Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2018-130
Canada Gazette, Part II, Volume 152, Number 14
June 22, 2018
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
P.C. 2018-846 June 21, 2018
Whereas, pursuant to subsection 332(1)footnote a of the Canadian Environmental Protection Act, 1999footnote b, the Minister of the Environment published in the Canada Gazette, Part I, on December 10, 2016, a copy of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the annexed form, 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, pursuant to subsection 90(1) of that Act, the Governor in Council is satisfied that the substance set out in the annexed Order is a toxic substance;
Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of the Canadian Environmental Protection Act, 1999footnote b, makes the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
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 1 is amended by adding the following in numerical order:
140 Phenol, 5-chloro-2-(2,4-dichlorophenoxy)-, which has the molecular formula C12H7Cl3O2
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.)
The Government of Canada (the Government) completed a scientific assessment on triclosanfootnote 2 and determined that the substance is entering or may enter the environment in a quantity or concentration that have or may have an immediate or long-term harmful effect on the environment or its biological diversity and it therefore meets the environmental toxicity criterion as defined in paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA). As a result, the Government is adding triclosan to the List of Toxic Substances in Schedule 1 of CEPA.
The Chemicals Management Plan (CMP)footnote 3 is a federal program launched in 2006 that aims to assess and manage chemical substances that may be harmful to human health or the environment. Triclosan was identified as a priority under the CMP based on ecological concerns.
Substance description and sources of release
Triclosan is a synthetic organic chemical used as an antibacterial agent and preservative in a range of products used by consumers to stop the growth of bacteria, fungi, and mildew, and to prevent odours (e.g. skin cleansers, moisturizers, deodorants, cleaning products and toothpastes). Triclosan was used in pest control products, but such a use is no longer registered in Canada.
In Canada, the use of triclosan in products used by consumers is the major source of release of triclosan into the environment, which results in the continuous release of the substance to aquatic ecosystems via wastewater treatment systems. The industrial manufacture of products containing triclosan is also a source of release of this substance to wastewater; however, based on an analysis of the results obtained through the survey conducted under section 71 of CEPA, the overall relative contribution of triclosan releases to wastewater treatment systems from manufacturing facilities, compared to households, is expected to be minor.
Existing and international risk management measures
The following section provides a summary of existing risk management measures in Canada and internationally. These measures were taken into account when deciding upon the proposed risk management approach for triclosan.
In Canada, the use of triclosan in cosmetics, drugs and natural health products is regulated under the Food and Drugs Act. The concentration limits for triclosan in cosmetics are recommended by the Department of Health and are described on Health Canada’s Cosmetic Ingredient Hotlist. The Hotlist entry for this substance restricts triclosan to a concentration of 0.03% in mouthwashes and 0.3% in other cosmetic products, such as soaps. These limits are consistent with other jurisdictions, for example Australia and the European Union.
In addition, the Department of Health administers regulations for other products containing triclosan. In order to sell a drug product in Canada, including those containing triclosan as an active ingredient, a manufacturer must submit an application for a Drug Identification Number (DIN) to the Department of Health. These applications are reviewed to determine if the product meets safety, efficacy and quality standards before it can be sold in Canada.
Triclosan can also be used as an antimicrobial preservative in natural health products. Limits for triclosan in natural health products are specified in the Natural Health Products Ingredients Database and are identical to the limits described in the Cosmetic Ingredient Hotlist.
In the United States, the Food and Drug Administration (FDA) issued a final rule establishing that over-the-counter consumer antiseptic wash products containing 19 specific active ingredients, including triclosan, can no longer be marketed because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Moreover, an additional final rulefootnote 4 was issued on December 20, 2017, restricting the use of 23 active ingredients, including triclosan, in non-prescription antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital. In addition, the State of Minnesota has banned the use of triclosan in some consumer products (i.e. any cleaning product that contains triclosan and is used by consumers for sanitizing or hand and body cleansing) sold in the state effective January 1, 2017. The US Environmental Protection Agency did conduct an assessment in 2008 but it was limited to pesticidal uses only. It was determined that all uses of triclosan are eligible for reregistration as a pesticide, with the exception of the paint use, provided that the risk mitigation and data requirements are provided and implemented as required.
In the European Union, under Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures, products containing triclosan are classified both as an irritant to eyes and skin and as dangerous for the environment (for both acute and chronic aquatic exposure). Cosmetic products are exempt from the requirements of this regulation. In addition, in June 2015, the European Union Standing Committee on Biocidal Products ruled that the antibacterial pesticide triclosan is toxic and bioaccumulative and will therefore be phased out for hygienic use in favour of more suitable alternatives. Triclosan is not approved for use as disinfectants and algaecides not intended for direct application to humans or animal, film preservatives, and fibre, leather, rubber and polymerized materials preservatives. However, triclosan is notified in the framework of the European regulations on biocides (Directive 98/8/EC) for use in veterinary hygiene biocidal products.
