. /.WORLD TRADE
ORGANIZATIONG/SPS/N/CAN/55
14 July 1999
(99-2909)
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:  Department of Health
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers may be provided in addition, where
applicable).  Regions or countries likely to be affected, to the extent relevant or
practicable:  Biotechnology substances
4. Title and number of pages of the notified document:  Proposed Environmental
Assessment Regulations (Department of Health) (pages 2000-2012)
5. Description of content:  It is proposed that regulations entitled Environmental Assessment
Regulations, be added to the Food and Drugs Act (the Act).  These regulations will provide
for the environmental assessment of new substa nces from biotechnology that are foods, drugs
or cosmetics.
The proposed regulations will provide for both health and environmental assessments to be
carried out by Health Canada for products of biotechnology, regulated under this Act.  These
regulations will apply to foods, drugs and cosme tics that are microorganisms, cultured cells or
transgenic animals, or products derived fro m microorganisms, cultured cells, transgenic
animals or plants.
The proposed regulations will provide a flexible regulatory framework for this rapidly
evolving technology while protecting the health a nd safety of Canadians.  They also fulfill the
Government’s commitment to develop environmental assessment regulations under the Act to
provide a single window for product review.  The environmental assessment requirements
outlined in these regulations complement the no tification and human health assessments in the
Food and Drug Regulations and the Cosmetic Regulations.
Health Canada will be working in close cooperation with the Canadian Food Inspection
Agency (CFIA) for all environmental assessmen ts of products from transgenic animals and
plants.  In such instances, it is proposed that CFIA will carry out the environmental
assessment of the animal or the plant, while at  the same time, Health Canada will assess the
products, thus eliminating duplication.
6. Objective and rationale: [  X ] food safety,  [  X ] animal health,  [  X ] plant protection,
[    ] protect humans from animal/plant pest or disease, [     ] protect territory from
other damage from pests           G/SPS/N/CAN/55
Page 2
7. An international standard, guideline or recommendation does not exist [  X ].
If an international standard, guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:           
8. Relevant documents and language(s) in which these are available:  Canada Gazette,
Part I, 3 July 1999 (Available in English and French)
9. Proposed date of adoption:  Not stated.
10. Proposed date of entry into force:  Not stated.
11. Final date for comments:  17 August 1999
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:           
12. Texts available from: [     ] National notification authority, [  X ] National enquiry point
or address, fax number and E-mail address (if available) of other body: