Order 2024-87-22-01 Amending the Domestic Substances List: SOR/2024-235

Canada Gazette, Part II, Volume 158, Number 26

Registration
SOR/2024-235 November 29, 2024

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the substances set out in the annexed Order are specified on the Domestic Substances List ^{footnote a};

And whereas the Minister of the Environment and the Minister of Health suspect that the information concerning a significant new activity in relation to any of those substances may contribute to determining the circumstances in which the substances are toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 ^{footnote b};

Therefore, the Minister of the Environment makes the annexed Order 2024-87-22-01 Amending the Domestic Substances List under subsection 87(3)^{footnote c} of the Canadian Environmental Protection Act, 1999 ^{footnote b}.

Ottawa, November 25, 2024

Steven Guilbeault
Minister of the Environment

Order 2024-87-22-01 Amending the Domestic Substances List

Amendments

1 Part 1 of the Domestic Substances List ^{footnote a} is amended by deleting the following:

101-77-9
25214-70-4

2 Part 2 of the List is amended by adding the following in numerical order:
Column 1 Substance	Column 2 Significant New Activity for which substance is subject to subsection 81(3) of the Act
101-77-9 S′	1 The use of the substance benzenamine, 4,4′-methylenebis-in the manufacture of any of the following products if the product contains the substance at a concentration equal to or greater than 0.1% by weight: (a) a consumer product to which the Canada Consumer Product Safety Act applies; or (b) a cosmetic, as defined in section 2 of the Food and Drugs Act. 2 The importation of the substance benzenamine, 4,4′-methylenebis-in any of the following products that contains the substance at a concentration equal to or greater than 0.1% by weight if the total quantity imported in all such products in a calendar year is greater than 10 kg: (a) a consumer product to which the Canada Consumer Product Safety Act applies; or (b) a cosmetic, as defined in section 2 of the Food and Drugs Act. 3 Any other activity where one of the following conditions is met: (a) the activity involves the use of the substance in a quantity equal to or greater than 1 000 000 kg in a calendar year; (b) the activity involves the use of the substance in a quantity equal to or greater than 100 000 kg but less than 1 000 000 kg in a calendar year, and fewer than three control measures described in section 5 are implemented at the facility where the activity occurs; or (c) the activity involves the use of the substance in a quantity equal to or greater than 10 000 kg but less than 100 000 kg in a calendar year, and fewer than two control measures described in section 5 are implemented at the facility where the activity occurs. 4 Despite sections 1, 2 and 3, an activity is not a significant new activity if the substance is a site-limited intermediate substance, as that term is defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers), and is used in a quantity less than 100 000 kg in a calendar year. 5 The following are the control measures referred to in section 3: (a) an on-site mechanism or process that removes 90% or more of the substance from the effluents of the facility where the activity occurs; (b) dedicated containers that are used only for transportation of the substance such that rinsing between uses is not required; and (c) a mechanism or process where water resulting from the cleaning or rinsing of any equipment or surface that comes into contact with the substance, directly or indirectly, is either reused at the facility where the activity occurs or disposed of through incineration or through an engineered hazardous waste landfill facility. [An engineered hazardous waste landfill facility refers to a facility that is part of an overall integrated hazardous waste management system where wastes that do not require additional treatment or processing are sent and where hazardous materials are confined or controlled until the end of their effective contaminating lifespan.] Once it has reached the end of its useful life, any rinse water that was reused in the facility where the activity occurs must be disposed of through incineration or through an engineered hazardous waste landfill facility. 6 For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the significant new activity begins: (a) a description of the significant new activity in relation to the substance; (b) the anticipated annual quantity of the substance to be used; (c) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers); (d) the information specified in paragraphs 2(d) to (f) of Schedule 5 to those Regulations, or the percent composition by weight of the components of the substance including its constituents, such as monomers and other reactants, additives, stabilizers and solvents, and the information specified in paragraphs 8(a), (b), (f) and (g) of that Schedule; (e) the information specified in paragraph 11(b) of Schedule 6 to those Regulations; (f) a description of the consumer product or cosmetic that contains the substance, the intended use and method of application of that consumer product or cosmetic, and the function of the substance in that consumer product or cosmetic; (g) the total quantity of the consumer product or cosmetic expected to be sold in Canada in a calendar year by the person proposing the significant new activity; (h) if known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the anticipated quantity by site; (i) a description of the manufacturing process involved in the significant new activity that details the reactants used, the reaction stoichiometry, the batch or continuous nature of the process, and the scale of the process; (j) a flow diagram of the overall process and the steps involved in the significant new activity that result or may result in the entry or release of the substance into the environment, including the use of holding tanks and distillation towers, if applicable; (k) a description of each of the steps referred to in paragraph (j), the quantities and concentrations that are or may be released at each step, the physical form of the substance for each location where the substance will or may be released and, if applicable, the anticipated frequency, duration and rate of release; (l) a description of the waste management practices to be implemented to prevent or minimize the release of the substance at the facility where the significant new activity will be conducted, including (i) the quantity of the substance, in effluents and emissions, that is anticipated to be released to the environment, including average and maximum concentrations, (ii) if the substance is anticipated to be released into a municipal wastewater system, the name and address of the municipal wastewater treatment facility, the name of the receiving body of water and the location of the point of release, as well as the total quantity of the substance that is anticipated to be released per day at that location, expressed in kilograms, (iii) if the substance is anticipated to be released directly into surface waters, the name of the receiving body of water and the location of the point of release, as well as the total quantity of the substance that is anticipated to be released per day at that location, expressed in kilograms, and (iv) if waste containing the substance is anticipated to be treated on-site, a description of the treatment system, the total quantity of the substance that is anticipated to be released per year, expressed in kilograms, the percentage of the substance to be removed from the waste, the name of the receiving body of water and the location of the point of release; (m) all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of the adverse effects that the substance may have on the environment and human health and the degree of environmental and public exposure to the substance; (n) the name of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency; (o) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf; and (p) a certification that the information is accurate and complete, dated and signed by the person proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf. 7 The information referred to in section 6 is to be assessed within 90 days after the day on which it is received by the Minister.
