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.

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

Here another answer of the Commission about trans-fats. It’s quite fresh (25th February 2014).

It’s clear from this answer that:

1) The Commission is following with great attention the FDA move about trans fats;

2) Probably the report of the Commission on trans-fats (art. 30(7) Reg. EU n. 1169/2011) will not be released in the next few weeks. My opinion is that it’s quite sure the Commission will wait the end of the comment period (4th March 2014) to see how FDA will proceed on this issue;

3) The Commission refuses to address the matter applying the precautionary principle, strongly invoked by MEPs, but I think a little bit out of context in this case.

Enjoy the healthy reading!

Question for written answer to the Commission – Rule 117 – Antonyia Parvanova (ALDE)

P-001091-14 (4th February 2014)

In October 2013, the US Food and Drug Administration (FDA) issued a Federal Register Notice stating that, based on new scientific evidence and the findings of expert scientific panels, partially hydrogenated oils (PHOs), which are the primary dietary source of industrially produced trans fatty acids, or trans fats, are not generally recognised as safe for any use in food, based on current scientific evidence establishing the health risks associated with the consumption of trans fat. The Notice states that PHOs are therefore food additives which should be subject to a pre-market approval by the FDA.

The FDA decision is based on the latest scientific evidence which has demonstrated and confirmed the significant health risks posed by trans fats. These are responsible for the burden of diet-related chronic disease which the Commission aims to address.

Has the Commission been liaising with the FDA in order to update its policy and legislative response to the risks posed by trans fats?

Can the Commission provide an update on the progress made on the report on trans fats, which is to be submitted by December 2014 as required by Regulation 1169/2011? In light of the latest scientific evidence and the FDA Notice, is the Commission willing to bring forward the publication of this report?

Would the Commission consider applying the precautionary principle and take immediate regulatory action in order to restrict the presence of trans fats in processed food and to allow its use only after pre-market approval has been granted, as planned by the FDA?

P-001091/2014 – Answer given by Mr Borg on behalf of the Commission (25.2.2014)

The Commission is aware of the US Food and Drug Administration (FDA) Federal Register Notice on partially hydrogenated oils (PHOs), from October 2013, which includes FDA’s preliminary determination that PHOs, the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” (GRAS) for use in food. The FDA has opened a 60-day comment period on this preliminary determination to collect additional data and to gain input on the time potentially needed for food manufacturers to reformulate products that currently contain artificial trans fat should this determination be finalized, which was extended by 60 days, to March 8, 2014. The Commission has so far not yet liaised with the FDA but is continuing to follow the issue, including the results of the consultation and the final decision of the FDA.

 The Commission is in the process of drafting the report on trans fats as required in Article 30(7) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers. In order to be able to include new data, the Commission is undertaking a consumer research study that will be finalised in 2014. Therefore, it is difficult to advance the publication of the report.

The issue of trans fat has been discussed during the negotiations of Regulation (EU) No 1169/20011. The co legislator has agreed that the Commission will submit afore mentioned report that would address all the pertinent questions. Therefore, there is no need at this stage to take a differing approach.

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