Notice of Modification - Prohibiting the Use of Partially Hydrogenated Oils (PHOs) in Foods

Reference Number: [NOM/ADM-C-2017-3]

September 15, 2017

Table of Contents

Summary

The purpose of this notice is to inform consumers and interested stakeholders that Health Canada will be implementing a prohibition on the use of partially hydrogenated oils (PHOs) in foods by adding PHOs to Part 1 of the List of Contaminants and Other Adulterating Substances in Foods (the List).  

The prohibition will take effect the day on which PHOs are added to Part 1 of the List. Health Canada will be amending the List 12 months from the date of publication of this notice.

Description

The List of Contaminants and Other Adulterating Substances in Foods (the List) is incorporated by reference into Division 15 of the Food and Drug Regulations and is divided into two parts: Part 1 sets out substances which, if present in food at any level, would result in the food being declared as adulterated. Part 2 sets out maximum levels for specific substances in certain foods, which if exceeded, would result in a declaration of adulteration.

Health Canada will be amending Part 1 of the List as follows to add a new item (no. 18) for PHOs:

Item No. Substance Food
18 Partially Hydrogenated Oils (PHOs) All foods

By adding PHOs to Part 1 of the List, any food containing PHOs would be declared adulterated and its sale in Canada prohibited in accordance with section 4 of the Food and Drugs Act. 

Scope of the Prohibition

The prohibition applies to PHOs, which are defined as those fats and oils that:

  • have been hydrogenated, and
  • have an iodine value of greater than 4

The two bulleted conditions described above must be met in order for a fat or oil to be considered a PHO. Ingredients which do not satisfy both conditions are excluded from the definition.

The definition for PHOs is consistent with the definition set out by the United States Food and Drug Administration (U.S. FDA) in its Final Determination Regarding Partially Hydrogenated Oils.

Inclusions and Exclusions

The definition applies to PHOs used in foods destined for human consumption. It also applies to PHOs added to foods for minor use applications or technical purposes such as pan release agents. PHOs used in products other than foods, such as natural health products (NHPs) and drugs, fall outside the scope of the prohibition.

Examples of excluded ingredients include:

  • PHOs used as raw materials to synthesize other ingredients as well as ingredients derived from PHOs so long as the resulting ingredients no longer contain PHOs and the trans fatty acids initially present in the raw materials are not found in the final food;
  • conjugated linoleic acids;
  • partially hydrogenated methyl ester of rosin;
  • ingredients that contain only naturally occurring trans fats (e.g., non-hydrogenated ruminant sources); and
  • ingredients or foods containing trans fats which have been produced inadvertently as an outcome of high temperature processing.

Fully hydrogenated oils (FHOs) are also excluded from the scope of the prohibition. FHOs are defined as those fats and oils that:

  • have been hydrogenated, and
  • have an iodine value of 4 or less

As with the definition for PHOs, the two bulleted conditions described above must be met in order for a fat or oil to be considered an FHO. This definition is also consistent with the definition set out by the U.S. FDA.

Note: The iodine value (IV) is not a direct measure of trans fat content but is a technical measurement of the level of unsaturation. FHOs are oils that have been hydrogenated to complete or near complete saturation and therefore have a low degree of unsaturation. FHOs, and most fat-based food ingredients containing FHOs, contain trans fats at a similar level to non-hydrogenated refined oils, generally less than 2% of the oil (Dhaygude et al. 2017; Farfán et al. 2015; Tarrago-Trani et al. 2006; Mjos and Pettersen 2003; Petrauskaite et al. 1998). In contrast, PHOs are oils that have been hydrogenated but not to complete or near complete saturation. PHOs generally have trans fat levels ranging from 25 to 45% of the oil (Ackman and Mag 1998).

Related Consequential Amendments

Prohibiting the use of PHOs in foods requires certain consequential amendments to the Food and Drug Regulations to: prescribe the definitions for PHOs and FHOs; address references to PHOs; and ensure the regulatory language is consistent with the prohibition. These consequential amendments will be pursued through a separate regulatory proposal that Health Canada anticipates pre-publishing in the Canada Gazette, Part I in fall 2017.