25214-70-4 S′	1 The use of the substance formaldehyde, polymer with benzenamine in the manufacture of any of the following products if the product contains the substance at a concentration equal to or greater than 0.1% by weight: (a) a consumer product to which the Canada Consumer Product Safety Act applies; or (b) a cosmetic, as defined in section 2 of the Food and Drugs Act. 2 The importation of the substance formaldehyde, polymer with benzenamine in any of the following products that contains the substance at a concentration equal to or greater than 0.1% by weight if the total quantity imported in all such products in a calendar year is greater than 10 kg: (a) a consumer product to which the Canada Consumer Product Safety Act applies; or (b) a cosmetic, as defined in section 2 of the Food and Drugs Act. 3 Any other activity where one of the following conditions is met: (a) the activity involves the use of the substance in a quantity equal to or greater than 1 000 000 kg in a calendar year; (b) the activity involves the use of the substance in a quantity equal to or greater than 100 000 kg but less than 1 000 000 kg in a calendar year, and fewer than three control measures described in section 5 are implemented at the facility where the activity occurs; or (c) the activity involves the use of the substance in a quantity equal to or greater than 10 000 kg but less than 100 000 kg in a calendar year, and fewer than two control measures described in section 5 are implemented at the facility where the activity occurs. 4 Despite sections 1, 2 and 3, an activity is not a significant new activity if the substance is a site-limited intermediate substance, as that term is defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers), and is used in a quantity less than 100 000 kg in a calendar year. 5 The following are the control measures referred to in section 3: (a) an on-site mechanism or process that removes 90% or more of the substance from the effluents of the facility where the activity occurs; (b) dedicated containers that are used only for transportation of the substance such that rinsing between uses is not required; and (c) a mechanism or process where water resulting from the cleaning or rinsing of any equipment or surface that comes into contact with the substance, directly or indirectly, is either reused at the facility where the activity occurs or disposed of through incineration or through an engineered hazardous waste landfill facility. [An engineered hazardous waste landfill facility refers to a facility that is part of an overall integrated hazardous waste management system where wastes that do not require additional treatment or processing are sent and where hazardous materials are confined or controlled until the end of their effective contaminating lifespan.] Once it has reached the end of its useful life, any rinse water that was reused in the facility where the activity occurs must be disposed of through incineration or through an engineered hazardous waste landfill facility. 6 For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the significant new activity begins: (a) a description of the significant new activity in relation to the substance; (b) the anticipated annual quantity of the substance to be used; (c) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers); (d) the information specified in paragraphs 2(d) to (f) of Schedule 5 to those Regulations, or the percent composition by weight of the components of the substance including its constituents, such as monomers and other reactants, additives, stabilizers and solvents, and the information specified in paragraphs 8(a), (b), (f) and (g) of that Schedule; (e) the information specified in paragraph 11(b) of Schedule 6 to those Regulations; (f) a description of the consumer product or cosmetic that contains the substance, the intended use and method of application of that consumer product or cosmetic, and the function of the substance in that consumer product or cosmetic; (g) the total quantity of the consumer product or cosmetic expected to be sold in Canada in a calendar year by the person proposing the significant new activity; (h) if known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the anticipated quantity by site; (i) a description of the manufacturing process involved in the significant new activity that details the reactants used, the reaction stoichiometry, the batch or continuous nature of the process and the scale of the process; (j) a flow diagram of the overall process and the steps involved in the significant new activity that result or may result in the entry or release of the substance into the environment, including the use of holding tanks and distillation towers, if applicable; (k) a description of each of the steps referred to in paragraph (j), the quantities and concentrations that are or may be released at each step, the physical form of the substance for each location where the substance will or may be released and, if applicable, the anticipated frequency, duration and rate of release; (l) a description of the waste management practices to be implemented to prevent or minimize the release of the substance at the facility where the significant new activity will be conducted, including (i) the quantity of the substance, in effluents and emissions, that is anticipated to be released to the environment, including average and maximum concentrations, (ii) if the substance is anticipated to be released into a municipal wastewater system, the name and address of the municipal wastewater treatment facility, the name of the receiving body of water and the location of the point of release, as well as the total quantity of the substance that is anticipated to be released per day at that location, expressed in kilograms, (iii) if the substance is anticipated to be released directly into surface waters, the name of the receiving body of water and the location of the point of release, as well as the total quantity of the substance that is anticipated to be released per day at that location, expressed in kilograms, and (iv) if waste containing the substance is anticipated to be treated on-site, a description of the treatment system, the total quantity of the substance that is anticipated to be released per year, expressed in kilograms, the percentage of the substance to be removed from the waste, the name of the receiving body of water and the location of the point of release; (m) all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of the adverse effects that the substance may have on the environment and human health, and the degree of environmental and public exposure to the substance; (n) the name of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency; (o) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf; and (p) a certification that the information is accurate and complete, dated and signed by the person proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf. 7 The information referred to in section 6 is to be assessed within 90 days after the day on which it is received by the Minister.

