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Consultation document on the risk management of short-chain, medium-chain and long-chain chlorinated alkanes

Executive summary

A screening assessment of short-chain chlorinated alkanes (SCCAs), medium-chain chlorinated alkanes (MCCAs) and long-chain chlorinated alkanes (LCCAs) up to 20 carbon atoms concluded that these groups of substances meet criteria for toxicity set out under the Canadian Environmental Protection Act, 1999 (CEPA). Subsequently, SCCAs were prohibited through the Prohibition of Certain Toxic Substances Regulations, 2012. This consultation document intends to (1) inform stakeholders and solicit comments on the proposed regulatory approach to prohibit the manufacture, import, use and sale of MCCAs and LCCAs up to 20 carbon atoms, and products containing them through their addition to the Prohibition of Certain Toxic Substances Regulations, 2012; (2) solicit information regarding concentration thresholds for SCCAs and MCCAs; and (3) outline and solicit comments on the proposed regulatory approach to control the exports of SCCAs, MCCAs and LCCAs up to 20 carbon atoms through their addition to the Export Control List (ECL) in Schedule 3 to CEPA. Comments received will be considered in the development of proposed regulatory instruments.

Table of contents

1. Background

Chlorinated alkanes (CAs), also referred to as chlorinated paraffins, are chlorinated hydrocarbons (n-alkanes) with carbon chain lengths ranging from 10 to 38 carbon atoms and varying chlorine contents (Environment Canada and Health Canada, 2008a). Short-chain chlorinated alkanes (SCCAs) have carbon chains containing 10-13 carbon atoms, medium-chain chlorinated alkanes (MCCAs) have carbon chains containing 14-17 carbon atoms, and long-chain chlorinated alkanes (LCCAs) have carbon chains containing 18 or more carbon atoms. Known uses of SCCAs include metalworking fluids, plastics and rubbers, flame retardants, paints and coatings, and adhesives and sealants. Known uses of MCCAs and LCCAs in Canada include uses in metalworking fluids, rubber/elastomers, adhesives and sealants, paints and coatings, polyvinyl chloride, inks and air filters.

In August 2008, a final follow-up assessment report published by Environment and Climate Change Canada (ECCC) and Health Canada concluded that CAs containing up to 20 carbon atoms 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 and meet the definition of “toxic” under paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA) (Environment Canada and Health Canada, 2008a). CAs that have the molecular formula CnHxCl(2n+2–x) in which 10 ≤ n ≤ 20 were added to Schedule 1 to CEPA in 2011 based on the conclusions of this assessment (GoC, 2011). In addition, based on that report and a 2012 Update on the Human Health Assessment for LCCAs, it was concluded that SCCAs and MCCAs are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health and therefore meet the criteria under paragraph 64(c) of CEPA (Environment Canada and Health Canada, 2008a). Furthermore, CAs up to 20 carbon atoms meet the criteria for persistence and bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations and were recommended for virtual elimination. Under Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act, the virtual elimination provisions were repealed and replaced with a new regime that remains risk-based but provides that toxic substances of highest risk should be managed by giving priority to prohibition.

1.1 Stockholm and Rotterdam Conventions

Canada is a Party to the Stockholm Convention on Persistent Organic Pollutants (the Stockholm Convention). The objective of the Stockholm Convention is to protect human health and the environment from persistent organic pollutants (POPs). POPs are organic substances that have a combination of harmful characteristics. POPs remain in the environment for long periods, cause adverse effects to the environment and/or human health, have the potential to migrate long distances and tend to accumulate in northern climates.

In 2017, SCCAs, known as short-chain chlorinated paraffins (SCCPs) under the Stockholm Convention, were listed to Annex A, for elimination with time-limited specific exemptions. Parties to the Convention must take measures to eliminate the production, use, import and export of substances listed under Annex A (UNEP, 2017). In the case of SCCPs, the Stockholm Convention does not apply to quantities of SCCPs occurring as unintentional trace contaminants in mixtures at concentrations less than 1% by weight.

