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

Reference Number: [NOP/ADP-C-2017-3]

April 7, 2017

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On September 15, 2017, Health Canada published the Notice of Modification: Prohibiting the Use of Partially Hydrogenated Oils (PHOs) in Foods – Reference Number: NOM/ADM-C-2017-3 confirming it decision to proceed with prohibiting the use of PHOs.

Table of Contents

Summary

The purpose of this notice is to inform consumers and interested stakeholders of Health Canada’s intent to implement 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 prohibition is proposed to take effect in the summer of 2018. This would allow industry stakeholders time to phase-out the use of PHOs.

Further information on the Department’s rationale for proceeding with this proposal as well as a summary of comments received during the pre-consultation, held from November 14, 2016 to January 13, 2017, is provided in the Background and Rationale and Other Relevant Information sections of this notice.

Description of the Proposal

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 is proposing to add PHOs as a new item (no. 18) to Part 1 of the List. 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.

Overview of the proposed modifications to Part 1 of the List of Contaminants and Other Adulterating Substances in Foods
Item No. Substance Food
18 Partially Hydrogenated Oils (PHOs) All foods

Scope of the Prohibition - Defining PHOs

Health Canada proposes to define PHOs in the Food and Drug Regulations as follows:

“Those fats and oils that:

  1. have been hydrogenated, but not to complete or near complete saturation, and
  2. have an iodine value (IV) greater than 4”

Note that both conditions “a” and “b” of the proposed definition 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 scope of the proposed definition.

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

Inclusions and Exclusions

The proposed 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 processing aids, pan release agents, etc.

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 trans fatty acids 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 introduced inadvertently as an outcome of high temperature processing.

Defining Fully Hydrogenated Oils (FHOs)

For greater clarity and in response to stakeholder feedback (further details provided in the “Stakeholder Views on the Proposed Definition” section of this notice), Health Canada also proposes to define Fully Hydrogenated Oils (FHOs) in the Food and Drug Regulations as follows:

“Those fats and oils that:

  1. have been hydrogenated to complete or near complete saturation, and
  2. have an iodine value (IV) of 4 or less”

As with the proposed definition for PHOs, both conditions “a” and “b” of the definition must be met in order for a fat or oil to be considered a FHO. This proposed definition is also consistent with the definition set out by the US FDA.

Other Amendments

Prohibiting the use of PHOs in foods will require certain consequential amendments to a small number of labelling and other provisions of the Food and Drug Regulations to remove references to PHOs and ensure the regulatory language is consistent with the prohibition. The Regulations will also be amended to prescribe definitions for PHOs and FHOs.  Health Canada intends to pursue these amendments through a separate regulatory proposal.

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 World Health Organization (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. Although this approach has proven 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), some shortenings and certain types of margarines. This can be a health concern for Canadians who choose these foods regularly, and for vulnerable subpopulations who 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 a further reduction in risk of CHD among the general population.

Note - The pre-consultation document Toward the Prohibition of Partially Hydrogenated Oils in the Canadian Food Supply provides further details on the Department’s rationale for pursuing the proposal to prohibit PHOs in foods.

Other Relevant Information

International Considerations

Internationally, Health Canada’s proposal 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 US 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 2018 to reformulate products to remove PHOs.

Stakeholder Pre-Consultation

A pre-consultation on Health Canada’s proposal to prohibit the use of PHOs was held between November 14, 2016 and January 13, 2017. A total of 555 responses were received from a range of stakeholders, including consumers, industry representatives and associations, individual health professionals and organizations, academics, government representatives and non-government organizations (NGOs).

During the pre-consultation, respondents were asked to provide feedback on the following three key questions:

  1. Do you support Health Canada's proposal to prohibit the use of PHOs in foods?
  2. Do you have any comments/concerns with the proposed definition for PHOs?
  3. Do you have any comments/concerns with the proposed transition period of 12 months following adoption into regulation of the prohibition?

