Canada Regulatory News

On 18 November 2023, in a significant move to safeguard both the environment and public health, the Government of Canada unveiled the Certain Products Containing Toxic Substances Regulations. This ini...

On 18 November 2023, in a significant move to safeguard both the environment and public health, the Government of Canada unveiled the Certain Products Containing Toxic Substances Regulations. This initiative is part of the broader Chemicals Management Plan (CMP), which aims to evaluate and reduce risks posed to the environment and human health by potentially harmful chemical substances. 

Upgraded Management of Harmful Chemicals 

Under the Canadian Environmental Protection Act (CEPA), substances that are considered toxic to the environment or human health are subject to strict regulations. The CMP, backed by CEPA, empowers the Governor in Council to enact regulations to reduce the risks associated with these toxic substances. 

Focus on Coal Tars and Distillates 

The proposed regulations focus on coal tars and their distillates. These substances, which consist of complex mixtures of hydrocarbon and other chemicals, are essential for the production of various materials like creosote, crude naphthalene, and coal tar pitch and oils. They are also used in certain veterinary and human pharmaceuticals. 

Key Objectives of the New Regulations 

The primary goal of these new regulations is to ban the manufacture, import, and sale of specific coal tar-based sealant products and sealants containing Polycyclic Aromatic Hydrocarbons (PAH) levels exceeding 1,000 ppm. This action is a proactive measure to prevent ecological damage and reduce health risks associated with these toxic substances in Canada. 

Implementation Timeline and Exceptions 

By 1 January 2025, the regulations will prohibit the manufacture and import of certain sealant products containing coal tar and PAHs above the 1,000-ppm threshold. Excemptions include products manufactured for export only or in transit through Canada, and those manufactured under a specific permit. The ban covers pavement and roofing sealant products and, for coal tars, includes industrial-use sealants on various materials. 

The sale and offer of these products will be prohibited by 30 June 2025, with certain temporary exemptions. In particular, coal tar-based industrial sealants will be exempt until 1 January 2028. 

Integration of 2-BE Regulations 

The new regulations will also incorporate the existing 2-BE Regulations to improve their consistency with the current legislative draft. The 2-BE Regulations set the limits on the amount concentration of 2-butoxyethanol (2-BE) contained in cleaning, painting and coating products designed for indoor use. However, the core permitting and record-keeping requirements under the 2-BE Regulations will remain unchanged. 

Enforcement Measures 

Enforcement of these regulations, under CEPA's Compliance and Enforcement Policy, will be stringent to ensure compliance to the new standards. This move reflects Canada's commitment to a healthier environment and public safety, emphasizing the government's proactive approach to chemicals management. 

On 18 November, in a significant move to protect both the environment and public health, the Government of Canada unveiled the Certain Products Containing Toxic Substances Regulations. This groundbrea...

On 18 November, in a significant move to protect both the environment and public health, the Government of Canada unveiled the Certain Products Containing Toxic Substances Regulations. This groundbreaking initiative is part of the broader Chemicals Management Plan (CMP), which aims to evaluate and reduce  risks posed to the environment and human health by potentially harmful chemical substances. 

Upgraded Management of Harmful Chemicals 

Under the Canadian Environmental Protection Act (CEPA), substances that are considered toxic to the environment or human health are subject to strict regulations. The CMP, backed by CEPA, gives the Governor in Council the authority to enact regulations to reduce the risks associated with these toxic substances. 

Focus on Coal Tars and their Distillates 

The proposed regulations particularly focus on coal tars and their distillates. These substances, which consist of  complex mixtures of hydrocarbon and other chemicals, are essential for the production of various materials like creosote, crude naphthalene, and coal tar pitch and oils. They are also used in certain veterinary and human pharmaceuticals. 

Key Objectives of the New Regulations 

The primary goal of these new regulations is to ban the manufacture, import, and sale of specific coal tar-based sealant products and sealants containing Polycyclic Aromatic Hydrocarbons (PAH) above 1,000 ppm. This is a proactive measure to prevent ecological damage and reduce health risks associated with these toxic substances in Canada. 

