Canada Regulatory News

On 11 May 2024, the Canadian Department of Environment published a notice proposing amendments to the Domestic Substance List (DSL) and introducing significant new activity (SNAC) notification require...

On 11 May 2024, the Canadian Department of Environment published a notice proposing amendments to the Domestic Substance List (DSL) and introducing significant new activity (SNAC) notification requirements for certain consumer and cosmetic uses of piperazine.

Amendments to be considered following the implementation of the draft:

• Significant New Activity Notification (SNAN): The Order amending the DSL proposes that individuals or corporations undertaking significant new activities with a substance must submit a Significant New Activity Notification (SNAN) at least 90 days before the activity begins.
• Human Health Concerns: The Order aims to address human health concerns by targeting the use of the substance in consumer products and cosmetics, as these are potential sources of direct exposure.
• Notification Requirements: SNAC notification is required for the use of piperazine in the manufacture of consumer products and cosmetics if the concentration of the substance is equal to or greater than 0.1% by weight, and for the import of the substance in consumer products if the total quantity is greater than 10 kg per year.
• Exemptions: An activity is not a SNAC if the substance is a R&D substance, a site-limited intermediate or if the substance or the product containing the substance is only intended for export.

Assessment report

Along with the notice the Department of Environment and the Department of Health have published the piperazine assessment study, which concludes that piperazine has a low risk of environmental impact.

Piperazine does not meet the criteria outlined in paragraphs 64(a) and (b) of CEPA because it does not enter the environment in a quantity or concentrations or under conditions, that have or may have an immediate or long-term harmful effect on the environment or its biological diversity, or that constitute or may constitute a danger to the environment on which life depends.

Comment deadline

The draft Notice draft is open for public comment for the next 60 days, until 10 July 2024.

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 May 11, 2024, the Minister of the Environment published a Notice of Intent to amend the Domestic Substances List (DSL) under the Canadian Environmental Protection Act, 1999 (CEPA) by adding the let...

On May 11, 2024, the Minister of the Environment published a Notice of Intent to amend the Domestic Substances List (DSL) under the Canadian Environmental Protection Act, 1999 (CEPA) by adding the letter “P” to the identifiers of 264 polymers. These polymers have been assessed to meet the reduced regulatory requirement (RRR) criteria for polymers.

Purpose of the Amendment

The amendment ensures that only polymers that meet the RRR criteria are included on the DSL. This clarification requires that non-RRR forms of these polymers undergo environmental and health risk assessments prior to import or manufacture in Canada.

Background Information

The DSL lists substances that are manufactured or imported into Canada on a commercial scale. Substances not listed on the DSL are new and are subject to rigorous assessment under CEPA. The letter “P” will denote polymers that have been assessed as being of low concern under the RRR criteria, simplifying regulatory requirements.

Public Comment Period

Individuals and organizations are invited to provide comments within 120 days of the publication of the notice. Comments should clearly reference the specific polymer identifier(s) and can be submitted through Environment and Climate Change Canada’s Single Window online reporting system, by mail, or by email.

Next Steps

Following the 120-day comment period, feedback will be reviewed and a final order will be published in the Canada Gazette, Part II. The amendment will not take effect until it is published in Part II.

Additional Information

Detailed guidance can be found in section 4.7 of the New Substances Notification Regulations (Chemicals and Polymers).

The Notice underscores the Government's commitment to protecting the environment and public health through the careful monitoring and regulation of chemical substances in Canada.

