New substances: Risk assessment summaries

Background

Risk assessments of new substances (chemicals, polymers and living organisms) are conducted by Environment and Climate Change Canada and Health Canada. These assessments determine whether a substance is or may become harmful to human health or the environment as set out in section 64 of the Canadian Environmental Protection Act, 1999 (CEPA). When potential risks are identified, CEPA empowers the Minister of Environment and Climate Change to impose control measures.

To promote transparency of the New Substances (NS) program, Environment and Climate Change Canada and Health Canada publish summaries of environmental and human health risk assessment reports for new substance. These summaries provide an overview of information examined during the assessment period, as well as the conclusions and regulatory decisions that were made. All experimental and calculated values are listed as ranges to protect confidential business information. 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

For more information on the risk assessment summaries or to obtain a full copy of a summarized risk assessment report, please contact us.

Summaries for chemicals and polymers

The NS program receives approximately 400 chemical and polymer notifications annually. For more information on these notifications, please consult the Guidance Document for the notification and testing of new substances: chemicals and polymers.

Risk assessment summaries are published on a regular basis for notifications where control measures are applied (including significant new activity requirements and ministerial conditions) and for the most complete notifications including those under schedules 5, 6, 10 and 11 of the New Substances Notification Regulations (Chemicals and Polymers). No risk assessment summaries are published for notifications of Reduced Regulatory Requirement polymers^{Footnote 1} as these substances are considered to be of low concern.

The qualifiers used in the risk assessment summaries for chemicals and polymers (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.

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

Summaries for living organisms

The NS program receives approximately 50 notifications annually of living organisms that are products of biotechnology. For more information on these notifications, please consult the Guidelines for the Notification and Testing of New Substances: Organisms.

Risk assessment summaries are 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.

To access risk assessment summaries for living organisms, go to Substances Search, select “New Substances Risk Assessment Summaries” in the drop-down menu, click "Export to Excel" and filter the results for "Organism" in the "Additional Information" column.

Substance identification in summaries

Where the substance identity of a chemical or polymer is not considered to be confidential, it is identified in the summary by its explicit chemical name and Chemical Abstract Services Registry Number^{Footnote 2}.

Where the substance identity of a living organism is not considered to be confidential, it is identified by its explicit biological name in the summary.

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, which permit the masking of one or more distinctive elements of the explicit name. The Department of the Environment and Climate Change assigns each confidential substance identity numbers, also referred to as a confidential accession number by the NS program.