Canada Gazette, Part I, Volume 156, Number 14: Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
April 2, 2022
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 substance methanone, diphenyl- (CAS RNfootnote 1 119-61-9; hereafter referred to as “benzophenone”) meets the human health criterion for a toxic substance as set out in paragraph 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA or “the Act”). In accordance with subsection 90(1) of CEPA, the Minister of the Environment and the Minister of Health (the ministers) are recommending to the Governor in Council to make an order adding benzophenone to Schedule 1 to the Act (the List of Toxic Substances).
The Chemicals Management Plan (CMP) is a federal program that assesses and manages chemical substances and micro-organisms that may be harmful to the environment or human health. The ministers assessed benzophenone in accordance with section 74 of CEPA as part of the CMP.
Description and uses
Benzophenone is an organic substance (aromatic ketone) that is both naturally occurring in the environment and synthetically manufactured. Benzophenone is a semi-volatile organic compound that is moderately soluble in water and freely soluble in organic solvents. The Department of the Environment and the Department of Health (the departments) issued mandatory surveys under section 71 of CEPAfootnote 2 regarding benzophenone. Information from industry for reporting year 2008 indicated that less than 1 000 kg of benzophenone were manufactured in Canada, and that between 35 000 kg and 135 000 kg were imported into the country.
In Canada, benzophenone was reported to be used as an additive in paints and coatings, as well as in stains, as a fragrance ingredient, as a photosensitive substance in ink, toner, and colourants, as a laboratory substance for medical devices, as an industrial photoinitiator (compound that creates reactive species when exposed to radiation), and as an additive in adhesives and sealants. According to notifications received under the Cosmetic Regulations, benzophenone is present in certain cosmetic products in Canada, such as nail polish, fragrances, makeup, and hair products. Benzophenone has also been identified as a component in some printing inks used in a limited number of food packaging materials that have no direct contact with food, and may also be used as a food flavouring agent, as a formulant in pest control products, and as an additive in deck stains, deck crack fillers, and automotive cleaning products available to the general population.
Current risk management activities
The safety of chemicals used in food packaging materials is subject to the provisions of paragraph 4(1)(a) of the Food and Drugs Act and Division 23 of the Food and Drug Regulations. Benzophenone is not currently included on the Department of Health’s Lists of Permitted Food Additives and is therefore not an approved food additive in foods sold in Canada. While benzophenone is present in cosmetics (according to notifications submitted under the Cosmetic Regulations), it is not currently included on the Department of Health’s Cosmetic Ingredient Hotlist. Benzophenone, unlike some of its derivatives, is not listed as a medicinal ingredient in the Department of Health’s Secondary Sunscreen Monograph. Any potential use of benzophenone as a component of medical devices is subject to biocompatibility testing as part of the assessment of device safety and effectiveness as per the Medical Devices Regulations. Benzophenone is a permitted formulant in pest control products regulated under the Pest Control Products Act. Final end-use paint, stain, and coating products available to consumers must meet the labelling requirements set out in the Consumer Chemicals and Containers Regulations, 2001.
In the United States, benzophenone was previously permitted as a direct and indirect food additive in certain applications. In 2018, the U.S. Food and Drug Administration (FDA) ruled in favour of a 2015 petition to amend their food additive regulations to no longer authorize these uses of benzophenone. While the U.S. FDA’s scientific analysis determined that benzophenone does not pose a risk to public health under the conditions of its intended use, the U.S. FDA indicated that they would remove benzophenone from their food additive regulations, since they are not permitted to approve the use of any food additive that has been found to induce cancer in humans or animals at any dose. Benzophenone is one of the substances included in a bill submitted to the U.S. Congress in September 2018, proposing that benzophenone be listed as a prohibited ingredient for use in personal care products such as cosmetics.
Benzophenone is listed on the U.S. Toxic Substances Control Act Inventory as a substance subject to testing requirements for high production volume chemicals, and the U.S. Environmental Protection Agency subjects benzophenone to a pilot fragrance notification program for pesticides. There are no specific restrictions for benzophenone in paint and coatings in the United States, although consumer products of that nature are subject to applicable labelling and information requirements.
In the European Union (EU), benzophenone is listed as a permitted flavouring substance for food, and is authorized for use as an additive or polymer production aid in food contact materials, provided it meets the specific migration limit set out in the associated EU regulation. Benzophenone is currently permitted for use in cosmetics as an ultraviolet (UV) light absorber (a product that protects the cosmetic against the effects of UV light). Benzophenone is included in the EU call for data on ingredients used in cosmetic products with potential endocrine-disrupting properties (disruptions to the network of glands that produce hormones). In Australia, benzophenone is excluded from the list of sunscreening agents permitted as active ingredients in listed products sold domestically.
