Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2026-47

Canada Gazette, Part II, Volume 160, Number 6

Registration
SOR/2026-47 March 13, 2026

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

P.C. 2026-211 March 13, 2026

Whereas, under subsection 332(1)footnote a of the Canadian Environmental Protection Act, 1999 footnote b, the Minister of the Environment published in the Canada Gazette, Part I, on March 2, 2019, a copy of the proposed Order under the title Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999, title that has since been changed, and persons were given an opportunity to file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

And whereas, under subsection 90(1)footnote c of that Act, the Governor in Council is satisfied that the substance set out in the annexed Order is toxic;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, makes the annexed Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 under subsection 90(1)footnote c of the Canadian Environmental Protection Act, 1999 footnote b.

Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999

Amendment

1 Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 footnote b is amended by adding the following in numerical order:

Coming into Force

2 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 of the environment to substancesfootnote 1 are assessed and managed. As part of the CMP under the authority of the Canadian Environmental Protection Act, 1999 (the Act or CEPA), the substance hexanoic acid, 2-ethyl-, 2-ethylhexyl ester, which has the molecular formula C16H32O2 (CAS Registry Numberfootnote 2 7425-14-1), also known as “2-ethylhexyl 2-ethylhexanoate” was assessed to determine whether the substance meets one or more of the criteria for a toxic substance as set out in section 64 of the Act. It was concluded that 2-ethylhexyl 2-ethylhexanoate meets the human health criterion set out in paragraph 64(c) of the Act. In accordance with subsection 90(1) of the Act, the Minister of the Environment and the Minister of Health (the ministers) recommended that the Governor in Council make an order adding 2-ethylhexyl 2-ethylhexanoate to Part 2 of Schedule 1 to the Act.

Background

Strengthening Environmental Protection for a Healthier Canada Act

On June 13, 2023, the Strengthening Environmental Protection for a Healthier Canada Act (hereinafter referred to as Bill S-5) received royal assent. It amended various provisions of the Act, and, for that reason, some provisions referenced throughout this document have since been repealed or replaced and are no longer in force. Particular to additions of substances to Schedule 1 to the Act, Bill S-5 divided Schedule 1 into two parts. Toxic substances added to Part 1 require the ministers to prioritize the total, partial, or conditional prohibition of activities involved with those substances when managing their risks. Toxic substances added to Part 2 require the ministers to prioritize pollution prevention actions, which may include total, partial or conditional prohibition when managing their risks.

Chemicals Management Plan

In 2006, the Government of Canada launched the CMP, a federal program with the objective of reducing the risks posed by substances to Canadians and the environment through sources of exposure, such as food and food products, consumer products, cosmetics, drugs, drinking water and industrial releases. 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 the Act to identify existing or potential environmental and human health risks posed by exposure to substances. When risks are identified, the ministers may recommend the development of risk management measures to mitigate these risks under the authority of a broad suite of federal laws, including the Act, the Canada Consumer Product Safety Act, the Food and Drugs Act, the Pest Control Products Act, and the Fisheries Act.

As part of the CMP, the ministers assessed 2-ethylhexyl 2-ethylhexanoate under section 68 of the Act, as it read before the coming into force of the Strengthening Environmental Protection for a Healthier Canada Act.

Description, uses and sources of release

2-Ethylhexyl 2-ethylhexanoate can occur naturally in the environment at very low concentrations as a volatile component in certain foods. In Canada, the Minister of the Environment issued a mandatory survey under section 71 of the Act encompassing the substance (reporting year 2011) to obtain information on its use in Canada. Information reported by industry indicated that 2-ethylhexyl 2-ethylhexanoate was neither manufactured in, nor imported into Canada above a threshold of 100 kilograms (kg). Given this survey result, the substance is not expected to be released into the environment in significant quantities.

