Biotechnology (Living Organisms)
Welcome to the biotechnology section of the New Substances website. Here you will find regulatory information on the New Substances Program as it relates to "animate products of biotechnology" that are "new".
The organisms portion of the New Substances Notification Regulations (NSNR) for products of biotechnology have been in place since September 1, 1997Footnote 1. Animate products of biotechnology refers to the use of living organisms such as microorganisms that are used in microbial products or are used to produce various biomolecules. The Regulations also apply to various 'higher' organisms such as fish, livestock and insects (depending on the type of use). In some cases, Environment Canada has agreements with other Federal Departments to conduct assessments of certain types of organisms.
Briefly, the Regulations establish classes or groups of organisms; they identify administrative and information requirements; and they specify the timing of notification before import, or manufacture can proceed.
Click on the appropriate heading (Who Should and How To Notify) on the left to find out more information about the notification and assessment aspects of the program for animate products of biotechnology.
- 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
- Footnote 1
Animate products of biotechnology (living organisms) are covered under Part 6 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), whereas Part 5 of CEPA 1999) covers new substances that are chemicals, polymers or inanimate products of biotechnology.
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