Canada Regulatory News

Canada’s environment and health ministries have suggested including solvent violet 13 to the Cosmetic Ingredient Hotlist, a move that would restrict the dye’s use in cosmetic...

Canada’s environment and health ministries have suggested including solvent violet 13 to the Cosmetic Ingredient Hotlist, a move that would restrict the dye’s use in cosmetics placed in the country.  

The two government agencies nominated to add the dye to Schedule 1 of the Canadian Environmental Protection Act (CEPA), that is, the country’s toxic substances list. To manage exposure risks, the government has recommended imposing potential bans or restrictions on the substance’s use in certain cosmetics through its addition to Health Canada’s Hotlist.  

The government proposed this upon the findings of 2018 screening assessment which concluded that exposure to the substance can increase one’s risk of cancer and lead to toxic effects in the kidneys, liver, spleen or bones. The colourant was one of seven anthraquinone substances assessed.  

The government said solvent violet 13 are not only used in cosmetics but also in candles, pet shampoos, and food packaging. However, no other exposure routes were identified as sources of concern beyond cosmetics. 

Interested parties may submit comments on the proposed risk management action and any other related information until 15 September. 

The ministries said the other six substances do not meet the criteria set out in section 64 of CEPA to justify a toxic substance listing. As a result, the government proposed taking no further regulatory action on: 

•  pigment blue 60; 
•  solvent violet 59; 
•  solvent blue 36; 
•  disperse red 60; 
•  acid blue 239; and 
•  9,10-anthracenedione, 1,4-diamino-, N,N′-mixed 2-ethylhexyl and me and pentyl derivs. 

Performance measurement evaluations provide Canadians with information on the effectiveness of the risk management actions in place for the substances that are found to be toxic under the Can...

Performance measurement evaluations provide Canadians with information on the effectiveness of the risk management actions in place for the substances that are found to be toxic under the Canadian Environmental Protection Act, 1999 (CEPA 1999). The risk management, human health, and environmental objectives are systematically evaluated using robust data and expert analysis under this plan.

Performance Measurement Evaluation report has been published for Bis (2-ethylhexyl) phthalate having a CAS Registry Number 117-81-7.

DEHP was first assessed by the Government of Canada in 1994, where it was concluded that DEHP may enter the environment in a quantity or concentration or under conditions that may constitute a danger in Canada to human health. Risk management tools (Cosmetic Ingredient Hotlist [2009], the Phthalates Regulations [2011], reporting of DEHP content under the Medical Devices Regulations [2008], and provisions under the Food and Drugs Act [1985]) were established to help reduce exposure of DEHP to the general population of Canada in these products.

Overall, risk management tools are intended to meet their goals. Biomonitoring data was collected from three cycles (2007 to 2017) of the Canadian Health Measures Survey (CHMS) which indicates that Canadians’ exposure to DEHP has progressively decreased since risk management tools were adopted.

The performance measurement evaluation recommends ongoing measurement of DEHP in the CHMS and monitoring of the Phthalates Regulations. Ongoing reporting of DEHP concentrations in medical devices is also recommended.

Concluded details on the Performance Management Evaluation for DEHP can be accessed at Performance Measurement Evaluation for Risk Management of Bis(2-ethylhexyl) phthalate (DEHP), Health Component.

Latest update: 2021-06-30

Environment and Climate Change Canada (ECCC) has suggested federal environmental quality guidelines (FEQGs) for aluminum, selenium, and octamethylcyclotetrasiloxane (D4). For this, a draft has bee...

Environment and Climate Change Canada (ECCC) has suggested federal environmental quality guidelines (FEQGs) for aluminum, selenium, and octamethylcyclotetrasiloxane (D4). For this, a draft has been set out for the threshold levels acceptable in the environment for these substances.

FEQGs have laid down concentration levels for these chemicals below which the government assumes that there is a low likelihood of adverse effects on aquatic life or animals in the food chain.

