Certain Products Containing Toxic Substances Regulations: SOR/2025-36

Canada Gazette, Part II, Volume 159, Number 6

Registration
SOR/2025-36 February 26, 2025

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

P.C. 2025-161 February 25, 2025

Whereas, under subsection 332(1)^{footnote a} of the Canadian Environmental Protection Act, 1999 ^{footnote b}, the Minister of the Environment published in the Canada Gazette, Part I, on November 18, 2023, a copy of the proposed Certain Products Containing Toxic Substances Regulations, and persons were given an opportunity to file comments with respect to the proposed Regulations or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

Whereas, under subsection 93(3) of that Act, the National Advisory Committee has been given an opportunity to provide its advice under section 6^{footnote c} of that Act;

And whereas, in the opinion of the Governor in Council, under subsection 93(4) of that Act, the proposed Regulations do not regulate an aspect of a substance that is regulated by or under any other Act of Parliament in a manner that provides, in the opinion of the Governor in Council, sufficient protection to the environment and human health;

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 Certain Products Containing Toxic Substances Regulations under subsection 93(1)^{footnote d} of the Canadian Environmental Protection Act, 1999 ^{footnote b}.

Certain Products Containing Toxic Substances Regulations

General Provisions

Interpretation

Definition of regulated product

1 (1) For the purposes of these Regulations, regulated product means a product that belongs to a product category specified in section 13, 17 or 21 and that contains the toxic substance that is specified both in that section and on the list of toxic substances in Schedule 1 of the Canadian Environmental Protection Act, 1999.

Product category

(2) For the purposes of these Regulations, a product belongs to a product category if, according to information on its container or included in any documentation relating to the product that is made available by the manufacturer or importer or their authorized representative, the product may be used as a product that belongs to that category.

Non-application

Non-application

2 These Regulations do not apply to waste or a product that is at the end of its useful life and that is to be recycled.

Permits

Application

3 (1) A manufacturer or importer who wishes to obtain a permit referred to in paragraph 14(a), 18(a) or 22(b) must submit an application to the Minister in accordance with sections 8 and 9 that contains the following information and documents:

• (a) respecting the applicant,
  • (i) their name, civic and postal addresses, telephone number, email address and, if any, business number assigned by the Minister of National Revenue, and
  • (ii) if applicable, the name, title, civic and postal addresses, telephone number and email address of their duly authorized representative;
• (b) respecting the regulated product,
  • (i) its common or generic name and, if any, trade name and trademark,
  • (ii) the product category, any information establishing that the regulated product belongs to that category and the part of these Regulations that applies in respect of the product,
  • (iii) the total quantity and concentration of the toxic substance contained in the regulated product and the units of measurement used to express that quantity and concentration,
  • (iv) the estimated quantity of the regulated product to be manufactured, imported or sold, as the case may be, by the applicant in each calendar year of the validity period of the permit requested under paragraph (e) and, if applicable, the unit of measurement used to express that quantity, and
  • (v) an identification and description of its intended use and any of its other potential uses;
• (c) evidence — along with all supporting documents — that, at the time of the application, it is not technically or economically feasible for the applicant to use an alternative to or a substitute for the regulated product or the toxic substance contained in the regulated product that
  • (i) achieves a similar result as would be achieved by using the toxic substance, and
  • (ii) has a less harmful effect on the environment or on human health than the toxic substance;
• (d) a plan that identifies and describes
  • (i) the measures that the applicant will take to minimize or eliminate any harmful effect that the toxic substance contained in the regulated product has or may have on the environment and human health, including measures to ensure that the toxic substance is handled and transported safely and is not released into the environment during normal use of the regulated product and at the end of its useful life, and
  • (ii) the measures that the applicant will take to, within a stated period, eliminate the toxic substance contained in the regulated product or reduce its concentration to the point that these Regulations no longer apply to the product; and
• (e) the requested validity period for the permit which must not exceed three years with reasons for that requested period.

Clarifications

(2) The Minister may, on receiving the application, require any clarifications respecting the information or documents provided that are necessary for the application to be processed.

Notice of change to information

(3) The applicant must notify the Minister in accordance with sections 8 and 9 of any change to the information and documents provided under this section and must do so within 30 days after the day on which the change occurs.

Issuance

4 (1) The Minister may issue only one permit per regulated product to each applicant.

Conditions

(2) Subject to subsection (3), the Minister must issue the permit if the following conditions are met:

• (a) the applicant has established that, at the time of the application, it is not technically or economically feasible for them to use an alternative to or a substitute for the regulated product or the toxic substance contained in the regulated product that
  • (i) achieves a similar result as would be achieved by using the toxic substance, and
  • (ii) has a less harmful effect on the environment or on human health than the toxic substance; and
• (b) the applicant has submitted the plan referred to in paragraph 3(1)(d) and that plan identifies and describes
  • (i) measures that can reasonably be considered to minimize or eliminate any harmful effect that the toxic substance contained in the regulated product has or may have on the environment and human health, including measures to ensure that the toxic substance is handled and transported safely and is not released into the environment during normal use of the regulated product and at the end of its useful life, and
  • (ii) measures that can reasonably be considered to, within a stated period, eliminate the toxic substance contained in the product or reduce its concentration to the point that these Regulations no longer apply to the product.

Refusal

(3) The Minister must refuse to issue a permit if

• (a) the Minister has reasonable grounds to believe that the applicant has provided false or misleading information in support of their application;
• (b) the information and documents required under section 3 have not been provided or are insufficient to enable the Minister to process the application; or
• (c) the Minister has reasonable grounds to believe that, if the permit were issued, the manufacturing, importing or selling, as the case may be, of the regulated product would pose a threat of serious or irreversible damage to the environment or human health or would not contribute to sustainable development.

Expiry

(4) Unless the permit is renewed under subsection 5(3), it expires on the day indicated in the permit, which must not be later than three years after the day on which the permit is issued.

Renewal of permit

5 (1) A permit may be renewed only once and for a period of not more than three years.

