On the 12^th of July this year, the European Court of Justice in Luxembourg announced that it was upholding most aspects of the controversial EU Food Supplements Directive (FSD), a ruling which was initially seen by many commentators to be a disappointing one, as it contradicted the EU Advocate General’s recommendation that the directive should be invalidated in its entirety. 

The FSD is a piece of legislation that restricts the sale of certain vitamins and minerals – only those forms of supplements that are included in a positive list may be legally sold in the UK and other EU countries.  In order for an ingredient to be accepted onto the positive list, manufacturers would have to go through a time consuming and costly process to prove that each natural ingredient was safe – even those that have been used by many people across the world for thousands of years.  This process could cost up to (or more than) £250,000 per ingredient, and with many supplement companies being small companies, this effectively meant that many ingredients would be banned from August 1^st when the Directive came into force.

A legal challenge to the FSD was mounted in 2003 by the Alliance for Natural Health, the National Association of Health Stores, and the Health Food Manufacturers Association.   This pan-European organisation has been fighting the FSD in the courts, and the 12th July ruling was in response to their legal challenge.  Due to the challenge, and increasing co-operation between the health industry and the government, the wide-scale ban that was expected has been avoided.  Although the Directive was upheld, and the ban on ingredients not on the positive list became effective as of the 1^st August, the EU Court ruling reduced the scale of the Directive and made it much easier to understand, thus removing many of the obstacles to the health food industry. 

In particular, access to the positive list has been made much easier.  The requirements for the technical dossiers that are needed to allow an ingredient to be used until 2009 have been greatly simplified.  505 dossiers had already been submitted prior to 12^th July, and the UK Food Standards Agency further extended the deadline to 1^st August.

While the onus remains on the health food industry to make submissions to the positive list, which contains only 112 ingredients compared to over 300 used by the industry, the primary burden of proof of safety is now on government authorities rather than industry.

What this all means is that if the ban on vitamins and minerals had been brought in without the restrictions now imposed by the EU Courts of Justice:

·         Over 5000 products would have been removed from the shelves of health food stores as a result of the ban removing access to 300 vitamin and mineral ingredients.  These include the natural forms of Vitamin E, several forms of vitamin C, the main natural form of folic acid, MSM and a range of minerals such as vanadium, silicon and boron, all being products which millions of consumers choose to take as part of their regular health regime and have done so without any ill effects for many years. 

·         An individual’s freedom of choice to take safe natural health products would have been removed – 40% of the UK’s population take vitamins and minerals.

·         Products would have been banned with absolutely no scientific justification. Many of the world’s leading scientific and medical experts in nutrition support the absence of any proper basis for the proposed bans.

Although the restrictions that have been applied to the FSD must be seen as a victory for the legal challenge, further legislative proposals relating to herbal products, the maximum dosages of vitamins and minerals, and the health claims of products are due to be considered by the European Parliament later in 2005 and 2006.  Again, the Alliance for Natural Health is working to “positively shape the legislation using its policy of ‘good science and good law’”.

It is recommended that anyone wishing to take vitamin and mineral supplements seeks professional advice from a nutritional practitioner first, to ensure the correct balance of nutrients is achieved.  Please click here to use our search engine to find your nearest practitioner.