Canada Regulatory News

On 24 April 2024, Health Canada published an amendment to the labeling and notification requirements for cosmetic ingredients. The amendment was published in the Canada Gazette, part II, Volume 158, N...

On 24 April 2024, Health Canada published an amendment to the labeling and notification requirements for cosmetic ingredients. The amendment was published in the Canada Gazette, part II, Volume 158, No.9. The amendment was adopted on 12 April 2024 and comes into force 180 days after the publication in the Gazette. The requirement for the disclosure of fragrance allergens comes into force on the second anniversary of the day on which these Regulations were registered.

Background Information

Health Canada is amending the Regulations to require the disclosure of certain fragrance allergens on cosmetic labels if they are present above a specified threshold. The amendments require fragrance allergens to be listed in the ingredient list on cosmetic labels and to be included in the cosmetic notification.

In July 2023 the EU adopted amendments to the Cosmetic Regulation (EC 1223/2009), so that Annex III now contains 81 entries that identify fragrance allergens for disclosure on cosmetic labels when present above a defined concentration level. The transition time for implementing the modifications is three years (July 31, 2026) for new products that enter the market, and five years (July 31, 2028) for current products to sell through.

The amended Canadian Regulations incorporate these allergens via an ambulatory incorporation by reference, ensuring compliance with EU regulations. This ensures that the rollout of new fragrance allergen disclosures on cosmetic labels in the Canadian market coincides with similar implementations in the European Union (EU) market, maintaining alignment between the two regions' timelines.

Other amendments to the cosmetic regulations are as follows:

• Health Canada is amending the Regulations to allow cosmetics sold in small packages to disclose their ingredients, including fragrance allergens, on a website. A bilingual statement is required on the label and a digital mechanism, such as a QR code, is also proposed.

• Improving the control of cosmetics.

• Updating the definition of manufacturer and adding the definition of importer.

• Strengthen the cosmetic notification requirement.

• Remove distributor information from the cosmetic notification.

• Add a requirement to identify rinse-off or leave-on in the cosmetic notification.

• Add a requirement to identify ingredients by their INCI name on the cosmetic notification.

• Amend the table of concentration ranges for the cosmetic notification.

• Add the possibility to request evidence of safety from the importer.

• Modernization of the contact information on the label.

• Administrative changes.

On April 20, 2024, the Canadian government announced the approval of eight hydrocarbon-based chemicals following a thorough assessment under the Canadian Environmental Protection Act, 1999 (CEPA). Acc...

On April 20, 2024, the Canadian government announced the approval of eight hydrocarbon-based chemicals following a thorough assessment under the Canadian Environmental Protection Act, 1999 (CEPA). According to the findings, these substances are safe in terms of their effects on human health and the environment and do not meet the strict toxicity criteria of CEPA.

Substances Evaluated

The assessment, conducted by the Minister of Health and the Minister of the Environment, examined substances that are widely used in industries ranging from construction materials to household products. The substances include:

- Petroleum resins and hydrocarbon resin used primarily in adhesives.

- Polymerized C5-12 distillates, a petrochemical used in intermediate stages of manufacturing.

- Oxidized hydrocarbon waxes containing EA and 2-MAE, substances previously evaluated and found to be safe.

- Alkylated naphthalene sulfonate sodium salt polymers with formaldehyde, used in pest control products and industrial applications.

- Heavy oxo ends, used in applications such as industrial defoamers.

- Sulfurized petroleum, used in metalworking and other industrial applications.

Low Environmental and Health Risks

These assessments ensure that none of the substances pose significant risks to the environment or human health under current use and disposal practices. The investigation confirmed the low ecological and human health risks associated with these materials and supports their continued use in Canada under regulated conditions.

Government Commitment

This decision is consistent with ongoing efforts to ensure environmental safety and public health and reflects the government’s commitment to uphold the standards set by CEPA. For more details on the substances and the assessment process, the full report is available through the Government of Canada official environmental publications.

The Canadian Department of the Environment announced on April 20, 2024, an enhanced regulation under the Canadian Environmental Protection Act, 1999, that will now require industries involved with pla...