Australia has concluded that triclosan released to wastewater systems from various cosmetic and personal care products during washing and bathing, or from the disposal of cleaning products, may pose a risk to algae, aquatic plants and fish. Further information is being collected on the presence of triclosan in wastewater (effluent and biosolids). Australia concluded that human health risk from triclosan is generally considered to be low.
Quantities of triclosan in Canada
In 2013, the Minister of the Environment (the Minister) requested, under section 71 of CEPA, information on the manufacture, import, export, and use of triclosan in a quantity greater than 10 kg and at concentrations of 0.001% or more, excluding any use in pest control products, for the 2011 calendar year.footnote 5 The total quantity imported into Canada in 2011 ranged from 10 000 kg to 100 000 kg, either as a pure substance to manufacture formulated products or as an ingredient in formulated products. Triclosan was not manufactured in Canada in 2011. Twenty companies reported using triclosan as an ingredient to manufacture formulated products, and five companies reported exporting a total between 100 kg and 1 000 kg of triclosan in formulated products. Formulated products containing triclosan include cosmetics, drugs, natural health products and cleaning products. These products include antibacterial soaps, skin cleansers, toothpastes, makeup, deodorants, skin creams, fragrances, general purpose cleaners, and detergents.
Scientific assessment summary
An assessment of triclosan was conducted by the Department of the Environment and the Department of Health, under which operates the Pest Management Regulatory Agency (PMRA), to determine whether the substance meets one or more of the toxicity criteria set out in section 64 of CEPA. Specifically, this involves determining whether triclosan 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 ecological and human health components of the assessment have undergone external written peer review or consultation by Canadian and international experts. These were selected from government organizations, academia and stakeholders. The assessment concluded that triclosan meets the criterion for a toxic substance under paragraph 64(a) but not (b) or (c) of CEPA. Below, please find summaries of the ecological and human health components of the assessment for triclosan.
Ecological assessment summary
Triclosan is toxic at very low concentration to a variety of aquatic organisms, such as algae, aquatic plants, invertebrates, amphibians and fish. Adverse effects that have been observed include reduction in growth, reproduction and survival, and there is evidence of endocrine-disrupting effectsfootnote 6 at environmentally relevant concentrations. While not meeting the bioaccumulation criteria set out in the Persistence and Bioaccumulation Regulations of CEPA, triclosan can considerably bioconcentrate in fish, and there is evidence of bioaccumulation in algae and aquatic invertebrates. Triclosan is also toxic to certain soil organisms.
The use of triclosan in products used by consumers is the major contributor to releases of triclosan into the environment in Canada, which results in the release of the substance to aquatic ecosystems via publicly owned wastewater treatment systems. Although wastewater treatment systems may partly remove triclosan, the substance has been found in numerous water bodiesfootnote 7 across Canada, from both heavily and sparsely populated areas, and has been measured to be in the range of 4 nanogramsfootnote 8 per litre (ng/L) to 874 ng/L. The target for acceptable environmental quality, intended to protect all forms of freshwater aquatic life for indefinite exposure periods, is 470 ng/L in the Federal Environmental Quality Guidelines for triclosan.footnote 9
Though triclosan as an organic chemical tends to degrade relatively quickly in the environment, the monitoring of triclosan in water bodies across Canada, between early 2000 and 2014, indicates that triclosan continues to be present.
Given the widespread presence of triclosan in water bodies across Canada, including at levels at or near those that can harm aquatic organisms, it is concluded that the ongoing release of triclosan to the aquatic ecosystem is a source of concern to the environment in Canada. The assessment has therefore determined that triclosan meets the environmental criterion for a toxic substance as defined under paragraph 64(a) of CEPA. However, the substance did not meet the environmental criterion for a toxic substance under paragraph 64(b) of CEPA as the substance was not found to be a risk to the broader integrity of the environment on which life depends.
Human health assessment summary
To determine whether triclosan has the potential to pose a risk to human health, estimates of human exposure to triclosan in Canada (in the general population, as well as in infants and children under the age of three) were compared with levels of triclosan demonstrated in animal studies to cause adverse health effects (liver effects observed in mice). The assessment shows that current levels of exposure to triclosan do not pose a risk to human health for Canadians, including children and pregnant women.
Considering all available lines of evidence presented in the assessment and the current risk management measures controlling the use of triclosan in products used by consumers, it was concluded that, in Canada, the substance does not constitute a danger in Canada to human life or health. Therefore, it is concluded that triclosan does not meet the human health criterion as defined in paragraph 64(c) of CEPA.
On November 26, 2016, the final assessment report for triclosan was published on the Canada.ca (Chemical Substances) website.footnote 10,footnote 11 On December 10, 2016, the proposed Order recommending the addition of triclosan to Schedule 1 of CEPA was published in the Canada Gazette, Part I.footnote 12,footnote 13
The objective of the making of the Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the Government to take risk management measures for toxic substances under CEPA to manage risks associated with triclosan.
