Order 2022-87-24-01 Amending the Domestic Substances List: SOR/2022-178
Canada Gazette, Part II, Volume 156, Number 16
Registration
SOR/2022-178 July 18, 2022
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Whereas the substances set out in the annexed Order are specified on the Domestic Substances Listfootnote 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, 1999footnote b;
Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999footnote b, makes the annexed Order 2022-87-24-01 Amending the Domestic Substances List.
Gatineau, July 14, 2022
Steven Guilbeault
Minister of the Environment
Order 2022-87-24-01 Amending the Domestic Substances List
Amendments
1 Part 1 of the Domestic Substances List footnote a is amended by deleting the following:
- 110-71-4
- 111-96-6
- 112-49-2
| Column 1 Substance |
Column 2 Significant New Activity for which substance is subject to subsection 81(3) of the Act |
|---|---|
110-71-4 S′ |
1 The use of the substance ethane, 1,2-dimethoxy- in the manufacture of any of the following products such that the substance is present in the product in a concentration equal to or greater than 0.1% by weight:
2 Any activity involving the use of the substance in a quantity greater than 10 kg in a calendar year in any of the following products, if the product contains the substance at a concentration equal to or greater than 0.1% by weight:
3 Despite sections 1 and 2, a use of the substance is not a significant new activity if the substance is used
4 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 proposed significant new activity begins:
5 The information referred to in section 4 is to be assessed within 90 days after the day on which it is received by the Minister. |
111-96-6 S′ |
1 The use of the substance ethane, 1,1′-oxybis[2-methoxy- in the manufacture of any of the following products such that the substance is present in the product in a concentration equal to or greater than 0.1% by weight:
2 Any activity involving the use of the substance in a quantity greater than 10 kg in a calendar year in any of the following products, if the product contains the substance at a concentration equal to or greater than 0.1% by weight:
3 Despite sections 1 and 2, a use of the substance is not a significant new activity if the substance is used
4 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 proposed significant new activity begins:
5 The information referred to in section 4 is to be assessed within 90 days after the day on which it is received by the Minister. |
112-49-2 S′ |
1 The use of the substance 2,5,8,11-tetraoxadodecane in the manufacture of any of the following products such that the substance is present in the product in a concentration equal to or greater than 0.1% by weight:
2 Any activity involving the use of the substance in a quantity greater than 10 kg in a calendar year in any of the following products, if the product contains the substance at a concentration equal to or greater than 0.1% by weight:
3 Despite sections 1 and 2, a use of the substance is not a significant new activity if the substance is used
4 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 proposed significant new activity begins:
5 The information referred to in section 4 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
Three substances have properties of concern that could pose a risk to the environment or human health in Canada if exposure levels to these substances were to increase due to certain new activities. In order to address this concern, the Minister of the Environment (the Minister) is amending the Domestic Substances List (DSL) in accordance with subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA) to apply the Significant New Activity (SNAc) provisions of CEPA to the following three substances:
- ethylene glycol dimethyl ether; ethane, 1,2-dimethoxy- (CAS RNfootnote 1 110-71-4), hereinafter referred to as “monoglyme”;
- diethylene glycol dimethyl ether; ethane, 1,1’-oxybis[2-methoxy- (CAS RN 111-96-6), hereinafter referred to as “diglyme”; and
- triethylene glycol dimethyl ether; 2,5,8,11- tetraoxadodecane (CAS RN 112-49-2), hereinafter referred to as “triglyme.”
Background
The Chemicals Management Plan (CMP) is a federal program that assesses and manages chemical substances and living organisms that may be harmful to the environment or human health. The Minister of the Environment and the Minister of Health (the ministers) assessed monoglyme, diglyme and triglyme in accordance with section 68 of CEPA as part of the CMP.
Description and uses of monoglyme, diglyme, and triglyme
Monoglyme, diglyme and triglyme do not occur naturally in the environment. Through a mandatory survey under section 71 of CEPAfootnote 2 conducted in 2008, monoglyme was reported to not be manufactured in Canada, though between 100 and 100 000 kilograms (kg) were reported to be imported into the country annually. Under section 71, a survey conducted in 2001 determined that there was no manufacture of diglyme reported in Canada, although between 100 and 1 000 kg per year was reported to be imported. Similarly, a survey conducted in 2012 found no reported manufacture of triglyme in Canada, but between 1 000 and 10 000 kg per year of triglyme was reported to be imported.