The Canadian Department of the Environment announced on April 20, 2024, an enhanced regulation under the Canadian Environmental Protection Act, 1999, that will now require industries involved with plastic resins and products to report extensively to the Federal Plastics Registry. This initiative, rooted in subsection 46(1) of the Act, underscores Canada's commitment to reducing plastic waste through improved transparency and accountability.

The regulation requires all entities, including manufacturers and importers of plastic resins and products to maintain detailed records documenting their compliance for three years (2024-2026),. These records should include calculations, measurements and any other data supporting the information provided and should be stored at the parent company’s head office in Canada. The information must be submitted by September 29 of the following year.

The mandate details a comprehensive list of 24 specific plastic resins classified under the North American Product Classification System (NAPCS) Canada 2022 Version 1.0, which includes commonly used plastics such as polyethylene terephthalate (PET) and polyvinyl chloride (PVC). The notice also covers a wide range of plastic products in various sectors such as electronic and electrical equipment, transportation, construction and agriculture, as well as items intended for single use or disposal.

Key components of the regulation include:

- Recordkeeping and Reporting: Companies are required to keep and report data on the volume and types of plastics produced or managed. This includes details such as the resin types, their sources (virgin fossil-based, virgin bio-based, post-consumer recycled, and post-industrial recycled), and detailed categorization of plastic products in terms of their applications in various industries.

- Confidentiality Requests: In response to the Notice, companies may requests that their information be treated as confidential, on the basis of section 52 of the Act. However, the Minister retains the authority to disclose such information as necessary under subsection 53(3).

- Penalties for Non-Compliance: The Notice explicitly states that non-compliance may result in penalties under the applicable offence provisions of the Act, underscoring the strict enforcement of these environmental regulations.

This regulation extends to detailed reporting of plastic packaging, both filled and unfilled, within specific sub-categories such as rigid and flexible packaging types, covering a range of products from beverage containers to packaging for hazardous materials.

Through this initiative, Canada aims not only to monitor and reduce the environmental impact of plastic production but also to improve recycling and disposal processes. This is part of a broader national effort to ensure a sustainable future through responsible environmental stewardship and industrial practices.

Health Canada and Environment Climate Change Canada (ECCC) have unveiled a comprehensive action plan detailing the development of new regulations following the recent review of the Canadian Environmen...

Health Canada and Environment Climate Change Canada (ECCC) have unveiled a comprehensive action plan detailing the development of new regulations following the recent review of the Canadian Environmental Protection Act (CEPA). As part of the initiative, they have outlined a series of public consultations that will begin in the spring of 2024. These consultations will focus on establishing criteria for classifying high-risk substances and exploring potential restrictions and authorizations of certain toxic substances.

The legislative update, enacted through Bill S-5 - entitled the Strengthening Environmental Protection for a Healthier Canada Act – received Royal Assent on June 13, 2023. This important legislation reinvigorates CEPA, first introduced in 1999, by affirming the right to a healthy environment, strengthening the chemicals management framework, and increasing the transparency of administrative processes.

The Government of Canada is actively working to implement the modernized Act through a variety of measures, including the creation of new frameworks, policies, strategies, regulations, and processes. These initiatives will provide numerous opportunities for public engagement and input, ensuring a participatory approach to environmental management.

Upcoming Public Consultation Opportunities

The schedule for the public consultations, that are essential to the strengthened and modernized CEPA is as follows. Each consultation period will last 60 days unless otherwise specified. Given the dynamic nature of policy development, these dates are subject to change and updates will be provided as necessary.

Consultation Timeline:

- Winter 2024: Discussion on implementation framework for the right to a healthy environment

- Spring/Summer 2024: Introduction of a Proposed Watch List approach

- Summer 2024: Plan outlining priorities for chemicals management

- Summer/Fall 2024: Strategies to replace, reduce, or refine testing on vertebrate animal

- Summer/Fall 2024: Draft implementation framework for the right to a healthy environment

- Winter 2025: Discussion document on regulations for the highest risk toxic substances

- Winter/Spring 2025:  Discussion on the restriction and authorization of certain toxic substances

Health Canada and the ECCC aim to streamline the consultation process to avoid overlapping requests and to align with the government’s policy-making cycle. Stakeholders and the public are encouraged to actively participate in these discussions to help shape a more robust and effective environmental protection regime under CEPA.

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.