Canada Gazette, Part I, Volume 156, Number 14: Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
April 2, 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
Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 meet the ecological criterion for a toxic substance as set out in paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA or the Act). Malachite Green also meets the human health criterion set out in paragraph 64(c) of 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 the four substances listed in Table 1 to Schedule 1 to CEPA (List of Toxic Substances).
| CAS RNfootnote a | Chemical name of the substance | Common name |
|---|---|---|
| 569-64-2 | Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, chloride | Malachite Green |
| 548-62-9 | Methanaminium, N-[4-[bis[4-(dimethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, chloride | Basic Violet 3 |
| 2390-59-2 | Ethanaminium, N-[4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, chloride | Basic Violet 4 |
| 2390-60-5 | Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, chloride | Basic Blue 7 |
Table 1 note(s)
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Background
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 Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 in accordance with section 68 or 74 of CEPA and as part of the CMP.
Description, uses, and sources of release
Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 do not occur naturally in the environment and have common structural features as non-sulfonated triarylmethane dyes. Mandatory surveys under section 71 of CEPAfootnote 1 encompassing Basic Violet 3 and Malachite Green (reporting year 2008) as well as for Basic Violet 4 and Basic Blue 7 (reporting year 2011) were issued. Information reported by industry indicated that Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 were not manufactured in Canada above the reporting threshold of 100 kg in one calendar year, but were imported to Canada in powder or liquid form, or within a product, in the range of 1 000 kg to 100 000 kg in one calendar year for each substance.
Based on information obtained from CEPA section 71 surveys, Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 are used as dyes in inks, toners, and colourants, in paper products and manufactured items, and in medical devices used in laboratory settings in Canada. Publicly available information and information held by the Department of Health also identified these substances as being used in Canada in food packaging materials for commercial and consumer use, in products available to consumers, including cosmetics (e.g. body cream, hair products, hair dyes, makeup, perfume), and in water treatment for aquarium fish. Table 2 presents a summary of the uses for each substance.
| Usage | Malachite Green | Basic Violet 3 | Basic Violet 4 | Basic Blue 7 |
|---|---|---|---|---|
| Inks, toners and colourants | Yes | Yes | Yes | Yes |
| Paper products and manufactured items | Yes | Yes | Yes | No |
| Food packaging materials | No | Yes | No | No |
| Cosmetics | Yes | No | Yes | Yes |
| Water treatment for aquarium fish | Yes | No | No | No |
| Medical devices (laboratory) | No | Yes | No | No |
There are potential releases of the four non-sulfonated triarylmethane substances to water from industrial facilities involved in the deinking of paper and paper dyeing, as well as the formulation or manufacture of products containing these substances. Down-the-drain releases to wastewater treatment systemsfootnote 2 and to surface water could result from various uses of products available to consumers that contain these substances. Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 are not expected to be released to air or soil given their intended uses and their physical-chemical properties. Malachite Green was reported to the National Pollutant Release Inventory by one company involved in chemical manufacturing, with around 4 kg per year released to the environment between 2003 and 2007.
Current risk management activities
National level
The safety of chemicals used in food packaging materials is subject to the provisions of section 4(1)(a) of the Food and Drugs Act and Division 23 of the Food and Drug Regulations. Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 are not included in the Department of Health’s Lists of Permitted Food Additives and are therefore not permitted food additives in Canada. Malachite Green is also not approved for use in food-producing aquatic animals or livestock feed in Canada.
Basic Violet 3 is described as a prohibited ingredient in cosmetic products on Health Canada’s Cosmetic Ingredient Hotlist. The Hotlist is used to communicate that certain substances may not be compliant with requirements of the Food and Drugs Act or provisions of the Cosmetic Regulations. Basic Violet 3 is also listed in the Natural Health Products Ingredients Database. Since June 2019, human and veterinary drugs containing Basic Violet 3 are not permitted for sale in Canada, and the Department of Health has issued a recall and safety alert for Basic Violet 3 drugs.footnote 3 Basic Violet 3 is also on the Canadian Food Inspection Agency’s Aquaculture Therapeutant Residue Monitoring List, and as a result cannot be used during any part of the aquaculture fish production life cycle. There is no specific risk management for Basic Violet 4 or Basic Blue 7 in Canada.
