New substances: Living organisms
The New Substances Notification Regulations (Organisms) [NSNR (Organisms)] help protect Canadians and the environment as they allow for the assessment of new living organisms prior to their introduction into the Canadian marketplace. Following a New Substances Notification (NSN), Environment and Climate Change Canada and Health Canada carry out a joint assessment process in order to determine whether there is a potential for risk to the environment and human health. When potential risks are identified, the Canadian Environmental Protection Act, 1999 (CEPA) empowers the Minister of Environment and Climate Change to impose control measures.
If you plan to manufacture or import a new living organism subject to notification under the NSNR (Organisms), you are required to provide information to Environment and Climate Change Canada.
Services and information
Fact sheet: New substances (Organisms)
Fact sheet for manufacturers or importers of new living organisms
Notification guidelines: Organisms
Determine whether a living organism is subject to notification and access instructions for the completion of an NSN
Advisory notes providing clarification on various aspects of the New Substances program
New Substances Notification Regulations (Organisms)
Read the Regulations under CEPA, review recent amendments and obtain information about legislative changes and consultations.
Microbial identification framework
Guidance on the methodology and analysis of scientific data required for adequate microbial identification
Notification guidance for organisms used in cell and gene therapy
Guidance for notification related to organisms used in cell and gene therapy and administered to human patients
Masked Name Regulations
Regulations respecting the masking of substance names to prevent the disclosure of confidential information
Voluntary public engagement initiative
Consultations supporting risk assessments of higher organisms (e.g., genetically modified plants and animals)
Administration of the New Substances program - Processing of submissions
Learn how the New Substances program manages your submission throughout the notification process and best practices for your files
Report a problem or mistake on this page
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