Notifications submitted to the Department of Health under the Cosmetic Regulations indicate that 2-ethylhexyl 2-ethylhexanoate is found in certain cosmetic products in Canada, including foot lotion and face make-up. No occurrence of 2-ethylhexyl 2-ethylhexanoate in food in Canada was identified, though it was reported as a volatile component of a limited number of foreign food samples at very low concentrations.

Current risk management activities

National

There are requirements for the notification of substances found in cosmetic products under the Cosmetic Regulations, and 2-ethylhexyl 2-ethylhexanoate is restricted to maximum concentrations of 0.1% for body lotion, 0.5% for foot lotion and 0.6% for face make-up under the Cosmetic Ingredient Hotlist.

International

In the United States (U.S.), 2-ethylhexyl 2-ethylhexanoate is subject to the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) requirement, for which companies must submit reports for certain activities involving the substance. Under the CDR rule, the U.S. EPA periodically collects basic exposure-related information on the types, quantities and uses of chemical substances produced domestically and imported into the United States. This constitutes the most comprehensive source of basic screening-level, exposure-related information on chemicals available to the U.S. EPA, and is used by the U.S. EPA to protect the public from potential chemical risks.

In the European Union, 2-ethylhexyl 2-ethylhexanoate is prohibited for use in cosmetics due to its classification as a Category 2 reproductive toxicant,footnote 3 unless an evaluation by the Scientific Committee on Consumer Safety (SCCS) finds it safe for use in cosmetic products. As of spring 2025, no specific evaluation has been completed to identify exceptions for 2-ethylhexyl 2-ethylhexanoate in cosmetics.

In Australia, 2-ethylhexyl 2-ethylhexanoate has been subject to labelling requirements under the Australian Poisons Standard since June 2017. These requirements include warnings against the use of products containing the substance by pregnant women.

Summary of the screening assessment

In December 2018, the ministers published a screening assessment on 2-ethylhexyl 2-ethylhexanoate on the Canada.ca (Chemical substances) website.footnote 4 The screening assessment was conducted to determine whether the substance meets one or more of the criteria for a toxic substance as set out in section 64 of the Act.

Under section 64 of the Act, a substance is considered toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that

The ministers collected and considered information from multiple sources (including literature reviews, internal and external database searches, modelling, data from mandatory surveys issued pursuant to section 46 and section 71 of the Act, and, where warranted, data from targeted follow-ups with interested parties) to inform the screening assessment conclusion. The ecological and human health portions of this assessment have undergone external peer review, as well as consultation with academics and other relevant interested parties.

The screening assessment concluded that 2-ethylhexyl 2-ethylhexanoate meets the human health criterion for a toxic substance as set out in paragraph 64(c) of the Act and thus constitutes a risk to human health in Canada. Below are summaries of the ecological and human health assessments.

Summary of the ecological assessment

The ecological component of the screening assessment was conducted using the ecological risk classification of organic substances (ERC). The ERC, which was developed by the Department of the Environment, is a risk-based approach that considers multiple metrics of hazard and exposure to determine the risk classification of a substance. Based on this approach, the hazard and exposure classifications for 2-ethylhexyl 2-ethylhexanoate were both determined to be low and the substance was classified as having a low potential for ecological risk.

The screening assessment concluded that 2-ethylhexyl 2-ethylhexanoate does not meet the ecological criteria for a toxic substance set out in paragraphs 64(a) or 64(b) of the Act. The assessment also determined that 2-ethylhexyl 2-ethylhexanoate does not meet the persistence criteria but does meet the bioaccumulation criteria, as set out in the Persistence and Bioaccumulation Regulations.

Summary of the human health assessment

The human health assessment included both an exposure and a health effects characterization. Human exposure to 2-ethylhexyl 2-ethylhexanoate through environmental media is not expected, since it was not identified as being manufactured in or imported into Canada. Similarly, human exposure from food is expected to be negligible. The primary mode of human exposure is through the use of cosmetic products that contain it, including foot lotion and face make-up, and the use of these products could result in daily exposures. Modelling with ConsExpofootnote 5 was used to estimate systemic exposure via the dermal route.