Coming into Force

3 This Order comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

The Chemicals Management Plan (CMP) is a Government of Canada initiative through which the risk of exposure of Canadians and the environment to substances^{footnote 1} is assessed and managed. As part of the CMP, the Minister of the Environment (the Minister) may apply the significant new activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA) to certain substances to request information to assess the potential for environmental and human health risks when the substance is used in a significant new activity. A significant new activity is an activity that results in the entry of a substance in the environment in a different quantity or concentration, or in different circumstances, than those in which the substance previously entered the environment, which could affect the environmental or human exposure to that substance in Canada. If risks are identified, the Government of Canada may recommend risk management measures to mitigate them.

In accordance with subsection 87(3) of CEPA, the Minister is issuing the Order 2024-87-22-01 Amending the Domestic Substances List (DSL)^{footnote 2} to apply the SNAc provisions of CEPA to the following two substances:

Benzenamine, 4,4′-methylenebis-(CAS RN^{footnote 3} 101-77-9), also known as “4,4′-MDA”; and
Formaldehyde, polymer with benzenamine (CAS RN 25214-70-4), also known as “pMDA.”

Background

The Chemicals Management Plan

In 2006, the Government of Canada launched the CMP, a federal program with the objective of reducing the risks posed by certain substances to Canadians and the environment from exposure to activities that involve them (e.g., industrial releases from manufacturing) or products that contain them (e.g., consumer products use and disposal). As part of the CMP, government officials from the Department of the Environment and the Department of Health (the departments) conduct assessments under the authority of CEPA to analyze the available information on substances (e.g., hazardous properties and uses) in order to identify existing and potential environmental and human health risks posed by exposure to those substances. The Minister of the Environment and the Minister of Health (the ministers) may recommend the development of risk management measures to mitigate these risks wherever identified, under the authority of a broad suite of federal laws, including CEPA, the Canada Consumer Product Safety Act, the Food and Drugs Act, the Pest Control Products Act, and the Fisheries Act.

