November 8, 2004

Revised rules offer user-friendly structure for new substance notification process

Revisions to the New Substance Notification Regulations (NSNR) under the Canadian Environmental Protection Act (CEPA) will provide an updated, user-friendly process for businesses to report any new substances they plan to manufacture domestically or to import from other countries. The proposed regulations will create a new regulatory structure, dividing the NSNR into two separate regulations, one dealing with chemicals and polymers, the other dealing with organisms. They have been published in the October 30, 2004 Canada Gazette, Part I.

The NSNR (Chemicals and Polymers) will apply to chemicals (including biochemicals) and polymers (including biopolymers) intended for a use not covered under federal legislation listed in Schedule 2 of CEPA. The NSNR (Organisms) will apply to living organisms intended for a use not covered under other federal legislation listed in Schedule 4 of the act. In addition, the New Substances Fees Regulations, which apply to chemicals and polymers, are being amended to ensure consistency with the other two proposed regulations. Final versions of all three regulations are expected to be published early in 2005.

The new regulatory structure will ensure the same level of environmental and human health protection as the existing NSNR, while better reflecting the structure of CEPA. It will also facilitate the implementation of consensus-based changes to the chemicals and polymers portion of the current NSNR, and will simplify the NSNR by grouping together regulatory provisions for substances which share a similar nature (e.g. animate, living organisms versus inanimate chemicals and polymers) and similar information requirements and notification triggers.

"Besides helping the Government to monitor chemicals that could be introduced to the country, these proposed revisions will help businesses to save both time and money and to improve their competitive edge in the marketplace," said federal Environment Minister St√ąphane Dion. Health Minister Ujjal Dosanjh observed that the new regulations "will increase the relevance of information about new substances and will improve health and environmental protection."

To further facilitate compliance, the proposed NSNR (Chemicals and Polymers) are written in plain language, with reader aids such as a table of contents and margin notes included to increase ease of use for notifiers. They contain schedules, which have been reorganized to reduce repetition and optimize information requirements, and flowcharts designed to help notifiers find relevant provisions and schedules.

Among the key changes in the proposed regulations are the following.

*Notifiers will no longer have to track their cumulative and in-possession quantities of new chemicals and polymers.

*Previously separate categories of "research and development" and "product development" have been simplified into a single definition.

*Notifiers of special-category chemicals and polymers will be required to submit only readily available test data; they will not have to generate new test data specifically for notification purposes.

*New notification requirements will apply to certain high-volume chemicals and polymers.

*Information requirements, notification triggers and assessment periods have been optimized for each category of chemical and polymer.

Subject to certain assumptions (outlined in the regulatory impact statement), the net cost to notifiers of compliance with the new regulations is projected at approximately $642,000 per year.

The proposed NSNR (Organisms) have also been redrafted and reorganized in sections for added clarity and harmonization with the NSNR (Chemicals and Polymers). Overall, these draft regulations contain only minor amendments to the sections relating to organisms previously set out in Part II.1 of the NSNR. The changes, noted below, are not expected to have cost implications for the government or for notifiers.

*Provisions for transitional substances (i.e. those not on the Domestic Substances List and which were manufactured or imported between January 1987 and June 1994) have expired and are not included in the proposed regulations.

*The definition of "research and development substance" has been revised to include a specific reference to organisms and scale-up trials.

*Notifiers will be required to provide a signed certification attesting to the accuracy and completeness of notification information (this formalizes a requirement previously included as a guideline).

The federal government receives approximately 900 notifications annually from businesses wishing to manufacture or import new substances to Canada.

Comments on the proposed Regulations are due by December 29th, 2004 and should be sent to the Notification and Client Services Division, New Substances Branch, Risk Assessment Directorate, Environment Canada, Place Vincent Massey, 14th Floor, Gatineau, Quebec K1A 0H3; FAX 819/953-7155, E-mail nsn-infoline@ec.gc.ca.

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