SNAc for Toy and Cosmetic Chemical

Summary#

This is Order 2021-87-13-01 Amending the Domestic Substances List. It adds one chemical (CAS 1661012-65-2, long name: 1,2-cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate)) to the Domestic Substances List and keeps special notification rules (Significant New Activity, or SNAc) for certain uses in toys, child care articles and cosmetics. The order was registered on December 17, 2021 and parts of it take full effect on March 21, 2022.

What it does#

• Adds the chemical (CAS 1661012-65-2) to the federal Domestic Substances List so it is no longer treated as “new” under the New Substances rules.
• Keeps SNAc reporting requirements for these activities when the substance is present at 0.1% by weight or more:
  • Use in the manufacture of a toy or child care article.
  • Use in the manufacture of a cosmetic.
  • Import of the substance in a cosmetic (see thresholds below).
• Sets a short transitional threshold while the order phases in:
  • From registration until March 20, 2022, the rule applies only if the use or import during that period is 100 kg or more.
  • Starting March 21, 2022, importation of the substance in a cosmetic triggers the SNAc if it is 1 kg or more in a calendar year.
• Requires anyone planning a significant new activity to submit a Significant New Activity Notification (SNAN) to the minister at least 90 days before starting.
• Lists the specific information and studies that must be included with a SNAN. Examples include an OECD two-generation reproduction toxicity study, skin absorption tests (in vitro and in vivo), and an oral migration test for toys. Those studies must follow Good Laboratory Practice and the ministers will assess submissions within 90 days of receiving complete information.
• Excludes certain uses from the notification requirement, such as research and development, site-limited intermediates, and manufacture of products for export only. Uses already regulated under some other federal acts (for example, the Pest Control Products Act) are also exempt.

Who's affected#

• Manufacturers and importers of the chemical itself (CAS 1661012-65-2).
• Companies that make or import toys, child care articles, or cosmetics that could contain this chemical at 0.1% by weight or higher.
• Testing laboratories and consultants who would run or prepare the required studies and reports.
• Suppliers, downstream users and possibly retailers who might need to check product formulations to see if the chemical is present.
• Small businesses may be affected if they plan to introduce or import products containing this chemical in the regulated concentrations or quantities.

Why it matters#

• The government identified potential developmental toxicity concerns with this chemical. Keeping SNAc rules means companies must notify the government and provide safety data before starting new uses in toys or cosmetics. That gives regulators a chance to assess risks and require controls if needed.
• Adding the chemical to the Domestic Substances List is partly administrative: it removes one set of “new substance” regulatory hurdles. But the retained SNAc rules still control certain new uses, so some new business plans will need extra time and testing.
• For consumers, this helps ensure that potentially risky new uses in products for children or skin-contact cosmetics are reviewed before they reach the market.