Aquatic biotechnology regulation

Learn about aquatic biotechnology regulations, risk assessment, published orders, guidance documents and notification forms.

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Scientists from Fisheries and Oceans Canada (DFO) contribute to regulating fish products of biotechnology through research and scientific advice.

We also helped put into effect the New Substances Notification Regulations (Organisms) under the Canadian Environmental Protection Act, 1999, by:

  • assisting with administration of the New Substances Program
  • conducting risk assessments of fish products of biotechnology

This is done in partnership with Health Canada, and Environment and Climate Change Canada.

Acts and regulations

The Canadian Environmental Protection Act, 1999, provides the authority to address pollution problems:

  • on land
  • in water
  • through all layers of the atmosphere

The act is administered by Health Canada, and Environment and Climate Change Canada. It ensures all new living organism products of biotechnology are assessed for their potential to harm the environment and human health. The measures target these products prior to their import into or manufacture in Canada.

New substances

The New Substances Notification Regulations (Organisms) specify the information you need to submit if a living organism isn't on the domestic substances list. This includes:

  • fish products of biotechnology
  • products intended for import or manufacture

Fish products of biotechnology on the domestic substances list don't require notification unless they're proposed for a significant new activity.

We may issue a notice if we suspect that a significant new activity may result in the fish becoming toxic.  

You must provide additional information on the product if you intend to:

  • use
  • import
  • manufacture

The additional information will allow us to assess the new activity's potential environmental and human health risks.

The regulations don't apply to:

  • fish products of biotechnology that:
    • are research and development organisms
    • are imported to or manufactured in a facility from which there's no release into the environment of:
      • the organism
      • the genetic material of the organism
      • material from the organism involved in toxicity
  • aquatic animal strains that are indigenous to Canada, including Canadian wildlife species and their offspring produced through:
    • traditional breeding
    • artificial insemination
    • surrogate hosting

Risk assessment decisions

You must provide the information requested in Schedule 5 of the New Substances Notification Regulations (Organisms) at least 120 days prior to importing or manufacturing your product.

We use this information to conduct a risk assessment to determine if the product is toxic. If we suspect that a fish product of biotechnology is toxic, our government partners may impose control measures, such as:

  • controls on import and manufacture
  • prohibition of import and manufacture
  • prohibition pending submission and assessment of additional information

Published orders for biotechnology

The Canada Gazette publishes new substance biotechnology orders of regulatory decisions, including:

Guidance documents

For individuals responsible for complying with regulations, we've prepared:

Notification forms

The new substances notification form (PDF, 809 KB) aids in:

  • complying with the regulations
  • completing the New Substances Notification dossiers prior to submission to Environment and Climate Change Canada

For help in completing and submitting the forms, contact us by:

  • phone, toll-free within Canada: 1-800-567-1999
  • phone outside Canada: 1-819-953-7156
  • email:

Informing us that you've made a submission

If you send in a regulatory submission to the minister for Environment and Climate Change Canada, we encourage you to notify us as well. You can do this by providing a copy of the new substances notification form to:

Director, Biotechnology and Aquatic Animal Health Sciences Branch
Fisheries and Oceans Canada
200 Kent St, 12E-236
Ottawa ON  K1A 0E6

If you have any questions, contact us by:

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