Monsanto Agricoltura Italia SpA and Others v Presidenza del Consiglio dei Ministri and Others.
Date: 2003-09-09
72. The need for the uniform application of Community law and the principle of equality require that the terms of a provision of Community law which, like Article 3(4) of Regulation No 258/97 and the concept of substantial equivalence set out therein, makes no express reference to the law of the Member States for the purpose of determining its meaning and scope must normally be given an autonomous and uniform interpretation throughout the Community, which must take into account the context of that provision and the purpose of the legislation in question (see, to that effect, in particular Case C-287/98  Linster  [2000] ECR I-6917, paragraph 43).
74. The twofold objective of Regulation No 258/97, which is to ensure the functioning of the internal market in new foodstuffs (the first recital in the preamble to the Regulation) and to protect public health against the risks to which they may give rise (the second recital in the preamble to the Regulation and the first indent in Article 3(1)), is an important factor supporting an interpretation according to which the concept of substantial equivalence does not preclude novel foods which display differences in composition that have no effect on public health from being considered substantially equivalent to existing foods.
106. If the twofold objective of Regulation No 258/97, namely ensuring the functioning of the internal market in novel foods and protecting public health against the risks to which those foods may give rise, is not to be adversely affected, protective measures adopted under the safeguard clause may not properly be based on a purely hypothetical approach to risk, founded on mere suppositions which are not yet scientifically verified (see to that effect, as regards a non-harmonised field, the judgment of the EFTA Court in Case E-3/00  EFTA Surveillance Authority  v  Norway , EFTA Court Reports 2000-2001, p. 73, paragraphs 36 to 38).
107. Such protective measures, notwithstanding their temporary character and even if they are preventive in nature, can be adopted only if they are based on a risk assessment which is as complete as possible in the particular circumstances of an individual case, which indicate that those measures are 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.
110. In addition, given that, as the national court has rightly observed, the safeguard clause must be understood as giving specific expression to the precautionary principle (see, by analogy with Article 11 of Directive 90/220,  Greenpeace France and Others , cited above, paragraph 44), the conditions for the application of that clause must be interpreted having due regard to this principle.
111. According to the case-law of the Court, it follows from the precautionary principle that where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent (see Case C-157/96  National Farmers ' Union and Others  [1998] ECR I-2211, paragraph 63, and Case C-180/96  United Kingdom  v  Commission  [1998] ECR I-2265, paragraph 99).
113. Such measures presuppose, in particular, that the risk assessment available to the national authorities provides specific evidence which, without precluding scientific uncertainty, makes it possible reasonably to conclude on the basis of the most reliable scientific evidence available and the most recent results of international research that the implementation of those measures is necessary in order to avoid novel foods which pose potential risks to human health being offered on the market.
128. In such a case, the question arises in particular whether the simplified procedure, which does not require a comprehensive risk assessment, is coupled with detailed rules sufficient to ensure a high level of protection of human health and the environment within the meaning of Articles 152(1) EC and 174(2) EC respectively and to guarantee compliance with the precautionary principle and the principle of proportionality.
133. As regards the precautionary principle, it is to be observed (see paragraph 110 of the present judgment) that the safeguard clause provided in Article 12 of Regulation No 258/97 gives specific expression to that principle and that the principle must therefore, where relevant, be an integral part of the decision-making process leading to the adoption of any measure for the protection of human health based on Articles 12 and 13 of that regulation. Moreover, that principle must also be taken into account where relevant under the normal procedure,  inter alia  for the purpose of deciding whether, in the light of the conclusions concerning the assessment of risk, placing on the market may be authorised without any danger for the consumer.
135. In a sphere in which the Community legislature is called on to undertake complex assessments, judicial review of the exercise of its powers must be limited to examining whether it is vitiated by a manifest error of assessment or a misuse of powers or whether the legislature has manifestly exceeded the limits of its discretion ( Generics (UK) and Others , paragraph 67).