Key facts of the case:
Reference for a preliminary ruling: Tribunal de grande instance de Grasse - France.
Food supplements - Directive 89/398/EEC - Transposition - Conditions - Retention of previous national legislation - Additive - L-Carnitine.
Outcome of the case:
On those grounds, THE COURT (Sixth Chamber), in answer to the questions referred to it by the Tribunal de Grande Instance, Grasse, by judgment of 19 July 1996, hereby rules:
- Article 1(2) of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses must be interpreted as meaning that food supplements such as those at issue in the main proceedings, which contain L-carnitine in high doses and which are marketed on the basis that they are suitable for a particular nutritional purpose, fall within the scope of the Directive unless the national court establishes that they are not suitable for the nutritional purposes that the manufacturer claims they are or that they do not fulfil the particular nutritional requirements of one of the categories of persons referred to in Article 1(2)(b)(i) and (ii) of the Directive.
- As Community law presently stands, Directive 89/398/EEC and the directives adopted pursuant to it do not prevent Member States from maintaining in force after the transposition of Directive 89/398/EEC prior national legislative provisions such as those at issue in the main proceedings which apply to additives authorised in the manufacture of foodstuffs intended for particular nutritional uses, even if those provisions are based on a classification other than that used in Directive 89/398/EEC.
- In the absence of any provision in Directive 89/398/EEC itself, or in the directives adopted pursuant to Article 4 of the Directive, as to the composition of foodstuffs intended for particular nutritional uses or the use of additives or substances for specific nutritional purposes in the manufacture of that type of product, no relevant Community rules exist, as Community law presently stands, on which individuals may rely in order to challenge national rules on additives and substances for nutritional purposes authorised in the manufacture of foodstuffs of the kind at issue in the main proceedings.
- Member States are subject, in their monitoring of the composition of foodstuffs intended for particular nutritional uses and, in particular, of additives and substances for nutritional purposes used in their manufacture, to the requirements flowing from general principles recognised by Community law, and, in particular, the principle of the protection of legitimate expectations. However, in the main proceedings the relevant Community rules could not give rise to a legitimate expectation on the part of Arkopharma on which it could reasonably rely. It is for the national court to decide whether the rules on the free movement of goods within the Community have any application to an activity such as that at issue in the main proceedings.