. /.WORLD TRADE
ORGANIZATIONG/SPS/N/CAN/183
29 August 2003
(03-4520)
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 number(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):  Pectinase enzyme (ICS: 67.160.01, 67.080.01)
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 the pectinase enzyme in the manufacture of cider, wine,
fruit juices, and unstandardized fruit and vegetable products (Available in English and
French; pages 2500-2501)
6. Description of content:  Provision currently exists in the Food and Drug Regulations for
the use of the pectinase enzyme, at a maximum level of use consistent with good
manufacturing practice, in the production of cider, wine, distillers’ mash, single-strengthfruit juices, natural flavour and colour extractives, skin of citrus fruits destined for jam,
marmalade and candied fruit production, vegetable stock for use in soups and tea leaves for
the production of tea solids.
Health Canada has received a submission to permit the use of the pectinase enzyme
obtained from a genetically modified Aspergillus oryzae organism, the A.oryzae Km-1-1
(pA2PEI), that carries the gene from A.aculeatus strain KSM510 coding for this enzyme.
This pectinase enzyme would be used in the manufacture of cider, wine, fruit juices, and
unstandardized fruit and vegetable products.
Therefore, it is the intention of Health Canada to recommend that the Food and Drug
Regulations be amended to permit the use of the pectinase enzyme obtained from the
genetically modified A.oryzae Km-1-1 (pA2PEI).  The use of this enzyme will be permitted
in the production of cider, wine, fruit juices, and unstandardized fruit and vegetable
products, at a maximum level of use 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 the pectinase enzyme,
as indicated above, while the regulatory process is undertaken to formally amend theRegulations.  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/183
Page 2
7. Objective and rationale:  [  X ] food safety, [   ] animal health, [   ] plant protection,
[  ] protect humans from animal/plant pest or di sease,  [   ]  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, 16 August 2003 (Available 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 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/2003/20030816/pdf/g1-13733.pdf