EU Supplements Directive Faces UK Courts


The European dietary supplements industry is closely watching separate legal challenges launched against the implementation of the Food Supplements Directive in the UK.

One challenge is being jointly led by the National Association of Health Stores (NAHS) and the Health Food Manufacturers Association (HFMA). A pan-European group, the Alliance for Natural Health, is mounting the other action.

Although there are differences in their arguments, both actions question the right of the Directive, under EU constitutional law, to ban nutrients that don?t appear on the Directive?s positive list.

HFMA chairman Peter Aldis stated: ?There are strong grounds for mounting our challenge. Our case argues that the Directive is disproportionate, discriminatory and irrational and also uses some of the technical arguments that resulted in the overturn of a previous EU Directive.?

Products Blacklisted
It is estimated that 5,000 products and 300 nutrient sources will be blacklisted when the Directive comes into force in the UK in August 2005. A similar situation exists in other liberal European markets such as Sweden, Ireland and the Netherlands where a similar number of local and imported products will have to be reformulated if the Directive becomes law.

For the more conservative EU markets, the Directive will have a liberalising influence and hence resistance is minimal.

NAHS director Ralph Pike said the UK action had to be mounted now because it could take up to two years for a decision to be reached. ?If we don?t win the debate on the submission of scientific dossiers to get nutrients on the positive list, and we don?t win the debate on reasonable maximum permitted levels in food supplements, and we hadn?t mounted this action, all would have been lost. We had to move now.?

Cheryl Thallon, managing director of UK-based supplements manufacturer, Viridian, said legal action, although not popular in all quarters of industry, had been forced upon the industry. ?The industry saw this Directive coming 10 years ago,? she said. ?We thought common sense would have prevailed by now but it hasn?t so finally something is happening. What irritates a lot of people is that we have signed up to this Directive as a country without knowing its detail.?

Opposition Not Unanimous
Other groups, such as the Proprietary Association of Great Britain, which represents both food supplement manufacturers and pharmaceutical companies, have more faith in the Directive. ?The procedure has been defined to allow any additional ingredients and products to be added to the positive list,? PAGB communications director Mike Owen, said. ?It?s up to the companies who are concerned about these products to get the dossiers together.?

Sindy Staesson, government and regulatory affairs manager at the UK division of supplement company, Herbalife, said the legal challenges would alienate industry from the legislative process. ?If the European and UK MPs stop co-operating with industry, where are we then? We are prepared to reformulate some products in the interest of keeping food supplements freely available on the market. We believe compromise is necessary if we are not to lose everything.? For Pike, there is everything to gain by mounting the action. ?We are compelled to take this action and people who don?t understand that are na?ve or have a vested interest in allowing the Directive to pass into law as it is,? he said.

Judicial Reviews of the two actions are expected by January, 2004. If successful, the cases will then be presented to the European Court of Justice at some point next year.

More Help With Scientific Dossiers
The Directive remains open to negotiation in two key areas—upper safe levels (currently being assessed by various scientific bodies) and the positive list of permitted substances.

The European Food Safety Authority (EFSA), responsible for assessing the scientific dossiers, said applicants can communicate with EFSA at any time during the assessment process and the agency will inform applicants of any weaknesses in dossiers as soon as such information becomes available. The EFSA stated that toxicological and biological data can be simplified in three ways:

  1. Data can be shared between nutrient sources where sources are similar to a source already on the positive list (eg, sodium molybdate or potassium molybdate).
  2. Data can be shared for sources included in the Food Additives Directive positive list.
  3. Data submitted under other related Directives could be shared. The EC has indicated it may merge several directives including the Food Supplements and Fortified Foods Directives? lists.

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