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.

Written Q&A to EU Commission – Joint answer on trans fatty acids

In this answer to four written questions by MEPs (click the highlighted numbers to open them), Mr. Borg analyses the state of the art in EU about trans fatty acids.

In US the issue is at the top of the FDA agenda.

FDA has made a preliminary determination that partially hydrogenated oils (PHOs), the major dietary source of trans fat in the processed food supply, are no longer Generally Recognized as Safe, or GRAS. If FDA makes a final determination that partially hydrogenated oils are not GRAS, a company could not use PHOs in food without approval from the FDA, although it may take some time for the change to be fully implemented.

FDA made this preliminary determination because trans fats have significant adverse health effects. Scientific evidence has shown that consumption of trans fat raises low density lipoprotein (LDL-C or “bad) cholesterol, which increases the risk of developing heart disease. Trans fat may also have other adverse health effects, including lowering high-density lipoprotein cholesterol (HDL-C). Considering only the effects of trans fat from partially hydrogenated oils on levels of LDL-C, “bad” cholesterol, the Centers for Disease Control and Prevention estimates that eliminating intake of trans fat from partially hydrogenated oils could prevent up to 20,000 cases of coronary heart disease (CHD) and up to 7,000 deaths annually.

The trans fat found in foods can either be natural or artificial. Naturally occuring trans fat is produced in the gut of some grazing animals, and that is why small quantities can be found in animal-based foods such as milk, milk products, and certain meats. FDA’s action would not affect these foods.

Artificial trans fat is formed during food processing through hydrogenation of vegetable oils.

Joint answer given by Mr Borg on behalf of the Commission (20 December 2013) – Written questions: E-012709/13, E-012853/13, E-012895/13, E-012777/13

Based on requests of the Commission, the European Food Safety Authority adopted two Scientific Opinions, one on the presence of trans fatty acids in foods and their effect on human health and one on Dietary Reference Values for fats, including trans fatty acids.

The Commission is aware that the consumption of trans fatty acids is, along with saturated fat and overall fat intake, known to be a risk factor for the development of cardiovascular disease.

Article 30(7) of Regulation (EU) No 1169/20011 of the European Parliament and of the Council on the provision of food information to consumers requires the Commission to submit by 13 December 2014 ‘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 is also asked to accompany this report with a legislative proposal, if appropriate. This report will address the issue of consumers’ perception of trans fatty acids.

Currently, Denmark, Austria and Hungary have notified national measures limiting the presence of trans fatty acids of non-ruminant origin in foods.

Further, it should be noted that the Commission is encouraging self-regulatory action in order to further decrease the content of trans fatty acids in food products. There are commitments in the EU Platform for Action on Diet, Physical Activity and Health that concern the reformulation of products to reduce the content of trans fatty acids.