. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/CAN/554/Add.1 
17 April 2012  
 (12-2014) 
Committee on Sanitary and Phytosanitary Measures Original:   English/ 
  French 
 
 
 
NOTIFICATION 
 
Addendum 
 
 
The following communication, received on 5 April 2 012, is being circulated at the request of 
the Delegation of Canada. 
_______________ 
 
Regulations Amending the Food and Drug Regulations (1571 - Food Additives) 
 Health Canada has received a submis sion from industry requesting that the Food and Drug 
Regulations  be amended to permit the use of two food a dditives:  (1) L-leucine to be used as a 
lubricant and/or binder in the production of table- top sweetener tablets containing sucralose, at a 
maximum level of use of 10 per cent of tablet wei ght;  and (2) carboxymethyl cellulose, cross-linked, 
also called sodium carboxymethyl cellulose, cross-linked,  to be used for tablet disintegration in table-
top sweetener tablets containing sucralose, at a maximum level of use of 2 per cent of tablet weight. 
 An Interim Marketing Authorization ("IMA") was issued to permit the immediate use of L-
leucine as proposed in the submission while the regulatory process was undertaken to amend the 
Regulations.  The IMA for L-leucine was publis hed in the government notices section of the Canada 
Gazette , Part I, on 10 May 2008 (G/SPS/N/CAN/329). 
 As a new food additive, carboxymethyl cellu lose, cross-linked (sodium carboxymethyl 
cellulose, cross-linked), did not meet the IMA el igibility requirements.  Consequently, a public 
consultation on the proposal to ame nd the Regulations to permit the use of carboxymethyl cellulose, 
cross-linked (sodium carboxymethyl cellulose, cross-linked) in table-top sweetener tablets was conducted through postings on Hea lth Canada's Web site on 28 July 2011 (G/SPS/N/CAN/554). 
 Evaluation of available data supports the saf ety and effectiveness of these food additives in 
the above specified uses.  Therefore, the Food and Drug Regulations  have been amended to permit 
the use of the food additives mentioned above in the specified applications.  
 These Regulations entered into force on 15 March 2012.  
This addendum concerns a: 
[ ] Modification of final date for comments 
[X] Notification of adoption, publication or entry into force of regulation 
[ ] Modification of content and/or scope of previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[ ] Other:    G/SPS/N/CAN/554/Add.1 
Page 2  
 
  Comment period:  (If the addendum extends the scope of th e previously notified measure in terms 
of products and/or potentially affected Members, a new deadline for receipt of comments should be 
provided, normally of at least 60 calendar days.  Under other circumstances, such as extension of 
originally announced final date for comments, th e comment period provided in the addendum may 
vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) :  Not applicable 
Agency or authority designated to handle comments:  [ ] National Notification Authority, 
[ ] National Enquiry Point.  Address, fax num ber and e-mail address (if available) of other 
body: 
   
Text available from:  [ ] National Notification Au thority, [X] National Enquiry Point.  Address, 
fax number and e-mail address (if available) of other body: 
The full text of the adopted measure can be downl oaded from the Internet addresses indicated below: 
http://www.gazette.gc.ca/rp-pr/p2/201 2/2012-03-28/html/sor-dors44-eng.html  (English) 
http://www.gazette.gc.ca/rp-pr/p2/201 2/2012-03-28/html/sor-dors44-fra.html  (French) 
http://www.gazette.gc.ca/rp-pr/ p2/2012/2012-03-28/p df/g2-14607.pdf  (SOR/2012-44)   
or requested from: 
Canadian Enquiry Point 
Standards Council of Canada 200-270 Albert Street 
Ottawa, Ontario 
K1P 6N7 Tel:  +(613) 238-3222 Fax:  +(613) 569-7808 E-mail:  enquirypoint@scc.ca 
 
__________