Renewal application

(2) A renewal application must be submitted in accordance with section 3 at least 90 days before the day on which the permit expires and must contain

• (a) the information and documents specified in paragraphs 3(1)(a) to (e);
• (b) the permit number;
• (c) the actual quantity of the regulated product that was manufactured, imported or sold, as the case may be, by the applicant in each calendar year of the validity period of the permit and, if applicable, the unit of measurement used to express that quantity; and
• (d) information about the implementation of the plan that was contained in the original application for a permit under paragraph 3(1)(d), including — if that plan was not fully implemented — an explanation of why it was not fully implemented and how the applicant will ensure that the plan contained in the renewal application will be fully implemented within the period referred to in subparagraph 3(1)(d)(ii).

Renewal or refusal

(3) The Minister must renew the permit if the conditions set out in paragraphs 4(2)(a) and (b) are met and must refuse to renew the permit in any of the circumstances set out in paragraphs 4(3)(a) to (c).

Grounds for revocation

6 (1) The Minister must revoke a permit if

• (a) the permit holder requests the revocation;
• (b) the Minister has reasonable grounds to believe that the permit holder has provided false or misleading information; or
• (c) the permit holder has not, for reasons within their control and to the extent feasible, implemented the plan that was contained in the permit application.

Conditions for revocation

(2) Before revoking a permit, the Minister must provide the permit holder with written reasons and an opportunity to make written representations concerning the revocation.

Accredited Laboratory

Accredited laboratory

7 (1) Any analysis performed to determine the concentration of a toxic substance for the purposes of these Regulations must be performed by a laboratory that meets the following conditions at the time of the analysis:

• (a) it is accredited
  • (i) under the International Organization for Standardization standard ISO/IEC 17025, entitled General requirements for the competence of testing and calibration laboratories, by an accrediting body that is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement, or
  • (ii) under the Environment Quality Act, CQLR, c. Q-2; and
• (b) subject to subsection (2), the scope of its accreditation includes the analysis performed to determine the concentration of the toxic substance.

Standards of good practice

(2) If no method has been recognized by a standards development organization in respect of the analysis performed to determine the concentration of the toxic substance and the scope of the laboratory’s accreditation does not therefore include that analysis, the analysis must be performed in accordance with standards of good scientific practice that are generally accepted at the time that it is performed.

Format for Submission

Certification

8 Any information or document that is submitted to the Minister under these Regulations must be accompanied by a certification, dated and signed by the individual submitting the information or document, or by their authorized representative, stating that the information or document is accurate and complete.

Electronic submission

9 (1) Any information or document submitted to the Minister under these Regulations must be submitted electronically in a format that is compatible with the format used by the Minister.

Electronic signature

(2) If the certification referred to in section 8 is submitted electronically, it may be signed electronically.

Paper submission

(3) Despite subsection (1), if it is not feasible for a person to submit information or a document electronically in accordance with that subsection due to circumstances beyond their control, they may submit the information or document on paper in the format specified by the Minister. If the Minister has not specified a format, the person may submit the information or document in any format.

Record Keeping

Records

10 (1) Subject to sections 16 and 20, the following persons must maintain records:

• (a) any person who manufactures or imports a regulated product; and
• (b) any person who sells a regulated product for export only.

Information

(2) The records must be maintained in English or French or both languages and must contain the following information and all supporting documents:

• (a) in the case of a manufacturer,
  • (i) the regulated product’s common or generic name and, if any, trade name and trademark,
  • (ii) the product category to which the regulated product belongs, any information establishing that the regulated product belongs to that category, the part of these Regulations that applies in respect of the product and, if the regulated product is an aerosol or liquid, or if it is in a pump-spray container, a statement to that effect,
  • (iii) the date of the regulated product’s manufacture,
  • (iv) the quantity of the regulated product manufactured at each manufacturing plant and, if applicable, the unit of measurement used to express that quantity,
  • (v) the total quantity and concentration of the toxic substance contained in the regulated product and the units of measurement used to express that quantity and concentration, and
  • (vi) if applicable, the results of any analysis conducted to determine the concentration of the toxic substance in the regulated product, either as diluted in accordance with the manufacturer’s written instructions — in the case of a product that is to be diluted — or as it is manufactured, as well as any supporting documents related to the analysis and the name and civic address of the laboratory that performed the analysis;
• (b) in the case of an importer,
  • (i) the regulated product’s common or generic name and, if any, trade name and trademark,
  • (ii) the product category to which the regulated product belongs, any information establishing that the regulated product belongs to that category, the part of these Regulations that applies in respect of the product and, if the product is an aerosol or liquid, or if it is in a pump-spray container, a statement to that effect,
  • (iii) the date on which the regulated product was imported and the port of entry,
  • (iv) the quantity of the regulated product imported and, if applicable, the unit of measurement used to express that quantity,
  • (v) the total quantity and concentration of the toxic substance contained in the regulated product and the units of measurement used to express that quantity and concentration,
  • (vi) if applicable, the results of any analysis conducted to determine the concentration of the toxic substance in the regulated product, either as diluted in accordance with the manufacturer’s written instructions — in the case of a product that is to be diluted — or as it is manufactured, as well as any supporting documents related to the analysis and the name and civic address of the laboratory that performed the analysis,
  • (vii) the name, civic and postal addresses, telephone number and email address of the principal place of business of the shipper,
  • (viii) the Harmonized Commodity Description and Coding System number for the regulated product, as set out in the Customs Tariff, and
  • (ix) the business number assigned to the importer by the Minister of National Revenue; and
• (c) in the case of a person who sells a regulated product,
  • (i) the regulated product’s common or generic name and, if any, trade name and trademark,
  • (ii) the quantity of the regulated product sold and, if applicable, the unit of measurement used to express that quantity, and
  • (iii) the date of sale of the regulated product.

Timeline

(3) The records must be made no later than 30 days after the day on which the information or documents become available.

Retention of records

(4) The records must be kept for a period of at least five years after the day on which they are made.

