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New Substances Notification Advisory Note 02-2002
Publication in Canada Gazette, Part II, of the New Substances Fees Regulations (NSFR)
This advisory note provides the date of implementation of the New Substances Fees Regulations, briefly explains the regulations, and introduces the "Guide to the New Substances Fees Regulations".
The New Substances Fees Regulations were approved by the Ministers of Environment Canada and Health Canada, and will be published in the Canada Gazette, Part II, on November 6, 2002. The date of implementation for the New Substances Fees Regulations is January 1st, 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.
The Minister of the Environment will use the authority provided under the Canadian Environmental Protection Act (CEPA), 1999, to charge fees to recover part of the cost of processing and assessing notifications for new chemicals and polymers. The fees will be collected under the regulations developed under section 328 of CEPA 1999.
When consultations on the Fees Regulations began, the New Substances Notification Regulations for biotechnology products were not in effect and were therefore not discussed. The Fees Regulations therefore do not apply to new substances that are biotechnology products (e.g., biochemicals, biopolymers, microorganisms, organisms) at this time. The regulations also do not apply to notifiers whose substance is for a use that is already regulated under another Federal Act of Parliament, whether or not it is listed in CEPA 1999, Schedules 2 or 4. This includes substances whose use is regulated by the Food and Drugs Act, the Fisheries Act and the Health of Animals Act. It was never the intent to capture these stakeholders under the Fees Regulations, and they are only temporarily subject to CEPA 1999 new substances notification requirements.
The fees structure was developed as a result of multistakeholder consultations which included representatives from federal government, the chemical industry and non-government organizations (NGOs).
The fee for a notification assessment ranges 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.
Environment Canada has responded to all comments received from stakeholders during the 60-day comment period following publication in the Canada Gazette, Part I, on Saturday, June 30th, 2001. 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.
An Industry/Government advisory panel is being established to review implementation of the fee structure. Further, the fee structure will be adjusted if required and as any amendments are made to the New Substances Notification Regulations.
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 notification assessment. The guide will be available in hard copy and on the New Substances Program Web site. The guide will be updated as needed.
Director, New Substances Branch
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