Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2026-222

Canada Gazette, Part II, Volume 160, Number 22

Registration
SOR/2026-222 October 23, 2026

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

P.C. 2026-1009 October 23, 2026

Whereas, under section 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 May 22, 2021, a copy of the proposed Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the annexed form, under the title Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999, 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, under subsection 90(1)footnote c of that Act, the Governor in Council is satisfied that the substance set out in the annexed Order is toxic;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, makes the annexed Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 under subsection 90(1)footnote c of the Canadian Environmental Protection Act, 1999 footnote b.

Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999

Amendment

1 Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 footnote b is amended by adding the following in numerical order:

139 Talc, which has the molecular formula Mg3H2(SiO3)4

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.)

Issues

The Chemicals Management Plan (CMP) is a Government of Canada initiative through which health and environmental risks of exposure to substancesfootnote 1 are assessed and managed. A CMP assessment conducted under the authority of the Canadian Environmental Protection Act, 1999 (the Act) concluded that the substance talc (CAS RNfootnote 2 14807-96-6) meets the human health criterion set out in section 64 of the Act. The Minister of the Environment and the Minister of Health (the ministers) have therefore recommended that the Governor in Council make an order adding talc to Part 2 of Schedule 1 to the Act.

Background

Strengthening Environmental Protection for a Healthier Canada Act

On June 13, 2023, the Strengthening Environmental Protection for a Healthier Canada Act (hereinafter referred to as the Healthier Canada Act) received royal assent. The Healthier Canada Act divided Schedule 1 into two parts. Toxic substances added to Part 1 require the Ministers to prioritize the total, partial, or conditional prohibition of activities involving those substances when managing their risks. Toxic substances added to Part 2 require the Ministers to prioritize pollution prevention actions when managing their risks, which in some cases may include total, partial or conditional prohibition.

Talc was assessed under section 74 of the Act, as it read before the enactment of the Healthier Canada Act.

Chemicals Management Plan

In 2006, the Government of Canada launched the CMP, a federal program with the objective of reducing the risks posed by substances to people in Canada and the environment through sources of exposure, such as food and food products, consumer products, cosmetics, drugs, drinking water and industrial releases. As part of the CMP, government officials from the Department of the Environment and the Department of Health (the departments) conduct assessments under the authority of the Act to identify existing or potential environmental and human health risks posed by exposure to substances. When a risk is identified, the ministers may recommend the development of risk management measures to mitigate these risks under the authority of a broad suite of federal laws, including the Act, the Canada Consumer Product Safety Act, the Food and Drugs Act (FDA), the Pest Control Products Act, and the Fisheries Act.

Description, uses, and sources of release and exposure

Talc, which has the molecular formula Mg3H2(SiO3)4, is one of the softest naturally occurring minerals. The pure mineral is made up of magnesium, hydrogen, silicon, and oxygen. The term “talc” refers to both the pure mineral and a wide variety of soft, talc-containing rocks that are mined and used for a variety of applications. Relatively pure talc ore is also referred to as steatite, and soapstone refers to impure, massive talc rock. Commercially exploited talc contains 20% to 99% of the pure mineral and can be categorized into different grades (e.g. pharmaceutical or cosmetic grades).

In Canada, the Minister of the Environment issued a mandatory survey notice pursuant to section 71 of the Act encompassing the substance (reporting year 2011) to obtain information on its use in Canada. Information reported by industry indicated that between 50 000 and 75 000 tonnes of talc were manufactured in Canada in 2011.footnote 3 According to the Canadian International Merchandise Trade Database, approximately 100 000 tonnes of natural steatite and talc (crushed or powdered) and 4 700 tonnes of natural steatite and talc (not crushed, not powdered) were imported into Canada in 2016. While import quantities can be variable, they are not expected to have changed significantly since 2016. Talc is found in most provinces of Canada, with major deposits located in Ontario, Quebec, British Columbia, and Newfoundland and Labrador. Currently, there is only one talc producing mine and concentrator facilityfootnote 4 and one micronizing facility in Canada, which are both located in Ontario. In 2019, China was the largest producer of talc, followed by India and Brazil.

