Canada Regulatory News

On February 5, 2025, the Government of Canada registered SOR/2025-17, officially amending the Domestic Substances List (DSL) under subsection 87(3) of the Canadian Environmental Protection Act, 1999 (...

On February 5, 2025, the Government of Canada registered SOR/2025-17, officially amending the Domestic Substances List (DSL) under subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA). This amendment, entitled Order 2024-87-21-01, applies the Significant New Activity (SNAc) provisions of CEPA to the substance ethanol, 2-[(2-aminoethyl)amino]- (CAS RN 111-41-1), commonly known as AEEA.

Why Was This Order Issued?

The amendment results from Canada’s ongoing efforts under the Chemicals Management Plan (CMP), a federal initiative to assess and manage the risks posed by chemicals to human health and the environment. While AEEA was not found to be “toxic” under CEPA’s section 64 criteria during its 2016 screening assessment, it was identified as a substance of concern due to properties that could pose risks if its use increases in new applications.

To ensure that future uses of AEEA do not result in unanticipated environmental or health effects, the SNAc provisions will now be triggered if the substance is used in ways that are significantly different from those previously assessed.

What Is AEEA and How Is It Used?

AEEA does not occur naturally in the environment and is used in various industrial and commercial applications, including:

• Food packaging adhesives and inks (non-direct food contact)

• Paper manufacturing agents

• Closed-loop cooling systems

• Epoxy adhesives and corrosion inhibitors

• Asphalt paving and patching materials

• Pigments for fibers such as carpets

The substance is primarily used as a chemical intermediate and curing agent in the production of resins and sealants. In previous surveys, it was reported that over 500,000 kg of AEEA was imported into Canada, although domestic production was negligible or non-existent.

Internationally, AEEA is used in epoxy hardeners, personal care products, and industrial chemicals, particularly in the United States, Europe, Japan, and Switzerland.

What Are the New Requirements?

The SNAc provisions of CEPA require that any person (individual or corporation) who plans to engage in a significant new activity involving AEEA must submit a Significant New Activity Notification (SNAN) to the Minister of the Environment at least 90 days prior to the proposed activity.

Activities That Trigger Notification:

1. Manufacture or import of AEEA in concentrations ≥0.1% by weight in:

   • Consumer products (under the Canada Consumer Product Safety Act) sold in containers >250 ml

   • Cosmetics (as defined in the Food and Drugs Act)

2. Importing any of the above products containing AEEA if the total annual import exceeds 10 kg.

Activities Exempt from Notification:

• Use in research and development or as a site-limited intermediate

• Products intended solely for export

• Uses regulated under other Acts such as the Pest Control Products Act, Fertilizers Act, or Feeds Act

• Incidental presence in products, or substances formed as impurities or contaminants

Required Information for SNAN Submission:

Notifiers must provide detailed information about the activity and product, including:

• Description and function of the product

• Anticipated annual quantity

• Method of application and use

• Toxicological and environmental data

• Previous notifications to other government agencies

• Contact information and certification of accuracy

Once received, the Minister has 90 days to assess the submission before the activity may proceed.

Impact on Stakeholders and Industry

This Order does not affect currently authorized uses of AEEA in Canada. It only applies to new or modified uses that may increase the risk of exposure. Businesses using AEEA in previously assessed activities are not subject to any new regulatory obligations under this amendment.

For new uses, the SNAN process ensures pre-market review to prevent environmental or public health risks. This requirement is consistent with similar policies in international jurisdictions and supports Canada's alignment with global chemical management practices, including cooperation with the U.S. EPA and the European Chemicals Agency (ECHA).

Regulatory Context and Consultation Process

This regulatory change follows previous Notices of Intent published in the Canada Gazette, Part I in 2016 and 2020, which allowed for public and industry consultation. A stakeholder submission in 2016 resulted in refinements in the scope of what constitutes a significant new activity. No objections were received during the second public consultation.

Compliance, Enforcement, and Guidance

The Order is effective from the day of registration (February 15, 2025). Compliance promotion efforts will include direct outreach, guidance materials, and the availability of pre-notification consultations (PNCs) to help notifiers understand and meet their obligations.

Enforcement of this Order falls under the Compliance and Enforcement Policy for CEPA, which allows for a range of measures from warnings to legal action, depending on the severity and nature of the violation.

