Proposed amendments to the Prohibition of Certain Toxic Substances Regulations, 2018 consultation document: chapter 2

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2. Proposed regulatory approach

The proposed regulatory approach would be to continue to phase out the use of the toxic substances currently controlled by the regulations. Some exemptions were initially available for PFOS, PFOA, LC-PFCAs, PBDEs and HBCD to allow specific market sectors to transition to using alternatives. The next phase of risk management for these substances would be to remove or provide a time limit for the remaining exemptions.

Therefore, the proposed regulatory approach for PFOS, PFOA, LC-PFCAs (including the four new fluorotelomer-based substances), PBDEs, (except decaBDE) and HBCD would be to remove all current exemptions from the regulations. For decaBDE, an exemption for spare automotive parts would be granted until 2036.

For DP and DBDPE, the proposed regulatory approach would be to amend the regulations to prohibit their manufacture, import, use, sale and offer for sale, as well as products that contain them.

Exemptions will only be considered in exceptional circumstances, taking into account socio-economic factors, the demonstrated absence of suitable alternatives with consideration of environmental risks. This includes information provided through this consultation. Should any exemptions be included under the amended regulations, fixed time limits may be proposed, and may be accompanied by reporting, record-keeping, monitoring, labelling and/or other requirements to inform the public of the presence of the substances.

The next sections provide more details on the proposed approach for each substance.

2.1 Perfluorooctane sulfonate, its salts and precursors that contain one of the following groups: C8F17SO2, C8F17SO3 or C8F17SO2N (PFOS)

2.1.1 Background

PFOS was never manufactured in Canada. It was primarily used as a surfactant in the metal plating industry and in aqueous film-forming foam (AFFF) used in fire-fighting. Historically, PFOS was also used in a wide variety of surface treatments for textiles, upholstery, leather, carpet and packaging to provide water, oil, soil and grease repellent properties. The use of PFOS is still allowed, under the regulations, in photography (films, papers and printing plates) and in semi-conductor manufacturing (photolithography applications) (Environment and Climate Change Canada, 2018).

An ecological screening assessment report on PFOS, published in June 2006, concluded that PFOS is entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. It also concluded that PFOS is extremely persistent in all media and can bioaccumulate and biomagnify in mammals and piscivorous birds. A State of the Science Report for a Screening Health Assessment for PFOS, published in January 2006, concluded that PFOS was not harmful to human health at the levels of exposure that were assessed.

A Risk Management Strategy for PFOS, published in June 2006, stated that the ultimate environmental objective is to reduce the concentrations of PFOS in the Canadian environment to the lowest level possible.

2.1.2 International risk management

PFOS is of concern globally due to its widespread use and presence in the environment and its potential for long-range environmental transport. As a result, measures have been and continue to be taken by several countries, regional authorities (such as the European Union (EU)) and under multi-lateral environmental agreements, including the Stockholm Convention, to severely restrict PFOS. More detailed information about international risk management is available in Annex B.

2.1.3 Proposed changes to exemptions under the regulations

The regulations prohibit the manufacture, use, sale, offer for sale and import of PFOS and products that contain it, with a limited number of exemptions.

Environment and Climate Change Canada (ECCC) is proposing to amend the regulations to remove the exemptions for PFOS in order to better achieve the environmental objective.

Table 1: Current exemptions and proposed amendments to the regulations for PFOS
Current exemption Proposed amendment
Import, manufacture, use, sale and offer for sale of PFOS or a product containing it if it is designed for use in photoresists or anti-reflective coatings for photolithography. Remove this exemption as this use has been discontinued globally.
Import, manufacture, use, sale and offer for sale of PFOS or a product containing it if it is designed for use in photographic films, papers and printing plates. Remove this exemption as this use is declining globally.
Use of PFOS in AFFF present in a military vessel or military fire-fighting vehicle contaminated during a foreign military operation. Remove this exemption as the use of PFOS in AFFF has been discontinued and alternatives are available globally.
The use of AFFF that contains residual levels of PFOS at a maximum concentration of 10 ppm. Remove this exemption as PFOS use in AFFF was prohibited in 2008 and alternatives are available globally.

2.1.4 Information gathering related to PFOS

In order to address remaining data gaps and understand any potential challenges faced by stakeholders, ECCC is asking for specific information related to activities currently permitted under the regulations. If your company undertakes an activity listed in Table 2, ECCC invites you to submit information identified below according to the procedure indicated in section 3 Next steps.

Table 2: Information needs for PFOS with respect to the activities currently exempt under the regulations
Activity Information needs

Import, manufacture, use, sale and offer for sale of PFOS or a product containing it if it is designed for use in photoresists or anti-reflective coatings for photolithography processes.

  • Quantities of coating your company manufactures, uses, sells, offers for sale or imports annually (with the unit of measurement).
  • Concentration of PFOS in the coating according to Safety Data Sheet (SDS) or lab analysis (with the unit of measurement).
  • Availability of alternatives to PFOS for this activity.
  • Achievable timeline for your company to complete a phase-out, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

Import, manufacture, use, sale and offer for sale of PFOS or a product containing it if it is designed for use in photographic films, papers and printing plates.

