Canada Regulatory News

In a major move to protect the environment, the Canadian government has established comprehensive risk management strategies for thallium and its compounds, highlighting the significant risks they pos...

In a major move to protect the environment, the Canadian government has established comprehensive risk management strategies for thallium and its compounds, highlighting the significant risks they pose to the environment, especially to aquatic ecosystems. This decision follows the definitive findings released on March 30, 2024, which confirmed the preliminary assessment from 2020 that thallium compounds meet the harmful criteria under Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA).

Final Assessment Under CEPA: A Call for Regulation

The final assessment is a critical part of the Canadian Environmental Protection Act, 1999, focusing on thallium and its compounds that are listed on the Domestic Substances List and those identified for further evaluation. This assessment has led to a recommendation by the Ministers of the Environment and Health that these substances be considered for inclusion in Part 2 of Schedule 1 to CEPA, which represents a step towards strict regulatory management.

Proposed Risk Management Approach: Stakeholder Engagement

In response to the conclusions of the assessment, the government has released a Proposed Risk Management Approach document on the Canada.ca website. This initiative is intended to foster dialogue with stakeholders on the development of regulations or tools to implement prevention or control measures against the identified risks of thallium compounds, while underscoring a commitment to environmental protection.

Comprehensive Strategy Under the Chemicals Management Plan 

The strategy addresses the environmental impact of all forms of thallium, including elemental thallium and its compounds that can release thallium into the environment. This comprehensive approach is part of the Chemicals Management Plan (CMP), which aims to reduce environmental exposure and potential harm from these substances.

Existing and International Risk Management Practices

The document also outlines current risk management practices, such as the Metal and Diamond Mining Effluent Regulations under the Fisheries Act, which includes thallium monitoring. Additionally, it highlights the Environmental Code of Practice for Metal Mines and emission standards for iron ore pelletizing facilities, which contribute to the effective management of the environmental impact of thallium. International actions in the United States and the European Union provide a global perspective on thallium risk management efforts, and underscore the universal recognition of the need for strong environmental protection measures.

Call for Public and Stakeholder Participation

As the Canadian government moves forward with its proposed risk management plan for thallium and its compounds, it is encouraging public and stakeholder participation. By seeking comments and additional information, the government aims to ensure informed decision-making in its environmental protection efforts, reflecting a collaborative approach to addressing the public health and environmental challenges posed by thallium compounds to. The deadline for submitting information or additional studies on thallium is May 29, 2024.

Health Canada and Environment and Climate Change Canada (ECCC) are currently seeking feedback from industry stakeholders and interested parties on the regulation of low boiling point naphthas (LBPNs)....

Health Canada and Environment and Climate Change Canada (ECCC) are currently seeking feedback from industry stakeholders and interested parties on the regulation of low boiling point naphthas (LBPNs). The deadline for comments is May 15, 2024. 

Understanding Low Boiling Point Naphthas: Key Considerations and Regulatory Assessment 

In the realm of petrochemicals, low boiling point naphthas (LBPNs) are emerging as a complex group of hydrocarbons that are essential for a variety of industrial applications. Derived from the distillation of crude oil, LBPNs include a wide range of hydrocarbons from C4 to C14 in the carbon chain spectrum. These substances include alkanes, cycloalkanes, alkenes, and aromatic hydrocarbons and their chemical diversity makes them invaluable in the production of gasoline, solvents, and numerous consumer and industrial products. 

Classified as UVCBs (Unknown or Variable Composition, Complex Reaction Products or Biological Materials), the intricate nature of LBPNs presents challenges to their consistent characterization. However, their significant role in fuel blending processes and as components in manufacturing underscores their industrial relevance. 

Health Canada and Environment and Climate Change Canada (ECCC) have classified LBPNs into four distinct subgroups, based on their health effects, presence in consumer products, and aromatic content. These include: 

- Subgroup 1: C9-C14 hydrocarbon solvents 

- Subgroup 2: C9 aromatic hydrocarbon solvents 

- Subgroup 3: C6-C9 aliphatic hydrocarbon solvents 

- Subgroup 4: LBPNs not used in consumer products 

LBPNs are used in a wide range of solvents, viscosity adjustors, and fuel additives, and play a central role in petroleum production, industrial processing and products ranging from lubricants to personal care products. Despite their widespread use, the health and environmental impacts of certain LBPNs require careful management and regulation. 

In a recent draft assessment by Health Canada and the ECCC, 17 out of 27 LBPN substances have been provisionally identified as meeting toxicity criteria under the Canadian Environmental Protection Act (CEPA). This assessment further divides LBPNs into four main categories for regulatory focus and risk management. 