Broader Impacts and Benefits

This regulatory action is designed to prevent potential environmental and health risks from new uses of AEEA without disrupting current, low-risk uses. The application of the SNAc provisions reflects Canada's precautionary approach to chemical safety, allowing for proactive intervention before risks arise.

A Strategic Environmental and Economic Assessment concluded that this initiative supports the objectives of the CMP and will have a positive impact on human health and the environment. No adverse impacts were identified under Gender-based Analysis Plus (GBA+) or modern treaty obligations.

On March 8, 2025, the Government of Canada published two regulatory proposals in the Canada Gazette to list boric acid, its salts and precursors, as well as certain substances in the benzotriazoles an...

On March 8, 2025, the Government of Canada published two regulatory proposals in the Canada Gazette to list boric acid, its salts and precursors, as well as certain substances in the benzotriazoles and benzothiazoles group, specifically 2-mercaptobenzothiazole (MBT) and its precursors, under Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA). The proposals follow updated risk assessments that identified potential risks to the environment and, in the case of boric acid, to human health,. The public consultations are now open, providing stakeholders with an opportunity to submit comments and additional information by May 7, 2025.

1. Boric Acid, Its Salts and Precursors: Proposed Addition to Schedule 1

Background and Scope:

The updated assessment focuses on boric acid, a common substamce of concern. It includes any boron-containing substance that can release boric acid through environmental or physiological transformation pathways. Boric acid is found naturally and is widely used in industrial and consumer applications.

Between 2017 and 2020, Canada imported 54,810 to 65,795 tonnes of boric acid-related substances annually, with significant domestic use in sectors such as:

• Insulation and engineered wood manufacturing

• Agriculture and fertilizers

• Consumer and self-care products

• Oil and gas extraction

• Waste and water treatment

Environmental Risk:

A weight of evidence approach indicates that boric acid poses a low ecological risk in most sectors. However, the metal ore processing industry presents a localized environmental risk due to aquatic releases of boric acid. A predicted no effect concentration (PNEC) of 1.5 mg B/L has been established based on Canadian Water Quality Guidelines.

Boric acid is persistent in the environment but not considered bioaccumulative or biomagnifying.

Risk to Human Health:

Canadians are exposed to boric acid from natural sources (e.g. fruits, vegetables, drinking water) and products such as cleaning agents, cosmetics, and DIY materials. Urine and blood biomonitoring data were used to assess population-level exposure.

Key findings include:

• Higher boron levels in young children and women,

• Exposure margins in some products (e.g. toys, self-care items, flame retardants) may be insufficient to protect against health risks such as reproductive toxicity (e.g., reduced testicular weight)

Conclusion:

The assessment suggests that boric acid and its related substances:

• Meet CEPA section 64(a): harmful to the environment

• Meet CEPA section 64(c): pose a risk to human health

• Do not meet section 64(b): not a threat to life-supporting environmental systems

• Meet persistence but not bioaccumulation criteria under CEPA regulati

2. Benzotriazoles and Benzothiazoles Group (Including MBT)

Overview:

The government also published its final assessment of the benzotriazoles and benzothiazoles group, which includes:

• 9 benzotriazole substances (used in UV stabilizers, lubricants, cosmetics).

• 6 benzothiazole substances (including MBT and its precursors, used in rubber and automotive products).

Key Findings:

• Benzotriazoles: Do not meet CEPA section 64 criteria; no significant environmental or health risks identified.

• Benzothiazoles (MBT and precursors):

  • Meet section 64(a): pose environmental risks.

  • Do not meet section 64(b): no threat to environmental systems.

  • Do not meet section 64(c): no current threat to human health but remain substances of concern.

MBT is identified as a Group 2A carcinogen (probably carcinogenic to humans) by the IARC. Exposure scenarios - especially in rubber manufacturing and metalworking fluids – indicate a risk to the aquatic environment. While current public exposures are not of concern, elevated levels in the future could pose health risks.

Proposed Actions:

The Ministers recommend that MBT, its salts, and chemical derivatives be added to Part 2 of Schedule 1 of CEPA. A risk management approach document is available for public comment.