In September 2024, the POPs Review Committee of the Stockholm Convention completed a review of MCCAs, known as medium-chain chlorinated paraffins (MCCPs) under the Convention, and decided to recommend their listing to Annex A with time-limited specific exemptions (UNEP, 2024). The Committee also decided to recommend that the Convention not apply to quantities of MCCPs occurring as unintentional trace contaminants in substances or mixtures at concentrations less than 3% by weight. The Conference of the Parties to the Stockholm Convention will consider listing MCCPs at its twelfth meeting in April/May 2025. As a Party to the Convention, Canada aims to align its domestic regulatory measures with listings to the Stockholm Convention in the best possible timeframe. The Prohibition of Certain Toxic Substances Regulations, 2012 (the Regulations) enable the implementation of Canada’s obligations for industrial chemicals under the Stockholm Convention, and consultation with Canadian stakeholders will both inform Canada’s position for the MCCPs listing, and proposed domestic risk management in the Canadian context.

The Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (the Rotterdam Convention) aims to promote shared responsibility and cooperative efforts among Parties in the international trade of certain hazardous chemicals in order to protect human health and the environment from potential harm and to contribute to the environmentally sound use of those hazardous chemicals, by facilitating information exchange about their characteristics, providing for a national decision-making process on their import and export and disseminating these decisions to Parties.

The Rotterdam Convention imparts obligations for exports of substances listed in Annex III to the Convention as well as substances subject to domestic controls that prohibit or severely restrict their use. Substances listed in Annex III to the Rotterdam Convention are subject to the Prior Informed Consent procedure, which requires the consent of the importing country. For substances that are subject to a domestic prohibition or severe restrictions and that are not listed in Annex III to the Rotterdam Convention, Canada is obligated to provide a notification of export to importing Parties prior to the export.

SCCAs, or SCCPs as they are referred to under the Rotterdam Convention, were listed to Annex III to the Rotterdam Convention in 2017.

2. Domestic risk management

In August 2008, ECCC and Health Canada published the Proposed Risk Management Approach for Chlorinated Alkanes (Environment Canada and Health Canada, 2008b). The Risk Management Approach outlined that the human health objective for the management of CAs is to minimize human exposure to the extent practicable and that the environmental objective for the management of CAs up to 20 carbon atoms is virtual elimination. The proposed risk management objective for CAs up to 20 carbon atoms is to reduce their releases to the lowest level possible from all sources and prevent the re-introduction of their manufacture in Canada.

SCCAs were added to the Prohibition of Certain Toxic Substances Regulations, 2012 (the Regulations) in 2013. The Regulations prohibit the manufacture, use, sale, offer for sale or import of SCCAs and products containing SCCAs unless they are incidentally present.

Since 1999, on-site environmental releases of CAs used as an industrial chemical in Canada must be reported to the National Pollutant Release Inventory (NPRI) by companies meeting the reporting criteria. At this time, any person who owns or operates a facility described in Schedule 3 to the Notice with respect to the substances in the National Pollutant Release Inventory for 2022, 2023 and 2024 (including MCCAs and LCCAs up to 20 carbon atoms), and who possesses or who may reasonably be expected to have access to information described in Schedule 4 to the Notice, shall provide the Minister of the Environment with this information (Environment and Climate Change Canada, 2020).

ECCC has also developed Federal Environmental Quality Guidelines for Chlorinated Alkanes in various environmental media, including water, fish tissue, sediment, and mammalian wildlife diet (Environment and Climate Change Canada, 2016).

3. International risk management

3.1 United States

The United States Environmental Protection Agency (US EPA) added the category of polychlorinated alkanes to its list of toxic chemicals subject to Toxics Release Inventory reporting based on available carcinogenicity and ecotoxicity data for short-chain species.

In December 2014, the US EPA issued a Significant New Use Rule (SNUR) under the Toxic Substances Control Act for SCCAs. The SNUR requires manufacturers, importers and processors of the chemical to notify the US EPA before starting or resuming new uses of the chemical. Notifications under the SNUR allow the US EPA to evaluate the intended uses and manage risks associated with the uses if necessary (US EPA, 2024).