The SNAc provisions of CEPA

Following the assessments of substances, the Minister may apply the SNAc provisions of CEPA to certain substances that are determined to have properties of concern, to request information to assess the environmental and human health risks of increased exposure to those substances in the event of their use in a significant new activity in Canada. The SNAc provisions establish a requirement for any person (individual or corporation) considering manufacturing, importing or using a substance for a significant new activity to submit a Significant New Activity Notification (SNAN) to the Minister containing the prescribed information for that substance. Upon receipt of the complete information, government officials would conduct further assessment of that substance before the activity is undertaken, to determine whether exposure to that substance from that activity could pose a risk to the environment or human health and whether further risk management considerations may be required to mitigate those risks.

To see the substances subject to the SNAc provisions of CEPA, please visit the Canada.ca Open Data Portal.

Description, uses, and sources of release

The two substances (4,4′-MDA and pMDA) are Methylenediphenyl Diamine (MDA) substances, which do not occur naturally in the environment.

The Minister issued mandatory surveys under section 71 of CEPA^{footnote 4} that included the substances. Information received from industry for the reporting year 2011 indicated no manufacture of the two substances in Canada, though 1000 kilograms (kg) to 10 000 kg of 4,4′-MDA and 100 kg to 1000 kg of pMDA were reported to have been imported.

Internationally, MDAs are mainly used as intermediates in the production of other synthesized substances. They are also used as curing agents in the production of plastics, foams, coatings, adhesives, and resins. Other known international uses of MDAs include use as chemical compounds in metals testing, finishing agents for welding, curative agents in rubbers, and as cross-linking agents in epoxy resins, as well as corrosion inhibitors and antioxidants in metalwork. In Canada, 4,4′-MDA is blended into a product used as a catalyst for industrial processes and is used as an intermediate in the production of azo dyes. The other substance, pMDA, is blended into a product used for coating machinery.

The release of MDAs into the environment can occur from their use in industrial processes such as polyurethane manufacturing. 4,4′-MDA is on the list of reportable substances under the National Pollutant Release Inventory, though no releases were reported for the years 2008 to 2013. In Canada, the waste generated by one industrial use of 4,4′-MDA is disposed of at a hazardous materials facility, due to the presence of other hazardous materials in that waste.

Summary of the assessment

As part of the CMP, in June 2017, the ministers published the screening assessment for Methylenediphenyl Diisocyanates and Methylenediphenyl Diamines, which assessed 4,4′-MDA and pMDA, along with five other substances^{footnote 5} on the Canada.ca (Chemical Substances) website.

The assessment concluded that the substances do not meet the environmental or human health criteria for a toxic substance as set out in paragraphs 64(a), (b) or (c) of CEPA.^{footnote 6} The assessment also determined that the substances have properties of concern that could pose a risk to the environment or human health if exposure levels to the two substances were to increase from their use in a significant new activity in Canada. As a result, the Minister decided to apply the SNAc provisions of CEPA to 4,4′-MDA and pMDA.

Objective

The objective of Order 2024-87-22-01 Amending the Domestic Substances List (the Order) is to apply the SNAc provisions of CEPA to 4,4′-MDA and pMDA in accordance with subsection 87(3) of CEPA. As part of the CMP, the Order contributes to the protection of the environment and human health by reducing the risks associated with increased exposure of Canadians and the environment to two substances in the event of their use in a significant new activity in Canada.

Description

Pursuant to subsection 87(3) of CEPA, the Order applies the SNAc provisions under subsection 81(3) of CEPA to 4,4′-MDA and pMDA. For a description of the significant new activities associated with these substances, please see the regulatory text in the Order.

Applicability

The Order does not impose any regulatory requirements on existing activities involving the two substances in Canada, which have been determined to present no or limited risk, or are adequately managed.

The SNAc provisions of CEPA target potential significant new activities involving a substance that could result in a new or increased exposure to that substance in Canada. A significant new activity is an activity that results in the entry of the substance in the environment in a different quantity or concentration, or in different circumstances, than those in which the substance previously entered into the environment.^{footnote 7} For details on the significant new activities associated with 4,4′-MDA and pMDA, please see the regulatory text in the Order.