How to Participate in the Consultations

For both the boric acid and MBT proposals, interested stakeholders can provide input during the open public comment period. Comments should reference the Canada Gazette, Part I, the date of publication, and include any requests for confidentiality under section 313, of CEPA if applicable.

Regulatory Implications and Follow-up

These proposals do not impose any immediate new obligations, but allow for future risk management measures, such as pollution prevention plans, restrictions, or monitoring. Substances associated with health risks but currently at safe exposure levels may be tracked to monitor commercial use and emerging risks.

The Government will use the data collected through these consultations to:

• Inform future regulatory development,

• Track trends in chemical use.

• Evaluate the effectiveness of current and proposed risk management measures.
   

On February 14, 2025, Canada published SOR/2025-27, officially listing decabromodiphenyl ethane (DBDPE) and dechlorane plus (DP) under Part 2 of Schedule 1 of the Canadian Environmental Protection Act...

On February 14, 2025, Canada published SOR/2025-27, officially listing decabromodiphenyl ethane (DBDPE) and dechlorane plus (DP) under Part 2 of Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA). This action follows detailed risk assessments and public consultations and is part of Canada’s ongoing commitment to strengthen environmental protection through the Chemicals Management Plan (CMP).

Why Are DBDPE and Dechlorane Plus Considered Toxic?

Both DBDPE and DP were evaluated under the ecological and human health criteria set out in section 64(a) of CEPA. The final screening assessments concluded that while human health risks are minimal, environmental exposure and persistence of both substances pose significant ecological risks.

• DBDPE: Identified as persistent in the environment, especially in sediments, and has the potential to break down into bioaccumulative compounds.

• Dechlorane Plus: Shows long-range transport capability and is highly bioaccumulative, found in wildlife and remote environments.

These findings led to their classification as toxic under CEPA and listing in Part 2, which focuses on pollution prevention strategies.

CEPA Schedule 1 – What Does Part 2 Mean?

Under amendments introduced by the Strengthening Environmental Protection for a Healthier Canada Act (2023), CEPA Schedule 1 is now divided into two parts:

• Part 1 contains high-risk substances that require immediate or full prohibition.

• Part 2, where DBDPE and DP are now listed, requires risk management through pollution prevention measures such as controlled use, import limitations, or eventual bans.

The designation allows federal authorities to develop regulatory tools to mitigate the risks posed by these substances.

Industrial Use, Environmental Release, and Exposure in Canada

While neither substance is manufactured in Canada, industry data shows significant import volumes:

• DBDPE: 1,000 to 10,000 tonnes/year

• DP: 10 to 100 tonnes/year

Both are used as flame retardants in sectors including:

• Plastics and electronics

• Automotive and aerospace parts

• Construction materials and adhesives

Releases to the environment occur primarily during manufacturing, industrial use, and through waste streams over the lifecycle of products containing these chemicals.

International Regulation and Alignment

Canada's actions are aligned with global regulatory trends:

• United States: Both substances are listed under the Toxic Substances Control Act (TSCA).

• European Union: Under assessment by the European Chemicals Agency (ECHA), with DBDPE and DP included in restriction strategies for brominated flame retardants.

• Australia: Both substances are listed for environmental regulation under the Industrial Chemicals Environmental Management (Register) Act 2021.

• Stockholm Convention: DP is listed in Annex A for global phase-out with specific exemptions.

Stakeholder Consultation and Public Input

The federal government engaged with industry, non-governmental organizations, and the public during consultations in 2016 and 2019. Industry feedback included concerns about:

• Substitute availability and socio-economic impact

• Consistency with international regulations

• Potential for  misclassification of waste

NGOs supported the listing and called for class-based regulation of flame retardants to prevent regrettable substitution.

Next Steps in Regulatory Development

While this listing does not impose immediate regulatory obligations, it allows the government to propose risk management tools under CEPA, such as:

• Amendments to the Prohibition of Certain Toxic Substances Regulations

• Import or manufacturing restrictions

• Pollution prevention programs

Future regulatory proposals will be subject to further public and industry consultation.

Impact on Businesses and Small Enterprises

The Order SOR/2025-27 does not introduce direct compliance costs or administrative burdens. Analyses under the small business lens and one-for-one rule confirmed no impact on small businesses or reporting requirements. Economic implications will be assessed if further restrictions are developed.

