Order 2022-87-23-01 Amending the Domestic Substances List: SOR/2022-183
Canada Gazette, Part II, Volume 156, Number 17
SOR/2022-183 July 27, 2022
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Whereas the substance set out in the annexed Order is 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 the substance 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, 1999 footnote b, makes the annexed Order 2022-87-23-01 Amending the Domestic Substances List.
Gatineau, July 22, 2022
Minister of the Environment
Order 2022-87-23-01 Amending the Domestic Substances List
1 Part 1 of the Domestic Substances List footnote a is amended by deleting the following:
Significant New Activity for which substance is subject to subsection 81(3) of the Act
1 The use of the substance hexanoic acid, 2-ethyl-, calcium salt in the manufacture of any of the following products such that the substance is present in the product in a concentration greater than 0.1% by weight:
2 The importation of the substance hexanoic acid, 2-ethyl-, calcium salt 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 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 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.)
The substance hexanoic acid, 2-ethyl-, calcium salt (CAS RNfootnote 1 136-51-6; also known as “calcium 2-ethylhexanoate”) has properties of concern that could pose a risk to the environment or human health in Canada if exposure levels to the substance were to increase due to certain new activities. In order to address this concern, the Minister of the Environment (the Minister) amended the Domestic Substances List (DSL) in accordance with subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA or “the Act”) to apply the Significant New Activity (SNAc) provisions of CEPA to calcium 2-ethylhexanoate.
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 calcium 2-ethylhexanoate in accordance with section 74 of CEPA as part of the CMP.
Description and uses
The Department of the Environment and the Department of Health (the departments) issued a mandatory survey under section 71 of CEPAfootnote 2 encompassing calcium 2-ethylhexanoate. Information received from industry for 2011 indicated no reports of the manufacture of calcium 2-ethylhexanoate in Canada above the reporting threshold of 100 kg, though 10 000 to 100 000 kg of the substance was reported to have been imported into the country.
In Canada, calcium 2-ethylhexanoate is used as an additive in interior and exterior paints, as a formulant in registered pest control products (antifouling paints), and as a component of no-rinse aid in the drying cycle of commercial dishwasher machines. It has also been identified for use in the manufacture of certain food packaging materials, including resins and printing inks.
Internationally, calcium 2-ethylhexanoate is used in paints, coatings, inks and toners, which can be found in or on metal, paper, or wood products available to consumers. International commercial applications of the substance include pharmaceuticals and cosmetics.
Summary of the screening assessment
In December 2018, the ministers published a screening assessment on calcium 2-ethylhexanoatefootnote 3 on the Canada.ca (Chemical Substances) website. The screening assessment was conducted to determine whether the substance meets one or more of the criteria set out in section 64 of CEPA (i.e. to determine if the substance could pose a risk to the environment or human health in Canada).
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 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 screening assessment conclusion that calcium 2-ethylhexanoate does not meet any of the criteria set out in section 64 of CEPA. The assessment also determined that calcium 2-ethylhexanoate has properties of concern that could lead to a risk to human health if exposure levels were to increase due to certain new activities. Below are summaries of the ecological and human health assessments.
Summary of the ecological and human health assessments
The ecological risks of calcium 2-ethylhexanoate 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, calcium 2-ethylhexanoate was classified as having low potential for ecological risk and, therefore, unlikely to be resulting in concerns for the environment in Canada.
Substance-specific health effects data for calcium 2-ethylhexanoate were not identified. However, literature characterizing the human health risks associated with another substance expected to have a similar risk profile to calcium 2-ethylhexanoate, called 2-ethylhexanoic acid (CAS RN 149-57-5; hereafter referred to as “2-EHA”),footnote 4 identified 2-EHA as a developmental toxicant (a substance that may damage fertility or a fetus). Current exposure to calcium 2-ethylhexanoate through consumer products in Canada could occur dermally (through skin) for paints. Exposure of the general population to calcium 2-ethylhexanoate from food is expected to be negligible. An estimate of current exposure for calcium 2-ethylhexanoate was derived based on a scenario of dermal exposure to interior or exterior paint and was compared to a critical effect level (the threshold at which effects on human health are observed) for 2-EHA. The margin between the critical effect level and the estimated exposure were considered adequate to address uncertainties in the health effects and exposure databases, indicating that calcium 2-ethylhexanoate is unlikely to pose a risk to human health.
