Opinion of the Advocate General — ECLI:EU:C:1998:500
Date: 1998-10-22
Language of the case: French
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Agriculture and Fisheries;Foodstuffs;Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: France

Summary of the Judgment 
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» 
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SUMMARY — CASE C-107/97 
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) 
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 nutri­
tional requirements of one of the 
categories of persons referred to in 
Article 1(2)(b)(i) and (ii) of the Direc­
tive. 
(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 par­
ticular nutritional uses, which does not 
itself regulate either additives autho­
rised 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 speci­
fic directives adopted pursuant to it do 
not prevent Member States from main­
taining in force after the transposition 
of Directive 89/398 prior national 
legislative provisions which apply to 
additives authorised in the manufac­
ture 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. 
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ROMBI AND ARKOPHARMA 
In the absence of any provision in 
Directive 89/398 itself, or in the direc­
tives 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 Commu­
nity 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 recog­
nised in the Community legal order, 
including the principle of the protec­
tion of legitimate expectations, are also 
binding on Member States when they 
implement Community rules. Accord­
ingly, 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 prin­
ciple 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 pre­
viously created a situation which can 
give rise to a legitimate expectation, as 
Community law currently stands, in 
the absence of provisions in the Direc­
tive 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 particu­
lar, those on maximum permitted 
doses, to a legitimate expectation on 
which it could reasonably rely. 
(see paras 65, 67, 73, and 
operative part 4) 
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