This article originally appeared in Food in
Canada and is republished with the permission of the
As Canada's food supply continues to diversify, foods that
have not been traditionally consumed in western cultures are
becoming part of the Canadian diet. In mainstream stores it's
now commonplace to find foods from different cultures, like
aloe-beverages, or traditional foods with exotic additions, like
maca ice cream. Globalization, lower transportation costs, and
changing consumer preferences towards functional foods are driving
the increased introduction of foods and ingredients that could be
considered "novel" into the Canadian marketplace.
The consumer-driven demand for these products poses a dilemma
for industry and regulators alike - can the novel food regulatory
framework provide the necessary flexibility to adapt to these
trends while maintaining the safety standards Canadians expect?
With the regulatory tools at our disposal, and a fresh perspective,
the potential exists for both needs to be met.
The legal requirement to notify Health Canada prior to
sale of a novel food, places the burden of determining if a food or
ingredient is novel on manufacturers/importers. This determination
can be complex as the legal definition for "novel food"
is broad and includes foods or ingredients that do not have a
history of safe use as food. Novelty status can be especially
difficult to assess where an ingredient is an extract of a herb or
food that does have a history of safe use, or where the food is
consumed in other parts of the world but information is difficult
to access or apply to use in Canada. So how do you know
definitively if a food is novel? Well, foods are assessed on a
case-by-case basis and when in doubt, manufacturers/importers are
encouraged to consult with the Novel Foods Section. In my experience,
depending on the nature of the ingredient, the information
provided, the volume of requests and whether a previous
determination has been made, a response can be received within a
short timeframe, or several months.
Given the rapidly changing marketplace, can this process be
improved? Part of the answer might be in the new template for
novelty determination developed by Food Directorate, which may
provide structure to the process. As well, looking to the approach
Food Directorate is considering to address novel ingredients in
products that transitioned from the NHP to the food regulatory
framework and are currently being sold under Temporary Marketing
Authorizations (TMAs) as
When these products originally gained market access as NHPs,
they were subject to a safety assessment based on consumption of a
limited dose – a different criteria than novel foods which
are expected to be consumed freely (at one's pleasure). Now
that these products are regulated as foods, to address this issue
without immediate disruption to the marketplace, Food Directorate
is considering using the TMA tool to exempt supplemented foods
containing certain novel food ingredients from the novel food
notification process. Under this approach, a list of ingredients eligible for
exemption would be published and if a supplemented food
contains those ingredients, a safety assessment would be undertaken
during the TMA period.
The list of ingredients eligible for exemption is not an
indication that these ingredients are safe for use in foods -
rather these ingredients are being assessed for use only in
supplemented foods considering that the sale of these products
could be subject to certain conditions (e.g. labelling statements,
directions of use, max. levels of use). What remains to be
determined, is what will occur with respect to the novel status of
these ingredients upon the expiry of the TMAs.
In exploring new approaches, it may be possible to continue to
improve the novel foods framework – for example, expanding
the TMA approach to a wider variety of potentially novel
ingredients with a history of use in other cultures, or developing
a searchable database identifying those ingredients that have been
assessed for use in all foods and found either not to be novel or
safe within certain usage levels. Improved transparency and
efficiency would help Canada keep pace with the evolving global
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guide to the subject matter. Specialist advice should be sought
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