Current Situation on Health Claims in the EU

The following information has been provided by IADSA in response to a number of its members outside Europe requesting an overview of the current situation on claims in the EU and the actions underway by European groups.

For more information contact:

Devon Powell
Executive Director, IASC
dpowell@iasc.org
Phone: 301.588.2420 x102
Cell: 240.398.8018
8630 Fenton St., Ste. 918 | Silver Spring, MD | 20910

What is the European Health Claims Regulation?
Since the mid 1980’s the EU has wanted to harmonize the claims that can be made for foods to both help manufacturers trade more freely and to ensure a common level of consumer protection.

It was only in 2003, however, that serious work started on what is now the Nutrition and Health Claims Regulation that was finally adopted as EU law in 2006. This Regulation covers all food products, including dietary supplements.

Why are European companies concerned?
The Regulation requires that a list of permitted and prohibited claims is developed for the whole of the EU. European trade associations invested huge resources in 2007-8 to build a list of more than 700 established claims that were being used for dietary supplement products. This list and the substantiation of the claims were submitted to the European authorities and eventually to the European Food Safety Authority (EFSA) for review.

However, it looks as though this investment was wasted. On the basis of the EFSA evaluations so far, it is expected that virtually no claims apart from those for vitamins and minerals will be approved. Even antioxidant claims and claims for probiotics, glucosamine and all botanical claims could disappear from the market.

Why is this happening?
EFSA is requiring an inappropriate level of evidence for the substantiation of claims, at a level which is similar to that required for a drug claim. There are simply very few substances with this type of data.

What is being done about it?
It is clear that EFSA is not going to change its approach. The only hope therefore is to ensure that the national regulatory bodies and the European Commission who will have to make a final decision on EFSA's opinions fully understand and recognize the severe impact this will have for both the supplement and food businesses. Almost all energy is now focused on political action. The European lobby is being led by the European level manufacturers' Federation, EHPM, and a new group composed of senior managers from food and supplement companies, called the European Health Claims Alliance. In addition, the European Responsible Nutrition Alliance is leading work on a new approach to claims evaluation. The intensive activity is focused on the governments of the 27 EU Member States and the European Commission and European Parliament. In addition, work is continuing across the scientific community to engage them in action for a change of approach.

What are the main targets at this point?
The Member States are aiming for a vote on the first batch of established claims primarily relating to vitamins and minerals on 11 October. While the industry associations have few objections to the claims for vitamins and minerals that are likely to be proposed, any vote would set a precedent for the future. If the vote goes through in October, or even in early December if there is a delay, it may be more difficult to prevent the second and third batches of claims containing all the other ingredients being voted in the future.

What is the alternative?
There must be a political recognition that the EFSA process is inappropriate for the majority of the claims currently made on the market. Claims which have been made for many years without challenge should be permitted to be sold if they have reasonable substantiation – not the drug-like substantiation required by EFSA. Consumers need these claims and so do manufacturers. If this political understanding is achieved, a long hard look will need to be taken at the Regulation to find ways to permit these claims onto the market.

In addition, the European Federation of Associations of Health Product Manufacturers (EHPM) has recently issued a complaint to the European Ombudsman regarding the EU health claims Regulation. The European Ombudsman looks at cases of maladministration of issues handled by European institutions such as the Commission and EFSA. Its role is to act as a mediator within the EU, aiming to achieve agreement between parties outside courts.

The EHPM’s complaint calls upon the European Ombudsman to issue a formal recommendation that the Commission should wait for EFSA to deliver all of its evaluations on the Article 13.1 claims before any further steps are taken towards a formal decision about the Community list of permitted Article 13.1claims, on the grounds that the current batch-wise approach is maladministration.

And if there is no success?
With the exception of claims for vitamins and minerals, almost all claims will be illegal in the 27 Member States of the EU. Once a claim is prohibited, a manufacturer will have 6 months to withdraw it from the market. Since EU law is so widely followed in other parts of the world, it can be expected that this will impact marketing worldwide. Inevitably this will encourage many companies to go into illegal marketing practices to get their messages across, lowering the credibility of the sector and bringing further problems for the industry with the regulators.

Immediate Steps

1) Sign up to the letter asking for a time-out on the legislation
(www.healthclaimsletter.org)

2) Consider attending or asking your European counterpart to attend the conference in Brussels on 30 September at which these issues will be debated between the European decision-making bodies and industry (healthclaimsconference.org).