In Canada, monoglyme is used as an additive in lithium for the manufacture of all types of batteries, which are used to power various electronic products such as small appliances, computers and other digital devices. Monoglyme is also found as an impurity in air fresheners and laundry products, though the substance is not identified to be present in many products available on the market. Internationally, monoglyme has been identified to be used in a variety of products, such as cleaning products, medical, health, and veterinary products, paints and coatings, printing, writing products and printing inks.
Due to the versatility and known uses of monoglyme commercially and internationally, there is a potential for the substance to be used in a wider range of products available to consumers in Canada, such as in cosmetics, natural health products and non-prescription drugs.
In Canada, diglyme and triglyme were identified to be used in a range of industrial and commercial processes. Specifically, triglyme was reported in a section 71 survey to be used as a processing aid in petroleum production and oil and gas refining.
Summary of the screening assessments
In September 2018, the ministers published a Screening Assessment for the Ethylene Glycol Ethers Group, which assessed monoglyme along with six other substances, on the Canada.ca (Chemical Substances) website. In November 2018, the ministers published the Screening assessment for substances identified as being of low concern using the ecological risk classification of organic substances and the threshold of toxicological concern (TTC)-based approach for certain substances, which assessed diglyme and triglyme as well as 70 other substances, on the Canada.ca (Chemical Substances) website. These screening assessments were conducted to determine whether any of the substances assessed meet one or more of the criteria set out in section 64 of CEPA (i.e. to determine if the substances could pose a risk to the environment or human health).
Under section 64 of CEPA, a substance is considered toxic if it is entering or may enter the environment in a quantity, concentration, or under conditions that
- (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- (b) constitute or may constitute a danger to the environment on which life depends; or
- (c) constitute or may constitute a danger in Canada to human life or health.
The Department of the Environment and the Department of Health (the departments) collected and considered information from multiple sources (e.g. literature reviews, internal and external database searches, modelling, data from mandatory surveys issued under section 71 of CEPA and, where warranted, data from targeted follow-ups with stakeholders) to inform the conclusion that monoglyme, diglyme and triglyme do not meet any of the criteria set out in section 64 of CEPA. The screening assessments also determined that these substances have properties of concern that could lead to a risk to human health or the environment if exposure levels were to increase in relation to certain new activities.
Summary of the ecological and human health assessments
The ecological risks of monoglyme, diglyme and triglyme were characterized using the Ecological Risk Classification of Organic Substances (ERC) approach. The ERC is a risk-based approach that identifies, weighs and combines multiple metrics of hazard and exposure for organisms in aquatic and terrestrial environments, to identify substances either as warranting further evaluation of their potential to cause harm, or as having a low likelihood to cause harm. On the basis of low hazard and/or low exposure classifications according to information considered under the ERC, these three substances were classified as having a low potential for ecological risk, and therefore unlikely to be resulting in concerns for the environment in Canada.
The human health risks of monoglyme were characterized through literature reviews and database searches on repeated-dose and developmental toxicology studies. In Europe and Australia, monoglyme is classified as a reproductive and developmental toxicant (a substance that may impair fertility or damage a fetus) and as a suspected carcinogen (a substance that may cause cancer). In addition, monoglyme metabolizes into a substance called 2-methoxyethanol, which is on the List of Toxic Substances in Schedule 1 of CEPA.footnote 3 While current exposure levels to monoglyme (mostly due to the usage of air fresheners indoors) do not constitute a risk to human health, the substance was determined to have properties of concern to human health.
The human health risks of diglyme and triglyme were characterized using the Threshold of Toxicological Concern-based Approach for Certain Substances (TTC-based approach). The TTC-based approach first establishes a threshold value for human exposure to a substance (i.e. the threshold at which a substance could pose a risk to human health) based on chemical-specific data on genotoxicity (toxicity relating to the damage of genetic material in cells). It then compares that value to an estimate of actual exposure based on scenarios of potential concern (e.g. product use and availability of the substance in cosmetics). Substances with an exposure estimate below the threshold value are classified as having low concern to human health at current exposure levels. While exposures to diglyme and triglyme were not of concern at current levels, these substances were determined to have properties of concern to human health, based on their classification by other national or international agencies as reproductive and developmental toxicants.
The screening assessments concluded that current exposure levels to monoglyme, diglyme and triglyme do not meet any of the criteria set out in section 64 of CEPA. However, they determined that these substances could pose a risk if exposure levels were to increase due to certain new activities. In order to address this concern, the Minister is applying the SNAc provisions of CEPA to these three substances.