Current Regulatory Landscape and Risk Management Initiatives 

In Canada, regulatory action on LBPNs spans several areas including cosmetics, food additives, food packaging, pest control products, and consumer safety. In particular, certain LBPNs are highlighted for their absence from the Cosmetic Ingredient Hotlist and the List of Permitted Food Additives, emphasizing their restricted use in these sectors. Additionally, their use in food packaging and pest control underline the nuanced approach towards ensuring public health and safety. 

Internationally, the regulation of LBPNs varies, with specific restrictions and approvals in the United States and Europe, particularly regarding their use in cosmetics, food-related applications, and environmental emissions. These regulatory frameworks reflect a concerted effort to mitigate health risks while recognizing the essential industrial applications of LBPNs. 

Invitation for Stakeholder Engagement 

As the assessment progresses, industry stakeholders, and interested parties are encouraged to participate in the consultation process. The input received will be critical in refining risk management strategies and ensuring a balanced approach to regulating the use of LBPNs use and addressing potential health and environmental impacts. The deadline for comments is May 15, 2024, providing a valuable opportunity to contribute to informed decision-making. 

In summary, the evolving landscape of LBPN regulation underscores the importance of these substances in various sectors, while highlighting the need for vigilant risk management to protect public health and the environment. Stakeholder engagement remains a critical component of this process, ensuring comprehensive and effective regulatory action. 

On February 3, 2024, the Canadian government published a draft assessment to restrict the use of six essential oils in personal care products. A notice summarizing the scientific considerations of ...

On February 3, 2024, the Canadian government published a draft assessment to restrict the use of six essential oils in personal care products.

A notice summarizing the scientific considerations of the draft assessment for 12 substances was published in the Canada Gazette, Part I (Canada 2024).

The consultation period for the proposed draft assessment and risk assessment is from February 3, 2024, to April 3, 2024.

The Government of Canada is considering the following options to address the health concerns

• Health Canada is implementing measures to reduce exposure to certain cosmetic ingredients, such as tarragon oil, jasmine oil, and fragrances, as prohibited or restricted ingredients.

• It is also identifying jasmine oil and fragrances in certain Natural Health Products (NHPs) as restricted ingredients in the NHP Database to protect human health.

• Regulatory and non-regulatory measures are also being taken to reduce exposure to essential oils in consumer products and promote public awareness.

A risk assessment has been published for the substances in the group of phenylpropanoids and aldehydes listed in the table below.

Conclusion of assessment

The draft assessment suggests that bay oil, tarragon oil, jasmine oil, perfumes, violet oil, and lilial are toxic under CEPA's 64(c) criteria due to potential hazards to human life or health. Other substances such as verdantiol, myrac-aldehyde, myrmac-aldehyde, myrmac-carboxaldehyde, cetonal, and vernaldehyde do not meet these criteria. The 12 substances in the phenylpropanoids and aldehydes group are not harmful to the environment or biological diversity.

This period is dedicated to overhauling the nation’s approach to chemical management and embedding a groundbreaking right to a healthy environment within the Canadian Environmental Protection Act (C...

This period is dedicated to overhauling the nation’s approach to chemical management and embedding a groundbreaking right to a healthy environment within the Canadian Environmental Protection Act (CEPA). This legislative development sets the stage for a comprehensive update to the existing framework, ensuring that environmental protection measures are both modernized and effective. In February Environment and Climate Change Canada (ECCC) published a list of public consultation opportunities for initiatives that will support a strengthened and modernized CEPA. 
 

Public Engagement and Consultation: Shaping the Future Together 

A key component of the modernization process is public consultation. The Government is committed to facilitating public input on a wide range of initiatives to strengthen CEPA. A schedule for these consultations has been outlined, with each session scheduled to last 60 days, subject to adjustment based on the latest information. Efforts will be made to minimize overlapping consultations to ensure that the public can fully engage with each initiative without the burden of simultaneous requests for feedback. 

Participating in the Development of a Healthier Environment 

The Government invites public participation in the development of a framework for the right to a healthy environment under CEPA. Interested parties are encouraged to review the discussion document and provide their perspectives to help shape the development of the framework. This initiative represents an important step towards the recognition of environmental rights in Canada’s legal framework. 

Key Initiatives Underway 

- Right to a Healthy Environment: Efforts are underway to formulate a framework that recognizes the right to a healthy environment, a fundamental aspect of the updated CEPA. 

- Enhancing Chemicals Management: The government is developing a comprehensive plan that outlines priorities for chemicals management. This plan includes risk assessment, information gathering, research, and strategies to minimize the use of vertebrate animals in testing. 

