Environmental Impact Initiative

The Canadian Environmental Protection Act (CEPA) 1999 requires that all new substances for use in Canada be evaluated for their potential risks to the Canadian environment and human health. All substances contained in products regulated under the Food and Drugs Act (F&DA) are currently regulated under the New Substance Notification Regulations (NSNR).

However, the NSNR were developed for industrial chemicals. As such, there is a need to develop Environmental Assessment Regulations with specific information requirements respecting the risks to the environment and human health. Health Canada's Environmental Impact Initiative (EII) was established within the Health Products and Food Branch (HPFB) in 2001.

The Environmental Assessment Regulations will cover all new substances contained in products regulated under the F&DA including:

• pharmaceuticals/ radiopharmaceuticals/ therapeutic products
• biologics/ generic therapies
• veterinary drugs
• natural health products
• medical devices
• cosmetics
• food additives and novel foods

Since 2001, EII has been working with the Healthy Environment and Consumer Safety Branch (HECSB) of Health Canada, the HPFB Directorates that represent the above commodity groups, and the New Substances Branch of Environment Canada in the development of appropriate Environmental Assessment Regulations that will meet the requirements of CEPA 1999.

Along with the previous mentioned working partners, EII also collaborates with other colleagues, in Canada and internationally, to build the scientific evidence base regarding the direct and indirect health impacts of substances in products regulated under the F&DA, and to identify best practices to help manage them.

The Guide to New Substances Notification for Products Regulated Under the Food and Drugs Act is intended to assist importers and manufacturers, of products subject to regulation under the Food and Drugs Act (F&DA), to comply with the New Substances Notification Regulations (NSNRs) under the Canadian Environmental Protection Act, 1999 (CEPA 1999).