New Substances Notification Regulations Biotechnology Products

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August 2000

Retail products containing microorganisms, biochemicals (such as enzymes) or biopolymers, are "biotechnology products" and may be subject to the New Substances Notification (NSN) Regulations, pursuant to the Canadian Environmental Protection Act, 1999 (CEPA, 1999).

If you intend to import or manufacture any products that contain these substances you should be aware of these Regulations since notification is required prior to import or manufacture.

The following are examples of products that may be subject to the NSN Regulations if they claim to have enzymatic action or be microbial based:

• compost starters
• septic tank treatments
• pond cleaners
• water conditioners
• degreasers and drain cleaners
• carpet cleaners and deodorizers
• janitorial and sanitary cleaning products
• adhesives

Examples of terminology on packaging to signify that the NSN Regulations may apply are:

• "environmentally friendly bacteria"
• "biodegradable enzymes"
• "naturally occurring micro-organisms"

What Should You Do?

Ask yourself:

• Do I purchase any "biotechnology products" from anywhere outside of Canada? (IMPORTER)
• Do I purchase any of these products from anywhere within Canada and then re-formulate (mix) and create new products for sale? (MANUFACTURER)
• Do I manufacture any "biotechnology products" for sale? (MANUFACTURER)
• Does my supplier know about the NSN Regulations and whether or not the substances in products they are selling are on the Domestic Substances List (DSL)?

If you suspect you are an importer or manufacturer of "biotechnology products" then contact Environment Canada Headquarters or your regional office to determine whether they are subject to the NSN Regulations.

For More Information

NSN Information line:

1-800-567-1999 (if calling within Canada)
1-819-953-7156 (if calling from outside Canada)
New Substances Web Site

Regional Environment Canada Offices:

Please refer to the Contact Us/Comments section of the New Substances Website.

Background

A "new" substance (ingredient) is one that is not on the Domestic Substances List (DSL) and may be subject to notification under the NSN Regulations.

The Canadian Environmental Protection Act, 1999 (CEPA, 1999) requires that all "new" substances (ingredients), including those that are living organisms and their products, be examined for the likelihood that they will harm the environment before they are brought into (imported) or made (manufactured) in Canada. The NSN Regulations provide the tools for Environment Canada and Health Canada to make this assessment and are therefore an important part of the federal government’s national pollution prevention strategy.

What is A Biotechnology Product?

Biotechnology is the combination of biology and technology. Biotechnology takes a living organism and uses it to produce something else. It also takes parts of the living organism, such as a piece of a living cell, and changes it to produce something new. Under CEPA and the NSN Regulations, biotechnology is defined as "the application of science and engineering in the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms" and a biotechnology product is "a substance that is produced by means of biotechnology". Items covered under the biotechnology term are all organisms, their parts and products. Although this is a very broad definition only certain products of biotechnology are regulated by Environment Canada or other federal government departments/agencies.

Remember

A new substance is one that is not on the DSL and may be subject to notification under the NSN Regulations. To ensure that the substance is on the DSL and that you may import it into Canada from another country (including the USA), please contact Environment Canada.