SNAc for cyclohexanedicarboxylic ester

Summary#

This Canada Gazette notice (published December 14, 2019) collects several Environment department actions about chemical review and reporting. Key points: the government removed earlier manufacturing/import conditions for one specific ester, put a new “significant new activity” (SNAc) rule on that same substance that requires advance notification and tests for certain uses, announced a set of waivers of data requirements for several companies, and published draft screening assessments for sodium cyclamate and cyclohexylamine and for a 21‑substance Poly(alkoxylates/ethers) group with a 60‑day public comment period.

What it does#

• Rescinds previous conditions on the manufacture or import of 1,2‑cyclohexanedicarboxylic acid, 1‑butyl 2‑(phenylmethyl) ester (CAS RN 1200806‑67‑2) because the ministers no longer suspect it is toxic under the Canadian Environmental Protection Act, 1999.
• Places a Significant New Activity (SNAc) Notice No. 20087 on the same substance under the Canadian Environmental Protection Act, 1999. Under that notice:
  • Companies must submit a Significant New Activity Notification (SNAN) at least 90 days before starting certain new uses.
  • Notification is required if the substance is used at concentrations of ≥ 0.1% by weight in toys or child care articles, natural health products, drugs, or cosmetics.
  • A use of ≥ 1 kg per calendar year in drugs, natural health products, or cosmetics at ≥ 0.1% by weight triggers notification.
  • Transitional threshold: between publication and December 6, 2020, the annual quantity threshold is 100 kg (i.e., higher temporarily).
  • The notice lists specific tests and data that must accompany a SNAN (for example, reproduction and skin‑absorption tests and a specific “Head over Heels” migration test for toys).
• Publishes lists of granted waivers that reduce some testing or reporting requirements:
  • Waivers for living‑organism data were granted to companies including Catalent Pharma Solutions, CRISPR Therapeutics (and CRISPR Therapeutics AG), Ottawa Hospital Research Institute (OHRI), and Pfizer Canada Inc.
  • Waivers for substance data were granted to companies including BASF Canada Inc., Novozymes Canada, Chevron Oronite LLC, and others (each waiver is specified for particular tests or data).
• Publishes draft screening assessments and proposed next steps:
  • Proposes to take no further action now on sodium cyclamate (CAS RN 139‑05‑9) and cyclohexylamine (CAS RN 108‑91‑8) but notes some human‑health effects of concern and that follow‑up activities to track exposure are being considered. A 60‑day public comment period is open.
  • Proposes to take no further action now on 21 substances in the Poly(alkoxylates/ethers) group after draft assessment found low ecological and human‑health risk overall; the draft is open for 60‑day public comment. The draft notes one substance (POEA) has a moderate hazard profile for human health.

Who's affected#

• Manufacturers, importers and formulators who make, import or plan new uses of 1,2‑cyclohexanedicarboxylic acid, 1‑butyl 2‑(phenylmethyl) ester (CAS RN 1200806‑67‑2) — especially if they put it into toys, child care articles, natural health products, drugs or cosmetics.
• Companies that handle the substances covered by the two draft screening assessments and the 21‑substance Poly(alkoxylates/ethers) group.
• The specific companies named in the waiver lists (examples: Catalent Pharma Solutions, CRISPR Therapeutics, Pfizer Canada Inc., BASF Canada Inc., Novozymes Canada, Chevron Oronite LLC) — their reporting or testing obligations were partially waived.
• Consumer product makers (toys, cosmetics, natural health products, pharmaceuticals) who may need to check product formulation and supply chains to see if the SNAc applies.
• Interested members of the public and stakeholders who may submit comments during the 60‑day comment periods on the draft assessments.

If it’s unclear whether a particular product or use is covered (for example, whether a component is present at ≥ 0.1% by weight), the notice says companies should check their formulations, import records and safety data sheets.

Why it matters#

• The government removed earlier restrictions for one chemical but added a SNAc rule. That means the substance is no longer treated as suspected toxic in the earlier context, but the government still wants advance notice and test data before it’s used in products that could cause consumer exposure — especially items used by children or products applied to the body.
• Companies planning to start new uses of the substance may need to run specified laboratory tests and file a SNAN 90 days in advance. That can affect timelines, costs, and product design decisions.
• The waivers mean regulators accepted reduced information in particular cases. That speeds some projects but also means less public data may be available about environmental or health effects for those specific submissions.
• The draft screening assessments say current exposure to sodium cyclamate and cyclohexylamine and to the Poly(alkoxylates/ethers) group is not of immediate concern at present levels, but they note possible health concerns if exposures increase and flag follow‑up monitoring. Public comments can influence final decisions or follow‑up actions.