. /.WORLD TRADE
ORGANIZATIONG/SPS/N/CAN/177
30 June 2003
(03-3464)
Committee on Sanitary and 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 num ber(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):  Maltogenic amylase (ICS: 67.180)
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 maltogenic amylase in starch used in the production of
dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup)
and a variety of baking products (available in English and French;  pages 1920-1921)
6. Description of content:
Provision currently exists in the Food and Drug Regulations for the use of the maltogenic
amylase from Bacillus subtilis  DN1413 (pDN1413), at levels of use consistent with good
manufacturing practice, in starch used in the production of dextrins, maltose, dextrose,glucose (glucose syrup) or glucose solids (dried glucose syrup) and a variety of baking
products.  Health Canada has received a submission to permit the use of a maltogenic
amylase obtained from a genetically modified Bacillus subtilis organism, the Bacillus
subtilis  LFA63 (pLFA63), that carries the gene from Bacillus stearothermophilus coding
for this enzyme.
Therefore, it is the intention of Health Canada to recommend that the  Food and Drug
Regulations be amended to permit the use of the maltogenic amylase enzyme obtained
from the genetically modified Bacillus subtilis LFA63 (pLFA63).  The use of this
maltogenic amylase will be permitted for the same purposes as the other maltogenicamylase enzyme, namely in starch used in the production of dextrins, maltose, dextrose,
glucose (glucose syrup) or glucose solids (dried glucose syrup) and a variety of baking
products, 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 maltogenic amylase
enzyme
 as indicated above while the regulatory process is undertaken to formally amend
the Regulations.  A revision to this notification 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.G/SPS/N/CAN/177
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, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection 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, 21 June 2003 (Available in English and French)
10. Proposed date of adoption:  Immediate for this IMA.  For this final regulation, will be
stated in subsequent Revision or Addendum to this notification.
11. Proposed date of entry into force:  Immediate for this IMA.  For this 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 Revision 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 notification authority, [ X ] National enquiry point,
or address, fax number and E-mail address (if available) of other body:
The electronic version of the regulatory text can be downloaded at:
http://canadagazette.gc.ca/partI/2003/20030621/pdf/g1-13725.pdf