Implementation Timeline and Exceptions 

By January 1, 2025, the regulations will prohibit the manufacture and import of certain sealant products containing coal tars and PAHs above the 1,000 ppm threshold. Exemptions include products manufactured for export only or in transit through Canada, and those manufactured under a specific permit. The ban extends to pavement and roofing sealant products and, for coal tars, includes industrially applied sealants on various materials. 

The sale and offer of these products will be prohibited by June 30, 2025, with certain temporary exemptions. Notably, coal tar-based industrial sealants will be exempt until January 1, 2028. 

Integration of 2-BE Regulations 

The new regulations will also incorporate the existing 2-Butoxyethanol Regulations (2-BE Regulations), to improve their consistency with the current legislative draft. However, the core requirements for permitting and record-keeping under the 2-BE Regulations will remain unchanged. 

Enforcement Measures 

Enforcement of these regulations, under CEPA's Compliance and Enforcement Policy, will be stringent to ensure compliance with the new standards. This move reflects Canada's commitment to a healthier environment and public safety and underscores the government's proactive approach to chemicals management. 

The Canadian Environmental Protection Act, 1999 (CEPA), under its vigilant section 68, recently underwent a comprehensive assessment by the Environment Ministry and the Health Ministry. This review fo...

The Canadian Environmental Protection Act, 1999 (CEPA), under its vigilant section 68, recently underwent a comprehensive assessment by the Environment Ministry and the Health Ministry. This review focused on a group of 13 substances, known collectively as the Titanium-containing Substances Group. The aim was to determine their potential environmental and health impacts. This article discusses the findings of this assessment and what they mean for Canada. 

What are these Titanium-containing Substances? 

Titanium, a naturally occurring metal, forms the core of these 13 evaluated substances. They range from well-known compounds such as titanium dioxide (TiO2), used in a variety of consumer products, to more complex chemicals such as titanium tetrachloride and tetrahydroxytitanium. The 13 chemicals are listed in the table below. 

Assessment Methods and Key Findings: 

The inter-ministerial team employed the Ecological Risk Classification of Inorganic Substances (ERC-I) method, which focuses on both hazard and exposure levels, to assess ecological risks. This innovative approach combined predictive models, water quality data, and various statistical metrics. The conclusion? These 13 substances are unlikely to cause significant  damage to the ecosystem. 

Human Health and Exposure 

The assessment extended beyond ecological impacts, to explore potential health risks to Canadians. The main sources of human exposure to these substances include air, water, food, and consumer products. Notably, food emerged as a major source of titanium exposure for the general population. Intriguingly, titanium was barely detectable in blood samples from the Canadian population, suggesting minimal health risks at current exposure levels. 

Specific Risks and Safety Thresholds 

Going deeper, the study identified a no-observed-adverse-effects level (NOAEL) for systemic exposure to titanium, taking into account various health endpoints. Moreover, for inhalation exposure, the study identified non-cancerous respiratory effects as the primary concern but deemed these to be unlikely at current exposure levels in the general population. 

Conclusion 

Encouragingly, this comprehensive study suggests that the 13 substances in the Titanium-containing Substances Group do not meet the CEPA criteria for being environmentally or health hazardous under current conditions. This conclusion represents a critical step in the understanding and management of these substances in Canada, ensuring a balance between use and safety. 

Health Canada has extended the comment period for stakeholders to provide feedback on the proposed disclosure requirements for hazardous substances found in household chemical products such as cleaner...

Health Canada has extended the comment period for stakeholders to provide feedback on the proposed disclosure requirements for hazardous substances found in household chemical products such as cleaners and lubricants. This pre-consultation is open for public comment until October 20, 2023.This initiative is part of Health Canada's ongoing efforts to improve consumer safety by introducing new requirements for chemical products under the Canadian Consumer Product Safety Act (CCPSA). 

The primary aim of this proposal is to protect the well-being of Canadians by implementing a comprehensive hazard classification and information disclosure framework for Hazardous Household and Health-Related Chemicals (HHHOCs). In conjunction with this, additional protective measures, such as prohibitions, restrictions, and child-resistant container requirements, will be considered. This approach will ensure that consumers are well informed about the presence of HHHOCs in household chemical products and are provided with essential precautionary information, including safe use instructions and first aid guidelines on the associated risks. 

