Part IIOrderPublished: February 19, 2020

14 Substances Added to Domestic List

Order 2020-87-02-01 Amending the Domestic Substances List: SOR/2020-17

The order adds 14 substances to the Domestic Substances List under the Canadian Environmental Protection Act, 1999, removing their “new” status under the New Substances Notification Regulations. It retains Significant New Activity (SNAc) reporting requirements for CAS 1000172-32-6 (nonadecane, 9-methylene-, mixed with 1-decene, dimers and trimers, hydrogenated) because of potential inhalation risks from spray uses, requiring a 90‑day notification with specified exposure and OECD Test No. 412 inhalation toxicity data. Most provisions came into force on 2020-01-30, with the SNAc threshold changes phased in (transitional period through 2020-06-07) and parts of the order coming into force on 2020-06-08.

Published
February 19, 2020
Department
Unavailable
Section
Order 2020-87-02-01 Amending the Domestic Substances List
Comment deadline
Unavailable
Effective date
January 30, 2020
Publication part
Part II

Summary

Summary#

Order 2020-87-02-01 Amending the Domestic Substances List: SOR/2020-17 adds 14 substances to the federal inventory called the Domestic Substances List under the Canadian Environmental Protection Act, 1999. The order keeps special reporting rules (a “significant new activity” or SNAc requirement) for one substance, CAS 1000172-32-6, because of possible lung risks if it is used in spray products. The order was registered on January 30, 2020, and some parts come into force on June 8, 2020 (with a transitional period ending June 7, 2020).

What it does#

  • Adds 14 substances to the Domestic Substances List:

    • 7 substances by CAS number to Part 1.
    • 1 substance (1000172-32-6) to Part 2 with SNAc reporting requirements.
    • 6 substances by masked names to Part 3.
  • Keeps SNAc reporting rules for 1000172-32-6 (the substance named in the order). Under those rules:

    • Anyone proposing a covered new activity must notify the Minister at least 90 days before starting.
    • The notification must include details about the planned use, expected annual quantity, exposure information and toxicity data. This includes a current OECD inhalation toxicity study (Test No. 412: Subacute Inhalation Toxicity: 28‑Day Study) done according to Good Laboratory Practice.
    • The SNAc applies when the substance is used in the manufacture of products intended to be sprayed (consumer products covered by the Canada Consumer Product Safety Act or cosmetics under the Food and Drugs Act) where the substance is present at 0.1% by weight or more.
    • Quantity thresholds:
      • During the transitional period (the day the order comes into force up to June 7, 2020) the trigger is use of 100 kg or more.
      • After the transitional period the trigger is use of more than 10 kg in a calendar year (with the 2020 calendar year excluding Jan 1–Jun 7 for this rule).
    • Exemptions include uses as research and development substances, site-limited intermediates, export-only products, and uses regulated under other federal laws such as the Pest Control Products Act, the Fertilizers Act, and the Feeds Act.
  • Timing:

    • The order was registered on January 30, 2020 and most of it came into force on that date.
    • The specific SNAc timing and threshold changes in subsections come into force on June 8, 2020 (transitional rules apply until June 7, 2020).

Who's affected#

  • Chemical manufacturers, importers and formulators.
  • Makers of consumer products and cosmetics — especially those that make sprayable products.
  • Suppliers, retailers and others who handle or sell products that may contain 1000172-32-6 at ≥ 0.1% by weight.
  • The general public could be indirectly affected because the retained SNAc is meant to reduce inhalation risks from sprayed products.
  • Research labs and exporters are less affected because some uses are specifically exempted.

If it’s unclear whether a particular product or use is covered, the order’s definitions and the SNAc rules determine that; businesses are expected to check their formulations and sales quantities.

Why it matters#

  • Administrative step: adding these substances to the Domestic Substances List means they are no longer treated as “new” under the New Substances Notification Regulations. That can make it easier for businesses to use or import them for activities already covered.
  • Health protection: keeping the SNAc for 1000172-32-6 forces companies to notify and supply inhalation toxicity data before starting certain new spray uses. That is meant to prevent products that could cause pulmonary harm from being widely introduced without assessment.
  • Practical impact for industry: companies planning new spray uses of this substance will need to plan for a notification at least 90 days ahead and may need to commission an OECD Test No. 412 inhalation study, which can take time and money.
  • Transitional timing: the order gives a short transitional window (until June 7, 2020) with a higher threshold (100 kg) before the stricter yearly 10 kg threshold applies from June 8, 2020 onward.

Key topics

Canadian Environmental Protection Act, 1999CEPADomestic Substances ListSignificant New Activity (SNAc)nonadecane, 9-methylene-, mixed with 1-decene, dimers and trimers, hydrogenated1000172-32-6New Substances Notification Regulations (Chemicals and Polymers)OECD Test No. 412Canada Consumer Product Safety ActFood and Drugs ActEnvironment and Climate Change CanadaHealth Canadasprayable consumer productsinhalation toxicity

Source: Canada Gazette

Official source