Substances identified as being of low concern using the ecological risk classification of inorganic substances and biomonitoring or rapid screening science approaches - information sheet
The risks posed by a substance are determined by both its hazardous properties (potential to cause adverse human health or ecological effects) and the amount or extent of exposure to people or the environment.
When needed, the Government applies risk management measures under CEPA 1999 and other federal acts to help prevent or reduce potential harm.
The Government concluded that these 34 substances are not harmful to human health or to the environment at levels of exposure considered in the assessment.
The human health risks of these 34 substances were assessed using one of the following human health approaches:
Biomonitoring-based approach 1 considers substances to be of low concern for human health when biomonitoring data indicates that exposure to people in Canada is limited or unlikely
Biomonitoring-based approach 2 compares human biomonitoring data (exposure) against biomonitoring guidance values that are protective of human health (health effects)
According to information gathered by the Government, a few of these substances may be used in Canada for a variety of industrial, commercial and consumer uses (including as a component in food packaging materials, drugs, natural health products, cosmetics, sealants, lubricants and greases, paper products, paints and coatings, batteries, water treatment products, pesticides, and disinfectants).
Human and ecological exposures
The human health exposure and risks of 33 of the 34 substances were characterized using 2 science approaches based on biomonitoring data. Human biomonitoring is the measurement of substances in blood, urine or other human tissues and fluids (such as human milk, nails or hair) through health studies or surveys, such as the Canadian Health Measures Survey. The information on levels in humans is important to estimating exposure to people in Canada.
Substances containing cerium, germanium, lanthanum, neodymium, praseodymium, tellurium, and yttrium (10 substances) were characterized using the biomonitoring-based approach 1. Exposure to these substances is considered unlikely or limited.
Twenty-three bismuth- and lithium-containing substances were characterized using the biomonitoring-based approach 2. Exposure to these substances is below levels associated with critical health effects.
The human health exposure and risk of sodium bromate (1 substance) was characterized using the rapid screening of substances with limited general population exposure.
The ecological exposure for all 34 substances was characterized in the ERC-I Approach using predictive modelling and an analysis of measured concentrations of metals. Ecological exposure was characterized using information gathered from mandatory surveys, the National Pollutant Release Inventory, the Canada Border Services Agency, market research, and a number of federal and provincial water quality monitoring datasets.
Key health and ecological effects (hazard)
The health effects characterization in the assessment considered any available data from international and national reports on these substances, among other sources of information. This included assessments by the United States (U.S.) Environmental Protection Agency, the U.S. Food and Drug Administration, and other Health Canada reviews.
Health effects associated with substances containing cerium, germanium, lanthanum, neodymium, praseodymium, tellurium, and yttrium are not expected because exposure to these substances is unlikely or limited in Canada.
Bismuth- and lithium-containing substances were assessed under the biomonitoring-based approach 2; therefore, biomonitoring equivalents (concentration in blood related to health-based guidance values) were determined and accounted for any potential health effects associated with these substances.
Health effects for sodium bromate are not expected, as exposure from this substance to the general population is considered minimal.
For the 34 substances, ecological hazard was characterized using the ERC-I Approach. The approach uses published predicted no-effect concentrations (PNECs; the concentration below which exposure to a substance is not expected to cause adverse effects in the environment) and water quality guidelines from domestic and international assessments. When no suitable PNECs were available, new ones were derived considering multiple sources of information.
Consideration of subpopulations who may have greater susceptibility or greater exposure
There are groups of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be more vulnerable to experiencing adverse health effects from exposure to substances.
Certain subpopulations are routinely considered throughout the assessment process, such as infants, children, and people of reproductive age. For instance, age-specific exposures are routinely estimated and developmental and reproductive toxicity studies are evaluated for potential adverse health effects.
Risk assessment outcomes
Assessments focus on information critical to determining whether substances are harmful to human health or the environment under CEPA. This is done by considering scientific information, including information, if available, on subpopulations who may have greater susceptibility or greater exposure, vulnerable environments and cumulative effects and by incorporating a weight of evidence approach and precaution.
Using the 3 approaches mentioned above, it was determined that the risk to human health from the 34 substances is low, at levels of exposure considered in the assessment.
Using the ERC-I Approach, these 34 substances are considered unlikely to be causing ecological harm.
Assessment conclusions
The Government concluded that the 34 substances are not harmful to human health or the environment at levels of exposure considered in the assessment.
Related resources
These substances may be found in products available to consumers. People living in Canada should follow any safety warnings and directions related to the product and dispose of products responsibly.
Use the Substances Search tool to find substances that are referenced in certain legislative or regulatory instruments or on Government of Canada websites.
Assessments conducted under CEPA focus on risks of exposure of the general population. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). If a substance is harmful to the general population, it could also be of concern for individuals in situations where a higher volume of the substance is used or where the substance is used for a longer duration (for example, the workplace). The Government of Canada recognizes that it is the responsibility of the federal, provincial and territorial occupational health and safety organizations to coordinate legislation for the safe use of chemicals in the workplace. We are working to support this role by integrating the information, tools, and/or technical expertise of the CMP and Health Canada's Workplace Hazardous Products Program.
