Canada Regulatory News

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. 

The Government of Canada, led by the Honourable Jean-Yves Duclos, Minister of Health, the Honourable Steven Guilbeault, Minister of Environment and Climate Change Canada (ECCC), and the Honourable Mar...

The Government of Canada, led by the Honourable Jean-Yves Duclos, Minister of Health, the Honourable Steven Guilbeault, Minister of Environment and Climate Change Canada (ECCC), and the Honourable Marie-Claude Bibeau, Minister of Agriculture and Agri-Food Canada (AAFC), has unveiled significant initiatives to promote responsible pesticide management across the country while supporting farmers in providing safe and nutritious food. These measures are in line with Canada's commitment to the 2022 Kunming-Montreal Global Biodiversity Framework, which aims to reduce the overall risk from pesticides by at least half by 2030. 

1. Amendments to the Pest Control Products Regulations (PCPR): 

- Health Canada is launching consultations on proposed amendments to the PCPR, following consultations on the Pest Control Products Act in 2022. 

- The amendments aim to evaluate acceptable increases in pesticide residue limits in line with international guidelines. 

- Ensuring the health and safety of Canadians remains a top priority throughout the process. 

2. Elimination of Cosmetic Pesticide Use on Federal Lands: 

- The Government of Canada, through the Greening Government Strategy (GGS) led by the Treasury Board of Canada Secretariat (TBS), is banning the use of cosmetic pesticides on federal lands. 

- The GGS focuses on transitioning to net-zero carbon and climate-resilient operations by 2050, reducing environmental impacts beyond carbon, including waste, water, and biodiversity. 

3. Generating Real-World Data: 

- The ECCC will gather real-world data to enhance understanding of pesticide impacts on the environment and to support sustainable pesticide management in Canada. 

4. Alignment with the Biodiversity Framework:   

- These actions align with Canada's commitment to the 2022 Kunming-Montreal Global Biodiversity Framework, which emphases the reduction of pesticide risks by 2030. 

- The focus is on the impacts of pesticides and risk management, rather than specifying reductions in pesticide use. 

5. Transparency and Accountability: 

- Health Canada is increasing transparency by posting plain language summaries of key decisions online and disclosing applicants' names during the review stage. 

- The external Scientific Advisory Committee (SAC) for pest control products has been established and stakeholders are consulted on a continuous oversight approach and systematic review of emerging science. 

In a recent update, the Government of Canada has informed WTO Members about a delay in the release of the final "Prohibition of Certain Toxic Substances Regulations, 2022." Originally slated for publi...

In a recent update, the Government of Canada has informed WTO Members about a delay in the release of the final "Prohibition of Certain Toxic Substances Regulations, 2022." Originally slated for publication in 2023, these regulations are now expected to be made available no earlier than the summer of 2024. 

Background 

On May 14, 2022, the Government of Canada introduced the "Prohibition of Certain Toxic Substances Regulations, 2022" (proposed Regulations). This announcement was made via the Canada Gazette, Part I, initiating a 75-day public comment period that ended on July 28, 2022. 

Key Changes 

These proposed regulations were designed to replace the existing "Prohibition of Certain Toxic Substances Regulations, 2012" (current Regulations) on the day when the final Regulations would come into effect. The primary goal of the proposed Regulations was to impose stricter controls on specific categories of per- and polyfluoroalkyl substances (PFASs), as well as two types of flame retardants and related products already under regulation. Additionally, two additional flame retardants and their products were slated for inclusion under these regulations. 

Ongoing Review 

During the public comment period, a significant number of complex and technical comments were received. Authorities are diligently assessing these comments and taking them into consideration in the development of the final Regulations. 

This delay in the publication of the final Regulations underscores the Government of Canada's commitment to ensuring a comprehensive and well-considered approach to the regulation of toxic substances. Stay tuned for updates on this crucial matter. 

On August 3, 2023, Health Canada issued a consumer product recall notice for four cosmetic goods manufactured by the US-based company Yes To due to the presence of plastic microbeads. Microbeads are l...

