Canada Gazette, Part I, Volume 153, Number 9: Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
March 2, 2019
Canadian Environmental Protection Act, 1999
Department of the Environment
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
The Government of Canada (the Government) completed a screening assessment of 2-ethylhexyl 2-ethylhexanoate to determine whether the substance may pose a risk to the environment or human health. footnote 1 The screening assessment determined that the substance does not pose a risk to the environment but may pose a risk to human health in Canada, and it therefore meets the criterion for a toxic substance as set out in paragraph 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA). As a result, the Government is proposing to add 2-ethylhexyl 2-ethylhexanoate to the List of Toxic Substances in Schedule 1 of CEPA.
The Chemicals Management Plan (CMP) was launched in 2006 by the Government to assess and manage chemical substances that may be harmful to the environment or human health. 2-Ethylhexyl 2-ethylhexanoate was identified as a priority under the CMP based on potential human health concerns.
In response to a survey conducted under section 71 of CEPA, industry did not report 2-ethylhexyl 2-ethylhexanoate as being manufactured in or imported into Canada in 2011 above the reporting threshold of 100 kg. However, notifications submitted under the Cosmetic Regulations to Health Canada indicate that the substance is found in certain cosmetic products in Canada, including foot lotion and face makeup. 2-Ethylhexyl 2-ethylhexanoate may occur naturally in very low concentrations in a limited number of foods; however, this exposure is considered to be negligible.
Although there are requirements under the Cosmetic Regulations for notification of the use of substances found in cosmetic products, 2-ethylhexyl 2-ethylhexanoate is not currently subject to any control measures.
International risk management activities
International risk management activities are taken into account when deciding upon risk management actions for 2-ethylhexyl 2-ethylhexanoate in Canada.
In the United States, the substance is subject to the Chemical Data Reporting (CDR) requirement under the Toxic Substances Control Act (TSCA) of the U.S. Environmental Protection Agency (EPA). In accordance with this requirement, companies must submit reports for certain activities involving the substance. Under the CDR rule, the EPA collects basic exposure-related information on the types, quantities and uses of chemical substances produced domestically and imported into the United States. This information constitutes the most comprehensive source of basic screening-level, exposure-related information on chemicals available to the EPA, and is used by the Agency to protect the public from potential chemical risks.
In Europe, 2-ethylhexyl 2-ethylhexanoate is classified as a Category 2 reproductive toxicant, as it is suspected of damaging fertility or the unborn child. It is subject to European Commission regulations, which prohibit the use of the substance in cosmetics due to its classification as a Category 2 reproductive toxicant, unless an evaluation by the Scientific Committee on Consumer Safety (SCCS) finds it safe for use in cosmetic products. As of December 2017, the SCCS had not yet carried out a safety evaluation of 2-ethylhexyl 2-ethylhexanoate in cosmetics.
Summary of the screening assessment
The Government conducted a screening assessment of 2-ethylhexyl 2-ethylhexanoate to determine if the substance may pose a risk to the environment or human health in Canada. Specifically, the assessment involves determining whether the substance is entering or may enter the environment in a quantity or 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 screening assessment concluded that 2-ethylhexyl 2-ethylhexanoate meets the criteria for a toxic substance under paragraph 64(c) of CEPA. The findings of the screening assessment are summarized in the following sections.
The ecological risk of 2-ethylhexyl 2-ethylhexanoate was characterized using the ecological risk classification (ERC) of organic substances. The ERC, which was developed by the Department of the Environment, is a risk-based approach that considers multiple indicators of hazard and exposure to determine the risk classification of a substance.
Data on physical-chemical properties, fate,footnote 2 acute fish ecotoxicity, and chemical import or manufacture volume in Canada were collected from the scientific literature, large publicly available comprehensive databases, responses to surveys conducted under section 71 of CEPA and models. These data were used to complete the hazard and exposure profiles of the substance. The ERC results show that potential releases of the substance into the environment do not pose an ecological concern in Canada. Therefore, the screening assessment concluded that 2-ethylhexyl 2-ethylhexanoate does not meet any of the environmental criteria under paragraph 64(a) or (b) of CEPA.
Human health assessment
No occurrence data on 2-ethylhexyl 2-ethylhexanoate in food in Canada was identified. It was reported as a volatile component of certain foreign food samples such as wild peanuts, muskmelon, roasted barley, and beef.footnote 3 Given the very low concentration of the substance and the limited number of foods in which it is present, the level of exposure from these sources is likely to be negligible and, thus, the substance does not pose a human health concern in Canada.footnote 4 Therefore, the main source of exposure of the general population to the substance was determined to be through the skin, from the use of certain cosmetic products, including foot lotion and face makeup.
Substance-specific health effects data for the relevant route and durations of exposure were not identified. Hexanoic acid, 2-ethyl (2-ethylhexanoic acid) [2-EHA] was selected as an analogue for the characterization of the potential health effects of 2-ethylhexyl 2-ethylhexanoate. The use of 2-EHA as an analogue for the substance is supported by a recent assessment by the Australian Government Department of Health,footnote 5 the European Chemicals Agency and the Globally Harmonized System of Classifications and Labelling of Chemicals. As a result, the screening assessment completed for 2-EHA by the Government was used to characterize the human health risks of 2-ethylhexyl 2-ethylhexanoate. Estimates of dermal exposure to the substance, alongside exposure studies in laboratory settings were also considered.
