European Commission v French Republic.
Date: 2010-01-28
73. It should be recalled, as a preliminary observation, that the free movement of goods between Member States is a fundamental principle of the Treaty which finds its expression in the prohibition, set out in Article 28 EC, of quantitative restrictions on imports between Member States and all measures having equivalent effect.
74. The prohibition on measures having an effect equivalent to restrictions set out in Article 28 EC covers all commercial rules enacted by the Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade (see, in particular, Case 8/74 Dassonville  [1974] ECR 837, paragraph 5; Case C-192/01 Commission  v Denmark  [2003] ECR I-9693, paragraph 39; and Case C‑24/00 Commission  v France  [2004] ECR I-1277, paragraph 22).
80. According to consistent case-law, national legislation making the addition of a nutritive substance to a foodstuff lawfully manufactured and/or marketed in other Member States subject to prior authorisation is not in principle contrary to Community law provided certain conditions are fulfilled (see, to that effect, Case C-344/90 Commission  v France  [1992] ECR I-4719, paragraph 8, and Commission  v Denmark , paragraph 44).
81. First, such legislation must be accompanied by a procedure allowing economic operators to obtain the entry of that nutritive substance in the national list of authorised substances. That procedure must be easily accessible, must be capable of being concluded within a reasonable time, and, if it leads to a refusal, the refusal decision must be capable of review before the courts (see, to that effect, Case C‑344/90 Commission  v France , paragraph 9, and Case C‑24/00 Commission  v France , paragraph 26).
82. Second, an application for the entry of a nutritive substance on the national list of authorised substances may be rejected by the competent national authorities only if that substance poses a genuine threat to public health ( Commission v Denmark,  paragraph 46, and Case C‑24/00 Commission  v France , paragraph 27).
85. As regards the objective of protecting public health, it is for the Member States, in the absence of harmonisation and in so far as doubts subsist in the current state of scientific research, to decide at which level they intend to ensure the protection of the health and life of persons, and whether to require prior authorisation for the marketing of processing aids and foodstuffs in the preparation of which such aids have been used, whilst at the same time taking into account the requirements of the free movement of goods within the Community (see, to that effect, Case 174/82 Sandoz  [1983] ECR 2445, paragraph 16; Case C‑42/90 Bellon  [1990] ECR I-4863, paragraph 11; Commission  v Denmark , paragraph 42; and Case C‑24/00 Commission  v France , paragraph 49).
86. That discretion relating to the protection of public health is particularly wide where it is shown that uncertainties continue to exist in the current state of scientific research as to certain substances used in the preparation of foodstuffs ( Commission  v Denmark , paragraph 43, and Case C–24/00 Commission  v France , paragraph 50).
87. Since Article 30 EC contains an exception, which must be narrowly interpreted, to the rule of the free movement of goods within the Community, it is for the national authorities which invoke it to demonstrate in each case, taking account of the results of international scientific research, that their legislation is necessary in order effectively to protect the interests referred to in that provision, and, in particular, that the marketing of the products in question poses a genuine threat to public health (see, to that effect, Commission  v Denmark , paragraph 46, and Case C‑24/00 Commission  v France , paragraph 53 and case-law cited).
88. A prohibition on marketing processing aids or foodstuffs in which processing aids have been used which have been lawfully manufactured and/or marketed in other Member States must therefore be based on an in-depth assessment of the risk alleged by the Member State invoking Article 30 EC (see, to that effect, Commission  v Denmark , paragraph 47; Case C‑24/00 Commission  v France , paragraph 54; and Case C‑41/02 Commission  v Netherlands  [2004] ECR I-11375, paragraph 48).
89. A decision to prohibit marketing, which indeed constitutes the most restrictive obstacle to trade in products lawfully manufactured and marketed in other Member States, can be adopted only if the real risk alleged for public health appears sufficiently established on the basis of the latest scientific data available at the date of the adoption of such decision. In such a context, the object of the risk assessment to be carried out by the Member State is to appraise the degree of probability of harmful effects on human health from the addition of certain nutrients to foodstuffs and the seriousness of those potential effects ( Commission  v Denmark , paragraph 48; Case C‑24/00 Commission  v France , paragraph 55; and Commission  v Netherlands , paragraph 49).
