Waivers for New-Substance Information

Summary#

This Canada Gazette notice (published July 15, 2023) says the federal government waived some information requirements under the Canadian Environmental Protection Act, 1999 for specific new substances and living organisms. The waivers let several companies omit certain laboratory or property data when they file declarations to import or make items not on the Domestic Substances List.

What it does#

• It records waivers that the Minister of the Environment granted for some information normally required under the Canadian Environmental Protection Act, 1999 when declaring new substances or living organisms.
• For new chemical substances and polymers, the notice lists companies that were allowed to skip supplying specific physical‑chemical or biodegradation test data. Companies named include:
  • Arkema Canada Inc. — waived data from an in vivo mammalian mutagenicity test for chromosomal aberrations or gene mutations.
  • BASF Canada Inc. — waived several physical‑chemical and biodegradation data points (melting point, boiling point, vapour pressure, octanol/water partition coefficient, ready biodegradation test, adsorption‑desorption screening test, hydrolysis rate by pH).
  • Brenntag Canada Inc. — waived data on water solubility.
  • Sika Canada Inc. — waived data on number average molecular weight and on maximum concentrations of low‑molecular‑weight residual constituents.
  • SNF Holding Company — waived data on melting point, boiling point and vapour pressure.
• For living organisms, the notice lists companies that were allowed to omit certain ecological or antibiotic‑susceptibility tests. Companies named include:
  • Allogene Therapeutics Inc. — waived tests on effects to aquatic species likely to be exposed.
  • Editas Medicine, Inc. — waived tests on effects to aquatic and terrestrial species likely to be exposed, and tests of antibiotic susceptibility.
  • Freeline Therapeutics Limited — waived tests on effects to aquatic and terrestrial species likely to be exposed, and tests of antibiotic susceptibility.
  • Fumoir Grizzly Inc. — waived tests on effects to aquatic and terrestrial species likely to be exposed.
  • Future Fields — waived an ecological effects test (pathogenicity, toxicity or invasiveness).
  • Janssen Inc. — waived tests on effects to aquatic and terrestrial species likely to be exposed, and tests of antibiotic susceptibility.
• The notice includes an explanatory note saying each waiver decision is made case‑by‑case by the Minister in consultation with the Minister of Health.

Who's affected#

• Companies that import or manufacture substances or living organisms not already on the Domestic Substances List. Several of those companies are listed above.
• Regulators and public health or environmental lab scientists — because the waivers change which test results are submitted for review.
• The general public and communities near facilities that handle new substances or organisms, since the waivers relate to what environmental and safety information regulators will have when assessing new items.

If it’s unclear who is affected in a particular case, the notice does not provide further details on quantities, uses, or locations.

Why it matters#

• These waivers mean regulators may receive less laboratory or property data when assessing certain new chemicals and organisms. That can speed up filing for the company, but it also means the public record contains less technical information about those items.
• The notice notes that about 400 regulatory declarations are submitted each year and around 100 waivers are granted annually, so waivers are a regular part of how new substances and organisms are handled under the law.