Keywords
Summary

Keywords

1. Approximation of laws - Foodstuffs intended for particular nutritional uses - Directive 89/398 - Scope - Food supplements which contain L-carnitine - Included - Conditions

(Council Directive 89/398, Art.1(2))

2. Approximation of laws - Foodstuffs intended for particular nutritional uses - Directive 89/398 - Maintenance in force, after the transposition of the directive, of national legislative provisions applying to additives authorised in the manufacture of that type of foodstuffs - Whether permissible - Conditions - Possibility, in the absence of measures taken by the Community authorities to implement the directive, of relying on the directive in the national court - Precluded

(Council Directive 89/398)

3. Approximation of laws - Foodstuffs intended for particular nutritional uses - Directive 89/398 - Observance by Member States of general principles of Community law when implementing directives - Absence of measures taken by the Community authorities to implement the directive - Principle of the protection of legitimate expectations - Breach - None

(Council Directive 89/398)

Summary

1. Article 1(2) of Directive 89/398 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 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.

( see para. 43, and operative part 1 )

2. As Community law presently stands, Directive 89/398 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, which does not itself regulate either additives authorised in general in the manufacture of that type of foodstuffs or substances with specific nutritional purposes to be added to such foodstuffs and does not itself include any specific requirement as to their composition, and the specific directives adopted pursuant to it do not prevent Member States from maintaining in force after the transposition of Directive 89/398 prior national legislative provisions which apply to additives authorised in the manufacture of that type of foodstuffs and, in particular, to maximum authorised doses, even if those provisions are based on a classification other than that used in the Directive.

In the absence of any provision in Directive 89/398 itself, or in the directives adopted pursuant to Article 4 of that 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 rule exists, 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 that type of foodstuffs.

( see paras 47, 60, 62, and operative part 2-3 )

3. The requirements flowing from the protection of general principles recognised in the Community legal order, including the principle of the protection of legitimate expectations, are also binding on Member States when they implement Community rules. Accordingly, as regards Directive 89/398 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, Member States are subject, in their monitoring of the composition of that type of foodstuffs and, in particular, of additives and substances for nutritional purposes used in their manufacture, to the requirements flowing from the above principles, in particular the principle of the protection of legitimate expectations.

However, since the principle of the protection of legitimate expectations may be relied on in order to challenge Community rules only to the extent that the Community itself has previously created a situation which can give rise to a legitimate expectation, as Community law currently stands, in the absence of provisions in the Directive 89/398 itself or in the directives adopted pursuant to that Directive, Community rules did not give rise, in the case of an economic operator which marketed foodstuffs which did not comply with national rules on additives authorised for use in the preparation of foodstuffs intended for particular nutritional uses, in particular, those on maximum permitted doses, to a legitimate expectation on which it could reasonably rely.

( see paras 65, 67, 73, and operative part 4 )