New substances notifications

Those required to notify under the revised New Substances Notification Regulations (Chemicals and Polymers) [NSNR (Chemicals and Polymers)] and the New Substances Notification Regulations (Organisms) [NSNR (Organisms)] are any person who intends to import or manufacture a new substance in Canada (i.e. the Canadian Importer, the Canadian Manufacturer or the Foreign Importer of Record and their Canadian Agent. These regulations apply to chemicals, polymers, biochemicals, biopolymers and Living organisms (Biotechnology). New Substances Notification (NSN) packages must be submitted to Environment and Climate Change Canada prior to importing or manufacturing. Please follow the steps below to ensure you are submitting your NSN Package under the correct regulation (see exemptions below). If you are submitting a NSN Package under the Regulations follow the steps below to ensure your submission is complete.

The assessment process carried out by Environment and Climate Change Canada and Health Canada, which must be completed within a time limit specified by the Regulations, results in either:

  • a determination that the substance is not suspected of being "Toxic" or capable of becoming "toxic";
  • a suspicion that the substance is "toxic" or capable of becoming "toxic"; or
  • a suspicion that a significant new activity (SNAc) may result in the substance becoming toxic.

The Canadian Environmental Protection Act, 1999 (CEPA 1999) approach to the control of new substances is both proactive and preventive, employing a pre-import or pre-manufacture notification and assessment process. When this process identifies a new substance that may pose a risk to human health or the environment, the Act empowers the Minister of the Environment and the Minister of Health to intervene prior to or during the earliest stages of its introduction into Canada. This ability to act early makes the New Substances (NS) program an essential component of the federal management strategy for toxic substances.

What is a Substance?

A substance is any matter, whether organic or inorganic, animate (live) or inanimate (lifeless).

What is a New Substance?

A new substance is a substance that requires notification prior to import or manufacture and includes:

  1. All substances that do not appear on the Domestic Substances List (DSL). There are some exemptions - please see the "Exemptions" portion of the "Who Should Notify" page,
  2. Substances listed on the DSL with a "S" Flag. "S" Flag substances are proposed for a significant new activity and,
  3. Polymers listed on the DSL with a "P" Flag for which non RRR (Reduced Regulatory Requirement) version of the polymer is being proposed for import or manufacture

The DSL is a compilation of all known substances that were in Canadian commerce between 1984 and 1986 or that are added to the DSL in accordance with the Canadian Environmental Protection Act, 1999 (CEPA 1999). The DSL is amended regularly.

You can check to see if a substance you wish to import or manufacture is already on the DSL, on the DSL with P or S Flags, or not on the DSL, by viewing the DSL.

Please note a substance can have several names. To properly identify a substance, the DSL lists substances by unique identifiers:

For example:

  • The Chemical Abstract Service (CAS) Registry Number is used to identify chemicals and polymers
  • The Enzyme Commission (EC) number provided by the International Union of Biochemistry and Molecular Biology (IUBMB) is used to identify biochemicals that are enzymes
  • Strain numbers are used to identify micro-organisms such as the American Type Culture Collection (ATCC)
  • The Confidential Accession Numbers are used to identify substances listed on the Confidential portion of the DSL

If you know the unique identifier please use it to see if the substance is listed on the DSL. If you believe that the substance is listed on the confidential portion of the DSL but you do not know the Confidential Accession Number then you may submit a request for a confidential search to Environment and Climate Change Canada using the contact information below or see the "Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers" or "Guidelines for the Notification and Testing of New Substances: Organisms" for direction on how to submit a Confidential Search Request.

Determining the Need to Notify Under the New Substance Notification Regulations

  1. If your substance (s) unique identifier has been located on the DSL and is not subject to a "Flag":
    • The substance can be imported or manufactured in Canada without notification to the NSprogram
    • Please note - There may be other regulatory requirements under other Regulations (listed in Schedule 2 or 4 of the Act), other Acts or other jurisdictions. Please see below for the listing of CEPA-equivalent Acts (Schedules 2 and 4): listing the Acts that meet CEPA criteria.
  2. If your substance unique identifier has been located on the DSL and it is subject to a Flag:
    • Notification to the New Substances Division of Environment and Climate Change Canada must be made prior to import or manufacture unless
      1. it is subject to a P Flag and a RRR version of the polymer is proposed for import or manufacture
      2. it is subject to an S Flag and it is not proposed for a Significant New Activity
  3. If your substance unique identifier has not been located on the DSL:
    • An NSN Package must be submitted to the NSprogram prior to import or manufacture.
    Please note - There may be other regulatory requirements under other Regulations (listed in Schedule 2 or 4 of the Act), other Acts or other jurisdictions. Please see below for the listing of CEPA-equivalent Acts (Schedules 2 and 4): listing the Acts that meet CEPA criteria.
    • If you suspect the substance is on the confidential portion of the DSL you can submit a Confidential Search Request. Please see the Guidelines for the "Notification and Testing of New Substances: Chemicals and Polymers" or "Guidelines for the Notification and Testing of New Substances: Organisms" for direction on how to submit a Confidential Search Request.
  4. Exemptions and substances "Not Subject" to the Regulations
    • If your substance falls under one of the following exemptions or exclusions, then notification under the Regulations may not be required:
      • NS -Substances regulated under an Act listed in Schedule 2 or 4 of CEPA 1999
      • NS -Transient reaction intermediates
      • NS -Impurities
      • NS -Incidental reaction products
      • NS - Low volumes
      • NS -Naturally occurring substances
      • E - Substances carried through Canada
      • E - DSL listed bio/polymers modified by < 2% by weight
      • E - mixtures (includes hydrates and alloys)
      • E - Organism and micro-organism Research & for Development
    • See Section 3 of "Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers" or "Guidelines for the Notification and Testing of New Substances: Organisms" for more details on exemptions and substances not subject to the Regulations.

