European Union: Food Supplements Directive Upheld

On 12 July 2005 the European Court of Justice (ECJ) upheld the validity of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements. In particular it upheld the internal market legal base and the positive list of vitamins and minerals that can be used in supplements.

In June 2002 the European Parliament and the Council adopted Directive 2002/46/EC on the approximation of the laws of Member States relating to food supplements ("the Directive"). The Directive is based on Article 95 EC which allows measures to be taken to ensure the functioning of the internal market.

Food supplements are defined by the Directive as "foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquid, drop dispensing bottles, and other similar forms or liquids and powders designed to be taken in measured small unit quantities." Nutrients are defined as vitamins and minerals, which means that the scope of the Directive is generally limited to vitamins and minerals.

The Directive aims to approximate the laws of the Member States on the use of vitamins and minerals in food supplements. This should allow these products to move freely throughout the Community. At the same time it aims to achieve a high level of consumer protection. The Directive establishes a positive list whereby only products containing the vitamins and minerals included in the lists in the annexes to the Directive can be marketed in the Community. There is a mechanism by which nutrients can be added to the positive list. The legislation will also set maximum and minimum dosage levels for the vitamins and minerals. Labelling requirements are set out in the Directive.

In the UK, the National Association of Health Stores and Health Food Manufacturers Ltd (trade associations representing around 580 companies, the majority of which are small firms which distribute dietary products in the UK) and the Alliance for Natural Health (a Europe-wide association of manufacturers, wholesalers, distributors, retailers and consumers of food supplements) and Nutri-Link Ltd (a small distributor and retailer) (together "the applicants") applied to judicially review the national implementing measures: the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003. The UK court referred a number of questions to the ECJ.

The national court asked the ECJ to consider the validity of certain articles¹ of the Directive for several reasons but including questioning if Article 95 EC is the correct legal base. The applicants argued that the Directive does not contribute to improving the conditions for the establishment and functioning of the single market and that some articles are contrary to the principle of the free movements of goods. In particular they argued that the provisions that prohibited trade in products which do not comply with the Directive infringed a number of EU principles and were adopted on the wrong legal base.

In April 2005 Advocate General Geelhoed argued that the Directive 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 had not been properly taken into account. However the opinion of an Advocate General is merely persuasive and the final decision was to be taken by the ECJ.

On 12 July 2005 the European Court of Justice (ECJ) upheld the validity of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements.

The ECJ noted that before the Directive was adopted food supplements were regulated by a variety of different national rules. The discrepancies between the national rules were likely to impede the free movement of goods and the functioning of the internal market. In particular before the proposal for the Directive was brought forward by the Commission, the ECJ noted that there had been a substantial number of complaints from economic operators on account of the differences between national rules which the application of the principle of mutual recognition did not succeed in overcoming. Therefore the Court took the view that the Directive was correctly founded on the internal market legal base, Article 95 EC.

The applicants argued that the Directive was incompatible with the principle of the free movement of goods. However the ECJ took the view that the restrictions imposed by the Directive, particularly the use of the positive list of vitamins and minerals, were justified by the protection of public health and considered the measures to be necessary and appropriate for the purpose of achieving that objective, in other words the ECJ considered the Directive to be proportionate.

The ECJ found that a negative list might not be sufficient to achieve the same objective as the positive list. The Court took the view that a negative list could allow a substance to be used in food supplements even though it had not been subject to any scientific assessment proving that it posed no risk to human health.

The ECJ added that the positive list should be accompanied by a procedure to allow substances to be added to the list. The procedure should be consistent with the general principles of Community law, including, the principle of sound administration and legal certainty. It should also be accessible and must be completed in a reasonable time. Any refusal should be based on a full risk assessment and should be open to challenge before the courts. Whilst there are no provisions to ensure that the procedure is timely and transparent the Court is of the view that it is for the Commission to ensure that it is.

The ECJ found that the Directive does not breach the principle of subsidiarity². The ECJ took the view that action by the Member States cannot satisfactorily achieve the objective of removing the barriers resulting from the differences between the national rules on vitamins and minerals in food supplements whilst ensuring a high level of health protection. The objective could be best achieved at Community level.

In summary the ECJ found:

• the Directive is correctly based on the internal market legal base Article 95 EC
• the restrictions that exist in the Directive are justified on the basis of the protection of public health and the measures in question are necessary and appropriate for their purpose, and
• upheld the system of a positive list of vitamins and minerals.

As a consequence of this judgment upholding the Directive in its entirety, Member States were obliged to prohibit trade in products which did not comply with the Directive from 1 August 2005. Reaction to the judgment has been mixed. Some take the view that the Directive will help to ensure that all such products on the market are safe.

Others believe the new legislation is too restrictive, effectively banning safe products.

Several Member States, in particular the UK, have well developed markets in food supplements. Some products that are currently on the market (and that have been on the market for a considerable period of time) may not be compatible with the new legislation in the future.

Minerals that are not currently on the positive list include tin, silicon, nickel, boron, cobalt and vanadium. Under the Directive these minerals will not be able to be included in new products. Member States may provide derogations for products already on the market until December 2009 in certain circumstances.

Now that the ECJ has upheld this Directive relating to vitamins and minerals, it may be that other nutrients are more likely to be regulated at the Community level in the foreseeable future. Indeed under the Directive the Commission is required to report to the European Parliament and Council on the situation relating to these other nutrients by 12 July 2007.

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