1. By judgment of 19 February 2001, received at the Court on 27 February 2001, the Tribunal de grande instance de Paris (Regional Court, Paris) referred to the Court for a preliminary ruling under Article 234 EC a question on the interpretation of Articles 28 EC and 30 EC.
2. That question was raised in the course of criminal proceedings against Mr Greenham and Mr Abel, joint directors of NSA France SARL (hereinafter " NSA France" ), whose seat is in Paris (France), which distributes foodstuffs from NSA International, a company established in the United Kingdom. Legal background Community legislation
3. It is common ground that at the time of the facts which gave rise to the main proceedings there were no provisions of Community legislation laying down the conditions under which nutrients, such as vitamins and minerals, could be added to foodstuffs for daily consumption.
4. As regards foodstuffs intended for particular nutritional uses, some are now covered by directives adopted by the Commission under 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). National legislation
5. Article L. 213-1 of the French Code de la consommation (Consumer Code), in the version applicable to the main proceedings provides that: " Anyone, whether or not a party to the contract, who by any means or conduct whatsoever, even through a third party, deceives or attempts to deceive a contracting party: 1. as to the nature, type, origin, material qualities, composition or content in active principles of any goods, 2. as to the quantity of items delivered or as to their identity by delivering goods other than those specified as the subject-matter of the contract, or 3. as to fitness for use, the risks inherent in the product ' s use, the checks made, the methods of use or the precautions to be taken shall be liable to imprisonment for two years or to a fine of FRF 250 000 or to both. "
6. The French legislation applicable to the marketing of food supplements and foodstuffs for daily consumption fortified with vitamins, minerals and other nutrients such as amino-acids is the Decree of 15 April 1912 laying down administrative regulations for implementing the Law of 1 August 1905 to prevent deception in the sale of goods and adulteration of foodstuffs relating to victuals, and particularly meat, prepared meat products, fruit, vegetables, fish and preserved foods.
7. Article 1 of the Decree, as amended by Decree No 73-138 of 12 February 1973 (JORF of 15 February 1973, p. 1728), provides: " It shall be an offence to possess with a view to sale, to put on sale or to sell any goods or foodstuffs intended for human consumption to which chemical products have been added other than those whose use has been declared lawful by orders made jointly by the Minister for Agriculture and Rural Development, the Minister for the Economy and Finance, the Minister for Industrial and Scientific Development and the Minister for Public Health, on the advice of the Conseil supérieur d ' hygiène publique de France (French Public Health Authority, " the CSHPF" ) and the Académie nationale de médecine (National Academy of Medicine). "
8. Decree No 99-242 of 26 March 1999 (JORF of 28 March 1999, p. 4653) amended the Decree of 15 April 1912 by substituting the advice of the Agence française de sécurité sanitaire des aliments (French Food Safety Agency, " AFSSA" ) for that of the CSHPF and the Académie nationale de médecine.
9. Article 1 of Decree No 91-827 of 29 August 1991 on foodstuffs intended for particular nutritional uses (JORF of 31 August 1991, p. 11424) provides: " Foodstuffs are regarded as being intended for particular nutritional uses if, as a result of their particular composition or of a particular process in their manufacture, they are clearly different from foodstuffs for daily consumption, are suitable for the stated nutritional purpose and are marketed in such a way as to indicate that they fulfil that purpose."
10. Article 3 of the same decree reads as follows: " Joint orders made by the ministers responsible for consumer affairs, agriculture and health after obtaining the opinion of the [CSHPF], shall determine: (a) The list and conditions for use of substances with a nutritional purpose, such as vitamins, minerals, amino acids and other substances, which it is lawful to incorporate in foodstuffs intended for particular nutritional uses, as well as the standards of purity which are applicable to those substances; ... "
11. Decree No 97-964 of 14 October 1997 (JORF of 21 October 1997, p. 15266), which supplements the Decree of 15 April 1912, defines, for the first time, food supplements as " products intended to be ingested in addition to the daily diet, in order to compensate for an actual or presumed insufficiency of daily intake" . The main proceedings and the question referred for a preliminary ruling
12. Mr Greenham and Mr Abel were prosecuted for having committed, in the course of 1998, two offences relating to the sale of foodstuffs.