Retention of information submitted to Minister

11 Any person who submits information or documents to the Minister under these Regulations must keep a copy of that information or those documents for a period of at least five years after the day on which the information or documents are submitted.

Place of retention

12 (1) The records referred to in section 10 and all copies of the information and documents that were submitted to the Minister under these Regulations must be kept at the person’s principal place of business in Canada or at any other place in Canada where they can be inspected. If they are kept at any other place in Canada where they can be inspected, the person must provide the Minister with the civic address of that place.

Electronic form

(2) Any records, information and documents that are kept electronically must be in a readily readable form.

Change of address

(3) If the civic address referred to in subsection (1) changes, the person must notify the Minister in accordance with sections 8 and 9 within 30 days after the change.

PART 1
Sealant Products Containing Coal Tars and Their Distillates

Application

Application

13 This Part applies in respect of products that belong to any of the following categories of products containing coal tars and their distillates:

• (a) pavement sealant products;
• (b) roofing sealant products; and
• (c) sealant products for industrial use on metal, structural steel or concrete components or on pipelines or other buried services.

Prohibitions

Manufacture or import

14 A person must not, after October 1, 2025, manufacture or import a product that belongs to any of the categories specified in section 13 unless

• (a) the person holds a permit issued under subsection 4(2);
• (b) the product is manufactured for export only; or
• (c) the product is in transit through Canada, from a place outside Canada to another place outside Canada.

Sell

15 (1) A person must not, after December 31, 2025, sell a product that belongs to any of the categories specified in section 13 unless

• (a) the product was manufactured or imported under a permit issued under subsection 4(2) and the sale occurs no later than one year after the expiry date of the permit; or
• (b) the product is sold for export only.

Temporary exception

(2) Despite subsection (1), a person may, until July 1, 2028, sell any product that belongs to the category specified in paragraph 13(c).

Record Keeping

Delayed application

16 Section 10 does not apply in respect of a product that belongs to any of the categories specified in section 13 until October 1, 2025.

PART 2
Sealant Products Containing Polycyclic Aromatic Hydrocarbons

Application

Application

17 This Part applies in respect of products that belong to any of the following categories of products containing polycyclic aromatic hydrocarbons, other than sealant products containing coal tars and their distillates:

• (a) pavement sealant products; and
• (b) roofing sealant products.

Prohibitions

Manufacture or import

18 A person must not, after October 1, 2025, manufacture or import a product that belongs to a category specified in section 17 and whose total concentration of polycyclic aromatic hydrocarbons exceeds 1,000 parts per million unless

• (a) the person holds a permit issued under subsection 4(2);
• (b) the product is manufactured for export only; or
• (c) the product is in transit through Canada, from a place outside Canada to another place outside Canada.

Sell

19 A person must not, after December 31, 2025, sell a product that belongs to a category specified in section 17 and whose total concentration of polycyclic aromatic hydrocarbons exceeds 1,000 parts per million unless

• (a) the product was manufactured or imported under a permit issued under subsection 4(2) and the sale occurs no later than one year after the expiry date of the permit; or
• (b) the product is sold for export only.

Record Keeping

Delayed application

20 Section 10 does not apply in respect of a product that belongs to any of the categories specified in section 17 until October 1, 2025.

PART 3
Products Containing 2-Butoxyethanol

Application

Application

21 (1) This Part applies in respect of the products that belong to any categories of products set out in column 1 of the table to this subsection that contain 2-butoxyethanol, which has the molecular formula C₆H₁₄O₂, and that are for indoor use, except if they are for use

• (a) in a manufacturing or processing activity;
• (b) in a commercial activity as paints or coatings, including automobile refinish coatings;
• (c) as a solvent in a laboratory for analysis;
• (d) in scientific research; or
• (e) as a laboratory analytical standard.

TABLE

Concentration Limits

Item	Column I Product Category	Column II Concentration Limit (% w/w)
1	Automobile cleaner other than automobile degreaser or internal engine cleaner	10.0
2	Rug or carpet cleaner	10.0
3	Floor or baseboard stripper	2.0
4	Paint stripper or thinner	0.5
5	Laundry stain remover	22.0
6	Any other aerosol cleaner that is not a pump-spray	5.0
7	Any other non-aerosol cleaner	6.0
8	Aerosol paint or coating other than a pump-spray	0.1
9	Non-aerosol paint or coating	0.5

Definition of cleaner

(2) For the purposes of items 6 and 7 of the table to subsection (1), cleaner means a product to be used to degrease and clean glass, floors and other surfaces, including bathroom and kitchen surfaces, but does not include automobile degreasers.

Prohibitions

Manufacture or import

22 A person must not manufacture or import a product that belongs to any of the categories set out in column 1 of the table to subsection 21(1) if its concentration of 2-butoxyethanol exceeds the limit set out in column 2 for that category unless

• (a) the product is to be diluted before it is used, in accordance with the manufacturer’s written instructions, to a concentration equal to or less than the limit set out in column 2 for that category and that product is either labelled with or accompanied by those instructions in both official languages and those instructions would not result in dilution of the product to a concentration greater than the limit set out in that column for that category;
• (b) the manufacturer or importer has been issued a permit under subsection 4(2) and, in the case of a product that is to be diluted before it is used, that product is either labelled with or accompanied by the manufacturer’s written dilution instructions in both official languages;
• (c) the product is manufactured for export only; or
• (d) the product is in transit through Canada, from a place outside Canada to another place outside Canada.

Sell

23 A person must not sell a product that belongs to any of the categories set out in column 1 of the table to subsection 21(1) if its concentration of 2-butoxyethanol exceeds the limit set out in column 2 for that category unless

• (a) the product is to be diluted before it is used, in accordance with the manufacturer’s written instructions, to a concentration equal to or less than the limit set out in column 2 for that category and that product is either labelled with or accompanied by those instructions in both official languages and those instructions would not result in dilution of the product to a concentration greater than the limit set out in that column for that category; or
• (b) the product was manufactured or imported under a permit issued under subsection 4(2), the sale occurs no later than one year after the expiry date of the permit and, in the case of a product that is to be diluted before it is used, that product is either labelled with or accompanied by the manufacturer’s written dilution instructions in both official languages.

