New Substances Notification Advisory Note 02-2002

Publication in Canada Gazette, Part II, of the New Substances Fees Regulations (NSFR)

This advisory note informs of the date of implementation of the New Substances Fees Regulations, briefly explains the regulations, and introduces the "Guide to the New Substances Fees Regulations" as well as the Advisory Panel.

Effective Date of Implementation

The New Substances Fees Regulations, developed under section 328 of the Canadian Environmental Protection Act (CEPA) 1999, were approved by the Ministers of Environment Canada and Health Canada, and published in the Canada Gazette, Part II, on November 6, 2002.

The date of implementation for the New Substances Fees Regulations is January 1, 2003.

From this date forward, all notifiers will be required to pay the prescribed fees at the time of their notification or when a special service is requested. Environment Canada will be responsible for administering the regulations. These fees recover part of the cost of processing and assessing notifications for new chemicals and polymers.

New Substance Notifications received prior to January 1, 2003 and for which prescribed information was deemed missing will be subject to the New Substances Fees Regulations if the new substance notification package is not completed prior to that date.

Application

The multistakeholder consultations on the New Substances Fees Regulations, which included representatives from the federal government, the chemical industry and non-governmental organizations, concerned only chemicals and polymers since the New Substances Notification Regulations for biotechnology products were not in effect. The New Substances Fees Regulations therefore do not apply at this time to new substances that are biotechnology products (e.g., biochemicals, biopolymers, microorganisms, organisms).

The regulations also do not apply to notifiers whose substance is for a use(s) that is exclusively regulated under another Federal Act of Parliament, whether or not it is listed in CEPA, 1999, Schedules 2 or 4. As a consequence, substances whose use(s) is regulated by the Food and Drugs Act, the Fisheries Act and the Health of Animals Act are not subject to the Fees Regulations.

Comments Following Publication in Canada Gazette, Part I

The New Substances Fees Regulations were published in Canada Gazette, Part I, on Saturday, June 30, 2001. Environment Canada has responded to all comments received from stakeholders during the 60-day comment period.

Copies of the New Substances Fees Regulations and Environment Canada’s response to comments can be obtained from the New Substances Program Web site or the Environmental Registry Web site.

Fees Structure

The fees for a notification assessment range from $50 to $3,500, with reductions available for staged, matched, or consolidated notifications, and for notifiers having annual sales in Canada that total $40 million (Canadian) or less. The New Substances Fees Regulations also include fees for special services such as a confidential search of the Domestic Substances List or the Non-domestic Substances List, masked name requests, and Four Corners Agreement submissions.

Refund Policy

A New Substances Program Refund Policy is being finalized that will outline the circumstances for which refunds will or will not be issued. This policy will be available on the New Substances web site as soon as possible.

Fees Guide

A Guide to the New Substances Fees Regulations is being developed to assist notifiers in understanding the regulations and in determining the applicable fee for a new substance notification assessment. The guide will include a Fee Form and instructions on how to complete it. A separate Fee Form must be submitted for each notification except consolidated notifications. The guide will be available in hard copy and on the New Substances Program Web site at [www.ec.gc.ca/substances]. The guide will be updated as needed.

Advisory Panel

An Industry/Government Advisory Panel is being established to develop an evaluation framework for the New Substances Fees Regulations and, in consultation with stakeholders, to re-examine the fee structure as required. The Advisory Panel will also be tasked with further exploring opportunities for further improving the effectiveness and efficiency of the New Substances Program.

David McBain
Director, New Substances Division
Environment Canada