13. First, they were charged with having displayed and put on sale allegedly adulterated foodstuffs by marketing products (food supplements " Juice Plus + vegetable mixture" and " Juice Plus + fruit mixture" ) to which had been added the substance coenzyme Q10, a nutrient whose addition is not authorised in France for human consumption, and vitamins in quantities exceeding that of the recommended daily intake or exceeding the safety limits laid down by the CSHPF.
14. Secondly, they were prosecuted for having misled consumers, in particular as to the material quality of the products, by marketing meal substitutes " Juice Plus + Lite, chocolate and vanilla flavour" which do not comply with the regulatory requirements applicable with regard to Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction (OJ 1996 L 55, p. 22), particularly because of an energy rating lower than the threshold set by the regulations and a deficiency of certain minerals.
15. The charges were based on two samples taken on 23 March 1998 by the Directorate-General for Competition, Consumers and Prevention of fraud from foodstuffs marketed in France by NSA France.
16. Before the referring court, the defendants in the main proceedings argued, first, that the foodstuffs in question were already lawfully marketed in the other Member States of the European Union when they took up their posts, and, secondly, that coenzyme Q10 is permitted in, among others, Spain, Italy, Germany and the United Kingdom. Therefore, the French authorities could not prohibit the free movement and the marketing of those foodstuffs in France.
17. Since it considered that the outcome of the proceedings before it required an interpretation of Articles 28 EC and 30 EC, the Tribunal de grande instance de Paris decided to stay the proceedings and to refer the following question to the Court for a preliminary ruling: " Must Articles 28 and 30 of the Treaty be interpreted as prohibiting a Member State from preventing the free movement and marketing of a food supplement lawfully sold in another Member State?" The question referred Observations submitted to the Court
18. The defendants in the main proceedings maintain that national legislation such as that at issue in the main proceedings, which precludes the free marketing of food supplements lawfully marketed in another Member State although no serious health risk has been proved, constitutes a measure having equivalent effect to a quantitative restriction, contrary to Articles 28 EC and 30 EC.
19. They submit that the French authorities have been unable to prove that the national legislation is necessary in order to avoid a serious risk to public health and that it cannot be replaced by a measure which is less restrictive of intra-Community trade, such as labelling.
20. In addition, they argue that, contrary to the requirements of Community law, traders cannot obtain authorisation to market those food supplements by a readily accessible procedure which can be completed within a reasonable time.
21. The French Government submits that a system prohibiting marketing without authorisation is compatible with Community law if it meets certain requirements laid down thereby. The authorisation procedure must be readily accessible, capable of being completed within a reasonable time and permit refusals to be challenged before the courts.
22. It points out that in the main case no application for authorisation was submitted by NSA France, which, indeed, deliberately proceeded to market the products in question without having previously submitted an application which could have been examined by the French authorities.
23. The Greek Government submits that the mere fact that a particular food supplement is freely marketed in other Member States is not sufficient for its marketing to be permitted automatically in the Member State concerned without undergoing the authorisation procedure provided for for that purpose by the rules in force in that Member State. The relevant national provisions can and should lay down certain conditions for authorising the marketing of food supplements, whether they are produced in the Member State concerned or imported from another Member State. Such conditions can consist of a procedure for prior authorisation.
24. Whilst refraining from taking a position on the question referred, the Spanish Government observes that under its own food legislation none of the products which are the subject of the question referred is regarded as a foodstuff and that, therefore, they cannot be marketed freely on the Spanish foodstuffs market. Moreover, the addition of coenzyme Q10 is not provided for in that legislation.
25. The Commission submits that the addition to foodstuffs of a particular nutrient allowed in another Member State must be permitted in a product imported from that State provided that, taking account of the results of international scientific research and the nutritional habits in the Member State where it is imported, the nutrient does not pose a risk for public health.