90. In exercising their discretion relating to the protection of public health, the Member States must comply with the principle of proportionality. The means which they choose must therefore be confined to what is actually necessary to ensure the safeguarding of public health; they must be proportional to the objective thus pursued, which could not have been attained by measures which are less restrictive of intra-Community trade ( Commission  v Denmark , paragraph 45, and Case C‑24/00 Commission  v France , paragraph 52).
91. It is true that the assessment which a Member State is required to make may reveal a high degree of scientific and practical uncertainty in that regard. Such uncertainty, which is inseparable from the concept of precaution, influences the extent of the discretion of the Member State and thus has an impact on the means of applying the proportionality principle. In such circumstances, it must be acknowledged that a Member State may, under the precautionary principle, take protective measures without having to wait for the reality and the seriousness of those risks to be fully demonstrated (see, to that effect, Case C-157/96 National Farmers’ Union and Others  [1998] ECR I‑2211, paragraph 63, and Commission  v Netherlands , paragraphs 51 and 52). However, the assessment of the risk cannot be based on purely hypothetical considerations (see, to that effect, Case C‑236/01 Monsanto Agricoltura Italia and Others  [2003] ECR I‑8105, paragraph 106; Commission  v Denmark , paragraph 49; and Commission  v Netherlands , paragraph 52).
92. A correct application of the precautionary principle presupposes, first, identification of the potentially negative consequences for health of the proposed use of processing aids, and, secondly, a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research ( Monsanto Agricoltura Italia and Others , paragraph 113; Commission  v Denmark , paragraph 51; and Commission  v Netherlands , paragraph 53).
93. Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures, provided they are non-discriminatory and objective ( Commission  v Denmark , paragraph 52, and Commission  v Netherlands , paragraph 54).
103. A Member State cannot justify a systematic and untargeted prior authorisation scheme such as that laid down by the 1912 Decree by pleading the impossibility of carrying out more exhaustive prior examinations by reason of the considerable quantity of processing aids which may be used or by reason of the fact that manufacturing processes are constantly changing. As is apparent from Articles 6 and 7 of Regulation No 178/2002, concerning the analysis of risks and the application of the precautionary principle, such an approach does not correspond to the requirements laid down by the Community legislature as regards both Community and national food legislation and designed to achieve the general objective of a high level of health protection.
105. It should also be noted, as the French Republic has pointed out, that the mere fact that one Member State imposes less strict rules than those applicable in another Member State does not mean that the latter are incompatible with Articles 28 EC and 30 EC (see, to that effect, Case C‑514/03 Commission  v Spain  [2006] ECR I-963, paragraph 49). However, the absence of a prior authorisation scheme with regard to the use of processing aids in the preparation of foodstuffs in all or nearly all of the other Member States may be relevant when assessing the objective justification put forward in relation to the French legislation, and, particularly, with regard to the assessment of its proportionality.
117. In that respect, it should be noted that, as is apparent from paragraph 81 of this judgment, national legislation making the addition of a substance such as a processing aid to a foodstuff subject to prior authorisation must be accompanied by a procedure allowing economic operators to obtain the entry of that substance in the national list of authorised substances. That procedure must be easily accessible, must be capable of being concluded within a reasonable time, and, if it leads to a refusal, the refusal decision must be capable of review before the courts (see, to that effect, Case C-344/90 Commission  v France , paragraph 9, and Case C‑24/00 Commission  v France , paragraph 26).
118. In paragraph 40 of its judgment in Case C-24/00 Commission  v France , the Court held, having regard to the examples provided by the Commission concerning the registration procedure laid down by the 1912 Decree, that applications for authorisation submitted by economic operators were not dealt with either within a reasonable period or according to a procedure which was sufficiently transparent as regards the possibility of challenging refusal to authorise before the courts.