Risk assessment summaries for living organisms

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.

For more information on how the New Substances program conducts risk assessment summaries of new living organisms, please consult the following resources:

Microbial risk assessment framework (MRAF) under the New Substances Notification Regulations (Organisms) of the Canadian Environmental Protection Act, 1999

Risk assessment of living organisms subject to the Canadian Environmental Protection Act, 1999 and the New Substances Notification Regulations (Organisms)

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.

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 can also be found below:

Risk assessment summaries of living organisms published in 2026

Saccharomyces cerevisiae expressing lactate dehydrogenase (LDH) from Rhizopus oryzae (New Substances Notification 21573)

Anaerobic 1,1,1-Trichloroethane Degrading Consortium KB-1 Plus 1,1,1-TCA (New Substances Notification 21661)

Recombinant, chimeric vesicular stomatitis virus (VSV) carrying the envelope glycoprotein of the visceral non-neurotropic WE-HPI strain of the lymphocytic choriomeningitis virus, and a codon optimized human CD80 gene fused to the Fc IgG1 heavy chain constant region (VSV-GP-CD80Fc) (New Substances Notification 21695)

Live Vaccinia Virus Acambis clone 2000 (New Substances Notification 21722)

Four genetically modified Drosophila melanogaster strains with a single insert of a construct containing a gene expressing human prolactin, bovine activin, TGF-beta 1, or bovine albumin respectively, each with a marker gene balanced over a chromosome balancer (New Substances Notifications 21725, 21726, 21727, and 21728)

Escherichia coli BL21 ΔrhaB M1RI_pLMAR, BL21 ΔrhaB A1RI_pLMAR, BL21 ∆rhaB M2RI_pLMAR and BL21 ∆rhaB LacZ::Taq (New Substances Notifications 21737, 21738, 21739, and 21740)

Bacillus paralicheniformis CH00005 (New Substances Notification 21835)

Saccharomyces species YS219-A3, YS372-C8, YS392-F7, and YS344-D1 (New Substances Notifications 21838, 21840, 21841 and 21842)

Two genetically modified Drosophila melanogaster strainswith a single insert of a construct containing a gene expressing human IL-10 and human FGF-7 respectively, each with a market gene balanced over two and one chromosome balancers respectively (New Substances Notifications 22022 and 22023)

Unmodified Pseudomonas bacteriophage 1 and 2 (New Substances Notifications 22052 and 22053)

Recombinant and replicative human Herpes Simplex Virus encoding human derived genes for FMS like tyrosine kinase 3 ligand, single chain interleukin-12, cluster of differentiation 40 agonist, and antibody to human cytotoxic T-lymphocyte associated protein 4 (JNJ-87704916) (New Substances Notification 22095)

Alphainfluenzavirus influenzae A/Victoria/4897/2022 IVR-238, A/California/122/2022 SAN-022, and B/Michigan/01/2021 (New Substances Notifications 22147, 22148 and 22149)

Four lines of gene-edited Sus scrofa domesticus with deletion of the SRCR5 domain of the CD163 protein conferring resistance to porcine reproductive and respiratory virus (New Substances Notifications 22051, 22196, 22197 and 22198)

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
Risk assessment summaries of living organisms published in 2019
Risk assessment summaries of living organisms published in 2018
Risk assessment summaries of living organisms published in 2016
Risk assessment summaries of living organisms published in 2015
Risk assessment summaries of living organisms published in 2014
Risk assessment summaries of living organisms published in 2013
Risk assessment summaries of living organisms published in 2012
Risk assessment summary of a living organism publlished in 2010

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2026-05-20