26. According to the Commission, it is for the national court to decide whether the competent authorities of the Member State concerned have evaluated the risks relating to the nutrients in question, thus enabling them to decide whether the legislation relating to such nutrients is necessary for the effective protection of public health.
27. With regard to the main proceedings, it states that the referring judgment gives no indication as to either the safety limits fixed by the CSHPF for the consumption of vitamins or how those limits were established.
28. In relation to coenzyme Q10, the Commission submits that no information has been produced concerning the public health risks which the addition of that nutrient to a foodstuff could entail. Reply of the Court
29. By its question, the referring court is asking, in essence, whether Articles 28 EC and 30 EC must be interpreted as meaning that they preclude a Member State from prohibiting the marketing without prior authorisation of foodstuffs lawfully manufactured and marketed in another Member State, if nutrients such as vitamins or minerals have been added thereto other than those whose use has been declared lawful in the first Member State.
30. It must be observed at the outset that, while the main proceedings concern charges relating both to food supplements and to meal substitutes, the question referred covers only food supplements to which have been added coenzyme Q10, whose addition is not authorised in France, and vitamins in quantities exceeding the safety limits laid down by the CSHPF or exceeding the recommended daily intake.
31. 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.
32. The prohibition set out in Article 28 EC on measures having an effect equivalent to restrictions 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, and Case C-192/01 Commission v Denmark [2003] ECR I-0000, paragraph 39).
33. The file of the main proceedings seems to indicate that they concern foodstuffs imported from another Member State where they are lawfully manufactured and/or marketed. It is, however, for the national court, which alone has jurisdiction to determine and evaluate the facts in the proceedings before it, to check that such is the case and that the rules and principles flowing from the free movement of goods are indeed to be applied to those proceedings (see, to that effect, Case C-107/97 Rombi and Arkopharma [2000] ECR I-3367, paragraph 72).
34. National rules such as those at issue in the main proceedings, which prohibit the marketing of foodstuffs to which nutrients have been added, such foodstuffs being lawfully manufactured and/or marketed in the exporting Member State but prohibited in the importing Member State, or which require that such substances have been previously included on a national list provided for for that purpose in order that the marketing of the foodstuffs to which they have been added may be authorised, can be justified, as a measure having equivalent effect to a quantitative restriction within the meaning of Article 28 EC, in so far as they comply with the requirements of Article 30 EC, as interpreted by the Court.
35. First, such rules must make provision for a procedure enabling economic operators to have a nutrient included on the national list of authorised substances. The procedure must be one which is readily accessible and can be completed within a reasonable time, and, if it leads to a refusal, the decision of refusal must be open to challenge before the courts (see to that effect Case C-344/90 Commission v France [1992] ECR I-4719, paragraph 9, and today ' s judgment in Case C-24/00 Commission v France [2004] ECR I-0000, paragraph 26).
36. Secondly, an application to obtain the inclusion of a nutrient on the national list of authorised substances may be refused by the competent national authorities only if such substance poses a genuine risk to public health (see Commission v Denmark , cited above, paragraph 46).
37. It is of course for the Member States, in the absence of harmonisation and to the extent that there is still uncertainty in the current state of scientific research, to decide on the level of protection of human health and life they wish to ensure and whether to require prior authorisation for the marketing of foodstuffs, taking into account the requirements of the free movement of goods within the Community (see Commission v Denmark , cited above, paragraph 42).
38. That discretion relating to the protection of public health is particularly wide where it is shown that there is still uncertainty in the current state of scientific research as to certain nutrients, such as vitamins, which are not as a general rule harmful in themselves but may have special harmful effects solely if taken to excess as part of the general diet, the composition of which cannot be foreseen or monitored (see Case 174/82 Sandoz [1983] ECR 2445, paragraph 17, and Commission v Denmark , cited above, paragraph 43).
39. However, 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 proportionate to the objective thus pursued, which could not have been attained by measures less restrictive of intra-Community trade (see Sandoz , paragraph 18, and Commission v Denmark , paragraph 45).