In order to address the potential human health concerns if exposure to calcium 2-ethylhexanoate were to increase due to certain new activities, the Minister is applying the SNAc provisions of CEPA to the substance.
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 instruments under the Act. 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 5 These provisions establish a requirement for any person considering undertaking a significant new activityfootnote 6 (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.
The objective of Order 2022-87-23-01 Amending the Domestic Substances List (the Order) is to contribute to the protection of the environment and human health by applying the SNAc provisions of CEPA to calcium 2-ethylhexanoate. The Order requires that the Minister be notified of any significant new activity involving the substance so that further assessment of the substance is conducted and, if necessary, risk management measures are implemented before the activity is undertaken.
Pursuant to subsection 87(3) of CEPA, the Order applies subsection 81(3) of CEPA (i.e. the SNAc provisions) to calcium 2-ethylhexanoate.
The Order requires any person wishing to engage in a significant new activity in relation to calcium 2-ethylhexanoate 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 the substance for the proposed significant new activity.footnote 7 The ministers will use the information submitted in the SNAN, and other available information, to conduct further assessment of the substance before the activity is undertaken and, if necessary, implement risk management measures.
Below is a summary of the notification requirements for calcium 2-ethylhexanoate. 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, other than paint, or another surface coating material that dries to a solid film if the substance is present in the paint or surface coating material in a concentration that is less than or equal to 0.5% by weight, 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 the importation of the substance, 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 substance as a research and development substance, site-limited intermediate substance, or export-only substance,footnote 8 as no exposure of concern to the general population is expected from these activities;
- 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
- any use of the substance 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 9
Below is a summary of the information requirements for the notification of a proposed significant new activity in relation to calcium 2-ethylhexanoate. 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.
On December 15, 2018, the Minister published a Notice of Intent (NOI) to apply the SNAc provisions of CEPA to calcium 2-ethylhexanoate, in the Canada Gazette, Part I, for a 60-day public comment period. No comments were received during that 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
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 introduce any new regulatory requirements related to 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 Notice of Intent.
For any substance that does not meet any of the criteria for a toxic substance as 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 a 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 suspicion that a significant new activity could pose a risk.footnote 11
The screening assessment informed the determination that applying the SNAc provisions of CEPA is the most appropriate follow-up action for calcium 2-ethylhexanoate, since current activities involving the substance do not pose a risk to the environment or human health, but the substance has properties of concern that could pose a risk if exposure levels were to increase due to certain new activities.
Benefits and costs
The Order contributes to the protection of the environment and human health by requiring that proposed significant new activities involving calcium 2-ethylhexanoate 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 or compliance costs) on businesses related to current activities. The Order only targets significant new activities involving the substance, should any person choose to pursue such an activity. In the event that any person wishes to use, import, or manufacture calcium 2-ethylhexanoate 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.
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 of Economic Co-operation and Development) and is party to several international multilateral environmental agreements in the area of chemicals and waste.footnote 12 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
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.
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 13
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 who 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 14
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 firstname.lastname@example.org.
In the event that a SNAN is submitted to the Minister in relation to calcium 2-ethylhexanoate, the ministers will assess the information after the complete information is received, within the prescribed timelines set out in the Order.
Acting Executive Director
Program Development and Engagement Division
Department of the Environment
Substances Management Information Line:
1‑800‑567‑1999 (toll-free in Canada)
819‑938‑3232 (outside of Canada)
Risk Management Bureau
Department of Health