Significant new activity provisions: Canadian Environmental Protection Act

The significant new activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA) trigger an obligation for a person to provide the Government of Canada with information about a substance when proposing to use, import or manufacture the substance for a significant new activity. The government then assesses the substance for potential risks to human health and/or the environment. If risks are identified, the government may impose management measures.

What is a significant new activity?

A significant new activity is an activity conducted with a substance in a different quantity, concentration or in different circumstances that could affect the environmental or human exposure to the substance. For a more detailed definition of a significant new activity, please refer to section 80 and section 104 of CEPA.

What constitutes a significant new activity (or activities) is specific to each substance and is found in the relevant SNAc publication in the Canada Gazette.

When are the significant new activity provisions applied to a substance?

The SNAc provisions are applied when a substance has been assessed and there is a suspicion that new activities may pose a risk to human health and/or the environment. These provisions can be applied to the full suite of substances managed under CEPA including chemicals, polymers, biochemicals, biopolymers and animate products of biotechnology (living organisms). The SNAc provisions can be applied to substances new to Canada (that is, not on the Domestic Substances List [DSL], regardless of Non-Domestic Substances List [NDSL] status), substances on the DSL or listed on Toxic substances list: schedule 1; irrespective of commercial status. See the policy on the use of significant new activity provisions of the Canadian Environmental Protection Act, 1999 for more information.

How does a person know if a substance is subject to the significant new activity provisions?

The search engine for substances is a searchable record of the substances that have been published in the Canada Gazette (for example, substances on the DSL, NDSL, as well as both new and existing substances subject to the SNAc provisions). The significant new activity publications under the Canadian Environmental Protection Act, 1999 also provides a searchable list of substances subject to the SNAc provisions. However, the Canada Gazette publications are the official source for SNAc publications.

If a substance that is listed on the DSL is subject to the SNAc provisions, the definition of the significant new activity or activities with respect to the substance, as well as the information required to be submitted to the government, appears next to the substance identifier (that is, Chemical Abstract Services Registration Number, strain identification number in the case of a living organism, or masked name or confidential accession number if the substance is listed on a confidential part of the DSL). The regulatory flags « S » or « S’ » next to the substance identifier on the DSL also serve as indicators that the substance is subject to the SNAc provisions.

If the substance is not listed on the DSL, it is considered a “new substance” and is subject to the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms) and requires notification prior to import or manufacture. If the SNAc provisions are applied to a new substance, a SNAc notice is published in the Canada Gazette, Part I.

How is a significant new activity notice or order published?

If a substance is on the DSL, the DSL must be amended to indicate that the SNAc provisions apply to the substance. Normally, a notice of intent (NOI) to amend the DSL is published in the Canada Gazette, Part I (CG I), followed by a public comment period, and publication of an order amending the DSL in the Canada Gazette, Part II (CG II). The SNAc provisions apply as soon as the order is registered (that is, in force), unless the order indicates otherwise.

If a substance is not on the DSL (a new substance), a notice indicating that the SNAc provisions apply to the substance is published in the Canada Gazette, Part I. Unless the Notice indicates otherwise, the SNAc provisions apply as soon as the notice is published.

When a substance that is not on the DSL is subject to the SNAc provisions, and is subsequently added to the DSL, an order amending the DSL is published in the Canada Gazette, Part II (CG II). The order adds the substance to the DSL and typically maintain the SNAc provisions.

The publication differences between SNAc provisions for new and existing substances are outlined in the table below.

General exclusions to the significant new activity provisions

The SNAc provisions do not apply to uses of a substance that are regulated under any act of parliament listed in Schedule 2 or scheduleSchedule 4 of CEPA, including but not limited to the Pest Control Products Act, the Fertilizers Act and the Feeds Act. They also do not apply to transient reaction intermediates, impurities, contaminants, partially unreacted materials, and in some circumstances to items such as, but not limited to, wastes, mixtures or manufactured items. However, it should be noted that individual components of a mixture may be notifiable under the SNAc provisions. See section 3 and subsections 81(6) and section106(6) of CEPA for more information.

If a person’s activities are captured by a significant new activity notice or order, what is the person required to do?

If a person’s proposed activities with a substance are captured by the definition of a significant new activity, that person is required to submit a significant new activity notification (SNAN) to the government for assessment within the specified regulatory time period prior to the new activity being undertaken.

What is a significant new activity notification?

Information submitted to the government in compliance of a SNAc notice or order is called a significant new activity notification (SNAN).

The SNAN must contain all of the information prescribed in the published notice or order.

SNANs must be submitted to the Minister of Environment and Climate Change Canada through the Regulatory Operations, Policy and Emerging Sciences Division.

A company can submit a SNAN on behalf of its clients. For example, in cases where a person receives possession and control of a substance from another person, it may not be required to submit a SNAN, under certain conditions, if the activities were covered by the original SNAN submitted by the supplier. 

