Prohibition of Certain Toxic Substances Regulations, 2012: overview

These regulations prohibit the manufacture, use, sale, offer for sale and import of certain toxic substances, and products containing them, with a limited number of exemptions.

Disclaimer

This information has been prepared for convenience of reference only and is not to be understood as a legal document. For interpreting and applying these regulations, please read the regulations.

The substances prohibited by these regulations are some of the most harmful. They were declared toxic to the environment and/or human health under the Canadian Environmental Protection Act, 1999 (CEPA), and are generally persistent and bioaccumulative.  

Since their creation in 1996, these regulations have been amended or republished multiple times to add or remove substances, or to remove exemptions. They include:

• substances that have been prohibited for many years, preventing their re-introduction into commerce
• substances that have been recently prohibited, some with exemptions to accommodate critical uses that could not immediately be phased out

Planned changes to these regulations are currently being proposed.

On May 14, 2022, the proposed Prohibition of Certain Toxic Substances Regulations, 2022 were published in Canada Gazette, Part I. These proposed regulations would repeal and replace the Prohibition of Certain Toxic Substances Regulations, 2012 on the day the final regulations come into force.

These regulations are also the main tool to implement Canada’s obligations for industrial chemicals under the Stockholm Convention on Persistent Organic Pollutants.

These regulations only apply to certain toxic substances that are included on the List of Toxic Substances (Schedule 1 of CEPA).

• Certain groups of per- and polyfluoroalkyl substances (PFAS):
  • Perfluorooctanoic acid, which has the molecular formula C₇F₁₅CO₂H (PFOA) and its salts
  • Compounds that consist of a perfluorinated alkyl group that has the molecular formula C_nF_2n+1 in which n = 7 or 8 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom (PFOA precursors)
  • Perfluorocarboxylic acids that have the molecular formula C_nF_2n+1CO₂H in which 8 ≤ n ≤ 20 (LC-PFCAs) and their salts
  • Compounds that consist of a perfluorinated alkyl group that has the molecular formula C_nF_2n+1 in which 8 ≤ n ≤ 20 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom (LC-PFCA precursors), including 4 fluorotelomer-based substances:
    • Hexane, 1,6-diisocyanato-, homopolymer, reaction products with alpha-fluoro-omega-2- hydroxyethyl-poly(difluoromethylene), C16-20-branched alcohols and 1-octadecanol
    • 2-Propenoic acid, 2-methyl-, hexadecyl ester, polymers with 2-hydroxyethyl methacrylate, gamma-omega-perfluoro-C10-16-alkyl acrylate and stearyl methacrylate
    • 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with butyl 2-propenoate and 2,5 furandione, gamma-omega-perfluoro-C8-14-alkyl esters, tert-Bu benzenecarboperoxoate-initiated
    • 2-Propen-1-ol, reaction products with pentafluoroiodoethane tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine
  • Perfluorooctane sulfonate (PFOS) and its salts
  • Compounds that contain one of the following groups: C₈F₁₇SO₂, C₈F₁₇SO₃ or C₈F₁₇SO₂N (PFOS precursors)
• Hexabromocyclododecane, which has the molecular formula C₁₂H₁₈Br₆ (HBCD)
• Polybrominated diphenyl ethers that have the molecular formula C₁₂H_(10-n)Br_nO in which 4 ≤ n ≤ 10 (PBDEs)
• Chlorinated alkanes, that have the molecular formula C_nH_xCl_(2n+2-x) in which 10 ≤ n ≤ 13 (short-chain chlorinated alkanes)
• Tributyltins, which contain the grouping (C₄H₉)₃Sn (TBTs)
• Polychlorinated naphthalenes, which have the molecular formula C₁₀H_8-nCl_n in which “n” is greater than 1 (PCNs)
• 2-Methoxyethanol, which has the molecular formula C₃H₈O₂ (2-ME)
• Pentachlorobenzene, which has the molecular formula C₆HCl₅ (PeCB)
• Tetrachlorobenzenes, which have the molecular formula C₆H₂Cl₄ (TeCB)
• Dichlorodiphenyltrichloroethane, which has the molecular formula C₁₄H₉Cl₅ (DDT)
• Hexachlorobutadiene, which has the molecular formula C₄Cl₆ (HCBD)
• N-Nitrosodimethylamine, which has the molecular formula C₂H₆N₂O (NDMA)
• Benzidine and benzidine dihydrochloride, which have the molecular formula C₁₂H₁₂N₂ and C₁₂H₁₂N_2^•2HCl, respectively
• Hexachlorobenzene (HCB)
• (4-Chlorophenyl)cyclopropylmethanone, O-[(4-nitrophenyl)methyl]oxime that has the molecular formula C₁₇H₁₅ClN₂O₃ (NCC ether)
• Chloromethyl methyl ether that has the molecular formula C₂H₅ClO (CMME)
• Bis(chloromethyl) ether that has the molecular formula C₂H₄Cl₂O (BCME)
• Polychlorinated terphenyls that have a molecular formula C₁₈H_(14-n)Cl_n in which "n" is greater than 2 (PCT)
• Polybrominated biphenyls that have the molecular formula C₁₂H_(10-n)Br_n in which "n" is greater than 2 (PBB)
• Dodecachloropentacyclo [5.3.0.0^2,6.0^3,9.0^4,8] decane (Mirex)

