A debate too far

After two decades of debate, 2008 sees the Food Supplements Directive lumber into the end game of the setting of maximum permitted levels for vitamins and minerals in supplements.

The working group meetings already begun by the European Commission will continue throughout the year, seeking common ground between 27 Member States as they search for consensus that meets political needs without abandoning science.

In tandem with the setting of levels for nutrients in fortified foods under the Addition of Vitamins, Minerals and other Nutrients to Foods Regulation, the process targets January 2009 for the figures to emerge.

Debate rages. Well, to those who care passionately, it rages - to the rest of the world it meanders on - about how to produce a risk management model. This has to deliver figures with some basis in science while meeting the conflicting demands of those Member States that take a restrictive approach and those that seek a more permissive interpretation.

Commission officials could be forgiven for wishing they had never conceived this legislation and had instead encouraged industry to go down the route of mutual recognition.

This might have offered harmonising opportunities without so much delay and political intervention.

But the Commission exists to legislate and it is hardly surprising, therefore, that legislation is what it endlessly brings forward.

The official leading the project, Basil Mathioudakis, has no desire to see the measure remove safe products from the market. European law is clear: levels must be set on a case-by-case basis and any restrictions must be warranted and proportionate, or they will be open to challenge in the courts.

But the Commission equally knows that the process must deliver figures that the Council will approve, so it moves forward gradually. We wait to see how far it can progress before the pressure for political compromise outweighs the need for scientific detachment.

Basil Mathioudakis and I have been involved for so long that we have grown old together on the project. It will be interesting to see where life takes us once it is over. But one certain thing about Brussels Regulations is that there will be another one along soon!

2008 also promises to be an interesting year for the regulators as they square up to each other to defend their roles under the Nutrition and Health Claims Regulation.

Compliance with this measure remains a challenge for industry, but sparks will fly as the medicines regulators try to draw and hold a line in the sand to prevent the food authorities straying into medicinal claims.

Meanwhile, the advertising regulators are limbering up by rejecting warnings from the medicines camp that functional claims for probiotics authorised under food law are a pill that they will not swallow.

There will be much inter-agency squabbling and a mountain of case law before this is resolved, but the Regulation clearly does legally shift the balance. It gives the food sector a greater envelope in which to operate, particularly in the area of functional claims and disease risk reduction claims.

When I first coined the latter term, I never believed it would go on to become law and spawn a whole new claim substantiation industry!

Another area in which tension may grow, and ultimately consensus emerge, is in sports nutrition.

The specialist sports nutrition sector has established a constructive dialogue with the Commission about specialist sports products under the PARNUTs (food for particular nutritional uses) legislation.

It does now appear that if legislation is brought forward, and it remains a big if, then the Commission is likely to stick to the wording in the framework Directive and limit it to products intended for the 'expenditure of intense muscular effort' rather than being much more widely drafted to include any product that makes reference to 'sport'.

Chris Whitehouse is md of The Whitehouse Consultancy, which advises clients how best to identify, approach and influence key decision-makers in Brussels and the UK government. Contact him at: puevf.juvgrubhfr@juvgrubhfrpbafhygvat.pb.hx​​