  • Quantities of PFOS or PFOS-containing products your company manufactures, uses, sells, offers for sale or imports annually (with the unit of measurement).
  • Concentration of PFOS in the product according to SDS or lab analysis (with the unit of measurement).
  • Availability of alternatives to PFOS for this activity.
  • Achievable timeline for your company to complete a phase-out, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

Use of AFFF in fire-fighting that contains residual levels of PFOS at a maximum concentration of 10 ppm.

  • Quantity of AFFF contaminated with PFOS (at a maximum concentration of 10 ppm) installed and ready for use.
  • Quantity of AFFF contaminated with PFOS (at a maximum concentration of 10 ppm) in inventory in concentrate or diluted foam (with the unit of measurement).
  • Whether the AFFF contaminated with PFOS (at a maximum concentration of 10 ppm) is used during training or system testing.
  • Availability, suitability and efficiency of alternatives to PFOS for this activity.
  • Achievable timeline for your company to complete the phase-out of AFFF contaminated with PFOS (at a maximum concentration of 10 ppm), explaining significant challenges, and cost estimates.

2.2 Perfluorooctanoic acid which has the molecular formula C7F15CO2H, its salts and precursors (PFOA)

2.2.1 Background

PFOA was primarily used as water, oil and grease repellents, and also as surfactants and surface treatment agents. While PFOA was never manufactured in Canada, it was historically imported and may continue to be imported in AFFF used in fire-fighting applications, and in manufactured itemsFootnote 1 such as textiles (rugs, carpets, clothing and outdoor equipment); paper and packaging; and electrical and electronic equipment.

A Screening Assessment Report on PFOA, published in August 2012, concluded that PFOA, its salts and its precursors are entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. In addition, it is concluded that PFOA and its salts are extremely persistent and meet the criteria for persistence as set out in the Persistence and Bioaccumulation Regulations. PFOA and its salts do not meet the criteria for bioaccumulation as set out in the Persistence and Bioaccumulation Regulations. Nevertheless, the weight of evidence is sufficient to conclude that PFOA and its salts accumulate and biomagnify in terrestrial and marine mammals. The report also conclude that PFOA and its salts are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. Precursors of PFOA that can degrade to PFOA in the environment were not individually assessed.

The Proposed Risk Management Approach for Perfluorooctanoic Acid (PFOA), its Salts, and its Precursors and Long-Chain (C9-C20) Perfluorocarboxylic Acids (PFCAs), their Salts, and their Precursors, published in August 2012, stated that the proposed environmental objective for PFOA is to minimize release of the substances to the Canadian environment.

2.2.2 International risk management

PFOA is of concern globally due to its widespread use and its potential for long-range environmental transport. As a result, measures have been and continue to be taken by several countries.

In the United States (U.S.), a stewardship program was established in 2010 to eliminate PFOA emissions from facilities. In 2015, the United States Environmental Protection Agency (US EPA) proposed a Significant New Use Rule (SNUR) to require notification for new uses.

The EU established regulations to prohibit PFOA with minor exemptions. These regulations will come into force in 2020.

In addition, the listing of PFOA will be considered under multilateral environmental agreements, including the Stockholm Convention, for elimination. More detailed information about international risk management is available in Annex B.

2.2.3 Proposed changes to exemptions under the regulations

The regulations prohibit the manufacture, use, sale, offer for sale and import of PFOA, and products that contain it, with a limited number of exemptions.

ECCC is proposing to amend the regulations to remove the exemptions on PFOA in order to better achieve the environmental objectives.

Table 3: Current exemptions and proposed amendments to the regulations for PFOA
Current exemption Proposed amendment
Import, use, sale and offer for sale of AFFF that contains PFOA for fire-fighting. Remove this exemption as this use has been discontinued and alternatives are available globally.
Use or import of a product containing PFOA, if the product is for personal use. Remove this exemption as alternatives are available globally.

Import, use, sale and offer for sale of manufactured items containing PFOA. This includes:

  • Nano coatings
  • Surface treated paper and cardboard packaging for commercial and consumer use
  • Textiles – Outdoor applications such as awning, outdoor furniture and camping gears
  • Textiles for oil and water repellency for the protection from dangerous liquids for the protection of workers from risks to their health and safety
  • Membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment
  • Semiconductors or related electronic devices that contain fluoropolymers and/or fluoroelastomers with PFOA residues
  • Spare parts for transportation sector
Remove this exemption as alternatives are available globally for most uses.

2.2.4 Information gathering related to PFOA

In order to address remaining data gaps and understand any potential challenges faced by stakeholders, ECCC is asking for specific information related to activities currently permitted under the regulations. If your company undertakes an activity listed in Table 4, ECCC invites you to submit information identified below according to the procedure indicated in section 3 Next steps.

Table 4: Information needs for PFOA with respect to activities currently exempt under the regulations
Activity Information needs

Use of AFFF already contained in fire-fighting devices for use in fire-fighting.