The departments also gathered information about the usage of talc in Canada from voluntary stakeholder engagement and the websites of talc producers. In Canada, talc is used in adhesives and sealants; automotive, aircraft, and transportation applications; building and construction materials (e.g. wood and engineered wood); ceramics; electrical products and electronics; textiles; floor coverings; inks, toner, and colourants; lubricants and greases; oil and natural gas extraction applications; paints and coatings; paper and paper products, mixtures, or manufactured items; plastic and rubber materials; toys, playground equipment and sporting equipment; and in water treatment. Talc is also a formulant in pest control products registered in Canada.

Additionally, in Canada, talc is a permitted food additive for limited uses in a small number of foods. It may be present in food packaging materials and in incidental additivesfootnote 5 used in food processing establishments. Talc is present in approximately 10 000 self-care products.footnote 6 This includes approximately 7 750 cosmetics, 2 100 natural health products and 150 non-prescription drugs. In addition, talc is present as a non-medicinal ingredient in approximately 1 550 marketed or approved non-over-the-counter human and veterinary drug products in Canada.

Risk management activities (Canada and international)

National

In Canada, cosmetics, natural health products and non-prescription drugs all require disclosure of the ingredients (medicinal and non-medicinal) on the product label. The existing entry for talc on the Cosmetic Ingredient Hotlistfootnote 7 was modified in May 2024 to help reduce chronic inhalation exposure to talc in cosmetics that may result in non-cancer lung effects (such as inflammation or fibrosis), as well as genital exposure to the population with intact ovary/ovaries, which may result in ovarian cancer. Cautionary statements related to acute inhalation risks were also modified to include all cosmetics containing talc in loose powder form, not just those intended to be used on infants and children. The existing entry for talc in the Natural Health Products Ingredients Database (NHPID) was also modified in June 2024 to align with the May 2024 revisions to the Cosmetic Ingredient Hotlist. The NHPID also includes entries for talc used in homeopathic medicines and in traditional Chinese medicines. Talc is included on the Department of Health’s List of Permitted Food Additives with Other Purposes of Use. The use of talc as a colourant in drugs is subject to the provisions of the Food and Drug Regulations.

International

The United States and the European Union allow the use of talc in cosmetics. The European Union requires a warning statement for cosmetics similar to that in Canada. In the European Union, talc is an approved food additive and is also used in food packaging materials. In the United States, talc is “generally recognized as safe” for specified food uses in food packaging.

Summary of the screening assessment

On April 24, 2021, the ministers published a screening assessment of talc on the Canada.ca (Chemical substances). 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 the Act.

Under section 64 of the Act, a substance is considered toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that

The ministers collected and considered information from multiple sources (e.g. literature reviews, internal and external database searches, modelling, data gathered from a mandatory survey notice issued pursuant to section 71 of the Act, and, where warranted, data from targeted follow-ups with interested parties) to inform the screening assessment conclusion. The assessment has also undergone external peer review, as well as consultation with academics and other relevant interested parties, as stated in the introduction of each screening assessment, before being published in draft form for a 60-day public comment period.

The screening assessment concluded that talc meets the human health criterion for a toxic substance as set out in paragraph 64(c) of the Act 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 risk of talc was characterized using the ecological risk classification of inorganic substances (ERC-I) approach, which is a risk-based approach that employs multiple metrics that consider both hazard and exposure in a weight of evidence. Its purpose was to classify a set of inorganic substances as either warranting further evaluation of their potential to cause harm to the environment or as having a low likelihood of causing ecological harm. Using the ERC-I approach, talc was characterized as being of low ecological concern and therefore unlikely to be causing harm to the environment at levels of exposure considered in the screening assessment.

The screening assessment concluded that talc does not meet the criteria set out in paragraph 64(a) or (b) of the Act. It has also been determined that talc meets the persistence but not the bioaccumulation criterion as set out in the Persistence and Bioaccumulation Regulations made under the Act.

Summary of the human health assessment

The assessment considered potential human health effects on both the general population in Canada and vulnerable populations/subpopulations who may be disproportionately impacted in the assessment of substances under the Act.