Determination of Concentration of 2-Butoxyethanol in Regulated Products

Concentration of 2-butoxyethanol

24 The concentration of 2-butoxyethanol contained in a regulated product is determined in accordance with the Reference method for the analysis of 2-butoxyethanol (2-BE) and other glycol ethers (GEs) in selected products (automotive and household cleaners, paints, paint strippers and solvents), published by the Department of the Environment, as it read on the day on which these Regulations came into force.

PART 4
Consequential Amendments, Repeal and Coming into Force

Consequential Amendments

25 Item 18 of the schedule to Regulations Designating Regulatory Provisions for Purposes of Enforcement (Canadian Environmental Protection Act, 1999) ^{footnote 1} is repealed.

26 The schedule to the Regulations is amended by adding the following in numerical order:

Item	Column 1 Regulations	Column 2 Provisions
39	Certain Products Containing Toxic Substances Regulations	(a) section 14 (b) subsection 15(1) (c) section 18 (d) section 19 (e) section 22 (f) section 23

Repeal

27 The 2-Butoxyethanol Regulations ^{footnote 2} are repealed.

Coming into Force

Registration

28 These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues

In 2021, the Department of the Environment and the Department of Health (the Departments) concluded that coal tars and their distillates, hereinafter referred to as coal tars, are toxic to human health and the environment under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA). Coal tars were added to Schedule 1 to CEPA on December 16, 2024, allowing the Minister of the Environment and the Minister of Health to take measures, including regulatory measures, to prevent their release into the environment.^{footnote 3} Coal tars constitute a risk to human life or health in Canada, as they are entering the environment under conditions that have an immediate or long-term harmful effect on the environment and its biological diversity. Regulations are needed to prohibit the manufacture, import and sale of coal tar-based sealants to protect human health and the environment.

As well, sealants containing high levels of polycyclic aromatic hydrocarbons (PAHs) have been identified as possible replacement products to coal tar-based sealant products. An assessment published in 1994 concluded that PAHs, as a class, are toxic under CEPA, resulting in the addition of PAHs to Schedule 1 to CEPA in 1999. Current risk management instruments for PAHs do not address potential concerns from pavement and roofing sealants. Therefore, there is a need to regulate the manufacture, import and sale of sealants containing PAHs with a combined content above 1000 parts per million (ppm) to mitigate the risk of substitution from coal tars to alternatives that may also pose a risk to human health and the environment following the prohibition of coal tar-based sealants.^{footnote 4}

Background

The Chemicals Management Plan (CMP) is a Government of Canada initiative that assesses and manages the risks associated with chemical substances that may be harmful to the environment and/or human health. Harmful substances are declared toxic to the environment and/or human health under CEPA based on criteria in section 64. CEPA provides the authority for the Governor in Council to make regulations to help reduce the risks associated with toxic substances.

Coal tars and their distillates

Coal tars and their distillates are complex mixtures of hydrocarbons (mainly aromatic) and other chemical components. Coal tars can be distilled into many fractions, referred to as coal tar distillates. Coal tar distillates are used in the production of substances such as creosote, crude naphthalene, carbon black feedstock, coal tar pitch and oils. Upon further distillation, coal tars are used as an active ingredient in veterinary and human drugs.^{footnote 5}

In Canada, coal tars are a by-product of coke-making operations in four integrated steel mills located in Ontario. Coke is a solid fuel made by heating coal in the absence of air so that the volatile components are driven off. It is used in blast furnaces in the conversion of iron ore to iron, which can be further refined to produce steel. There is only one coal tar refinery in Canada, also located in Ontario.^{footnote 5}

Coal tars and their distillates meet the criteria for a toxic substance as set out in paragraphs 64(a) and (c) of CEPA, as they constitute a risk to the environment and human health in Canada. The final Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 for coal tars and their distillates was registered on December 16, 2024.^{footnote 5}

Polycyclic aromatic hydrocarbons (PAHs)

PAHs are compounds in groups of two to six aromatic rings. Each aromatic ring may contain five to six carbon atoms. These substances are contained in replacement products to coal tar-based sealant products such as ethylene cracker residue (ECR), which contains high levels of PAHs. PAHs were added to Schedule 1 to CEPA in 1999.^{footnote 6} Following amendments to CEPA, the substance is now listed under Part 2 of Schedule 1.

2-Butoxyethanol (2-BE)

The 2-Butoxyethanol Regulations were published in the Canada Gazette, Part II, on December 27, 2006.^{footnote 7} These Regulations apply in respect of cleaning, paint and coating products set out in Schedule 1 of the 2-Butoxyethanol Regulations that contain 2-BE, which has the molecular formula C₆H₁₄O₂ and is specifically used in an indoor setting. These Regulations include exceptions for when 2-BE is used in a manufacturing or processing activity, in a commercial activity as paints or coatings, as a solvent in a laboratory for analysis, in scientific research, or as a laboratory analytical standard.

Objective

The main objective of the Certain Products Containing Toxic Substances Regulations (the Regulations) is to prohibit the manufacture, import and sale of certain coal tar-based sealant products and certain sealant products containing PAH levels above 1000 ppm to prevent harmful ecological impacts and to help reduce the risk of adverse health impacts resulting from exposure to these toxic substances in Canada.^{footnote 8}

Description

Prohibition of sealant products containing coal tars and PAHs

The Regulations will prohibit the manufacture and import of certain sealant products containing coal tars and certain sealant products containing PAHs whose total concentration exceeds 1000 ppm by October 1, 2025. The Regulations include exemptions for permit holders and for products that are manufactured for export only or products that are in transit through Canada. Regulated products for coal tars and PAHs include pavement and roofing sealant products and, additionally for coal tars, sealant products for industrial use on metal, structural steel or concrete components or on pipelines or other buried services.