In 2019, a final SNUR for MCCAs and LCCAs up to 20 carbon atoms was published (ECFR, 2019). This was a result of the US EPA’s assessment of several pre-manufacturing notices (PMN) submitted for these substances.

3.2 European Union

SCCAs were identified as Substances of Very High concern and added to the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations in 2009 (ECHA, 2009) and are subject to the EU Persistent Organic Pollutants (POPs) regulations. Their use is therefore broadly prohibited barring certain exemptions, including an exemption for the manufacturing, placing on the market and use of substances or mixtures containing SCCAs in concentrations lower than 1% by weight or articles containing SCCAs in concentrations lower than 0.15% by weight.

In the EU, MCCAs are classified according to the Globally Harmonized System criteria provided under Regulation No 1272/2008 on classification, labelling and packaging of substances and mixtures. In July 2021, MCCAs were identified as Substances of Very High Concern and added to the REACH Candidate List, due to their persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) properties.

The EU is currently in the process of proposing restrictions for MCCAs under Annex XVII of the REACH regulation. The Committee for Risk Assessment and Committee for Socio-Economic Analysis final opinions to restrict MCCAs were published in September 2023, which included a proposed threshold of 0.1% by weight for MCCAs in substances, mixtures, and articles (ECHA, 2023a).

In 2023, ECHA issued a Decision on a Compliance Check that requires registrants of LCCAs to provide the following information by September 2026: in vitro gene mutation studies in bacteria; growth inhibition studies in aquatic plants; and long-term toxicity testing on aquatic invertebrates (ECHA, 2023b).

3.3 Other jurisdictions

In the United Kingdom (UK), the manufacture, sale and use of products containing SCCAs are prohibited unless the concentration is below 1% by weight for substances or preparations, or below 0.15% by weight for articles (Environment Agency, 2024). MCCAs were assessed and concluded to meet UK REACH Annex XIII criteria (Environment Agency, 2019), which outlines the criteria for the identification of PBT and vPvB substances (Government of the United Kingdom, 2020). Furthermore, LCCAs are listed on the UK REACH rolling action plan for substance evaluation due to a PBT concern (HSE, 2022).

In Australia, the import, manufacture and export of SCCAs is prohibited with limited exemptions (Government of Australia, 2024). MCCAs were assessed and concluded to meet PBT criteria (NICNAS, 2020). In addition, this substance is listed on the Australian Hazardous Chemical Information System as hazardous to the aquatic environment (acute) and hazardous to the aquatic environment (chronic).

4. Proposed Risk Management

4.1 Proposed prohibition of MCCAs and LCCAs up to 20 carbon atoms

The 2008 Final Follow-Up Report and the 2012 Update on the Human Health Assessment for LCCAs conclude that MCCAs meet criteria for toxicity set out in paragraphs 64 (a) and (c) of CEPA and that LCCAs up to 20 carbon atoms meet the criteria for toxicity set out in paragraph 64 (a) of CEPA. Releases to the environment of these substances are associated with anthropogenic activities. MCCAs and LCCAs up to 20 carbon atoms are used in certain industrial applications and consumer goods, providing opportunities for potential widespread and continuous release into the Canadian environment and/or exposure to humans.

As a result, ECCC is proposing to prohibit the manufacture, use, sale and import of MCCAs and LCCAs up to 20 carbon atoms, and products containing these substances, under the Prohibition of Certain Toxic Substances Regulations, 2012 (the Regulations). Exemptions to the prohibition will only be considered in exceptional circumstances, taking into account relevant information on socio-economic factors, the demonstrated absence of suitable alternatives, and with consideration of the international context and environmental and human health risks. Relevant information includes information provided through this consultation. Time limited exemptions are under consideration for certain types of products, such as metalworking fluids, plastics and rubbers, certain automotive parts and adhesives and sealants. Should any exemptions be included under the Regulations, fixed time limits and specific conditions may be proposed for targeted products, and may be accompanied by reporting, record-keeping, monitoring, labelling and/or other requirements to inform the public of the presence of the substances. Stakeholders are encouraged to present relevant information to the Government of Canada. Prohibiting MCCAs and LCCAs up to 20 carbon atoms under the Regulations will require further amendments to the Regulations.

