The effect of the UK-led challenge to the Food Supplements Directive, which looks as if it will be at least partially successful when the European Court of Justice (ECJ) delivers its verdict later this month, is dividing industry opinion.
If, as expected, the ECJ adopts the view of the advocate general and finds the directive invalid, it will be hailed a triumph by those groups mounting the cases — the Health Food Manufacturers Association (HFMA), the National Association of Health Stores and the Alliance for National Health. Others are not so sure, seeing it as a pyrrhic victory.
The advocate general opined that the directive was invalid because it infringes upon the principle of proportionality — in particular highlighting the inadequacy and opaqueness of the evidence submission process for adding nutrients to the positive lists. However, the advocate general gave his support to the concept of a positive list, an important vindication given the directive is being held up as a template for other EU-wide food regulations.
?If the ECJ follows the advocate general, that could cause more problems than it resolves,? said Ric Hobby, chairman of the UK Council for Responsible Nutrition. ?This will now make it far more difficult for the industry to lobby in the future for negative lists in other areas, such as botanicals.?
The chairman of the European Health Product Manufacturers Association, Peter van Doorn, believed that the system is working as well as could be expected. ?We know there are about 50 scientific dossiers supporting nutrient sources that will go to the UK Food Safety Authority. These cover most of the key substances.?
Chris Whitehouse of White-house Europe, representing several UK industry and consumer groups, was more optimistic. ?If the ECJ upholds the opinion, the European Commission will have to rewrite the legislation. That is why the UK campaign is important; if they keep up the pressure on the parliament, there is every possibility the legislation will allow a national derogation from the directive for the UK. Member states should be allowed to have extra products on their markets. That way there is harmony and market freedom.?
The HFMA appeared to be hedging its bets, as it revealed it was co-ordinating the compilation of what industry sources believe to be ?simplified? dossiers for many nutrients before the July 12 deadline. ?The HFMA is discussing with the Food Standards Agency what action might be taken to ensure that as many dossiers as possible are developed before 12 July,? HFMA director David Adams said. ?The exact number of dossiers to be submitted is likely to run into three figures.? This would allow nutrients with dossiers to remain on the UK and other European markets until 2009 or until EFSA delivers a verdict on their safety.
NBTY?s UK-based supplements manufacturer Holland & Barrett was preparing some simplified dossiers, according to regulatory affairs manager Sharon Morey. ?We don?t know how they will be received, but in the short term it is welcomed because it is a reprieve for a host of ingredients. It buys valuable time to develop dossiers before they reach EFSA. The intention is to get as many through as possible.?