United States: European Court of Justice Confirms Validity of Controversial EU Food Supplements Rules — Restrictions Apply From 1 August 2005

Originally published 5 August 2005

The European Court of Justice (ECJ) recently ruled that a controversial Directive on food supplements remains valid. Consequently, as of 1 August 2005, Member States of the EU must prohibit trade in food supplements that do not comply with the Directive. Companies interested in marketing food supplements containing vitamins and minerals that are not included on the list of permitted substances should consider filing a request with the European Commission to modify the list.

The Principal Restriction: Only Certain Substances Can Be Marketed

Directive 2002/46/EC states that vitamins and minerals may not be used in food supplements in the EU unless they are included in a ‘positive list’ of allowable substances which is annexed to the Directive. This limit will affect manufacturers, importers, distributors, and retailers of vitamins, minerals, and food supplements from 1 August 2005 onwards.

EU Member States may introduce exceptions from this restriction. However, such exceptions can only apply if: (a) the substance was marketed in a food supplement that was on the EU market on 12 July 2002 and (b) a dossier supporting the use of the substance was submitted to the Commission by 12 July 2005 and the European Food Safety Authority (EFSA) has not given an unfavorable opinion with respect to the use of that substance. Moreover, the exceptions can only be in place until 31 December 2009.

In the United Kingdom, all substances for which dossiers have been submitted in any Member State will be allowed in food supplements either until 31 December 2009 or for a shorter time if the EFSA issues an unfavorable opinion before that date. Other Member States may decide not to make any exceptions from the ban, in which case it will apply from 1 August 2005. Companies that market food supplements on the EU market should carefully verify if they are in compliance with all applicable (national) laws on that date.

Parties interested in continuing to market substances that are not included on the ‘positive list’ may want to consider working toward adding additional vitamins and minerals to the list of permitted substances. This is also the only approach for companies that wish to market ‘new’ vitamins or minerals, or forms of such substances that were not on the EU market in 2002. Applications to add substances to the positive list should be submitted to the Commission, which in turn requests an opinion from the EFSA. On the basis of that opinion the Commission prepares a draft decision, which is adopted if it is supported by a qualified majority of the Standing Committee of the Food Chain and Animal Health.

In its ruling, the ECJ emphasized that the procedure for adding new products to the lists must be accessible, that it must be completed in a reasonable time, and that applications can only be rejected on the basis of a full scientific assessment of the risks posed to public health. Moreover, any refusal must be open to challenge before the courts. The ECJ also stated that it is the responsibility of the Commission to ensure that consultations with the EFSA are carried out transparently and within reasonable time. It is not yet clear what the Commission will do to comply with these requirements. Interested parties should monitor the Commission’s intentions in the coming months.

An Additional Restriction: Daily Minimum and Maximum Amounts Will Be Set

In addition to the limitations on the permitted substances, the Directive states that minimum and maximum daily levels of vitamins and minerals present in food supplements per daily portion must be set. Trade in products that do not comply with these levels, once they are set, will be prohibited and it will not be possible for Member States to make exceptions from them. As yet, these levels have not been decided and there may be an opportunity for interested parties to influence the legislative process in Brussels.

This article has been prepared by Sidley Austin Brown & Wood LLP for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Readers should not act upon this without seeking professional counsel.