ARCHIVED - Environmental Assessment Regulations

Effective September 14, 2001, manufacturers or importers of new substances in products regulated by the Food and Drugs Act are obliged to notify under the New Substances Notification Regulations (NSNR) and the enabling statutory authority of the Canadian Environmental Protection Act, 1999 (CEPA 1999) in order that an environmental assessment may be conducted.

The NSNR specify the prescribed information to be submitted if a substance intended for import or manufacture is not on the Domestic Substances List (DSL). An agreement was signed between Environment Canada and Health Canada which gives Health Canada the responsibility to conduct the full assessment of notified substances in products regulated under the Food and Drugs Act.

Health Canada’s Environmental Assessment Unit (EAU) conducts assessments of new substances in Food and Drugs Act products notified after September 13, 2001, while the In Commerce Substance Unit (ICSU) is responsible for conducting prioritization and assessment of products regulated under the Food and Drugs Act that were in commerce (i.e. on the In Commerce List (ICL)) on or before September 13, 2001.

The current NSNR and Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers Version 2005 (see also the Guide to New Substances Notification for Products Regulated Under the Food and Drugs Act) emerged from multi-stakeholder consultations that took place between November 1999 and August 2001. The NSNR were developed primarily to address the potential risks to the Canadian environment and human health posed by large scale (industrial) use of commercial chemicals, polymers and animate products of biotechnology.

In September 2001, the Minister of Health announced that substances in products regulated by the Food and Drugs Act would be subject to the NSNR, but since there had never been any formal consideration of the appropriateness of the NSNR for the regulation of new substances found in products regulated under the Food and Drugs Act, Canada’s Minister of Health committed to developing new, appropriate environmental regulations for substances in Food and Drugs Act regulated products. A notice of intent to develop new regulations for these substances was published in Canada Gazette Part I, September 1, 2001.

Health Canada’s Environmental Impact Initiative (EII) is the lead on the development of these new Environmental Assessment Regulations (EARs). The objective of the new EARs is to ensure that new substances in products regulated under the Food and Drugs Act are evaluated for their potential risks to the Canadian environment and human health through environmental exposure.

The EARs will cover all new substances contained in products regulated in Food and Drugs Act commodities including:

• biologics
• cosmetics
• food additives
• medical devices
• natural health products
• novel foods
• pharmaceuticals
• radiopharmaceuticals
• veterinary drugs

The EII has been consulting with various stakeholders to develop appropriate EARs addressing new substances in these commodity groups that will meet the requirements of CEPA 1999.