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New Substances Program

• Who is Required to Notify?
• What is a New or Flagged Substance?
• How to Notify?
• Published Orders
• Additional Information and Resources

Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Government of Canada uses a preventative approach to managing the risks new substances may pose to humans or to the Canadian environment.

Under the New Substances Program, Health Canada and Environment Canada examine the potential risks to Canadians and their environment before the substances enter the Canadian marketplace.

The  New Substances Program is responsible for administrating the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) of CEPA 1999. These regulations were created to ensure that no new substances (chemicals, polymers or organisms) are introduced into the Canadian marketplace before undergoing ecological and human health assessments. A substance is considered to be new to Canada if it is not listed on the  Domestic Substances List (DSL).

Who is Required to Notify?

Any company or individual who intends to import or manufacture a new or flagged substance in Canada is required to notify under the New Substances Notification Regulations (NSNR).

What is a New or Flagged Substance?

Any substance not included on the DSL or that appears on the DSL and is flagged with a Significant New Activity Notice (SNAc) or a  Reduced Regulatory Requirement (RRR) is subject to the NSNR. These regulations apply to chemicals, polymers, biochemicals, biopolymers and biotechnology (living organisms). View the  Comprehensive Listing of Substances that are Subject to a Significant New Activity Notice.

How to Notify?

The NSNR require that any person who intends to import or manufacture a substance subject to notification under the regulations must submit a New Substances Notification (NSN) package to Environment Canada, containing all information prescribed in the regulations, prior to import or manufacture of the substance.

For guidelines relating to notification and testing of new substances, please consult:

•  Guidance Documents for Biotechnology (Living Organisms)
•  Guidance Documents for Chemicals and Polymers

Advisory notes are available to clarify certain aspects of the NSN Program for the benefit of individuals responsible for complying with the NSNR:

•  Advisory Notes: Biotechnology (Living Organisms)
•  Advisory Notes: Chemicals and Polymers
•  Advisory Notes: Nanomaterials

For information regarding the preparation of NSN packages, please consult:

•  Notification Forms for Chemicals, Polymers, Biochemicals, and Biopolymers
•  Notification Forms for Biotechnology (Living Organisms or Micro-organisms)

Additional information and forms required for the notification process can be acquired from the  New Substances Notification Web page.

Published Orders

When Environment Canada and Health Canada suspect that a new substance may meet one or more of the criteria of  section 64 of CEPA 1999, control measures are imposed to minimize any risks to the environment or human health. Additionally, when it is suspected that a SNAc in relation to a substance may result in the substance meeting one or more of the criteria of section 64 of CEPA 1999, a notice is issued to ensure that adequate additional information is provided by the notifier or any other proponent who wishes to manufacture, import or use the substance for activities not specified by the notice. These Orders are published in the  Canada Gazette.

Consult the CEPA Environmental Registry to view details on published  Orders.

Additional Information and Resources

Search the DSL for substances using:

•  Search Engine for Chemicals and Polymers
•  Search Engine for Organisms

Other good sources for information regarding the regulation of New Substances in Canada:

•  Administrative Change for New Substances Used in Products Regulated by the Food & Drugs Act
•  Environmental Assessment unit
•  Factsheets by Industry sector
•  It's Your Health - Assessing and Managing Health Risks of New Substances under the Canadian Environmental Protection Act, 1999
•  New Substances Fees Regulations

For further information on  chemicals and polymers or  biotechnology (living organisms) subject to the NSNR and determining the need to notify, please consult Environment Canada's  New Substances Notification webpage.

For all other information on the notification and assessment of new substances under CEPA 1999, please contact the Substances Management Information Line.