  • Quantity and concentrations of AFFF already contained in fire-fighting devices.
  • Reason for the presence of PFOA in the AFFF: is it as an active ingredient or a contaminant? (may need to confirm with your supplier)
  • Availability of alternatives to PFOA for this activity.
  • Achievable timeline for your company to complete a phase-out, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

Use, sale or offer for sale, and import of AFFF for use in fire-fighting.

  • Quantities and concentration of AFFF used annually, please specify if the value provided is for concentrate or diluted foam (with the unit of measurement).
  • Quantities and concentration of AFFF currently held in stock, please specify if the value provided is for concentrate or diluted foam (with the unit of measurement).
  • Whether the AFFF also used during training or system testing.
  • Availability of alternatives to PFOA for this activity.
  • Achievable timeline for your company to complete a phase-out, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

Import or use of manufactured items made outside Canada containing PFOA, whether or not they are made from recycled material.

  • Name and description of the manufactured items imported or used.
  • Quantities of manufactured items imported or used annually (with the unit of measurement).
  • Indicate if the presence of PFOA in the manufactured item results from the use of recycled material.
  • Concentration of PFOA (with the unit of measurement) in each type of item.
  • Availability of alternatives to PFOA in these manufactured items.
  • Achievable timeline for your company to complete a phase-out, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

2.3 Long chain perfluorocarboxylic acids that have the molecular formula CnF2n+1CO2H in which 8 ≤ n ≤ 20, their salts and precursors (LC-PFCAs)

2.3.1 Background

LC-PFCAs were primarily used as water, oil and grease repellents, and also as surfactants and surface treatment agents. While LC-PFCAs were never manufactured in Canada, they were historically imported and may continue to be imported in AFFF used in fire-fighting applications, and in manufactured items such as textiles (rugs, carpets, clothing and outdoor equipment); paper and packaging; and electrical and electronic equipment.

A Screening Assessment Report on LC-PFCAs, published in August 2012, concluded long-chain (C9-C20) PFCAs, their salts and their precursors are entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. In addition, it is concluded that long-chain (C9-C20) PFCAs and their salts are extremely persistent and meet the criteria for persistence as set out in the Persistence and Bioaccumulation Regulations. Long-chain (C9-C20) PFCAs do not meet the criteria for bioaccumulation as set out in the Persistence and Bioaccumulation Regulations. Nevertheless, the weight of evidence is sufficient to conclude that long-chain (C9-C20) PFCAs and their salts accumulate and biomagnify in terrestrial and marine mammals. LC-PFCAs were not assessed with regards to human health.

The Proposed Risk Management Approach for Perfluorooctanoic Acid (PFOA), its Salts, and its Precursors and Long-Chain (C9-C20) Perfluorocarboxylic Acids (PFCAs), their Salts, and their Precursors, published in August 2012, stated that the proposed environmental objective for LC-PFCAs is to minimize release of the substances to the Canadian environment.

2.3.2 International risk management

LC-PFCAs are of concern globally due to their widespread use and their potential for long-range environmental transport. As a result, measures are being considered by several countries, regional authorities (such as the EU). More detailed information about international risk management is available in Annex B.

2.3.3 Proposed changes to exemptions under the regulations

The regulations prohibit the manufacture, use, sale, offer for sale and import of LC-PFCAs, and products that contain them, with a limited number of exemptions.

ECCC is proposing to amend the regulations to remove the exemptions on LC-PFCAs in order to better achieve the environmental objectives.

Table 5: Current exemptions and proposed amendments to the regulations for LC-PFCAs
Current exemption Proposed amendment
Import, use, sale and offer for sale of AFFF that contains LC-PFCAs for fire-fighting. Remove this exemption as this use has been discontinued and alternatives are available globally.
Use or import of products containing LC-PFCAs, if the product is for personal use. Remove this exemption as alternatives are available globally.

Import, use, sale and offer for sale of manufactured items4 containing LC-PFCAs. This includes:

  • Nano coatings
  • Surface treated paper and cardboard packaging for commercial and consumer use
  • Textiles – Outdoor applications such as awning, outdoor furniture and camping gears
  • Textiles for oil and water repellency for the protection from dangerous liquids for the protection of workers from risks to their health and safety
  • Membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment
  • Semiconductors or related electronic devices that contain fluoropolymers and/or fluoroelastomers with PFOA residues
  • Spare parts for transportation sector
Remove this exemption as alternatives are available globally for most uses.

2.3.4 Information gathering related to LC-PFCAs

In order to address remaining data gaps and understand any potential challenges faced by stakeholders, ECCC is asking for specific information related to activities currently permitted under the regulations. If your company undertakes an activity listed in Table 6, ECCC invites you to submit information identified below according to the procedure indicated in section 3 Next steps.

Table 6: Information needs for LC-PFCAs with respect to activities currently exempt under the regulations
Activity Information needs

Use of AFFF already contained in fire-fighting devices for use in fire-fighting.