This table summarizes the timeline and focus of upcoming public consultations and provides a clear roadmap for stakeholders to engage in improving Canada's environmental protection: 

On February 5, 2024, the Canadian Food Inspection Agency (CFIA) notified the World Trade Organization (WTO) of an interim standard for per- and polyfluoroalkyl substances (PFAS) in municipal biosolids...

On February 5, 2024, the Canadian Food Inspection Agency (CFIA) notified the World Trade Organization (WTO) of an interim standard for per- and polyfluoroalkyl substances (PFAS) in municipal biosolids imported or sold in Canada as fertilizers. The deadline for comments is April 5, 2024. 

Background Information 

Per- and polyfluoroalkyl substances (PFAS) have become a major concern due to their persistence and potential adverse effects on human health and the environment. Commonly found a variety of products and industrial processes, the substances have the potential to contaminate soil, air, water, and even municipal biosolids (the product of wastewater treatment processes). In response to this threat, the Canadian Food Inspection Agency (CFIA) is taking action by proposing an interim standard to reduce PFAS contamination in municipal biosolids imported or sold as fertilizers. This initiative is part of the Government of Canada's broader efforts to reduce human and environmental exposure to PFAS throughout their lifecycle, from production to disposal. 

Purpose of the Consultation 

The CFIA has launched a consultation to gather input from Canadians, including producers, farmers, and the general public, on the implementation of the interim standard for PFAS in biosolids. 

Proposed Risk Management Approach 

Under CFIA’s proposed interim standard biosolids marketed as commercial fertilizer must meet a standard of less than 50 parts per billion (ppb) of perfluorooctane sulfonate (PFOS), which serves as an indicator of PFAS contamination. To import or sell biosolids as fertilizer in Canada, applicants will need to meet the following requirements: 

1. Certificate of Analysis (CoA): Applicants must provide a CoA for PFOS as an indicator, dated within the last six months. This document must confirm that the concentration of PFOS in the biosolids is less than 50 ppb based on dry weight. Testing must be performed at least every six months to account for potential variations in inputs and treatment. The CoA provided at the time of import or domestic inspection should have a sampling date within the previous six months. CFIA will provide a list of accredited laboratories for guidance. 

2. Attestation Form: A template attestation form provided by the CFIA must be completed and signed by the responsible party. This form is used to certify to the validity of the CoA. 

These requirements apply to all biosolids products that are represented as fertilizers, including those that are exempt from registration, and those that are required to be registered as defined in the List of Primary Fertilizer and Supplement Materials. 

Scientific Basis: 

To determine the most appropriate risk management approach, the CFIA conducted a thorough review of the scientific literature on PFAS, with a particular focus on their impact on agriculture. This review also considered assessments conducted by other regulatory bodies, both domestic and international, including Environment and Climate Change Canada, Health Canada, the U.S. Environmental Protection Agency, the European Chemical Agency, and the European Environment Agency. In addition, the CFIA collected data on PFAS levels in soils and other matrices and investigated the beneficial uses of biosolids. 

Results and Conclusion: 

An analysis of the data revealed that the majority (92%) of domestic biosolids had PFOS concentrations below 50 ppb, indicating a relatively low level of contamination. CFIA was inspired by the Michigan Department of the Environment, Great Lakes, and Energy, which implemented a similar interim strategy in March 2021 with considerable success in reducing PFAS contamination levels in biosolids. 

The CFIA is commited to ongoing collaboration with federal and provincial partners and stakeholders to monitor scientific developments related to PFAS, actions taken in other jurisdictions, and contamination levels in biosolids. The interim approach will be reviewed after one year to ensure its continued effectiveness in protecting human health and the environment. 

In accordance with the Canadian Environmental Protection Act, 1999 (CEPA), the Government of Canada is actively engaged in the comprehensive evaluation of substances to assess their potential risks to...

In accordance with the Canadian Environmental Protection Act, 1999 (CEPA), the Government of Canada is actively engaged in the comprehensive evaluation of substances to assess their potential risks to human health and the environment. This process involves a thorough examination of both the intrinsic hazardous properties of the substances and the extent of their exposure to humans and the environment. 

Focus on four substituted phenols 

As part of this ongoing effort, the government is currently focusing on a group of 15 substances in the substituted phenols group. Four substances in this group, CAS RNs 118-82-1, 128-37-0, 36443-68-2, and 61788-44-1, have been identified as potential sources of environmental concern. These four substances have the potential to cause adverse effects to organisms if released into the environment. 

To address these concerns, the Government of Canada is considering a range of regulatory and non-regulatory options for industrial formulation activities involving these substances. The objective is to minimize their release into the environment and thereby reduce potential harm. 