Background and Rationale

Trans fats are a type of unsaturated fatty acid that are found naturally in foods from ruminant animals (e.g., milk and beef) and can also be industrially produced. The major source of industrially produced trans fats in the food supply are PHOs, which are produced via partial hydrogenation.

The consumption of trans fats increases the risk of coronary heart disease (CHD), one of the leading causes of death in Canada. In light of the adverse health effects of trans fats, several authoritative health bodies, such as the Institute of Medicine (IOM) and the Food and Agriculture Organization/World Health Organization (FAO/WHO) have recommended limiting their consumption.

Since the early 2000s, Health Canada has pursued a multi-faceted approach aimed at reducing the trans fat intakes of Canadians. This included introducing mandatory trans fat labelling; setting voluntary targets for processed foods; and establishing a two year monitoring and open reporting program to measure industry’s progress toward meeting the voluntary targets.

Although these initiatives proved successful in reducing trans fat levels in the Canadian food supply, some foods still contain industrially produced trans fats, namely PHOs. These foods include some commercially baked goods (e.g., cookies) as well as some shortenings and certain types of margarines. This can be a health concern for Canadians who choose these foods regularly, and for vulnerable subpopulations that are at risk for higher trans fat intakes, such as children and teens, Canadians in remote areas and price sensitive consumers (Krenosky et al. 2012).

The 2015 mandate letter to the Minister of Health included bringing in tougher trans fat regulations, similar to those in the United States. On October 24, 2016 the Minister launched the Healthy Eating Strategy (HES), which included among its many initiatives, a proposal to prohibit the use of PHOs in foods.

Proceeding with prohibiting the use of PHOs in foods will effectively reduce trans fats in the food supply to the lowest level possible. It will also help achieve the public health objective of reducing trans fat intake by the great majority of Canadians to less than 1% of total energy intake. Achieving this public health objective is expected to lead to an overall reduction in risk of CHD among the general population.

Consultations

A pre-consultation on Health Canada’s policy proposal to prohibit the use of PHOs in foods was held from November 14, 2016 to January 13, 2017. This was followed by the publication of the Notice of Proposal: Prohibiting the Use of Partially Hydrogenated Oils (PHOs) in Foods (Ref. No. NOP/ADP-C-2017-3) on April 7, 2017 for a 75-day comment period ending June 21, 2017. 

A total of 30 comments were received during the comment period for the Notice of Proposal (NOP). Respondents included: nine consumers; one academic; nine government representatives/organizations; three health professional organizations; three individual companies; four industry associations; and one non-governmental organization (NGO).

1. Views on the Proposed Prohibition

Almost all respondents supported the proposal to prohibit the use of PHOs in foods and did not raise objections to adding PHOs to Part 1 of the List of Contaminants and other Adulterating Substances in Foods. Reasons for supporting the proposal were similar to those voiced during the pre-consultation which are summarized in the April 2017 NOP (e.g. improving the health of Canadians, protecting vulnerable subpopulations, aligning with the U.S., etc.). One government representative and one health professional organization highlighted that the prohibition should extend to imported foods and foods prepared and sold in food service establishments, respectively. One consumer sought clarification as to why FHOs are not also being prohibited along with PHOs. There was also a question on whether the PHO prohibition would extend to natural health products (NHPs).

Two industry associations voiced concerns regarding the proposed prohibition and requested that a minimum use level be considered either for specific functional purposes or to account for potential inadvertent introduction of PHOs into foods. One of these industry associations further speculated that the minor use of PHOs for specific functional purposes would not be expected to impact public health since, at these low levels, they would not contribute meaningfully to total consumption of trans fats. Based on these arguments, it was suggested that PHOs with associated tolerance levels be added to Part 2 of the List, rather than Part 1.

Health Canada’s Response

Health Canada is proceeding with the PHO prohibition since no data was submitted to suggest an alternative course of action for meeting the public health objective of reducing trans fat intake by the great majority of Canadians to less than 1% of total energy intake. Prohibiting the use of PHOs will ensure that industrially produced trans fats are virtually eliminated from all foods, thus making the desired objective achievable. It will also ensure that the objective is not only achieved, but maintained as the prohibition will prevent any reversion back to the use of PHOs.

