New substances: evaluating new substances
Assessment and management of new substances in Canada
This section is for individuals or companies required to notify new substances regulated under the Canadian Environmental Protection Act, 1999 (CEPA 1999) (the Act) and to provide general information on the New Substances (NS) program.
The NS program is responsible for administering the New Substances Notification Regulations (Chemicals and Polymers) [NSNR (Chemicals and Polymers)] and the New Substances Notification Regulations (Organisms) [NSNR (Organisms)] of CEPA, 1999. Collectively known as the Regulations they are an integral part of the federal government's national pollution prevention strategy. As part of the "cradle to grave" management approach for toxic substances laid out in the Act, the Regulations were created to ensure that no new substances (chemicals, polymers or animate products of biotechnology) are introduced into the Canadian marketplace before an assessment of whether they are potentially toxic has been completed, and any appropriate or required control measures have been taken.
Any company or individual who plans to import or manufacture a substance subject to notification under the Regulations must provide Environment and Climate Change Canada with a New Substances Notification (NSN) package containing all information prescribed in the Regulations prior to import or manufacture. The type of information required and the timing of the notification will depend on such factors as the type of substance, the quantity that will be imported or manufactured, the intended use of the substance and the circumstances associated with its introduction.
When Environment and Climate Change Canada receives a NSN Package from a company or individual proposing to import or manufacture a new substance, a joint assessment process is carried out with Health Canada to determine whether there is a potential for adverse effects of the substance on the environment and human health. To facilitate this assessment, the NSN Package must contain all required administrative and technical data, and must be provided to the NS program, New Substances Division at Environment and Climate Change Canada prior to the manufacture or import of the substance.
The assessment time limit is typically 60 days, but it varies from 5 to 120 days depending on the type of substances and quantities which the companies want to import or manufacture.
When this process identifies a new substance that may pose a risk to human health or the environment, CEPA 1999 empowers Environment and Climate Change Canada to intervene prior to or during the earliest stages of its introduction into Canada. This ability to act early makes the NS program a unique and essential component of the federal management of toxic substances.
International activities are undertaken within the NS program to support effective and efficient decision-making about human health and the environment by seeking common ground in international efforts. Such initiatives further the Canadian Environmental Protection Act's principles of pollution prevention and sustainable development.
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Program Development and Engagement Division
Environment and Climate Change Canada
New Substances Assessment and Control Bureau
Related Act, Regulations and Guidance Material
- Canadian Environmental Protection Act, 1999
- New Substances Notification Regulations (Chemicals and Polymers)
- New Substances Notification Regulations (Organisms)
- Regulations Amending the New Substances Fees Regulations
- Guidance Documents - Chemicals, Polymers, Biochemicals and Biopolymers
- Guidance Documents - Animate Products of Biotechnology
- The Significant New Activity Provisions under CEPA 1999
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