. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/329 
20 May 2008  
 (08-2335) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
1. Member to Agreement notifying:  CANADA   
If applicable, name of local government involved:     
2. Agency responsible:  Health Canada 
3. Products covered (provide tariff item numb er(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):  Table-top sweetener tablets containing su cralose (ICS: 67.220) 
4. Regions or countries likely to be affected, to the extent relevant or practicable :  All 
trading partners 
5. Title, language and number of pages of the notified document:  Interim Marketing 
Authorization regarding the us e of L-leucine as a lubricant and/or binder in table-top 
sweetener tablets containing sucralose  (ava ilable in English and French,  2 pages) 
6. Description of content:  Health Canada has received a submission to permit the use of L-
leucine as a lubricant and/or binder in tabl e-top sweetener tablets containing sucralose. 
Evaluation of available data suppor ts the safety and effectiveness of L-leucine as a lubricant 
and/or binder in table-top sweetener tablets.  
The use of L-leucine will bene fit consumers through increased availability of quality table-top 
sweetener products. It will al so benefit industry through more efficient and improved 
manufacturing conditions.  
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations be amended to permit the use of L-leucin e as a lubricant and/or binder in table-
top sweetener tablets at levels consis tent with good manufacturing practice.  
As a means to improve the responsiveness of the regulatory system, an Interim Marketing 
Authorization (IMA) is being issued to permit the immediate use of L-leucine in the 
manufacture of table-top sweetener tablets containing sucralos e, at levels consistent with good 
manufacturing practice, while the regulatory process is undert aken to formally amend the 
Regulations.  
The proposed regulatory amendments would be en abling measures to allow the sale of table-
top sweetener tablets c ontaining L-leucine as a lubricant a nd/or binder. The amendments are 
supported by the safety  assessment and would have a lo w impact on the economy and the 
environment. Consequently, the regulatory am endments may proceed directly to final 
approval and publication in the Canada Gazette , Part II. G/SPS/N/CAN/329 
Page 2  
 
  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    
8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [ X ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:    
9. Relevant documents and language(s) in which these are available:   Canada Gazette , 
Part I, 10 May 2008, Pages 1442-1443 (ava ilable in English and French) 
10. Proposed date of adoption:  Immediate for this IMA. For the final regulation, normally 
within 12-18 months of publication of the Noti ce of Interim Marketing Authorization in the 
Canada Gazette , Part I, 10 May 2008. 
11. Proposed date of entry into force:  Immediate for this IMA. For the final regulation, 
normally within 12-18 months of publicati on of the Notice of Interim Marketing 
Authorization in the Canada Gazette , Part I, 10 May 2008. 
12. Final date for comments:  24 July 2008 
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: 
13. Texts available from:  [   ] National notifica tion authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
The electronic version of the regulator y text can be downloaded at:   
http://canadagazette.gc.c a/partI/2008/20080510/pdf/g1-14219.pdf  (Canada Gazette ) 
or  http://canadagazette.gc.ca/part I/2008/20080510/html/notice-e.html#d107
 (English) 
http://canadagazette.gc.ca/part I/2008/20080510/html/notice-f.html#d107   (French)