Guide to understanding the Canadian Environmental Protection Act: chapter 6
6. New substances
6.1 What are new substances?
The Canadian Environmental Protection Act, 1999 (CEPA 1999) ensures that no new substances are introduced into the Canadian marketplace before they have been assessed to determine whether or not they are toxic or capable of becoming toxic to the environment or human health. Substances that are not on the Domestic Substances List are considered to be new to Canada and must be notified. New substances that are accepted as being in commercial use internationally are listed on the Non-Domestic Substances List. Substances on the Non-Domestic Substances List must also be notified, but are subject to lesser information requirements. New substances cannot be manufactured or imported until:
- the Minister has been notified prior to manufacturing or importation of the substance
- relevant information needed for an assessment of its potential toxicity has been provided to the Minister and the appropriate fee has been paid and
- the period for assessing the information (as set out in regulations) has expired
What is the Non-Domestic Substances List?
The Non-Domestic Substances List is an inventory of substances that are not on the Domestic Substances List but are accepted as being in commercial use internationally. The list is based on the United States Environmental Protection Agency's Toxic Substances Control Act Chemical Substances Inventory, and contains more than 58 000 entries.
The risks of substances determined to be or suspected of being toxic or capable of becoming toxic may be managed, as necessary, through conditions or prohibitions imposed on their import or manufacture.
If these notification and assessment requirements are met by another federal act, then the CEPA 1999 requirements do not apply. This means that CEPA 1999 in effect acts as a "safety net" -- unless new substances fall under other acts that are specifically listed in Schedule 2 regarding chemicals and polymers, CEPA 1999 requirements will apply to all new substances. Federal acts and regulations currently listed on Schedule 2 are the Pest Control Products Act, Feeds Act and Fertilizers Act, as well as their regulations.
6.2 How are the risks assessed?
Anyone interested in manufacturing or importing a new substance will be required to provide specific information for risk assessment purposes. Importers or manufacturers may also be required to provide information on "significant new activities," where a substance's exposure may change significantly based on factors such as new uses or volume of use (see Section 6.4).
Environment Canada and Health Canada evaluate new substances for risks to the environment and human health. A new substance assessment results in one of the following outcomes:
- if the substance is not suspected to be toxic, the notifier may import or manufacture the substance after the assessment period has expired
- if the substance is suspected of being toxic or becoming toxic, the government may take risk management measures
- if the substance is not suspected of being toxic but a significant new activity could result in the substance becoming toxic, the substance can be subject to re-notification under certain conditions
6.3 How are the risks managed?
The government can take the following risk management measures for new substances that are toxic or suspected to be toxic:
- permit the manufacture or import of the substance subject to specified conditions
- prohibit the manufacture or import of the substance for a period not exceeding two years unless replaced by a regulation or
- prohibit the manufacture or import of the substance until additional information or test results have been submitted and assessed
The government must undertake these risk management measures and publish them in the Canada Gazette, Part I before the expiration of the assessment period. The Gazette notices are also made public on the CEPA Registry.
6.4 What is a significant new activity?
A significant new activity is an alternative use of a substance or other activity that results or may result in:
- a significantly greater quantity or concentration of the substance in the environment or
- a significantly different manner or circumstances of exposure to the substance
If there is a suspicion that a significant new activity in relation to the substance may result in the substance becoming toxic, the substance can be subject to a significant new activity notice. The Notice communicates the criteria under which the government must be re-notified. The government assesses the new information on the substance to determine if it is toxic in relation to the significant new activity. Significant new activities can apply to existing substances on the Domestic Substances List or to new substances.
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