Hard times for industrial trans fats: EU upcoming legal limit and FDA moves

The EU Commission recently launched a public consultation on a draft Regulation setting a legal limit for trans fat, other than trans fat naturally occurring in animal fat, in foods intended for the final consumer.

The consultation will be open until 1st November 2018 and anybody can participate.

The draft Regulation is pretty straightforward and it is made of just 2 articles.

Basically it states that, after EFSA opinion suggesting to limit as much as possible the intake of industrial trans fat – and the following assessment of the EU Commission about the viable options to reach this goal – setting a limit was the only realistic option to protect public health.

Therefore art. 1 states that in Part B of Annex III to Regulation (EC) No 1925/2006 (on fortification of food and substances that might add to food and supplements), the following entry is added:

Trans fat

The following conditions shall apply:

a. The content of trans fat, other than trans fat naturally occurring in animal fat, in food which is intended for the final consumer, shall not exceed 2 grams per 100 grams of fat.

b. The definitions of “fat” and of “‘trans fat” set out respectively in points (2) and (4) of Annex I to Regulation (EC) No 1169/2011 shall apply.”

Therefore, the limit would not be applicable to B2B foods, provided that they are used in a way that grants no more that 2 g T-fat/100 g fat on the final products.

A transitional period is given by art. 2: food which does not comply with this draft Regulation may continue to be placed on the market until 1 April 2021.

In the meantime I remember to all our readers that in 2015, US FDA determined that PHOs (partially hydrogenated oils), the major source of artificial trans fat in the food supply, are no longer “Generally Recognized as Safe” (GRAS). For the majority of uses of PHOs, June 18, 2018, remains the date after which manufacturers cannot add PHOs to foods, without filing a specific GRAS petition affirming the safety of use. However, to allow for an orderly transition in the marketplace, FDA is allowing more time for products produced prior to June 18, 2018 to work their way through distribution. FDA is extending the compliance date for these foods to January 1, 2020.

You can find the FDA related resources here.

FDA ruling on Trans-Fats

FDA released its’ final determination that Partially Hydrogenated Oils (PHOs) are not Generally Recognized as Safe (GRAS). The determination is based on extensive research into the effects of PHOs, as well as input from stakeholders during the public comment period.

PHOs are the primary dietary source of artificial trans fat in processed foods. In FDA view, removing PHOs from processed foods could prevent thousands of heart attacks and deaths each year.

Implementation

FDA has set a compliance period of three years. This will allow food companies to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs. Many companies have already been working to remove PHOs from processed foods and the FDA anticipates that many may eliminate them ahead of the three-year compliance date.

It’s important to note that trans fat will not be completely gone from foods because it occurs naturally in small amounts in meat and dairy products, and is present at very low levels in other edible oils.

The FDA encourages consumers seeking to reduce trans fat intake to check a food’s ingredient list to determine whether or not it contains partially hydrogenated oil.

Background

In January 2006, FDA required the food industry to declare the amount of trans fat in food on the Nutrition Facts label. FDA data indicate that many processed foods have been reformulated to reduce the amount of trans fat since the requirement was instituted, but a substantial number of products still contain PHOs.

One of FDA’s core regulatory functions is ensuring that food, including all substances added to food, is safe. In November 2013, FDA made a preliminary determination that PHOs are not “generally recognized as safe” (GRAS) for use in food. FDA opened a 60-day public comment period on this measure to solicit data and information on a number of issues, including:

1. Whether FDA should finalize its tentative determination that PHOs are no longer GRAS;
2. How long it would take producers to reformulate food products to eliminate PHOs.

The comment period was then extended an additional 60 days and closed March 8, 2014.

The final determination was released June 16, 2015. This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period (see Final Determination Regarding Partially Hydrogenated Oils, June 2015).

To learn more about trans fat, see also the FDA Trans Fat page.

EU Situation

In EU art. 30.7 of the FIC Regulation (“Food Information to Consumers” Reg. (EU) n. 1169/2011) says that “by 13 December 2014, the Commission, taking into account scientific evidence and experience acquired in Member States, shall submit a report on the presence of trans fats in foods and in the overall diet of the Union population. The aim of the report shall be to assess the impact of appropriate means that could enable consumers to make healthier food and overall dietary choices or that could promote the provision of healthier food options to consumers, including, among others, the provision of information on trans fats to consumers or restrictions on their use. The Commission shall accompany this report with a legislative proposal, if appropriate.”

Today the report has not been submitted yet and the Commission has been deeply criticized, especially from consumers associations for the unexpected delay. As a matter of fact in this situation is not even possible to declare voluntary the trans fat value in the EU format of the nutrition declaration (while in USA is mandatory from 2006).

Here below, you can find the definition of Trans fatty acids (TFA) and the advice given by EFSA in a 2010 Scientific Opinion:

“Trans fatty acids are not synthesised by the human body and are not required in the diet. Therefore, no Population Reference Intake, Average Requirement, or Adequate Intake is set. Consumption of diets containing trans-monounsaturated fatty acids, like diets containing mixtures of saturated fatty acids, increases blood total and LDL cholesterol concentrations in a dose-dependent manner, compared with consumption of diets containing cis-monounsaturated fatty acids or cispolyunsaturated fatty acids. Consumption of diets containing trans-monounsaturated fatty acids also results in reduced blood HDL cholesterol concentrations and increases the total cholesterol to HDL cholesterol ratio. The available evidence indicates that trans fatty acids from ruminant sources have adverse effects on blood lipids and lipoproteins similar to those from industrial sources when consumed in equal amounts. Prospective cohort studies show a consistent relationship between higher intakes of trans fatty acids and increased risk of coronary heart disease. The available evidence is insufficient to establish whether there is a difference between ruminant and industrial trans fatty acids consumed in equivalent amounts on the risk of coronary heart disease. Dietary trans fatty acids are provided by several fats and oils that are also important sources of essential fatty acids and other nutrients. Thus, there is a limit to which the intake of trans fatty acids can be lowered without compromising adequacy of intake of essential nutrients. Therefore, the Panel concludes that trans fatty acids intake should be as low as is possible within the context of a nutritionally adequate diet. Limiting the intake of trans fatty acids should be considered when establishing nutrient goals and recommendations.”