The human health risks of talc were characterized (that is, identified and described for the purposes of the human health assessment) based on non-cancer lung effects and ovarian cancer. Based on the results of the human health assessment, it was determined that inhalation and female perineal (genital) exposure to talc from the use of certain self-care products represent a potential concern for human health. This was based on an assessment of risks following inhalation and perineal (genital) exposure. The human health assessment found no critical health effects from oral and dermal exposure to talc.

The human health assessment identified the potential for non-cancer lung effects (e.g. inflammation, impaired lung function or fibrosis) following inhalation exposure to respirable talc particles. Margins of exposure (MOEs) associated with baby powder, body powder, face powder, foot powder and dry hair shampoo were estimated. These MOEs were derived by comparing the estimated air concentration following the use of self-care products containing talc and levels at which critical lung effects were observed in an animal study. Based on these MOEs, the human health assessment determined that the inhalation of talc from the use of baby powder, body powder and loose face powder poses a potential risk to human health. The human health assessment also identified ovarian cancer as a critical health effect for the perineal (genital) route of exposure to talc from the use of various self-care products (e.g. body powder, baby powder, diaper and rash creams, genital antiperspirants and deodorants, body wipes, bath bombs and bubble bath). Analyses of the available human studies in the peer-reviewed literature indicate a consistent and statistically significant positive association between perineal (genital) exposure to talc and ovarian cancer.

The screening assessment concluded that talc meets the human health criterion under paragraph 64(c) of the Act.

Objective

The objective of the Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (the Order) is to enable the ministers to propose risk management instruments for a toxic substance under the Act that prioritize pollution prevention actions, which may include prohibitions, when managing potential human health risks associated with the talc.

Description

The Order adds talc, which has the molecular formula Mg3H2(SiO3)4, to Part 2 of Schedule 1 to the Act.

Regulatory development

Consultation

On December 8, 2018, the ministers published a Notice with a summary of the draft screening assessment conducted for talc (which included a link to the complete 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 to initiate discussions with interested parties on the development of risk management options. Over 100 submissions were received on the draft screening assessment and risk management scope from interested parties, including 9 from the cosmetics, consumer products and mining industries and/or their industry associations, 3 from non-governmental organizations (NGOs), and 5 from private individuals that provided unique scientific analysis. The remainder of the comments were from 90 private individuals. The majority of these individuals (87 in total) participated in one of two letter-writing campaigns and submitted one of two verbatim letters as comments. Subsequently, a summary of public comments on the draft screening assessment and risk management scope, which includes government responses to these comments, was released on the Canada.ca (Chemical substances) website.

The comments on the draft screening assessment were considered in finalizing the screening assessment, but they did not change the conclusion that talc meets the criterion set out in paragraph 64(c) of the Act. The comments on the risk management scope document were considered in the development of the risk management approach document, published on April 24, 2021, to continue discussions with interested parties on the development of risk management actions.

In accordance with the Cabinet Directive on Regulation (CDR), further consultation on the development of risk management actions, including consideration of comments received on the risk management approach for the substance, will take place during the regulatory development of any risk management proposal for talc.

On May 22, 2021, the proposed Order recommending the addition of talc to Schedule 1 to the Act was published in the Canada Gazette, Part I, for a 60-day public comment period.footnote 8 During this period, the departments received comments from five industry stakeholders opposing the proposed listing Order for the substance. Below is a summary of the comments received by interested parties and government responses to these comments.

The departments informed the provincial and territorial governments about all publications through the Act’s National Advisory Committeefootnote 9 via a letter and provided them with an opportunity to comment. No comments were received from the Committee.

Indigenous engagement, consultation and modern treaty obligations

The Government of Canada has a duty to consult and, where appropriate, accommodate Indigenous groups when it is contemplating conduct that could have an adverse impact on Aboriginal or treaty rights. The duty to consult can arise in relation to established historical or modern treaty rights, and in relation to rights not yet determined, often referred to as asserted or potential rights. The United Nations Declaration on the Rights of Indigenous Peoples Act states that the Government of Canada is committed to taking effective measures, including legislative and policy measures, in consultation and cooperation with Indigenous peoples, to achieve the objectives of the United Nations Declaration on the Rights of Indigenous Peoples (UN Declaration). Orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act do not introduce any new regulatory requirements, and, therefore, do not result in any impact on Aboriginal or treaty rights, or implicate any rights in the UN Declaration. Therefore, specific engagement and consultations with Indigenous Peoples were not undertaken.

