New Restrictions for Cyclohexane Ester

Summary#

Significant New Activity Notice No. 20521 tells anyone who wants to start new uses of the chemical 1,2‑cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4‑trimethyl‑1,3‑pentanediol mono(2‑methylpropanoate) (CAS 1661012-65-2) that they must notify the government first. Under the Canadian Environmental Protection Act, 1999, the federal ministers have set rules so new uses in toys, child care articles or cosmetics are reviewed before those activities begin. The notice was published on March 20, 2021.

What it does#

• Defines a "significant new activity" (SNAc) for this specific substance:
  • Any use in making a toy or child care article, or in a cosmetic, where the substance is present at ≥ 0.1% by weight.
  • Any distribution for sale in a cosmetic where ≥ 1 kilogram of the substance is used in a calendar year and the substance is present at ≥ 0.1% by weight.
• Gives a temporary higher threshold while industry adapts:
  • Between publication and March 20, 2022, the yearly quantity threshold is ≥ 100 kilograms (instead of 1 kilogram) for the same cosmetic and manufacturing uses.
• Requires advance notification and information:
  • Anyone planning a significant new activity must submit a notification at least 90 days before starting.
  • The notice lists the kinds of information required, including the intended use, expected annual quantity, exposure estimates, and the function of the substance.
  • It also requires specific toxicity and migration tests, for example OECD Test No. 416 (Two‑Generation Reproduction Toxicity), OECD Test No. 428 (Skin Absorption: In Vitro), OECD Test No. 427 (Skin Absorption: In Vivo), and an oral migration “Head over Heels” test for toys.
  • Tests must follow Good Laboratory Practice and certain international test methods.
• Lists some activities that do NOT trigger the SNAc:
  • Use as a research and development substance or a site‑limited intermediate.
  • Manufacture of products for export only.
  • Uses already regulated under other federal acts listed in the notice (for example, some pesticide or feed rules).
• Promises a government assessment:
  • Information submitted will be assessed within 90 days after the Minister receives a complete notification.

Who's affected#

• Manufacturers, importers, distributors, sellers and formulators who use or plan to use the chemical in:
  • toys and child care articles (as defined by the Phthalates Regulations),
  • cosmetics (as defined in the Food and Drugs Act).
• Companies that handle quantities around the notification thresholds: 1 kilogram per year (long term) or 100 kilograms per year during the transitional period (until March 20, 2022).
• Anyone who would use the substance in products sold in Canada at concentrations of ≥ 0.1% by weight, including downstream product makers and brand owners.
• The federal departments that assess the information: Environment and Climate Change Canada (the Minister of the Environment) and Health Canada — they will review the submitted data and test results.
• It is unclear from the notice how broadly the rules apply to complex mixtures or multi‑ingredient products; the notice reminds companies to check whether individual components need notification.

Why it matters#

• The government flagged this chemical because it resembles a substance linked to developmental toxicity. The notice is meant to stop potentially risky new uses from happening without review.
• If you make, import, or sell toys, child care items or cosmetics in Canada, you may have to pause new uses and send detailed information and safety tests 90 days before you begin. That can affect product timelines, testing budgets, and supply plans.
• The transitional allowance (higher 100 kg threshold until March 20, 2022) gives businesses limited time to adapt before stricter rules apply.
• This is not an approval or ban; it is a notification and review requirement so federal authorities can assess health and environmental risks before major new uses proceed.