The UK will see hundreds of its products disappear from shelves under the new legislation. In response, the Alliance for Natural Health (ANH) has lined up a high calibre legal team to challenge the directive on EU constitutional law grounds.
"We say that the ban on food supplements imposed by the directive is quite unnecessary in order to facilitate the internal market and thus goes beyond the legal powers of the Community legislator. This case may well prove to be a landmark decision on the interface between EU legislative powers, the sovereignty of Member States and the protection of individual and companies' rights," said David Hinde, solicitor and legal director of the ANH.
He added that while the group supports 'appropriate legislation', the directive in its present form is "unworkable and will have a catastrophic effect on the emerging market for advanced high potency and effective food supplements".
The UK's supplement industry claims that the new law will affect 41 per cent of the country's adults who currently buy over £335 million (€482m) worth of vitamins and minerals annually.
British companies expect the directive (2002/46/EC), which aims to harmonise supplement trade across member states, to restrict the sale of many higher dose nutrients, such as antioxidant vitamins C, B6 and E and essential minerals including selenium and zinc, currently available in the UK but not permitted in many other European nations.
This also means that consumers wishing to maintain their daily nutrient consumption will be forced to make multiple purchases for their usual intake, paying prices several times their current outlay, claim trade groups.
The positive nutrient list is also a source of considerable concern to the British market, as it does not include around 270 ingredients widely used in supplements in the UK. By the end of last year, there were only 12 safety dossiers under preparation to allow the missing ingredients to remain on European shelves. Dossiers are estimated to cost up to £200,000 per substance and must be submitted before the end of July 2005.
The directive will also affect countries like Sweden, Holland and Ireland, which like the UK have a more liberal supplement market. ANH executive director Dr Robert Verkerk explained: "This Directive is supposed to be promoting trade in food supplements in the EU but actually has the reverse effect, forcing these countries to comply with a much more restrictive regime more typical of the existing regimes in countries like Germany and France."
He said the goal was to obtain 'a legal regime which befits the 21st century'.
Erica Murray of the Irish Association of Health Stores added that the directive in its current form "will give a huge competitive advantage to the big companies, which dominate mass-market sales of lower potency vitamin and mineral supplements from supermarkets and pharmacies. We have lodged voluminous evidence from the UK, Sweden, Ireland and Italy to show that the directive - if unchallenged - will have dire consequences for hundreds of smaller businesses in the UK and other parts of Europe".
Other UK trade associations, the National Association of Health Stores and the Health Food Manufacturers Association, are running a parallel challenge to the directive. It must be enforced from 1 August 2005 but the NAHS and HFMA are also applying for an injunction to stop the directive coming into effect in the UK.
In July, the UK government's upper house, the House of Lords, rejected proposals to implement the food supplements directive in the UK. But revoking the directive would breach EC Treaty obligations, resulting in the usual fines for the state.