. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/257 
24 February 2006 
 (06-0796) 
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 number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):  Phospholipase enzyme (ICS: 67. 020, 67.120)  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  not 
stated  
5. Title, language and number of p ages of the notified document:  Interim Marketing 
Authorization regarding the use of the phospholipase enzyme for the hydrolysis of phospholipids (English and French; pages 328-329).  
6. Description of content:   
Health Canada has received a submission to  permit the use of a phospholipase enzyme 
obtained from a conventional strain of Streptomyces violaceoruber .  Phospholipase enzymes 
are classified under the broad class of lip ase enzymes.  This phospholipase enzyme would 
be used for the hydrolysis of phospholipids, such  as lecithin, at levels consistent with good 
manufacturing practice.  Evaluation of availabl e data supports the safe ty and effectiveness 
of this phospholipase obtaine d from the above-cited source. 
 Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations  be amended to permit the use of this phospholipase enzyme obtained from the 
micro-organism specified above in the production of modified lecithins, and the hydrolysis of phospholipids in egg yolk, whole egg, blends  of yolk and albumen and soy lecithin at 
levels consistent with good manufacturing practice. 
 
As a means to improve the responsiveness of th e regulatory system, an Interim Marketing 
Authorization (IMA) is being issued to permit the immediate use of the phospholipase enzyme, as indicated above, while the regulat ory process is undertaken to formally amend 
the Regulations.  A revision to this notifica tion will be published at the start of the 
amendment process and Members will be given the opportunity at that time to submit 
comments on this proposed measure.  
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   G/SPS/N/CAN/257 
Page 2  
 
  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, 18 February 2006 (avail able in English and French).  
10. Proposed date of adoption:  Immediate for this IMA.  For the final regulation, will be stated 
in subsequent Revision or A ddendum to this notification.  
11. Proposed date of entry into force:  Immediate for this IMA.  For the final regulation, will 
be stated in subsequent Revision or Addendum to this notification.  
12. Final date for comments:  This document is not for comment at this time.  A comment 
period will be provided in a Re vision of this notification.  
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 noti fication authority, [ X ] National enquiry 
point, or address, fax number and E-mail address (if available) of other body:   
The electronic version of the regulat ory text can be downloaded at: 
http://canadagazette.gc.ca/partI/2006/20060218/pdf/g1-14007.pdf