Safety of remaining substances 

It is important to note that the remaining 11 substances in the group have not been found to pose harm to the environment. The ecological hazard and exposure potential of these substances has been assessed using the Ecological Risk Classification of Organic Substances (ERC) approach. 

While some substances within this group may be associated with health effects, the assessment does not indicate any harm to human health when exposure levels are taken into account. These substances, which are used as antioxidants, can come into contact with humans through various routes, such as drinking water, food, food packaging, and consumer products, including cosmetics. 

Ongoing commitment and future actions 

The Government of Canada remains committed to its role in assessing and managing the risks associated with various substances under CEPA to protect both the environment and public health. Further actions and risk management strategies will be developed as deemed necessary to mitigate potential harm from these substances. 

Canada's health and environment ministries, namely Health Canada (HC) and Environment and Climate Change Canada (ECCC), are actively seeking public input as they embark on the development of a com...

Canada's health and environment ministries, namely Health Canada (HC) and Environment and Climate Change Canada (ECCC), are actively seeking public input as they embark on the development of a comprehensive strategy to reduce the use of vertebrate animal testing in the assessments of chemicals. HC and ECCC are responsible for assessing and managing a wide range of health and environmental risks, including those posed by chemicals, under the Canadian Environmental Protection Act (CEPA). CEPA is the primary legislative framework governing pollution prevention in Canada and provides the legal foundation for a range of federal environmental and health protection initiatives. 

Background 

The process of prioritizing and assessing chemical risks largely relies on data derived from toxicity tests conducted on vertebrate animals to evaluate potential adverse effects. Nonetheless, these studies using experimental vertebrate animals are not only costly and time-consuming but may also have limited biological relevance, in addition to ethical concerns related to animal welfare. In light of these challenges, New Approach Methods (NAMs) have emerged as a promising alternative to traditional vertebrate animal-based approaches for chemical toxicity testing and risk assessment. 

NAMs are broadly defined as any technology, methodology, approach, or combination thereof that can replace, reduce, or refine animal toxicity testing, potentially leading to faster and more effective prioritization and assessment of chemicals. These methods cover a wide range of possibilities, including the use of computer-based models, modernized whole organism assays, assays using biological molecules, cells, tissues, or organs, as well as exposure prediction techniques. 

As part of their ongoing commitment to integrate NAMs into regulatory programs under CEPA, the HC and ECCC are working diligently to develop and standardize of NAMs. Simultaneously, they are actively establishing frameworks and tools to facilitate the ongoing evaluation and incorporation of non-animal data and alternative approaches in prioritization and risk assessment.  

These scientific advances are in line with the efforts by various regulatory authorities around the world, such as those in the United States, Australia, and the European Union, which are increasingly emphasizing modern approaches to minimize the use of vertebrate animals in toxicity testing. These efforts include strategies and research programs designed to accelerate the development and implementation of NAMs for regulatory decision-making. 

The current initiative involves the formulation of a comprehensive strategy to guide the future efforts of the HC and ECCC in their quest to minimize the reliance on vertebrate animal testing under CEPA for the assessment of potential risks to human health and the environment. Although initially developed within the context of CEPA, this strategy has the potential for broader applicability to other Government of Canada regulatory programs, where relevant and feasible. Canada intends to collaborate closely with national and international partners in the development, standardization, and implementation of fit-for-purpose NAMs. Furthermore, building scientific confidence and garnering acceptance of NAMs within the Government of Canada and among external stakeholders is considered critical to the successful advancement and timely adoption of alternative methods and strategies for regulatory testing and assessment.  

This strategy responds to CEPA's commitment outlined in the Plan of Chemicals Management Priorities, which underscores the inclusion of activities and initiatives to promote the development and timely integration of scientifically justified alternative methods and strategies to replace, reduce, or refine the use of vertebrate animals in chemical testing. 

Key elements 

Key elements proposed to be addressed in this strategy include: 

1. Identifying and prioritizing the requirements for NAMs within chemical regulatory programs under CEPA. 

2. Promoting research and data generation for NAMs to support method development, standardization, and translational research. 

3. To promote harmonization, collaboration, communication, and engagement. 

4. Implement NAMs to reduce reliance on vertebrate animal toxicity testing in chemical regulatory programs under CEPA. 

Deadline 

This strategy, which is expected to be published alongside the Plan of Chemicals Management Priorities by June 2025, is an important step towards a more sustainable and ethical approach to chemical assessment. Comments on the animal testing notice are encouraged and should be submitted by January 29, 2024, providing a valuable opportunity for public input into this transformative endeavor.