The prohibition will apply to all foods sold in Canada, including imported foods and foods prepared and sold in food service establishments. It will not apply to FHOs as the level of trans fats in these oils is similar to that of refined vegetable oils (Dhaygude et al. 2017; Farfán et al. 2015; Tarrago-Trani et al. 2006; Mjos and Pettersen 2003; Petrauskaite et al. 1998). Regarding NHPs, as stated in the section of this notice on inclusions and exclusions, the prohibition pertains to PHOs used in foods only and does not extend to NHPs or drugs.

With respect to accommodating the use of very low levels of PHOs for specific functional purposes, no data was submitted to Health Canada to support the need for continued PHO use. Furthermore, no data was submitted to support the claim that the use of PHOs for these purposes would not impact public health. Should the food industry wish to use PHOs at low levels in foods, they may request to do so by providing sufficient supporting safety evidence to Health Canada for consideration.

As to the inadvertent introduction of PHOs to foods, no evidence was provided to support that this is indeed a potential risk.

2. Views on the Proposed Definitions

There was strong support for Health Canada’s PHO definition. The list of inclusions and exclusions was deemed valuable for helping to clearly identify PHOs. Support was also expressed for the inclusion of a definition for fully hydrogenated oils (FHOs).

3. Views on the Proposed Transition Period

The majority of respondents who commented on the proposed 12 month transition period were supportive. In fact, one of Canada’s largest food manufacturers commented that 12 months would provide industry with sufficient time to find suitable PHO replacements. In contrast, one government organization and two industry associations expressed concerns that 12 months is insufficient and the latter requested a minimum transition period of 5 years. In their view, a longer period is required to enable for the assessment of PHO alternatives, product development and testing, as well as ingredient sourcing. One industry association speculated that low level use of PHOs will likely continue to be permitted in the United States through the U.S. FDA’s food additives petition process and that further investment into seeking PHO alternatives for Canada alone, would be limited and challenging.

Health Canada’s Response

No new data was presented to Health Canada supporting the need for a longer transition period. Feedback from one of Canada’s largest food manufacturers supports the 12 month timeline as do results from Health Canada’s 2016 Call for Data on PHOs. Respondents to the Call for Data included seven manufacturers, two fats and oil processors, one restaurant, two industry associations and one academic. The majority of respondents indicated that they had already removed PHOs or were moving away from their use as part of their current business plans.

The implementation of a 12 month transition period following publication of the Notice of Modification closely mirrors the U.S. FDA’s implementation timelines for the revocation of the Generally Recognized as Safe (GRAS) status of PHOs. It is unclear at this time whether the U.S. FDA will be permitting minor uses for PHOs. As previously noted, should the food industry wish to use PHOs at low levels for specific functional purposes, it is their responsibility to provide sufficient supporting safety evidence to Health Canada for consideration.

4. Other Comments

4.1 Continued Trans Fat Monitoring

One government organization and two health professional organizations stressed the importance of routine trans fat monitoring even after the implementation of the PHO prohibition. They recommended that monitoring of exposure to trans fats from PHOs should include data in consumers' tissues such as blood (to monitor exposure) and foods (to monitor the food supply) in order to improve Canadians’ confidence in the food supply. 

Health Canada’s Response

At present, Health Canada does not intend to implement trans fat monitoring of the food supply. Rather, the focus will be on assessing Canadians’ exposure to trans fats as reflected by red blood cell measurements. Data from the Canadian Health Measures Survey (CHMS) Cycles 3 and 4, collected in 2012-13 and 2014-15, will serve as the baseline (i.e. pre-prohibition) measurement. Once the PHO prohibition is in effect, this analysis will be repeated (i.e. using data from future CHMS cycles) to assess changes over time.

Note that product-specific concerns regarding adherence to the prohibition following its implementation can be reported to the Canadian Food Inspection Agency (CFIA). Further information on reporting a food safety or labelling concern is available on their website.

