Judgment of the Court of Justice (First Chamber) of 9 June 2005 in Joined Cases C-211/03, C-299/03 and C-316/03 to C-318/03 (References for a preliminary ruling from the Oberverwaltungsgericht für das Land Nordrhein-Westfalen): HLH Warenvertriebs GmbH, Orthica BC v Federal Republic of Germany (Free movement of goods — Distinction between medicinal products and food additives — Product marketed as a food additive in the Member State of origin but treated as a medicinal product in the Member State of import — Marketing authorisation)
Date: 2005-08-06
Institutions: Court of Justice
Subjects: Germany, consumer protection, food supplement, foodstuffs legislation, interpretation of the law, intra-EU trade, marketing, medicinal product, product designation, public health

C 193/4

EN

Official Journal of the European Union

6.8.2005

1. Articles 2, 3 and 8(4) of Council Framework Decision
2001/220/JHA of 15 March 2001 on the standing of victims
in criminal proceedings must be interpreted as meaning that the
national court must be able to authorise young children, who, as
in this case, claim to have been victims of maltreatment, to give
their testimony in accordance with arrangements allowing those
children to be guaranteed an appropriate level of protection, for
example outside the trial and before it takes place.

öffentlichen Interesses beim Oberverwaltungsgericht für
das Land Nordrhein-Westfalen, the Court (First Chamber)
composed of P. Jann, President of the Chamber, N. Colneric,
Ilešič and E. Levits,
J.N. Cunha Rodrigues (Rapporteur), M.
Judges; L.A. Geelhoed, Advocate General, K. Sztranc, Adminis-
trator, for the Registrar, gave a judgment on 9 June 2005, the
operative part of which is as follows:

2. The national court is required to take into consideration all the
rules of national law and to interpret them, so far as possible, in
the light of the wording and purpose of the Framework Decision.

(1) OJ C 146 of 21.06.2003

1. The classification of a product as a medicinal product or as a
the
foodstuff must
product, established both in the initial stage of the product and
where it is mixed, in accordance with the method by which it is
used, with water or with yoghurt.

the characteristics of

take account of all

JUDGMENT OF THE COURT OF JUSTICE

(First Chamber)

of 9 June 2005

2. Regulation (EC) No 178/2002 of the European Parliament and
of the Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing the Euro-
pean Food Safety Authority and laying down procedures in
matters of food safety constitutes an additional set of rules in
relation to Directive 2002/46/EC of the European Parliament
and of the Council of 10 June 2002 on the approximation of
the laws of the Member States relating to food supplements, the
application of which is precluded to the extent to which a Com-
munity rule, such as that directive, contains specific provisions
for certain categories of foodstuffs.

in Joined Cases C-211/03, C-299/03 and C-316/03 to C-318/
03 (References for a preliminary ruling from the Oberver-
waltungsgericht für das Land Nordrhein-Westfalen): HLH
Warenvertriebs GmbH, Orthica BC v Federal Republic of
Germany (1)

3. Only the provisions of Community law specific to medicinal
products apply to a product which satisfies equally well the condi-
tions for classification as a foodstuff and the conditions for clas-
sification as a medicinal product.

(Free movement of goods — Distinction between medicinal
products and food additives — Product marketed as a food
additive in the Member State of origin but treated as a medic-
inal product in the Member State of import — Marketing
authorisation)

(2005/C 193/06)

(Language of the case: German)

in the light of

the potential capacities of

4. The pharmacological properties of a product are the factor on the
basis of which the authorities of the Member States must ascer-
tain,
the product,
whether it may, for the purposes of the second subparagraph of
Article 1(2) of Directive 2001/83/EC of the European Parlia-
ment and of the Council of 6 November 2001 on the Com-
munity code relating to medicinal products for human use, be
administered to human beings with a view to making a medical
diagnosis or to restoring, correcting or modifying physiological
functions in human beings. The risk that the use of a product
may entail for health is an autonomous factor that must also be
taken into consideration by the competent national authorities in
the context of the classification of the product as a medicinal
product.

