Fact sheet: substances subject to Food and Drugs Act and possibly new substances regulations, organisms

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Find out about the New Substances Notification Regulations (Organisms)

If you manufacture or import (produce, grow, develop) new substances, then you must ensure that these new substances have been assessed for the potential risk to the environment or human health as required by the Canadian Environmental Protection Act, 1999 (CEPA 1999).

CEPA 1999 is the key authority for the government to ensure that all new substances are assessed for their potential to harm the environment or human health before they are imported into or manufactured in Canada. However, substances imported or manufactured for uses regulated by other Acts and Regulations that meet certain pre-market notification and assessment criteria are not subject to the New Substances Notification Regulations (Organisms) [NSNR (Organisms)]. Acts and Regulations that meet these criteria are listed in Schedule 4 of CEPA 1999. New substances intended for uses other than those covered under these Acts and Regulations are subject to notification under the NSNR (Organisms) of CEPA 1999. Please note that the Food & Drugs Act is not listed in Schedule 4.

If you manufacture or import a new substance for use in any of the following applications, whether for commercial purposes or for research and development, you may be subject to the NSNR (Organisms) of CEPA 1999. Please note that this list is not exhaustive:

• Pharmaceuticals
• Natural Health Products
• Novel Foods
• Cosmetics
• Veterinary Drugs
• Biologics
• Food Additives
• Personal Care Products
• Production Organisms
• Medical Devices
• Food Packaging
• Other products of biotechnology

We all benefit when you comply with the law.

New Substances Notification Regulations (Organisms)

Why such regulations?

The New Substances Notification Regulations (Organisms) [NSNR (organisms)] of the Canadian Environmental Protection Act, 1999 (CEPA 1999) are an integral part of the federal government's national pollution prevention strategy. As part of the "cradle to grave" management approach for toxic substances laid out in CEPA 1999.

CEPA 1999's approach to the control of new substances is both proactive and preventative, employing a pre-manufacture and pre-import notification and assessment process. When this process identifies a new substance that may pose a risk to the environment or human health, CEPA 1999 empowers Environment Canada to intervene prior to or during the earliest stages of its introduction into Canada. This ability to act early makes the New Substances program a unique and essential component of the federal management of toxic substances.

What is a substance?

A substance is defined as any distinguishable kind of organic or inorganic matter, whether animate or inanimate. Animate matter, or “living organisms”, is addressed under the NSNR (Organisms) and consists of micro-organisms (e.g. bacteria, fungi, yeasts, protozoa, algae, viruses, eukaryotic cell culture and any culture which is not pure) and other organisms (e.g. 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) of CEPA 1999.

What is the Domestic Substances List?

The DSL is a compilation of all known substances that were in Canadian commerce between 1984 and 1986 or that were added to the DSL 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 substance that does not appear on the DSL is subject to the NSNR (Organisms).

Are there new substances that are not subject to the New Substances Notification Regulations (Organisms)?

Yes. Substances regulated under other Federal Acts and Regulations that meet certain pre-market notification and assessment criteria are not subject to the NSNR (Organisms). Acts and Regulations that meet these criteria are listed in Schedule 4 of CEPA 1999. Please note that the Food & Drugs Act is not listed in Schedule 4.

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

Please consult us in advance of initiating the manufacture or importation process of a new substance. You will need information on the composition and use of the new substance to determine how to fulfill your obligation under CEPA 1999and the NSNR (Organisms).

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

Are there fees for submitting a new sustance notifcation for a living organism?

No, at this time, the New Substances Fees Regulations do not apply to substances subject the NSNR (Organism).

Where can I get more information?

To find out more about the NSNR (Chemicals and Polymers) provisions, to consult the DSL or to obtain instructions on how to prepare and submit a notification, visit the New Substances Website.

Who do I contact?

National Office (Gatineau, Hull Sector):
Telephone: (800) 567-1999 (Toll Free in Canada); (819) 953-7156 (Outside of Canada)
Fascimile: (819) 953-7155
E-mail: nsn-infoline@ec.gc.ca

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

Published with the Authority of the Federal Minister of the Environment.
© Minister of Public Works and Government Services 2006.