Should a person (individual or corporation) choose to engage with a substance, they would be required to comply with any regulations associated with that substance. In the same manner, if a person chooses to engage in a significant new activity in relation to a substance subject to the SNAc provisions of CEPA, they would be required to submit a SNAN to the Minister. The SNAN must contain all the information prescribed in an order and must be submitted in the prescribed period before the day on which the significant new activity begins. The prescribed information to complete a SNAN is specific to each substance and is described in the order that applied the SNAc provisions of CEPA to a substance.^{footnote 8} For details on the information that would be required to be submitted in a SNAN for 4,4′-MDA and pMDA, please see the regulatory text in the Order.

Notification requirements

Below is a summary of the notification requirements for 4,4′-MDA and pMDA. For specific details, please see the regulatory text in the Order.

Activities subject to notification requirements

The notification requirements apply to

the use of the substance in the manufacture of a consumer product to which the Canada Consumer Product Safety Act applies or in the manufacture of a cosmetic as defined in section 2 of the Food and Drugs Act, such that the substance is present in the consumer product or cosmetic in a concentration equal to or greater than 0.1% by weight;
the importation of the substance in a total quantity greater than 10 kg in a calendar year in a consumer product to which the Canada Consumer Product Safety Act applies or in a cosmetic as defined in section 2 of the Food and Drugs Act, if the consumer product or cosmetic contains the substance at a concentration equal to or greater than 0.1% by weight; and
any other activity involving the substance in which the total quantity of the substance involved in the activity in a calendar year is:
- 1 000 000 kg or more;
- 100 000 kg to 1 000 000 kg, if fewer than three control measures (as defined in the Order) are implemented at the facility where the activity occurs; or
- 10 000 kg to 100 000 kg, if fewer than two control measures (as defined in the Order) are implemented at the facility where the activity occurs.

Activities not subject to notification requirements

The notification requirements do not apply:

if the substance is a site-limited intermediate substance^{footnote 9} in a quantity of less than 100 000 kg in a calendar year;
to any use of the substance that is regulated under the Acts of Parliament listed in Schedule 2 of CEPA, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act; and
if the substance is exempt or excluded from notification requirements under CEPA (i.e., as a transient reaction intermediate, impurity, contaminant, partially unreacted material, or incidental reaction product, and, under certain circumstances, in mixtures, manufactured items, or wastes).^{footnote 10}

Information requirements

Below is a summary of the information requirements for the notification of a proposed significant new activity in relation to 4,4′-MDA and pMDA. For specific details, please see the regulatory text in the Order.

The Order requires the submission of

a description of the proposed significant new activity;
relevant information in Schedules 4, 5, and 6 to the New Substances Notification Regulations (Chemicals and Polymers) (SOR/2005-247);
a description of the product that contains the substances, the intended use and method of application of that product, and the function of the substances within that product;
information regarding the manufacturing, operational, import, and export processes at the facility, including equipment schematics and identification of stages where releases of the substance into the environment could occur;
if applicable, a description of the waste management practices that are implemented at the facility to prevent or minimize releases of the substance in effluents and emissions; and
other information in respect of the substances, including additional details surrounding use, and exposure information.

Regulatory development

Consultation

As part of the CMP, on June 10, 2017, the Minister published a Notice of Intent (NOI) to apply the SNAc provisions of CEPA to 4,4′MDA and pMDA in the Canada Gazette, Part I, for a 60-day public comment period. The Department received no comments during this period.

The departments also informed the provincial and territorial governments about the Order through the CEPA National Advisory Committee (CEPA NAC)^{footnote 11} via a letter and provided them with an opportunity to comment. No comments were received from the Committee.

Modern treaty obligations and Indigenous engagement and consultations

An assessment of modern treaty implications conducted in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders amending the DSL to apply the SNAc provisions of CEPA to certain substances do not result in any impact on modern treaty rights or obligations, as they do not impose regulatory requirements (see Applicability section) that could result in incremental impacts (see Benefits and costs section) that would warrant specific engagement and consultation with Indigenous Peoples separate from the 60-day public comment period that followed the publication of the NOI.

Instrument choice

The decision to use the SNAc provisions of CEPA is risk-based. The SNAc provisions will be considered for use where there is reasonable suspicion that certain new activities with respect to a substance may result in new or increased risks to the environment or human health. That suspicion could be based on factors such as the specific properties of that substance, the function of that substance and the presence of that substance in markets in other jurisdictions.^{footnote 12}

As part of the CMP, the assessment informed the determination that applying the SNAc provisions of CEPA to 4,4′MDA and pMDA is the most appropriate instrument to mitigate the risks of increased exposure of Canadians and the environment to the substances in the event of use in a significant new activity in Canada.