Affected Substance Identifiers

The proposed order, 2025-66-01-01, aims to amend Part 1 and Part 3 of the DSL by adding “P” to the following substance identifiers:

Part 1 Amendments:

- 9070-52-4 T

- 25053-63-8 T

- 25120-19-8 T

- 25212-83-3 T

- 25214-36-2 T

- 25322-25-2 T

- 25639-14-9 N

- 25852-38-4 N

- 26061-90-5 N

- 26124-53-8 T

- 26282-37-1 N

- 26426-80-2 T

- 26568-80-9 N

- 26590-75-0 N

- 26713-18-8 T

- 26916-05-2 T

- 27081-93-2 T

- 27791-59-9 T

- 28064-24-6 T

- 28301-43-1 T

- 28431-58-5 T

- 28679-45-0 N

- 32875-88-0 N

- 34150-07-7 T

- 36179-98-3 N

- 36487-02-2 T

- 37324-79-1 T

- 41171-14-6 T

- 42847-45-0 N

- 49603-78-3 T

- 51541-08-3 N

- 51999-21-4 T

- 52257-10-0 T

- 52496-38-5 T

- 54452-17-4 T

- 57516-88-8 T

- 59326-15-7 T

- 61909-78-2 T

- 62386-95-2 T

- 63330-34-7 T

- 63625-36-5 T

- 63744-65-0 T

- 64652-60-4 N

- 64771-95-5 T

- 65104-04-3 T

- 65408-87-9 T

- 65483-24-1 T

- 65802-03-1 N

- 66070-77-7 T

- 66228-39-5 N

- 67762-18-9 T

- 67846-36-0 T

- 67906-91-6 T

- 67931-19-5 T

- 67939-49-5 T

- 68015-11-2 T

- 68052-55-1 N

- 68110-06-5 T

- 68110-14-5 N

- 68139-67-3 T

- 68188-50-1 N

- 68333-71-1 T

- 68389-60-6 T

- 68410-42-4 T

- 68475-51-4 T

- 68604-67-1 N

- 68683-26-1 T

- 68784-99-6 T

- 71077-24-2 T

- 71394-06-4 T

- 72452-28-9 T

- 72480-46-7 T

- 72828-34-3 T

- 77553-50-5 T

- 79084-85-8 T

- 79771-02-1 T

- 80407-29-0 T

- 86797-81-1 N

- 87194-23-8 T

- 87483-43-0 T

- 88285-91-0 T

- 89066-72-8 T

- 89492-19-3 N

- 95038-69-0 T

- 95991-18-7 T

- 96591-30-9 T

- 96805-65-1 T

- 96828-30-7 T

- 96828-31-8 T

- 96899-94-4 N

- 97649-74-6 T

- 99716-31-1 N

- 100486-98-4 T

- 100588-06-5 T

- 102242-83-1 T

- 103192-64-9 N

- 103991-34-0 T

- 104677-82-9 T

- 104836-00-2 N

- 107175-81-5 T

- 110532-17-7 T

- 113010-50-7 T

- 114223-00-6 N

- 115035-53-5 T

- 115079-34-0 N

- 116736-81-3 N

- 117222-27-2 T

- 117581-13-2 T

- 118922-88-6 N

- 118948-85-9 N

- 123447-94-9 T

- 125229-71-2 T

- 127104-71-6 N

- 128781-91-9 T

- 130935-48-7 T

- 132674-73-8 T

- 132937-27-0 T

- 134211-52-2 N

- 138155-73-4 T

- 143239-44-5 T

- 149610-57-1 T

- 150739-87-0 T

- 151006-66-5 T

- 152722-38-8 T

- 152957-31-8 T

- 154530-32-2 T

- 156509-98-7 N

- 156984-48-4 T

- 157937-76-3 T

- 157969-17-0 T

- 158061-47-3 T

- 159451-98-6 T

- 160369-81-3 T

- 161075-47-4 N

- 162162-69-8 T

- 163440-74-2 N

- 163961-33-9 T

- 164002-57-7 T

- 164843-73-6 T

- 165245-17-0 T

- 165800-58-8 N

- 168886-09-7 N

- 170082-99-2 T

- 170475-04-4 T

- 170557-44-5 T

- 173524-62-4 T

- 174254-28-5 T

- 174662-92-1 T

- 174881-72-2 T

- 175779-57-4 N

- 179733-16-5 N

- 181493-03-8 T

- 183681-08-5 N

- 184181-25-7 N

- 184785-39-5 T

- 185260-02-0 T

- 188958-72-7 N

Part 3 Amendments:

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.