February 08, 2018

Health Canada Proposes to Ban Partially Hydrogenated Oils by Summer 2018

M. Katie Gates Calderon and Alyse M. Zadalis – August 31, 2017

On April 7, 2017, Health Canada announced a proposal to ban the use of partially hydrogenated oils (PHOs) in food by adding them to the agency's List of Contaminants and Other Adulterating Substances in Food, effective summer 2018. This ban is based on what regulators see as a broad and growing scientific consensus that high consumption of trans fats—the main source of which are PHOs—significantly increases the risk of coronary heart disease and may also be associated with increased risk of other cardiovascular diseases, obesity, and type 2 diabetes. See European Parliamentary Research Serv., Briefing, Trans Fats—Overview of Recent Developments (Mar. 2016). Canada joins a growing number of countries that are voluntarily implementing regulatory limits on the amount of allowable PHOs in food products, including the United States. Canada's proposal to ban PHOs largely mirrors the 2015 PHO ban by the U.S. Food and Drug Administration (FDA) and advances ongoing efforts to align the U.S. and Canadian food regulatory environments, thereby easing the burden on food manufacturers and suppliers conducting cross-border trade.

The FDA's 2015 Decision to Ban PHOs
On June 17, 2015, the FDA published its Final Determination Regarding Partially Hydrogenated Oils, which stated that PHOs—the primary dietary source of industrial trans fats in processed foods—were no longer "generally recognized as safe" for use in human food. For purposes of this rulemaking, the FDA defined PHOs as "fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value (IV) greater than 4." The agency also set forth certain inclusions and exclusions from the PHO definition. Asserting that qualified experts no longer unanimously agreed that PHOs were safe, the FDA set a deadline—June 18, 2018—by which food manufacturers must remove PHOs from their products. After this three-year phase-in period has run, PHOs will qualify as food additives and will be subject to FDA review and approval. As with any food additive, manufacturers must seek approval for exemptions under section 409 of the Food, Drug, and Cosmetic Act by presenting "data demonstrating a reasonable certainty of no harm" resulting from the proposed uses. 80 Fed. Reg. 34,650 (June 17, 2015).

The FDA's decision followed a 2006 agency requirement that manufacturers include trans fat content information in a product's Nutrition Facts label. FDA credits this move, along with manufacturers' subsequent food reformulations, with reducing overall trans fat consumption by about 78 percent between 2003 and 2012. Despite that marked decrease, consumer intake of trans fats remains a public health concern, according to the FDA. The agency expects that implementation of the trans fats ban will further reduce consumption and ultimately reduce the risk of coronary heart disease among American consumers. See Press Release, Food & Drug Admin., The FDA Takes Steps to Remove Trans Fats in Processed Foods (June 16, 2015).

Health Canada Announces PHO Ban Earlier This Month
Much like the United States, Canada has worked toward a reduction in the overall consumption of trans fats since the early 2000s. Health Canada cited reported health risks arising from PHOs in food products and, starting in 2002, mandated disclosure of a product's trans fat content in its Nutrition Facts table. Like its U.S. counterpart, Health Canada also adopted voluntary PHO reduction targets for industry in 2006. See Health Canada, Backgrounder, Prohibiting the Main Source of Industrially Produced Trans Fats in Foods (Apr. 2017). While Health Canada views these efforts as successful, PHOs remain on the market in many food products, and the agency believes that PHOs continue to present a risk for certain subpopulations, including children, teens, consumers living in remote areas, and price-sensitive consumers. To curb consumption in these subpopulations and to achieve the public health goal of "reducing the trans fat intakes of the great majority of Canadians to less than 1% of total energy intake[,]" Health Canada issued its initial public consultation to ban the use of PHOs in food products in 2016 as part of its broader Healthy Eating Strategy. See Health Canada, Notice of Proposal—Prohibiting the Use of Partially Hydrogenated Oils (PHOs) in Foods [NOP/ADP-C-2017-3] (Apr. 7, 2017).

Health Canada's resulting April 7, 2017, proposal largely mirrors the FDA's PHO decision. The proposal defines PHOs as fats and oils that (i) "have been hydrogenated, but not to complete or near complete saturation," and (ii) "have an iodine value (IV) greater than 4." This definition is consistent with the definition promulgated by the FDA, and, like the FDA, the Health Ministry intends to set forth specific inclusions and exclusions to the definition. Whether those will also mirror the FDA's decision remains to be seen. Health Canada further proposes adding PHOs to Part 1 of its List of Contaminants, which sets out substances that, if present in food at any level, will result in a food being declared adulterated. Notably, this designation would leave no room for an exception. Instead, Health Canada "is proposing a complete prohibition on the use of PHOs, including PHOs used in foods for minor applications as there is presently insufficient evidence supporting a safe threshold of intake." 80 Fed. Reg. 34,651 (June 17, 2015); Health Canada, Notice of Proposal, supra.

Health Canada will continue to consider additional information or comments on its PHO proposal through June 21, 2017, but anticipates that all PHOs will be phased out by the summer of 2018, bringing Canada in line with the FDA's June 2018 deadline.

Regulatory Alignment—Tips for Industry
We do not expect that Health Canada will extend the transition period to remove PHOs from products beyond the proposed 12 months, and manufacturers and retailers doing business there should plan accordingly. Health Canada takes the position that domestic and international efforts to reduce trans fats have been ongoing for over a decade and, moreover, that companies doing business in Canada were on notice regarding the government's intent to implement tougher trans fat measures following the minister of health's 2015 mandate letter. See Health Canada, Notice of Proposal, supra. Health Canada's position is bolstered by the relatively small number of products on the market that remain to be reformulated and the decreasing availability of PHOs as the FDA's ban phase-in comes to a close.

Manufacturers that have not already considered product reformulation should (1) consider the logistics and costs of doing so on an appropriate timeline to comply with both the FDA and Health Canada bans; (2) consider the FDA's PHO definition inclusions and exclusions as informative, but not necessarily determinative, when analyzing products sold in Canada; and (3) be cognizant and stay abreast of exceptions to the PHO ban that may apply in the United States but not in Canada. For example, in 2015, the Grocery Manufacturers Association petitioned the FDA under section 409 to allow PHOs to be used as a food additive for certain minor uses, including as color and flavor carriers or as processing aids. See Press Release, Grocery Manufacturers Ass'n, FDA Accepts GMA Petition Seeking Continued Low-Level Uses of PHOs in Food Products (Oct. 1, 2015). Although the FDA has not yet ruled on this petition, manufacturers should remain aware that, if allowed, these incidental uses could create incongruities between the Canadian and U.S. regulatory frameworks.

M. Katie Gates Calderon and Alyse M. Zadalis – August 31, 2017