Environmental and Health Implications

Although current human health exposure levels are low, the ecological risk posed by the substances - especially their persistence and bioaccumulation - warrants proactive management. The federal Strategic Environmental Assessment concluded that the listing of these substances supports Canada’s broader goals for environmental and human health protection.

On February 13, 2025, the Government of Canada launched a consultation on risk management measures for short-chain chlorinated alkanes (SCCAs), medium-chain chlorinated alkanes (MCCAs), and long-chain...

On February 13, 2025, the Government of Canada launched a consultation on risk management measures for short-chain chlorinated alkanes (SCCAs), medium-chain chlorinated alkanes (MCCAs), and long-chain chlorinated alkanes (LCCAs) with up to 20 carbon atoms. A screening assessment found  that these substances meet the toxicity criteria under the Canadian Environmental Protection Act, 1999 (CEPA). The objectives of this consultation are to:

1. Inform stakeholders and obtain comments on the proposed prohibition of MCCAs and LCCAs up to 20 carbon atoms under the Prohibition of Certain Toxic Substances Regulations, 2012.

2. Gather information on concentration thresholds for SCCAs and MCCAs.

3. Propose the addition of SCCAs, MCCAs, and LCCAs to the Export Control List (ECL) in Schedule 3 of CEPA.

Background

Chlorinated alkanes, also known as chlorinated paraffins, are hydrocarbons with carbon chain lengths ranging from 10 to 38 atoms. SCCAs (10-13 carbon atoms) have been prohibited in Canada since 2013, while MCCAs (14-17 carbon atoms) and LCCAs (18-20 carbon atoms) continue to be used in industrial applications such as metalworking fluids, plastics, rubber, paints, coatings, adhesives, and sealants.

Assessments by Environment and Climate Change Canada (ECCC) and Health Canada concluded that chlorinated alkanes up to 20 carbon atoms are harmful to the environment and human health, resulting in their inclusion in Schedule 1 of the CEPA in 2011.

International Risk Management

Chlorinated alkanes are under global regulatory scrutiny due to their persistence and potential harm to human health and the environment. Various international agreements and national regulations have restricted or prohibited their use and trade.

• Stockholm Convention: SCCAs were listed for elimination in 2017; MCCAs are recommended for inclusion in 2025.

• Rotterdam Convention: SCCAs were listed in 2017, requiring prior informed consent for international trade.

• United States: MCCAs and LCCAs are subject to Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA).

• European Union: MCCAs are classified as Substances of Very High Concern (SVHCs) under REACH and are subject to strict regulatory controls.

Proposed Risk Management Measures

To protect human health and the environment, Canada proposes to ban certain chlorinated alkanes, set concentration limits, and restrict exports.

1. Prohibition of MCCAs and LCCAs

The Government of Canada proposes to amend the Prohibition of Certain Toxic Substances Regulations, 2012 to prohibit the manufacture, use, sale, and import of MCCAs and LCCAs with up to 20 carbon atoms. Temporary exemptions may be considered for:

• Metalworking fluids

• Plastics and rubbers

• Adhesives and sealants

• Automotive parts

2. Establishment of Concentration Thresholds

Proposed incidental presence thresholds for regulatory alignment:

• SCCAs: 1% by weight for substances, 0.15% for manufactured items

• MCCAs: 0.1% by weight for all products

• LCCAs: Further data required

3. Addition to the Export Control List (ECL)

In order to comply with international obligations, SCCAs, MCCAs, and LCCAs with up to 20 carbon atoms may be added to Part 2 and Part 3 of the ECL under CEPA, thereby restricting exports.

Information Gathering

Stakeholders are invited to submit information on:

• Product use and industry applications.

• Available alternatives and transition timelines.

• Socio-economic impacts of prohibition.

• Data on incidental presence thresholds.

Next Steps

The Government of Canada is inviting industry stakeholders, manufacturers, and environmental groups to provide feedback by April 14, 2025. Stakeholder feedback will help refine the regulatory amendments and inform Canada’s position at the Stockholm Convention in April/May 2025.

On January 25, 2025, the Government of Canada published regulatory updates in the Canada Gazette, Part I, Volume 159, Number 4, regarding the management of chemical substances, specifically addressing...

