Canada Gazette, Part I, Volume 156, Number 40: Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 [Solvent Violet 13]

October 1, 2022

Statutory authority
Canadian Environmental Protection Act, 1999

Sponsoring departments
Department of the Environment
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

Government officials conducted an assessment as part of its Chemicals Management Plan on 9,10- anthracenedione, 1-hydroxy-4-[(4-methylphenyl)amino]- (CAS RNfootnote 1 81-48-1; hereafter referred to as “Solvent Violet 13”), which concluded that the substance 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 that the Governor in Council make an order adding Solvent Violet 13 to Schedule 1 (List of Toxic Substances) to the Act.

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 ministers assessed 7 of 15 substances (including Solvent Violet 13) referred to collectively under the CMP as the Anthraquinones Group in accordance with section 68 or 74 of CEPA as part of the CMP.

Description, uses, and sources of release

Solvent Violet 13 is an organic substance, which is part of the Anthraquinones Group. The Department of the Environment and the Department of Health (the departments) issued a mandatory survey pursuant to section 71 of CEPAfootnote 2 encompassing Solvent Violet 13 (reporting year 2011). Information reported by industry indicated that Solvent Violet 13 was not manufactured in Canada above the reporting threshold of 100 kilograms (kg), but the substance was imported in the range of 1 000 kg to 10 000 kg in the 2011 calendar year.

In Canada and globally, Solvent Violet 13 is used as a colourant. Based on information obtained from the CEPA section 71 survey, Solvent Violet 13 is used in the manufacture of candles in Canada. According to notifications received under the Cosmetic Regulations, Solvent Violet 13 is present in certain cosmetics in Canada such as body creams, bath products, lipsticks and lip balms, make-up, nail products, shampoos and conditioners, hair styling products, perfumes and face painting products. Solvent Violet 13 may also be used as a component in food packaging materials and may also be used in food processing establishments as a component in incidental additives (i.e. hand sanitizers and cleaners), with negligible exposure or no expected food contact. It is used in natural health products (such as acne therapy products, anti-dandruff products, and antiseptic skin cleansers), in pet shampoos, and as a formulant in pest control products. Globally, Solvent Violet 13 was found to be used as a colourant in non-plastic toys and in other products including textiles, paper, and plastics; however, these were not identified for use in Canada.

Current risk management activities

National level

The safety of chemicals used in food packaging materials and incidental additives is subject to the provisions of the Food and Drugs Act. Food packaging materials are also subject to the Food and Drug Regulations. While Solvent Violet 13 is present in cosmetics (based on notifications submitted under the Cosmetic Regulations), it is not currently included on the Cosmetic Ingredient Hotlist. Solvent Violet 13 is listed with a non-medicinal role for external use only as colour additive in the Natural Health Products Ingredients Database, as well as in the Licensed Natural Health Products Database as being present as a non-medicinal ingredient, in natural health products. Solvent Violet 13 is listed under the Food and Drug Regulations as a colouring agent permitted in drugs for external use. Solvent Violet 13 is a permitted formulant in pest control products regulated under the Pest Control Products Act.

International level

Solvent Violet 13 is listed in the United States (U.S.) Federal Food, Drug and Cosmetic Act as a colour additive that is subject to certification, and is permitted for use in cosmetics for external use only, but not allowed in the eye area or generally when applied where it may be ingested (including lipsticks). It is also allowed for use in externally applied drugs and in medical devices under specific conditions. Solvent Violet 13 is also listed in the U.S. Food and Drug Administration’s Color Additives That Are Subject to Certification and Permitted for Use in Cosmetics where it is restricted from use in the manufacture of ingested drugs or cosmetics subject to ingestion. The U.S. Food and Drug Administration’s “Inventory of Effective Food Contact Substance (FCS) Notifications” database lists Solvent Violet 13 as a colourant in food-contact polystyrene, at levels not to exceed 0.70 part per million, for all food types except for use in contact with infant formula and breast milk. It is also listed as a component in epoxy resin coatings for repeat use in contact with beer, at a maximum level of one percent by weight of the cured epoxy coating.

