Legal challenge and cooperation between industry and government avert wide-scale food supplement ban previously anticipated today.

FOOD SUPPLEMENT BAN AVOIDED BY MUTUAL COOPERATION

Today could have seen up to 5,000 vitamin and mineral products being banned from health store shelves in the UK alone, with further products being banned in other EU countries such as Ireland and Sweden.

But, following the legal challenge to this ban implicit in the EU Food Supplements Directive, mounted in 2003 by the Alliance for Natural Health and two UK trade associations, the National Association of Health Stores and the Health Food Manufacturers Association, mutual cooperation between the health industry and government authorities has seen the wide-scale ban circumvented.

The ban would have affected products containing over 200 vitamin and mineral ingredients which had not been subject to extensive safety evaluation by the European Food Safety Authority, but nevertheless had been consumed safely as part of the normal diet for thousands of years.

Dr Robert Verkerk, executive director of the pan-European Alliance for Natural Health said: “Without positive pressure from our legal challenge, and increasing amounts of cooperation between industry and government authorities, thousands of products containing nutrients which are increasingly difficult to find in our normal diet, but known to be of great importance to our health and wellbeing, could have today been removed from our food supply. We are working hard to bed in our barristers' positive interpretation of the European Court ruling. However, we cannot afford to sit back as future provisions in the Directive set to limit maximum potencies of food supplements could have devastating consequences at least equal to those caused by the originally proposed food supplement ingredients ban.”

The European Court of Justice handed down its ruling on the legal challenge to the Food Supplements Directive on 12 July. Although the Directive was upheld, the ruling reduced its scope and greatly improved its clarity, so reducing obstacles to the health food industry. In particular the ruling will make it much easier to access the ‘‘positive list’’ of allowed ingredients, a process previously described by a senior advisor to the Court, Advocate General Leendert Geelhoed in his 5 April Opinion, as “clear as a black box”.

The Directive provided a derogation system which would allow ingredients present on the market prior to 2003 to be used at least to the end of 2009, on the condition that technical dossiers were submitted to governmental authorities, for subsequent consideration by the European Food Safety Authority. The dossier requirements were seen as excessive and pressure from the industry, facilitated by the legal challenge, led the government to agree simplified dossier criteria.

Accordingly, some 505 dossiers for vitamin and mineral ingredients were submitted by 12 July, the official deadline for derogation dossier submissions. To facilitate the process further, the UK’s Food Standard Agency has also extended the dossier deadline until today. All products containing ingredients subject to dossiers will remain on the market to at least the end of 2009 unless they are given an unfavourable review, on the grounds of risks to public health, by the European Food Safety Authority.

In the meantime, onus is on the health food industry to make submissions to the previously limited ‘‘positive list’’, which currently contains just 112 vitamin and mineral forms, as compared with over 300 used by the industry. As a result of the European Court ruling, exemption for certain natural forms of vitamins and minerals, clarified and simplified requirements for access to the ‘positive list’, and placement of the primary burden of proof of safety on government authorities rather than industry, the Alliance for Natural Health is confident that the ‘positive list’ will no longer act as a major barrier to getting products on to the EU’s ‘positive list’ of ingredients allowed in food supplements.

Provisions in the EU Food Supplements Directive which aim to set maximum dosages for vitamin and mineral products are in the process of being finalised by the European Commission and the Codex Alimentarius Commission, which is developing international guidelines for food supplement potencies modelled very closely on the EU Directive. The Alliance for Natural Health has argued, with the support of scientists around the world, that the scientific method being considered to set maximum potencies is flawed.

“We must now move from a legal battle to a scientific battle”, adds Verkerk, “the risk assessment framework that is being considered by the authorities has been borrowed from those systems assessing intrinsically toxic substances such as drugs and pesticides, and have no place for use with nutrients that are essential to life. A new paradigm for safety/benefit analysis is needed specifically for nutrients, and we have commissioned the Netherlands-based HAN Foundation to come up with a new framework that could be used EU-wide and internationally through Codex.”

For further information contact:

Alliance for Natural Health
www.alliance-natural-health.org