1. By application lodged at the Court Registry on 24 July 2002, the Commission of the European Communities brought an action under Article 226 EC for a declaration that, by maintaining in force legislation which subjects the marketing of food products for sportsmen and women lawfully manufactured and marketed in other Member States to a requirement of applying for prior authorisation and of initiating a procedure for that purpose without having shown that it is necessary and proportionate, the Italian Republic has failed to fulfil its obligations under Articles 28 EC and 30 EC. Legal background Community law
2. Under Article 28 EC, quantitative restrictions on imports and all measures having equivalent effect are to be prohibited between Member States. However, according to Article 30 EC, restrictions on imports which are justified, in particular, on grounds of the protection of health and life of humans, animals or plants are authorised in so far as they do not constitute either a means of arbitrary discrimination or a disguised restriction on trade between Member States.
3. Although Article 4(1) of and Annex I to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (OJ 1989 L 186, p. 27), as amended by Directive 1999/41/EC of the European Parliament and of the Council of 7 June 1999 (OJ 1999 L 172, p. 38) provides that specific provisions applicable to groups of foods, including foods intended to meet the expenditure of intense muscular effort, especially for sportsmen and women, are to be laid down by means of specific directives, to date no such directive has yet been adopted for that kind of foodstuff. Italian law
4. In Italy, Article 8 of Legislative Decree No 111 of 27 January 1992 concerning the manufacture and importation for sale of certain products ( GURI No 39, of 17 February 1992, Ordinary Supplement, hereinafter " Legislative Decree No 111/92" ), including foods intended to meet the expenditure of intense muscular effort, aimed especially at sportsmen and women, provides that the manufacture and the importation, for sale, of products intended for particular nutritional uses, belonging to the groups referred to in Annex I to the abovementioned legislative decree, are subject to the authorisation of the Ministry of Health and to the payment of the costs entailed by the administrative handling of the application. The detailed rules for that procedure are laid down in a regulation adopted subsequently, Presidential Decree No 131 of 19 January 1998. Pre-litigation procedure
5. The Commission was alerted by a complaint lodged by a British manufacturer of foods for sportsmen and women, namely energy bars and rehydrating drinks, in response to alleged difficulties met by its Italian distributor when marketing those products in Italy. The products were subject to prior authorisation by the Italian ministry of health and to the payment of administrative costs entailed by the application for authorisation, pursuant to Article 8 of Legislative Decree No 111/92.
6. The abovementioned manufacturer also informed the Commission of the fact that the Italian authorities had indicated that, were the word " sport" to be deleted from the packaging, the mere submission of a model of the labelling would obviate the need to apply for authorisation.
7. On 11 June 1998, taking the view that the prior authorisation procedure constitutes a measure having an effect equivalent to a quantitative restriction on imports, which is contrary to Article 28 EC, that that procedure was not justified by any of the reasons set out in Article 30 EC and that it was neither necessary nor proportionate to the pursuit of a lawful objective, the Commission sent a letter of formal notice to the Italian Republic.
8. As it received no response from it, on 18 December 1998 the Commission sent a reasoned opinion to the Italian Republic, calling on it to take the necessary measures to comply with that opinion within two months of its notification.
9. The Italian Republic replied to the reasoned opinion, first, by letter of 4 February 1999, stating that the purpose of the legislation in issue was to protect the health of the consumer and that the guidelines relating to the issuing of an authorisation had been drawn up to that effect and, next, by letter of 26 April 1999, with which were enclosed copies of the abovementioned guidelines.
10. On 25 July 2001, the Commission not being satisfied with the reply which the Italian authorities sent to it on 4 February 1999 nor with the explanations provided by them during a " packaging" meeting of 2 July 1999, it issued an additional reasoned opinion.
11. In the absence of a reply within the prescribed period, the Commission therefore brought the present action. The action Arguments of the parties
12. Given the case-law of the Court in relation to Articles 28 EC and 30 EC, the Commission considers that the fact that there has been a failure to fulfil obligations appears to be beyond dispute.
13. First of all, legislation such as that in issue constitutes an obstacle to the free movement of the products in question. However, the Italian Republic has not shown that there is a risk to public health as well as a link between the objective of preventing such a risk and the legislation which was adopted nor that there is no other solution enabling that objective to be achieved by less restrictive means.
14. Next, the Commission submits that, as the guidelines on which the Italian Government relied during the pre-litigation procedure merely point out the nutritional and informative aspect of the product and do not make any mention of a health risk entailed by its use nor indicate the conditions for its use, it therefore does not understand the grounds of the protection of public health put forward by the Italian authorities to justify the prior authorisation procedure.