On January 25, 2025, the Government of Canada published regulatory updates in the Canada Gazette, Part I, Volume 159, Number 4, regarding the management of chemical substances, specifically addressing trisiloxane and a group of terpene and terpenoid substances.

Significant New Activity Notice for Trisiloxane

The Department of the Environment has issued a Significant New Activity (SNAc) Notice under the Canadian Environmental Protection Act, 1999 (CEPA) for trisiloxane, 3-ethyl-1,1,1,3,5,5,5-heptamethyl- (CAS RN 17861-60-8). This notice requires that any significant new activities involving this substance, particularly in cosmetic applications, require prior notification to the Minister of the Environment.

Key Restrictions

• Cosmetics Use Limits: The substance cannot be used in cosmetics beyond prescribed limits, such as 5% in hair dyes and 10% in rinse-off cosmetics.

• Advance Notification: New significant activities involving the substance must be notified 90 days in advance.

• Exemptions: Use of the substance in manufacturing for export only is exempt from these regulations.

These measures are intended to prevent potential environmental and health risks associated with excessive use of trisiloxane in consumer products.

Assessment of Terpene and Terpenoid Substances

The Department of the Environment and the Department of Health have conducted a draft assessment of 14 terpene and terpenoid substances and proposed 12 of them be added to Part 2 of Schedule 1 of CEPA due to health risks.

Key Findings

• Substances of concern include cade oil, verbena officinalis extract, ginkgo biloba extract, and sage oil.

• Potential health risks: Identified concerns include carcinogenicity, reproductive toxicity, and effects on the nervous system.

• Public consultation period: A 60-day public comment period is open from January 25, 2025, to March 26, 2025, during which stakeholders are invited to submit comments and scientific data to support further assessments.

These findings reinforce the Canadian Government’s commitment to consumer safety and regulatory oversight in the management of chemical substances.

For detailed information and to participate in the consultation process, stakeholders are encouraged to consult the official publications in the Canada Gazette here.

On February 12, 2025, the Government of Canada officially added 2,4,11,13-tetraazatetradecanediimidamide, N,N″-bis(4-chlorophenyl)-3,12-diimino-(chlorhexidine) and its salts to Part 2 of Schedule 1 ...

On February 12, 2025, the Government of Canada officially added 2,4,11,13-tetraazatetradecanediimidamide, N,N″-bis(4-chlorophenyl)-3,12-diimino-(chlorhexidine) and its salts to Part 2 of Schedule 1 under the Canadian Environmental Protection Act, 1999 (CEPA) through Order SOR/2025-13. This regulatory action, published in the Canada Gazette, follows scientific assessments that identified environmental risks associated with chlorhexidine compounds, prompting the government to prioritize pollution prevention actions for these substances.

Why is Chlorhexidine Now Considered Toxic?

In 2019, a screening assessment conducted by Environment and Climate Change Canada (ECCC) and Health Canada concluded that chlorhexidine (CAS no 55-56-1) and its salts meet the environmental toxicity criteria outlined in paragraph 64(a) of CEPA. Key findings highlighted that:

• Chlorhexidine persists in aquatic environments and poses long-term risk to aquatic and benthic organisms, with algae being particularly sensitive.

• Although its bioaccumulation potential is low, the substance remains in water, sediment, and soil for prolonged periods of time.

• Releases primarily come from consumer use, wastewater discharge, and industrial formulation processes.

Despite these environmental concerns, the assessment found no significant risks to human health at current exposure levels from products such as antiseptics, cosmetics, and disinfectants.

Regulatory Impact and Next Steps

The addition of chlorhexidine and its salts to Part 2 of Schedule 1 allows the government to develop pollution prevention measures, which may include restrictions or prohibitions on certain uses. Unlike substances listed in Part 1 of Schedule 1, which require immediate bans or severe restrictions, substances listed in Part 2 are managed through targeted risk reduction strategies.

Canada’s Chemicals Management Plan (CMP) will now oversee the development of risk management measures, with stakeholder consultations expected before any final regulations come into effect. The government has also taken steps to:

• Include chlorhexidine in the National Pollutant Release Inventory (NPRI), which requires industry to report its environmental releases.

• Establish an Environmental Performance Agreement (EPA) with industrial formulators to limit chlorhexidine discharges to wastewater.

