Judgment of the Court of 9 September 2003 in Case C-236/01 (Reference for a preliminary ruling from the Tribunale amministrativo regionale del Lazio): Monsanto Agricoltura Italia SpA and Others v Presidenza del Consiglio dei Ministri and Others (Regulation (EC) No 258/97 — Novel foods — Placing on the market — Safety assessment — Simplified procedure — Substantial equivalence to existing foods — Foods produced from genetically modified maize — Presence of residues of transgenic protein — Measure by a Member State temporarily restricting or suspending the trade in or use of a novel food in its territory)
Date: 2003-11-01
Institutions: Court of Justice
Subjects: EU Member State, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, interpretation of the law

C 264/10

EN

Official Journal of the European Union

1.11.2003

and J.N. Cunha Rodrigues,
Jacobs, Advocate
General; M.-F. Contet, Principal Administrator, for the Regis-
trar, has given a judgment on 11 September 2003, in which it
has ruled:

Judges; F.G.

Articles 81, 82 and 85 EC and Council Directive 92/12/EEC of
25 February 1992 on the general arrangements for products subject
to excise duty and on the holding, movement and monitoring of
such products, as amended by Council Directive 96/99/EC of
30 December 1996, must be interpreted as meaning that they do
not preclude a national rule providing for the levy of surcharges on
the price of electricity such as those at issue in the main proceedings
when the electricity is used in an electro-chemical process and that
Council Recommendation 81/924/EEC of 27 October 1981 on
electricity tariff structures in the Community is not capable of
preventing a Member State from levying such surcharges.

(1) OJ C 200 of 14.7.2001.

JUDGMENT OF THE COURT

(Fifth Chamber)

of 11 September 2003

in Case C-211/01: Commission of the European Communi-
ties v Council of the European Union (1)

lishing certain conditions for the carriage of goods by road
and the promotion of combined transport (OJ 2001 L 108,
p. 27), but only in so far as they are based on Article 93 EC
and without altering their effects, which should be maintained,
the Court (Fifth Chamber), composed of: M. Wathelet (Rappor-
teur), President of
the Chamber, C.W.A. Timmermans,
D.A.O. Edward, A. La Pergola and S. von Bahr, Judges; S. Alber,
Advocate General; H.A. Rühl, Principal Administrator, for the
Registrar, has given a judgment on 11 September 2003, in
which it:

conclusion of

1. Annuls Council Decision 2001/265/EC of 19 March 2001
concerning the
the agreement between the
European Community and the Republic of Bulgaria establishing
certain conditions for the carriage of goods by road and the
promotion of combined transport and 2001/266/EC of
19 March 2001 concerning the conclusion of the agreement
between the European Community and the Republic of Hungary
establishing certain conditions for the carriage of goods by road
and the promotion of combined transport;

2. Declares that the effects of the decisions are to be maintained
until the measures necessary to implement the present judgment
have been adopted;

3. Orders the Council of the European Union to pay the costs;

4. Orders the Federal Republic of Germany and the Grand Duchy

of Luxembourg to bear their own costs.

(1) OJ C 212 of 28.7.2001.

(EC/Bulgaria and EC/Hungary Agreements — Carriage of
goods by road and combined transport — Taxation — Legal
basis — Articles 71 EC and 93 EC)

JUDGMENT OF THE COURT

of 9 September 2003

(2003/C 264/16)

(Language of the case: French)

(Provisional translation; the definitive translation will be published
in the European Court Reports)

In Case C-211/01, Commission of the European Communities
(Agent: initially by M. Wolfcarius, subsequently by W. Wils) v
Council of the European Union (Agents: A. Lopes Sabino and
E. Karlsson) supported by Federal Republic of Germany
(Agents: W.-D. Plessing and M. Lumma) and by Grand Duchy
of Luxembourg (Agents: J. Falts and N. Mackel): Application
for the annulment of Council Decisions 2001/265/EC of
19 March 2001 concerning the conclusion of the agreement
between the European Community and the Republic of
Bulgaria establishing certain conditions for the carriage of
goods by road and the promotion of combined transport (OJ
2001 L 108, p. 4), and 2001/266/EC of 19 March 2001
concerning the conclusion of the agreement between the
European Community and the Republic of Hungary estab-

in Case C-236/01 (Reference for a preliminary ruling
from the Tribunale amministrativo regionale del Lazio):
Monsanto Agricoltura Italia SpA and Others v Presidenza
del Consiglio dei Ministri and Others (1)

(Regulation (EC) No 258/97 — Novel foods — Placing on
the market — Safety assessment — Simplified procedure —
Substantial equivalence to existing foods — Foods produced
from genetically modified maize — Presence of residues of
transgenic protein — Measure by a Member State tempor-
arily restricting or suspending the trade in or use of a novel
food in its territory)

(2003/C 264/17)

(Language of the case: Italian)

(Provisional translation; the definitive translation will be published
in the European Court Reports)

In Case C-236/01: Reference to the Court under Article 234
EC by the Tribunale amministrativo regionale del Lazio (Italy)

