Proposed European Legislation on Claims to hit Functional Food, Nutraceuticals and Dietary Supplements industry

By Patrick Coppens, EAS, Brussels

The growing number of health claims made on foods and the increasing incidence of obesity and non-communicable diseases in Europe have united the Member States of the European Union around new legislation on nutrition and health claims. This proposal, which was met with mixed emotions by the food industry, will fundamentally change the way in which many functional foods, nutraceuticals and dietary supplements are marketed in the EU. While the proposal will create a centralised pre-marketing authorisation procedure and make Reduction of Disease Risk Claims possible, it is expected to drive from products many of the lower level claims currently in use.

While the draft has been welcomed by some of the larger multi-national food companies many smaller businesses are still largely unaware of the tidal wave that is going to hit them when this legislation comes into force.

Some of the more controversial elements of the proposed legislation include:

Scope: The Regulation is set to cover all health and nutrition claims not only in the labelling but also in the presentation and advertising of a food. It even covers brand names and trade names. Since the brand name of many functional foods, nutraceuticals or dietary supplements is often selected to reflect the effect of the product, this means that such names will in future need to be substantiated with scientific data if they are to continue to be used.

Nutrient profiles: During the initial discussions on the proposal, the European Commission, which has responsibility for drafting legislation in the EU, has looked for a tool to prevent companies from making nutrition and health claims on foodstuffs high in fat, sugar and salt. The European Commission therefore came up with the concept of nutrient profiles. This means that the composition of the food will decide if it will be allowed or prohibited to make nutrition or health claims. This is needless to say a highly controversial concept given that people do not eat individual foods, but that the sum of all the foods they eat determines the healthiness of their diet. Furthermore, some particularly successful functional foods do not have a particularly good nutrient profile (e.g. phytosterol enriched fat spreads, probiotic milk drinks, iodised salt, calcium enriched fruit juice). Since the profiles have not been established, much uncertainty remains on how these will affect a company’s product portfolio and research projects underway.

Control of the wording: The Regulation is set to regulate the precise wording of the claim. Unless flexibility of the wording is agreed in the final stages of the decision-making process, each alternative wording would either have to be approved or would not be allowed. If literally applied, this would make commercial communication very hard, if not impossible.

Authorisation procedure: The creation of a pre-marketing authorisation procedure for innovative claims is also of great for many food manufacturers. The experiences gained with similar procedures (e.g. Novel Foods) have shown that timings are often not kept, the process is long and costly, there is little confidentiality, and there is little opportunity to defend ones interests. It may be assumed that for smaller companies, this procedure will be very hard to follow.

In order to accommodate possibilities for SME’s the proposal also foresees the elaboration of a list of so-called generally accepted ‘generic’ claims. There is much uncertainty on what claims will be acceptable for inclusion in the list, and it is feared that quite a number of functional ingredients and herbs currently in use will not be accepted, thereby eliminating all claims for these ingredients from the European market.

Discussions on this rather controversial piece of legislation are due to restart in February 2006 with second reading in European Parliament and Council, representing the EU’s 25 Member States. And the debate may prove rather heated with the two Institutions have taken exactly opposite positions on two of the key principles of this text: nutrient profiles and the authorisation procedure.

Efforts are underway by many companies to seek the best result from this legislative process, and although compromises are likely, it is likely that there will be rough road ahead for those companies wishing to make claims for food products in Europe.


European Advisory Services (EAS) is a Brussels based consultancy specialising in regulatory advice on nutritional issues. EAS has been advising private and public organisations on regulatory strategies for over 14 years. For further details on EAS services visit the web-site: Or you can contact: EAS – Strategic Advice on Nutritional Products, Rue de l’Association 50, 1000 Brussels, Belgium Tel: +322 218 1470, Fax: +322 219 7342, E-mail: [email protected]

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