1. Stakeholder Views on the Proposed Prohibition

Almost all consumers, health professionals, health professional organizations, government representatives, NGOs, academics, individual industry representatives, as well as some industry associations supported the proposal to prohibit the use of PHOs in foods. However, most industry associations along with a few respondents in other stakeholder groups did voice concerns regarding the proposed prohibition, stating that: the voluntary approach in place since 2007 has been effective; and that prohibiting PHOs could result in unintended consequences, such as PHOs being replaced by unhealthy and/or environmentally unfriendly alternatives. Some industry respondents indicated that they could support a prohibition provided that exemptions are provided for minor uses of PHOs that have a trivial contribution to daily energy intake.

Health Canada’s Response

Health Canada agrees that the voluntary approach has generally proven effective in helping to reduce the level of trans fats, specifically industrially-produced trans fat from PHOs, in foods. However, while significant progress has been made, a 2011 survey of approximately 10,000 prepackaged and restaurant foods found that there were still certain food categories that continued to have large proportions of foods not meeting the voluntary targets for trans fat established by the Trans Fat Task Force (Arcand et al. 2014). Furthermore, in May 2016 Health Canada launched a Call for Data to collect information on the current use of PHOs in the food supply. While many respondents indicated that they had removed PHOs or were moving away from their use, there nevertheless still remain foods containing PHOs on the Canadian market.

Maintaining the current voluntary approach would not address products that still contain PHOs, and would be insufficient to achieve the public health objective of reducing the trans fat intakes of 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 regression back to the use of PHOs. It is also important to note that the WHO’s 2009 Scientific Update recognizes that the public health objective could be achieved by the virtual elimination of PHOs from the food supply.

Regarding the replacement of PHOs with unhealthy alternatives (e.g., saturated fats), according to a 2011 analysis of the Canadian food supply, most food categories that had reformulated to remove PHOs showed no increase in saturated fats, although there were exceptions such as baked goods, dessert toppings, lard and shortening (Arcand et al. 2014). While replacing PHOs with saturated fats is not as desirable as replacing them with unsaturated fats, saturated fats are less detrimental to health than trans fats (WHO, 2016). Further to the 2016 Call for Data, given that PHOs have already been removed or are in the process of being removed from a large number of prepared foods on the Canadian market, the impact of a PHO prohibition on Canadians’ saturated fat intakes is expected to be limited. With respect to palm oil, Health Canada has not received any data indicating that prohibiting the use of PHOs would result in industry turning to unsustainable sources of palm oil.

Health Canada intends to provide further information to stakeholders regarding more healthful alternatives to PHOs (e.g., unsaturated rather than saturated fats). Furthermore, Health Canada’s proposal to include a front of pack warning on products that are high in saturated fats would also serve in certain cases, as a disincentive for industry to replace PHOs with saturated fats.

With respect to providing an exemption from the prohibition for minor uses, as previously mentioned, most respondents to the 2016 Call for Data indicated they have either already replaced PHOs or are moving away from their use. No data was received that supported the need to maintain allowance for PHO use, including minor uses.

As previously discussed in this notice and in Health Canada’s pre-consultation document, 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.

2. Stakeholder Views on the Proposed Definition

The majority of respondents across categories supported the proposed definition. A recurring suggestion was to refine the definition by providing clear inclusions/exclusions, similar to the US FDA. A number of respondents also expressed concerns that the proposed definition, as worded, may inadvertently capture naturally occurring trans fats as the iodine value (IV) does not distinguish between natural and industrial sources. Some also requested that a definition for fully hydrogenated oils (FHOs) be provided to help to minimize any potential confusion with PHOs.

Health Canada’s Response

As discussed in the “Scope of the Prohibition - Defining PHOs” section of this notice, the proposed PHO definition includes two conditions: the fat or oil must have been hydrogenated, but not to complete or near complete saturation and must also have an IV greater than 4. Both conditions 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 proposed definition. Therefore, although a food or food ingredient with naturally occurring trans fats could have an IV greater than 4, it would not be considered a PHO unless it also satisfied the hydrogenation requirement.

