Canada | Science approach substances low human health hazard potential
Synopsis - Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA), Health Canada has evaluated a subset of 14 substances of the approximately 1550 remaining priority substances under the Chemicals Management Plan.
These 1550 substances were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA and/or were considered a priority based on human health concerns. This updated Science Approach Document (SciAD) presents a qualitative hazard-based approach to identify substances of low concern for human health from the remaining priorities.
This hazard-based approach considers available toxicological data based on human and/or animal studies. When sufficient toxicological data indicate that health effects are unlikely up to the Limit Doses (of 1000 mg/kg-bw/day as defined by the Organisation for Economic Co-operation and Development), or are limited to recoverable or localized effects above 100 mg/kg-bw/day, in repeated dose studies of high quality, the substances or moieties are considered to be of low concern with respect to human health. To determine if health effects of the substance are limited or unlikely, a number of metrics are taken into consideration, including the effects noted in animal and human studies, and the relevant route of exposure of the substance.
Application of the hazard-based approach is illustrated by 14 substances, which are of low concern for the general population with respect to human health. An assessment of these substances conducted under section 74 of CEPA will be published at a later date.
The SciAD was subject to a 60-day public comment period. While external comments were taken into consideration, the final content and outcome of the SciAD remain the responsibility of Health Canada. The publication of this updated scientific approach will assist the government in addressing substances that are likely of low concern in an efficient and effective manner.
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