Speciality Chemicals Magazine JAN / FEB 2026 | Page 63

REGULATION & COMPLIANCE exclusions, workplace protection requirements and extensions for specific uses. They include:

• An exclusion for products or articles containing DecaBDE or PIP( 3:1) at concentrations of < 0.1 wt % if the substance was not intentionally added

• Extended compliance deadlines for PIP( 3:1) in articles used in industries like semiconductor manufacturing and HVAC equipment

• New exclusions for certain uses of PIP( 3:1) in circuit boards and wire harnesses

CBI substantiations due to expire

Under the 2016 TSCA Reform, most CBI claims will expire after ten years( i. e. in 2026), unless reasserted and substantiated. According to the final rule, the EPA will publish a list of TSCA submissions with confidentiality claims at least 60 days prior to their expiry dates, along with instructions for reasserting and substantiating them.

Additionally, if the EPA denies the claim, the submitter will be notified at least 30 days prior to the intended disclosure of the information. The agency expects to develop an electronic reporting tool to further implement this provision.

Check your CBI claims. Confirm the expiry date, check that the stated agents and authorised officials are correct, and think about whether you need to retain the claim.

Notable Canadian updates

Bill S-5 went to the Canadian Senate in February 2022 and received royal assent in June 2023. This bill amends CEPA in two main ways: formally recognising Canadians’ rights to a healthy environment, as provided under CEPA; and strengthening the foundation for the management of chemicals and other substances. Notice with respect to the implementation framework for the former was published in July 2025.3

In addition, there have been several recent updates to Canada’ s New Substances Notification( NSN) requirements. There will be annual fee adjustment, effective 1 April 2025, and an annual inflation-based adjustment based on the Consumer Price Index( 2.7 % in 2025). The New Substances Programme( NSP) also outlines payments to be made if the programme fails to meet a regulatory timeline or performance standard.

With regard to higher organisms, there have been revised assessment timelines according to risk: 180 days( formerly 120) for those manufactured or imported anywhere in Canada; 150 for those used in experimental field studies; and 120 for those used in containment.

To reduce the regulatory burden for low-risk substances, cultured human cells and certain non-replicative viral vectors for cell and gene therapies are exempt from notification if they meet specified criteria. Regulation can also be streamlined for unmodified microorganisms from the Canadian environment that are used in contained facilities and identified as low-risk by the Public Health Agency of Canada.

The fundamental NSN structure remains unchanged( Table 1). Substances not listed on the Domestic or Non-Domestic Substances Lists are still considered‘ new’ and require notification before import or manufacture. The system remains volume-based, with data requirements becoming more

extensive at higher annual tonnage thresholds. Fees continue to be indexed to inflation, though annual adjustments may be small.

Summary

Staying abreast of the ever-changing regulatory environment is essential: use whichever method works best for you. This article can serve as the foundation for action plans, including internal audits, material risk assessments to evaluate potential hazards and opportunities associated with raw materials, and educating and securing assurance from supply chains. Before closing, don’ t forget:

• Many US states have their own PFAS regulations

• Canada is in the process of implementing the Federal Plastics Registry, which focuses on collecting data for plastic products that end up in household waste streams. The completed Phase 1 reporting requirements applied to any Canadian company that imported, manufactured, or placed on the Canadian market plastic packaging, electronic and electrical equipment, or singleuse and disposable products in quantities of ≥ 1,000 kg / calendar year. Stay tuned for Phase 2 ●

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