  • Quantity of AFFF that contains LC-PFCAs already contained in fire-fighting devices.
  • Reason for the presence of LC-PFCAs in the AFFF: is it as an active ingredient or a contaminant? (may need to confirm with your supplier)
  • Availability of alternatives to LC-PFCAs for this activity.
  • Achievable timeline for your company to complete a phase-out, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

Use, sale or offer for sale, and import of AFFF for use in fire-fighting.

  • Quantities and concentration of AFFF used annually, please specify if the value provided is for concentrate or diluted foam (with the unit of measurement).
  • Quantities and concentration of AFFF currently held in stock, please specify if the value provided is for concentrate or diluted foam (with the unit of measurement).
  • Whether the AFFF also used during training or system testing.
  • Availability of alternatives to LC-PFCAs for this activity.
  • Achievable timeline for your company to complete a phase-out, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

Import or use of manufactured items made outside Canada containing LC-PFCA, whether or not they are made from recycled material.

  • Name and description of the manufactured items imported or used.
  • Quantities of manufactured items imported or used annually (with the unit of measurement).
  • Indicate if the presence of LC-PFCAs in the manufactured item results from the use of recycled material.
  • Concentration of LC-PFCAs (with the unit of measurement) in each type of item.
  • Availability of alternatives to LC-PFCAs in these manufactured items.
  • Achievable timeline for your company to complete a phase-out, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

2.4 Four new fluorotelomer-based substances

2.4.1 Background

The four new fluorotelomer-based substances identified in the regulations are precursors to LC-PFCAs. They were never manufactured in Canada although they may have been imported and may continue to be imported within manufactured items.

Fluorotelomer-based substances are commonly used in water, oil, soil and grease repellents for fabric, leather, rugs and carpets, as well as stone and tile; in sizing agents (to resist the spreading and penetration of liquids) for packaging and paper products; and in levelling agents (to provide an even surface) for coatings.

The four new fluorotelomer-based substances were assessed under the New Substances Notification Regulations. The assessments indicated that the four fluorotelomer-based substances are ultimately sources of PFCAs through the release of precursors. The decision to prohibit these substances was a precautionary and preventative measure. These four fluorotelomer-based substances are considered to meet the criteria set out in section 64 of CEPA as they may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity; and constitute or may constitute a danger in Canada to human life or health.

2.4.2 International risk management

LC-PFCAs and their precursors, such as the four new fluorotelomer-based substances, are of concern globally due to their widespread use and their potential for long-range environmental transport. As a result, measures considered for LC-PFCAs also target their fluorotelomer precursors. More detailed information about international risk management is available in Annex B.

2.4.3 Proposed changes to exemptions under the regulations

The regulations prohibit the manufacture, use, sale, offer for sale and import of the four new fluorotelomer-based substances, and products that contain them, with a limited number of exemptions.

Because the four new fluorotelomer-based substances are precursors to LC-PFCAs, ECCC is proposing to remove the separate listing for these substances in the regulations and consolidate the regulatory requirements under the LC-PFCAs. As a result, the current exemption for the import, use, sale and offer for sale of manufactured items containing any of the four fluorotelomer-based substances would be removed because alternatives are available globally for most uses.

2.4.4 Information gathering related to the four new fluorotelomer-based substances

In order to address remaining data gaps and understand any potential challenges faced by stakeholders, ECCC is asking for specific information related to activities currently permitted under the regulations. If your company undertakes an activity listed in Table 7, ECCC invites you to submit information identified below according to the procedure indicated in section 3 Next steps.

Table 7: Information needs for the four new fluorotelomer-based substances with respect to the activity currently exempt under the regulations
Activity Information needs

Import or use of manufactured items made outside Canada containing any of the four new fluorotelomer-based substances, whether or not they are made from recycled material.

  • Name and description of the manufactured items imported or used.
  • Quantities of manufactured items imported or used annually (with the unit of measurement).
  • Indicate if the presence of any of the four fluorotelomer-based substances in the manufactured item results from the use of recycled material.
  • Concentration of the fluorotelomer-based substance(s) (with the unit of measurement) in each type of item.
  • Availability of alternatives to fluorotelomer-based substances in these manufactured items.
  • Achievable timeline for your company to complete a phase-out, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

2.5 Hexabromocyclododecane (HBCD)

2.5.1 Background

HBCD is a brominated flame retardant. There is more than one Chemical Abstract Service (CAS) number that applies to this substance.

The only known intentional use of HBCD in products in Canada is within the automotive sector. HBCD may also be present in products made from recycled plastics including toys. HBCD has also been used historically in expanded and extruded polystyrene foam used in the building and construction industry, and in electronics.

A Screening Assessment Report published in November 2011 concluded that HBCD is entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. The report also concluded that HBCD is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. In addition, HBCD meets the criteria for persistence and bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations.

The Proposed Risk Management Approach for HBCD, also published in November 2011, stated that the ultimate environmental objective for HBCD is virtual elimination of releases into the environment. According to CEPA, virtual elimination means, in respect of a toxic substance released into the environment as a result of human activity, the ultimate reduction of the quantity or concentration of the substance in the release.

