Like watching a train wreck in slow motion, we who have dreaded this moment for two years, who have jumped up and down in protest over the European Food Supplements Directive (FSD), have now been eyewitness to the full-on crash. Although an Advocate General of the European Union had declared the Food Supplements Directive illegal last April, in a surprise reversal, the European Court upheld its legality on 12 July. As planned, the FSD will become law across Europe at the beginning of August.
Both the Health Food Manufacturers Association and the Nation-al Association of Health Stores are demanding that Tony Blair have a showdown with Brussels and demand that the legislation be rewritten so that the UK is excluded.
Amid the general weeping and wailing, the Alliance for Natural Health, the third player in opposition to the directive, is celebrating. In their eyes, this represented a quiet victory – and to understand why, it is necessary to understand the nuts and bolts of the directive. The FSD, as it originally stood, apparently banned some substances which are difficult to obtain from conventional food, but which have been part of the human diet for thousands of years.
In reaching its decision, the European Court amended the directive so as to apply only to “food supplements containing vitamins and/or minerals derived from a manufacturing process using ‘chemical substances’”.
According to Rob Verkerk, executive director of the ANH, this means that any natural vitamin or mineral (ignoring any chemical excipients) will be regarded as safe and must be allowed on the positive list. As ‘food’, they will continue to be governed by food law.
ANH’s second complaint concerned the lack of any clear procedure for manufacturers to obtain any amendments to the positive list. To get an additional ingredient onto the positive list, manufacturers would have had to have gone through a lengthy process costing about a quarter of a million pounds per ingredient. In other words, once a supplement was excluded, it would remain banned until proven safe – at a price beyond the reach of most small vitamin companies: guilty until proven innocent.
On this issue, the Court changed the wording of the directive and resorted to general EU law to formulate the procedures that must be followed. Although the manufacturer will have to produce data, the burden of proof has been shifted to the European regulator. Once an ingredient has been submitted for consideration, it cannot be banned until a full safety assessment has proven it unsafe: innocent until proven guilty. As some 550 safety dossiers have been presented about products, the ban, says the ANH, will now be extremely limited.
So, if ANH is right, the vast majority of the quality supplements that were on the market will now stay on the market.
This may be a victory, but there’s still the next hurdle – the allowable safe upper limits. Once in place, the regulators could place a very low ceiling on the maximum potency.
The ANH has worked tirelessly and usually at loggerheads with the other organisations fighting this directive. Three groups each had individual support and scrabbled about for their own funding. The train wreck we tried to prevent had to do with lots of little guys fighting one big guy. What would have happened if the hundreds of thousands of practitioners, suppliers and consumers of natural medicine had all worked together and spoken with a single voice? Perhaps we wouldn’t be sifting through the ashes now, looking for the phoenix.