./.WORLD TRADE
ORGANIZATIONG/SPS/N/CAN/41
2 October 1998
(98-3830)
Committee on Sanitary and Phytosanitary Measures
NOTIFICATION
1. Member to Agreement notifying:  CANADA
If applicable, name of local government involved:           
2. Agency responsible:   Department of Health
3. Products covered (tariff item number(s) as specified in national schedules deposited
with the WTO.  ICS numbers may be provided in addition, where applicable):   Novel
foods
4. Title and number of pages of the notified document:   Proposed Amendment to the Food
and Drug Regulations (948) (pages 2502-2509)
5. Description of content:
Rapid advances in food science and biotechnology have resulted in the development of a
variety of foods that were not previously ava ilable in the Canadian marketplace, or that have
been modified from their traditional composition.  In view of these developments, there is a
need for a formal mechanism whereby these foods, commonly referred to as “novel foods”,
are notified to the Department of Health and, if deemed necessary, are assessed for safetyprior to their sale to consumers.
Currently, a voluntary system exists where firms seeking to place a novel food on the market
voluntarily submit information to the Departme nt, enabling a safety review.  This proposed
amendment will formalize the current voluntar y system.  Public satisfaction with the
thoroughness of the approaches implemented fo r evaluating the safety of novel foods is
important to their acceptance by consumers.
The Food and Drug Regulations offer a number of mechanisms to control the sale of food in
Canada.  These mechanisms include pre-market  notification, an approach which entails the
submission of information regarding the product in question to the Health Protection Branch
of Health Canada (HC) such that a determina tion can be made with respect to its acceptability
as food prior to sale.  This is the approach which has been selected with respect to "novel
foods".
It is proposed that a new Di vision (i.e. chapter) of the Food and Drug Regulations be
established that defines the concept of a "novel food" and provides for notification prior to the
sale or advertising for sale of such products.
6. Objective and rationale:  Protection of human health
7. An international standard, guideline or recommendation does not exist [ X ].G/SPS/N/CAN/41
Page 2
If an international standard, guideline or  recommendation exists, whenever possible,
identify deviations:           
8. Relevant documents and language(s) in which these are available:  Canada Gazette,
Part I, 26 September 1998;  English and French
9. Proposed date of adoption:  Not stated.
10. Proposed date of entry into force:  Not stated.
11. Final date for comments:  25 November 1998
Agency or authority designated to handle comments:  National Enquiry Point
12. Texts available from:  National enquiry point [  X ] or address, telefax number and
E-mail address (if available) of other body:            