Background  

A wide range of consumer chemical products, including household cleaning products, adhesives, and lubricants, are readily available to the Canadian public. The Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the CCPSA play a crucial role in protecting Canadians from acute human health and physical hazards associated with consumer chemical products. These regulations accomplish this through various means, such as prohibiting dangerous consumer chemical products, imposing restrictions, requiring information disclosure, and specifying container standards. The specific requirements for consumer chemical products are determined through scientific assessments of the hazards associated with the substances contained in the products, evaluated against the classification criteria established in the regulations. 

As of now, the CCCR, 2001 address acute human health and physical hazards, which include: 

1. Acute toxicity, which includes lethal or serious, non-lethal effects. 

2. Corrosivity, which covers chemical burns and eye damage. 

3. Flammability, which covers chemicals that can catch fire. 

4. Pressurized containers, which can explode if heated or punctured. 

5. Quick skin-bonding adhesives, adhesives that bond skin rapidly. 

However, there is a need to reduce the risks associated with Hazardous Household and Health-Related Chemicals (HHHOCs), which can cause adverse health effects from long-term or intermediate exposure. The current CCCR, 2001, lacks requirements to address the following HHHOCs: 

1. Carcinogenicity, associated with the induction of cancer. 

2. Germ cell mutagenicity, which involves heritable gene mutations. 

3. Reproductive toxicity, which includes adverse effects on sexual function, fertility, or developmental toxicity in the offspring. 

4. Specific target organ toxicity, resulting in adverse effects in target organs after single or repeated exposure. 

5. Respiratory or skin sensitization, resulting in allergic reactions or hypersensitivity. 

Requirements for consumer chemical products 

The proposed requirements for consumer chemical products under the CCPSA include: 

1. Classification criteria for HHHOCs, in line with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). 

2. Information disclosure requirements for HHHOCs, based on the GHS labelling elements, including hazard symbols, signal words (e.g., "Danger" or "Warning"), hazard statements (e.g., "May cause cancer"), precautionary statements (e.g., instructions for safe use and first aid), and ingredient disclosure requirements. 

3. Additional protective measures, such as prohibitions, restrictions, or child-resistant container requirements, as deemed necessary. 

It is important to note that the existing requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001), including classification criteria, prohibitions, information disclosure requirements, and container specifications, will remain in force under this proposed regulation. 

Deadline 

To implement these proposed requirements, Health Canada is exploring various regulatory options, such as amending the CCCR, 2001, or introducing a new regulation under the CCPSA. This pre-consultation period is open for public comment until October 20, 2023. 

In a move to enhance public safety, Health Canada has recently released information on six Hazardous Substance Assessments (HSAs). These assessments, fundamental for suppliers of hazardous products un...

In a move to enhance public safety, Health Canada has recently released information on six Hazardous Substance Assessments (HSAs). These assessments, fundamental for suppliers of hazardous products under the Hazardous Products Act (HPA) and its regulations, serve as indispensable educational tools. The Health Canadahas meticulously compiled comprehensive reports on the following substances: 

1. 4,4'-Methylenediphenyl Diisocyanate 

2. Diethylene Glycol 

3. d-Limonene 

4. EDTA Tetrasodium Salt 

5. Morpholine 

6. Toluene 

These technical documents provide critical insight into the safe handling and use of these substances to ensure compliance with regulatory standards. Health Canada's commitment to public well-being is demonstrated through the release of these detailed assessments, which provide valuable information to both manufacturers and consumers alike. 

On 14 September 2023, Health Canada's Pest Management Regulatory Agency (PMRA) submitted a proposal under the Pest Control Products Act to review an application to expand the permissible use of the fu...