SNAc provisions of CEPA
Under CEPA, any person (individual or corporation) is permitted to carry out activities associated with any substance listed on the DSL without an obligation to notify the Minister of such activities, provided the substance is not subject to any risk management, or other instrument under CEPA. However, if the ministers assess a substance and available information suggests that certain new activities related to that substance may pose a risk to the environment, or human health, the Minister may apply the SNAc provisions of CEPA to the substance.footnote 4 These provisions establish a requirement for any person considering undertaking a significant new activityfootnote 5 (in relation to any substance subject to the provisions) to submit a Significant New Activity Notification (SNAN) to the Minister containing certain required information. Upon receipt of the complete information, the ministers would conduct further assessment of the substance before the activity is undertaken and, if necessary, implement risk management measures.
Objective
The objective of Order 2022-87-24-01 Amending the Domestic Substances List (the Order) is to contribute to the protection of human health and the environment by applying the SNAc provisions of CEPA to monoglyme, diglyme and triglyme. The Order requires that the Minister be notified of any significant new activity involving these substances so that further assessment of the substances is conducted before the activity is undertaken in Canada and, if necessary, risk management measures are implemented.
Description
Pursuant to subsection 87(3) of CEPA, the Order applies subsection 81(3) of CEPA (i.e. the SNAc provisions) to monoglyme, diglyme and triglyme.
Applicability
The Order requires that any person wishing to engage in a significant new activity in relation to any of the three substances to submit a SNAN to the Minister. The SNAN must contain all of the information prescribed in the Order and must be submitted at least 90 days prior to the import, manufacture, or use of any of the three substances for the proposed significant new activity.footnote 6 The ministers will use the information submitted in the SNAN, and other available information, to conduct further assessment of the substances before the activity is undertaken and, if necessary, implement risk management measures.
Notification requirements
Below is a summary of the notification requirements for the three substances. For specific details, please see the regulatory text in the Order.
Activities subject to notification requirements
The notification requirements apply to
- any consumer product to which the Canada Consumer Product Safety Act applies, any natural health product as defined in subsection 1(1) of the Natural Health Products Regulations, or any cosmetic within the meaning of section 2 of the Food and Drugs Act that
- uses the substance in the manufacture of the product, if the product contains the substance at a concentration equal to or greater than 0.1% by weight; or
- relates to uses of the substances in the product (i.e. other than the manufacture of one of these products, such as, but not limited to, their import), if the product contains the substance at a concentration equal to or greater than 0.1% by weight, and the total quantity of the substance used in the product is greater than 10 kg in one calendar year.
Activities not subject to notification requirements
The notification requirements do not apply to
- any use of the substances as a research and development substance, site-limited intermediate substance, or export-only substance,footnote 7 as no exposure of concern to the general population is expected from these activities;
- any use of the substances 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
- any use of the substances that 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, wastes, or substances carried through Canada).footnote 8
Information requirements
Below is a summary of the information requirements for the notification of a proposed significant new activity in relation to any of the three substances. 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 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 of that product, and the function of the substance within that product; and
- all other information in respect of the substance, including additional details surrounding use, and exposure information.
Regulatory development
Consultation
On September 1, 2018, the Minister published a Notice of Intent (NOI) to apply the SNAc provisions of CEPA to monoglyme in the Canada Gazette, Part I, for a 60-day public comment period. The only comment received sought confirmation that manufactured items were not included in the SNAc definition, which was confirmed by government officials. On November 3, 2018, the Minister published an NOI to apply the SNAc provisions of CEPA to diglyme and triglyme in the Canada Gazette, Part I, for a 60-day public comment period. One public comment was received regarding the assessment and management of occupational hazards of these substances. The comment was considered in the SNAc Order; however, this issue is beyond the scope of CEPA and requires no amendments to the SNAc definition, or to the information requirements.
The requirements set out in both NOIs are combined in this Order. The departments also informed the provincial and territorial governments about the Order through the CEPA National Advisory Committee (CEPA NAC)footnote 9 via a letter, and provided them with an opportunity to comment. No comments were received from CEPA NAC.
Modern treaty obligations and Indigenous engagement and consultation
The 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 do not impose any new regulatory requirements related to the current activity; and therefore, do not result in any impact on modern treaty rights or obligations, nor create any need for specific engagement and consultation with Indigenous peoples separate from the public comment period that followed publication of the NOI.