These substances are listed to the substances search tool and are associated with a non-exhaustive number of Chemical Abstracts Service registry numbers (CAS RNs) that are known to represent them. For the official non-exhaustive list of CAS RNs, contact us at the email address listed below.

These regulations include a limited number of general and substance-specific exemptions. In a few cases, these exemptions include reporting requirements.

These regulations do not apply to certain products or activities, regardless of the substance involved.

• incidental presence (subsections 4(1) and 6(1))
  • for the purpose of these regulations, incidental presence is generally understood to be a residual, trace contaminant or impurity that was not intentionally added to the formulation.
• laboratory use (section 3)
• hazardous waste, hazardous recyclable material or non-hazardous waste (section 2)
• pest control products (section 2)
• non-emissive or destructive uses of chemical feedstock (section 2)

There are also a limited number of substance-specific exemptions that allow the manufacture, use, sale, offer for sale or import of substances and/or products containing them.   

For more details about the exemptions, please read the regulations.

You are responsible to comply with all aspects of these regulations. Each person is best placed to determine how these regulations may affect their activities. The measures you take to ensure compliance will vary according to your activities.

Some measures you may take include:

• checking with your supply chain
• familiarizing yourself with the substances that are listed to these regulations
• reviewing manufacturing formulations, engineering specifications, safety data sheets and other available documentation
• asking your suppliers for certification that the products are not made with prohibited substances
• if you import substances or products in which the presence of a prohibited substance has been detected, verifying with your suppliers whether the presence is incidental or if a specific exemption applies, and maintaining records accordingly
• specifying the absence of prohibited substances in your contracting documents
• having your substances or products periodically tested
• maintaining records that demonstrate your efforts to comply with the regulations

These actions are not requirements of the regulations; they are provided as examples for guidance purposes only.

CEPA and its regulations, including the Prohibition of Certain Toxic Substances Regulations, 2012, are enforced in accordance with the Compliance and Enforcement Policy for CEPA.

Importers must comply with all relevant requirements of the regulations. Depending on the substance, prohibited items can include:

• consumer products
• industrial products
• intermediary articles used in manufacturing
• chemical or recycled material feedstock

Substances and/or products containing them that are prohibited in Canada may still be legally manufactured or used in other countries. Importers must therefore take the necessary precautions to avoid imports that may lead to accidental regulatory violations.

Below are some examples of imported products that may be more likely to contain prohibited substances, due to their ongoing use in other countries. However, these are only examples and other substances that are prohibited by the regulations may also be found in imported products. As an importer, it is your responsibility to ensure that your products comply with the regulations.

In addition, note that certain substances subject to these regulations are also listed on the Export Control List (Schedule 3 of CEPA) and their export is controlled by the Export of Substances on the Export Control List Regulations, whether or not they are contained in a product.

