11 minute read
Food Safety
CanaDa KeePIng PaCe on fooD safeTy
Food safety is an important part of the health and safety of Canadians, but we often don’t consider what it takes for a product to arrive at the dinner table.
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We typically hear about food safety issues only when something goes wrong. Canada has robust food and beverage regulatory structure and food safety policies and procedures designed to protect Canadians. This article will examine Canada’s food safety system with regard to food labelling, including that for genetically engineered foods, as well as recent changes with respect to how Natural Health Products and beverages are regulated.
FooD saFety In CanaDa
In 2008, Canada went through a period of reflection when 23 Canadians died due to the presence of Listeria monocytogenes in ready-to-eat meat products. Following this unfortunate event, there was an independent investigation that culminated in what is referred to as the Weatherhill report. This report set out 57 recommendations ranging from reporting requirements at meat plants and recommendations on equipment design, to the training of inspectors and reviewing inspector resources.
Many steps have been and continue to be taken to comply with the recommendations such as the Canadian Food Inspection Agency increasing food safety controls and implementing new procedures to reduce safety risks. Furthermore, the concept of food safety is evolving beyond just meat products to the food chain as a whole, and to food-like natural health products (NHPs). While NHPs are currently regulated as a subset of drugs, Health Canada is now taking a position that certain NHPs that look and feel like food may more appropriately be regulated as food. Health Canada is also looking at increased import controls with respect to both food (in the form of an import licence requiring each importer to have a Preventive Food Safety Control System) and natural health products (in the form of increased monitoring of good manufacturing practices). genetICally engIneereD (ge) FooDs
A topic of continued interest is that of labelling for GE foods. In the 1990s, environmentalists and others coined the term “frankenfoods” to imply foods containing genetically engineered (GE) ingredients were not safe. In the 17 years consumers have been eating GE foods, there have been no documented cases of any one taking ill by eating GE foods. Under our existing regulatory regime, which requires premarket approval for GE crops, if there is a clear, scientifically-established health risk or if the genetic modification significantly alters the nutritional value of the food, labelling is mandatory. These risks, however, have never been found and the labelling of GE foods continues to be an issue.
Some groups continue to argue the public’s right to know should require mandatory labelling, enforced by government regulation. The issue is not that simple however. If GE and non-GE foods are substantially equivalent as Canada and the U.S. maintain, requiring labelling would likely confuse consumers. Consumers may conclude the labelling must mean something, but with more than 90% of processed food containing GE ingredients, labelling would not provide the consumer with much information that would be useful for decision-making. Moreover, mandatory labelling would be illegal under trade laws because without a scientific basis, the regulation would be a technical barrier to trade.
The labelling issue became a hot topic in October 2011 when several media stories erroneously reported the United Nation’s Codex Alimentarius Commission (Codex) received consensus for a mandatory labelling scheme. Codex did not. What Codex did was finally achieve consensus on the rules for what would be described as containing, or not containing, GE. Countries could adopt the standard or not as Codex is a voluntary system.
CanaDa’s labellIng systeM
Canada has a voluntary labelling system for genetically engineered products, which was formally adopted in April 2004 as the culmination of four years of meetings, drafts and lobbying. Under the Canadian General Standards Board, a draft standard was developed, later adopted by the Canadian Standards Council of Canada and set the voluntary standards for labelling and advertising of foods obtained, or not obtained, through genetic engineering. The Standard may be found at: http://www. tpsgc-pwgsc.gc.ca/ongc-cgsb/programmeprogram/norms-standards/internet/032-0315/ documents/commite-commmittee-eng.pdf.
The essential provisions of the standard include, in section four, governing the claims that may be made about such products, requiring that they be understandable, informative, not false, not misleading and subject to verification. Section five sets out more detailed rules about making claims that foods are products of genetic engineering, setting out different rules for single-ingredient foods and multi-ingredient foods, providing for a level of 95 per cent for each, meaning that such a claim can only be made if, for single ingredient foods, more than 95 per cent of the source of the food is a product of genetic engineering. For an ingredient in a multi-ingredient food, such a claim can only be made when
more than 95 per cent of the source of the ingredient is a product of genetic engineering.
Section six of the standard addresses products that are not products of genetic engineering, and the degree to which one can make such claims. The standard here is the reverse of what one can claim for GE food in that, for a single ingredient food, claims the food is not a product of genetic engineering may be made when less than 5 per cent is genetically engineered.
Section seven sets out the requirement for verification and testing of claims as only verifiable claims are permitted.
