Advocate General's opinion on the food supplements directive
Friday 3 June 2005
In October 2003, two sets of proceedings were commenced in the High Court of Justice of England and Wales, seeking annulment of the national domestic legislation implementing the provisions of the Food Supplements Directive (2002/46/EC).
The first set of proceedings was brought by the National Association of Health Stores and Health Food Manufacturers Association against the Secretary of State for Health and the National Assembly for Wales on 10 October 2003. The Alliance for Natural Health and Nutri-Link Ltd brought the second set against the Secretary of State for Health on 13 October 2003.
The Claimants submit that the legislation is restrictive to trade in goods, is made under the wrong legal base and infringes a series of superior norms of Community Law, in particular, free movement of goods, common commercial policy, general principles of proportionality, equal treatment and subsidiarity, the protection of fundamental rights and duty to give reasons.
On 30 January 2004 the High Court of Justice of England and Wales granted permission for the two sets of applicants to apply for judicial review of the domestic legislation implementing the Food Supplements Directive 2002/46/EC. The relevant domestic legislation is the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003. In the case of both actions the judge ordered that there be a reference to the European Court of Justice (ECJ) requesting it to give a preliminary ruling on the validity of the underlying Directive. For the purposes of the ECJ, the two cases were joined by order of the President of the Court and the ECJ hearing was held on 25 January 2005.
The Advocate General's Opinion
The Advocate General's Opinion was issued on 5 April 2005. This concluded that the Food Supplements Directive 2002/46/EC is invalid on the grounds that it infringes the principle of proportionality because basic principles of Community law, such as the requirements of legal protection, of legal certainty and of sound administration have not been properly taken into account.
The Advocate General's Opinion does not have a binding effect. The European Court of Justice will reach its own judgement in due course. The Advocate General's opinion assists the ECJ in reaching its decision and in practice the opinion is usually followed by the ECJ. The ECJ judgement is expected within the next three months. The UK remains under legal obligation to implement the Directive unless it is declared invalid by the court. Dependent on the outcome of the ECJ ruling, the European Commission will decide on an appropriate course of action.
A number of scenarios may occur depending on the judgement of the European Court of Justice:
Scenario1
ECJ judgement declares the Directive to be invalid in part but upholds the rest of the Directive. Depending on which parts of the Directive are upheld by the court under scenario 1 if, for example, the judgement did not remove the need for companies to submit dossiers for substances not on the positive list, than those dossiers may need to be submitted by 12 July to the Commission via member states in order for substances not on the positive lists to remain on the market from 1 August 2005. The national regulations would need to be amended to reflect the ECJ ruling. The Commission would bring forward proposals for amendment of the Directive to deal with the sections, which had been declared invalid.
Scenario 2
ECJ judgement declares the Directive to be invalid in its entirety. National regulations would need to be revoked. The European Commission would bring new proposals forward for negotiation by member states.
Scenario 3
ECJ judgement upholds the validity of the Directive in its entirety. The Directive stands and dossiers will need to be submitted by 12 July to the Commission via member states in order for substances not on the positive lists to remain on the market from 1 August 2005.