International and Domestic Context

While Canada has now classified chlorhexidine and its salts as toxic to the environment, regulatory actions vary worldwide:

• United States: Chlorhexidine digluconate is under review by the U.S. Environmental Protection Agency (EPA) for its safety as an antiseptic.

• European Union: Chlorhexidine is registered under REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) to monitor its effects on human health and the environment.

• Canada: The country will now prioritize pollution prevention strategies while continuing to allow the use of chlorhexidine in medical and personal care products.

What Happens Next?

The Canadian government is expected to initiate consultations with industry stakeholders, environmental groups, and health agencies to develop risk management tools. These measures could range from manufacturing and disposal guidelines to specific restrictions in industrial applications.

The full regulatory order can be accessed in the Canada Gazette here, and stakeholders have until April 14, 2025, to submit comments on future risk management plans.

The Canadian Environmental Protection Act 1999 (CEPA 1999) remains Canada’s most important chemical control law, requiring assessments of new substances placed on the market after 1994. It mandates ...

The Canadian Environmental Protection Act 1999 (CEPA 1999) remains Canada’s most important chemical control law, requiring assessments of new substances placed on the market after 1994. It mandates reviews of substances introduced before 1994, ensuring their safety for human health and the environment. Substances not on the Domestic Substances List (DSL) cannot be manufactured or imported without prior government approval, reinforcing Canada’s commitment to regulating hazardous chemicals effectively.

Bill S-5, known as the Strengthening Environmental Protection for a Healthier Canada Act, was adopted in 2023, marking a major amendment to CEPA for the first time in over two decades. It enhances protection for vulnerable communities, advances Indigenous reconciliation, strengthens chemical management strategies, and reduces reliance on animal testing. The government has until June 2025 to develop a comprehensive new plan for managing chemicals and integrating the right to a healthy environment into CEPA.

Canada has also begun transitioning to the seventh revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS7), replacing the fifth edition previously in use. This transition will occur over three years to allow industry stakeholders time to comply with updated classification and labeling standards.

Key News from 2024

Modernizing Canada's Environmental Protection: The Journey of Bill S-5

The modernization of the Canadian Environmental Protection Act (CEPA) is underway, embedding the right to a healthy environment into law. The government has launched a public consultation schedule to strengthen CEPA, focusing on chemicals management, environmental monitoring, and reducing vertebrate animal testing. The initiative aligns with global best practices and aims to improve environmental health standards. Read more here.

Health Canada and Environment and Climate Change Canada (ECCC) Announce New Regulatory Developments under Updated CEPA

Following the passage of Bill S-5, Health Canada and ECCC have initiated new regulations focusing on high-risk substances and toxic chemical restrictions. A series of public consultations will take place in 2024–2025 to shape new frameworks for environmental protection, including a watch list approach for hazardous chemicals and strategies to minimize animal testing.Read more here.

Canada Amends Domestic Substances List to Enhance Environmental Protection and Public Health

The Canadian government has amended the Domestic Substances List to regulate three chemicals—AGE, o-CGE, and TGIC—introducing new Significant New Activity (SNAc) requirements. The move ensures that any significant new uses of these substances undergo thorough risk assessment before approval, aligning with the country's Chemicals Management Plan. Read more here.

Government of Canada Publishes Notice on Amendments to the Domestic Substances List Under CEPA

The government plans to unmask the identities of 198 substances currently listed under Part 3 of the Domestic Substances List to improve transparency. Public consultations are open for stakeholders to provide feedback on confidentiality and regulatory impacts, with changes expected to align with Bill S-5’s amendments. Read more here.

Government of Canada Publishes Notice on Amendments to the Domestic Substances List under CEPA

The government plans to unmask the identities of 198 substances currently listed under Part 3 of the Domestic Substances List to improve transparency. Public consultations are open for stakeholders to provide feedback on confidentiality and regulatory impacts, with changes expected to align with Bill S-5’s amendments. Read more here.

Key Dates for 2025

Health Canada amended the Hazardous Products Regulation (HPR) to align with GHS 7 and introduce a new "Chemicals Under Pressure" hazard class from GHS 8. A three-year transition period has been set, requiring full compliance by December 15, 2025.