The Order adds Phenol, 5-chloro-2-(2,4-dichlorophenoxy)-, which has the molecular formula C12H7Cl3O2 (i.e. triclosan), to Schedule 1 of CEPA (the List of Toxic Substances).
The “One-for-One” Rule does not apply, as the Order will not impose any administrative burden on business.
Small business lens
The small business lens does not apply, as the Order will not impose any compliance or administrative costs on small business.
On March 31, 2012, the Minister of the Environment and the Minister of Health published a summary of the preliminary assessment for triclosan in the Canada Gazette, Part I, for a 60-day public comment period. The preliminary assessment proposed that triclosan posed an environmental risk as defined in paragraph 64(a) of CEPA. More than 40 sets of comments were received on the preliminary assessment.footnote 14 These comments were considered during the preparation of the final assessment. Some adjustments were made to the assessment based on new data that was provided, but the conclusion of the assessment did not change. The final assessment was published on November 26, 2016, on the Canada.ca (Chemical Substances) website.footnote 15
On December 10, 2016, the proposed Order, recommending the addition of triclosan to Schedule 1 of CEPA and a summary of the comments received on the preliminary assessment and the Government’s responses were published in the Canada Gazette, Part I, for a 60-day public comment period.footnote 16 No comments were received during the public comment period for the proposed Order recommending the addition of triclosan to Schedule 1 of CEPA. However, more than 60 sets of comments were received on the proposed risk management approach document for triclosan published for a 60-day public comment period on November 26, 2016.
Although comments were not expected on the final assessment (given there was a public comment period following the publication of the preliminary assessment in 2012), 43 of the 60 comments received touched on some aspects of the risk assessment. Generally, these comments included statements in support of the conclusion of triclosan meeting the criteria under section 64 of CEPA. In addition, a number of stakeholders from non-governmental organizations requested clarification on modifications made to the ecological section of the final assessment (e.g. update to the predicted no-effect concentration value and evaluation of triclosan bioaccumulation), and certain comments made on the human health section reiterated comments that had been made on the preliminary assessment (including comments on the non-toxic health conclusion). Government officials met with these stakeholders in July 2017 to provide clarifications on the changes made in the final assessment as well as an explanation of the outcome of the assessment. The meeting was well received by stakeholders.
A table summarizing the comments received on the risk management approach and the final assessment along with the Government’s responses were published in December 2017 and can be found at https://www.canada.ca/en/environment-climate-change/services/evaluating-existing-substances/public-comments-rm-triclosan.html. All comments received were considered and did not change the recommendation to add triclosan to Schedule 1 of CEPA.
Prior to these publications, the Department of the Environment and the Department of Health had informed the governments of the provinces and territories, through the CEPA National Advisory Committee (NAC), of the release of these documents and of the related public comment period. No comments were received from CEPA NAC.footnote 17
Triclosan is used as an antibacterial agent and preservative in a variety of products used by consumers. The range of uses of triclosan in cosmetics, drugs, natural health products and cleaning products results in its continued release to aquatic ecosystems via publicly owned wastewater treatment systems. Triclosan is hazardous to a number of non-human organisms and can cause adverse effects even at low exposure levels. These effects, which include reduction in growth, reproduction and survival, have been observed in studies with aquatic invertebrates and vertebrates, as well as certain soil organisms. Therefore, the assessment concluded that triclosan meets the criterion defined in paragraph 64(a) of CEPA.
One of the following measures must be proposed after an 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 about the use of triclosan in Canada and the conclusions of the scientific assessment, the Government determined that choosing option 1 or 2 is not appropriate to manage the potential ecological risk associated with the continuous releases of triclosan into the environment in Canada. Therefore, option 3, which recommends that triclosan be added to the List of Toxic Substances in Schedule 1 of CEPA, is the option selected by the Government.footnote 18
The addition of triclosan to Schedule 1 of CEPA will not result in any incremental impacts (benefits or costs) on the public or industry, since the making of the Order does not impose any compliance requirements on stakeholders. Accordingly, there will be no compliance or administrative burden imposed on small businesses or businesses in general. Rather, the making of the Order enables risk management measures for toxic substances under CEPA to be proposed, should such measures be deemed necessary to manage potential ecological risks associated with triclosan.
The Minister has considered socio-economic factors and will consult with the public and other stakeholders during the development of risk management proposals for a toxic substance under CEPA for triclosan.
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment (SEA) was completed under the CMP. 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.footnote 19
Implementation, enforcement and service standards
The Order adds triclosan to Schedule 1 of CEPA, thereby enabling risk management measures respecting preventive or control actions for toxic substances under CEPA to be proposed. Developing an implementation plan and an enforcement strategy and establishing service standards are only considered necessary when a specific risk management approach is proposed. As the 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:
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Department of Health