Since substance-specific health effects data for 2-ethylhexyl 2-ethylhexanoate were not identified, 2-ethylhexanoic acid (2-EHA) was used as an analogue for the health effects assessment. The use of 2-EHA as an analogue is supported by similar assessments conducted by the Australian Government's Department of Health and the European Chemicals Agency. The literature cited in the departments’ 2011 (ARCHIVED) screening assessment for 2-EHA was therefore used to characterize the human health risks of 2-ethylhexyl 2-ethylhexanoate, including an oral study in which adverse developmental effects were observed in experimental animals following repeated exposure to 2-EHA. These developmental effects include skeletal variations (wavy ribs and reduced cranial bone formation) and skeletal malformations (club foot). 2-EHA has also been found to cause liver toxicity in pregnant rats.

To determine if the use of 2-ethylhexyl 2-ethylhexanoate is safe, exposure estimates from foot lotion or face make-up for this substance were compared to critical effect levels for 2-EHA. Given the uncertainties in the health effects and available exposure data, current uses and practices may affect human health.

The screening assessment concluded that 2-ethylhexyl 2-ethylhexanoate meets the human health criterion for a toxic substance set out in paragraph 64(c) of the Act.

Objective

The objective of the Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (the Order) is to enable the ministers to propose risk management instruments for a toxic substance under the Act that prioritize pollution prevention actions, which may include prohibitions when managing potential human health risks associated with 2-ethylhexyl 2-ethylhexanoate.

Description

The Order adds hexanoic acid, 2-ethyl-, 2-ethylhexyl ester, which has the molecular formula C16H32O2, to Part 2 of Schedule 1 to the Act.

Regulatory development

Consultation

On March 25, 2017, the ministers published a Notice with a summary of the draft screening assessment for calcium 2-ethylhexanoate and 2-ethylhexyl 2-ethylhexanoate in the Canada Gazette, Part I, for a 60-day public comment period. The Notice also informed of the publication of the risk management scope document for 2-ethylhexyl 2-ethylhexanoate to initiate discussions with interested parties on the development of risk management actions. During this period, no comments were received on the draft screening assessment or on the risk management scope document.

On December 15, 2018, the ministers published a Notice with a summary of the final screening assessment for calcium 2-ethylhexanoate and 2-ethylhexyl 2-ethylhexanoate in the Canada Gazette, Part I. The Notice also informed of the publication of the Risk management approach document for 2-ethylhexyl 2-ethylhexanoate to continue discussions with interested parties on the development of risk management actions for a 60-day public comment period. During this period, no comments were received on the risk management approach document.

On March 2, 2019, the proposed Order recommending the addition of 2-ethylhexyl-2-ethylhexanoate to Schedule 1 to the Actfootnote 6 was published in the Canada Gazette, Part I, for a 60-day public comment period. No comments were received during this period.

Indigenous engagement, consultation and modern treaty obligations

Orders adding substances to Part 2 of Schedule 1 to the Act do not introduce any new regulatory requirements, and therefore, do not result in any impact on modern treaty rights or obligations. Therefore, specific engagement and consultations with Indigenous Peoples were not undertaken.

Instrument choice

Following an assessment conducted for a substance under section 68 of the Act, the publication of the assessment conclusion under section 77 of the Act must propose one of the following measures:

Toxic substances that pose the highest risk are recommended for addition to Part 1 of Schedule 1 to the Act. These substances would be prioritized for total, partial, or conditional prohibition. Other toxic substances are recommended for addition to Part 2 of Schedule 1 to the Act and are prioritized for pollution prevention actions, which may include total, partial or conditional prohibition. Until regulations specifying criteria for the classification of substances that pose the highest risk or that are carcinogenic, mutagenic, or toxic to reproduction are developed, toxic substances that are determined to be persistent and bioaccumulative as per the criteria under the Persistence and Bioaccumulation Regulations are recommended for addition to Part 1 of Schedule 1 to the Act. 2-Ethylhexyl 2-ethylhexanoate does not meet the persistence criteria but does meet the bioaccumulation criteria under the Persistence and Bioaccumulation Regulations.