4.2 Proposed incidental presence threshold for SCCAs and MCCAs

Through previous consultations, stakeholders have requested that the Regulations include measurable and feasible incidental presence thresholds that are harmonized with other jurisdictions for listed substances. Thresholds may facilitate regulatory compliance through testing and would allow companies to specify material compositions to global suppliers. As such, and to align with international agreements and other international jurisdictions, incidental presence thresholds are being considered for the Regulations for SCCAs and MCCAs, below which the prohibition would not apply. For SCCAs, a threshold of 1% by weight in substances and products that are not manufactured items, and 0.15% by weight in products that are manufactured items is proposed. For MCCAs, a threshold of 0.1% by weight is proposed for substances and all products, including manufactured items. The proposed incidental presence thresholds are in alignment with the thresholds established by the E.U. At this time, insufficient information is available to propose a threshold for LCCAs up to 20 carbon atoms. As information becomes available thresholds for these substances may also be considered.

4.3 Proposed addition of SCCAs, MCCAs, and LCCAs up to 20 carbon atoms to the Export Control List

The Export of Substances on the Export Control List Regulations (ESECLR) establish export controls on substances restricted in Canada and implement export obligations under international agreements, such as the Stockholm Convention and Rotterdam Convention. These export controls apply to substances identified on the Export Control List (ECL), as well as mixtures and products containing them.

The ECL contains substances grouped in three parts:

The procedures for exporting a substance vary depending on the part of the ECL to which the substance is listed and the requirements under the ESECLR.

To ensure Canada’s continued compliance with its international export obligations, ECCC is considering adding SCCAs to Part 2 of the ECL. ECCC is also considering adding MCCAs and LCCAs up to 20 carbon atoms to Part 3 of the ECL. When domestic controls on the use of substances are being developed in Canada, ECCC assesses whether these measures would be considered a prohibition or severe restriction under the Rotterdam Convention and whether they would trigger export obligations. This assessment is ongoing throughout the regulatory development process, to ensure that decisions to list substances on the ECL are based on the final risk management measures.

5. Information gathering

A Notice with respect to certain chemicals under the Chemicals Management Plan - 2023 was published under section 71 of CEPA in Canada Gazette, Part I, in June 2023 requiring that any person described in sections 2 and 3 of the notice provide information required in sections 5 to 10 of the notice. This notice applied to certain MCCAs and LCCAs up to 20 carbon atoms, amongst other substances, and input was requested by January 17, 2024. The information received to date is under consideration for, and integrated into, the analysis and development of risk management actions for MCCAs and LCCAs up to 20 carbon atoms.

In order to address remaining data gaps and understand any potential challenges faced by stakeholders, ECCC is asking for information related to SCCAs, MCCAs and LCCAs up to 20 carbon atoms and activities that are proposed to be managed. If your company undertakes an activity listed in sections 5.1, 5.2 and/or 5.3 of the present document, or any other activity concerning these substances, ECCC invites you to submit information identified below according to the procedure indicated in section 6, Next Steps. Stakeholders are encouraged to present information to the Government that would help determine if time-limited exemptions are needed for certain products, uses or applications, both domestically, and in the case of MCCAs, internationally, to help industry phase-out these substances in Canada. Stakeholders are also encouraged to provide information that would help support proposed incidental presence concentration thresholds, including information that would help the Government consider a threshold for LCCAs up to 20 carbon atoms.

