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.
The full text of Bill C-38 can be viewed at: http://parl.gc.ca/HousePublications/Publication.aspx?Docid=5524772&file=4
Article prepared with assistance from Colleen McMullin.
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