. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/257/Add.1 
11 August 2010  
 (10-4269) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
NOTIFICATION 
 
Addendum
 
  
The following communication, received on 6 Augus t 2010, is being circulated at the request 
of the Delegation of Canada
. 
 
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Regulations Amending the Food and Drug Regulations (1560 - Food Additives)  
 Health Canada has received submissions from industry requesting that the Regulations be 
amended to enable the use of the lipase and phospholipase enzymes produced from the genetically 
modified and conventional sources of micro-organisms.  
 As a means to improve the responsiveness of the regulatory system, Interim Marketing 
Authorizations (IMAs) were issued to permit the immediate use of these food additives, while the 
regulatory process was undertaken to formally ame nd the Regulations.  They were published in the 
"Government Notices" section of the Canada Gazette , Part I, as follows: 
− 15 September 2001, lipase from Aspergillus oryzae  AI-11 (pBoel 960) in the production of 
modified triglycerides (modified fats and oils) a nd in flour used in the production of bread.  
− 8 October 2005, lipase from Aspergillus oryzae  BECh2#3 (pCaHj559) in the production of bread, 
flour and unstandardized bakery pr oducts, and in whole egg or e gg yolk modification and lecithin 
hydrolysis (notified as G/SPS/N/CAN/252).  
− 14 January 2006, lipase from Aspergillus oryzae  (MStr115) in the production of bread, flour and 
unstandardized bakery products a nd in whole egg or egg yolk modification and lecithin hydrolysis 
(notified as G/SPS/N/CAN/255).  
− 18 February 2006, phospholipase from Streptomyces violaceoruber  in the production of modified 
lecithins, and the hydrolysis of phospholipids in egg yolk, whole egg, blends of yolk and albumen and in soy lecithin (notified as G/SPS/N/CAN/257).  
− 5 August 2006, phospholipase from Aspergillus oryzae  (pPFJo142) in the production of cheddar, 
mozzarella and pizza cheese (notified as G/SPS/N/CAN/271).  
− 9 September 2006, lipase from Aspergillus niger  (pCaHj600/MBin118#11) in the production of 
modified fats and oils (notified as G/SPS/N/CAN/272).  
 Members were informed that a revision to the notifications would be published at the start of 
the amendment process at which time a comment period would be provided.  (In the case of the September 2001 Government Notice, this IMA was issu ed prior to June 2002, the date Canada began 
to notify its IMAs.  At the time that the IMA was issued, it was anticipated that the WTO notification 
would occur later when the appropriate re gulatory amendments were published in the Canada 
Gazette , Part I.) 
 However, in July 2006, the Canadian regul atory process was modified to permit regulatory 
amendments having low significance when assessed against a triage frame work to proceed directly to 
final approval and publication in Canada Gazette , Part II. G/SPS/N/CAN/257/Add.1 
Page 2  
 
   The IMAs noted above are enabling measures as they allow the sale of additional foods 
containing the food additive, or the sale of food containing the food additive at higher levels than 
previously permitted.  No concerns or issues have been identified by Canada's trading partners since 
the IMAs were issued.  
 Therefore, the Food and Drug Regulations  have been amended to permit the use of the food 
additives mentioned above in the specified applications. 
 These IMAs were revoked on 7 July 2010, the date on which these amendments came into 
force. 
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:    
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 commen ts:  [ ] National Notification Authority, [ ] 
National Enquiry Point.  Address, fax number 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 0/2010-07-07/html/sor-dors143-eng.html
 (English) 
http://canadagazette.gc.ca/rp-pr/p2/20 10/2010-07-07/html/sor-dors143-fra.html   (French) 
 
http://www.gazette.gc.ca/rp-pr/ p2/2010/2010-07-07/p df/g2-14414.pdf  (SOR/2010-143)   
 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  
 
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