. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/308 
7 December 2007  
 (07-5427) 
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):  Glucoamylase enzyme (ICS: 67.160.20, 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 glucoamylase  in the production of standardized fruit juice 
(available in English and French, 1 page) 
6. Description of content:  Health Canada has received a subm ission to permit the use of the 
enzyme glucoamylase derived from Aspergillus niger  in the production of standardized fruit 
juice, specifically, apple juice, banana juice, gr ape juice, grapefruit juice, lemon juice, lime 
juice or lime fruit juice, orange juice, pear juice and pineapple juice.  Evaluation of available 
data supports the safety an d effectiveness of this glucoamylase derived from Aspergillus niger  
in these food products.  
The use of this glucoamylase enzyme derived from this micro-organism will benefit the 
consumer through the availability of quality f ood products.  It will also benefit industry 
through more efficient and improved manufacturing conditions. 
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations be amended to permit the use of glucoamylase derived from Aspergillus niger  in 
the production of single strength fruit juices at  levels consistent with good manufacturing 
practices. 
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 this glucoamylase 
enzyme derived from Aspergillus niger  in the single strength fruit juices listed above, at levels 
consistent with good manufacturing practices, wh ile the regulatory process is undertaken to 
formally amend the Regulations. 
The proposed regulatory amendments would be enabling measures to allow the use of the 
glucoamylase enzyme derived from Aspergillus niger .  The amendments are supported by the 
safety assessment and would have low impact  on the economy and on the environment.  
Consequently, the regulatory amendments ma y proceed directly to  final approval and 
publication in the Canada Gazette , Part II. G/SPS/N/CAN/308 
Page 2  
 
  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, 1 December 2007, Page 3300 (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, 1 December 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 Gazette , Part I, 1 December 2007. 
12. Final date for comments:  14 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/2007/20071201/pdf/g1-14148.pdf   (Canada Gazette) 
or  http://canadagazette.gc.ca/part I/2007/20071201/html/no tice-e.html#i7
  (English) 
http://canadagazette.gc.ca/part I/2007/20071201/html/notice-f.html#i7   (French)