The U.S. Environmental Protection Agency (EPA) regulations find it safe to use Solvent Violet 13 as an ingredient in pesticides.

While the European Commission regulation allows the use of Solvent Violet 13 in cosmetic products as a colourant, it is also listed as a substance prohibited in cosmetic products, specifically when used as a substance in hair dye.

New Zealand restricts the use of Solvent Violet 13 as a component in hair dye products.

The Australian Government regulation of cosmetics listed Solvent Violet 13 as a colourant for use as excipients in medicines for topical use only and does not require evaluation of toxicology data.

Summary of the screening assessment

In July 2021, the ministers published a screening assessment on the Anthraquinones Group on the Canada.ca (Chemical substances) website.footnote 3 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.

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

The departments collected and considered information from multiple sources (including literature reviews, internal and external database searches, modelling, data gathered from a mandatory survey issued pursuant to section 71 of CEPA, and, where warranted, data from targeted follow-ups with stakeholders) to inform the screening assessment conclusion. The ecological and human health portions of this assessment have undergone external peer review and consultation with academics and other relevant stakeholders.

The screening assessment concluded that Solvent Violet 13 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 the substances in the Anthraquinones Group (including Solvent Violet 13) 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 as either 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, Solvent Violet 13 was classified as having a low potential for ecological risk; therefore, it is unlikely to result in concerns for the environment in Canada. The screening assessment concluded that Solvent Violet 13 does not meet the ecological criteria for a toxic substance set out in paragraph 64(a) or 64(b) of CEPA.

The assessment also determined that Solvent Violet 13 meets the persistence criteria, but not the bioaccumulation criteria, as set out in the Persistence and Bioaccumulation Regulations.

Summary of the human health assessment

The human health risks of Solvent Violet 13 were characterized in the assessment based on carcinogenicity and non-cancer systemic effects (kidney, liver, spleen, and bone marrow toxicity) in laboratory animals and estimates of exposure derived for uses with the greatest potential for exposure for the general population of Canada. In the screening assessment, certain dermal exposures (through the use of body creams, spray perfumes, permanent hair dyes and face paints), and certain oral exposures (through the use of lipsticks or lip balms) of Canadians to Solvent Violet 13 were identified as potential concerns.

Given the limited substance-specific hazard data for chronic toxicity and carcinogenicity endpoints, a read-across approach (using data from other similar substances) based on health effects information for the substance anthraquinone was used to inform this part of the hazard assessment for Solvent Violet 13. Substance-specific hazard data for Solvent Violet 13 were available to inform all other endpoints relevant to the health risk assessment (e.g. shorter-term studies, genotoxicity studies).

The screening assessment compared estimated levels of exposure associated with the use of Solvent Violet 13 in certain cosmetics against the critical endpoints. The health risk assessment found that the margins of exposure (MOEs) between levels of exposure of the general population from daily use of Solvent Violet 13 in certain cosmetics (i.e. body cream, spray perfume) and levels associated with non-cancer health effects were potentially inadequate to address uncertainties in the health effects and exposure databases. MOEs between levels of exposure of the general population from daily use of Solvent Violet 13 in certain cosmetics (i.e. lip balm, lipstick, body cream, hair dye, spray perfume and face paint) and cancer effects were also potentially inadequate.

The screening assessment concluded that Solvent Violet 13 meets the human health criterion for a toxic substance set out in paragraph 64(c) of CEPA.

Objective

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 9,10-anthracenedione, 1-hydroxy-4-[(4-methylphenyl)amino]-, which has the molecular formula C21H15NO3 to Schedule 1 to CEPA. This would enable the ministers to propose risk management instruments for a toxic substance under CEPA to manage potential human health risks associated with the substance.

Description

The proposed Order would add 9,10-anthracenedione, 1-hydroxy-4-[(4-methylphenyl)amino]-, which has the molecular formula C21H15NO3 to Schedule 1 to CEPA (the List of Toxic Substances).