The use of these set guidelines is voluntary unless they are integrated into other regulations. However, they can be used in environmental monitoring, risk management as well as performance measures of these chemicals.

The ECCC has suggested an equation to calculate a site-specific FEQG for aluminum, based on a fresh water body’s level of dissolved oxygen, pH, and water hardness. For selenium, the department has set separate guideline values for fish egg ovary tissue (14.7µg/g), fish whole body tissue (6.7µg/g) and bird eggs (11µg/g). 

Suggested target for D4 in water is 0.2µg/L. 

Comments would be accepted on the proposed threshold by August 11.

Reference: Chemical Watch

Latest Update:  2021-06-15

The Government of Canada evaluated the risks of PFOS, PFOA, and LC-PFCAs, and published the findings in screening assessment reports in 2006 and 2012. The PFOS, PFOA, and LC-PFCAs (and ...

The Government of Canada evaluated the risks of PFOS, PFOA, and LC-PFCAs, and published the findings in screening assessment reports in 2006 and 2012. The PFOS, PFOA, and LC-PFCAs (and their salts and precursors) are prohibited through regulations in Canada; however, scientific evidence to date indicates the PFAS used to replace regulated PFOS, PFOA, and LC-PFCAs may also be associated with environmental and/or human health effects. These substances are predominately known for their composition of carbon-fluorine bonds. This kind of bond is so strong that it makes it difficult to degrade naturally. The Government of Canada has been conducting regular monitoring and surveillance of certain PFAS in terms of exposures from sources, including air, dust, water, products, and food.

The PFAS called the Per and Polyfluorinated substances are a large group of over 5000 human-made substances that have been used in firefighting foams, surfactants, cosmetic non-stick cookware, food packaging and stain-repellent fabrics, textiles, cosmetics and in other numerous areas. These substances are also referred as Forever chemicals because they remain for a longer time in the environment. Therefore, there are growing concerns about how they accumulate in both human and wildlife tissues. 

Adverse environmental and health effects have been observed for well-studied PFAS. Therefore, the Government of Canada intends to approach PFAS as a Single Class. A notice of intent to address the broad class of PFAS was published in the Canada Gazette, Part I: Vol. 155 No. 17 – April 24, 2021. 

With this background, the Canadian Government will continue to collect and examine information on PFSA to inform class-based approach and review policy development in other jurisdictions. They will publish various Reports which will contain information on PFAS Classification.  The input will be welcomed from the various stakeholders and interested parties. stakeholders are invited to provide initial feedback on the intent to address PFAS as a class, including challenges or opportunities they foresee or indicate their interest in being engaged in future discussions by emailing eccc.substances.eccc@canada.ca. 

Final screening assessment and proposed risk management approach  The Government of Canada under the Act of Canadian Environmental Protection Act (CEPA), has added sel...

Final screening assessment and proposed risk management approach 

The Government of Canada under the Act of Canadian Environmental Protection Act (CEPA), has added selenium and 28 of its compounds to Schedule 1 (list of toxic substances).  For the Second Phase of CMP (Chemical Management Plan), some of the Selenium-containing substances are identified as priorities for Action.  

Its selection is based on the Categorization process that has been completed in 2006. Final screening assessment was performed on Substances with selenium moiety ie. on Selenium and its compound. It included substances containing Selenium in all oxidation states like Selenite, Selenate, elemental, selenide, etc and other Organic selenium and all forms of selenium found in the environment that met the categorization criteria and the same was added in Domestic Substance List as well and the same was added in Domestic Substance List as well. The assessment considered the combined exposure to all selenium compounds from natural or industrial sources, whether it is present in water, sediment, soil, air, food, or products available to consumers. 

The Government concluded that selenium and its compounds are harmful to human health, based on the potential for elevated levels in certain subpopulations in Canada; however, they are not considered harmful to the general population of Canada. They are also considered to have a harmful impact on the environment. 