2.5.2 International risk management

The EU, U.S., Japan and China have taken risk management actions for HBCD.

Within the EU, the production, import and use of HBCD and articles containing HBCD above 100 ppm is prohibited.

In the U.S., companies must notify the U.S. EPA ninety days prior to manufacture, import, or processing of HBCD in consumer textiles (except for use in motor vehicles) or in textile articles. Additionally, certain U.S. states have regulations for HBCD. For instance, in Minnesota and Washington, there is a limit of 1000 ppm for HBCD contained in residential upholstered furniture and children’s products. In California, flame retardants including HBCD contained in certain upholstered furniture must be labelled.

Japan and China also have prohibited the production, use and import of HBCD. China however, permits the use of HBCD in expanded and extruded polystyrene foam for building applications until December 2021.

More detailed information about international risk management is available in Annex B.

2.5.3 Proposed changes to exemptions under the regulations

The regulations prohibit the import, manufacture, use, sale and offer for sale of HBCD, and expanded and extruded polystyrene foam and their intermediary products containing HBCD for building or construction applications only, with a limited number of exemptions.

ECCC is proposing to amend the regulations to prohibit the import, manufacture, use, sale and offer for sale of all products containing HBCD.

2.5.4 Information gathering related to HBCD

In order to address remaining data gaps and understand any potential challenges faced by stakeholders, ECCC is asking for specific information related to activities currently permitted under the regulations. If your company undertakes an activity listed in Table 8, ECCC invites you to submit information identified below according to the procedure indicated in section 3 Next steps.

Table 8: Information needs for HBCD
Type of product Information needs
Products made from recycled materials containing HBCD
  • The names and descriptions of products made from recycled materials containing HBCD your organization uses, sells, offers for sale or imports annually.
  • The quantity of each product made from recycled materials containing HBCD your organization uses, sells, imports or recycles annually.
  • The concentration of HBCD in each product.
    • What are the trends? Have levels increased, decreased or stayed the same?
  • Potential releases associated with this usage of HBCD in each type of product.
  • Availability of recycled materials without HBCD.
  • Achievable timeline for your company to complete a phase-out, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.
Products containing HBCD
  • The names and description of products containing HBCD your organization use, sell, offer for sale or import annually.
  • The quantity of each product containing HBCD your organization uses, sells or imports annually.
  • The concentration of HBCD in each product.
    • What are the trends? Have levels increased, decreased or stayed the same?
  • Potential releases associated with this usage of HBCD for each product.
  • Availability of alternative to HBCD for each product.
  • Achievable timeline for your company to complete a phase-out, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

2.6 Polybrominated diphenyl ethers (PBDEs)

2.6.1 Background

PBDEs are brominated flame retardants used in a variety of products, such as electronics and furniture. There are seven PBDE congener groups that have been assessed by ECCC and Health Canada (see Table 9). PBDEs have generally been sold in three commercial mixtures (PentaBDE, OctaBDE and DecaBDE) that each contain different amounts of the seven PBDE congener groups.

Table 9:  PBDE congener groups that have been assessed by ECCC and Health Canada
PBDE CAS No.a Molecular Formula
tetrabromodiphenyl ethers (tetraBDE) 40088-47-9 C12H6Br4O
pentabromodiphenyl ethers (pentaBDE) 32534-81-9 C12H5Br5O
hexabromodiphenyl ethers (hexaBDE) 36483-60-0 C12H4Br6O
heptabromodiphenyl ethers (heptaBDE) 68928-80-3 C12H3Br7O
octabromodiphenyl ethers (octaBDE) 32536-52-0 C12H2Br8O
nonabromodiphenyl ethers (nonaBDE) 63936-56-1 C12HBr9O
decabromodiphenyl ethers (decaBDE) 1163-19-5 C12Br10O

a The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society

PentaBDE and OctaBDE are no longer intentionally added to manufactured items, imported into Canada. DecaBDE is still used within certain manufactured items such as automotive parts and pallets used for the transportation of goods. Any of the seven PBDE congener groups may also be present within manufactured items made from recycled plastics containing PBDEs, such as pens, shredders, staplers, and wire spools.

A  Screening Assessment Report on PBDEs, published in June 2006, concluded tetraBDE, pentaBDE, hexaBDE, heptaBDE, octaBDE, nonaBDE and decaBDE, are entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity and thus meets the criteria under paragraph 64(a) of CEPA. Based on considerations of potential contribution to atmospheric processes, it is also concluded that PBDEs are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends, and thus do not meet the criteria under paragraph 64(b) of CEPA. The available data regarding persistence and bioaccumulation of tetraBDE, pentaBDE and hexaBDE indicate that they satisfy the criteria outlined in the Persistence and Bioaccumulation Regulations of CEPA.

An Ecological State of the Science Report on decaBDE, published in August 2010, concluded that decaBDE may transform into tetraBDE, pentaBDE and hexaBDE, in organisms and the environment.