The Notification Process

1. For chemicals and polymers only: Determine the import volumes or the quantities manufactured in Canada.

2. To notify a chemical, polymer, biochemical, or biopolymer, use the chemicals and polymers NSN reporting form including the guide for the required fees:

A detailed explanation of the New Substances Notification Regulations: Chemicals and Polymers and the obligations of notifiers is contained in the "Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers".

Note: Notifiers have the option of submitting test data by regular mail, CD or email.

3. To notify Living Organisms (Biotechnology), use the Organisms NSN reporting form:

A detailed explanation of the New Substances Notification Regulations (Organisms) and the obligations of notifiers are contained in the "Guidelines for the Notification and Testing of New Substances: Organisms", link available below or go to the Biotechnology (Living Organisms) section of the website.

Note: Notifiers have the option of submitting test data by regular mail, CD or email.

Questions, Require Assistance?

If you require hard copies of the above documents or any part of the NSN process or other questions concerning new substances, please contact us

More information

The documents listed below are to provide assistance and information on compliance to the NSNR and the notification process.

The CEPA Environmental Registry is a comprehensive source of public information relating to activities under the Canadian Environmental Protection Act, 1999 (CEPA 1999). In addition to providing up-to-date copies of current CEPA 1999 instruments, the primary objective of the Environmental Registry is to encourage and support public participation in environmental decision-making, by facilitating access to documents arising from the administration of the Act. Under Section 12 of the Canadian Environmental Protection Act, 1999, the Minister of the Environment is mandated to establish a registry, to be called the "Environmental Registry". The Environmental Registry may be referred to as the CEPA Environmental Registry (or the "CEPA Registry").

Interpretation of "Toxic"

Except where the expression "inherently toxic" appears in Parts 5 and 6 of CEPA 1999, a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that:

  1. have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
  2. constitute or may constitute a danger to the environment on which life depends; or
  3. constitute or may constitute a danger in Canada to human life or health.

Foreign Importer of Record and Canadian Agent - Definitions

A Foreign Importer of Record is a company or individual that does not have a permanent physical residence in Canada. A Canadian Agent is a legal entity (whether individual or company) that represents a Foreign company (known as the Importer of Record). The Canadian Agent must have a permanent physical residence in Canada. Please see the "Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers" or "Guidelines for the Notification and Testing of New Substances: Organisms" for more information.

Living organisms (Biotechnology)

Living Organism is an animate product of biotechnology ("biotechnology" means the application of science and engineering in the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms)

Examples of living organisms

  • All genetically modified or bio-adapted micro-organisms
  • All genetically modified, bio-adapted, cloned, and chimeric plants and animals (including vertebrates and invertebrates)
  • Interspecies hybrids
  • Animals derived from in-vitro culture
  • Naturally occurring micro-organisms, plants and animals used in biotechnology applications such as bio-remediation, industrial enzyme production, fermentation

Examples of organisms not captured by the definition of a living organism

  • Naturally occurring micro-organisms, plants and animals including exotics not used in biotechnology applications such as pets, zoo animals, bait, livestock, horticulture
  • including those produced through artificial insemination, surrogate hosting and embryo splitting

What is a Flag?

Substances published on the DSL with an "S" Flag:

  • The "S" Flag indicates that the substance is subject to the Significant New Activity (SNAc) provisions under CEPA 1999
  • A substance published in the Canada Gazette with an "S" Flag is listed on the DSL once it has met all the eligibility criteria.
  • Any substance listed on the DSL with an "S" Flag must be re-notified if a significant new activity as outlined in the SNAc Notice is being proposed

Substances published on the DSL with a "P" Flag:

  • The "P" Flag indicates that it is a Reduced Regulatory Requirement (RRR) Polymer which is listed on the DSL
  • Any substance listed on the DSL with a "P" Flag must be re-notified if a Non RRR version of the polymer is being proposed for manufacture or import. The non-RRR version is not considered to be listed on the DSLand is considered to be a new substance.
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