Summary of the screening assessment
In January 2021, the ministers published a screening assessment of benzophenone on the Canada.ca (Chemical Substances) website. 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 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 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 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-up engagement with stakeholders) to inform the screening assessment conclusion. The ecological and human health portions of the screening assessment underwent external peer review or consultation with academics and other relevant stakeholders.
The screening assessment concluded that benzophenone meets the human health criterion for a toxic substance as set out in paragraph 64(c) of CEPA, 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 risks of benzophenone were characterized using the ecological risk classification of organic substances (ERC), which is a risk-based approach that uses multiple metrics for hazard and exposure, with subjective consideration of multiple lines of evidence 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 low exposure classifications according to information considered under ERC, benzophenone was classified as having a low potential for ecological risk and is therefore unlikely to result in concerns for the environment. The screening assessment concluded that benzophenone does not meet the criteria as set out in paragraphs 64(a) and 64(b) of CEPA.
Summary of the human health assessment
To identify and characterize the human health effects of benzophenone, the screening assessment considered international data reports on the substance. This included reviews by the International Agency for Research on Cancer (IARC) and the European Food Safety Authority. According to the IARC assessment, benzophenone can be absorbed through inhalation, oral, and dermal (through the skin) pathways. The IARC report evaluated the risk of cancer from benzophenone exposure, and concluded that sufficient evidence exists to classify the substance as a carcinogen in laboratory animals (based on chronic oral exposure to benzophenone in rats and mice), and as a possible carcinogen to humans. Benzophenone was not classified as genotoxic (a substance that may damage genetic material in cells), but had been found to display non-cancer effects on the kidneys as well as maternal effects in laboratory animals.
Canadians may be exposed to benzophenone from environmental media (e.g. indoor air and dust, drinking water), food, and certain consumer products (i.e. baby bottles, nail polish, fragrance, body cleanser, interior and exterior paints, and stains). The screening assessment compared estimated levels of exposure from those sources against critical endpoints, and found that exposures to benzophenone from environmental media, food, as well as from the use of baby bottles, fragrance, and body cleanser were not scenarios of concern to the general population in Canada. By contrast, the margins between the critical endpoint and estimated exposure to benzophenone from the use of nail polish, interior and exterior paints, and stains were considered inadequate to account for uncertainties in the health effects and exposure databases.
Based on the lines of available evidence, the screening assessment concluded that benzophenone meets the criterion set out in paragraph 64(c) of CEPA.
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 add benzophenone to Schedule 1 to CEPA, which would enable the ministers to propose risk management measures under CEPA to manage potential human health risks associated with the substance.
The proposed Order would add methanone, diphenyl- (i.e. benzophenone) to Schedule 1 to CEPA (the List of Toxic Substances).
On August 4, 2018, the ministers published a notice with a summary of the draft screening assessment on benzophenone (which included a link to the complete draft assessment) in the Canada Gazette, Part I, for a 60-day public comment period. Comments were received from various stakeholders, including five from industry, one from a non-governmental organization, and one from an individual. These comments were considered in the development of the final screening assessment, but did not result in a change to the conclusion that benzophenone met the human health criterion for a toxic substance as set out in paragraph 64(c) of CEPA. A short summary of the comments received is found below, and a table summarizing the complete set of comments received and the responses to these comments is available on the Canada.ca (Chemical Substances) website.
Some industry stakeholders provided information on uses and releases of benzophenone in Canada and addressed certain data gaps. Departmental officials acknowledged the information provided by all stakeholders. Comments were received and questions raised about certain exposure scenarios and risk characterization pertaining to certain consumer products, and comments were also received about import quantities. These submissions were considered in the preparation of the final screening assessment. In addition, an individual requested further clarification on certain methodologies selected in the screening assessment, while validating several references and inputs used in the assessment. Officials responded by providing justifications for the methodological choices and the information presented in the screening assessment. In general, stakeholders were supportive of the proposed conclusion of the screening assessment; namely, that benzophenone may pose a risk to human health but not to the environment.
Other comments received pertained to the development of risk management measures, which informed the risk management approach document for benzophenone. These comments will be considered during the development of risk management measures, which would be subject to its own consultation process.