A Human Health State of Science Report on PBDEs, published in June 2006, concluded that levels of human exposure were expected to be low. A Human Health State of the Science Report on decaBDE, published in December 2012, concluded that margins of human exposure were considered adequate. TetraBDE, pentaBDE and hexaBDEs meet the conditions set out in CEPA for mandatory addition to the Virtual Elimination List. The Risk Management Strategy for PBDEs, published in August 2010, stated that the environmental objective for all seven PBDE congener groups is to reduce the concentrations of PBDEs in the Canadian environment to the lowest level possible.

2.6.2 International risk management

The US, EU, Norway, China, South Korea and India have taken risk management actions for PBDEs. These are described below and are being considered as the proposed amendments to the regulations are developed.

The EU prohibits tetraBDE, pentaBDE, hexaBDE and heptaBDE in articles above a concentration of 10 ppm with some exceptions, including articles made from recycled materials having a concentration up to 1000 ppm and electrical and electronic equipment having a concentration up to 1000 ppm. For octaBDE and decaBDE, the EU prohibits articles above a concentration of 1000 ppm. For decaBDE, the EU provides specific exemptions for the automotive and aerospace sectors. In addition to these regulations (details provided in Annex B), the EU has published a proposal for decaBDE that would prohibit decaBDE in articles above a concentration of 10 ppm with exemptions for aircraft, vehicles and electronics.

The US EPA issued a SNUR in 2006 to phase out pentaBDE and octaBDE. For decaBDE, manufacturers have voluntarily stopped production in the U.S. Under the 2016 Lautenberg Act, the US EPA must propose actions to reduce exposure to DecaBDE by June 2019. Certain states, such as California, Michigan, New York, Oregon and Rhode Island, have prohibitions on articles having PentaBDE, OctaBDE or DecaBDE concentration above 1000 ppm. Examples of articles covered include televisions, computers and residential upholstered furniture.

China, Korea and India have regulations that limit the use of PBDEs in electrical and electronic equipment to 1000 ppm.

More detailed information about international risk management is available in Annex B.

2.6.3 Proposed changes to exemptions under the regulations

The regulations prohibit the manufacture, use, sale, offer for sale and import of PBDEs and products containing them, with a limited number of exemptions.

ECCC is proposing to amend the regulations to remove the exemptions on PBDEs (except decaBDE) in order to better achieve their environmental objectives. For decaBDE, an exemption for spare automotive parts would be granted until 2036. This would align the amended Regulations with the exemption provided under the Stockholm Convention and would include various categories such as powertrain and under-hood components, fuel system applications, pyrotechnical devices and applications affected by pyrotechnical devices, suspension and interior applications, reinforced plastics, electrical and electronic equipment and fabrics.

Table 10: Current exemptions and proposed amendments to the regulations for PBDEs
Substance Current exemption Proposed amendment
PBDE (except decaBDE) Import, manufacture, use, sale and offer for sale of PBDE in manufactured items. Remove this exemption as this use has been discontinued and alternatives are available globally.
decaBDE Import, manufacture, use, sale and offer for sale of PBDE in manufactured items. Import, manufacture, use, sale and offer for sale of decaBDE in spare parts for vehicles until 2036 consistent with the exemption provided by the listing to the Stockholm convention for decaBDE.

2.6.4 Information gathering related to PBDEs

In order to address remaining data gaps and understand any potential challenges faced by stakeholders, ECCC is asking for specific information related to activities currently permitted under the regulations. If your company is involved with manufactured items listed in Table 11, ECCC invites you to submit information identified below according to the procedure indicated in section 3 Next steps.

Table 11: Information needs for PBDEs
Type of manufactured item Information needs
Manufactured items made outside Canada from recycled materials containing PBDEs, except pallets
  • Names and descriptions of manufactured items made from recycled materials containing PBDEs your company uses, sells, offers for sale or imports annually.
  • Quantity of each manufactured item containing PBDEs your company uses, sells or imports annually.
  • Concentration of each PBDE congener group in each manufactured item.
    • What are the trends? Have levels increased, decreased or stayed the same?
  • Potential releases associated with using PBDEs in each manufactured item.
  • Availability of recycled materials without PBDEs.
  • Achievable timeline for your company to complete a phase-out of manufactured items containing PBDEs, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.
PBDEs in other manufactured items
  • Names and description of manufactured items your organization uses, sells, offers for sale or imports annually.
  • Quantity of each manufactured item containing PBDEs your organization uses, sells or imports annually.
  • Concentration of each PBDE congener group in each type of manufactured item.
    • What are the trends? Have levels increased, decreased or stayed the same?
  • Potential releases associated with using PBDEs in each type of manufactured item.
  • The availability of alternatives to PBDEs for each manufactured item.
  • Achievable timeline for your company to complete a phase-out of PBDEs, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives
Pallets containing PBDEs
  • Quantities of pallets containing PBDEs your organization uses, sells, offers for sale or imports annually.
  • Concentration of each PBDE congener group in the pallets.
    • What are the trends? Have levels increased, decreased or stayed the same?
  • Potential releases associated with using pallets containing PBDEs.
  • Availability of alternatives pallets without PBDEs.
  • Achievable timeline for your company to complete a phase-out of PBDEs, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.
Military equipment containing PBDEs
  • The names and description of military equipment containing PBDEs your organization uses, sells, offers for sale or import annually.
  • Quantity of each military equipment containing PBDEs your organization uses, sells or imports annually.
  • The concentration of each PBDE congener group in each type of military equipment.
    • What are the trends? Have levels increased, decreased or stayed the same?
  • Potential releases associated with this usage of PBDEs in each type of military equipment.
  • The availability of alternatives to PBDEs in each type of military equipment.
  • Achievable timeline for your company to complete a phase-out of equipment containing PBDEs, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

