EU Preliminary Impact Assessment on Trans Fats policy options

The EU Commission just published an inception impact assessment about a potential upcoming Regulation about limitation of trans fats in foods (3rd quarter 2017).

Although different actions were taken in different Member States of the EU and intakes of trans fats have overall decreased over the past years, other Member States have not taken action.

Industrial trans fats are still present at levels of concern in certain foods in the EU and intakes are still excessive in certain cases (especially having in mind EFSA’s recommendation that trans fats intakes should be as low as is possible within the context of a nutritionally adequate diet). The issue is of particular relevance in certain Member States and for particular population groups. This lack of homogeneity in the EU hampers the effective functioning of the Internal Market, negatively affects the protection of consumers’ health and contributes to the perpetuation of health inequalities.

The Commission is currently considering an EU-based initiative to limit trans fats intakes, which would have the added value of coherent and simultaneous application in the entire EU. This initiative would focus on industrial trans fats, given that ruminant trans fats sources generally contribute in a limited way to the total daily energy intake and ruminant trans fats are naturally present in foods that are important in the EU diet and cannot therefore totally be avoided.

The Commission presented its first analysis on trans fats in its report to the European Parliament and the Council of 3 December 2015 regarding trans fats in foods and in the overall diet of the Union population. The report was requested by Article 30(7) of Regulation (EU) No 1169/2011 of the European Parliament and the Council on the provision of food information to consumers which stated: “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”.

The report concluded that a legal limit for industrial trans fats would be the most effective measure in terms of public health, consumer protection and compatibility with the Internal Market but that further investigation is required. In accordance with Better Regulation principles, the Commission communicated its intention to carry out an impact assessment, including a public consultation on the matter, in order to take an informed policy decision in the near future.

This Inception Impact Assessment (IIA) marks the beginning of the announced work of the European Commission.

All the stakeholders that intervened in the debate on trans fats so far have welcomed the Commission’s report and/or supported an EU initiative to set legal limits to industrial trans fats in foods, both on the consumers’ side and on the industry’s side. The issue would therefore appear not controversial and the added value of an EU initiative in the field would seem undisputed.

In several platforms, EU action on industrial trans fats has been defined by consumers’ organisations and food business operators as a “low hanging fruit” that would improve consumers’ health at very limited costs. In this context, of particular note are the number of reformulation commitments to lower the content of industrial trans fats in foods made in the past years by food manufacturers in the EU Platform for Diet, Physical Activity and Health.

The positions of industry stakeholders (well summarised in a statement by Food Drink Europe of 19 November 2015) 17 indicate that the industrial trans fats content of foods can effectively be lowered without disproportionate costs (this was confirmed in Denmark, the first Member State introducing a legal limit for industrial trans fats in foods), that an EU initiative would benefit not only to consumers but also to the industry by setting a level playing field in the Internal Market, and that particular support might be needed for SMEs.

In the EU, it is of particular note that legislative measures limiting the content of industrial trans fats to 2% of the total fat content of the food were adopted in Denmark (2003), Austria (2009), Hungary (2013) and Latvia (2015). In Belgium, Germany, the Netherlands, Poland, the UK and Greece, voluntary self-regulation measures have been agreed with the food industry. Legal measures limiting the content of industrial trans fats in foods exist also outside the EU (e.g. in Switzerland, Iceland, Norway as well as in the US, where the Food and Drug Administration concluded in 2015 that partially hydrogenated oils, the primary dietary source of industrial trans fats, are no longer to be considered as “generally recognized as safe” (GRAS) for use in food).

EU legislation sets legal limits for trans fats in infant formula and follow-on formula (3% of the total fat content of the food, to allow for the use of milk, which naturally contains ruminant trans fats, as a source of fat). Regulation (EU) No 1169/2011 requires since 13 December 2014 to specify in the ingredients list of all prepacked foods (non pre-packed foods are not covered by this provision) whether refined fats/oils are partly hydrogenated. The Regulation however does not require the indication of the exact trans fats content of foods in the nutrition declaration and they cannot even declared in the table on voluntary basis.

The options examined in this IIA, are the following:

  • Option 0 – No EU policy change (baseline scenario)
  • Option 1 – Establishment of a limit for the industrial trans fats content in foods

In this option, the EU would establish a limit for the presence of industrial trans fats in foods (both pre-packed and non-pre-packed), through voluntary agreement with relevant stakeholders or with legally binding measures.

  • Option 2 – Introduction of the obligation to indicate the trans fats content of foods in the nutrition declaration
  • Option 3 – Prohibition of the use of partly hydrogenated oils (PHO) in foods

In this option, the EU would follow the same approach as adopted in the US and would prohibit the use of PHOs in foods, on the basis of the consideration that these are the primary dietary source of industrial trans fats. As in the case of Option 1, this could be achieved through a voluntary agreement with the relevant food business operators, or a legally-binding measure

The following future consultations are planned in order to obtain further feedback in preparation for the Impact Assessment:

  • Open Public consultation (12 weeks): this consultation will be open to everyone and will be carried out on the basis of a consultation document that will take into account the comments submitted on the IIA. It will be aimed at obtaining feedback on the different policy options and the expected impacts.
  • Targeted consultation to be carried out by the contractor in the context of its study: this consultation will cover stakeholders with a specific interest in the initiative (consumers’ and health NGOs, food business operators and national authorities) and will be aimed at collecting feedback to triangulate (verify) the contractor’s findings on the expected impacts that the options finally retained for the Impact Assessment will have in a number of different areas (e.g. protection of consumers’ health, costs and regulatory burden, offer of products to consumers, functioning of the Internal Market, competitiveness, external trade, enforcement). The Commission will be particularly interested in collecting feedback at local level, from SMEs and manufacturers of non-pre-packed foods.

The last part of the IIA offers an interesting first evaluation of all the policy options impact on environment, economy, internal market, public health, SMEs, international trade and all the main stakeholders involved.

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.”