5.1 SCCAs

Activities for SCCAs concentration thresholds

Manufacture, import, use, sale, or export of a product that incidentally contains SCCAs (for example, in which SCCAs are a residual, trace contaminant or impurity that was not intentionally added to the formulation)

Information needs

5.2 MCCAs

Activities

Manufacture, import, use, sale, or export of MCCAs, or a product containing them, for use in any applications, including, but not limited to:

Information needs

5.3 LCCAs up to 20 carbon atoms

Activities

Manufacture, import, use, sale, or export of LCCAs up to 20 carbon atoms, or a product containing them, for use in any applications, including, but not limited to:

Information needs

6. Next Steps

6.1 Comment Period

Comments on this consultation document or information to address data gaps must be submitted no later than April 14, 2025 to the contact information below.

Comments received will be taken into consideration in the drafting of the proposed regulatory amendments to the Regulations and proposed Order amending the Export Control List in Schedule 3 to CEPA, and will inform Canada’s negotiating position for the proposed listing of MCCPs to the Stockholm Convention in April/May 2025.

Pursuant to section 313 of CEPA, any person who provides information to the Minister of the Environment under CEPA may submit with the information a written request that it be treated as confidential. Please address comments to the Chemical Management Division with the subject line “Consultation Document on the Risk Management of Chlorinated Alkanes”. Comments can be submitted by email (preferred) or mail.

By email:
interdiction-prohibition@ec.gc.ca
A confirmation email will be sent to those who submit their information and comments by email.

By mail:
Chemicals Management Division
Environment and Climate Change Canada
Place Vincent Massey 19th Floor
351 St. Joseph Boulevard
Gatineau (QC)
K1A  0H3

6.2 Planned timelines

The proposed regulatory amendments are expected to be published in the Canada Gazette, Part I, in 2026 and may include other modifications, as required.

7. References

(ECFR) Code of Federal Regulations. 2019. eCFR :: 40 CFR 721.11076 -- Alkanes, C14-17, chloro. Available from: https://www.ecfr.gov/current/title-40/chapter-I/subchapter-R/part-721/subpart-E/section-721.11076

(ECFR) Code of Federal Regulations. 2019. eCFR :: 40 CFR 721.11075 -- Alkanes, C18-20, chloro. Available from: https://www.ecfr.gov/current/title-40/chapter-I/subchapter-R/part-721/subpart-E/section-721.11075

(ECHA) European Chemicals Agency. 2008. Agreement of the Member State Committee on Identification of Alkanes, C10-13, chloro (SCCP) as a Substance of Very High Concern. Adopted on 8 October 2008. Available from: https://echa.europa.eu/documents/10162/e73faf8f-d27b-a9b2-67a8-5f6eb3afc8e3

(ECHA) European Chemicals Agency. 2009. Recommendation of the European Chemicals Agency (ECHA) of 1 June 2009 for the inclusion of substances in Annex XIV (the list of substances subject to authorisation) of Regulation (EC) No 1907/2006. Available from: https://echa.europa.eu/documents/10162/49376f1b-000a-8c75-5a93-511128b44c03

(ECHA) European Chemicals Agency. 2023a. Committee for Risk Assessment (RAC), Committee for Socio-economic Analysis (SEAC). Opinion on an Annex XV dossier proposing restrictions on Medium-chain chlorinated paraffins (MCCP) and other substances that contain chloroalkanes with carbon chain lengths within the range from C14 to C17. Available from: https://echa.europa.eu/documents/10162/3de158a7-8ab9-ba32-be7f-0125bb0174d3

(ECHA) European Chemicals Agency. 2023b. Decision on Compliance Check. 2023. Available from: https://echa.europa.eu/documents/10162/e8df9186-b2d8-f196-6418-943100d86d41

Environment Agency. 2019. Annex D: summary of UK proposal to list Chlorinated paraffins with carbon chain lengths in the range C14-17 and chlorination levels at or exceeding 45% chlorine by weight. Available from: https://www.gov.uk/government/publications/chlorinated-paraffins-with-carbon-chain-lengths-in-the-range-c14-17/annex-d-summary-of-uk-proposal-to-list-chlorinated-paraffins-with-carbon-chain-lengths-in-the-range-c14-17-and-chlorination-levels-at-or-exceeding-45