International level
The United States prohibits Malachite Green as a food additive or as a veterinary drug for food animals, aquaculture, or fish for human consumption and is not permitted for use in food packaging materials. Europe also prohibits Malachite Green in food, including fish for human consumption. The substance is banned from cosmetics in the European Union (EU), New Zealand, and by the Association of Southeast Asian Nations. Basic Violet 3 is banned from use in cosmetics in the EU and South Asian Countries. The U.S. Food and Drug Administration lists several human over-the-counter licensed drugs containing Basic Violet 3, but no veterinary drugs. The substance is also prohibited from use in animal feed in the United States. Basic Violet 4 and Basic Blue 7 are prohibited in cosmetics (i.e. hair dye) in the EU and by the Association of South Asian Countries.
Summary of the screening assessment
On October 17, 2020, the ministers published the screening assessment for the Triarylmethanes Group on the Canada.ca (Chemical Substances) website.footnote 4 The screening assessment was conducted to determine whether the substances meet one or more of the criteria set out in section 64 of CEPA (i.e. to determine if the substances 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-ups with stakeholders) to inform the screening assessment conclusion. The ecological and human health portions of the screening assessment underwent external peer review and consultation with academics and other relevant stakeholders.
The screening assessment concluded that Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 meet the criterion set out in paragraph 64(a) of CEPA, and thus constitute a risk to the environment. The assessment also concluded that Malachite Green meets the criterion set out in paragraph 64(c) of CEPA, and thus constitutes a risk to human health.
Summary of the ecological assessment
The ecological assessment found that Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 have the potential to cause adverse effects to aquatic organisms at low concentrations. The empirical information on Malachite Green and the modelled information for the other non-sulfonated triarylmethane substances indicate that they are not likely to bioaccumulate in aquatic organisms. Available studies on biodegradation indicate that these substances are expected to persist in water, sediment and soil, resulting in a potential prolonged exposure to these substances by living organisms.
The acute toxicity of Malachite Green and Basic Violet 3 to a variety of aquatic organisms is well documented in many ecological studies, where these substances have been shown to cause adverse effects to aquatic organisms at low concentrations with freshwater fish being the most sensitive organisms. However, there is a lack of aquatic toxicity data for Basic Violet 4 and Basic Blue 7. Due to the similarity in physical-chemical characteristics, the four non-sulfonated triarylmethane dyes are expected to have similar effects on organisms in the environment; therefore, the toxicity information for Malachite Green and Basic Violet 3 was used to assess the toxicity of Basic Violet 4 and Basic Blue 7.
Potential environmental exposure of living organisms to Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 occurs mainly through surface water. As no environmental monitoring data were available for any of these substances, the exposure assessment focused on the releases of the non-sulfonated triarylmethane substances through three key scenarios, namely paper dyeing, paper deinking and general formulation of products containing any of these four substances.
For the paper dyeing scenario, 32 pulp and paper mills in Canada with the capability to dye paper were considered. Information was compiled for each of these facilities, including site data for known paper production capacities, operating days, water discharge rates, receiving water body flow rates, and on-site wastewater treatment technologies. Information on whether facilities were discharging to another off-site wastewater treatment system was also considered. Other key parameters that are not specific to a particular site were estimated. The paper deinking scenario considered the removal of inks containing triarylmethane dyes from recycled paper.footnote 5 In this scenario, 13 pulp and paper recycling plants were considered, along with information such as their individual known recycling capacities, effluent flow rates, on-site wastewater treatment systems, and dilution factors. In the general formulation scenario, the analysis focused on site-specific information for the formulator that reported the largest quantities of the non-sulfonated triarylmethane dyes.
