Risk assessment summaries for living organisms

To access risk assessment summaries for new substances (including chemicals, polymers and living organisms), go to Substances Search and select “New Substances Risk Assessment Summaries” in the drop-down menu. Further information on accessing living organism risk assessment summaries is available on this page.

Background

Risk assessments of 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 to impose control measures.

To promote transparency of the New Substances program, Environment and Climate Change Canada and Health Canada publish summaries of environmental and human health risk assessment reports for living organisms. 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:

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.

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

Accessing risk assessment summaries for living organisms

All risk assessment summaries for new living organisms that have been published since 2010 can be obtained through the following steps: go to Substances Search, select “New Substances Risk Assessment Summaries” in the drop-down menu, click "Export to Excel". In the Excel file, filter the results for "Organism" in the "Additional Information" column. The links to the organisms’ risk assessment summaries can be found in the “Recent Publication(s)” column.

The risk assessment summaries for new living organisms published since January 1, 2022, can also be found below:

Risk assessment summaries of living organisms published in 2025

New substances: risk assessment, new substances notification no. 20598 - Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48

New substances: risk assessment, new substances notifications 20941, 20942, and 20943 - DGG-B Benzene degrading anaerobic consortium

New substances: risk assessment, new substances notifications 20941, 20942, and 20943 - DGG-T Toluene degrading anaerobic consortium

New substances: risk assessment, new substances notifications 20941, 20942, and 20943 - DGG-X Xylene degrading anaerobic consortium

New substances: risk assessment, new substances notifications 20433 and 20434 - Saccharomyces species, MeJi797

New substances: risk assessment, new substances notifications 20433 and 20434 - Saccharomyces species, yMHCT484

New substances: risk assessment, new substances notifications 21071, 21072, 21073, and 21074 - A genetically modified Puntigrus tetrazona, descended from Orange Barb 0, founder of the OB-0 line, with multiple copies of a construct containing genes expressing a yellow fluorescent protein derived from a foreign organism

New substances: risk assessment, new substances notifications 21071, 21072, 21073, and 21074 - A genetically modified Puntigrus tetrazona, descended from Purple Barb 0, founder of the PB-0 line, with multiple copies inserted of a construct containing genes expressing a far-red fluorescent protein

New substances: risk assessment, new substances notifications 21071, 21072, 21073, and 21074 - A genetically modified Puntigrus tetrazona, descended from Red Barb 0, founder of the RB-0 line, with multiple copies inserted of a construct containing genes expressing a red fluorescent protein derived from a foreign organism

New substances: risk assessment, new substances notifications 21071, 21072, 21073, and 21074 - A genetically modified Puntigrus tetrazona, descended from Green Barb 0, founder of the GB-0 line, with multiple copies inserted of a construct containing genes expressing a green fluorescent protein derived from a foreign organism

Risk assessment summaries of living organisms published in 2024

New substances: risk assessment summary 20497 - Coxsackivarius A21, Kuykendall strain

New substances: risk assessment summary 21300 - Escherichia coli strain SYBNB1934v1

New substances: risk assessment summary 21116 - Prevotella histicola strain ES894

New substances: risk assessment summary 21343 - Recombinant Human T-cells transduced with a non-replicative lentiviral vector expressing a chimeric antigen receptor binding the human B-cell cell surface proteins CD19 and CD22 (IMJ995)

New substances: risk assessment summary 20657 - Recombinant replication-defective chimpanzee adenovirus Ox1 expressing Spike protein (S protein) of SARS-CoV-2 (ChAdOx1-S)

New substances: risk assessment summary 20417 - Recombinant replication-defective human adenovirus type 5 expressing Spike protein (S protein) of SARS-CoV-2 (Ad5-nCoV)

New substances: risk assessment summary 21561 - A genetically modified Drosophila melanogaster strain with a single insert of a construct containing a gene expressing bovine FGF2 and a marker gene balanced over a chromosome balancer

New substances: risk assessment summary 21655 - A genetically modified Epalzeorhynchos frenatum, descended from Blue Shark 0, founder of the BS2017-0 line, with multiple inserted copies of constructs containing genes expressing a blue fluorescent protein and a chromoprotein derived from a foreign organism

New substances: risk assessment summary 21656 - A genetically modified Epalzeorhynchos frenatum, descended from Green Shark 0, founder of the GS2017-0 line, with multiple inserted copies of a construct containing genes expressing a green fluorescent protein derived from a foreign organism

New substances: risk assessment summary 21657 - A genetically modified Epalzeorhynchos frenatum, descended from Orange Shark 0, founder of the OS2016-0 line, with multiple inserted copies of a construct containing genes expressing an orange fluorescent protein derived from a foreign organism

New substances: risk assessment summary 21658 - A genetically modified Epalzeorhynchos frenatum, descended from Purple Shark 0, founder of the PS2016-0 line, with multiple inserted copies of a construct containing genes expressing a far-red fluorescent protein derived from a foreign organism

Risk assessment summaries of living organisms published in 2023
Risk assessment summaries of living organisms published in 2022

Substance identification in summaries

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 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 New Substances program.

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2025-10-24