. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/113 
18 May 2005 
 (05-2024) 
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  (118) 
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):   Sucralose  
(HS Chapter:  2106;  ICS:  67) 
5. Title, number of pages and language(s) of the notified document:   Food Labeling; 
Health Claims;  Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries 
(7 pages, in English) 
6. Description of content:   The Food and Drug Administration (FDA) is proposing to amend 
the regulation authorizing a health claim on noncariogenic carbohydrate sweeteners and 
dental caries, i.e., tooth decay, to include sucr alose, a nonnutritive sweetener.  Similar to the 
sweeteners currently authorized to make a h ealth claim, sucralose is used as a sugar 
substitute that is minimally fermented, relativ e to sugar, by oral microorganisms and thus 
does not contribute to production of organic aci ds by plaque bacteria as do the fermentable 
sugars for which it is a substitute.  FDA is taki ng this action in response to a health claim 
petition filed by McNeil Nutritionals.  The agen cy previously concluded that there was 
significant scientific agreement for the relati onship between slowly fe rmented carbohydrate 
sugar substitutes, specifically cer tain sugar alcohols, and the nonpromotion of dental caries. 
Based on the totality of publicly available scien tific evidence, FDA now has determined that 
the nonnutritive sweetener sucralose, like the sugar alcohols, is not fermented by oral 
bacteria to an extent sufficient to lower dental  plaque pH to levels that would contribute to 
the erosion of dental enamel.  Therefore, FDA has concluded that sucralose does not promote dental caries, and it is  proposing to amend the regulati on authorizing a health claim 
relating certain noncariogenic sweeteners and nonpromotion of dental caries to include 
sucralose as a substance eligible for the claim. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health G/TBT/N/USA/113 
Page 2  
 
 8. Relevant documents:   70 Federal Register (FR) 25496 13 May 2005;  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:  27 July 2005 
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:   
Full Text of this Notification is Now Available on the Internet at URLs: 
http://a257.g.akamaitech.net/7/257/24 22/01jan20051800/edocket.access.gpo.gov/2005/05-
9608.htm 
http://a257.g.akamaitech.net/7/257/24 22/01jan20051800/edocket.access.gpo.gov/2005/pdf/
05-9608.pdf