To determine if these scenarios posed an ecological risk, risk quotients were calculated as the ratio between predicted environmental concentrations (PECs) and predicted no-effect concentrations (PNECs) for these substances. When PEC values are greater than PNEC values, there is a potential for ecological harm. The PECs were calculated collectively for the four non-sulfonated dyes combined. The industrial release scenarios (paper dyeing and paper deinking) were based on the maximum production capacities of the facilities, and it was assumed that any one of the non-sulfonated triarylmethane dyes could be substituted for another. The results of this analysis indicate that these substances pose a risk to aquatic organisms from the dyeing and paper deinking scenarios, but not from the general formulation scenario.
The screening assessment concluded that Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 meet the criterion set out in paragraph 64(a) of CEPA, and thus constitute risk to the environment. The assessment also determined that the four substances meet the criterion for persistence but not the criterion for bioaccumulation, as set out in the Persistence and Bioaccumulation Regulations.
Summary of the human health assessment
The potential human health exposure to the four non-sulfonated triarylmethane substances (see Table 2) was assessed for drinking water, and products available to the consumer. For each non-sulfonated triarylmethane dye, scenarios with the highest exposure were selected for risk characterization.
Potential releases of non-sulfonated triarylmethane substances to the Canadian environment mainly occur through water, more specifically through wastewater treatment systems. Treatment technologies may only partially degrade these substances; therefore, a portion of these substances may be released into surface waters via wastewater treatment systems effluent and could contribute to general population exposure through drinking water.
Given the absence of surface water monitoring or drinking water data, theoretical concentrations in surface water and theoretical intake estimates for drinking water were estimated on an age group-specific basis. Margins of exposure (MOEs) associated with drinking water with Malachite Green and Basic Violet 3 were estimated to determine if this scenario may pose a human health risk in Canada. MOEs were estimated by comparing the levels of exposure to the general population to the levels at which critical health effects were observed in laboratory studies. Based on the estimated MOEs for this scenario, the assessment determined that the oral-systemic exposure to non-sulfonated triarylmethane substances from drinking water does not pose a potential risk to human health for any age group.
Only one of the four non-sulfonated triarylmethane substances, Basic Violet 3, is potentially used in food packaging materials, but dietary exposure resulting from potential use, if any, is expected to be negligible. While it has been reported that Malachite Green and Basic Violet 3 may be present in animal by-products containing meat or fish as residues from continued use in veterinary drugs and aquaculture, neither substance is currently approved for use in food-producing aquatic animals or livestock feed in Canada. Exposure of the general population to trace amounts of these substances in food due to non-compliant use or as a result of imported fish was determined to not pose a safety concern to consumers.
Exposures from the use of products available to consumers containing non-sulfonated triarylmethane dyes were assessed on an age group-specific basis. The scenarios with the highest levels of potential exposure were selected to characterize dermal risk from hair dye products for Malachite Green, Basic Violet 4, and Basic Blue 7. The potential exposure to these substances was estimated using conservative assumptions. To estimate potential non-cancer and cancer risks from exposure to these substances, the assessment used daily and per event systemic exposure, as applicable, on an age group-specific basis. For cancer risks, lifetime adjustments were applied to the exposure estimates for some scenarios. MOEs were estimated for the hair dye scenarios to characterize risk for both non-cancer (i.e. developmental effects) and cancer effects. Based on the estimated MOEs, the assessment found that Malachite Green may pose a risk to human health from dermal exposure. The assessment also determined that dermal exposure to Basic Violet 4 or Basic Blue 7 does not pose a potential risk to human health for any relevant age group.
The screening assessment concluded that Malachite Green 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. The assessment also concluded that Basic Violet 3, Basic Violet 4 and Basic Blue 7 do not meet the criterion under paragraph 64(c) of CEPA, as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to human life or health in Canada. While exposure of the general population to Basic Violet 3, Basic Violet 4 and Basic Blue 7 are not of concern at current levels, available studies suggest these substances could potentially have health effects of concern if exposure levels were to increase, based on their potential carcinogenicity.
Objective
The objective of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the proposed Order) is to add Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 to Schedule 1 to CEPA, which would enable the ministers to propose risk management measures under CEPA to manage potential environmental and human health risks associated with these substances.
