Waivers for New Substances and Organisms

Summary#

On July 15, 2023, the federal government published that the Minister of the Environment used powers in the Canadian Environmental Protection Act, 1999 to waive some information requirements for a number of companies. The waivers cover certain test results and property data that companies would normally need to provide before importing or making new chemical substances or living organisms in Canada.

What it does#

• For new chemical substances, the government waived specific data requirements for these companies:

  • Arkema Canada Inc. — in vivo mammalian mutagenicity test data for chromosomal aberrations or gene mutations.
  • BASF Canada Inc. — melting point, boiling point, vapour pressure, octanol/water partition coefficient, ready biodegradation test, adsorption‑desorption screening test, and hydrolysis rate by pH.
  • Brenntag Canada Inc. — water solubility.
  • Sika Canada Inc. — number average molecular weight (Mn) and maximum concentrations (percent) of residual constituents below 500 and 1,000 daltons.
  • SNF Holding Company — melting point, boiling point, vapour pressure.

• For living organisms, the government waived certain ecological and related test requirements for these developers:

  • Allogene Therapeutics Inc. — tests on effects to aquatic plants, invertebrates, and vertebrates likely to be exposed.
  • Editas Medicine, Inc. — tests on aquatic and terrestrial species likely to be exposed, and antibiotic susceptibility testing.
  • Freeline Therapeutics Limited — tests on aquatic and terrestrial species likely to be exposed, and antibiotic susceptibility testing.
  • Fumoir Grizzly Inc. — tests on aquatic and terrestrial species likely to be exposed.
  • Future Fields — a test of ecological effects (pathogenicity, toxicity or invasiveness).
  • Janssen Inc. — tests on aquatic and terrestrial species likely to be exposed, and antibiotic susceptibility testing.

• The Gazette notice also says these waiver decisions are made case‑by‑case and involve consultation with the Minister of Health.

Who's affected#

• The named companies above are directly affected because the waivers change what they must supply to the government before importing or manufacturing the listed substances or organisms.
• More broadly, anyone who plans to import or make a substance or living organism not already on Canada’s Domestic Substances List may be affected in the same way — because the notice shows waivers are being granted in some cases.
• Regulators, researchers, environmental groups, and potentially downstream users or communities near facilities might notice impacts when specific test data are not submitted. The notice does not say whether the waived data will be provided in another form or made public.

Why it matters#

• These waivers can speed up or lower the cost of bringing new chemicals or genetically modified/novel organisms into Canada by reducing the amount of testing companies must submit.
• They also mean less of certain test results may be added to government records for those substances or organisms, which could affect transparency about environmental or health risks.
• The Gazette item notes that each year about 400 regulatory declarations are submitted and about 100 waivers are granted. The notice does not explain the reasons for each individual waiver, only that they are decided case‑by‑case with health officials.