40. Furthermore, since Article 30 EC provides for an exception, to be interpreted strictly, to the rule of free movement of goods within the Community, it is for the national authorities which invoke it to show in each case, in the light of national nutritional habits and in the light of the results of international scientific research, that their rules are necessary to give effective protection to the interests referred to in that provision and, in particular, that the marketing of the products in question poses a real risk to public health (see to that effect Sandoz , paragraph 22, Case 227/82 Van Bennekom [1983] ECR 3883, paragraph 40, and Commission v Denmark , paragraph 46).
41. A prohibition on the marketing of foodstuffs to which nutrients have been added must therefore be based on a detailed assessment of the risk alleged by the Member State invoking Article 30 EC (see Commission v Denmark , paragraph 47).
42. A decision to prohibit the marketing of a fortified foodstuff, which is in fact the most restrictive obstacle to trade in products lawfully manufactured and marketed in other Member States, can be adopted only if the alleged real risk for public health appears to be 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 (see Commission v Denmark , paragraph 48).
43. It is clear that such an assessment of the risk could reveal that scientific uncertainty persists as regards the existence or extent of real risks to human health. In such circumstances, it must be accepted that a Member State may, in accordance with the precautionary principle, take protective measures without having to wait until the existence and gravity of those risks are fully demonstrated (see to that effect Case C-157/96 National Farmers ' Union and Others [1998] ECR I-2211, paragraph 63). However, the risk assessment cannot be based on purely hypothetical considerations (see Case C-236/01 Monsanto Agricoltura Italia and Others [2003] I-0000, paragraph 106, and Commission v Denmark , paragraph 49).
44. At the hearing, the Frenc h Government stated that NSA France had been informed by letter of 21 October 1996 that the Opinion of the CSHPF had not been in favour of the addition of coenzyme Q10 to human food, following an application by another economic operator for authorisation to place on the market. According to that Government, the Opinion, dated 11 June 1996, is based on the absence of nutritional need as regards the addition of coenzyme Q10 and, above all, on the lack of toxicological data on the effects of that substance.
45. It also argued at the hearing that the French authorities ' reasoning with regard to applications for authorisation concerning the addition of nutrients to foodstuffs is based on the conclusion that there is no reason to authorise the marketing of a foodstuff to which have been added such substances, which, even if at present they pose no danger to public health, are none the less capable of giving rise to such a risk in future, especially as such substances bestow no nutritional benefit.
46. While it is true that the Court has observed that, in a context of scientific uncertainty, the criterion of the nutritional need of the population of a Member State can play a role in its detailed assessment of the risk which the addition of nutrients to foodstuffs may pose for public health, the absence of such a need cannot, by itself, justify a total prohibition, on the basis of Article 30 EC, on marketing foodstuffs lawfully manufactured and/or marketed in other Member States (see Commission v Denmark , paragraph 54).
47. Moreover, as noted in paragraphs 41 to 43 of this judgment, a prohibition on marketing foodstuffs to which nutrients have been added must be based on a detailed assessment of the real risk to public health alleged by the national authorities invoking Article 30 EC, established on the basis of the most reliable scientific data available and the most recent results of international research (see Commission v Denmark , paragraph 51).
48. 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 (see Commission v Denmark , paragraph 52).
49. It is for the referring court to determine whether, in the legal and factual circumstances obtaining in the Member State concerned, the prohibition on marketing the foodstuffs in question satisfies the requirements of Community law in order that the restriction on the free movement of goods may be justified.
50. Having regard to all those considerations, the reply to the question referred must be that Articles 28 EC and 30 EC must be interpreted as meaning that they do not preclude a Member State from prohibiting the marketing without prior authorisation of foodstuffs lawfully manufactured and marketed in another Member State, where nutrients such as vitamins or minerals have been added thereto other than those whose use has been declared lawful in the first Member State, provided that certain conditions are satisfied. First, the prior authorisation procedure must be readily accessible and capable of being completed within a reasonable time and, if it leads to a refusal, the decision of refusal must be open to challenge before the courts. Secondly, refusal to authorise marketing must be based on a detailed assessment of the risk to public health, based on the most reliable scientific data available and the most recent results of international research.