Regulatory development

Consultation

On November 3, 2018, the ministers published a notice with a summary of the draft screening assessment of the Anthraquinones Group (which included a link to the draft screening assessment) in the Canada Gazette, Part I, for a 60-day public comment period. The notice also informed of the release of the risk management scope for Solvent Violet 13 to initiate discussions with stakeholders on the development of the risk management actions. Comments were received from five industry stakeholders and one non-governmental organization. A table summarizing the set of comments received and the response to these comments is available on the Canada.ca (Chemical substances) website.

The comments provided information on new data, new and existing uses, health and ecological effects, sources of human exposure, and considerations for the read-across approach. Officials acknowledged the information provided by all of the stakeholders. These comments were considered in the development of the final screening assessment, but did not change the conclusion that Solvent Violet 13 meets the criterion for a toxic substance as set out in paragraph 64(c) of CEPA.

Comments addressing the management of risks posed by Solvent Violet 13 would be addressed during the development of risk management measures, which would also be subject to its own consultation process. One stakeholder voiced that, given the available information on anthraquinones, the limited information on the substances under assessment, and the potential emphasis on informed substitution in a renewed CMP (the replacing of hazardous substances with safer alternatives), the Government of Canada should go beyond its proposed actions. The Government of Canada selects the most appropriate tools or actions to manage the risk related to a substance after taking into consideration information in the screening assessment and other sources. Another stakeholder advised that the Government of Canada consider all actual exposure scenarios to develop the most appropriate risk management tool. Government of Canada officials responded that a consistent instrument selection process is followed to select the most appropriate instrument (or mix of instruments) to manage risks associated with a toxic substance.

The departments informed the provincial and territorial governments about all publications through the CEPA National Advisory Committee (NAC)footnote 4 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 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. Specific engagement and consultations with Indigenous Peoples were therefore not undertaken. However, the prepublication comment period is an opportunity for Indigenous Peoples to provide feedback on the proposed Order, which is open to all Canadians.

Instrument choice

When a substance meets one or more of the criteria for a toxic substance as set out in section 64 of CEPA, the ministers may propose one of the following measures:

When proposing option C, the ministers shall recommend the implementation of virtual elimination under subsection 65(3) of CEPA if the substance was assessed under section 74 of CEPA, and, as set out in subsection 77(4) of CEPA, if the ministers are satisfied that

The duty to implement virtual elimination does not apply to Solvent Violet 13 as the substance was found to be persistent, but not bioaccumulative. Based on the available evidence, the ministers determined that it is not appropriate to manage the potential human health risks associated with the substance by taking no further action or adding the substances to the Priority Substances List (option A or option B). Therefore, the ministers are recommending that Solvent Violet 13 be added to Schedule 1 to CEPA (option C). An order is the only available instrument to implement this recommendation.

Regulatory analysis

Benefits and costs

The addition of Solvent Violet 13 to Schedule 1 to CEPA would not on its own impose any regulatory requirements on businesses, 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 instruments under CEPA for Solvent Violet 13. The Government of Canada would consult stakeholders on any future risk management instruments before implementation and would consider their potential impacts.footnote 7

Small business lens

Analysis under small business lens concluded that the proposed Order would not impact Canadian small businesses, as it would not impose any administrative or compliance costs on businesses.

One-for-one rule

The one-for-one rule does not apply as the proposed Order would not result in a change in administrative burden imposed on businesses.

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, European Chemicals Agency, and the Organisation of Economic Cooperation and Development). 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 this proposal.

Implementation, compliance and enforcement, and service standards

As no specific risk management measures are recommended as part of the proposed Order, developing an implementation plan and a compliance and enforcement strategy, as well as establishing service standards, are not necessary at this time.

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

PROPOSED REGULATORY TEXT

Notice is given, pursuant to subsection 332(1)footnote a of the Canadian Environmental Protection Act, 1999 footnote 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 (email: substances@ec.gc.ca; Environment and Climate Change Canada’s Single Window: https://ec.ss.ec.gc.ca/).

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, September 22, 2022

Wendy Nixon
Assistant Clerk of the Privy Council

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

Amendment

1 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.

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