New SNAc for Cyclohexanedicarboxylic Ester

Summary#

This is Order 2020-87-07-01 Amending the Domestic Substances List under the Canadian Environmental Protection Act, 1999. It adds several chemicals to the federal Domestic Substances List and creates special notification and testing requirements for 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl)ester (CAS 1200806-67-2); parts of the rules take effect on January 1, 2021 and the order was published on March 18, 2020.

What it does#

• Adds several substances to Part 1 of the Domestic Substances List (examples: 29350-58-1, 68412-87-3, 473252-12-9, 473268-27-8).
• Adds multiple polymer and reaction-product entries to Part 3 of the List (several new CAS or substance descriptions).
• Creates a Significant New Activity (SNAc) requirement for 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl)ester (CAS 1200806-67-2) in Part 2:
  • For the period until December 31, 2020, using 100 kg or more of the substance to make products where it is present at 0.1% or more by weight (including toys/child care articles, natural health products, drugs, cosmetics) triggers a requirement to notify the government.
  • There is a related SNAc rule that applies to certain uses in natural health products, drugs and cosmetics during the same period with the same 100 kg threshold.
  • The rules exclude: research and development uses, site-limited intermediates, and products that are for export only.
• Replaces parts of the Part 2 wording so that, once the replacement wording comes into force on January 1, 2021, a different threshold applies for some uses (the Order sets a threshold of more than 1 kg in a calendar year for certain product uses).
• Sets what must be sent to the Minister at least 90 days before a proposed significant new activity, including:
  • a description of the proposed activity and the anticipated annual quantity;
  • product function and expected sales in Canada;
  • existing test data the proposer has;
  • specific toxicity and exposure tests, including OECD Test No. 416 (Two‑Generation Reproduction Toxicity), an oral migration test using the "Head over Heels" method for toys/childcare articles, and skin absorption tests (OECD Test No. 428 in vitro on rat and human skin and OECD Test No. 427 in vivo on rats).
• Requires that the tests follow the Principles of Good Laboratory Practice and that the Minister assess the submitted information within 90 days of receiving it.
• Most of the Order comes into force on registration; subsections that change Part 2 wording become effective January 1, 2021.

Who's affected#

• Manufacturers and importers of 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl)ester (CAS 1200806-67-2).
• Companies that make or import toys and child care articles, cosmetics, natural health products, and drugs that could contain that substance.
• Chemical suppliers, product formulators, and testing laboratories that would prepare and run the required toxicity and migration tests.
• Export-only product makers and organizations doing R&D or site-limited intermediate work are explicitly excluded from the SNAc notice requirement.
• For the many other substances added to the List, the affected parties are less clear from the Order itself — it simply adds the substances to the federal inventory.

Why it matters#

• Being on the Domestic Substances List means the government has recorded these chemicals for tracking and regulatory purposes. That can lead to future limits, testing, or reporting.
• For businesses, the SNAc rules create a hard step: if you plan to start certain new uses (above the stated quantity or concentration), you must notify the government and supply specific, often costly test data well before the activity starts. That can delay product launches or add testing costs.
• The specific focus on toys, child care articles, cosmetics, drugs and natural health products reflects concern about human exposure, especially for children and skin contact. The tests requested are aimed at reproductive and absorption effects.
• The change in threshold wording that takes effect on January 1, 2021 (to a 1 kg per year threshold in some cases) may broaden when notification is required, so importers and manufacturers should check the exact timing and thresholds for their products.