The sale of specified products containing coal tars and PAHs above the 1000 ppm concentration limit will be prohibited by December 31, 2025, unless the product was manufactured or imported under a permit specified in the Regulations (and for which the sale occurs no later than one year after the permit expiry) or the product is sold for export only. The Regulations will provide a temporary exemption for the sale of coal tar-based sealant products for industrial use on metal, structural steel or concrete components or on pipelines or other buried services until July 1, 2028.

Repeal and replace of the 2-Butoxyethanol Regulations

The 2-Butoxyethanol Regulations will be repealed and amalgamated under the Regulations as part of a generic regulation strategy. Minor modifications to the 2-Butoxyethanol Regulations have been made to be consistent with the legislative drafting of more recent regulations, such as the addition of record-keeping requirements for any person who sells a regulated product for export only. Record-keeping provisions have also been updated in alignment with department enforcement policies and require businesses to notify the Minister of a change in address of the place where records are retained. Finally, a reference to a testing method for the analysis of 2-BE in products, which is currently used by the Departments for sampling and testing related to enforcement activities, was included directly in the regulatory text.

General provisions and administrative requirements

The Regulations include provisions outlining requirements for permit applications and renewal, conditions for issuance, and grounds for refusal or revocation of the permit. The Regulations also contain provisions for record-keeping, including information requirements, format, and timeline for retention of records.

Consequential amendments

The Regulations make consequential amendments to the Regulations Designating Regulatory Provisions for Purposes of Enforcement (Designation Regulations). The Designation Regulations identify provisions of various regulations made under CEPA as being subject to an enhanced fine range in the event of a successful prosecution of an offence involving harm or risk of harm to the environment, or obstruction of authority. In this case, the schedule to the Designation Regulations will be amended to include provisions related to the prohibitions in the Regulations.

Regulatory development

Consultation prior to publication in the Canada Gazette, Part I

The Departments consulted the public on proposed regulatory measures for coal tar-based sealant products in 2021. A consultation document was published in December 2021 to inform interested parties, including Indigenous Peoples, of the main elements of the proposed regulatory measures and allow them to submit comments during a 70-day public comment period.^{footnote 9} An email was sent to interested parties and other groups identified as being potentially involved or interested in the proposed regulatory measures to inform them of the publication of the consultation document and invite them to submit comments. This email was sent to industry, associations, environmental non-governmental organizations (ENGOs), the Assembly of First Nations, provincial and municipal government organizations, and other federal government departments.

Comments were received from industry representatives, associations, ENGOs, and experts in the field. In addition to these consultations, in 2022, the Departments followed up with key stakeholders who had submitted comments. Overall, stakeholders and Indigenous Peoples were generally supportive of the proposed regulatory measures. Canadian manufacturers and importers of coal tars indicated that asphalt and asphalt bitumen products are readily available as alternatives. Canadian ENGOs supported the proposed regulatory measures, commenting that it would serve Canada better to implement a nationwide phase-out to protect the health of people in Canada and the environment, rather than a piecemeal prohibition on coal tars like those in certain cities, counties, and states in the United States (U.S.).

A Canadian association representing manufacturers and importers of coal tar-based sealant products expressed concern about the prohibition of products other than pavement and roofing sealants and recommended that the Departments provide a two-to-three-year sell-through transition period following the implementation of the prohibition for certain coal tar-based sealants. The association indicated that no concerns were raised regarding cost impacts and no technical constraints were expected from removing these products from the Canadian market if sufficient time was allowed. The comments were taken into consideration during the drafting of the regulatory text and a temporary exemption was added for the sale of coal tar-based sealant products for industrial use on metal, structural steel, or concrete components or on pipelines or other buried services until July 1, 2028.

A U.S. industry association opposed regulating coal tar-based sealant products to avoid any impact on the industry. The association requested the Departments to take precautionary steps by further investigating the environmental impact of coal tar-based sealants in Canada before instituting a nationwide prohibition. The Departments used rigorous methodology and available up-to-date scientific and market information in their risk assessment conclusion that coal tars met the definition of toxic under CEPA, and this same information was considered in the proposed risk management approach. Economic, technological, social, health, and environmental implications were also considered during the development of the risk management measures.

The Departments are committed to consulting extensively with all affected stakeholders and Indigenous Peoples when developing risk management options to reduce releases of toxic substances to levels that are protective of human health and the environment. As such, a complementary consultation document was published in August 2022, for a 60-day public comment period, to solicit feedback on elements of a proposed regulatory approach for PAHs in sealant products.^{footnote 4} Comments were received in support of regulating PAHs from a U.S. expert and U.S. association whose members already complied with the prevailing regulatory level of 1000 ppm of PAHs in sealants. Therefore, the decision was made to also regulate PAHs in sealants with a combined content above 1000 ppm under the proposed Regulations.

Comments following prepublication in the Canada Gazette, Part I

The proposed Regulations were published in the Canada Gazette, Part I, on November 18, 2023, for a 70-day public comment period ending on January 27, 2024. Emails were sent to known and potential regulatees, key industry associations, Indigenous partners, ENGOs and other interested parties. The public was also invited to comment on the proposed Regulations, either directly on the Canada Gazette website or by email. In addition to these online consultations, the Departments held follow-up discussions with two associations that requested additional information or to provide clarification regarding their comments.

The Departments informed provincial and territorial governments of the publication of the proposed Regulations through the CEPA National Advisory Committee. The World Trade Organization’s Committee on Technical Barriers to Trade was also notified about the publication of the proposed Regulations in the Canada Gazette, Part I, as the proposed Regulations could have implications for international trade practices. No comments were received through either of these processes.

During the consultation period, thirty-three submissions were received from nine interested parties, including four associations, two companies and three individuals. Overall, interested parties were generally in favour of the proposed Regulations, including the generic framework and the substance-specific prohibitions and timelines. No comments were received from Indigenous Peoples or organizations. Comments from interested parties and responses provided by the Departments are summarized below.

