Waivers for New Substances and Organisms

Summary#

The federal government published a notice that the Minister of the Environment has waived some information requirements under the Canadian Environmental Protection Act, 1999 for a small number of new living organisms and chemical substances. The waivers mean the named companies did not have to submit certain test data when they filed their regulatory notifications. The notice appeared in the Canada Gazette on July 27, 2024.

What it does#

• For new living organisms, the Minister waived required test data for some companies. The types of data waived include:
  • data from tests of antibiotic susceptibility; and
  • data from tests to determine effects on aquatic plants, invertebrates and vertebrates likely to be exposed; and
  • data from tests to determine effects on terrestrial plants and invertebrates likely to be exposed.
• Companies listed for these living-organism waivers include Canadienzyme Inc., Cordex Biologics Inc., Janssen Inc., Qeen Biotechnologies, and Solid Biosciences (the notice shows how many times a particular requirement was waived in some cases).
• For new chemical substances, the Minister waived specific physical‑chemical test data for some companies. The types of data waived include:
  • octanol/water partition coefficient;
  • density;
  • water solubility; and
  • hydrolysis rate as a function of pH.
• Companies listed for these substance waivers include 3313045 Nova Scotia Company, Milliken & Company, NextStar Energy Inc., Sika Canada Inc., and Wego Chemical Group.
• The notice says waiver decisions are made case‑by‑case by the Minister of the Environment, in consultation with the Minister of Health.

Who's affected#

• The specific companies named in the notice (see above) are the main parties directly affected.
• More broadly, businesses that import or manufacture organisms or new chemical substances in Canada could be affected in future because they can request similar waivers.
• The notice does not list the exact organisms or substance formulas involved, so it’s not possible from this notice alone to tell which products, projects or markets will be affected.

Why it matters#

• A waiver reduces the testing a company must submit, which can save time and money for developers trying to bring new organisms or chemicals into Canada.
• It also means less publicly available test data for those specific items, which could matter to people tracking environmental or health risks.
• The government says this is a routine part of the new‑substances process: about 400 regulatory declarations are submitted each year and around 100 waivers are granted annually.