Food Supplement Directive – EU court challenge

The European Food Supplement Directive 2002/46/EC (“FSD”) is due to come into force on 1st August 2005. The FSD will make it illegal to supply any products containing ingredients not on its “positive list” of 140 permitted substances. An estimated 5,000 supplements will be affected. In order for any further ingredients to be added to the list in the Food Supplements Directive (FSD), they must be assessed for safety through submission of a dossier and have received a positive opinion from the European Food Safety Authority (“EFSA”).

The UK’s supplement industry had its case against the FSD heard by the European Court of Justice (ECJ) on 25 January 2005 and a judgement is expected on the verdict to be given on 5 April 2005.

The parallel cases brought by industry trade bodies the National Association of Health Stores and Health Food Manufacturers’ Association, as well as the health campaign group Alliance for Natural Health (ANH). The groups argue that the EU FSD, passed in 2002 and set to enter into force in August 2005, will see around 270 nutrients currently included in supplements removed from the market and significant damage to UK trade. The supplement industry is arguing for the EU to allow each member state the right to continue the sale of products it considers safe.

The Advocat General of the ECJ gave an advisory opinion in April 2005 that the directive, as it stands, is “invalid”. The current proposals lacked clear rules for the European Commission to follow when deciding whether or not to include an ingredient on the positive list. The Advocate General however upheld the concept of EU legislation on health supplements, saying only that the proposals needed to be reworked.

The full ECJ judgment is expected in July 2005.

This article first appeared in our Food industry law bulletin May 2005. To view this publication, please click here to open a new window.