Instrument choice

Following an assessment conducted for a substance under the authority of the Act, the publication of the assessment conclusion under subsection 77(2) of the Act must propose one of the following measures:

The assessment of talc concluded that it poses risks to human health under section 64 of the Act. As a result, the proposed measure was a recommendation to add talc to Schedule 1 to the Act.

As the proposed measure was made before the coming into force of the Strengthening Environmental Protection for a Healthier Canada Act, the proposed measure is, under subsection 61(2) of that Act, deemed to be a recommendation that talc be added to Part 2 of Schedule 1 to the Act.

Regulatory analysis

Benefits and costs

Orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), as they do not impose any regulatory requirements on businesses. Therefore, the Order will not result in incremental impacts. These orders grant the ministers the authority to develop risk management instruments for a toxic substance under the Act. The Government of Canada will consult interested parties before risk management instruments associated with those substances are implemented and will conduct a cost-benefit analysis to consider their potential impacts, as appropriate and in accordance with the Cabinet Directive on Regulation.

Small business lens

As described in the “Benefits and costs” subsection, the Order will not result in any incremental impacts (benefits and costs). Therefore, the Order will not impact Canadian small businesses.

One-for-one rule

Since orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), the one-for-one rule does not apply.

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). While the Order does not, on its own, relate to any international agreements or obligations, it enables the ministers to propose risk management measures that may align with actions undertaken by other jurisdictions.

International obligations

While Canada is a party to several international multilateral environmental agreements in the area of chemicals and waste,footnote 10 talc is not listed in any multilateral agreement to which Canada is a party.

Effects on the environment

In accordance with the Cabinet Directive on the Strategic Environmental and Economic Assessment (SEEA), a SEEA is required for proposals that are expected to have important effects (positive or negative, direct or indirect) on the environment and the economy. Since orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), a SEEA was not required for the Order. These orders grant the Ministers the authority to develop risk management instruments for a toxic substance under the Act. The Government of Canada will evaluate whether a SEEA may be required on any future risk management instruments for talc.

Gender-based analysis plus

Since orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), no gender-based analysis plus (GBA+)footnote 11 impacts have been identified for the Order.

Right to a healthy environment

The Government of Canada has a duty, in the administration of the Act, to protect the right to a healthy environment as provided for under the Act, subject to reasonable limits. An implementation framework sets out considerations to protect this right and uphold the principles described in the framework, and provides opportunities to ensure actions pursuant to the Act are aligned with the principles of the UN Declaration.

Work to inform the Order was completed before the implementation framework was published on July 19, 2025. As decisions under the Act are informed by analyses and consultations that are often the result of years of work, a transition period is in place to allow departments to support continued protection of the environment and human health. The objective of the transition period is to continue to advance timely decisions and actions under the Act in consideration of the right to a healthy environment and relevant principles are being fully integrated into the administration of the Act. The Order is proceeding under the transition period referenced in the framework.

Although the implementation framework was not available to be applied from the beginning of the work undertaken to inform the Order (e.g. the assessment and the proposed Order), many of the elements included in the implementation framework were considered. For example, the assessment of substances under the Act proactively evaluates potential risks posed to the environment and human health, which includes engaging with interested parties and informing policy decision-making and regulatory actions, as necessary, to help prevent harm to the environment and human health. Orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act authorize certain risk management actions under the Act, as necessary, to prevent any identified harm to the environment or human health.

Implementation, compliance and enforcement, and service standards

Since orders adding substances to Part 1 or Part 2 of Schedule 1 to the Act do not impose any regulatory requirements on businesses, developing an implementation plan and a compliance and enforcement strategy, as well as establishing service standards for the Order, are not warranted.

This Order comes into force on the day on which it is registered.

Contacts

Thomas Kruidenier
Executive Director
Substance Prioritization, Assessment and Coordination 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