. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/307 
28 November 2007  
 (07-5238) 
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):  Transglutaminase enzyme (ICS: 67.120, 67.220) 
4. Regions or countries likely to be affected, to the extent relevant or practicable :  Not 
stated. 
5. Title, language and number of pages of the notified document:  Interim Marketing 
Authorization regarding the use of transglutami nase in a variety of standardized meat and 
poultry products (available in English and French, 2 pages) 
6. Description of content:  Health Canada has received a subm ission to permit the use of the 
transglutaminase derived from Streptoverticillium mobaraense  strain S-8112 to improve the 
textural characteristics of a va riety of standardized meat a nd poultry products.  Evaluation of 
available data supports the sa fety and effec tiveness of using tran sglutaminase in these 
products at levels c onsistent with good manuf acturing practice.  
The use of transglutaminase will benefit consum ers by increasing the av ailability of a greater 
variety of quality meat and poultry products.  It will also benefit indus try by facilitating the 
manufacture of these food products. 
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations  be amended to permit the use of transglutaminase in prepared meat, prepared 
meat by-product, prepared poultry meat, prepar ed poultry meat by-product, solid cut meat 
with or without added phosphate salts, solid cu t poultry meat with or without added phosphate 
salts, pumping pickle and cover pickle, preser ved meat, preserved meat by-products, sausage, 
preserved poultry meat, preserved poultry meat by-product, meat loaf and meat by-product 
loaf at levels consistent 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 transglutaminase in the 
products listed above, while the regulatory pr ocess is undertaken to formally amend the 
Regulations. G/SPS/N/CAN/307 
Page 2  
 
   The proposed regulatory amendments would be enabling measures to allow the sale of 
additional foods containing transglutaminase  as an agent to improve the textural 
characteristics of the food.  The amendments are supported by the safety assessment and 
would have low impact on the economy and th e environment.  Consequently, the regulatory 
amendments may proceed directly to final approval and publication in the Canada Gazette , 
Part II.  
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, 24 November 2007, Pages 3242-3243 (available in English and French) 
10. Proposed date of adoption:  Immediate for this IMA.  Fo r the final regulation, normally 
within 12-18 months of publication of the Noti ce of Interim Marketing Authorization in the 
Canada Gazette, Part I, 24 November 2007. 
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 Gaze tte, Part I, 24 November 2007. 
12. Final date for comments:  7 February 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/2007/20071124/pdf/g1-14147.pdf   (Canada Gazette) 
or  http://canadagazette.gc.ca/part I/2007/20071124/html/no tice-e.html#i3
  (English) 
http://canadagazette.gc.ca/part I/2007/20071124/html/notice-f.html#i3   (French)