Regulatory analysis

Benefits and costs

Orders amending the DSL to apply the SNAc provisions of CEPA to certain substances do not result in incremental impacts (benefits and costs). The SNAc provisions aid in the protection of the environment and human health through their contribution to the main objective of the CMP. These orders usually do not apply to current activities identified at the time of the analysis involving those substances, as they are not considered to pose an environmental or human health risk, or their risk is adequately managed. These orders apply to the potential use of those substances in a significant new activity that could result in a new or increased exposure to those substances. Should a person (individual or corporation) choose to engage in a significant new activity involving a substance subject to the SNAc provisions of CEPA, they would be required to comply with all the regulations in place associated with that activity and that substance, including the requirement to submit a SNAN to the Minister. Therefore, the costs associated with a submission of a SNAN are not considered incremental to the SNAc provisions for a substance, but rather costs of conducting business and/or complying with federal laws and regulations in Canada.

Small business lens

Since orders amending the DSL to apply the SNAc provisions of CEPA to certain substances do not result in incremental impacts (benefits and costs), the assessment of the small business lens concluded that these orders do not have impacts on small businesses.^{footnote 13}

One-for-one rule

Since orders amending the DSL to apply the SNAc provisions of CEPA to certain substances do not result in incremental impacts (benefits and costs), the assessment of the one-for-one rule concluded that these orders do not have impacts on businesses that would need to be addressed under the rule.^{footnote 14}

Regulatory cooperation and alignment

Canada cooperates with other international organizations and regulatory agencies for the management of chemicals (e.g., United States Environmental Protection Agency, European Chemicals Agency, and Organisation for Economic Co-operation and Development) and is party to several international multilateral environmental agreements in the area of chemicals and waste.^{footnote 15} The CMP is administered in cooperation and alignment with these agreements.

Effects on the environment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a Strategic Environmental Assessment was completed for the CMP, which includes orders amending the DSL to apply the SNAc provisions of CEPA to certain substances. The assessment concluded that the CMP is expected to have a positive impact on the environment and human health.

Gender-based analysis plus

Since orders amending the DSL to apply the SNAc provisions of CEPA to certain substances do not result in incremental impacts (benefits and costs), Gender-based analysis plus does not apply.^{footnote 16}

Implementation, compliance and enforcement, and service standards

Implementation

Orders amending the DSL are in force on the day that they are registered. Compliance promotion activities conducted as part of the implementation of those orders will include developing and distributing promotional material, responding to inquiries from stakeholders and undertaking activities to raise industry stakeholders’ awareness of the requirements in those orders in the event a substance subject to the SNAc provisions of CEPA is used in a significant new activity in Canada.

Compliance

When assessing whether the use of a substance subject to the SNAc provisions of CEPA may be considered a significant new activity, a person (individual or corporation) is expected to make use of information in their possession, or to which they may reasonably be expected to have access. This means information in any of the notifier’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.^{footnote 17}

Where a person involved in activities with a substance obtains information that reasonably supports the conclusion that that substance is toxic or is capable of becoming toxic, the person is obligated, under section 70 of CEPA, to provide that information to the Minister without delay.

Under section 87.1 of CEPA, any person who transfers the physical possession or control of a substance subject to an order to another shall notify that person of their obligation to comply with that order, including the obligation to notify the Minister of any significant new activity and to provide all the required prescribed information specified in that order.

In cases where a person receives physical possession or control of a substance subject to the SNAc provisions of CEPA from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN submitted by the supplier on behalf of its clients.

A pre-notification consultation (PDF) (PNC) is available for notifiers who wish to consult during the planning or preparation of a SNAN to discuss any questions or concerns they have about the prescribed information and test plans. 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 contact the Substances Management Information Line.^{footnote 18}

Enforcement

Orders amending the DSL to apply the SNAc provisions of CEPA to certain substances are enforced in accordance with the Compliance and Enforcement policy for the Canadian Environmental Protection Act. In instances of non-compliance, deciding which enforcement measure to take will consider factors such as the nature of the alleged violation, effectiveness in achieving compliance with CEPA and its regulations and consistency in the application of enforcement measures. Suspected violations under CEPA can be reported to the Enforcement Branch by email at enviroinfo@ec.gc.ca.

