Canadian Government Issues Conditional Permit for Octanamide N-Hydroxy- with Strict Use Restrictions Due to Toxicity Concerns

According to the Canada Gazette of August 24, 2024, the Canadian Government has issued a conditional permit for the manufacture or import of octanamide, N-hydroxy- following concerns about its potential toxicity. After evaluating the substance, both the Minister of the Environment and the Minister of Health suspect that it may be toxic or may become toxic under section 64 of the Canadian Environmental Protection Act, 1999. The permit issued by the Minister of the Environment under paragraph 84(1)(a) of the Act contains strict conditions, outlined in the attached Annex, to address these risks. 

Octanamide, N-Hydroxy- 

Octanamide, N-Hydroxy- is a multifunctional chelating agent and preservative used mainly in cosmetics. However,  international data indicate that it will see extensive and frequent use as a chelating agent in various cosmetic and personal care products. According to the classifications provided by companies to ECHA in their CLP notifications, this substance is recognized as causing severe irritation to the eyes, skin and possibly the respiratory system. 

New Regulatory Conditions for Octanamide, N-Hydroxy-  

The Canadian Government has introduced specific conditions for the manufacture and import of octanamide, N-hydroxy- (CAS Registry Number 7377-03-9) as part of a conditional permit issued under paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999. Effective from August 12, 2024, the conditions include: 

• Prohibit its use in cosmetics 

• A requirement that it be transferred only to parties that agree to comply with these restrictions.  

The notifier must keep detailed records of the use and distribution of the substance and ensure that all records are kept in English, French or both for at least five years. The conditions aim to manage the potential risks associated with the substance while allowing for its controlled use. 

Implementation 

The Ministerial Conditions were officially published in the Canada Gazette on August 24, 2024, and came into force on August 12, 2024.