Instrument choice
For any substance that does not meet any of the criteria set out in section 64 of CEPA, but that has properties of concern for which certain increases in exposure could result in a risk to the environment or human health, several follow-up actions are available to the ministers. Such actions could include, but are not limited to applying the SNAc provisions of CEPA; conducting biomonitoring (for humans); conducting environmental monitoring (for air, water, sediment, wastewater, soil, or wildlife); issuing voluntary or mandatory surveys under section 71 of CEPA; requiring facilities to report to the National Pollutant Release Inventory; and conducting consumer product testing.
Among the options for follow-up actions, applying the SNAc provisions of CEPA will be considered when
- there are no or limited uses of the substance in Canada, but there is a suspicion that a significant new activity could pose risk;
- the current uses of the substance in Canada present no or limited risk, but there is a suspicion that a significant new activity could pose a risk; or
- the current uses of the substance in Canada are adequately managed, but there is a suspicion that a significant new activity could pose a risk.footnote 10
The screening assessments informed the determination that applying the SNAc provisions of CEPA is the most appropriate follow-up action for monoglyme, diglyme and triglyme, since current activities involving the substances do not pose a risk to the environment, or human health, but the substances have properties of concern that could pose a risk if exposure levels were to increase due to certain new activities.
Regulatory analysis
Benefits and costs
The Order contributes to the protection of human health and the environment by requiring that proposed significant new activities involving monoglyme, diglyme or triglyme undergo further assessment before the activity is undertaken and that, if necessary, risk management measures are implemented.
The Order does not impose any regulatory requirements (and therefore, any administrative of compliance costs) on businesses related to current activities. The Order would only target significant new activities involving any of the three substances, should any person choose to pursue such an activity. In the event that any person wishes to use, import, or manufacture any of the three substances for a significant new activity, they would be required to submit a SNAN to the Minister containing the complete information referred to in the Order. While there is no notification fee associated with submitting a SNAN to the Minister in response to the Order, the notifier may incur costs associated with generating data and supplying the required information. Similarly, in the event that a SNAN is received, the departments would incur costs for processing the information and conducting further assessments of the substance to which the SNAN relates. The Department of the Environment will incur negligible costs for conducting compliance promotion and enforcement activities associated with the Order.
Small business lens
The assessment of the small business lens concluded that the Order has no impact on small businesses, as it does not impose any administrative or compliance costs on businesses related to current activity.
One-for-one rule
The assessment of the one-for-one rule concluded that the rule does not apply to the Order, as there is no impact on industry related to current activity.
Regulatory cooperation and alignment
Canada cooperates with other 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 11 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. The assessment concluded that the CMP is expected to have a positive impact on the environment and human health.
Gender-based analysis plus
No gender-based analysis plus (GBA+) impacts have been identified for this Order.
Implementation, compliance and enforcement, and service standards
Implementation
The Order is in force on the day that it is registered. Compliance promotion activities conducted as part of the implementation of the Order will include developing and distributing promotional material, responding to inquiries from stakeholders and undertaking activities to raise industry stakeholders’ awareness of the requirements of the Order.
Compliance
When assessing whether or not a substance is subject to SNAc provisions, a person 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 12
If any information becomes available that reasonably supports the conclusion that a substance subject to SNAc provisions is toxic or capable of becoming toxic under section 64 of CEPA, the person who is in possession of, or has knowledge of the information and who is involved in activities with the substance, is obligated, under section 70 of CEPA, to provide that information to the Minister without delay.
Any person who transfers the physical possession or control of a substance subject to an Order to another should notify that person of their obligation to comply with the Order, including the obligation to notify the Minister of any significant new activity and to provide all the required information specified in that Order.
In cases where a person receives possession and control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by a SNAN submitted by the supplier on behalf of its clients.
A pre-notification consultation (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 13
Enforcement
The Order is made under the authority of CEPA, which is enforced in accordance with the Compliance and Enforcement Policy for the Canadian Environmental Protection Act. In instances of non-compliance, consideration is given to the following factors when deciding which enforcement measure to take: nature of the alleged violation, effectiveness in achieving compliance with CEPA and its regulations, and consistency in enforcement. 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 monoglyme, diglyme or triglyme, the ministers will assess the information after the complete information is received, within the prescribed timelines set out in the Order.
Contacts
Thomas Kruidenier
Acting Executive Director
Program Development and Engagement 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