Environment Agency. 2024. Using Persistent Organic Pollutants. Available here: https://www.gov.uk/guidance/using-persistent-organic-pollutants-pops

Environment and Climate Change Canada. 2016. Canadian Environmental Protection Act, 1999: Federal Environmental Quality Guidelines Chlorinated Alkanes. Available here: https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=C4148C43-1

Environment and Climate Change Canada. 2020. Canada Gazette, Part I, Volume 154, Number 7: Notice with respect to the substances in the National Pollutant Release Inventory for 2020 and 2021. Available from: https://www.gazette.gc.ca/rp-pr/p1/2020/2020-02-15/html/sup1-eng.html

Environment Canada and Health Canada. 2008a. Canadian Environmental Protection Act, 1999: Follow-up Report on a PSL1 Assessment for Which Data Were Insufficient to Conclude Whether the Substances Were "Toxic" to the Environment and to the Human Health: Chlorinated Paraffins. Available from: http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=D7D84872-1

Environment Canada and Health Canada. 2008b. Proposed Risk Management Approach for Chlorinated Paraffins. Available from: https://ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=D048964A-1

Government of Australia. 2024. Industrial Chemicals Environmental Management (Register) Instrument 2022. Available from: https://www.legislation.gov.au/F2022L01658/latest/text

(GOC) Government of Canada. 2011. Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 Available from: https://canadagazette.gc.ca/rp-pr/p2/2011/2011-10-12/html/sor-dors212-eng.html

Government of the United Kingdom. 2020. Regulation (EC) No 1907/2006 of the European Parliament and of the Council. Available from: https://www.legislation.gov.uk/eur/2006/1907/annex/XIII

Health & Safety Executive (HSE). 2022. Justification for inclusion of a substance in the Rolling Action Plan (RAP) for UK REACH: Paraffin waxes and Hydrocarbon waxes, chloro (Long-chain chlorinated paraffins, LCCP). Available from: https://www.hse.gov.uk/reach/reports/rap/docs/rap-justification-lccp.pdf

(NICNAS) National Industrial Chemicals Notification and Assessment Scheme. 2020. Alkanes, C14-17, chloro-: Environment tier II assessment. Available from: https://www.industrialchemicals.gov.au/sites/default/files/Alkanes%2C%20C14-17%2C%20chloro-_%20Environment%20tier%20II%20assessment.pdf

(UNEP) United Nations Environment Programme. 2017. Eighth Meeting of the Conference of the Parties to the Stockholm Convention. Available from: https://www.pops.int/TheConvention/ConferenceoftheParties/Meetings/COP8/tabid/5309/Default.aspx

(UNEP) United Nations Environment Programme. 2023. Nineteenth meeting of the Persistent Organic Pollutants Review Committee (POPRC.19). Available from: https://chm.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC19/Overview/tabid/9548/Default.aspx

(UNEP) United Nations Environment Programme. 2023. United Nations Environment Programme. Stockholm Convention on Persistent Organic Pollutants (POPs). Persistent Organic Pollutants Review Committee. Draft risk management evaluation: chlorinated paraffins with carbon chain lengths in the range C14–17 and chlorination levels at or exceeding 45 per cent chlorine by weight. 9 June 2023. UNEP/POPS/POPRC.19/2. Available from: https://www.pops.int/Convention/POPsReviewCommittee/Chemicals/tabid/243/Default.aspx

(UNEP) United Nations Environment Programme. 2024. Twentieth meeting of the Persistent Organic Pollutants Review Committee (POPRC.20). Report of the Persistent Organic Pollutants Review Committee on the work of its twentieth meeting (advance). Available from: https://www.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC20/Overview/tabid/9850/Default.aspx

(US EPA) United States Environmental Protection Agency, 2024. Risk Management for Short-Chain Chlorinated Paraffins. Available from: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-short-chain-chlorinated-paraffins

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