Service standards

In the event that a SNAN is submitted to the Minister in relation to 4,4′MDA or pMDA, government officials will assess the information received within the prescribed timelines set out in the Order.

Contacts

Joliane Lavigne
Acting Director
Regulatory Operations, Policy and Emerging Sciences Division
Department of the Environment
Gatineau, Quebec
K1A 0H3

Substances Management Information Line:
1‑800‑567‑1999 (toll-free in Canada)
819‑938‑3232 (outside of Canada)
Email: substances@ec.gc.ca

Andrew Beck
Director
Risk Management Bureau
Department of Health
Ottawa, Ontario
K1A 0K9
Phone: 613‑266‑3591
Email: andrew.beck@hc-sc.gc.ca

Footnotes

Footnote a

SOR/94-311

Return to footnote a referrer

Footnote b

S.C. 1999, c. 33

Return to footnote b referrer

Footnote c

S.C. 2023, c. 12, s. 26

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Footnote 1

Substances managed under the Canadian Environmental Protection Act, 1999 (CEPA) include chemicals, polymers, biochemicals, biopolymers, nanomaterials, unknown or variable composition complex reaction products or biological material (UVCB) and animate products of biotechnology (living organisms). For more information on the definition of a substance, see subsection 3(1) of CEPA.

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Footnote 2

The DSL is an inventory of substances manufactured in or imported into Canada on a commercial scale and can be accessed through Substances Search.

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Footnote 3

The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.

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Footnote 4

Section 71 surveys are a tool under CEPA used to collect information from industry and individuals on surveyed substances, such as their uses, as well as manufacture and import quantities, which may inform assessment conclusions for those substances.

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Footnote 5

The assessment for 4,4′-MDA and pMDA also assessed five other substances and concluded that those five other substances meet one or more of the criteria set out in section 64 of CEPA. The details of the assessment and subsequent risk-management measures for those five substances are not covered in this Order, but rather in the Order adding the five substances to Schedule 1 to CEPA (the List of Toxic Substances) published May 15, 2019.

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Footnote 6

For more information, please refer to section 64 of CEPA.

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Footnote 7

For more information, please refer to section 80 and section 104 of CEPA.

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Footnote 8

For guidance on preparing a SNAN, please see section 1.3 and section 4 of the Guidance document for the New Substances Notification Regulations (Chemicals and Polymers).

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Footnote 9

For more information on these terms, including their definitions, please see section 3.4 of the Guidance document for the New Substances Notification Regulations (Chemicals and Polymers).

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Footnote 10

For more information on these terms, including their definitions, please see section 3.2 of the Guidance document for the New Substances Notification Regulations (Chemicals and Polymers). Please note that individual components of a mixture may be subject to notification requirements under certain circumstances.

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Footnote 11

The CEPA NAC, established under section 6 of CEPA, is the main intergovernmental forum for the purpose of enabling national action and avoiding duplication in regulatory activity among governments within Canada. This committee has a representative from the Department of the Environment and the Department of Health, a representative of each of the provinces and territories, as well as up to six representatives of Indigenous governments.

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Footnote 12

For more information on SNAc instrument choice, please consult the Policy on the Use of Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999.

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Footnote 13

The assessment of the small business lens has the objective of reducing regulatory costs on small businesses without compromising the health, safety, security and environment of Canadians.

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Footnote 14

The one-for-one rule requires that when a new or amended regulation increases the administrative burden cost on business, regulators are required to offset — from their existing regulations — an equal amount on business.

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Footnote 15

For more information on the agreements, please see the Compendium of Canada’s engagement in international environmental agreements and instruments. Of particular interest are the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal; the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade; the Stockholm Convention on Persistent Organic Pollutants; and the Minamata Convention on Mercury.

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Footnote 16

Gender-based analysis plus is an analytical process that provides a rigorous method for the assessment of systemic inequalities, as well as a means to assess how diverse groups of women, men, and gender diverse people may experience the incremental impact of policies, programs and initiatives.

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Footnote 17

Although a Safety Data Sheet (SDS) is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products and may not include all the information on these hazards. Therefore, an SDS may not list all product ingredients or substances that may be subject to an order. Any person (individual or corporation) requiring additional information on product composition is encouraged to contact their supplier.

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Footnote 18

The Substances Management Information Line can be contacted at substances@ec.gc.ca (email), 1‑800‑567‑1999 (toll-free in Canada) and 819‑938‑3232 (outside of Canada).

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