WORLD TRADE  
ORGANIZATION   
G/SPS/N/CAN/554 
3 August 2011  
 (11-3934) 
Committee on Sanitary and Phytosanitary Measures Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
1. Notifying Member:  CANADA 
If applicable, name of local government involved:    
2. Agency responsible:  Health Canada 
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):  Cross-linked Carboxymethyl cellulose (ICS Code: 67.220) 
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:  Information Document on Health Canada's Proposal to 
amend the Food and Drug Regulations  to allow the use of cross-linked Carboxymethyl 
cellulose in table-top sweetener tablets  Language(s):  English and French  Number of 
pages:  8 and 9 
6. Description of content:  This document provides informati on on Health Canada's proposal 
to amend the Food and Drug Regulations  ("Regulations") to permit the use of cross-linked 
Carboxymethyl cellulose in table-top sweetener tablets.  Cross-linked Carboxymethyl cellulose (cross-linked CMC) would be used as a disintegrant to decrease the time required for tablets to dissolve in beverages. 
Health Canada received a submis sion requesting that the Regula tions be amended to permit 
the addition of L-leucine and cross-linked CMC at a level of 10 per cent and 2 per cent 
(w/w), respectively, in tablet formulations of sucralose-containing table-top sweeteners.  
L-leucine is an amino acid perm itted to be added to infant fo rmulas and formulated liquid 
diets.  A provision also currently exists in Table VIII, Division 16, of the Food and Drug 
Regulations for the use of L-leucine, at 3 per cent of tablet weight, as a lubricant in the 
manufacture of table-top sweetener tablets containing aspartame.  As L-leucine is already 
an approved food additive under Division 16, the requested extension of use to a new food 
was eligible for an Interim Marketing Aut horization (IMA) once the evaluation of the 
submission confirmed that there would be no huma n health concerns with the proposed use.  
As a result, the requested use of L-leucine as a lubricant and/or binder in table-top 
sweetener tablets at levels consistent w ith good manufacturing practice was enabled under 
an IMA that was published in the Government  of Canada's official newspaper, the Canada 
Gazette  on 10 May 2008 (notifie d under G/SPS/N/CAN/329). G/SPS/N/CAN/554 
Page 2  
 
  Cross-linked CMC is the product resulting from the treatment of Carboxymethyl cellulose 
with acid and heat, and is not a permitted f ood additive in Canada.  Although a related 
additive, Carboxymethyl cellulose is currently pe rmitted at different levels in a variety of 
foods as listed in Table IV, Division 16, of the Regulations, cross-linked CMC is considered a new food additive in Canada and w as therefore not eligible for an IMA.  As a 
result, cross-linked CMC is the focu s of the current notification.  
Health Canada's Food Directorate has completed a safety assessment of cross-linked CMC 
when used as described in the submission.  As no safety concerns have been raised with the 
proposed use in sucralose-containing table-top sweetener tablets, the department is proposing amendments to the Regulations to a llow the proposed use of cross-linked CMC.  
Further, based on the safety data, it is propo sed that the use of this additive may be 
permitted in table-top sweeteners  containing any of the sweetene rs approved for such use in 
table-top sweeteners under Table IX, Division 16, of the Regulations.  Such provisions 
would allow for the use of cross-linked CMC wh en there is a technological justification, 
that is, when the sweeteners are sold in tablet form.  This approach is consistent with that 
taken for L-leucine, the use of which has prev iously been enabled in table-top sweetener 
tablets. 
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. Is there a relevant international stan dard?  If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)  
 Cross-linked CMC (INS 468) was adopted in 2005 by the Codex Alimentarius 
Commission as an additive permitted for use in food in general, unless otherwise specified, in accordance with GMP (Table Three of the General Standard for Food 
Additives). 
 Available in English and French: 
 http://www.codexalimentarius.net/gsfaon line/foods/details.html?id=186&lang=en  
(English) 
 http://www.codexalimentarius.net/gsfaon line/foods/details.html?id=186&lang=fr  
(French) 
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] None Does this proposed regulation conform to the relevant international standard?   
 [X] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:     G/SPS/N/CAN/554 
 Page 3 
 
 
  9. Other relevant documents and language(s ) in which these are available:   
Health Canada's Food and Nutrition - "Public  Involvement and Partnerships" Website, 
posted 28 July 2011 (available in English and French):  
http://www.hc-sc.gc.ca/fn-a n/consult/index-eng.php  (English) 
http://www.hc-sc.gc.ca/fn-an/consult/index-fra.php  (French) 
10. Proposed date of adoption (dd/mm/yy) :  Normally within four to five months from the 
posting of the Information Document  on the Health Canada website. 
Proposed date of publication (dd/mm/yy) :    
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  On the date the measure is adopted. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  11 October 2011 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:    
13. Texts available from:  [ ] National Notification  Authority, [X] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:    
The electronic version of "Information Docume nt on Health Canada's Proposal to amend 
the Food and Drug Regulations to allow the use of cross-linked Carboxymethyl cellulose in 
table-top sweetener tablet s" can be downloaded at:  
"http://www.hc-sc.gc.ca/fn-an/consult/food- additives/carboxymethyl-cellulose/consult-
carboxymethyl-cellulose-eng.php " (English)  
"http://www.hc-sc.gc.ca/fn-an/consult/food- additives/carboxymethyl-cellulose/consult-
carboxymethyl-cellulose-fra.php " (French)