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NOTIFICATION OF BIOTECHNOLOGY SUBSTANCESUnder the New Substances Notification Regulations of the Canadian Environmental Protection Act, 1999Environment Canada has prepared this brochure to alert persons who manufacture or import new substances which are either organisms, biochemicals or biopolymers (the products of micro-organisms, such as enzymes), of their obligations to notify under the New Substances Notification Regulations (NSNR) of the Canadian Environmental Protection Act, 1999 (CEPA, 1999). This brochure is intended to provide a brief description of the New Substances Provisions of CEPA. A more detailed explanation is provided in the Guidelines for the Notification of New Substances: Organisms, and in the information note Reporting Substances that are Products of Microorganisms under the New Substances Notification Regulations provided with the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers. These Guidelines can either be accessed on the New Substances Website or purchased from the Environmental Technologies Advancement Directorate, Environmental Protection Service, Environment Canada, 351 St. Joseph Blvd, 18th Floor, Hull, Québec, K1A 0H3. PREAMBLEThe New Substances Notification Regulations (NSNR) of the Canadian Environmental Protection Act (CEPA) are an important component of the federal government’s pollution prevention strategy, by anticipating and preventing the introduction into Canada of new substances that may pose unacceptable risks to human health and the environment. The CEPA approach for the control of new substances are proactive and preventative as they employ a pre-import or pre-manufacture assessment process. Please note that this brochures deals only with the biotechnology portion of the NSNR. You may obtain our information package on the notification of new chemicals and polymers by contacting us at (800) 567-1999 (toll free within Canada) or at (819) 953-7156 (outside Canada) or visit the New Substances Website. THE CEPA NEW SUBSTANCES NOTIFICATION REGULATIONS (NSNR)
The NSNR are a federal initiative designed to respond to concerns over recent growth in the diversity and quantity of commercially available substances. As part of a "cradle to grave" management approach to toxic substances, the provisions for Substances New to Canada in CEPA are intended to ensure that no new substance is introduced into the Canadian marketplace before an assessment of its "toxicity" has been completed. Toxicity, as defined in CEPA, refers to risk to human health or the environment. Features of the new substances program include criteria for identifying "new substances", a mechanism for assessing new substances, and, when necessary, the enabling powers to implement specific controls. Substances suspected of being "toxic" may be controlled as necessary, including prohibiting their import or manufacture. The assessment process is initiated when Environment Canada receives a new substance notification prepared by the company or individual that proposes to import or manufacture a substance. New substance notifications must contain all required administrative and technical data and must be provided to Environment Canada by a prescribed date that precedes manufacture or import. Notification information is jointly assessed by the Departments of Environment and Health to determine the potential adverse effects of the substance on the environment and human health. This assessment, which must be completed within a time specified by the NSNR, will result in:
Parts I, II and III, of the NSNR, covering substances which are chemicals or polymers, have been in effect since July 1, 1994. Part II.1 of the NSNR, covering biotechnology substances that are organisms, or products of micro-organisms (biochemicals and biopolymers), have been in effect since September 1, 1997. WHO IS REQUIRED TO NOTIFY?Any person in Canada who manufactures or imports substances subject to notification under the NSNR, must provide a notification package to Environment Canada. This package must contain all information prescribed in the NSNR. The type of information required and the timing of the notification is dependent on many factors, including the following: type of substance, quantity imported or manufactured, listing on the Non-domestic Substances List, limited use, etc. In cases where the mandatory information required is considered, by a third party, to be confidential, the Canadian importer or manufacturer can initiate a notification and the remainder of the information can be provided directly by the third party to Environment Canada. Compliance with all regulations is mandatory. Environment Canada will act upon violations consistent with the CEPA Enforcement and Compliance Policy. WHAT IS A NEW SUBSTANCE?"Substance" is defined in section 3 of CEPA; it includes animate matter, i.e. organisms. A "new" substance is a substance that is not listed on the Domestic Substances List (DSL). WHAT IS THE DOMESTIC SUBSTANCES LIST?The DSL is a compilation of substances that were in commerce between January 1, 1984 and December 31, 1986, according to the criteria set out in section 25 of CEPA. An eligible organism is one that was in use in Canada between 1984 and 1986 such that its entry into the environment was unrestricted. For biochemicals and biopolymers, the rules of eligibility are the same as for chemical and polymer substances. These points are explained in detail in the document Reporting Biotechnology Products for the Domestic Substances List, available from Environment Canada headquarters. The DSL is the sole standard against which a substance is judged to be "new" to Canada. With few exceptions, all substances not on this list are considered new and must be notified prior to importation or manufacture. ARE THERE NEW SUBSTANCES WHICH DO NOT REQUIRE NOTIFICATION UNDER CEPA, 1999?Yes. CEPA and the NSNR establish criteria for new substances that do not require notification. These include (i) substances manufactured or imported in a quantity that does not exceed the maximum quantity prescribed, and (ii) substances manufactured or imported for a use that is regulated under any other Act of Parliament that provides for notice to be given prior to the manufacture, import or sale of the substance and for an assessment of whether it is toxic. Potential notifiers are encouraged to contact the following agencies to determine whether their substance is covered under an Act other than CEPA: (1) Pesticides: the Pest Control Products Act
(2) Plants: the Seeds Act
(3) Fertilizers: the Fertilizers Act
(4) Animal Feeds: the Feeds Act
(5) Veterinary Biologics: the Health of Animals Act
(6) Food, Drugs, Cosmetics and Medical Devices: the Food and Drugs Act For food, food additives, veterinary drugs:
For drugs for human use:
For medical devices:
In addition, the NSNR will not apply to substances that are located on carriers outside Canada and moved through Canada to a location outside Canada, even if there is a change of carrier in Canada. ARE THERE EXCLUSIONS FROM NOTIFICATION, FOR ORGANISMS, BASED ON THE SCOPE OF MANUFACTURE?Yes. An organism that is not isolated from its natural environment and processed in some way, is not considered to have been "manufactured". Consequently, the following activities do not constitute "manufacturing" and so do not require notification under the NSNR.
WHERE CAN I FIND OUT MORE ABOUT THE NSNR?Visit the New Substances Website or contact Environment Canada at the nearest regional office or at the headquarters in Ottawa. Environment Canada Headquarters Notification and Client Services
Telephone: (800) 567-1999 (toll free within Canada)
British Columbia and Yukon Environmental Protection
Tel: (604) 666-3197
Alberta, Saskatchewan, Manitoba, Northwest Territories and Nunavut Environmental Protection
Tel: (780) 951-8766
Ontario Environmental Protection
Tel: (416) 739-5892
Québec Environmental Protection
Tel: (514) 496-7396
New Brunswick, Nova Scotia, Prince Edward Island, Newfoundland and Labrador Environmental Protection
Tel: (902) 426-6135
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Disclaimer: Although care has been taken to ensure that the information found on this website accurately reflects the requirements prescribed, you are advised that, should any inconsistencies be found, the legal documents, printed in the Canada Gazette, will prevail. |
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