New Substances Program Advisory Note 2004-05

Publication in the Canada Gazette, Part 1 The proposed New Substances Notification Regulations (Chemicals and Polymers), the proposed New Substances Notification Regulations (Organisms) and the amendment to the New Substances Fees Regulations

This advisory note is to inform importers and manufacturers of chemicals, polymers and products of biotechnology and other stakeholders about the proposed New Substances Notification Regulations (Chemicals and Polymers) [NSNR (Chemicals and Polymers)] and New Substances Notification Regulations (Organisms) [NSNR (Organisms)] that will replace the current NSNR and to seek expressions of interest from stakeholders regarding attendance at information sessions on the revised NSNR (Chemicals and Polymers).

Background

When the chemicals and polymers portion of the NSNR came into force in 1994, Environment Canada and Health Canada committed to conduct a formal review of the regulations following the first three years of their implementation. A multistakeholder consultative process was initiated in 1999 to benefit from government, industry and public experience with the NSNR and New Substances Program. The outcome of these consultations was 76 consensus recommendations. The proposed NSNR (Chemicals and Polymers) are, in addition to changes in program administration and ongoing international collaboration efforts, Environment Canada's and Health Canada's implementation of these recommendations.

As with the current NSNR, the proposed NSNR (Chemicals and Polymers) and NSNR (Organisms) ensure that no new substance is introduced into the Canadian marketplace before an assessment of its potential effects on the environment and human health has been completed. Any substance not on the Domestic Substances List is considered to be a new substance to Canada and is subject to notification requirements under the NSNR.

The proposed regulations prescribe the information that must be submitted to the Ministers of the Environment and Health prior to a new substance being introduced into Canada. They also prescribe the timeframes during which the Minister of the Environment and the Minister of Health must complete the assessments.

The proposed new regulatory framework divides the proposed NSNR into two separate regulations: the NSNR (Chemicals and Polymers) and the NSNR (Organisms). These will replace the current NSNR while continuing to ensure the same level of protection for the environment and human health. The new framework achieves two main goals:

• To reduce the complexity of the current NSNR (Chemicals and Polymers) by using plain language and flowcharts to give manufacturers and importers a "roadmap" of the notification requirements under the proposed NSNR;
• To separate the provisions governing chemicals and polymers (including biochemicals and biopolymers) and organisms (animate products of biotechnology as defined under Part 6 of the Canadian Environmental Protection Act, 1999 (CEPA 1999) into two stand alone regulations, thus clarifying to manufacturers and importers the requirements pertinent to them.

Note that the proposed NSNR will not result in significant changes in testing and reporting for manufacturers or importers, but will make the notification process easier to use, thus saving time and money.

The modifications made to the NSNR (Organisms) are strictly administrative and will not create any changes to the provisions governing organisms.

The New Substances Fees Regulations, which only apply to chemicals and polymers, are being amended to ensure consistency with the proposed NSNR (Chemicals and Polymers) without altering the fee structure.

All of the revised Regulations are expected to come into force simultaneously in 2005. Environment Canada and Health Canada will publish updated Guidelines to facilitate understanding of, and compliance with, the changes to the new substances notification and assessment process for chemicals and polymers. Until these new Guidelines are finalized, the existing Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers (August 2001) will be in effect to the extent they are consistent with the proposed Regulations.

Information Sessions for the New Substances Notification Regulations (Chemicals and Polymers)

The purpose of the information sessions is to give participants an opportunity to become familiar with the proposed New Substances Notification Regulations (Chemicals and Polymers).

This session will last up to a half-day and will cover the regulatory modifications resulting from the proposed NSNR. A good working knowledge of the current NSNR is a prerequisite for this session.

Training Sessions for the New Substances Notification Regulations (Chemicals and Polymers)

This minimum half-day course will give participants an opportunity to become familiar with the NSNR (Chemicals and polymers) requirements. Practical cases involving compliance with the NSNR (Chemicals and polymers) will be discussed along with the roles and responsibilities of the various stakeholders.

Contact Information

New Substances Notification Information Line
Telephone: 1-800-567-1999 (toll-free in Canada)
1-819-953-7156 (outside Canada)
Facsimile: 1-819-953-7155
E-mail: nsn-infoline@ec.gc.ca

For additional information or documentation regarding the NSNR, please visit the New Substances Web Site at http://www.ec.gc.ca/substances/nsb/eng/index_e.htm.

Origninal signed by

Bernard Madé
Acting Director
New Substances Division
Environment Canada

Signed on October 20, 2004

Survey

The sessions are free and will be offered in French or/and English. This survey will assist Environment Canada in determining the cities where the sessions will be given, the preferred language, and the type of session(s), information and/or training, to be offered.

You can participate in the survey by completing the form provided below and returning it to the New Substances Program by facsimile at (819) 953-7155 or by e-mail at nsn-infoline@ec.gc.ca. The survey should be sent by November 30, 2004. The New Substances Program appreciates your cooperation.

Name:__________________________________________

Title: __________________________________________

Organization:___________________________________

Mailing Address:________________________________

City/Province/State:______________________________

Postal/Zip Code: ________________________________

Telephone:_____________________________________

Facsimile:____________________________________

E-mail :_________________________________________

I would like the session offered in:

___ English
___ French

I am familiar with the current NSNR and I would be interested to attend an information session:

___ Yes
___ No

I am not familiar with the current NSNR and I would be interested to attend a training session:

___ Yes
___ No

I would like to attend the session in:

___ Montreal
___ Toronto
___ Moncton
___ Regina
___ Calgary
___ Edmonton
___ Vancouver
___ Other (Please specify location)? _____________________________

Please share this information with anyone who may be interested.