Risk Assessment of Chemical Substances in Canada is performed under the purview of Canada's Ministry of Health and the Ministry of the Environment. The risks posed by chemical substances are determined by the scientific evaluations or risk assessments conducted under the Canadian Environmental Protection Act, 1999 (CEPA 1999). It helps to determine whether risks are resulting from the nature of the substance or the extent of exposure of the substance to the Canadians or the environment. Also, it identifies whether or not a risk management measure is needed.

Under section 64 - Part 5 of CEPA 1999, any substance that enters/may enter the environment in a quantity/concentration is considered toxic under the following conditions:

• The substances have/may have an immediate/long-term harmful effect on the biological diversity or the environment.
• The substances constitute/may constitute a threat to the environment on which life depends.
• The substances constitute/may constitute a risk to human life or health.

If a substance is confirmed to be toxic or capable of becoming toxic, the risk assessment is considered to prevent or control the identified risks.

Risk Assessment for Existing Substances

Collection of the information on each substance/substance group is the first step in the risk assessment process. The information must comprise of chemical properties, manufactured/imported quantity, concentrations in the environment and nature of exposure. Expert and stakeholder engagement is crucial throughout the process. The assessment reports must undergo external peer review and/or consultation involving experts and the draft screening assessments are subject to a 60-day public comment period. While all the comments are taken into consideration, the conclusion of screening assessments will be provided by Health Canada and Environment & Climate Change Canada.

Risk Assessment for New Substances

All new substances must undergo an ecological and human health risk assessment before manufacturing/importing into Canada. The process begins with a pre-manufacture/ pre-import notification of the substance. It means - any person intending to import or manufacture a new substance in Canada must submit a package containing all the information prescribed in the New Substances Notification Regulations. In general, the risk assessments of new substances and existing substances are conducted in a similar way.

In a nutshell, risk management is a global Regulatory requirement. Hence, the companies must mitigate risks and ensure maximum safety and effectiveness. If you are looking for a compliant and effective risk management system, reach out to a local expert team of Regulatory consultants. 

Stay informed. Stay compliant.