The departments informed the provincial and territorial governments about all publications through the CEPA National Advisory Committee (CEPA NAC)footnote 3 via a letter, and provided them with an opportunity to comment. No comments were received by CEPA NAC.
Modern treaty obligations and Indigenous engagement and consultations
An assessment of modern treaty implications conducted in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders adding substances to Schedule 1 to CEPA do not introduce any new regulatory requirements, and therefore do not result in any impact on modern treaty rights or obligations. As a result, specific engagement and consultations with Indigenous Peoples were not undertaken. However, the prepublication comment period, which is open to all Canadians, is an opportunity for Indigenous Peoples to provide feedback on the proposed Order. For any proposed risk management measures for benzophenone, the departments would assess any associated impact on modern treaty rights or obligations, and requirements for Indigenous engagement and consultations, during the development of such measures.
When a substance meets one or more of the criteria for a toxic substance as set out in section 64 of CEPA, the ministers shall propose one of the following options under subsection 77(2) of CEPA:
- (a) taking no further action in respect to the substance;
- (b) unless the substance is already on the Priority Substances List,footnote 4 adding the substance to the Priority Substances List; or
- (c) recommending that the substance be added to Schedule 1 to CEPA and, where applicable, recommending the implementation of virtual elimination.footnote 5
When recommending that the substance be added to Schedule 1 to CEPA, the ministers shall recommend the implementation of virtual elimination if the substance was assessed under section 74 of CEPA and if, as set out in subsection 77(4) of CEPA, the ministers are satisfied that
- the substance met at least one of the criteria for a toxic substance as set out in section 64 of CEPA;
- the substance was found to be persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations;
- the presence of the substance in the environment resulted primarily from human activity; and
- the substance was not a naturally occurring inorganic substance or a naturally occurring radionuclide.
The implementation of virtual elimination does not apply to benzophenone, as the substance was found to be neither persistent nor bioaccumulative. Based on the available evidence, the ministers determined that it is not appropriate to manage the potential health risks associated with benzophenone by taking no further action or adding the substance to the Priority Substances List. Therefore, the ministers are recommending that benzophenone be added to Schedule 1 to CEPA. An order is the only available instrument to implement this recommendation.
Benefits and costs
The addition of benzophenone to Schedule 1 to CEPA would not on its own impose any regulatory requirements on businesses or other entities, and therefore would not result in any incremental compliance costs for stakeholders or enforcement costs for the Government of Canada. The proposed Order would grant the ministers the authority to develop risk management measures under CEPA for benzophenone. If pursued, these measures could result in incremental costs for stakeholders and the Government of Canada. In the event that the ministers propose risk management measures for benzophenone, the departments would assess their benefits and costs and would conduct consultations with stakeholders, the public, and other interested parties during the development of such measures.
Small business lens
The small business lens analysis concluded that the proposed Order would have no associated impact on small business, as it would not impose any administrative or compliance costs on businesses. For any proposed risk management measures for benzophenone, the departments would assess any associated impact on small businesses during the development of such measures.
The one-for-one rule does not apply, as the proposed Order would not result in a change in administrative burden imposed on businesses. For any proposed risk management measures for benzophenone, the departments would assess any associated administrative burden during the development of such measures.
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 6 While the proposed Order would not on its own relate to any international agreements or obligations, it would enable the ministers to propose risk management measures that may align with actions undertaken by other jurisdictions.
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, inclusive of orders adding substances to Schedule 1 to CEPA. The assessment concluded that the CMP is expected to have a positive effect on the environment and human health.
Gender-based analysis plus
No gender-based analysis plus (GBA+) impacts have been identified for the proposed Order.
Implementation, compliance and enforcement, and service standards
Since no specific risk management measures are recommended as part of the proposed Order, it is not necessary at this time to develop an implementation plan, a compliance and enforcement strategy, or service standards. For any proposed risk management measures for benzophenone, the departments would assess these elements during the development of such measures.
Acting Executive Director
Program Development and Engagement Division
Environment and Climate Change Canada
Substances Management Information Line:
1‑800‑567‑1999 (toll-free in Canada)
819‑938‑3232 (outside of Canada)
Risk Management Bureau
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, Environment and Climate Change Canada, Gatineau, Quebec K1A 0H3 (fax: 819‑938‑5212; email: email@example.com).
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, March 24, 2022
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, 1999 footnote b is amended by adding the following in numerical order:
- 157 Methanone, diphenyl-
Coming into Force
2 This Order comes into force on the day on which it is registered.