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Listen to this siteFriday 27 May 2005
The Food Supplements Directive 2002/46/EC came into force in July 2002 and was implemented in England by the Food Supplements (England) Regulations 2003. Separate, equivalent legislation has been made in Scotland, Wales and Northern Ireland. The directive and these regulations apply from 1 August 2005.
The regulations define the term 'food supplement'; introduce a list of substances that may be used as sources of vitamins and minerals in the manufacture of food supplements; and set out requirements for labelling in addition to those already included in the Food Labelling Regulations 1996 (as amended).
One of the provisions of this directive is for lists of nutrients and their sources that can be included in food supplements. The first list covers the vitamins and minerals that may be used in food supplements (such as vitamin C, calcium, iron). It excludes six minerals (tin, silicon, nickel, boron, cobalt, and vanadium) that are currently used in food supplements on sale in the UK.
The second list covers the chemical forms (sources) of those vitamins and minerals that may be used. These lists can be added to following a favourable opinion on individual nutrients or nutrient sources from the European Food Safety Authority (EFSA) after consideration of a dossier containing safety data.
The requirements for companies who wish to use an ingredient in the UK after 1 August 2005 that is not yet included in Annexe 2 of the directive are:
Only one dossier is required per nutrient or nutrient source for assessment by EFSA.
In October 2003 two sets of proceedings started 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). On 30 January 2004 the High Court of Justice of England and Wales granted permission for the applicants to apply for judicial review of the domestic legislation implementing the Food Supplements Directive 2002/46/EC. The European Court of Justice (ECJ) hearing was held on 25 January 2005.
The Advocate General�s Opinion was issued on April 5 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. The Advocate General�s Opinion does not have a binding effect and the ECJ will reach its own judgement in due course. The UK remains under legal obligation to implement the Directive unless it is declared invalid by the court. Operators should be aware that these guidance notes may change in light of the judgement made by the ECJ.
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