Court of Justice of the European Communities (including Court of First Instance Decisions)

Legal framework

Community legislation

Directive 90/220/EEC

Regulation No 258/97

In order to protect public health, it is necessary to ensure that novel foods and novel food ingredients are subject to a single safety assessment through a Community procedure before they are placed on the market within the Community; ... in the case of novel foods and novel food ingredients which are substantially equivalent to existing foods or food ingredients a simplified procedure should be provided for.

1. This regulation concerns the placing on the market within the Community of novel foods or novel food ingredients.

2. This regulation shall apply to the placing on the market within the Community of foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Community and which fall under the following categories:

(a) foods and food ingredients containing or consisting of genetically modified organisms within the meaning of Directive 90/220/EEC;

(b) foods and food ingredients produced from, but not containing, genetically modified organisms;

...

1. Foods and food ingredients falling within the scope of this regulation must not:

- present a danger for the consumer,

- mislead the consumer,

- differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer.

2. For the purpose of placing the foods and food ingredients falling within the scope of this regulation on the market within the Community, the procedures laid down in Articles 4, 6, 7 and 8 shall apply ...

...

4. By way of derogation from paragraph 2, the procedure laid down in Article 5 shall apply to foods or food ingredients referred to in Article 1(2)(b), (d) and (e) which, on the basis of the scientific evidence available and generally recognised or on the basis of an opinion delivered by one of the competent bodies referred to in Article 4(3), are substantially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein.

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.

In the case of the foods or food ingredients referred to in Article 3(4), the applicant shall notify the Commission of the placing on the market when he does so. Such notification shall be accompanied by the relevant details provided for in Article 3(4). The Commission shall forward to Member States a copy of that notification within 60 days and, at the request of a Member State, a copy of the said relevant details. The Commission shall publish each year a summary of those notifications in the C series of the Official Journal of the European Communities.

With respect to labelling, the provisions of Article 8 shall apply.

Without prejudice to the other requirements of Community law concerning the labelling of foodstuffs, the following additional specific labelling requirements shall apply to foodstuffs in order to ensure that the final consumer is informed of:

(a) any characteristic or food property such as:

- 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;

(b) the presence in the novel food or food ingredient of material which is not present in an existing equivalent foodstuff and which may have implications for the health of certain sections of the population;

...

The Scientific Committee for Food shall be consulted on any matter falling within the scope of this regulation likely to have an effect on public health.

1. Where a Member State, as a result of new information or a reassessment of existing information, has detailed grounds for considering that the use of a food or a food ingredient complying with this regulation endangers human health or the environment, that Member State may either temporarily restrict or suspend the trade in and use of the food or food ingredient in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving the grounds for its decision.

2. The Commission shall examine the grounds referred to in paragraph 1 as soon as possible within the Standing Committee for Foodstuffs; it shall take the appropriate measures in accordance with the procedure laid down in Article 13. The Member State which took the decision referred to in paragraph 1 may maintain it until the measures have entered into force.

1. Where the procedure defined in this article is to be implemented, the Commission shall be assisted by the Standing Committee for Foodstuffs, hereinafter referred to as the Committee.

2. Matters shall be referred to the Committee by the Chairman either on his own initiative or at the request of the representative of a Member State.

3. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that article. The Chairman shall not vote.

4. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.

(b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

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

The concept of substantial equivalence has been introduced by WHO [the World Health Organisation] and OECD [the Organisation for Economic Cooperation and Development] with particular reference to foods produced by modern biotechnology. In the terminology of the OECD, the concept of substantial equivalence embodies the idea that existing organisms used as foods or as food sources can serve as a basis for comparison when assessing the safety of human consumption of a food or food component that has been modified or is new. If a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety, keeping in mind that establishment of substantial equivalence is not a safety or nutritional assessment in itself, but an approach to compare a potential new food with its conventional counterpart.

The application of the principle of substantial equivalence can be extended to the evaluation of foods from novel sources and processes. Substantially equivalent [novel foods and novel food ingredients] are thus comparable, in terms of safety, to their conventional counterpart. Substantial equivalence may be established either for the whole food or food component including the introduced new change, or it might be established for the food or food component except for the specific new change introduced. If a [novel food or novel food ingredient] has not been found to be substantially equivalent to an existing food or food component, this does not imply that it is unsafe. It just indicates that such a [novel food or novel food ingredient] should be evaluated on the basis of its unique composition and properties.

...

In principle, the toxicological requirements for [novel foods and novel food ingredients] need to be considered on a case-by-case basis. In establishing the need for the provision of toxicological data three scenarios may be considered:

(1) substantial equivalence can be established to an accepted traditional food or food ingredient, in which case no further testing is needed;

(2) substantial equivalence can be established except for a single or few specific traits of the [novel food or novel food ingredient], in which case any further assessment of safety should focus specifically on these traits;

...

The information gathered through this scheme focuses on the effects of the genetic modification on the properties of the GMO compared to the host organism. It differentiates between intended and unintended effects. In the latter case, special attention should be given to any nutritional, toxicological and microbiological impact on the foods.

