France must change the manner in which it administers its fortified foods and food supplements industry after a European court found its authorisation procedures to be unacceptable. They were ?not readily accessible, not transparent as regards to the possibility of appeal to the courts and subject to unreasonable delay,? the court stated.
In handing down its verdict to a case mounted against France by the European Commission, the European Court of Justice (ECJ) also noted that ?applications for authorisation may be refused by the competent French authorities only if such nutrients pose a real risk to public health.? It found France was illegally prohibiting products that did not pose such a threat.
In particular, it ruled France could not prohibit confectionery and vitamin-enriched drinks as well as food supplements containing L-tartrate and L-carnitine ?on the sole ground that they would increase the usual intake from an already sufficiently varied diet and that there is no nutritional need for them.?
Italy-based Sigma-Tau, an L-carnitine supplier, welcomed the decision while expressing concerns about its application. ?This is an old story,? said Franco Gaetani, Sigma-Tau?s research and development director. ?It?s definitely a step in the right direction, but we don?t expect France to follow the ECJ indication. Until the French authorities act on this, there is nothing to get excited about.?
EU law specialist Peter Willis, of Eurozone law firm Taylor Wessing, agreed France may take years to comply. Although potentially expensive, he recommended affected companies launch damages claims in French courts. ?Such companies can make life very difficult for the French. It will only take a couple of actions and the pressure will mount on them to cave in,? he said.
The European Health Product Manufacturers? Association (EHPM) is taking steps to have the decision implemented.
?We are having meetings with the EC to ensure it enforces the decision—but it is a long process. In the past the French have not responded,? said Pedro Vicente Azua, EHPM?s regulatory affairs director. ?This comes on top of France failing to properly implement the Food Supplements Directive.?
In an addendum to the decision, the ECJ upheld France?s decade-long ban on energy drinks, noting that French scientists had found high-caffeine drinks such as Red Bull posed a risk to public health if consumed to excess.
This ruling came despite numerous studies demonstrating the drink?s safety, the fact Red Bull and other energy drinks are available in more than 100 countries and the existence of a European Union Directive on caffeine and quinine that states, ?the contribution of ?energy drinks? to the total consumption of caffeine did not appear to be a cause for concern, assuming that ?energy drinks? replace other sources of caffeine.?
Commenting on the ruling, Willis said: ?Given the levels of coffee consumption in France, it is an argument that doesn?t seem so strong on the surface.?
In reaction to the decision, Ireland was reconsidering the status of energy drinks while the Netherlands confirmed their safety. Denmark is the only other EU member to ban Red Bull-like energy drinks. A 250ml can of Red Bull contains 80mg of caffeine, the equivalent of a percolated cup of coffee.