How does a person prepare a significant new activity notification?

The information required to complete a SNAN is unique to each substance and is described within the Canada Gazette publication that applied the SNAc provisions to the substance. Many of the information requirements of SNAcs reference the standard schedules of the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms).

Additional guidance on preparing a SNAN can be found in section 1.3 of the Guidance document for the New Substances Notification Regulations (Chemicals and Polymers) and section 7 of the new substances: guidelines for organisms.

Although a specific reporting form is not available for submitting a SNAN, nor is it required, sections of the new substances notification reporting form may be used as appropriate. 

A pre-notification consultation (PNC) is available for notifiers who wish to consult with the program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans. To request a PNC or get more information, please contact the substances management information line.

What happens after a significant new activity notification is submitted?

Once a complete SNAN is submitted to the government, the Minister of Environment and Climate Change Canada and the Minister of Health assess the information provided and other available information, within the regulated time period indicated in the Canada Gazette publication (typically 90, 120 or 180 days), to determine whether the substance could pose a risk to the environment or human health, and whether further risk management considerations are required.

The new activity cannot be undertaken until the assessment period of the SNAN has expired.

Where a SNAN assessment identifies a risk, there are a wide range of tools and regulatory instruments available under CEPA to manage both new substances and substances on the DSL.

The SNAN assessment may also result in an amendment to, or rescission of, the SNAc notice or order that applied the SNAc provisions to the substance.

Significant new activity notification risk assessment summaries

To promote transparency, the government publishes summaries of risk assessment of SNANs. SNAN risk assessment summaries provide information on the notified activity, the substance that was notified, the environmental and human health risk assessment conclusions, and risk management considerations. Published significant new activity notification risk assessment summaries for existing substances are available on-line. Risk assessment summaries for new substances, including SNANs, can be accessed through the search engine for substances.

Are there opportunities to comment on a proposal to apply the significant new activity provisions to a substance?

If the government is planning on applying the SNAc provisions to a substance that is on the DSL, a notice of intent (NOI) to amend the DSL is normally published in the Canada Gazette, Part I. The NOI will outline the proposed definition of a significant new activity in relation to the substance as well as the information that would need to be provided in the SNAN.

The NOI is an opportunity for the public to comment on the proposed amendment of the DSL. Any person may, within 60 days of publication of the NOI in the Canada Gazette, submit comments on the proposed SNAc to the Minister of Environment and Climate Change Canada. Comments received during this public comment period will be taken into consideration during the development of the order amending the DSL to apply the SNAc provisions to the substance.

All comments must cite the Canada Gazette, Part I, and the date of publication of the notice and be sent to the Regulatory Operations, Policy and Emerging Sciences Division at Environment and Climate Change Canada.

When the SNAc provisions are applied to a new substance (a substance not on the DSL), consultation occurs with current and previous notifiers of the substance prior to the publication of the SNAc notice in the Canada Gazette, Part I.

Compliance and enforcement

When assessing whether or not a particular SNAc notice or order applies, persons are expected to make use of information in their possession or to which they may reasonably be expected to have access. The phrase “to which they may reasonably be expected to have access” means information in any of the company’s offices worldwide or other locations where the notifier can reasonably have access to the information.

For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture or product are expected to have access to import records, usage information and the relevant safety data sheet (SDS). However, it should be noted that although an SDS is an important source of information on the composition of a purchased product, the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to the SNAc provisions, since SNAc provisions are implemented to address public health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact the supplier.

If any information becomes available that reasonably supports the conclusion that a substance may be dangerous to the environment or human health, the person in possession of or who has knowledge of the information, and is involved in activities with the substance, is obligated under section 70 of CEPA to provide that information to the Minister without delay.

Where a person has questions concerning their obligations to comply with an order, believes they may be out of compliance or would like to request a PNC, they are encouraged to discuss their particular circumstances by contacting the substances management information line.

CEPA is enforced in accordance with the publicly available compliance and enforcement policy. In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent and history of compliance.

Contact information

Substances management information line 

Telephone: 1-800-567-1999 (toll-free in Canada) 1-819-938-3232 (outside Canada)
Email: substances@ec.gc.ca

SNAN must be submitted to

Other useful links

• "United States significant new use rules and Canada significant new activity provisions” – an educational primer intended to promote compliance
• Significant new activity provisions under the Canadian Environmental Protection Act, 1999: frequently asked questions
• New substances web page
• Chemical substances web page (existing substances)
  • Significant new activity orders and notices of the chemicals management plan

Search for substances subject to the significant new activity provisions

• Significant new activity publications under the Canadian Environmental Protection Act, 1999
• Search engine for substances

Advisory notes

• New substances: substances management advisory note January 2014

Guidance documents

• Guidance document for the New Substances Notification Regulations (Chemicals and Polymers)
• Guidance documents: biotechnology
  • Guidelines for the notification and testing of new substances: organisms