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On April 26, 2012, Bill C-38, entitled the Jobs, Growth and
Long-term Prosperity Act was introduced to the House of Commons by
the Minister of Finance, Jim Flaherty. The Act amends the current
Food and Drugs Act (FDA) and includes provisions that aim to
dramatically change aspects of the regulatory framework for food in
Canada. To keep pace with changing technologies and developments in
nutritional science, the new legislation is geared at cutting red
tape and streamlining government processes, allowing more timely
approvals of safe, innovative products, in order to better respond
to industry advancements.
Under current legislation, approval of a new food additive,
vitamin, mineral nutrient or health claim can be held up for years
before it is addressed by a legislative change: this is despite
Health Canada's food scientists having already made the
requisite safety decisions. These delays limit Canadians'
access to many novel products and limit industry's ability to
respond to new scientific information.
A Health Canada briefing outlined how the Act will affect the
landscape of food regulation for industry participants. Division 19
will enable two major changes to the manner in which food is
regulated under Part B of the Food and Drug Regulations (FDR):
1. Replacement of the current interim marketing
authorization (IMA) process with new ministerial
powers
Section 416 of the Act provides the Minister with a new
marketing authorization tool that utilizes "administrative
lists" to expedite regulatory change. Unlike the current IMA
process which is subject to a three-year waiting period and may be
used only to augment existing legislation (i.e., it applies only to
currently approved food additives), this new tool allows the
introduction of new provisions to the FDR and extends what
exemptions may be permitted from compliance with the FDR. This is
expected to significantly reduce the timeframes associated with
getting new products such as novel food additives to market.
2. Incorporation by reference
The Act also allows the FDR to reference established lists,
rather than necessitating the inclusion of each individual
ingredient in the FDR itself. This will allow a faster response to
new scientific developments in the industry, as authorizations
canextend to new products as lists become updated, without the
requirement that each new food or ingredient go through the
regulatory process.
Although the Bill must follow the usual legislative course given
that it relates to the implementation of the federal budget, it
will likely receive a swift passage. As such, the Food Directorate
of the Health Products & Food Branch of Health Canada is
already exploring how to incorporate these changes into the
Regulations. Once the Act has been approved, Health Canada will be
able to consult with industry and other stakeholders on any new
developments.
Health Canada has indicated that the first stage in the new
regulatory shift is to transition all food additives currently
regulated under Part B of the FDR to the new regime. The Food
Directorate intends to include foods currently under an IMA in this
switch. Further, all new food additives will be exclusively
addressed by the Food Directorate under this new framework. Health
Canada's projected performance standards entail a six-month
waiting period for adding a new ingredient to a list to allow for a
risk assessment and administrative processing.
The Act is expected to considerably reduce procedural hurdles to
gaining market access and to significantly speed up approvals of
new foods and food ingredients. Bill C-38 represents what will
hopefully be a welcome change to industry members and consumers
alike.
Article prepared with assistance from Colleen McMullin.
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