Part IPublic NoticeVolume 159, Number 37Published: September 13, 2025

New-substance permits, waivers, and habitat protections

Canada Gazette, Part I, Volume 159, Number 37: GOVERNMENT NOTICES

This notice permits the controlled manufacture or import of three specific new chemical substances under conditions set out under the Canadian Environmental Protection Act, 1999, including 120-day pre-manufacture notification, record-keeping, and release-response requirements; those ministerial conditions state they came into force on 2025-09-04. It also lists granted waivers of certain information or testing requirements for named companies under the New Substances program and announces that Species at Risk Act critical habitat protections for several species in specified National Wildlife Areas will apply 90 days after publication (about 2025-12-12).

Published
September 13, 2025
Department
Unavailable
Section
DEPARTMENT OF THE ENVIRONMENT
Comment deadline
Unavailable
Effective date
September 4, 2025
Publication part
Part I

Summary

Summary#

This Canada Gazette notice records several Environment Department actions. It allows the controlled manufacture or import of three new chemical substances under conditions set out under the Canadian Environmental Protection Act, 1999, announces a number of formal waivers of testing or information requirements for companies proposing new living organisms or substances, and describes critical habitat protections under the Species at Risk Act for several species in federal National Wildlife Areas.

What it does#

  • Ministerial conditions:
    • Permit the manufacture or import of three named substances, each subject to detailed conditions:
      • butanoic acid ... sodium salt (CAS 832720-36-2)
      • 1-pyrrolidinecarboxamide ... (CAS 1310726-60-3)
      • spiro[6H-cyclopenta…] (CAS 1374248-77-7)
    • Require the notifier (the company that submitted the original information on August 27, 2025) to:
      • notify the Minister of the Environment at least 120 days before starting manufacture in Canada and provide information such as anticipated annual quantity, facility address, transport and storage plans, likely environmental releases, disposal methods, and details of the manufacturing process;
      • take immediate action and notify authorities if any release to the environment occurs;
      • tell any recipient in writing about these conditions and get written confirmation that they will comply;
      • keep records (in English or French) at their Canadian principal place of business for at least 5 years.
    • These ministerial conditions came into force on September 4, 2025.
  • Waivers of information requirements:
    • The ministers granted specific waivers under the new-substances rules for a list of companies. Examples include waivers for particular tests for living organisms for Cytophage Technologies Inc., Novozymes Canada Limited, Sanofi Pasteur Limited, and others.
    • Separate waivers for substances were granted to companies such as BASF Canada Inc., Evonik Canada Inc., International Flavors & Fragrances Inc., and others, for particular data (e.g., vapour pressure, density, mutagenicity tests).
    • The notice notes that roughly 300 new-substance declarations and about 100 waivers happen each year (explanatory context).
  • Species at Risk critical habitat:
    • Announces that subsection 58(1) of the Species at Risk Act will apply to critical habitat identified in recovery documents for these species, inside specified National Wildlife Areas, 90 days after publication:
      • Chestnut-collared Longspur — critical habitat in the Longspur National Wildlife Area.
      • Slender Mouse-ear-cress — critical habitat in the Canadian Forces Base Suffield National Wildlife Area and Great Sandhills National Wildlife Area.
      • Sprague’s Pipit and Swift Fox — critical habitat in the Longspur National Wildlife Area.
    • Because the publication date is September 13, 2025, the protections start 90 days later (on or about December 12, 2025).

Who's affected#

  • Companies that want to manufacture or import the three named chemical substances. They must follow the notification, record-keeping and release-response rules in the ministerial conditions.
  • The specific firms listed in the waiver tables. Those firms benefit from reduced testing or information requirements for certain living organisms or chemicals.
  • People and activities in and near the named National Wildlife Areas (Longspur, Canadian Forces Base Suffield, and Great Sandhills) — land managers, federal staff, conservation groups, and anyone planning projects there — because critical habitat protections will apply in those federal areas starting around December 12, 2025.
  • It is unclear from the notice which individual company is the “notifier” for each ministerial condition beyond the generic reference to the person who filed information on August 27, 2025.

Why it matters#

  • These ministerial conditions let specified substances be made or brought into Canada while the government manages potential risks. That can speed availability for industry but comes with reporting and safety obligations meant to limit environmental releases.
  • The waivers reduce some testing or paperwork for certain companies. That can cut time and cost for those projects, but it also means regulators relied on other information or risk judgments to grant the waivers.
  • The Species at Risk habitat notices give legal protection to areas important for endangered or threatened plants and animals. That can limit or change activities in those federal wildlife areas to help species recover.

Key topics

Canadian Environmental Protection Act, 1999CEPASpecies at Risk ActSARANew Substances programDomestic Substances ListRelease and Environmental Emergency Notification RegulationsEnvironment and Climate Change CanadaHealth Canadabutanoic acid, 4-[[(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-[[2-fluoro6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]amino]-, sodium salt (1:1) (CAS 832720-36-2)1-pyrrolidinecarboxamide, 3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)-, (3S,4R)- (CAS 1310726-60-3)spiro[6H-cyclopenta[b]pyridine-6,3′-[3H]pyrrolo[2,3-b]pyridine]-3-carboxamide,1′,2′,5,7-tetrahydro-N-[(3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)-3-piperidinyl]-2′-oxo-, (3′S)- (CAS 1374248-77-7)Chestnut-collared Longspur (Calcarius ornatus)Slender Mouse-ear-cress (Halimobolos virgata)Longspur National Wildlife Area

Source: Canada Gazette

Official source