15. Finally, according to the Commission, assuming that the objective of the abovementioned procedure is to ensure that the consumer is accurately informed, it appears that such an objective could be attained just as effectively by notifying the competent authority of the product, together with transmission of a model of the labelling.
16. In its defence, the Italian Republic merely states that it is in the course of amending Article 8 of Legislative Decree No 111/92 to provide that the marketing of the foodstuffs in question will no longer be subject to a prior authorisation procedure but only to a notification procedure. Findings of the Court
17. The free movement of goods between Member States is a fundamental principle of the EC 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.
18. 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 178/84 Commission v Germany [1987) ECR 1227 ( " Beer purity law " ), paragraph 27; and Case C-12/00 Commission v Spain [2003] ECR I-459, paragraph 71).
19. So far as concerns the marketing in a Member State of goods lawfully manufactured and marketed in another Member State and, in the absence of any harmonisation at Community level, a requirement such as that imposed in this case by Article 8 of Legislative Decree No 111/92, which requires foods intended to meet the expenditure of intense muscular effort, aimed especially at sportsmen and women, to be subjected to a prior authorisation procedure and to payment of the relevant administrative costs, renders the marketing of such foods more difficult and expensive (see, to that effect, Case C-33/97 Colim [1999] ECR I-3175, paragraph 36, and Case C-217/99 Commission v Belgium [2000] ECR I-10251, paragraph 17). Consequently, it constitutes a barrier to intra-Community trade and constitutes a measure having an effect equivalent to a quantitative restriction on imports within the meaning of Article 28 EC.
20. It is true that, according to the case-law of the Court, national legislation making the use of a nutritional substance in a foodstuff lawfully manufactured and/or marketed in other Member States subject to prior authorisation is not, in principle, contrary to Community law if certain conditions are satisfied (see, to that effect Case C-344/90 Commission v France [1992] ECR I-4719, paragraph 8, and Case C-24/00 Commission v France [2004] ECR I-0000, paragraphs 25 to 27).
21. However, a requirement such as that in issue can only be justified on one of the public-interest grounds set out in Article 30 EC, such as the protection of health and life of humans, or by an imperative requirement relating, inter alia , to consumer protection (see, among others, Case 120/78 REWE-Zentral [1979] ECR 649 ( " Cassis de Dijon " ), paragraph 8, and Case C-420/01 Commission v Italy [2003] ECR I-6445, paragraph 29).
22. According to settled case-law, it is for the competent national authorities to show that their rules are necessary in order to attain one or more objectives mentioned in Article 30 EC or meet imperative requirements and, where appropriate, that the marketing of the products in question poses a serious risk to public health and that those rules are in conformity with the principle of proportionality (Case 227/82 Van Bennekom [1983] ECR 3883, paragraph 40; Case C-358/95 Morellato [1997] ECR I-1431, paragraph 14; Case C-14/02 ATRAL [2003] ECR I-4431, paragraph 67; and Commission v Italy , cited above, paragraph 30).
23. In the present case, the Italian Government has not shown that the prior authorisation procedure for the marketing of sports foods is justified by and proportionate to one of the public-interest grounds set out in Article 30 EC, namely protection of public health.
24. Despite the requests of the Commission, the Italian Government has not shown any alleged risk to public health which the products in question are likely to pose. It failed to explain on what scientific data or medical reports the guidelines which it enclosed were based and has not given general information on those alleged risks. Furthermore, it has not made clear the link between the procedure in question and the alleged risk to public health nor explained the reasons why such protection is more effective than other forms of control and thus proportionate to the objective pursued.
25. Moreover, as the Commission contends, if the procedure in question is, in fact, intended mostly to protect consumers, the Italian Government has also failed to show in what way that procedure is necessary and proportionate to that objective. Less restrictive measures exist for the prevention of such residual risks as misleading consumers, such as notification of the marketing of the product in question of the competent authority by the manufacturer or distributor of that product together with transmission of a model of the labelling and the obligation requiring the manufacturer or the distributor of that product to furnish, if necessary, evidence of the accuracy of the factual data appearing on the label (see, to that effect, Case C-77/97 Unilever [1999] ECR I-431, paragraph 35, and Case C-221/00 Commission v Austria [2003] ECR I-1007, paragraphs 49 and 52).
26. In view of all the foregoing, it must be held that, by maintaining in force legislation which subjects the marketing of food products for sportsmen and women lawfully manufactured and marketed in other Member States to a requirement of applying for prior authorisation and of initiating a procedure for that purpose without having shown that it is necessary and proportionate, the Italian Republic has failed to fulfil its obligations under Articles 28 EC and 30 EC.