Fact sheet: micro-organisms or microbial based products

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Find out about the New Substances Notification Regulations

If you import or manufacture (produce, grow, develop) new¹ micro-organisms (such as bacteria, fungi, yeast, protozoa, algae, viruses, cell culture, etc.), or microbial based products, whether naturally occurring or genetically modified, then you must ensure that these new substances have been assessed for potential environment or human health risks as required by federal law.

The government does not assume that "naturally occurring" micro-organisms are necessarily safe; nor should you.

The Canadian Environmental Protection Act, 1999 (CEPA 1999) is the key authority for the government to ensure that all new substances are assessed for their potential to harm human health, the environment, including biodiversity. Recognizing that other Acts provide for an assessment process, CEPA 1999includes a provision whereby substances regulated by other Acts (i.e., Feeds Act, Seeds Act, Fertilizers Act, Pest Control Products Act, or Health of Animals Act) are exempt from the new substances notification requirements of CEPA 1999. New micro-organisms intended for uses other than those covered under these Acts are regulated under CEPA 1999and its New Substances Notification Regulations (NSNR).

If you import or manufacture any of the following, whether for commercial purposes or for research and development, you may be subject to CEPA 1999's NSNR²:

Micro-organisms or microbial based products intended for use in:

• Bioremediation
• Biosensing
• Biofiltration
• Mineral leaching
• Fuel productionGas desulfuration
• Enhanced Oil Recovery
• Fossil fuel or natural gas desulfurationproduction
• Pulp and Paper
• Biological waste treatment
• Products for RV holding tanks
• Septic Tank Starter
• Compost Starter
• Cleaners/detergents
• Odor Control Products
• Biomass Conversion
• Wax Separation
• Microbial drain cleaning/degreasing
• Field Trials
• Microbial Production Organisms
• Enzyme production

We all benefit when you comply with the law.

New Substances Notification Regulations (NSNR)

Why regulate new substances?

The approach to 'new' substances taken by the Government of Canada, as expressed in the Canadian Environmental Protection Act, 1999 (CEPA 1999), is that New Substances must be assessed for potential harm to the environment or human health before they are imported, or manufactured (produced, developed, grown), or sold in Canada. The New Substances Notification Regulations (NSNR) are an integral part of this approach and part of the federal government's national pollution prevention strategy.

The CEPA 1999 approach to the control of new substances is both proactive and preventative, employing a pre-import or pre-manufacture notification and assessment process. When this process identifies a new substance that may pose a risk to human health or the environment, or biodiversity, the Act empowers Environment Canada to intervene prior to or during the earliest stages of its introduction into Canada.

What is a substance?

A substance consists of either animate or inanimate matter. Animate matter or 'living organisms' consist of two groups: micro-organisms and other organisms (such as animals and plants). Micro-organisms are broadly defined as bacteria, fungi, yeasts, protozoa, algae, viruses, eukaryotic cell culture, and any culture which is not pure. "Other organisms" include animals and some plants, such as those that are not indigenous to Canada or are genetically modified.

What is a new substance?

A new substance is any substance that does not appear on the Domestic Substances List (DSL).

What is the Domestic Substances List?

The organisms portion of the DSL is list of existing organisms (i.e., that are not 'new' in accordance with CEPA 1999). In certain circumstances, the Minister of the Environment may amend the DSL by adding or deleting substances according to CEPA 1999.

Where can I get a copy of the Domestic Substances List?

The DSL can be searched on the New Substances Website.

Any organism that does not appear on the DSL may be subject to the NSNR.

Are there organisms that are not subject to the New Substances Notification Regulations?

Yes. New organisms regulated for a use covered under other Federal Acts listed in Schedule 4 of CEPA 1999. All other uses require notification under CEPA 1999. Schedule 4 lists the following: Feeds Act (Feeds Regulations), Seeds Act (Seeds Regulations) Fertilizers Act (Fertilizers Regulations), Health of Animals Act (Health of Animals Regulations), and Pest Control Products Act (Pest Control Products Regulations)

I want to manufacture or import a new substance. What should I do?

Please consult us in advance of initiating the manufacture or importation process of a new substance. Information on the composition and intended use of the new substance is used to determine whether or not the NSNR apply to you and determine how to fulfill your obligation under CEPA 1999 and the NSNR.

You must fulfill the requirements of the NSNR before manufacturing or importing a new substance.Enforcement of the NSNR will be conducted in accordance with the Compliance and Enforcement Policy of CEPA 1999.

Where can I get more information?

To find out more on the NSNR or its provisions, to consult the DSL, or to obtain instructions on how to complete the notification, visit the New Substances Website.

Who do I contact?

National Office (Gatineau):
Telephone: (800) 567-1999 (Toll Free in Canada); (819)-938-3232 (Outside of Canada)
Fascimile: (819) 938-5212
E-mail: substances@ec.gc.ca

The information presented here is not exhaustive. The intent is to highlight relevant points in the New Substances Notification Regulations established under CEPA 1999. In case of a discrepancy between this bulletin, CEPA 1999 and the New Substances Notification Regulations, the legislation and the Regulations will prevail. Please refer to the Regulations for complete details on the requirements.