These regulations do not apply to toxic substances or to any products containing them that are to be used:

• in a laboratory for analysis
• in scientific research
• as a laboratory analytical standard

However, all exempted laboratory users have reporting requirements if they are using more than 10 g of any toxic substances in a calendar year. The report(s) must clearly provide the information required, including:

• each proposed or actual use
• the anticipated period of use
• the quantities to be used per calendar year (January 1st to December 31st)

Aqueous film-forming foam, better known as AFFF, is a synthetic fire-fighting foam containing hydrocarbon-based surfactants and fluorinated surfactants that rapidly extinguish hydrocarbon fuel fires. It is mainly used in civil and military aviation, and oil industries. In Canada, AFFF containing the following PFAS is prohibited under these regulations, with a few exemptions that are outlined below:

• PFOS, its salts, and precursors
• PFOA, its salts, and precursors
• LC-PFCAs, their salts, and precursors

These regulations allow:

• the use of AFFF that contains residual levels of PFOS and its precursors at a concentration less than or equal to 10 ppm
• the use and import of AFFF contaminated with PFOS and its precursors in a military vessel or military fire-fighting vehicle returning from a foreign military operation
• the import, use, sale and offer for sale of AFFF that contains PFOA and/or LC-PFCAs, and their precursors, used in fire-fighting

These exemptions accommodate:

• the residual levels of PFOS and its precursors that remain in fire-fighting equipment as a result of historical use of the substance, and
• the transition to alternatives to PFOA and/or LC-PFCAs, and their salts and precursors

To find out if your AFFF contains prohibited PFAS, you should refer to the safety data sheet for the product or contact your AFFF supplier/manufacturer.

Since PFOS, PFOA and LC-PFCAs and their salts and precursors pose a risk to the environment, best environmental practices and available technologies should be used during all life cycle stages. AFFF that contains these toxic substances should be used and disposed of in an environmentally sound manner. Be sure to use appropriate procedures to avoid any release to the environment during routine use such as training activities and equipment testing.

Dispose of AFFF that contains these toxic substances at an authorized hazardous waste management facility. In Canada, provinces and territories have jurisdiction over the licensing and permitting of disposal facilities. Contact your provincial/territorial authorities to find the appropriate hazardous waste management facility for safe disposal.

Any laboratory testing performed for the purposes of these regulations, such as for compliance with the regulations, must be carried out by a laboratory accredited under the standard ISO/IEC 17025 or under the Environment Quality Act, CQLR, c. Q-2. The laboratory must meet the following conditions at the time that the analysis to determine the concentration of the toxic substance is performed:

• if there is a method recognized by a standards development organization, the analysis must be included in the scope of the laboratory's accreditation, or
• if no method has been recognized by a standards development organization, the analysis must be performed in accordance with standards of good scientific practice that are generally accepted.

For more detail, refer to section 13 of these regulations.

Depending on the substance and activity, you may be subject to reporting requirements if:

• you are a laboratory that uses more than 10 g of a toxic substance or a product containing it, in a calendar year (Schedule 3 of these regulations)
• you are a manufacturer or importer of short-chain chlorinated alkanes or benzidine and benzidine dihydro-chloride or products containing them, incidentally present or otherwise, above an annual reporting threshold (Schedule 5 of these regulations)

A separate report must be submitted for every calendar year for each toxic substance. Complete your report using the PDF version of the appropriate form below. Ensure that you have signed it and submit it to the email address listed below.

For more details, refer to section 3 or 12 of these regulations, respectively.

It is mandatory to keep records of all information submitted under these regulations in Canada for a minimum of five years. For more details, refer to section 15 of these regulations.

There are currently no permits available. Permits were only available when a prohibition first came into effect, or when a temporary permitted use expired. When available, permits temporarily allow the manufacture or import of certain substances or products containing them (Schedule 4 of these regulations). For more details, refer to sections 9, 10 and 11 of these regulations.

• Prohibition of Certain Toxic Substances Regulations, 2012
• Prohibition of Certain Toxic Substances Regulations, 2022 [Proposed]
• Risk management of chemical substances in Canada
• List of toxic substances (Schedule 1 of CEPA)
• Substances search
• Compliance and Enforcement Policy for CEPA
• Summary of flame retardant assessments and management conducted under CEPA
• Provincial, territorial, and international contacts
• Persistent organic pollutants: Stockholm Convention
• Export of Substances on the Export Control List Regulations

Chemicals Management Division
Environment and Climate Change Canada
351 St. Joseph Blvd, 10th floor
Gatineau QC K1A 0H3

Email: interdiction-prohibition@ec.gc.ca

Environment and Climate Change Canada Inquiry Centre:
Telephone: 819-997-2800 or 1-800-668-6767 (in Canada only)

Write to us at the email above if you would like to be added to the regulations distribution list.