1.11.2003

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Official Journal of the European Union

C 264/11

for a preliminary ruling in the proceedings pending before that
court between Monsanto Agricoltura Italia SpA and Others
and Presidenza del Consiglio dei Ministri and Others, on
the interpretation and validity of the first subparagraph of
Article 3(4) and the first paragraph of Article 5 of Regulation
(EC) No 258/97 of the European Parliament and of the Council
of 27 January 1997 concerning novel foods and novel food
ingredients (OJ 1997 L 43, p. 1), and on the interpretation of
Article 12 thereof, the Court, composed of: G.C. Rodríguez
Iglesias, President, J.-P. Puissochet and C.W.A. Timmermans
(Rapporteur)
(Presidents of Chambers), C. Gulmann,
D.A.O. Edward, A. La Pergola, P. Jann, V. Skouris, S. von Bahr,
J.N. Cunha Rodrigues and A. Rosas, Judges; S. Alber, Advocate
General; L. Hewlett, Principal Administrator, for the Registrar,
has given a judgment on 9 September 2003, in which it has
ruled:

1.

2.

foods and novel

The first subparagraph of Article 3(4) of Regulation (EC)
No 258/97 of the European Parliament and of the Council of
27 January 1997 concerning novel
food
ingredients must be interpreted as meaning that the mere
presence in novel foods of residues of transgenic protein at
certain levels does not preclude those foods from being considered
substantially equivalent to existing foods and, consequently, use
of the simplified procedure for placing those foods on the
market. However, that is not the case where the existence of a
risk of potentially dangerous effects on human health can be
identified on the basis of the scientific knowledge available at
the time of the initial assessment. It is for the national court to
determine whether that condition is satisfied.

In principle, the issue of the validity of the use of the simplified
procedure laid down in Article 5 of Regulation No 258/97 for
the placing of novel foods on the market does not affect the
power of the Member States to adopt measures falling under
Article 12 of the Regulation, such as the Decree of 4 August
2000 at issue in the main proceedings. Since the simplified
procedure does not
imply any consent, even tacit, by the
Commission, a Member State is not required to challenge the
lawfulness of such a consent before adopting such measures.
Nevertheless, those measures can be adopted only if the Member
State has first carried out a risk assessment which is as complete
as possible given the particular circumstances of the individual
the
case,
precautionary principle, the implementation of such measures is
necessary in order to ensure that novel foods do not present a
danger for the consumer, in accordance with the first indent of
Article 3(1) of Regulation No 258/97.

from which it is apparent that,

in the light of

3.

Consideration of the fourth question has disclosed no factor
such as to affect the validity of Article 5 of Regulation No 258/
97 as regards, inter alia, the condition for application of that

provision relating to substantial equivalence within the meaning
of the first subparagraph of Article 3(4) of the Regulation.

(1) OJ C 259 of 15.9.2001.

JUDGMENT OF THE COURT

of 9 September 2003

in Case C-285/01 (Reference for a preliminary ruling from
the Cour administrative d’appel de Douai): Isabel Burbaud
v Ministère de l’Emploi et de la Solidarité (1)

(Recognition of diplomas — Hospital managers in the public
service — Directive 89/48/EEC — Definition of ‘diploma’
— Entrance examination — Article 48 of the EC Treaty
(now, after amendment, Article 39 EC))

(2003/C 264/18)

(Language of the case: French)

(Provisional translation; the definitive translation will be published
in the European Court Reports)

In Case C-285/01: Reference to the Court under Article 234
EC by the Cour administrative d’appel de Douai (France) for a
preliminary ruling in the proceedings pending before that
court between Isabel Burbaud and Ministère de l’Emploi et de
la Solidarité, on the interpretation of Article 48 of the EC
Treaty (now, after amendment, Article 39 EC) and of Council
Directive 89/48/EEC of 21 December 1988 on a general
system for the recognition of higher-education diplomas
awarded on completion of professional education and training
of at least three years’ duration (OJ 1989 L 19, p. 16), the
Court, composed of: G.C. Rodríguez Iglesias, President,
J.-P. Puissochet, M. Wathelet, R. Schintgen and C.W.A. Timm-
ermans (Rapporteur) (Presidents of Chambers), C. Gulmann,
D.A.O. Edward, A. La Pergola, P. Jann, V. Skouris, F. Macken,
N. Colneric, S. von Bahr, J.N. Cunha Rodrigues and A. Rosas,
Judges; C. Stix-Hackl, Advocate General; L. Hewlett, Principal
Administrator, for the Registrar, subsequently H. von Holstein,
Deputy Registrar, has given a judgment on 9 September 2003,
in which it has ruled:

1.

Confirmation of passing the final examination of the École
nationale de la santé publique, which leads to permanent
appointment to the French hospital public service, must be
regarded as a ‘diploma’ within the meaning of Council Directive
89/48/EEC of 21 December 1988 on a general system for
the recognition of higher-education diplomas awarded on
completion of professional education and training of at least
three years’ duration. It is for the national court to determine,
for the purposes of applying point (a) of the first paragraph of