On August 3, 2023, Health Canada issued a consumer product recall notice for four cosmetic goods manufactured by the US-based company Yes To due to the presence of plastic microbeads. Microbeads are listed as toxic substances in Schedule 1 of the Canadian Environmental Protection Act (CEPA).

Yes To, a global pioneer in natural skincare products since 2006, is now devoted to sustainability. The company sells fruit and vegetable-based goods manufactured from natural ingredients such as tomatoes, grapefruit, cucumber, watermelon, avocado, and tea tree. 90% of the products are vegan.

The following four products of the Yes To brand are listed in the recall notice. 35,964 units of the products were sold in Canada between July 2018 and December 2022:

• Grapefruit Daily Facial Scrub

• Tomatoes Charcoal Detoxifying Daily Cleanser

• Tomatoes Detoxifying Charcoal Deep Cleansing Scrub

• Tomatoes detoxifying charcoal deep cleansing scrub CA

Since 2018, the Microbeads in Toiletries Regulation implemented by the Canadian Government bans the manufacturing, importation, and sale of exfoliating or cleansing toiletries using plastic microbeads, as well as non-prescription medications and natural health products. The manufacturing, import, and sale of personal care goods containing plastic microbeads of 5mm (about 0.2 in) or less in size is prohibited. The purpose of the ban is to prevent microplastic particles from contaminating waterways. Health Canada has asked users to cease using the goods immediately and return them to the retailer where they were purchased for proper disposal.  

On 13 July 2023, Health Canada opened a consultation on proposed updates to the Cosmetic Ingredients Hotlist concerning prohibited and restricted ingredients. The consultation is open for new inputs u...

On 13 July 2023, Health Canada opened a consultation on proposed updates to the Cosmetic Ingredients Hotlist concerning prohibited and restricted ingredients. The consultation is open for new inputs until 11 October 2023. 

Health Canada's Cosmetic Ingredient Hotlist serves as a valuable resource for manufacturers and other stakeholders, offering information on specific substances that may contravene the general prohibition outlined in section 16 of the Food and Drugs Act (FDA) or provisions of the Cosmetic Regulations when present in cosmetic products. Additionally, the Hotlist may identify substances that, when present or used under certain conditions, render the product unsuitable for classification as a cosmetic under the FDA. 

To ensure the safety and compliance of cosmetic products, Health Canada periodically updates the Hotlist, with the most recent revision dating back to August 2022. This list plays a crucial role in informing manufacturers and distributors about the restricted or prohibited status of certain substances under Canada's Food and Drug Act (FDA) and Cosmetic Regulations (CR). 

The proposed update includes specific concentration limits for several substances, as follows: 

1. Benzophenone: Health Canada proposes to add benzophenone (CAS 119-61-9) to the list of restricted substances. Some cosmetic uses of benzophenone have been associated with adverse maternal effects, such as decreased body weight. 

2. p-Chloro-m-cresol: Health Canada proposes to include p-Chloro-m-cresol (CAS 59-50-7) in the list of restricted substances due to potential effects on the adrenal organs from certain cosmetic applications. 

3. Retinal: The proposed maximum concentration for Retinal in leave-in products is 0.01% and 0.05% for use in other products. 

4. Solvent Violet 13: Health Canada suggests adding Solvent Violet 13 (CAS 81-48-1) to the list of restricted substances due to potential health concerns associated with specific cosmetic applications. 

5. Basic Green 4: Health Canada aims to prohibit Basic Green 4 (also known as Malachite Green, CAS 569-64-2) due to potential developmental effects. 

6. Thioglycolic acid esters: Health Canada is considering the addition of Thioglycolic acid esters to the list of prohibited substances due to an increased risk of skin sensitization. 

Furthermore, Health Canada proposes changes to existing substance entries, including: 

1. Mixed cresols and derivatives: The entry will be revised to create separate Hotlist entries for different cresols due to their different risk profiles. 

2. Dialkanolamines, secondary: The entry will be revised to include "secondary alkyl- and alkanolamines and their salts" due to their similar potential to act as precursors of carcinogenic nitrosamines. 

