Table 1: A Primer on Scientific Risk Assessment at Health Canada – Health Canada’s Six Key Product Classes
|Drugs, Devices, Biologics||Foods||Pesticides||New Substances||Existing Substances||Consumer Products (including cosmetics|
|Legislative Basis||The Food and Drugs Act and, when applicable, the Controlled Drugs and Substances Act||The Food and Drugs Act and the Department of Health Act||The Pest Control Products Act||The Canadian Environmental Protection Act, 1999(in cooperation with Environment Canada) and the Food and Drugs Act||The Canadian Environmental Protection Act, 1999(in cooperation with Environment Canada)||The Hazardous Products Act and the Food and Drugs Act (for cosmetics)|
|Products Assessed||Pharmaceutical drugs, natural health products, medical devices, biological drugs, radiopharmaceuticals, blood and blood products, cells, tissues and organs, as well as vaccines and veterinary drugs.||Food, including food ingredients and components and production processes related to safety and nutritional qualities.||Pest control products (including, for example, herbicides, insecticides, fungicides, animal repellents, wood preservatives, swimming pool algicides, material preservatives, certain disinfectants and sanitizers).||New substances (e.g., chemicals, polymers, products of biotechnology, nanomaterials) imported and manufactured in Canada that are not already listed in the Domestic Substances List (DSL), or for which there is a significant new activity notice (often this refers to a new use, an increase in quantity or concentration, or changes in the manner or circumstances of use). Environmental assessment of Food and Drugs Act products. Screening assessment of living organisms listed in the DSL.||The approximately 23,000 chemical substances used, imported or manufactured in Canada (at a quantity greater than 100 kg) that are included in the DSL.||Consumer products, (e.g., household chemicals and cleaning products, bedding, pyjamas and cosmetics).|
|Scope of Scientific Risk Assessment||Risks and benefits, includes efficacy.
(Predominantly risk in some cases, such as the post-market assessment of possible contaminants). Focus is on risk to human health with some attention to environmental consequences. Risks are normally assessed at the population or sub-population level. Detailed pre-market assessment (including clinical trials for some products) combined with post-market surveillance (e.g., through reporting of adverse reactions). Risks associated with manufacturing are assessed and Good Manufacturing Processes (GMPs) are required.
|Risks and efficacy.
Estimates of risk are normally based on exposure patterns for a population. Vulnerable sub-populations are identified for additional protection (i.e., infants). Pre-market risk assessment combined with post-market surveillance through inspection (via the Canadian Food Inspection Agency).
|Risks and efficacy (value).
Human health and environmental assessments at the individual and population level. Pre-market risk assessment, assessment of risks during use, post-market monitoring of pesticide residues (via the Canadian Food Inspection Agency), and incident reporting. No assessment at the manufacturing step. Cyclical re‑evaluation.
|Risks. Human health and environmental assessments often based on "structure-activity relationship" methods (for chemicals; more on this below). Assessments are done at the population or sub-population level. Pre-market risk assessments may be followed up by enforcement activities, which could include inspections (via Environment Canada). Risks from effluents at the manufacturing step are assessed.||Risks. Benefits may be considered in the risk management phase. Human health and environmental assessments. Acute exposure is evaluated at the individual level; chronic exposure at the population level. By definition, assessment is post-market. No formal assessment at the manufacturing step.||Risks. Consideration of benefits occurs predominantly during development of risk management options. Focused on human health assessment at the population level plus some attention to environmental consequences. Post-market surveillance regime, with triggers for human health and safety.|
Note: This table is not meant to be an exhaustive list of legislative basis and products assessed at Health Canada.
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