New substances: Risk assessment summaries
Adopted pursuant to the provisions of the Canadian Environmental Protection Act, 1999 (CEPA), the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) require new substances to undergo an assessment of their potential adverse effects on the environment and human health to determine whether they have potential to pose a risk before they are imported into or manufactured in Canada.
Any company or individual who plans to manufacture or import a new substance into Canada must provide the New Substances (NS) program with a New Substances Notification (NSN) containing all information prescribed in those regulations prior to import or manufacture.
Risk assessments on new substances are conducted by Environment and Climate Change Canada and Health Canada. These assessments consider other information such as biological characteristics (including genetic modifications), physical and chemical properties, inherent hazards, uses, release scenarios and routes of exposure to determine whether a substance is or may become harmful to human health or the environment as set out in section 64 of CEPA. If harm or potential harm is suspected, the Minister of Environment and Climate Change will then apply the required control measures.
Where a control measure (including significant new activity requirements, ministerial conditions, prohibitions) has been applied to a new substance following the risk assessment, a notice is published in the Canada Gazette Part I. When a substance subject to significant new activity requirements subsequently meets the criteria for addition to the Domestic Substances List, an order will then be published in the Canada Gazette Part II, adding the substance and the requirements to the Domestic Substances List.
Where a substance’s explicit chemical or biological name is considered to be confidential business information, CEPA allows for masked names to be published in their place. Masked names are regulated under the Masked Name Regulations. The Department of the Environment and Climate Change assigns each confidential substance identity numbers, also referred to as a confidential accession number (CAN) by the NS program.
Risk assessments under CEPA do not include an assessment of the potential exposure and health risks specifically associated with occupational exposure. They are not relevant to nor do they preclude an assessment against the hazard criteria for Workplace Hazardous Materials Information System that are specified in the Controlled Products Regulations or the Hazardous Products Regulations for products intended for workplace use.
Initiative to promote transparency
To promote transparency of the NS program, Environment and Climate Change Canada and Health Canada publish summaries of environmental and human health risk assessment reports for new substances that are chemicals, polymers, and living organisms. The risk assessment summaries can be accessed through Substances Search. To view or download a list of all published summaries, select “New Substances Risk Assessment Summaries” in the dropdown menu.
These summaries provide an overview of information examined during the assessment period, as well as the conclusions and regulatory decisions that were made. The key elements found in the summaries include:
- the substance identity
- its use
- its hazard
- its exposure
- its environmental fate
- the assessment of its ecological risk
- the assessment of its human health risk
- the regulatory decisions
Summaries for chemicals and polymers
On average, the NS program receives up to 500 chemical and polymer notifications annually. Risk assessment summaries will be published on a regular basis for notifications where control measures are applied (including significant new activity requirements, ministerial conditions, and ministerial prohibitions) and the most complete notifications (schedules 5, 6, 10 and 11) except for schedule 9 Reduced Regulatory Requirement (RRR) polymers.
RRR polymers have a high number average molecular weight and low percent of low molecular weight components (less than 1000 daltons), which are chemically stable and do not contain certain reactive or cationic moieties associated with human health or environmental concerns. The high molecular weight of these polymers prevents them from crossing biological membranes. Therefore, they are considered to be of low concern, which allows for fewer regulatory information requirements under the New Substances Notification Regulations (Chemicals and Polymers) than for non-RRR polymers. When a RRR polymer meets the criteria for addition to the Domestic Substances List, it is listed with a "P" flag, which means it must be re-notified if a non-RRR version of the polymer is being proposed for manufacture or import.
For a more detailed overview of how environmental and human health risk assessments are conducted for chemicals and polymers, please consult the following supporting documentation:
- Overview of the Ecological Assessment of Substances under the Canadian Environmental Protection Act, 1999
- Determination of "Toxic" for the Purposes of the New Substances Provisions (chemicals and polymers) under the Canadian Environmental Protection Act - Human Health Considerations
The qualifiers used in the risk assessment summaries (e.g. low, moderate, high) to describe hazard are generally aligned with those used in other jurisdictions, (e.g. used by the United States Environmental Protection Agency) and with the Global Harmonized System of Classification and Labelling of Chemicals. All experimental and calculated values are listed as ranges to protect confidential business information.
Where the substance identity is not considered to be confidential, it is identified in the summary by its explicit chemical name and Chemical Abstract Services Registry Number (CAS RN). The CAS RN is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
Summaries for living organisms
On average, the NS program receives (annually) up to 30 notifications of living organisms that are products of biotechnology. Based on the information received in these notifications, Environment and Climate Change Canada and Health Canada make risk assessment decisions for these living organisms. Risk assessment summaries will be published on a regular basis for notifications representing a wide spectrum of organism types, methods of manufacture, uses and risk levels, including but not limited to notifications where control measures are applied.
Where the organism's identity is not considered to be confidential, it is identified by its explicit biological name in the summary. In cases where the organism's identity is considered to be confidential business information, a masked name is used, where one or more components of the explicit biological name (such as genus, species, strain or line) are masked.
If you have any questions or comments concerning the publication of new substances risk assessment summaries, please contact the New Substances program.
Telephone: 1-800-567-1999 (Toll Free in Canada); or 1-819-938-3232 (Outside of Canada)
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