|
Acts Listed in CEPA Schedules 2 and/or 4 Considered as "CEPA-equivalent" for the Purposes of Risk Assessment of New Substances
PDF Version [20 KB]
Anyone (person or company) who wants to import,
manufacture or sell any new substance is required to
notify the appropriate Canadian regulatory authority so
the new substance can be evaluated for potential effects
on human health and the environment prior to the
importation, manufacturing or sale (as the case may be).
The Canadian Environmental Protection Act, 1999 (CEPA) is
the key authority for the government to ensure that all
new substances are assessed for their potential to harm
human health or the environment. Recognizing that other
Acts provide for such an assessment process, CEPA includes
a provision whereby substances regulated by other Acts are
exempt from the new substance notification requirements of
CEPA. This avoids regulatory duplication, while ensuring
that standards for protection of the environment and human
health are met, and applied to all substances.
Under CEPA, the Government determines, by order, which
Acts and Regulations meet the above criteria for providing
appropriate notification and assessment and lists them in
published Schedules (or 'annexes') to CEPA. Acts
and Regulations relating to new substances that are
chemicals or polymers are listed in Schedule 2 and those
that are animate products of biotechnology are listed in
Schedule 4. To date, it has been determined that the
following Acts and Regulations meet the CEPA criteria:
TABLE 1 - CEPA SCHEDULES OF ACTS AND REGULATIONS (SEPT
13, 2001)
Schedule 2 (chemicals and polymers)
|
Schedule 4 (animate products of
biotechnology)
|
Pest Control Products Act & Pest Control
Products Regulations
|
Feeds Act & Feeds Regulations
|
Fertilizers Act & Fertilizers Regulations
|
Seeds Act & Seeds Regulations
|
Health of Animals Act & Health of Animals
Regulations (veterinary biologics)
|
Other Acts, such as the Food and Drugs Act, the Plant
Protection Act and the Fisheries Act, may be added to
these Schedules at a later date as they are amended or
created, and when they meet the CEPA criteria for listing.
At this time, new substances subject to these
"non-listed" Acts are also subject to the CEPA
New Substances Notification Regulations. Proponents are
encouraged to contact the appropriate agency to obtain
clarification. For more information on the CEPA New
Substances program, please call 1 800 567-1999 or visit
the New Substances website at
http://www.ec.gc.ca/substances.
Tables 2 and 3 relate
the regulatory responsibilities for new substances to
various Acts and Regulations as of September 13, 2001.
Table 2 is organized by regulatory authority, and Table 3
is organized by substance type and use.
TABLE 2 - ACTS AND REGULATIONS APPLICABLE TO THE
ENVIRONMENTAL AND HUMAN HEALTH ASSESSMENT OF NEW
SUBSTANCES
APPLICABLE LEGISLATION AND
REGULATIONS
|
RESPONSIBLE DEPARTMENT OR AGENCY
|
NEW SUBSTANCE (whether imported, made or
sold in Canada)
|
Canadian Food Inspection Agency
www.inspection.gc.ca
|
All plants with novel (new) traits (PNT) including
food crops, trees, horticultural, and marine plants,
intended for planting in the environment
|
Canadian Food Inspection Agency
www.inspection.gc.ca
|
All new livestock feeds, including new feed
ingredients
|
Canadian Food Inspection Agency
www.inspection.gc.ca
|
All novel veterinary biologics (i.e. live veterinary
product like certain animals vaccines and test kits)
|
Canadian Food Inspection Agency
www.inspection.gc.ca
|
All new fertilizers (i.e. chemicals) and new novel
supplements (i.e. organisms)
|
Health Canada, Pest Management Regulatory Agency
www.hc-sc.gc.ca/pmra-arla/english/index-e.html
|
All new substances in pest control products
|
Environment Canada and Health Canada www.ec.gc.ca
|
All remaining new substances
including:
-
New industrial chemicals, biochemicals,
polymers and biopolymers, (e.g. pigments,
plasticizers, additives, etc.) and organisms
(e.g. used in bioremediation, industrial
enzyme production, etc.)
-
Imports of plant material with novel (new)
traits (PNT) intended for direct use as food,
non-livestock feed, or for processing into
food or industrial products and not covered by
either the Seeds Act or the Feeds Act and
Regulations.
-
Genetically modified microorganisms not
covered by a CEPA listed Act and Regulation
-
Novel feeds for non-livestock animals (e.g.
new substances in pet foods)
-
Transgenic animals and fish
-
New substances in fertilizers and novel
supplements manufactured for export only
-
New substances used as intermediates to
manufacture pest control products
-
New substances in drugs (human and
veterinary), human biologics, cosmetics,
medical devices
|
TABLE 3 - REGULATORY AUTHORITY ORGANIZED BY NEW
SUBSTANCE TYPE AND USE
New Substance
|
Regulatory Authority
|
Feeds Act and Feeds Regulations
|
|
Fertilizers Act and Fertilizers Regulations
|
|
Health of Animals Act and Health of Animals
Regulations (Veterinary Biologics)
|
|
Food and Drugs Act (human safety and efficacy)
Notification Regulations
|
Canadian Environmental Protection Act, 1999: New
Substances Notification Regulations
|
Pest Control Products Act and Pest Control Products
Regulations
|
|
Canadian Environmental Protection Act,1999: New
Substances Notification Regulations
|
|
Seeds Act and Seeds Regulations
|
|
Plant Protection Act (plant pest risk ass.) and Food
and Drugs Act (food safety)
|
Canadian Environmental Protection Act, 1999: New
Substances Notification Regulations
|
Feeds Act and Feeds Regulations
|
|
Canadian Environmental Protection Act,1999: New
Substances Notification Regulations
|
|
Fisheries Act (fish health permit) or Health of
Animals Act (animal health permit)
|
Canadian Environmental Protection Act, 1999: New
Substances Notification Regulations
|
Food and Drugs Act (food safety)
|
Canadian Environmental Protection Act, 1999: New
Substances Notification Regulations
|
Pest Control Products Act and Pest Control Products
Regulations
|
|
Feeds Act and Feeds Regulations
|
|
Fertilizers Act and Fertilizers Regulations
|
|
Health of Animals Act
|
Canadian Environmental Protection Act, 1999: New
Substances Notification Regulations
|
Food and Drugs Act (human or food safety, drug
efficacy)
|
Canadian Environmental Protection Act,1999: New
Substances Notification Regulations
|
Canadian Environmental Protection Ac,1999: New
Substances Notification Regulations
|
|
|