Therefore, the measure recommended by the ministers is that 2-ethylhexyl 2-ethylhexanoate be added to Part 2 of Schedule 1 to the Act.

Regulatory analysis

Benefits and costs

Orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), as they do not impose any regulatory requirements on businesses. Therefore, the Order will not result in incremental impacts. These orders grant the ministers the authority to develop risk management instruments for a toxic substance under the Act. In accordance with the Cabinet Directive on Regulation, the Government of Canada will consult interested parties on any future risk management instruments associated with those substances before implementation and will conduct a cost-benefit analysis to consider their potential impacts.

Small business lens

As described in the “Benefits and costs” subsection, the Order does not result in any incremental impacts. Therefore, the Order will not impact Canadian small businesses.

One-for-one rule

Since orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), the one-for-one rule does not apply, as the Order does not result in a change in administrative burden imposed on businesses.footnote 7

Regulatory cooperation and alignment

Canada cooperates with other international organizations and regulatory agencies for the management of chemicals (e.g. the U.S. EPA, 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 8 2-Ethylhexyl 2-ethylhexanoate is not listed in any multilateral agreement to which Canada is a party. While the Order does not on its own relate to any international agreements or obligations, it enables the ministers to propose risk management measures that may align with actions undertaken by other jurisdictions.

Effects on the environment

In accordance with the Cabinet Directive on the Strategic Environmental and Economic Assessment (SEEA), a SEEA is required for proposals that are expected to have important effects (positive or negative, direct or indirect) on the environment and the economy. Since orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), a SEEA was not required for the proposed Order. These orders grant the ministers the authority to develop risk management instruments for a toxic substance under the Act. The Government of Canada will evaluate whether a SEEA may be required on any future risk management instruments for 2-ethylhexyl 2-ethylhexanoate.

Gender-based analysis plus

Since orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), no gender-based analysis plus (GBA+) impacts have been identified for the Order.footnote 9

Right to a healthy environment

The Government of Canada has a duty, in the administration of CEPA, to protect the right to a healthy environment as provided for under CEPA, subject to reasonable limits. An implementation framework sets out considerations to protect this right and uphold the principles described in the framework.

Work to inform the Order was completed before the implementation framework was published on July 19, 2025. Recognizing that CEPA decisions are informed by analyses and consultations that are often the result of years of work, a transition period is in place to allow the departments to support continued protection of the environment and human health. The objective of the transition period is to continue to advance timely CEPA decisions and actions, while consideration of the right to a healthy environment and relevant principles are being fully integrated into the administration of CEPA. The Order is proceeding under the transition period referenced in the framework.

Although the implementation framework was not available to be applied from the beginning of the work undertaken to inform the Order, many of the elements included in the framework were considered. As part of the CMP, the assessment of substances under the Act aligns with the framework by proactively evaluating risks posed to the environment and human health by exposure to those substances, engaging with interested parties, and informing policy decision-making and regulatory actions as necessary to prevent harm to the environment and human health. Orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act align with the framework by granting the ministers the authority to propose risk management instruments for a toxic substance under the Act, as necessary, to prevent any identified harm to the environment or human health.

Implementation, compliance and enforcement, and service standards

Since orders adding substances to Part 1 or Part 2 of Schedule 1 to Act do not impose any regulatory requirements on businesses, developing an implementation plan and a compliance and enforcement strategy, as well as establishing service standards for the Order, are not warranted.

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

Contacts

Thomas Kruidenier
Executive Director
Substance Prioritization, Assessment and Coordination Division
Environment and Climate Change Canada
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
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613‑266‑3591
Email: andrew.beck@hc-sc.gc.ca