The primary metabolic pathway for the substance involves hydrolysis, a chemical reaction, to form 2-EHA and 2-ethylhexanol. Because current uses of the substance indicate that the predominant route of exposure is through skin, information on metabolism by skin enzymes was considered. Although the majority of enzyme activity in human skin is located in the epidermis and hair follicles, such activity has also been found in the outer skin layer. This suggests that 2-ethylhexyl 2-ethylhexanoate applied to the skin may be broken down to form 2-EHA and 2-ethylhexanol, which are more readily absorbed through the skin than the parent chemical.
As the extent of hydrolysis is unknown, it is conservatively assumed that all of the substance is hydrolyzed to 2-EHA, followed by complete absorption through the skin (i.e. it is assumed that absorption through the dermal route is equivalent to absorption through the oral route).
To determine if the use of 2-ethylhexyl 2-ethylhexanoate is safe, critical effect levels for 2-EHA were compared to exposure estimates for 2-ethylhexyl 2-ethylhexanoate. Given the uncertainties regarding health effects and the available exposure data, it is estimated that there exists the potential for harm to human health at current exposure levels.
Therefore, the screening assessment concludes that 2-ethylhexyl 2-ethylhexanoate poses a risk to human health and meets the human health criteria for a toxic substance as defined in paragraph 64(c) of CEPA.
Publication and conclusions
On December 15, 2018, the final screening assessment for calcium 2-ethylhexanoate and 2-ethylhexyl 2-ethylhexanoate was published on the Canada.ca (Chemical Substances) website. Based on the results of the final screening assessment, the Minister of the Environment and the Minister of Health (the ministers) have concluded that 2-ethylhexyl 2-ethylhexanoate meets the human health criterion for a toxic substance, as set out under paragraph 64(c) of CEPA, and therefore recommend the addition of 2-ethylhexyl 2-ethylhexanoate to Schedule 1 of CEPA.footnote 6
The objective of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the proposed Order) is to enable the Government to propose risk management measures for toxic substances under CEPA to manage potential human health risks associated with 2-ethylhexyl 2-ethylhexanoate.
The proposed Order would add 2-ethylhexyl 2-ethylhexanoate to Schedule 1 of CEPA.
The “One-for-One” Rule does not apply, as the proposed Order would not impose any administrative burden on business.
Small business lens
The small business lens does not apply, as the proposed Order would not impose any compliance or administrative costs on small business.
On March 25, 2017, the ministers published 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. No comments were received.
The Government completed a screening assessment of calcium 2-ethylhexanoate and 2-ethylhexyl 2-ethylhexanoate to determine whether the substances may pose a risk to the environment or human health. Based on the review of available information, it is concluded that the 2-ethylhexyl 2-ethylhexanoate may cause harm to human health.
Considering all available lines of evidence, it is concluded that 2-ethylhexyl 2-ethylhexanoate meets the criterion under paragraph 64(c) of CEPA, as it is entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
As a result, one of the following measures must be proposed after a screening assessment is conducted under CEPA:
- taking no further action with respect to the substance;
- adding the substance to the Priority Substances List for further assessment; or
- recommending that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA, and where applicable, recommending the implementation of virtual elimination.
Based on the available evidence, which includes data received from industry and the conclusions of the screening assessment, the Government determined that choosing options 1 or 2 is not appropriate to manage potential environmental and human health risks associated with the substance in Canada. Therefore, the ministers are proposing option 3, which recommends that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA.
The addition of the substance to Schedule 1 of CEPA would not result in any incremental impacts (benefits or costs) on the public or industry, since the proposed Order would not impose any compliance or administrative requirements on stakeholders. Accordingly, there would be no compliance or administrative burden imposed on small businesses or businesses in general. Rather, the proposed Order enables the Government to propose risk management measures under CEPA to manage potential ecological and human health risks associated with the substance.
If further risk management measures are deemed necessary for 2-ethylhexyl 2-ethylhexanoate, the Government will assess the costs and benefits if required and consult with the public and other stakeholders during the development of any risk management measure to address potential environmental and human health concerns associated with uses of the substance in Canada.
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment (SEA) for the CMP was completed. The detailed analysis that was completed as part of the SEA indicated that the CMP will have a positive effect on the environment and human health.
Implementation, enforcement and service standards
The proposed Order adds 2-ethylhexyl 2-ethylhexanoate to Schedule 1 of CEPA, thereby enabling the Government to propose risk management measures for toxic substances respecting preventive or control actions under CEPA. Developing an implementation plan, an enforcement strategy, and establishing service standards are only considered necessary when a specific risk management approach is proposed. As the proposed Order does not include a specific risk management proposal, there is no requirement for implementation, enforcement, or service standards.
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
PROPOSED REGULATORY TEXT
Notice is given, pursuant to subsection 332(1)footnote a of the Canadian Environmental Protection Act, 1999footnote b, that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3 (fax: 819‑938‑5212; email: firstname.lastname@example.org).
A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act.
Ottawa, February 21, 2019
Assistant Clerk of the Privy Council
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
1 Schedule 1 to the Canadian Environmental Protection Act, 1999footnote 7 is amended by adding the following in numerical order:
- 145 2-Ethylhexyl 2-ethylhexanoate
Coming into Force
2 This Order comes into force on the day on which it is registered.