On 14 September 2023, Health Canada's Pest Management Regulatory Agency (PMRA) submitted a proposal under the Pest Control Products Act to review an application to expand the permissible use of the fungicide A20259. This fungicide, which contains technical grade difenoconazole and pydiflumetofen, is currently registered under the Pest Control Products Act with Registration Number 33020. The proposed extension is to include the use of this fungicide on leaves of root and tuber vegetables, specifically within Crop Group 2. 

Objective of the proposal 

The primary objective of this proposed extension is to improve the efficacy of the product to control alternaria leaf blight (Alternaria spp.) and powdery mildew (Erysiphe spp.) in root and tuber vegtables. Additionally, it aims to suppress of white mould (Sclerotinia sclerotiorum) in these crops. Health Canada, through the PMRA, has thoroughly evaluated the safety and efficacy of this proposed use, leading to the current proposal. 

The specific details regarding the authorized use of this fungicide in Canada can be found on its product label, bearing the Pest Control Products Act Registration Number 33020. This label serves as a comprehensive guide for users, outlining the approved methods and conditions of use. 

Public comment period 

In line with transparency and public engagement, Health Canada is inviting the public to submit written comments on the proposed Maximum Residue Limit (MRL) for difenoconazole. Interested parties are encouraged to provide their input and insights within a 75-day window from the date of publication of the announcement. 

This collaborative approach allows Health Canada to consider a wide range of perspectives and ensure the safety and effectiveness of the proposed changes.  

Notification to the WTO 

To comply with Canada's international trade obligations, the consultation on the proposed MRL is also being conducted internationally. The World Trade Organization (WTO) was notified of the proposal on 19 September 2023. 

On the 16 September 2023, the Canadian government announced its intentions to make significant amendments to the Domestic Substances List (DSL), affecting 145 polymers by introducing new chemical noti...

On the 16 September 2023, the Canadian government announced its intentions to make significant amendments to the Domestic Substances List (DSL), affecting 145 polymers by introducing new chemical notification requirements. The DSL, which serves as a comprehensive registry of substances manufactured or imported on a commercial scale in Canada, is a critical reference point for regulatory compliance in the country. The proposed changes are aligned with the Canadian Environmental Protection Act (CEPA) and are designed to enhance the monitoring of substances entering the Canadian market, reinforcing measures to protect human health and the environment. 

New Substances Notification Regulations (Chemicals and Polymers) 

Under the CEPA framework, the import or manufacture of new substances in Canada, above specified thresholds, requires a comprehensive assessment of their potential effects on both human health and the environment. The guidelines for notification of such new chemicals and polymers are detailed in the New Substances Notification Regulations (Chemicals and Polymers), hereafter referred to as "the Regulations"

It is important to note that  substances already on the DSL are generally exempt from the notification requirements specified in the Regulations. However, a significant distinction arises when a substance identifier on the DSL is accompanied by a regulatory flag, represented by the letters "S," "S prime," or "P". In these cases, the substance is subject to notification requirements under particular circumstances. 

The “P” identifier and Reduced Regulatory Requirements 

The letter "P" appended to a substance identifier signifies that the substance in question has been assessed and found to meet the Reduced Regulatory Requirement (RRR) polymer criteria under the Regulations. Substances that meet these criteria are considered to be of lower concern, resulting in reduced regulatory information requirements compared to non-RRR polymers. It is important to note that if a substance is synthesized differently, it may either meet or not meet the RRR polymer criteria. 

The inclusion of the "P" identifier serves the purpose of notifying parties intending to manufacture or import the polymer in a form that does meet the RRR polymer criteria and exceeds prescribed thresholds. Such parties are required to submit the necessary information as specified in the Regulations. Detailed guidance on determining the applicable notification schedule can be found in section 4.7 of the Guidance document for the New Substances Notification Regulations (Chemicals and Polymers). 

Public comment period 

A 120-day window from the date of publication of this notice has been established to allow any concerned individual or organization to provide comments. Those who object to the inclusion of the "P" identifier for specific polymers should explicitly identify the relevant identifier(s) in their comments. 

Canada’s commitment to regulatory measures 

This proposed amendment to the DSL underscores Canada's commitment to strong regulatory measures for the evaluation and control of substances entering its borders, to ensure a safer and healthier environment for its citizens.