Substances identified as being of low concern using the ecological risk classification of inorganic substances and biomonitoring or rapid screening science approaches - information sheet

Publications summarized:

The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA 1999) to determine whether they present or may present a risk to human health or to the environment.

The risks posed by a substance are determined both by its hazardous properties (potential to cause adverse human health or ecological effects) and the amount or extent of exposure to people and the environment.

When needed, the Government implements risk management measures under CEPA 1999 and other federal acts to help prevent or reduce potential harm.

A draft screening assessment was conducted for a subset of 34 substances identified as being of low concern.
As a result of the draft screening assessment, the Government is proposing that these 34 substances are not harmful to human health or to the environment at levels of exposure considered in the assessment.

The screening assessment focuses on 34 substances being assessed under the third phase of the Chemicals Management Plan (CMP) using 4 different streamlined approaches noted below.
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 Canadians 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)
The Rapid screening of substances with limited general population exposure assessment, considers substances to be of low concern for human health when there is limited direct exposure to Canadians.

The ecological hazard and exposure potentials of these 34 substances were characterized using the Ecological Risk Classification of Inorganic Substances (ERC-I) Approach.
According to information gathered by the Government, a few of these substances may be used in Canada for a variety of industrial and consumer uses (including food packaging materials, drugs, natural health products, cosmetics, sealants, lubricants and greases, paper products, paints and coatings, batteries, water treatment products, pesticides, and disinfectants).

The human health exposure and risks of 33 of the 34 substances were characterized using 2 science approaches based upon biomonitoring data. Human biomonitoring is the measurement of substances in blood, urine or other human tissues and fluids (such as breast 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 Canadians.

Substances containing cerium, germanium, lanthanum, neodymium, praseodymium, tellurium, and yttrium (10 substances) were characterized using the biomonitoring-based approach 1, and Canadians' exposure to them is considered unlikely or limited.
Twenty-three bismuth- and lithium-containing substances were characterized using the biomonitoring-based approach 2, which found that Canadians' exposure 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.
For all 34 substances, the ecological exposure was characterized in the ERC-I Approach using predictive modelling (a generic near-field exposure model) and an analysis of measured concentrations of metals. Information was gathered from surveys issued under section 71 of CEPA 1999, the National Pollutant Release Inventory, the Canada Border Services Agency, market research and a number of federal and provincial water quality monitoring datasets.

To inform the health effects characterization in the screening assessment, international and national reports of data on these substances were considered. This included assessments by the United States (U.S.) Environmental Protection Agency, the U.S. Food and Drug Administration, the European Chemicals Agency (ECHA) and other Health Canada reviews.

Because bismuth- and lithium-containing substances were assessed under the biomonitoring-based approach 2, iomonitoring equivalents (concentration in blood related to health-based guidance values) were determined for these substances

For the 34 substances, ecological hazard was characterized in 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) from domestic and international assessments and water quality guidelines. When no suitable PNECs were available, new ones were derived considering multiple sources of information.

Using the 3 human health approaches noted above, it was determined that the risk to human health from these 34 substances is low at levels of exposure considered in this assessment.
Using the ERC-I Approach, these 34 substances were characterized as unlikely to be causing ecological harm.

The Government is proposing that these 34 substances are not harmful to human health or the environment at levels of exposure considered in this assessment.

These substances may be found in products available to consumers. Canadians 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.
The screening assessment focused on potential risks from exposure of the general population of Canada, rather than occupational exposure. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). For information concerning workplace health and safety and what steps to take in the workplace, Canadians should consult their employer and/or the Occupational Health and Safety Regulator in their jurisdiction.