Food may be put on market under simplified procedure for novel foods despite presence of residues of transgenic protein, provided there is no risk to health: judgment (with press release)

September 10, 2003

Luxembourg, 9 September 2003

C-236/01, Monsanto Agricoltura Italia SpA and Others v Presidenza del Consiglio dei Ministri and Others

Judgment of the Court of Justice on 9 September 2003 (link to English version when available). Full text

The case was referred to the Court by the Tribunale amministrativo regionale del Lazio (Italy)
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

The Court ruled:

1. The first subparagraph of Article 3(4) of Regulation (EC) No 258/97 of the European Parliament and of the Council of January 1997 concerning novel foods and 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.

2. 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 case, from which it is apparent that, in the light of the 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 .

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.


The mere presence of residues of transgenic protein in novel foods does not prevent their being placed on the market under a simplified procedure provided there is no risk to human health.

However, if a Member State has detailed grounds to suspect such a risk, it may temporarily restrict or suspend the trade in and use of the food in question in its territory

The Community regulation relating to novel foods1 provides that foods which are produced from genetically modified organisms but no longer contain them may be placed on the market within the Community under a "simplified" procedure, which requires merely that a notification be made to the Commission, if they are substantially equivalent to comparable traditional foods: proof of which can be given by a national food assessment body.

Monsanto Europe SA and other undertakings active in the development of genetically modified food plants for use in agriculture had obtained authorisations from France and the United Kingdom to market certain genetically modified maize grain (Bt-11 and MON 810). Genetically modified maize is resistant to certain insects and herbicides.

In 1997 and 1998 Monsanto and Others notified the Commission, under the "simplified procedure", of their intention to market products derived from genetically modified maize, such as cornflour.

The competent UK authority for food assessment had previously concluded that those foods were substantially equivalent to conventional foods. The Commission forwarded those notifications to the Member States.

In 2000, an Italian scientific institute noted the presence of residues of transgenic protein (expressed by the inserted gene) in the flour in question but did not consider that they posed any risk to human health.

The Italian Republic - in the light of the differing opinions put forward by Italian scientific bodies - had concerns as regards the safety of the products. It therefore adopted a decree on 4 August 2000 providing for the precautionary suspension of the trade in and use of products derived from those maize lines. Monsanto and Others subsequently challenged the Italian decree, which they considered to be in breach of Community law.

The Administrative Court of Lazio accordingly asked the Court of Justice of the European Communities whether novel foods which contain residues of transgenic protein at certain levels can be considered substantially equivalent to existing foods and may consequently be marketed under the simplified procedure.

The Court of Justice first observes that the Community regulation concerning novel foods has a twofold objective:

- to ensure the functioning of the internal market in novel foods, and

- to protect public health.

The Regulation characterises as "substantially equivalent to existing foods" those foods which present differences in composition but have no effect on public health.

Substantial equivalence is assessed by specialised bodies on the basis of the scientific evidence available, prior to the novel food being placed on the market: it does not require the risk assessment laid down under the normal procedure. On the other hand, the absence of substantial equivalence does not imply that the food is unsafe but merely that it should be subject to risk assessment.

The Court considers that in no case should the simplified procedure lead to a relaxation of the safety requirements that must be met by novel foods.

The Court nevertheless points out that certain differences in the composition of novel foods do not prevent their being deemed substantially equivalent: on the contrary, they must be specifically mentioned on the labelling.

It is for the Italian national court to decide whether the novel foods are substantially equivalent to existing foods in the light, inter alia, of the Court's ruling on the interpretation of Community law.

The Court finds that where use of the simplified procedure is not warranted, a Member State can - as a preventive measure - temporarily restrict or suspend the marketing of those foods in its territory (under the "safeguard clause" laid down in the Regulation) without first being required to challenge the lawfulness of the procedure.

Demonstration of the existence of a risk to health can justify the adoption of such a measure: in that case, the risk must not be purely hypothetical or be founded on mere suppositions which are not yet verified; the State must base its action on detailed grounds and not on reasons of a general nature.

The safeguard clause reflects the precautionary principle and allows protective measures to be taken without having to wait until the reality and seriousness of risks become fully apparent, even if a full risk assessment proves impossible because of the inadequate nature of the scientific data available.

In the framework of close cooperation between the Commission and the Member States, the initial assessment of substantial equivalence by a scientific body of a Member State is subject to verification at Community level. Similarly, the protective measure adopted by the Member State under the safeguard clause is subject to verification at Community level.

Unofficial document for media use; not binding on the Court of Justice. Available in English, French and Italian. For additional information please contact Christopher Fretwell. Phone: (00 352) 4303 3355; Fax: (00 352) 4303 31.

European Court of Justice, judgment 9 September 2003. Press and Information Division, Press Release No 67/03

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