GM plants

The principles for evaluating GM plants and their products are similar to those valid for non-GM plants and their products. The safety evaluation of a GM plant may be a simpler task than the evaluation of a novel non-GM plant, if the non-modified organism is a traditional food plant and the alteration has occurred by means of a precisely defined process of genetic modification. In this case, the safety assessment can focus on the results of the genetic modification.

Where the genetic modification results in a new phenotype, the compositional consequences of this modification should be defined and tested. If, for example, a genetically modified plant is so designed as to express a naturally occurring insecticide, encoded by a gene derived from another organism, and therefore become resistant to certain insect pests, then the toxicological profile of the introduced insecticidal component needs to be determined. The safety of this modification of the chemical composition can be evaluated by standard toxicological procedures; it should include an assessment of the potential allergenicity. In addition, secondary effects (positional effects) have to be taken into consideration. These effects of the insertional event, e.g. the insertional mutation itself or a genomic rearrangement, will influence the overall outcome of the genetic modification. A knowledge of the normal toxin production in the plant and the effect on it of various growth and culturing conditions to which the GM plant is subjected, as well as knowledge whether the new gene product appears in the final food, is essential. The same reasoning applies to nutritionally important components especially in food plants.

...

National legislation

1. Trade in and use of the transgenic maize products Bt-11, MON 810 and MON 809 ... shall be suspended in accordance with the preamble.

2. The present decree shall be published in the Gazzetta ufficiale della Repubblica italiana and shall immediately be notified to the European Commission and to the other Member States.

The main proceedings and the questions submitted for a preliminary ruling

... a number of Member States expressed concerns about the application of the simplified procedure to products derived from GMOs and insisted that this problem should be addressed before a decision on the Italian Decree [of 4 August 2000] could be taken. Clarification of the application of substantial equivalence to GM derived products such as GM maize products was needed, and this could be done, it was noted, under Article 3(4) of [Regulation No 238/97].

- the annulment of the Decree of 4 August 2000 in so far as it temporarily suspends the trade in and use of the novel foods within Italian territory, and of all preliminary, related or subordinate measures or courses of action expressly referred to in that decree, and

- full compensation for the damage which they have suffered, in the form of a grant of judicial authorisation to market those products.

(1) Is the first subparagraph of Article 3(4) of Regulation No 258/97 to be interpreted as meaning that foods and food ingredients covered by Article 1(2)(b) of the Regulation may be considered substantially equivalent to existing foods or food ingredients and may therefore be placed on the market by means of the simplified procedure, following notification, even if those foods and food ingredients contain residues of transgenic protein?

(2) If the answer to the first question is negative and use of the simplified procedure is therefore impermissible in the present case, what are the consequences, in particular for the power of the Member States to adopt measures such as the Decree of 4 August 2000 on the basis of the precautionary principle, which is given specific expression in Article 12 of Regulation No 258/97, and for the allocation of the burden of proof as regards risks to human health or the environment arising from the new product?

(3) Does it affect the answer to the second question if the simplified procedure is found to entail tacit consent by the Commission for the placing on the market of the products concerned in that the Member State concerned must first challenge the lawfulness of that tacit consent?

(4) If the answer to the first question is affirmative, is Article 5 of Regulation No 258/97 compatible with Articles 153 EC and 174 EC and with the precautionary principle and the principles of proportionality and reasonableness, in so far as:

- it does not provide for a full assessment of the safety of the foods and food ingredients with regard to the risks they pose to human health and the environment and does not ensure the informed participation of the Member States and of their scientific bodies, although such involvement is necessary in light of the requirement for protection of those values, as shown by the normal procedure provided for in Article 6 et seq. of the Regulation, and

- such a simplified procedure can be used, solely in order to speed up and simplify administrative action, for the placing on the market of foods and food ingredients in respect of which, since they contain transgenic protein, information is not available concerning all the implications of placing them on the market for the health of consumers, human consumption and the environment, as can be generally deduced from Recommendation 97/618?

The first question

Observations submitted to the Court

Findings of the Court

The second and third questions

Observations submitted to the Court

Findings of the Court

The fourth question

Observations submitted to the Court

- the general principle laid down in Article 3(1) of Regulation No 258/97 that novel foods must inter alia not present a danger for the consumer (see also the second recital in the preamble to the Regulation);

- the twofold condition to which the first subparagraph of Article 3(4) of the Regulation subjects the use of the simplified procedure, namely that those foods must come within certain categories not including foods containing GMOs and must be substantially equivalent to existing foods;

- the requirement that substantial equivalence must be based on prior scientific analysis carried out by a specialised body;

- the possibility for each Member State, in accordance with the second subparagraph of Article 3(4) of Regulation No 258/97, to request verification in accordance with the procedure laid down in Article 13 of the Regulation of the existence of substantial equivalence between novel and existing foods;

- the safeguard clause laid down in Article 12 of Regulation No 258/97 which is available to Member States in order to adopt measures contesting novel foods which have been authorised for placing on the market but which prove to present risks to public health.

Findings of the Court

Costs