Generic framework and general provisions

Summary of comments: Businesses and associations generally supported the use of a generic approach in these Regulations to simplify the regulatory landscape. However, one Canadian association had concerns that possible amendments to the general provisions and existing substance-specific parts may complicate consultation and inadvertently cause compliance issues in the future. Additionally, the association asked questions about the permitting scheme in the Regulations and encouraged the Departments to give special consideration to certain sectors that may require additional time to transition to alternatives under a permit.

Another Canadian association had concerns that changes to the record-keeping requirements were substantive and the addition of a reference to an accredited testing method was restrictive on businesses. The association noted that these modifications represent additional regulatory requirements and incremental costs on businesses, and that the original requirements under the 2-Butoxyethanol Regulations should be maintained.

Response: The Regulations are a flexible instrument designed to facilitate future consultation processes, as stakeholders will already be familiar with the Regulations. Amendments to existing substance-specific parts will only be considered if new information comes to light and amendments to the general provisions will only be considered as needed or when adding new substances. Any future amendments to the Regulations will go through the formal government consultation process, which includes pre-consultations and consultations after publication in Canada Gazette, Part I, ensuring impacted stakeholders have an opportunity to comment on proposed amendments. The permitting scheme established in the Regulations could be used to authorize the controlled manufacture or import of specific products containing a regulated toxic substance. Permits will only be issued in accordance with the conditions outlined in the Regulations. Permits are not intended to be used as a transitional measure for existing products for which alternatives currently exist. The Regulations include time-limited exemptions where additional time is needed to transition to alternatives.

Modifications to the record-keeping requirements are consistent with more recent regulations and are required for enforcement activities under the Regulations. As businesses maintain these records already, the Departments determined these changes to not be substantive nor representing an incremental burden on businesses. The 2-Butoxyethanol Regulations were published in 2006 and the Department of Environment later developed a reference method for the analysis of 2-BE in select products, which has since been used by departmental laboratories for sampling and testing related to the enforcement activities under the existing 2-Butoxyethanol Regulations. As this reference method was not cited in the 2-Butoxyethanol Regulations, it was added to the Regulations to facilitate understanding and to be transparent about the method used by departmental laboratories. The reference to the method in the regulatory text does not create any new requirements or any additional burden on stakeholders.

Substance-specific prohibitions

Summary of comments: Businesses and associations noted that industry has already moved away from using coal tars or PAHs above 1000 ppm in their products. There was also general support for the timelines of the prohibitions and the inclusion of the 2-Butoxyethanol Regulations under this initiative. Several comments requested additional clarification on the scope of the proposed prohibitions and suggested including definitions and terminology in the regulatory text. Comments specifically requested additional clarity around the regulated products and substances covered to ensure the Regulations do not inadvertently cover other products.

Response: The Departments have ensured that each substance-specific part in the Regulations clearly identifies the regulated products and the substance identities, which are reiterated in the prohibitions. Questions related to the scope of the Regulations were clarified during follow-up discussions with stakeholders. Further guidance material will also be developed to support the understanding and awareness of the new regulatory requirements.

Addition of coal tars to Schedule 1 to CEPA

Summary of comments: A U.S. industry association opposed the addition of coal tars to Schedule 1 to CEPA and requested the Departments to reconsider the need for the proposed Regulations, citing that the risk assessment results for coal tars were based on flawed science and that prohibiting coal tar-based sealants may have economic impacts on stakeholders.

Response: The Departments used rigorous methodology and available up-to-date scientific and market information in their risk assessment conclusion that coal tars met the definition of toxic under CEPA, and this same information was considered in the proposed risk management approach. Economic, technological, social, health, and environmental implications were also considered during the development of the risk management measures.

Modern treaty obligations and Indigenous engagement and consultation

The Regulations will not impact, directly or indirectly, the rights of Indigenous Peoples, and would respect the federal government’s obligations in relation to rights protected by section 35 of the Constitution Act, 1982, modern treaties, and international human rights obligations.

Instrument choice

To meet the objectives outlined above, it was determined that the only viable option was to introduce the Regulations. Maintaining the status quo was not considered to be a viable option as this would not reduce the risk of exposure to the extent feasible from coal tar-based sealants and their substitutes with PAH contents above 1000 ppm. Ultimately, voluntary actions were not considered as they would not accelerate phasing out these products and transitioning to safer alternatives that are readily available. Only by introducing the Regulations will a clear market signal be provided to Canadian manufacturers, importers, retailers, and consumers to accelerate phase-out of coal tar-based sealants.

For these reasons, introducing the Regulations was the preferred instrument choice. However, it would be inefficient to introduce separate regulations for coal tars and PAHs. Including multiple substances of concern in products in one generic products regulation is expected to simplify the regulatory landscape and help interested parties identify relevant regulatory requirements. The Regulations are also designed to serve as a single vehicle to manage the risks associated with multiple toxic substances in products over the coming years. A generic regulation can simplify and streamline the process for controlling several toxic substances in different products, as well as reduce regulatory and administrative burden. Once these Regulations are published, they can be open to future amendments to add substances and/or products that fit the objective of the Regulations.

Regulatory analysis

Benefits and costs

Compliance costs

An industry market report outlined that the North American sealers market has seen a shift in demand away from coal tar-based sealants and towards less toxic substitutes such as acrylic and asphalt sealers, mainly due to regulatory prohibitions across various jurisdictions. Increasing public awareness of PAH emissions from coal tar-based sealants has prompted numerous states to restrict the use of coal tar-based sealants. Several contractors and prominent hardware stores throughout North America have also stopped using and selling coal tar-based sealants.^{footnote 10}

In 2023, there were similar Canadian prices between coal tar sealants and their substitutes, referred to as asphalt and asphalt bitumen in the industry report. As coal tars are phased out in jurisdictions across North America, there is a projected price divergence between coal tars and their substitutes, which would result in incremental costs for consumers who would have to switch from less expensive coal tar sealants. The coal tar price initially in 2023 is $1,079,135 USD per US kiloton and is projected to grow at a compound annual growth rate of 2.24%. On the other hand, the substitute price in 2023 is at $1,091,244 USD per US kiloton and is projected to grow at 2.34%.^{footnote 10}

