«(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)»

1.. Approximation of laws – Novel foods and novel food ingredients – Placing on the market – Simplified procedure – Substantial equivalence to existing foods – Concept – Use of that procedure notwithstanding the presence of residues of transgenic protein in novel foods – Whether permissible – Limits – Potential risks to human health (Regulation No 258/97 of the European Parliament and of the Council, Art. 3(4), first subpara.)

2.. Approximation of laws – Novel foods and novel food ingredients – Placing on the market – Simplified procedure – Procedure not covered by consent, even tacit, by the Commission – Member States' right of recourse to the safeguard clause where use of that procedure is not warranted – Need for a preliminary challenge to such consent – Not required (Regulation No 258/97 of the European Parliament and of the Council, Art. 5 and Art. 12(1))

3.. Approximation of laws – Novel foods and novel food ingredients – Placing on the market – Member States' right of recourse to the safeguard clause regardless of the procedure followed for placing on the market and its validity (Regulation No 258/97 of the European Parliament and of the Council, Art. 3(4), second subpara. and Arts 5, 12 and 13)

4.. Approximation of laws – Novel foods and novel food ingredients – Placing on the market – Use of the safeguard clause – Justification – Potential risks to human health – Burden of proof (Regulation No 258/97 of the European Parliament and of the Council, Arts 3(1) and 12)

5.. Approximation of laws – Novel foods and novel food ingredients – Placing on the market – Simplified procedure – Condition of substantial equivalence – Detailed rules sufficient to ensure a high level of protection for human health and the environment – Compliance with the precautionary principle and the principle of proportionality – Validity (Arts 152(1) EC and 174(2) EC; Regulation No 258/97 of the European Parliament and of the Council, Art. 3(4), first subpara., and Art. 5)

JUDGMENT OF THE COURT 9 September 2003 (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 temporarily restricting or suspending the trade in or use of a novel food in its territory))

In Case C-236/01,

REFERENCE to the Court under Article 234 EC by the Tribunale amministrativo regionale del Lazio (Italy) for a preliminary ruling in the proceedings pending before that court between

and

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,

Advocate General: S. Alber,

after considering the written observations submitted on behalf of:

having regard to the Report for the Hearing,

after hearing the oral observations of Monsanto Agricoltura Italia SpA and Others, the Italian Government, the Parliament, the Council and the Commission at the hearing on 24 September 2002,

after hearing the Opinion of the Advocate General at the sitting on 13 March 2003,

gives the following

Community legislation

Directive 90/220/EEC

Regulation No 258/97

...

...

Where necessary, it may be determined in accordance with the procedure laid down in Article 13 whether a type of food or food ingredient falls under this paragraph.

composition,

nutritional value or nutritional effects,

intended use of the food, which renders a novel food or food ingredient no longer equivalent to an existing food or food ingredient. A novel food or food ingredient shall be deemed to be no longer equivalent for the purpose of this article if scientific assessment, based upon an appropriate analysis of existing data, can demonstrate that the characteristics assessed are different in comparison with a conventional food or food ingredient, having regard to the accepted limits of natural variations for such characteristics. In this case, the labelling must indicate the characteristics or properties modified, together with the method by which that characteristic or property was obtained;

...

If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.

Recommendation 97/618/EC

...

National legislation

Observations submitted to the Court

Findings of the Court

Observations submitted to the Court

Findings of the Court

Observations submitted to the Court

Findings of the Court

On those grounds,

THE COURT,

in answer to the questions referred to it by the Tribunale amministrativo regionale del Lazio by order of 18 April 2001, hereby rules:

Rodríguez Iglesias

Puissochet

Timmermans

Gulmann

Edward

La Pergola

Jann

Skouris

von Bahr

Cunha Rodrigues

Rosas

Delivered in open court in Luxembourg on 9 September 2003.

R. Grass

G.C. Rodríguez Iglesias

Registrar

President