Order 2024-87-23-01 Amending the Domestic Substances List: SOR/2024-161
Canada Gazette, Part II, Volume 158, Number 16
Registration
SOR/2024-161 July 15, 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 substance is 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 2024-87-23-01 Amending the Domestic Substances List under subsection 87(3)footnote c of the Canadian Environmental Protection Act, 1999 footnote b.
Gatineau, July 10, 2024
Steven Guilbeault
Minister of the Environment
Order 2024-87-23-01 Amending the Domestic Substances List
Amendments
1 Part 1 of the Domestic Substances List footnote a is amended by deleting the following:
- 106-92-3
- 2210-79-9
- 2451-62-9
| Column 1 Substance |
Column 2 Significant New Activity for which substance is subject to subsection 81(3) of the Act |
|---|---|
| 106-92-3 S′ | 1 The use of the substance oxirane, [(2-propenyloxy)methyl]- 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:
|
| 2210-79-9 S′ | 1 The use of the substance oxirane, [(2-methylphenoxy)methyl]- in the manufacture of a consumer product to which the Canada Consumer Product Safety Act applies if the product contains the substance at a concentration
|
| 2451-62-9 S′ | 1 The use of the substance 1,3,5-triazine-2,4,6(1H,3H,5H)-trione, 1,3,5-tris(oxiranylmethyl)- 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:
|
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 risks of exposure of Canadians and the environment to substancesfootnote 1 are 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 2024-87-24-01 Amending the Domestic Substances List (DSL)footnote 2 to apply the SNAc provisions of CEPA to the following three substances:
- oxirane, [(2-propenyloxy)methyl]- (CAS RNfootnote 3 106-92-3), also known as “AGE”;
- oxirane, [(2-methylphenoxy)methyl]- (CAS RN 2210-79-9), also known as “o-CGE”; and
- 1,3,5-Triazine-2,4,6(1H,3H,5H)-trione, 1,3,5-tris(oxiranylmethyl)- (CAS RN 2451-62-9), also known as “TGIC.”
Background
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 these 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.
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 the 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 three substances (AGE, o-CGE and TGIC) do not occur naturally in the environment. The Minister issued a mandatory survey under section 71 of CEPAfootnote 4 that included the substances. Information received from industry for the reporting year 2008 indicated that AGE and TGIC were not reported to be manufactured in Canada above the reporting threshold of 100 kg. Furthermore, o-CGE was reported to be manufactured in Canada between 100 kg to 1 000 kg in 2008. The imported quantities were reported to be between 100 kg to 10 000 kg for AGE, 79 000 kg for o-CGE, and 407 000 kg for TGIC.
Currently, AGE is primarily used in commercial applications as a resin intermediate and it may also be used as a stabilizer of other chemicals, resins and rubbers. The substance rapidly degrades in the environment. In Canada, o-CGE can be used in a variety of do-it-yourself consumer applications (flooring adhesives, epoxy flooring coating products for garage floors, epoxy finishing resins for sealing/finishing surfaces [including hobby and craft paints or adhesives]) and epoxy compound for making moulds or decorative items. The predominant use of TGIC is as a cross-linking agent in the formulation of polyester resins used in the manufacture of polyester powder coatings. TGIC may be used as an adhesive and sealant substance, chemical filler or additive in the manufacture of paints and coatings, adhesives and sealants, or formed metal articles, including automotive parts.
Internationally, in the United States, AGE is reported to be used as an industrial chemical intermediate in adhesive and sealant manufacturing, synthetic rubber manufacturing, paint and coatings manufacturing and food packaging. TGIC is used as a component in food packaging materials in the United States. In the European Union (EU), AGE is used at industrial sites and in manufacturing.
Due to the known industrial and commercial uses of the three substances domestically and internationally, there is a possibility for these substances to be used in greater quantities and in a wider range of applications in the future in Canada (including in products available to consumers).
Summary of the screening assessment
As part of the CMP, in August 2020, the ministers published the screening assessment for the Epoxides and Glycidyl Ethers Group, which assessed AGE, o-CGE and TGIC, along with two other substances on the Canada.ca (Chemical Substances) website.
The screening assessment concluded that the substances do not meet the environmental and health criteria for a toxic substance as set out in paragraphs 64(a), (b), and (c) of CEPA.footnote 5 The assessment also determined that the substances have properties of concern that could pose a risk to the environment and human health if exposure levels to the three 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 AGE, o-CGE and TGIC.