4.2 Alternatives to PHOs

A recurrent concern expressed across almost all respondent categories was that PHOs may be replaced with alternatives which are unhealthy (e.g. saturated fat); for which scientific data is lacking (e.g. interesterified fats) and/or that may not be environmentally sustainable (e.g. palm oil).

Health Canada’s Response

Health Canada strongly recommends that PHOs be replaced as much as possible by low saturated fat alternatives such as high oleic/monounsaturated oils instead of fat blends or interesterified fats high in saturated fats. Reformulating products to remove PHOs will help to improve the nutritional quality of the food supply, one important initiative under the Healthy Eating Strategy. This will be complemented by dietary guidance that will encourage the consumption of foods low in saturated fats as well as proposed front-of-package labelling of foods high in saturated fats. These initiatives may also serve, in certain cases, as a disincentive for replacing PHOs with saturated fats.

Health Canada is aware that, for certain foods, it is challenging to replace PHOs with oils rich in unsaturated fats as they may not impart the desired functional properties. As communicated in the April 2017 NOP, the replacement of PHOs with unhealthy alternatives, such as oils high in saturated fats, is not as desirable as substituting PHOs with unsaturated oils. Nonetheless, the overall effects of saturated fats on cardiovascular health are less detrimental than the effects of trans fats (Brouwer 2016; Wang et al. 2016; de Souza et al. 2015; Mozaffarian and Clarke 2009). Therefore, replacement of PHOs with oils high in polyunsaturated fats, monounsaturated fats and, although not ideal, saturated fats, is expected to have a public health benefit.

Interesterified fats have been used by the food industry as a replacement for PHOs for a number of decades. Their health effects are not well understood, due in part to their heterogeneous composition as well as challenges with quantifying intakes (Mensink et al. 2016). Research in this area is ongoing and Health Canada will continue to monitor this field.

As previously noted, most of the changes to product formulations have already occurred in recent years. Therefore, following the PHO prohibition, only a small residual increase to the intakes of saturated fats and interesterified fats would be expected even if all products were reformulated with these fats. Although no data was submitted that indicates a PHO prohibition would result in industry turning to non-environmentally sustainable alternatives, Health Canada encourages industry to seek sustainable sources whenever possible.

Finally, Health Canada is aware that some provincial governments may be providing additional support and resources to industry for PHO replacement. In fact, in response to the April 2017 NOP, one province’s agriculture department shared that they are developing a financial assistance program to help support the food industry in the identification of healthier replacements for PHOs.

4.3 Trans fat Labelling

In light of the PHO prohibition, two industry associations, one health professional organization and one non-government organization requested that the mandatory declaration of trans fat in the Nutrition Facts table (NFt) be reconsidered by Health Canada. Once PHOs are removed from the food supply, the primary source of remaining trans fat in foods will be ruminant meats and dairy. In their view, continuing to require mandatory trans fat labelling could convey an unfounded sense of risk to consumers since, unlike industrial trans fats, ruminant trans fats are not associated with detrimental health effects in the amounts customarily consumed.

Health Canada’s Response

Following the implementation of the PHO prohibition, a large number of foods will still contain trans fats, as a result of their natural occurrence in ruminant products. At this time, Health Canada will continue to require the declaration of trans fat in the NFt. This decision is based on the current status of scientific knowledge that does not allow drawing a firm conclusion on the relative effects of ruminant trans fats versus industrial trans fats on blood lipids and risk of CHD. Retaining the declaration of trans fat content in the NFt is also consistent with the U.S. FDA’s Nutrition Facts label. Health Canada intends to reevaluate this position in the future as new evidence emerges to ascertain whether trans fat labelling continues to support consumers in making healthier dietary choices.

International Considerations

Internationally, Health Canada’s decision aligns with global efforts toward the elimination of PHOs in foods. The WHO has called for the elimination of industrially produced trans fats from the global food supply in response to the rise in the prevalence of non-communicable diseases (NCDs). In June 2015, the U.S. FDA issued a final determination that PHOs are no longer Generally Recognized as Safe (GRAS) in food due to health risks associated with trans fat consumption. Manufacturers have until June 18, 2018 to reformulate products to remove PHOs.

