10 years of Food, Nutrition & Health Claims – Status Review and Future Outlook

Posted 8 March, 2016

A one-day interactive workshop took place in central Brussels on Friday 5 February 2016. Over 80 participants from the European Food Industry, Legal affairs and Clinical research companies joined to learn how to comply with the EU Food Regulatory framework.

Balancing consumer protection and trade to ensure fair competition

The programme was kicked-off by Ms Alexandra Nikolakopoulou from the EU Commission (DG SANTE Head of Unit E1 – Food information and composition, food waste). She emphasized that even though only 30 nutrition claims and 262 health claims are currently permitted (nine years after the Nutrition & Health Claim Regulation (EC) No 1924/2006 came into force), the scope of the regulation was not to approve a lot of claims but to achieve a high level of consumer protection, improve free movements of goods, increase legal security and ensure fair competition of foods.

During the next two years, the Commission will carry out an evaluation (described as a “Roadmap”) of the Nutrition & Health Claim Regulation, focusing on nutrient profiles and health claims for plants and their preparations used in foods. Nutrient profiles are thresholds of nutrients such as sugar and fat; foods high in these nutrients would be restricted to using nutrient and health claims, thus preventing positive health messages. More specifically, the Commission will assess the costs and benefits of not setting any nutrient profiles as well as the extent to which nutrient profiles are still sufficient to ensure the objectives of the regulations. They will also be looking into whether current rules on health claims for plants and their preparations added to foods are adequate, and how the use of such claims would interact with other regulatory frameworks already in place.

How to spot a health claim!

Even though health claims have been regulated for nearly 10 years, one of the main issues remaining is the definition of “health claim”. Mr Brian Kelly from Covington & Burling LPP made the interesting comment that “if you keep stewing over a label whether or not it is a health claim, it probably is…”. He also commented that even when claims are approved it may still be difficult to find the correct legal wording to use on the label.

Care needed when changing authorized wording

It is advisable to stick as closely as possible to the authorized wording for approved health claims, but the authorized wording may not always be understood by the average consumer. For example, the exact wording of the folic acid-claim is “Supplemental folic acid intake increases maternal folate status” and “Low maternal folate status is a risk factor in the development of neural tube defects in the developing foetus”. Most pregnant women would need additional information to understand that neural tube defects are birth defects of the spinal cord (e.g. spina bifida) and the brain (e.g. anencephaly). Changes to the wording of claims are permitted but only to aid consumers’ understanding and should not make the claim more appealing, exaggerate it or change its meaning.

Botanicals lack a legal definition

Dr Ina Gersberger (Wragge Lawrence Graham & Co) stepped in for Dr Barbara Klaus (Rödl & Partner) who had flu. She started a debate on the use of botanicals in foods and the legal implications. Botanicals are still a complicated topic in the EU as there is no clear legal definition of “botanicals” and Member States take different approaches on how to deal with botanicals in foods. Some countries apply the BELFRIT-list, while others have non-binding guidelines or plant lists to decide if certain botanicals can be used in foods. The only area of harmonization may be the Novel Food regulation when a botanical extract is considered a novel food ingredient. The audience also provided input and reference was made to the fact that a different approach is seen on the feed side, where botanicals could be considered “feed additives” and are strictly evaluated by EFSA (European Food Safety Authority).

Food for Special Medical Purposes versus Food Supplements

In the afternoon, Ing Liza Van den Eede from Pen & Tec Consulting shed light on the Food for Specific Groups (FSG) Regulation (EC) No 609/2013. This will repeal and replace the existing legislative framework for dietetic foods, including Food for Special Medical Purposes (FSMP).

One of the problems with the “old” legislative framework was that Member States interpreted the definition of FSMPs[1] differently causing products to be classified as food supplements in one EU territory and as FSMPs in another. This increased the risk of marketing abuse since some Food Business Operators chose to market their products as FSMPs, while from a strict legislative point of view they may have been food supplements; this allowed them to make certain claims while avoiding the restrictions of the Health Claims Regulation.

Shift in product classifications expected

As of 20 July 2016, Member States can forward notifications to the Commission should they have doubts of the legal category of a product that will be marketed as an FSMP. In order to decide if a notified product falls within the scope of the FSG regulation and can thus be considered an FSMP, the Commission may in some cases ask EFSA for scientific advice to evaluate the composition and proposed uses of the product to ensure their decision is based on sound scientific judgment. Ing Van den Eede expects that the new FSG Regulation and especially the involvement of EFSA will cause a shift in product classifications since there is a high chance that borderline products currently marketed as FSMPs will be re-classified as food supplements.

[1] FSMPs are foods that are specifically developed to feed patients who have difficulty consuming ordinary foods or who are malnourished because of a specific diagnosed disease, disorder or medical function; in addition, it is impossible or very difficult for these patients to satisfy their nutritional needs through the consumption of ordinary foods, including food supplements.