New substances risk assessment exemptions

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, 1999) 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 CEPAcriteria:

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 Pest Control Products Act & Pest Control Products Regulations
Feeds Act & Feeds Regulations Feeds Act & Feeds Regulations
Fertilizers Act & Fertilizers 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.

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)
Seeds Act and Seeds Regulations Canadian Food Inspection Agency Website All plants with novel (new) traits (PNT) including food crops, trees, horticultural, and marine plants, intended for planting in the environment
Feeds Act and Feeds Regulations Canadian Food Inspection Agency Website All new livestock feeds, including new feed ingredients
Health of Animals Act and Health of Animals Regulations (Veterinary Biologics) Canadian Food Inspection Agency Website All novel veterinary biologics (i.e. live veterinary product like certain animals vaccines and test kits)
Fertilizers Act and Fertilizers Regulations Canadian Food Inspection Agency Website All new fertilizers (i.e. chemicals) and new novel supplements (i.e. organisms)
Pest Control Products Act and Pest Control Products Regulations Health Canada - Pest Management Regulatory Agency All new substances in pest control products
Canadian Environmental Protection Act, 1999, New Substances Notification Regulations (Chemicals and Polymers) and New Substances Notification Regulations (Organisms) Environment Canada Website and Health Canada Website

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 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

Microorganism
New Substance Regulatory Authority
livestock feed Feeds Act and Feeds Regulations
fertilizer Fertilizers Act and Fertilizers Regulations
animal biologic Health of Animals Act and Health of Animals Regulations (Veterinary Biologics)
human biologic

Food and Drugs Act (human safety and efficacy) and Notification Regulations

Canadian Environmental Protection Act, 1999 and New Substances Notification Regulations

a pest control product Pest Control Products Act and Pest Control Products Regulations
any other use (e.g. bioremediation, industrial enzyme production, waster water, etc.) Canadian Environmental Protection Act,1999 and New Substances Notification Regulations
Plant
New Substance Regulatory Authority
grown in the environment Seeds Act and Seeds Regulations
imported plants used for food (directly)

Plant Protection Act (plant pest risk ass.) and Food and Drugs Act (food safety)

Canadian Environmental Protection Act, 1999 and New Substances Notification Regulations

plant material to be used as livestock feed (directly) Feeds Act and Feeds Regulations
any other use Canadian Environmental Protection Act,1999 and New Substances Notification Regulations
Animal or Fish
New Substance Regulatory Authority
released into the environment

Fisheries Act (fish health permit) or Health of Animals Act (animal health permit)

Canadian Environmental Protection Act, 1999 and New Substances Notification Regulations

used as food

Food and Drugs Act (food safety)

Canadian Environmental Protection Act, 1999 and New Substances Notification Regulations

Chemical or Polymer
New Substance Regulatory Authority
a pest control product Pest Control Products Act and Pest Control Products Regulations
a livestock feed Feeds Act and Feeds Regulations
a fertilizer Fertilizers Act and Fertilizers Regulations
veterinary drug

Health of Animals Act

Canadian Environmental Protection Act, 1999 and New Substances Notification Regulations

a drug, cosmetic, food or medical device

Food and Drugs Act (human or food safety, drug efficacy)

Canadian Environmental Protection Act,1999 and New Substances Notification Regulations

any other use Canadian Environmental Protection Ac,1999 and New Substances Notification Regulations
Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: