Canada Issues Significant New Activity Notice No. 21862 for Cosmetic Ingredient under CEPA

The Canadian Environmental Protection Act, 1999 (CEPA) governs the assessment and management of substances that may pose a risk to human health or the environment. On December 7, 2024, the Minister of the Environment and the Minister of Health issued Significant New Activity (SNAc) Notice No. 21862, under Section 85 of CEPA for phosphoric acid, mixed decyl and octyl esters, potassium salts (CAS no: 70879-47-9). The Notice outlines specific conditions of use to ensure that potential risks are effectively managed.

Key Highlights of the SNAc Notice

Substance Details

The substance regulated under this Notice is:

• Name: Phosphoric acid, mixed decyl and octyl esters, potassium salts

• CAS RN: 70879-47-9

This substance is not currently listed on the Domestic Substances List (DSL) and significant new activities involving it may result in risks to the environment or human health as defined in Section 64 of CEPA.

Purpose of the Notice

The purpose of this Notice is to:

• Identify activities that may require further risk assessment before proceeding.

• Outline mandatory information requirements for proposed new uses.

• Ensure compliance with CEPA’s precautionary approach to chemical safety.

Significant New Activities Defined

Activities Requiring Notification

The Notice specifies that a Significant New Activity (SNA) includes:

1. Manufacture or Distribution of Cosmetics:

   • Use of the substance in cosmetics in concentrations greater than 1% by weight.

   • Quantities of 10 kg or more per calendar year in products intended for sale.

2. Excluded Uses:

   • Research and development or use as a site-limited intermediate.

   • Manufacture of products intended solely for export.

Information Requirements

Individuals or organizations intending to conduct a significant new activity must submit a Significant New Activity Notification (SNAN) to the Minister of the Environment. Required information includes:

• Description of the Proposed Activity: A detailed outline of the significant new activity involving the substance.

• Anticipated Annual Quantities: Estimated volume of the substance to be used or distributed.

• Toxicological Data: Information on eye and skin irritation, dermal penetration, and any other relevant toxicity assessments.

• Environmental and Human Health Impact: Documentation identifying potential adverse effects and assessing exposure risks.

• Contact Details: Name, address, and contact information of the notifier and its Canadian representative (if applicable).

• Certification Statement: A signed declaration confirming the accuracy and completeness of the information provided.

Review Process

The SNAN will be reviewed by the Department of the Environment and the Department of Health within 90 days of a complete submission.

Transitional Provisions

To facilitate compliance, transitional provisions are in place until December 7, 2025. During this period, significant new activity thresholds are as follows:

• Manufacturing or Distribution Threshold: Quantities of up to 100 kg per year may be used in cosmetics in concentrations greater than 1% by weight.

From December 8, 2025, the threshold will revert to 10 kg per year for similar activities.

Compliance and Enforcement

Reporting Obligations

Entities engaging in activities involving the substance must comply with reporting requirements, including:

• Submitting timely and accurate SNANs.

• Reporting new information that indicates the substance is toxic or may become toxic under Section 70 of CEPA.

Transfers of Possession Obligations

Those who transfer physical possession or control of the substance must inform recipients of compliance requirements, including obligations under the SNAc Notice.

Pre-Notification Consultation (PNC)

Organizations or individuals are encouraged to consult with the regulatory authorities during the planning phase of their activities to clarify data requirements and regulatory expectations.