Part IIOrderPublished: September 14, 2022

1-hexanamine added, cosmetic reporting rules

Order 2022-87-07-01 Amending the Domestic Substances List: SOR/2022-192

The order adds CAS 1860-26-0 (1-hexanamine, 2-ethyl-N,N-bis(2-ethylhexyl)-) to the Domestic Substances List and maintains Significant New Activity (SNAc) reporting for specified cosmetic uses. It requires pre-notification for manufacture or import of the substance in cosmetics at or above 1% by weight, establishes a 10 kg/year import threshold starting January 1, 2023 (with a higher 1,000 kg transitional threshold through December 31, 2022), and corrects wording for CAS 1034343-98-0.

Published
September 14, 2022
Department
Unavailable
Section
Order 2022-87-07-01 Amending the Domestic Substances List
Comment deadline
Unavailable
Effective date
August 24, 2022
Publication part
Part II

Summary

Summary#

Order 2022-87-07-01 Amending the Domestic Substances List adds one chemical (CAS 1860-26-0) to the Domestic Substances List and keeps special reporting rules for certain new uses in cosmetics. It also corrects wording for another listed chemical (CAS 1034343-98-0). The order was registered on August 24, 2022 and published on September 14, 2022; one change comes into force on January 1, 2023.

What it does#

  • Adds the substance identified by CAS 1860-26-0 (1-hexanamine, 2-ethyl-N,N-bis(2-ethylhexyl)-) to Part 2 of the Domestic Substances List and keeps the Significant New Activity (SNAc) reporting rule for this substance.
  • Sets the types of cosmetic activities that trigger a required notification to the government:
    • Use in the manufacture of a cosmetic when the substance is present at 1% or more by weight.
    • Importation in a calendar year of 10 kg or more of the substance in a cosmetic when it is present at 1% or more by weight (this 10 kg threshold starts on January 1, 2023).
  • Provides a short transitional period (from the day the order came into force until December 31, 2022) during which notifications were required only if the use or import reached 1,000 kg or more.
  • Specifies what must be included in a Significant New Activity Notification (SNAN). Key items include:
    • A description of the planned activity and the expected annual quantity.
    • The substance’s function in the product.
    • Existing test data and studies the notifier already has access to.
    • New toxicity studies, including skin absorption tests (in vitro and in vivo) and a 28‑day repeated-dose dermal toxicity study, done to OECD standards.
  • Excludes certain situations from the notification requirement, for example:
    • Uses that are strictly research and development or site-limited intermediate uses.
    • Products intended only for export.
    • Uses already regulated under other federal acts (for example, the Pest Control Products Act, the Fertilizers Act, or the Feeds Act).
  • Fixes unclear wording in the SNAc description for the chemical with CAS 1034343-98-0 so reporting obligations are clearer.

Who's affected#

  • Companies that manufacture, import, or plan to start using the chemical (CAS 1860-26-0) in cosmetics in Canada. They must file a SNAN before certain new activities.
  • Chemical suppliers and formulation companies that sell ingredients for cosmetics.
  • Laboratories and contractors that provide the required toxicity and skin-absorption studies.
  • Government reviewers who will assess any submitted SNANs.
  • The order does not change existing, ongoing uses that are already in Canada; it mainly targets new activities. If it’s unclear whether a planned activity counts as a “significant new activity,” companies are expected to check with the regulator.

Why it matters#

  • The rule gives the government a chance to review and, if needed, manage health risks before the chemical is used more widely in cosmetics. This aims to protect public health by requiring safety information up front.
  • Companies that want to start new uses or import above the thresholds may need to run or compile tests and submit detailed information. That can take time and cost money.
  • The transitional thresholds (high initial 1,000 kg threshold through December 31, 2022) gave businesses a short window before the stricter 10 kg import threshold began on January 1, 2023.
  • Adding the substance to the Domestic Substances List removes it from the New Substances Notification Regulations, which can make access simpler for activities already occurring, while keeping controls on certain new cosmetic uses.

Key topics

Canadian Environmental Protection Act, 1999CEPADomestic Substances ListSignificant New ActivitySNAcSignificant New Activity NotificationSNAN1-hexanamine, 2-ethyl-N,N-bis(2-ethylhexyl)-1860-26-01034343-98-0Environment and Climate Change CanadaHealth CanadacosmeticsOECD Test No. 428OECD Test No. 410

Source: Canada Gazette

Official source