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:

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.