Overview and guidance documents

Purpose of the Regulations 

The Regulations are an integral part of the federal government's national pollution prevention strategy and were created under the authority of the Canadian Environmental Protection Act, 1999 (CEPA). They are part of the "cradle to grave" approach for management of toxic substances in CEPA. CEPA’s approach to the control of new substances is both proactive and preventative. When potential risks are identified, CEPA empowers the Minister of Environment and Climate Change to impose control measures.

The Regulations ensure that all new substances are assessed prior to their introduction into Canada. Any person (individual or corporation) who plans to manufacture or import a new living organism is subject to the Regulations. Therefore, they are required to notify Environment and Climate Change Canada (ECCC) of their activities.

Note that manufacturing may include activities such as producing, growing or developing new living organisms. Biotechnology is the application of science and engineering in the direct or indirect use of living organisms in their natural or modified forms. This also includes parts or products of living organisms.

Following a New Substances Notification (NSN), ECCC and Health Canada conduct a joint assessment process. This process determines whether there is a potential for risk to the environment, biodiversity and human health. 

New living organism

Any living organism that does not appear on the Domestic Substances List (DSL) of CEPA is considered new and is subject to the Regulations.

Living organism

A living organism, under the Regulations, is a substance that consists of micro-organisms and organisms other than micro-organisms (also referred to as higher organisms), whether non-indigenous, genetically modified or naturally occurring. Micro-organisms can be bacteria, fungi, yeast, protozoa, algae, viruses, or eukaryotic cell cultures and any culture other than a pure culture. Higher organisms can be invertebrate and vertebrate animals, and plants.

Examples of living organisms include:

• naturally occurring micro-organisms, plants and animals that are used in biotechnology applications, such as bioremediation, industrial enzyme production and fermentation;
• all genetically modified, bio-adapted or other modified micro-organisms;
• all genetically modified, bio-adapted, or chimeric plants and animals; and
• interspecies hybrids.

Notification under another Federal Act

The CEPA requirements apply to all new living organisms, unless they are imported or manufactured for a use regulated under one of the federal Acts listed in Schedule 4 of CEPA (currently, the Feeds Act, the Fertilizers Act, the Seeds Act, the Health of Animals Act and the Pest Control Products Act).

Assessment outcomes

The New Substances program will inform you on the outcome of the assessment once it is completed. Possible outcomes include:

1. There is no suspicion of toxicity: you can import or manufacture the living organism, with no further requirements, in any quantity in Canada once the assessment period is over; or
2. There is no suspicion of toxicity for the notified activities associated with the living organism provided that the activities do not change: you can only import or manufacture the living organism in Canada for the purpose of the notified activities. If it is suspected that other activities could result in the substance becoming toxic, Significant New Activity (SNAc) provisions would be applied. This would require further notifications before certain activities can be undertaken with the living organism; or
3. There is a suspicion of toxicity: additional information may be requested or control measures (condition or prohibition) may be imposed to manage any risks to the environment or human health in Canada from living organism.

Enforcement of the Regulations

Failing to comply with the Regulations constitutes an offence under CEPA and may lead to inspections and enforcement action in accordance with the Compliance and Enforcement policy. By complying with the law, you are directly helping to protect the health of Canadians and the environment.