or CD-ROM submissions): 
 Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD  20852 
For further information contact :  Blakeley Denkinger, Center for Food Safety and Applied 
Nutrition (HFS-830), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1450 
13. Texts available from:  [X] National Notification Authority, [ ] National Enquiry Point.  
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:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.spsenquirypoint@fas.usda.gov  
Complete text can be also be found on the Internet: 
http://edocket.access.gpo.g ov/2010/pdf/2010-30386.pdf