Certain risk management actions have already been initiated by the Government to limit the exposure of these substances. It has been limited in certain uses, including in some foods and natural healthcare products. Following measures have been initiated: 

• The Government lowered the maximum daily dose of selenium from 400 mg/day to 200 mg/day. 

• Health risk assessments and opinions on the potential risks posed by chemical substances in traditional foods or in the interpretation of biomonitoring results will be provided by the Government. Any subsequent risk management advice developed from these assessments, such as issuing a consumption advisory, would be the responsibility of the relevant authority. 

• the Government will continue to monitor the exposures of the general population to selenium through the Canadian Health Measures Survey 

The Schedule 1 listing gives government departments the authority to issue preventative or other control measures to manage potential health and environmental risks from the naturally occurring mineral. 

Last update: 2021-05-12

As per Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Che...

As per Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers).  The amount of fee will be dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List or Non-Domestic Substances List or masked name application).   

Environment and Climate Change Canada has implemented this fee adjustment for the New Substances Program to be in compliance with Canada's Service Fees Act which requires annual fee adjustments based on the country’s Consumer Price Index (CPI). Based on the decrease in CPI over the past twelve months, fees for NSN submissions will decrease by 0.2% starting from April 1, 2021 and it will be valid till March 31, 2022. 

The New Substances program consists of officials from Environment and Climate Change Canada and Health Canada. It is responsible for administering the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) [NSNR] made under the Canadian Environmental Protection Act, 1999 (CEPA). These regulations ensure that no new substances (chemicals, polymers or living organisms) are introduced into the Canadian marketplace before undergoing ecological and human health assessments, and that appropriate control measures have been taken, wherever required. 

To pay for services stated above, a complete New Substances Fees Payment Form, including a credit card authorization form, must be sent either by mail or by courier or one can use the Fee Payment phone line at 1-833-225-2883 (in Canada) or 819-994-8167 (outside Canada). 

All federal departments and agencies that collect fees for regulatory and non-regulatory services are required to develop and implement a Departmental Remissions Policy by April 1, 2021. Each program that charges fees is also required to establish a remissions approach that aligns with the Departmental Remissions Policy. 

The Remissions Approach by New Substances Program (NSP) sets out the scope and application for remission payments, regulatory timeline or non-regulatory performance standard be missed by the NSP.  

Last update: 2021-04-21

Under the New Substance Program, Environment and Climate Canada and Health Canada are responsible for administering the New Substances Notification Regulations (Chemicals and Polymers) a...

Under the New Substance Program, Environment and Climate Canada and Health Canada are responsible for administering the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). Recently, the Canadian government published the Guidelines for the Notification and Testing of New Substances were prepared to assist individuals responsible for complying with the New Substances Notification Regulations (NSNR) under the Canadian Environmental Protection Act, 1999(CEPA, 1999). There is a time-to-time amendments in the Domestic Substance List and Non-Domestic Substance List. Non-Domestic Substance list updates are based on the US EPA’s TSCA Chemical Substances Inventory. 

Guidance Document is meant to help notifiers determine whether a substance is subject to a notification under the regulations or not and to identify the information requirements for the notification.  

In addition to the above it provides, 

• step-by-step instructions for the completion of a New Substances Notification (NSN); 

• user-friendly flowcharts to aid in determining the appropriate schedule to file. 

• technical considerations of the information requirements. 

• detailed instructions on how to complete the New Substances Notification Form; 

• identification of appropriate test procedures and practices to use; and 

• an outline of how confidential information should be submitted. 

Comments provided by June 30, 2021 will be taken into consideration during the development of the final Guidance Document. Comments can be submitted using the online reporting system available through Environment and Climate Change Canada’s Single Window or by email to eccc.substances.eccc@canada.ca. In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information may submit, with the information, a request that it be treated as confidential. Comments received will be considered when developing the final Guidance Document, which is expected to be published late 2021. 

The draft Guidance Document can be found here.  

Last update: 2021-04-21