Description
The proposed Order would add Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 to Schedule 1 to CEPA (List of Toxic Substances).
Regulatory development
Consultation
On December 8, 2018, the ministers published a notice with a summary of the draft screening assessment of the Triarylmethanes Group (which included a link to the complete draft screening assessment) in the Canada Gazette, Part I, for a 60-day public comment period.
Comments were received from five industry stakeholders. These comments were considered in the development of the final screening assessment report but did not result in a change in the conclusion that Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 met the criterion for a toxic substance set out under paragraph 64(a) of CEPA and the conclusion that Malachite Green met the criterion for a toxic substance set out under 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 response to these comments is available on the Canada.ca (Chemical Substances) website.
The comments provided information on the uses, sources, and releases of those substances in Canada. A specific comment provided information on the number of pulp and paper facilities using triarylmethane dyes, and the particular uses for these substances. This information was considered in the preparation of the final screening assessment.
In regard to comments addressing the management of risks posed by those substances, it was indicated that officials would address them during the development of risk management measures, which would also be subject to their own consultation process. Stakeholders voiced concerns about supply chain transparency and targeting end-users of dye products over manufacturers and importers of the dye products containing Malachite Green, Basic Violet 3, Basic Violet 4, and/or Basic Blue 7. Officials from the Department of the Environment recognize that supply chain transparency can pose a challenge in many industrial sectors, including the pulp and paper sector.
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 adding substances to Schedule 1 to CEPA do not result in 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. In the event that the ministers propose risk management measures for Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7, 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.
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 shall propose one of the following options:
- (a) taking no further action with respect to the substance;
- (b) unless the substance is already on the Priority Substances List, adding the substance to the Priority Substances List; or
- (c) recommending that the substance be added to Schedule 1 to CEPA (List of Toxic Substances) and, where applicable, recommending the implementation of virtual elimination.footnote 6
The implementation of virtual elimination is applicable if the substance was assessed under section 74 of CEPA, and if
- the substance met 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 Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7, as the substances were found to be persistent, but not bioaccumulative. Based on the available evidence, the ministers determined that taking no further action or that adding the substances to the Priority Substances List are not appropriate measures to manage the potential ecological risks associated with Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7, and the human health risks associated with Malachite Green in Canada. Therefore, the ministers are recommending that the Governor in Council take an order to add these four non-sulfonated triarylmethane substances to Schedule 1 to CEPA (List of Toxic Substances). An order is the only available instrument to implement this recommendation.
Regulatory analysis
Benefits and costs
The addition of Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7 to Schedule 1 to CEPA (List of Toxic Substances) would not on its own impose any regulatory requirements on businesses, or other entities, and would therefore 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 these substances. 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 Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7, the departments would assess their benefits and costs and would conduct consultations with stakeholders, Indigenous Peoples, 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 impacts on small businesses, as it does not impose any administrative or compliance costs on businesses. In the event that the ministers propose risk management measures for Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7, the departments would assess any associated impact on small businesses during the development of such measures.
One-for-one rule
The one-for-one rule does not apply, as there is no incremental change in administrative burden imposed on businesses. In the event that the ministers propose risk management measures for Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7, 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 U.S. 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 7 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, which encompasses orders adding substances to Schedule 1 to CEPA (List of Toxic Substances). 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
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. In the event that ministers propose risk management measures for Malachite Green, Basic Violet 3, Basic Violet 4, and Basic Blue 7, the departments would assess these elements during the development of such measures.
Contacts
Thomas Kruidenier
Acting Executive Director
Program Development and Engagement 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
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 Toxic Substances 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: substances@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, March 24, 2022
Wendy Nixon
Assistant Clerk of the Privy Council
Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
Amendment
| 158 | Methanaminium, N-[4[bis[4-(dimethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, chloride |
|---|---|
| 159 | Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, chloride |
| 160 | Ethanaminium, N-[4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, chloride |
| 161 | Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, chloride |
Coming into Force
2 This Order comes into force on the day on which it is registered.