In Joined Cases C-211/03, C-299/03 and C-316/03 to C
318/03: references for a preliminary ruling under Article 234
EC, by the Oberverwaltungsgericht für das Land Nordrhein-
Westfalen (Germany), by decisions of 7 May and of 4, 3, 7 and
8 July 2003 respectively, received at the Court on 15 May and
11 and 24 July 2003, in the proceedings pending before that
court between HLH Warenvertriebs GmbH (C-211/03),
Orthica BV (C-299/03 and C-316/03 to C-318/03) and the
intervener: Vertreter des
Federal Republic of Germany,

5. A product which constitutes a medicinal product within the
meaning of Directive 2001/83 may be imported into another
Member State only upon acquisition of a marketing authorisa-
tion issued in accordance with the provisions of that directive,
even where it is lawfully marketed as a foodstuff
in another
Member State.

6.8.2005

EN

Official Journal of the European Union

C 193/5

6. The concept of ‘upper safe levels’ in Article 5(1)(a) of Directive
2002/46 is of no importance for the purposes of drawing a
distinction between medicinal products and foodstuffs.

JUDGMENT OF THE COURT

(Third Chamber)

of 9 June 2005

7. In the context of an evaluation by a Member State of the risks
that foodstuffs or food supplements may constitute for human
health, the criterion of the existence of a nutritional need in the
population of the Member State may be taken into consideration.
However, the absence of such a need does not in itself suffice to
justify, either under Article 30 EC or under Article 12 of Direc-
tive 2002/46, a complete ban on marketing foodstuffs or food
supplements lawfully manufactured or placed on the market in
another Member State.

in Case C-270/03: Commission of the European Commu-
nities v Italian Republic (1)

(Failure of a Member State to fulfil obligations — Environ-
ment — Management of waste — Directive 75/442/EEC as
amended by Directive 91/156/EEC — Transport and collec-
tion of waste — Article 12)

8. The fact that the discretion enjoyed by the national authorities as
regards the establishment of an absence of nutritional need is
subject to only limited review by the courts is compatible with
Community law, on condition that the national procedure for
judicial review of the decisions in that regard taken by those
authorities enables the court or tribunal seised of an application
for annulment of such a decision effectively to apply the relevant
principles and rules of Community law when reviewing its
legality.

foods and novel

9. Article 1(2) of Regulation (EC) No 258/97 of the European
Parliament and of the Council of 27 January 1997 concerning
novel
food ingredients is to interpreted as
meaning that a food or a food ingredient has not been used for
human consumption to a significant degree within the Com-
munity if, when all the circumstances of the case are taken into
account, it is established that that food or that food ingredient
has not been consumed in a significant quantity by humans in
any of the Member States before the reference date. 15 May
1997 is the reference date for the purpose of determining the
extent of human consumption of that food or food ingredient.

10. A national court cannot refer questions on the classification of
products to the European Food Safety Authority. An opinion
delivered by that Authority, possibly in a matter forming the
subject-matter of a dispute pending before a national court, may
constitute evidence that that court should take into consideration
in the context of that dispute.

(2005/C 193/07)

(Language of the case: Italian)

In Case C-270/03, Commission of the European Communities
(Agents: L. Visaggio and R. Amorosi) v Italian Republic
(Agents: I.M. Braguglia and M. Fiorilli) brought on 23 June
2003 — failure to fulfil obligations under Article 226 EC —
the Court (Third Chamber), composed of A. Rosas, President of
the Chamber, J. P. Puissochet (Rapporteur), S. von Bahr, J. Male-
novský and U. Lõhmus,
Judges; C. Stix-Hackl, Advocate
General; L. Hewlett, Principal Administrator for the Registrar,
gave a judgment on 9 June 2005, in which it:

1. Declares that, by permitting undertakings,

in accordance with
Article 30(4) of Decree-Law No 22 of 5 February 1997 imple-
menting Directive 91/156/EEC on waste, Directive 91/689/EEC
on hazardous waste and Directive 94/62/EC on packaging and
packaging waste, as amended by Article 1(19) of Law No 426 of
9 December 1998:

— to collect and transport their own non-hazardous waste, as a
normal and regular activity, without being required to be
entered in the Albo nazionale delle imprese esercenti servizi di
smaltimento rifiuti (national register of undertakings carrying
out waste-disposal services) and

— to transport

their own hazardous waste in quantities not
exceeding 30 kg and 30 l per day, without being required to
be entered in that register,

the Italian Republic has failed to fulfil its obligations under Article
12 of Council Directive 75/442/EEC of 15 July 1975 on waste,
as amended by Council Directive 91/156/EEC of 18 March
1991;

(1) OJ C 200 of 23.08.2003
OJ C 275 of 15.11.1003

2. Orders the Italian Republic to pay the costs.

(1) OJ C 200 of 23.08.2003.