A notification referred to in paragraph (1)(a) shall be signed by the manufacturer or importer, or a person authorized to sign on behalf of the manufacturer or importer, and shall include the following information:
a) the common name under which the novel food will be sold;
b) the name and address of the principal place of business of the manufacturer and, if the address is outside Canada, the name and address of the principal place of business of the importer;
c) a description of the novel food, together with
i) information respecting its development,
ii) details of the method by which it is manufactured, prepared, preserved, packaged and stored,
iii) details of the major change, if any,
iv) information respecting its intended use and directions for its preparation,
v) information respecting its history of use as a food in a country other than Canada, if applicable, and
vi) information relied on to establish that the novel food is safe for consumption;
d) information respecting the estimated levels of consumption by consumers of the novel food;
e) the text of all labels to be used in connection with the novel food; and
f) the name and title of the person who signed the notification and the date of signing.
Upon receipt of the notification, a letter of acknowledgement in which the file number for the product is indicated, will be sent to the petitioner. This number, along with pertinent dates, should be used in all subsequent correspondence.
As stated in B.28.003, within 45 days of receiving this notification, HPFB will review the notification and provide in writing either no objection to the sale of the novel food for
Within 90 days of receiving the safety assessment package, HPFB will review the data and provide in writing either a notice of no objection to the sale of the novel food for consumption or a request for additional scientific data to clarify outstanding issues.
Written notification should be provided well in advance of the period when the manufacturer intends to market the product. Health Canada is obligated to respond regarding its acceptability for sale or whether further information is required for assessment within 45 days of receiving the notification.
Officially, manufacturers and importers are required to notify the Assistant Deputy Minister of the Health Products and Food Branch (HPFB). However, the Novel Foods Section has been established in the Food Directorate of HPFB to coordinate the safety evaluation of novel foods intended for human consumption in Canada. The notification and/or submission package should be addressed to:
Novel Foods Section
Health Products and Food Branch Health Canada
4th Floor West, Sir Frederick G. Banting Research Centre Tunney's Pasture, Postal Locator 2204A1
Ottawa, Ontario. K1A 0L2
As the coordinating office, the Novel Foods Section (formerly Office of Food Biotechnology) is responsible for communicating with petitioners, receiving novel foods notifications and submission material and initiating the review process outlined in figure 1. The Novel Foods Section distributes the submission material to relevant Food Directorate bureaux, namely the Bureau of Chemical Safety, the Bureau of Nutritional Sciences, and the Bureau of Microbial Hazards for their respective reviews. In some cases, the Environmental Assessment Unit, Healthy Environments and Consumer Safety Branch will conduct environmental assessments of novel foods under proposed Environmental Assessment Regulations (EA Unit - see section 3.1). Evaluators have a period of 45 days to review a notification and 90 days to conduct a safety assessment of a submission package as outlined in the regulation. All requests for additional information by evaluators are communicated through the Novel Foods Section which creates a single window approach to submission reviews. Any request for information resets the 90 day assessment time to allow for the review of the additional information once it is received from the petitioner. Submission of unsolicited additional data by a petitioner may also reset the 90 day review period.
At the completion of the safety assessment, if and only if all members of the evaluation team agree there are no health risks associated with the consumption of the novel food product in question, a proposal is drafted which contains a summary of the scientific reviews conducted by the relevant bureaux of the Food Directorate. This proposal is presented to the Food Rulings Committee consisting of Food Directorate senior management and representatives from other agencies or departments within the Canadian government. If found acceptable by the Committee, the petitioner is notified in writing by the Director General of the Food Directorate that, based on the evaluation of the submitted data, Health Canada has no objection to the sale of the novel food product as human food in Canada as specified in the letter.
Novel food decisions and summary documents are made available on the Health Canada website for all products for which Health Canada has issued a letter of no objection to the use as food in Canada.