Objective
The objective of Order 2024-87-23-01 Amending the Domestic Substances List (the Order) is to apply the SNAc provisions of CEPA to AGE, o-CGE and TGIC 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 the three 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 AGE, o-CGE and TGIC. 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 three 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 6 For details on the significant new activities associated with AGE, o-CGE or TGIC, please see the regulatory text of 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 7 For details on the information that would be required to be submitted in a SNAN for AGE, o-CGE and TGIC, please see the regulatory text of the Order.
Notification requirements
Below is a summary of the new notification requirements for AGE, o-CGE and TGIC. For specific details, please see the regulatory text of the Order.
Activities subject to notification requirements
The notification requirements apply to
- the use of AGE and TGIC 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, if the product contains the substance at a concentration equal to or greater than 0.1% by weight;
- the importation of AGE and TGIC in any 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, 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;
- the use of o-CGE in the manufacture of a consumer product to which the Canada Consumer Product Safety Act applies, if the product contains the substance at a concentration equal to or greater than 0.1% by weight, except in cases where notification requirements do not apply (outlined below); and
- the importation of o-CGE in any consumer product to which the Canada Consumer Product Safety Act applies, if the product contains the substance at a concentration equal to or greater than 0.1% by weight if the total amount quantity imported in all such products in a calendar year is greater than 10 kg, except in cases where notification requirements do not apply (outlined below).
Activities not subject to notification requirements
The notification requirements do not apply
- to the use of o-CGE in the manufacture of the following consumer products to which the Canada Consumer Product Safety Act applies, or its importation if the total quantity imported in all such products in a calendar year is greater than 10 kg and the product contains the substance at a concentration
- less than or equal to 2.5%, in the case of a surface coating, adhesive or sealant,
- less than or equal to 30% by weight, in the case of an epoxy-based surface coating for hobby and craft use that is to be sold in a container or a two-part application system with a volume of less than 50 mL, and
- less than or equal to 30% by weight, in the case of an epoxy-based adhesive or sealant for hobby and craft use that is to be sold in a container or a two-part application system with a volume of less than 50 mL,
- if the substance is a research and development substance, site-limited intermediate substance, export-only substance;footnote 8
- to any 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 9
Information requirements
Below is a summary of the information requirements for the notification of a proposed significant new activity in relation to AGE, o-CGE and TGIC. For specific details, please see the regulatory text of the Order.
The Order requires the submission of
- a description of the proposed significant new activity;
- relevant information in schedules 4 and 5 of the New Substances Notification Regulations (Chemicals and Polymers) [SOR/2005-247];
- a description of the product that contains the substance, the intended use and method of application of that product, and the function of the substance within that product; and
- all other information in respect of the substances, including additional details surrounding use, annual quantity used and exposure information.
Regulatory development
Consultation
As part of the CMP, on August 8, 2020, the Minister published a Notice of Intent (NOI) to apply the SNAc provisions of CEPA to AGE, o-CGE and TGIC 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 10 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 consultation
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 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 the substance, the function of the substance and the presence of the substance in markets in other jurisdictions.footnote 11
As part of the CMP, the assessment informed the determination that applying the SNAc provisions of CEPA to AGE, o-CGE and TGIC is the most appropriate measure 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 aid in the protection of the environment and human health through their contribution to the main objective of the CMP. This means that any impact associated with these orders (e.g. benefits associated with the use of alternative substances over those subject to the SNAc provisions and costs associated with the use of substances subject to the SNAc provisions) has already been attributed to the CMP (see strategic environmental assessment section) and, therefore, considered baseline impacts. 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. As a result, these orders do not result in incremental impacts (benefits and costs).
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 12
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 13
Regulatory cooperation and alignment
Canada cooperates with international organizations and regulatory agencies for the management of chemicals (e.g. the United States Environmental Protection Agency, the European Chemicals Agency, and the Organisation for Economic Co-operation and Development), and is party to several international multilateral environmental agreements in the area of chemicals and waste.footnote 14 The CMP is administered in cooperation and alignment with these agreements.
Strategic environmental assessment
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), the gender-based analysis plus does not apply.footnote 15
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 of 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 16
Where a person involved in activities with the 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 17
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 AGE, o-CGE or TGIC, 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
Telephone: 613‑266‑3591
Email: andrew.beck@hc-sc.gc.ca