The incremental price in USD/US kiloton between coal tars and their substitutes was at $12,108 USD in 2023 and reaching $68,525 USD by 2034. After applying the gross domestic product (GDP) deflator to inflate from 2022 dollars to 2023 dollars, the incremental price is $12,466 USD and is projected to reach $70,549 USD by 2034. Using the 2023 purchasing power parity (PPP) exchange rate of 1.17 CAD/USD provided by the World Bank, the incremental price is at $14,585 CAD in 2023 and projected to be $82,542 CAD by 2034. The market volume or quantity of the coal tars in Canada is at 17.0 US kilotons in 2023 and is projected to grow by a compound annual growth rate of 2.3%, reaching 20.9 US kilotons in 2034. Assuming a one-for-one substitution between coal tars and their substitutes, the incremental cost can be calculated by multiplying the incremental price in Canadian dollars by the quantity, resulting in $247,955 CAD in incremental compliance costs in 2023 and projected to reach $1,722,595 CAD by 2034.^{footnote 10} This approach also assumes that product characteristics such as performance, durability, and application effort of substitutes for coal tar-based products are essentially equivalent.

Table 1: Incremental compliance cost analysis for coal tars in Canada

Year of analysis	2023 (actual)	2025 (projected)	2030 (projected)	2034 (projected)
1) Coal tar price (USD/US kiloton)	$1,079,136	$1,091,155	$1,125,258	$1,151,475
2) Substitute price (USD/US kiloton)	$1,091,244	$1,113,306	$1,173,285	$1,220,000
3) Incremental price (USD/US kiloton)	$12,108	$22,151	$48,027	$68,525
4) Inflated to 2023 USD (using GDP deflator)	$12,466	$22,805	$49,445	$70,549
5) Convert to CAD (using PPP rate)	$14,585	$26,682	$57,851	$82,542
6) Quantity in US kilotons (1 to 1)	17.0	17.8	19.9	20.9
7) Incremental costs in CAD	$247,955	$474,943	$1,151,238	$1,722,595

A summary of these calculations can be found in Table 2, which shows the present value compliance costs of the Regulations from 2025 to 2034. These are projected to be about $6.6 million in 2023 Canadian dollars, or $944,381 CAD annually, using a 7% annual discount rate.

Administrative costs

Throughout the consultation process, industry stakeholders generally signalled support for phasing out coal tar-based sealants. Manufacturers expressed that substitutes exist with asphalt bitumen and asphalt-based sealants at similar costs to coal tar-based sealants and certain sealant products containing PAHs. Provisions for permits have been included in the Regulations as a backstop to provide flexibility to industry. The permitting process in the Regulations is a backstopping measure that is not likely to be used, since alternatives to coal tar-based sealants and certain sealant products containing PAHs are readily available.^{footnote 4}

Finally, it was determined that the amendments to the 2-Butoxyethanol Regulations, which are being repealed and amalgamated under this initiative, do not represent any new incremental administrative costs. The record-keeping requirement for retailers of products for export only was not determined to be an incremental cost as these businesses already maintain the records required by the Regulations as a business practice and in compliance with other acts and regulations. Additionally, the requirement to inform the Minister if there is a change of address for the place of retention of records only applies if records are kept at a location other than the person’s principal place of business. Regulatees have this information readily available and already notify the Minister of any changes of address for enforcement purposes as a matter of policy. As a result, this requirement does not represent an incremental cost on affected businesses.

Government costs

The Regulations will impose total enforcement costs on the Department of $516,648 over the period of analysis. The federal government would incur incremental costs related to training, inspections, investigations, measures to deal with any alleged violations, and compliance promotion activities. Concerning enforcement costs, a one-time amount of $5,000 would be required for the training of enforcement officers and $10,178 for strategic intelligence assessment work. The annual enforcement costs are estimated to be about $50,147 broken down as follows: roughly $20,907 for inspections (which includes Operations and Maintenance costs, transportation, and sampling costs) and measures to deal with alleged violations (including warnings, environmental protection compliance orders and injunctions), approximately $4,092 for investigations, about $2,951 for prosecutions, and approximately $8,624 for ongoing intelligence. Finally, included in the annual enforcement costs are the estimated annual cost of administration, coordination, and analysis to support enforcement activities at $13,573.

Table 2: Summary of costs

• Number of years: 10 (2025–2034)
• Base year for costing: 2023
• Present value base year: 2025
• Discount rate: 7%

Description of costs / Year	Undiscounted / 2025	Undiscounted / 2030	Undiscounted / 2034	Total present value (discounted) / 2025–2034	Annualized value (discounted) / 2025–2034
Compliance costs	$474,943	$1,151,238	$1,722,595	$6,632,937	$944,381
Government costs	$65,325	$50,147	$50,147	$392,044	$55,818
Total costs	$540,268	$1,201,385	$1,772,742	$7,024,981	$1,000,199

Benefits

According to the departmental risk assessment, coal tars and their distillates may be released to air from activities associated with their production, transportation, and storage, as well as to water and soil from product use and disposal. The results of toxicity studies conducted using coal tar-based sealants indicate that exposure to these products in the environment can lead to adverse effects in organisms, attributed mainly, but not exclusively, to PAHs present as components in coal tars. It was concluded that exposure to PAHs associated with the use of coal tar driveway sealants may pose a human health risk. For this reason, PAHs have been considered in evaluating the human health and ecological risks of coal tars.^{footnote 11}

The Regulations will address exposure risks from sources of concern and reduce releases of coal tar-based sealants and sealants containing PAHs above 1000 ppm into the environment and reduce risks to human health in Canada. There is consistent empirical and predicted evidence to indicate that some components of coal tars have the potential to be highly bio-accumulative. In addition, PAHs depositing to soil from industrial air releases during coal tar refining have the potential to cause adverse effects. The screening assessment indicated that there is a potential risk of harm to aquatic organisms that might be exposed to PAHs through runoff from the surrounding contaminated terrestrial environment. It is anticipated that the reduction of coal tar-based sealants and sealants containing PAHs over 1000 ppm resulting from the Regulations will generate health benefits including reductions in carcinogenesis as quantified in the Coal Tars and Their Distillates assessment as well as other identified effects associated with exposures to PAHs such as narcosis, reproductive toxicity, impairment of growth and development, and disruptions to hormonal and immunological function.^{footnote 11}