2.7 Dechlorane plus (DP)

2.7.1 Background

DP is a substance within the Certain Organic Flame Retardants Substance Grouping under the Chemical Management Plan (CMP), which includes ten organic substances having a similar function: the application to materials to slow the ignition and spread of fire.

Based on responses to a survey conducted under section 71 of CEPA, DP imports to Canada ranged from 1 000 to 10 000 kg in 2011 and 2016, for use as an additive flame retardant. Known international uses of DP include applications in wire and cable jacketing, electronics, appliances, automobiles, hard plastic connectors, and plastic roofing materials. Similar uses are known or expected in Canada.

A draft screening assessment report for DP, published in October 2016, proposed to conclude that DP is entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity, or that constitute or may constitute a danger to the environment on which life depends. Additionally, it was proposed that DP meets both the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. Based on the available information on its potential to cause harm to human health, it was proposed to conclude that DP is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

A Risk Management Scope for DP, published in October 2016, stated that the proposed environmental objective for DP is to reduce its concentrations in the Canadian environment to the greatest extent practicable, taking into account social, economic and technical matters.

2.7.2 Domestic and international risk management

In the U.S., DP is listed under the Toxic Substances Control Act (TSCA) inventory and is subject to the Chemical Data Reporting Rule, which requires manufacturers and importers to provide the US EPA with production, import and use volumes, as well as other relevant information (e.g. facility size and location).

The European Chemical Agency (ECHA) has identified DP as a substance of very high concern (SVHC). On January 15, 2018, ECHA added DP to the Candidate List of substances of very high concern for Authorization, in accordance with Article 59(10) of the Registration, Evaluation, and Authorization of Chemicals (REACH) Regulation. DP’s inclusion on the Candidate List brings immediate obligations for suppliers, such as: supplying a safety data sheet, communicating on safe use, responding to consumer requests within 45 days, and notifying ECHA if the article they produce contains DP in quantities above one tonne per producer/importer per year and if DP is present in those articles above a concentration of 0.1% (w/w).

ECHA regularly assesses the SVHCs on the Candidate List to determine whether they should be included on the Authorization List as a priority. Authorization aims to ensure that SVHCs are progressively replaced by less dangerous substances or technologies. Once added to the Authorization List, a chemical cannot be placed on the market or used after a given date, unless an authorization is granted for a specific use or the use is exempted.

On September 5, 2018, DP was among 19 substances included in ECHA’s Draft 9th Recommendation of Priority Substances to be included in Annex XIV of the REACH Regulation (List of Substances Subject to Authorization). Recommendations will be finalized, following the conclusion of a public consultation period, closing on December 5, 2018.

2.7.3 Proposed amendments to the regulations

If the final screening assessment report, expected to be published in Spring 2019, concludes that DP meets criteria for toxicity set out in section 64 of CEPA, ECCC is proposing to amend the regulations to prohibit the manufacture, import, use, sale and offer for sale of DP and all products containing the substance.

2.7.4 Information gathering related to DP

In order to address remaining data gaps and understand any potential challenges faced by stakeholders, ECCC is asking for specific information related to DP and activities that are proposed to be managed under the regulations. If your company undertakes an activity listed in Table 12, ECCC invites you to submit information identified below according to the procedure indicated in section 3 Next steps.

Table 12: Information needs for DP
Activity Information needs

Import, use, sale, and/or offer for sale of DP or a product containing it (other than a manufactured item) for use in any application, including:

  • automobile manufacturing
  • electrical and electronic equipment (e.g. cable coatings and hard plastic connectors)
  • building and construction materials (e.g. plastic roofing)
  • Description of the specific application, including the quantity and concentration of DP, how DP is used and what products it is used in.
  • Known alternatives to DP in the application.
  • Achievable timeline for your company to complete a phase out, explaining significant challenges, cost estimates and efficiency or suitability of alternatives.
Import or use of manufactured items that contain DP
  • Name and description of the manufactured items imported or used.
  • Quantities and estimated concentrations of DP in each type of manufactured item imported or used annually (with units of measurement).
  • Known alternatives to DP in these manufactured items.
  • Achievable timeline for your company to complete a phase-out of these manufactured items, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

2.8 Decabromodiphenyl ethane (DBPDE)

2.8.1 Background

DBDPE is a substance within the Certain Organic Flame Retardants Substance Grouping under the CMP, which includes ten organic substances having a similar function: the application to materials to slow the ignition and spread of fire.