Eight years after the standard was developed in Canada, there are very few products labelled “does not contain GE ingredients”, presumably because most companies don’t see a marketing advantage. All but a small minority of Canadians accept the safety of GE foods and, for the reasons outlined above, Canada does not intend to introduce a mandatory labelling scheme.
tHe Crossover eFFeCt: energy DrInKs MaKe tHe sWItCH to FooDs
In October 2011, Health Canada announced caffeinated energy drinks in beverage form would no longer be regulated as Natural Health Products (NHPs) and would be reclassified as foods. This long-awaited regulatory shift is based on Health Canada’s assessment that the consumption patterns, history of use and marketing of energy drinks better fits the regulatory definition of a food. This decision also brings Canada in line with other major trading partners such as the U.S. where energy drinks are regulated as foods. Products that do not contain caffeine or are not in beverage form such as powders, syrups and shots, will not form part of this transition.
Coming just weeks after Postmedia News revealed the hotly contested findings of Health Canada’s questionable Expert Panel on Caffeinated Energy Drinks, Health Canada’s announcement reflected a more global approach. Taking into account all issues before arriving at a final decision, Health Canada has sent a signal to industry that it will be sticking to its plan to move forward with developing a regulatory framework for food-like NHPs. The first step in this transition is the issuance of Temporary Marketing Authorization Letters (TMALs), a mechanism built into the Food and Drugs Regulations that allows Health Canada to issue a temporary authorization for the sale of a food that is otherwise not compliant with the Food and Drug Regulations in order to generate information in support of an amendment to the Food and Drug Regulations. In this case, TMALs will permit the sale of energy drinks for a period of up to five years, giving Health Canada and the beverage industry time to gather necessary information such as consumption data and incident reports that will aid the government in designing an appropriate food regulatory framework for these products.
In order to be issued a TMAL, manufacturers have to agree to a strict set of requirements including: • Compliance with minimum and maximum limits for caffeine, vitamins, minerals and other ingredients (i.e. herbal extracts); • Including statements identifying these products as having a high caffeine content, not recommended for children, pregnant/ breastfeeding women or individuals sensitive to caffeine, or to be mixed with alcohol; • Compliance with all food labelling requirements including nutrition facts panels, ingredient and allergen labelling; • Adherence to specific requirements regarding serving sizes, resealable containers and the maximum amount of caffeine that will be permitted to be contained in either single serve containers or resealable containers; and • Agreeing to withdraw the product from sale if Health Canada determines it is in the public interest to do so.
The Food Directorate has worked closely with industry to establish the above criteria and the timeframe for industry to transition to the new food labelling, balancing the consumer interest in the new information to be found on the food labels and the impact to industry required to make the above changes. In addition, manufacturers either directly, or through trade associations, in partnership with Health Canada, will have to agree to undertake a series of consumer research projects in order to generate data on the consumption of energy drinks and reporting health related incidents. While Health Canada will have a hand in designing the framework for these studies, it is shifting the burden and cost of gathering this information to industry.
The second step in the transition of energy drinks to foods will begin once the analysis of consumer-generated data is completed by Health Canada, with the hope regulatory amendments will soon follow. In order for energy drinks to be properly classified as foods, amendments will have to prescribe that additives such as caffeine, vitamins and minerals can be added to these products; what, if any, herbs cannot be added; and ensure that the claims made are consistent with those permitted claims for foods.
Energy drinks may be the first products to transition to foods, but they will not be the last. Health Canada has been holding off on licensing many food-like NHPs such as vitamin waters, gums and bars in order to develop a strategy to transition these types of products over to foods after a framework has been established. Once the issuance of TMALs for energy drinks is complete, it is believed they will soon be followed by other food-like NHPs. Each category of products will have to undergo their own scientific assessment and will likely face a unique set of issues in making the transition. The exact process each will follow is expected to be similar. Perhaps, assuming these products are destined to become foods, all food-like NHPs that sit with the Natural Health Products Directorate should all be transferred over to foods under limited duration TMALs as the Food Directorate finalizes limits on ingredients and more long-term research requirements that could then be attached to a longer term TMAL.
Gowlings will continue to monitor and update clients on changes to Canada’s food safety system. We would be pleased to speak with you further about Canada’s regulatory system, labelling and what changes to the regulation of NHPs may mean for your company.
Adrienne Blanchard, Joel Taller and Lewis Retik are partners in Gowlings’ Ottawa office with an expertise in Canada’s regulatory systems for food, natural health and life sciences products. Ronald Doering is Counsel with the Firm and is former president of the Canadian Food Inspection Agency. www.gowlings.com
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