Small business lens

The assessment of the small business lens concluded that the Regulations will have no impact on small businesses, as they do not impose new administrative or compliance costs on businesses. During consultations, a Canadian industry association expressed concerns over the broadened scope of the regulatory measures for coal tar-based sealant products. However, the association noted that no major cost impact and technical constraints would be expected from the removal of certain coal tar-based sealant products from the Canadian market, as long as sufficient time was allowed to do so. This comment was considered in the regulatory design by providing a temporary exemption for sale of certain products until 2028 to allow clearing of inventory and finishing of projects. This transition period will help limit impacts on businesses and allow industry to adapt to new regulatory requirements at little to no cost. Therefore, no small business impacts are expected.

One-for-one rule

The Regulations repeal an existing regulation and replaces it with a new regulatory title, which results in no net increase or decrease in regulatory titles. The Regulations are not expected to introduce new administrative costs for regulated parties unless an unknown application exists that would justify application for an exemption. However, the Departments do not expect to receive permit applications. Permits could be granted in the case of unforeseen circumstances and under certain conditions. Permit applicants will be required to demonstrate that, at the time of applying, there are no alternatives to manufacturing or importing sealants containing coal tar, or that the alternatives are not technically or economically feasible for them. The term of the permit would not exceed three years. A regulated party would apply for a permit renewal, and the Minister of the Environment (Minister) could renew it once, for a term that would not exceed three years if the conditions underlying the Minister’s approval of the original permit would still be satisfied. Amendments to record-keeping requirements are also not expected to result in a change in administrative burden on businesses (see benefits and costs section). Therefore, according to the Guide on Limiting Regulatory Burden on Business, there are no expected changes in administrative burden resulting from this regulatory proposal.^{footnote 12}Regulatory cooperation and alignment

Regulatory initiatives targeting the use of coal tar-based sealant products were initiated in the U.S. in the mid-2000s when scientists confirmed that these types of sealants release PAHs, which can be harmful to human and ecosystem health. As of March 2023, coal tar-based sealants are prohibited in two states (Washington and Minnesota), in the District of Columbia, and in more than 30 cities and counties across the U.S., with a general trend towards a nationwide phase-out.^{footnote 13}

Moreover, many regions in the U.S. have begun phasing out pavement sealants with high PAH content. This includes the City of Austin in Texas, the District of Columbia, Montgomery County in Maryland, the City of Charlotte in North Carolina, as well as over 30 communities in Michigan and Wisconsin, which have instated 1000 ppm limits on PAHs. As well, some areas have adopted a higher PAH limit of 10,000 ppm for pavement sealants, including the State of Maine, the State of Maryland, the State of New York, and the Village of Elm Grove in Wisconsin. Furthermore, as of October 2024, the State of New York has introduced a Senate Bill to reduce the PAH limit to 1000 ppm in pavement sealant products.^{footnote 14}

In addition, the European Union (EU) enacted the registration, evaluation, authorisation, and restriction of chemicals (REACH) regulation on June 1, 2007. One goal of the REACH regulation was to identify substances of very high concern (SVHCs) and to adequately control and replace them with alternative substances. In January 2010, coal tars were included in the List of SVHCs of REACH and, since October 2020, it is prohibited to produce or use coal tar-based sealants in the EU without an authorization. The Regulations will align with the EU’s approach.^{footnote 15}

Effects on the environment

The Regulations have been developed under the CMP, a Government of Canada initiative aimed at reducing the risks posed by chemicals to people in Canada and their environment. A preliminary scan concluded that these Regulations are aligned with goal 13 of the 2022–2026 Federal Sustainable Development Strategy to protect people in Canada from harmful substances.^{footnote 16}

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for these Regulations.

Implementation, compliance and enforcement, and service standards

Implementation

The Regulations will come into force on the day on which they are registered, with new prohibitions not taking effect until later dates to allow time for industry to adjust to the prohibitions. To implement the regulatory requirements, the Departments would undertake several compliance promotion activities, including, but not limited to, developing and distributing guidance material, notifying stakeholders of new regulatory requirements and responding to public inquiries on the Regulations. These activities would aim to raise awareness and promote compliance as early as possible during the regulatory implementation process.

The Departments have selected a generic regulation approach to simplify and streamline the regulatory process under CEPA. This in turn simplifies the compliance process as it covers several toxic substances in different products under one set of regulations.

Compliance and enforcement

Since the Regulations would be made under CEPA, enforcement officers would apply the Compliance and Enforcement Policy for CEPA when verifying compliance with the regulatory provisions.^{footnote 17}

Service standards

If the conditions specified in the Regulations were met, a regulated party could request a permit to import or manufacture a product containing coal tars, PAHs, or 2-BE. Permit applications would be submitted to the Minister after the Regulations enter into force. The administrative procedure for permit approval would not be expected to take more than 90 days, upon submission of all the required documentation.

Contacts

Matt Lebrun
Director
Chemical Production and Products Division
Industrial Sectors and Chemicals Directorate
Environmental Protection Branch
Department of the Environment
Place Vincent Massey Building, 9th Floor
351 Saint-Joseph Boulevard
Gatineau, Quebec
K1A 0H3
Email: Produits-Products@ec.gc.ca

Matthew Watkinson
Executive Director
Regulatory Analysis and Valuation Division
Economic Analysis Directorate
Strategic Policy Branch
Department of the Environment
Place Vincent Massey Building, 16th Floor
351 Saint-Joseph Boulevard
Gatineau, Quebec
K1A 0H3
Email: RAVD.DARV@ec.gc.ca