Based on responses to surveys conducted under section 71 of CEPA, as well as data from the New Substances program, DBDPE imports to Canada ranged from 1 000 to 10 000 tonnes in 2011, and from 100 - 1 000 tonnes in 2016, including DBDPE in neat form, in formulations, and in commercial products or products available to consumers. DBDPE is used in Canada as an additive flame retardant in many applications, such as plastic and rubber materials, electrical and electronic equipment, adhesives and sealants, and in the automotive, aircraft and transportation sectors.

A draft screening assessment for DBDPE, published in October 2016, proposed to conclude that DBDPE meets the criteria under paragraph 64(a) of CEPA as it is entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. However, it was proposed to conclude that DBDPE does not meet the criteria under paragraph 64(b) of CEPA as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends. DBDPE was proposed to meet the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations (Canada 2000). However, DBDPE may contribute to the formation of persistent, bioaccumulative, and inherently toxic transformation products, such as lower brominated diphenyl ethanes (BDPEs), in the environment.

A Risk Management Scope for DBDPE, published in October 2016, stated that the proposed environmental objective for DBDPE is to reduce its concentrations in the Canadian environment to the greatest extent practicable, taking into account social, economic and technical matters.

2.8.2 Domestic and international risk management

DBDPE has been in commerce in Canada since 1994 (i.e. between the establishment of the Domestic Substances List (DSL) on January 1, 1987 and the coming into force of the New Substance Notification Regulations (Chemicals and Polymers) on July 1, 1994). As such, DBDPE is not listed on the DSL, and is presently subject to the New Substance Notification Regulations (Chemicals and Polymers) (NSNR) pursuant to CEPA.

Ecological and human health risk assessments completed under the New Substances program indicated this substance was suspected of being toxic for ecological concerns, as per paragraph 64(a) of CEPA. As a result, Ministerial Conditions under CEPA have been imposed on DBDPE to mitigate potential risks to the environment.

There are several Ministerial Conditions currently in force for DBDPE that apply only to specific stakeholders. These Conditions limit the import of the substance for specific use and impose restrictions on its handling and disposal in industrial settings. The Ministerial Conditions for DBDPE do not apply to stakeholders who submitted high volume notifications prior to the coming into force of the NSNR.

In the U.S., DBDPE is listed as a new chemical under the TSCA inventory. DBDPE is also subject to a SNUR. Under the SNUR, persons are required to submit a significant new use notice to the U.S. EPA at least 90 days before they manufacture, import or process DBDPE for industrial, commercial and consumer activities. However, the requirements of the SNUR do not apply once DBDPE has been incorporated into a resin, therefore a significant new use notice is not required to manufacture or import a resin incorporated with DBDPE. Additionally, export notification to the US EPA is required for DBDPE as a chemical substance or in a mixture.

In the EU, DBDPE was identified in 2012 for immediate evaluation as part of the Community Rolling Action Plan (CoRAP) under the REACH Regulation. REACH makes industry responsible for assessing and managing the risks posed by chemicals and providing appropriate safety information to their users. The addition of DBDPE to the CoRAP substance list required the designated Member State to complete the evaluation of DBDPE within 12 months. The evaluation recommended that additional information be submitted by industry to identify if DBDPE transformed into products that could be persistent, bioaccumulative and inherently toxic. Testing results are expected in 2019.

2.8.3 Proposed amendments to the regulations

If the final Screening Assessment Report, expected to be published in Spring 2019, concludes that DBDPE meets criteria for toxicity set out in section 64 of CEPA, ECCC is proposing to amend the regulations to prohibit the manufacture, import, use, sale and offer for sale of DBDPE and all products containing the substance.

2.8.4 Information gathering related to DBDPE

In order to address remaining data gaps and understand any potential challenges faced by stakeholders, ECCC is asking for specific information related to the DBDPE and activities that are proposed to be managed under the regulations. If your company undertakes an activity listed in Table 13, ECCC invites you to submit information identified below according to the procedure indicated in section 3 Next steps.

Table 13: Information needs for DBDPE
Activity Information needs

Import, use, sale, and/or offer for sale of DBDPE or a product containing it (other than a manufactured item) for use in any applications, including:

  • adhesives and sealants
  • automotive, aircraft and transportation
  • basic organic chemical manufacturing
  • electrical and electronic equipment
  • plastic and rubber materials
  • Description of the specific application, including the quantity and concentration of DBDPE, how DBDPE is used and what products it is used in.
  • Known alternatives to DBDPE in the application.
  • Achievable timeline for your company to complete a phase out, explaining significant challenges, cost estimates and efficiency or suitability of alternatives.
Import or use of manufactured items which contain DBDPE.
  • Name and description of the manufactured items imported or used.
  • Quantities and estimated concentrations of DBDPE in each type of manufactured item imported or used annually (with units of measurement).
  • Known alternatives to DBDPE in these manufactured items.
  • Achievable timeline for your company to complete a phase-out of these manufactured items, explaining significant challenges, cost estimates, and efficiency or suitability of alternatives.

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