Canada Regulatory News

The Canadian government has announced plans to restrict more than a dozen gas oil and kerosene substances in certain consumer products, citing potential risks to human health. The decision follows a p...

The Canadian government has announced plans to restrict more than a dozen gas oil and kerosene substances in certain consumer products, citing potential risks to human health. The decision follows a provisional determination that 16 substances in the ‘gas oils and kerosenes with uses in products available to consumers’ (GOKUPAC) group meet the toxicity criteria under section 64 of the Canadian Environmental Protection Act (CEPA), according to a draft assessment published on May 4.

 Key Dates

- May 4, 2024: Start of 60-day public comment period on the draft assessment and risk management scope. Notice published in the Canada Gazette, Part I: Vol. 158, No. 18.

- May 2025: Expected release of final assessment and proposed risk management approach.

Background Information

Initially, the 15 substances from the GOKUPAC group were part of a broader assessment involving 42 substances. Additional human health information led to the removal of these 15 substances from the original group. New ecological data also changed the proposed conclusion on environmental effects and determined that these substances are not harmful at the exposure levels considered in the assessment. The current draft assessment focuses on these 15 gas oils and kerosenes and one additional similar substance, CAS RN 64771-72-8.

 Public Comment Period

The public is invited to submit written comments within 60 days of the publication of the notice. Comments should address the proposed actions and the scientific basis for these actions. More scientific details can be found on the Canada.ca (Chemical Substances) website.

 By addressing these potential risks, the Canadian Government aims to improve consumer safety and protect public health from exposure to hazardous chemicals.

On March 26, 2024, Health Canada introduced significant changes to the Hazardous Materials Information Review Act (HMIRA) aimed at simplifying the process for companies seeking Confidential Business I...

On March 26, 2024, Health Canada introduced significant changes to the Hazardous Materials Information Review Act (HMIRA) aimed at simplifying the process for companies seeking Confidential Business Information (CBI) exemptions for Safety Data Sheets (SDS) and labels. Effective April 1, these changes are intended to streamline the timelines for CBI submission under the HMIRA.

Understanding the Canadian CBI Claim Exemption:

The CBI claim exemption mechanism allows companies to protect trade secrets that have significant economic value. If disclosed, these could cause financial harm. Approved information remains protected, and companies must compensate the Canadian government for protecting these trade secrets under the HMIRA regulations.

Key Changes and Service Standards:

- The timeline for service standard will exclude the period during which an applicant provides additional information in response to Health Canada's request.

- New CBI service standards effective April 1, 2024, are listed in the table below together with the fees:   

Terminating an Exemption:

Companies may request termination of their CBI exemption at any time during the 3-year exemption period if:

- Confidential information is disclosed.

- Prescribed concentration ranges are used.

- The hazardous product is no longer sold or imported into Canada.

On April 27, 2024, the Government of Canada has published the Acids and Bases Group Assessment, which concludes that these substances are not harmful to human health or the environment. A notice to th...

On April 27, 2024, the Government of Canada has published the Acids and Bases Group Assessment, which concludes that these substances are not harmful to human health or the environment. A notice to that effect has been published in the Canada Gazette, Part I: Vol. 158, No. 17.

Overview:

The Government of Canada conducts comprehensive risk assessments under the Canadian Environmental Protection Act, 1999 (CEPA) to evaluate potential risks to human health and the environment. The Acids and Bases Group assessment focused on 22 substances, which were divided into six subgroups as follows:

1. Ammonia (hydroxylammonium chloride)

2. Free Available Chlorine, Chlorate, and Chlorite (FACCC) substances: Chlorine, sodium hypochlorite, calcium hypochlorite, sodium chlorate, chlorine dioxide

3.Sulphite: Sodium bisulfite, sodium metabisulfite

4. Hydrogen and Hydroxide: Potassium hydroxide, sodium hydroxide, potassium silicate, sodium silicate, hydrochloric acid, sulphuric acid, potassium oxide

5. Phosphate: Diphosphorus pentoxide, phosphoric acid

6. Nitrate and Nitrite: Sodium nitrate, sodium nitrite, nitric acid, potassium nitrate, calcium nitrate

Human and Ecological Exposure:

- Thirteen of the 22 substances were assessed using the Low Human Health Hazard Potential Approach, indicating low concern for human health.

- FACCC Subgroup: Canadians may be exposed to these substances through air, drinking water, food, and consumer products (e.g., odor control, cleaning products, cosmetics).

- Nitrate and Nitrite Subgroup: Exposure pathways include air, drinking water, soil, dust, food, and consumer products (e.g., cosmetics, cleaning products).

Principal Health and Ecological Effects (Hazard):

- FACCC Subgroup: Inhalation, neurobehavioral, and thyroid effects.

- Nitrate and Nitrite Subgroup: Circulatory system effects.

- Other Subgroups: pH changes (10 substances), effects on aquatic organism (4 substances).

Consideration of Vulnerable Populations:

- Groups such as infants, children, and persons of reproductive age were considered.

- Developmental and reproductive toxicity studies were evaluated for adverse health effects.

Risk Assessment Results:

- Human Health: Thirteen substances posed a low risk to health. For the eight substances in the FACCC and Nitrate/Nitrite subgroups, exposure levels were compared with health effects and determined to be low risk.

- Environmental Health:

  - Sixteen substances do not cause environmental harm.

  - Ten substances are of low ecological concern based on pH measurements.

  - Six substances are of low environmental concern based on hazard and exposure potential.

Assessment Conclusions:

- The 22 substances in the Acids and Bases Group are not harmful to human health.

- Sixteen substances (sodium bisulfite, sodium metabisulfite, potassium hydroxide, sodium hydroxide, potassium silicate, sodium silicate, hydrochloric acid, sulphuric acid, potassium oxide, diphosphorus pentoxide, phosphoric acid, sodium nitrate, sodium nitrite, nitric acid, potassium nitrate, and calcium nitrate) are not harmful to the environment.

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.