Implementation and Enforcement

Implementation

The prohibition will take effect the day on which PHOs are added to Part 1 of the List. Health Canada will be amending the List 12 months from the date of publication of this notice.

Enforcement

The Canadian Food Inspection Agency (CFIA) is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods. The CFIA will verify that the industry has implemented appropriate measures to meet regulatory requirements through oversight activities such as inspections, audits and/or sampling.

Contact Information

For additional information or to submit comments or information related to this notice, please contact:

Bureau of Nutritional Sciences, Food Directorate
Health Products and Food Branch, Health Canada
251 Sir Frederick Banting Driveway
Tunney’s Pasture, PL: 2203E
Ottawa, ON K1A 0L2
Email: BNS-BSN@hc-sc.gc.ca
Fax: 613-941-6636

If communicating by fax or e-mail, please use the words “PHO NOM” in the subject line.

References

  • Ackman RG and Mag TK. (1998). Trans fatty acids and the potential for less in technical products. In: Trans Fatty Acids in Human Nutrition. Eds. Sébédio JL and Christie WW. Dundee, UK: The Oily Press, pp. 35-56.
  • Brouwer IA. (2016). Effect of trans-fatty acid intake on blood lipids and lipoproteins: a systematic review and meta-regression analysis. Geneva: World Health Organization. Available from: http://apps.who.int/iris/bitstream/10665/246109/1/9789241510608-eng.pdf [Accessed 2017-07-24].
  • de Souza RJ, Mente A, Maroleanu A, Cozma AI, Ha V, Kishibe T, Uleryk E, Budylowski P, Schünemann H, Beyene J, and Anand SS. (2015). Intake of saturated and trans unsaturated fatty acids and risk of all cause mortality, cardiovascular disease, and type 2 diabetes: systematic review and meta-analysis of observational studies. BMJ, 351:h3978.
  • Dhaygude V, Soós A, and Somogyi L. (2017). Solidification of the blends of fully hydrogenated coconut oil and non-hydrogenated coconut oil. Periodica Polytechnica Chemical Engineering, paper 9638. Doi: https://doi.org/10.3311/PPch.9638
  • Farfán M, Álvarez A, Gárate A, and Bouchon P. (2015). Comparison of Chemical and Enzymatic Interesterification of Fully Hydrogenated Soybean Oil and Walnut Oil to Produce a Fat Base with Adequate Nutritional and Physical Characteristics. Food technology and biotechnology, 53(3):361-366.
  • Krenosky S, L'Abbe M, Lee N, Underhill L, Vigneault M, Godfroy S, and Ratnayake N. (2012). Risk Assessment of Exposure to Trans Fat in Canada. International Food Risk Analysis Journal. 2: 1-15.
  • Mensink RP, Sanders TA, Baer DJ, Hayes KC, Howles PN, and Marangoni A. (2016). The Increasing Use of Interesterified Lipids in the Food Supply and Their Effects on Health Parameters. Advances in nutrition, 7(4):719-29.
  • Mozaffarian D and Clarke R. (2009). Quantitative effects on cardiovascular risk factors and coronary heart disease risk of replacing partially hydrogenated vegetable oils with other fats and oils. European journal of clinical nutrition, 63 Suppl 2:S22-33.
  • Mjos SA and Pettersen J. (2003). A rapid method for the analysis of hydrogenated fats by GC with IR detection. Journal of the American Oil Chemists' Society, 80: 839-846.
  • Petrauskaite V, De Greyt W, Kellens M, and Huyghebaert A. (1998). Physical and chemical properties of trans-free fats produced by chemical interesterification of vegetable oil blends. Journal of the American Oil Chemists' Society, 75 (4): 489–493.
  • Tarrago-Trani MT, Phillips KM, Lemar LE, and Holden JM. (2006). New and existing oils and fats used in products with reduced trans-fatty acid content. Journal of the American Dietetic Association, 106(6):867-80.
  • Wang D, Li Y, Chiuve S, Stampfer M, Manson J, Rimm E, Willet W, and Hu F. (2016). Association of specific dietary fats with total and cause-specific mortality. Journal of the American Medical Association Internal Medicine, 176(8): 1134-1145.
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