3. Alpha-hydroxy acids: Clarifications will be made to include polyhydroxy acids (PHAs) and bionic acids with alpha hydroxyl groups under the definition of alpha-hydroxy acids. Product-specific directions for safe use will also be added. 

4. Aluminum chlorohydrate and its associated complexes: The entry will be revised to indicate that these substances are not permitted in aerosol products, as inhaling small particles from aerosols may affect the lungs. 

5. Peroxide and peroxide-generating compounds: The entry will be revised to introduce a maximum permitted concentration for hair products to mitigate the risk of skin irritation. Additionally, specific conditions for eyelash and eyebrow products will be outlined to address the risk of eye irritation. Furthermore, these ingredients will not be permitted for use in products intended for application to the genital area due to the risk of irritation. 

6. Benzoyl peroxide: The entry will be revised to specify that the ingredient may only be used in nail products for professional use. 

7. Hydroquinone: The entry will be revised to include products for consumer use within the permitted nail product categories. Health Canada also proposes an increase in the maximum permitted concentration for these products and the introduction of a combined limit when both p-Hydroxyanisole and Hydroquinone are used in a nail product. 

8. p-Hydroxyanisole: The entry will be revised to introduce a combined limit when both p-Hydroxyanisole and hydroquinone are used in a nail product. 

9. Retinol and its esters: The entry will be revised to reduce the permitted concentration for certain products, such as body lotions, to prevent exposure levels that exceed the tolerable upper intake levels of vitamin A recommended by Health Canada. 

10. Talc: The entry will be revised to minimize exposure to talc from cosmetics that may be inhaled or result in genital exposure for individuals with intact ovary/ovaries. 

Health Canada invites stakeholders to submit comments on these proposed changes during a 90-day consultation period. All comments received will be carefully considered, and Health Canada will respond before publishing the revised Hotlist. Stakeholders are encouraged to submit their comments by 11 October. 

On the 27 June 2023, the Government of Canada has announced that it will prohibit the testing of cosmetic products on animals before the end of year 2023.  Bill C-47, Budget Implementation Act, 20...

On the 27 June 2023, the Government of Canada has announced that it will prohibit the testing of cosmetic products on animals before the end of year 2023. 

Bill C-47, Budget Implementation Act, 2023, No. 1, has brought about significant changes to the Food and Drugs Act (FDA), specifically targeting cosmetic animal testing. Under these new legislative amendments, companies in Canada are now prohibited from testing cosmetic products on animals or selling cosmetics that rely on animal testing data for safety assessments. 

The global trend towards ethical cosmetic testing has seen a remarkable reduction in the practice of animal testing, which was already infrequently conducted in Canada. By adopting these changes, Canada is aligning itself with other countries that have taken proactive measures to ban cosmetic animal testing, including all European Union member states, Australia, the United Kingdom, and South Korea. 

Moreover, Health Canada is actively collaborating with the international scientific and regulatory community to explore, validate, and implement alternative methods to animal testing, extending beyond the realm of cosmetics. The agency demonstrates its commitment to this cause by providing ongoing leadership and contributing to the efforts of various committees and organizations, such as the Organization for Economic Co-operation and Development (OECD) and the International Cooperation on Alternative Test Methods (ICATM). 

Starting from 22 December 2023, cosmetic product tests that inflict pain on animals or pose a risk to their well-being will be banned. Additionally, the new law will prohibit the sale of any cosmetic product that relies on animal testing data for safety evaluations and will prevent false labeling claims suggesting a product was not tested on animals. The updated legislation introduces several exceptions to the prohibition on animal testing, which include: 

1. Data published by the Canadian government in a scientific journal or on its website. 

2. Data that is publicly available and originates from a test not conducted by manufacturers. 

3. Data obtained from testing required under the laws of Canada or another country for a substance used or previously used in a non-cosmetic product. 

4. Data derived from a test conducted before the effective date of the ban. 

5. Cosmetics that were sold in Canada prior to the effective date of the ban.