News Details

The Government of Canada has officially added 2-ethylhexyl 2-ethylhexanoate (CAS No. 7425-14-1) to Part 2 of Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA). The Order (SOR/2026-47) was registered on March 13, 2026, and published in the Canada Gazette, Part II, Volume 160, Number 6 on March 25, 2026.

Substance Profile and Risk Concerns

2-Ethylhexyl 2-ethylhexanoate (hexanoic acid, 2-ethyl-, 2-ethylhexyl ester; molecular formula C₁₆H₃₂O₂)  is used in certain cosmetic products sold in Canada, including foot lotions and face makeup. Although the substance occurs naturally at trace levels in some foods, its primary route of human exposure is through dermal contact with cosmetics.

A screening assessment published by Environment and Climate Change Canada (ECCC) and Health Canada in December 2018 concluded that the substance meets the human health toxicity criterion under paragraph 64(c) of CEPA. The assessment found that current uses and exposure levels from cosmetic products may pose a risk to human health, particularly with regard to developmental toxicity, including skeletal malformations and liver toxicity as observed in animal studies using the analogue substance 2-ethylhexanoic acid (2-EHA).

Key Regulatory Details

Schedule 1, Part 2 Classification

Under the amendments introduced by the Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5, 2023), CEPA's Schedule 1 is now divided into two parts:

• Part 1 covers substances posing the highest risk, prioritized for total, partial, or conditional prohibition.

• Part 2 covers toxic substances prioritized for pollution prevention actions, which may also include prohibitions where warranted.

2-Ethylhexyl 2-ethylhexanoate has been placed in Part 2. While it meets CEPA's bioaccumulation criteria, it does not meet the persistence criteria under the Persistence and Bioaccumulation Regulations - a key factor in its classification as a Part 2 substance rather than Part 1 substance.

No Immediate Regulatory Burden on Industry

It is important to note that the addition of a substance to Schedule 1 does not, in itself, impose new regulatory requirements on businesses. Rather, it grants the Minister of the Environment and the Minister of Health the authority to develop and propose risk management instruments under CEPA. Any future measures will be subject to public consultation and cost-benefit analysis in accordance with the Cabinet Directive on Regulation.

Existing Risk Management Measures in Canada

2-Ethylhexyl 2-ethylhexanoate is already subject to concentration limits under the Cosmetic Ingredient Hotlist, which restricts its use to:

• 0.1% in body lotion

• 0.5% in foot lotion

• 0.6% in face make-up

These limits are administered under the Cosmetic Regulations of the Food and Drugs Act.

International Regulatory Context

Canada's action aligns with a broader international trend of tightening controls on this substance:

• European Union: 2-Ethylhexyl 2-ethylhexanoate is prohibited in cosmetics due to its classification as a Category 2 reproductive toxicant under EU regulations. No exceptions have been granted by the Scientific Committee on Consumer Safety (SCCS) as of spring 2025.

• United States: The substance is subject to Chemical Data Reporting (CDR) requirements under EPA's Toxic Substances Control Act (TSCA).

• Australia: Labelling requirements under the Australian Poisons Standard have been in effect since June 2017, including warnings against use by pregnant women.

What Comes Next?

Now that the substance is formally listed on Schedule 1, the Canadian government may proceed to develop additional risk management measures. Stakeholders, manufacturers, and importers of cosmetic products containing 2-ethylhexyl 2-ethylhexanoate should monitor upcoming consultations in the Canada Gazette for proposed instruments.