The proposed definition has been reformatted to make clearer the two conditions that must be met in order for a fat or oil to fall within the scope of the definition. Health Canada also intends to publish further information on specific inclusions/exclusions. Some examples are provided in the “Scope of the Prohibition - Defining PHOs” section of this document.

With respect to defining FHOs, as discussed in the section “Scope of the Prohibition - Defining PHOs”, Health Canada is also proposing to set out a definition for FHOs.

3. Stakeholder Views on the Proposed Transition Period

The majority of consumers, health professionals, government representatives and NGOs agreed that 12 months is an adequate transition period since the industry has had ample warning to prepare for this regulation. By contrast, most industry respondents expressed that 12 months is an insufficient time-frame to implement the change. Key reasons provided included: reformulation challenges, such as identifying and assessing alternatives, product development and testing, as well as sourcing; inadequate time to exhaust existing stock; and repackaging and re-labelling challenges, particularly in light of other federal labelling initiatives (e.g., the new nutrition labelling regulations, the food labelling modernization initiative and the proposed regulations for front-of-pack labelling).

In view of these arguments, opponents of the proposed 12-month transition period called for a longer period (between 2 to 5 years) noting that the US FDA provided a three-year period following its final determination on PHOs.

Health Canada’s Response

The reformulation concerns raised contrast evidence from food label data and feedback from the 2016 Call for Data. A 2011 analysis of trans fats in the Canadian food supply showed that for every food category analysed there was at least one product within that category meeting the voluntary targets. The authors inferred from these findings that technologies therefore must exist for reformulation (Arcand et al. 2014). In addition, most respondents to the 2016 Call for Data indicated that they had already removed PHOs or were moving away from their use. In a follow-up call with one industry association, it was conveyed that the supply of PHOs is starting to “dry up”. The coming into force of the US FDA’s decision on PHOs in June 2018 will further compound this supply dearth.

Health Canada acknowledges that certain industry stakeholders may face repackaging and re-labelling challenges, though this should be limited to a small number of pre-packaged products. Most companies responding to the 2016 Call for Data indicated that the removal of PHOs by 2018 was already part of their current business plan. The proposed 12 month transition period would align with the coming into force of the US FDA’s decision.

With respect to exhausting existing stock, no evidence was provided indicating why a 12 month transition period would not allow adequate time to exhaust existing stock.

Health Canada notes that domestic and international efforts towards the reduction of trans fats have been ongoing for over a decade and Canadians were made aware of the Government’s intent to proceed with tougher trans fat measures through the Minister of Health’s 2015 mandate letter. In addition to this, considering the relatively small number of products remaining to be reformulated, the decreasing supply of PHOs and the coming into force of the US FDA’s PHO decision in June 2018, in the absence of any other compelling data, there is insufficient evidence to support extending the transition period beyond the proposed 12 months.

Implementation and Enforcement

Implementation

The proposed change will take effect the day on which it is published in the List of Contaminants and Other Adulterating Substances in Foods. This date will be announced in a Notice of Modification (NOM) published on Health Canada's website.

Recognizing that prohibiting PHOs will require certain manufacturers to reformulate their products, Health Canada is proposing to delay adding PHOs to the List of Contaminants and Other Adulterating Substances in Foods by 12 months following the date on which the NOM is published.

Enforcement

The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.

Contact us

For additional information or to submit comments or information related to this proposal, 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

Health Canada is able to consider information received by June 21, 2017, 75 days from the date of this posting.

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

References

  • Arcand J, Scourboutakos M, Au J, and L'Abbe M. (2014). Trans Fatty acids in the Canadian food supply: an updated analysis. American Journal of Clinical Nutrition, 100(4): 1116-1123.
  • 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.
  • World Health Organization. (2016). Effects of trans-fatty acid intake on blood lipids and lipoproteins: a systematic review and meta-regression analysis. Available from: http://apps.who.int/iris/bitstream/10665/246109/1/9789241510608-eng.pdf [Accessed 24 October 2016].
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