Opinion of the Advocate-General
1. May a Member State prosecute, under its consumer protection legislation, a producer of foodstuffs on the grounds that these contain higher doses of a substance than is permitted in the national legislation on foodstuffs intended for particular nutritional uses, when the marketing of the same substance is authorised in other Member States?
I - Factual and legal background
2. L-Carnitine is a nutritional substance, derived from two amino acids, which occurs naturally both in the human body and in various foodstuffs. As L-Carnitine serves to transform fat into energy, the consumption of supplementary doses has been promoted, inter alia, as a slimming aid and as an energy-producing aid to those engaged in intense physical activity, such as sports.
3. Under the relevant French legislation, in particular the Decree of 15 April 1912, foodstuffs may only contain substances whose addition has been authorised by interministerial order adopted after a favourable opinion of the Conseil Supérieur d'Hygiène Publique de France (hereinafter the CSHPF), on the basis of information submitted by the applicant seeking to show that the substance is harmless at the recommended levels of use.
4. The defendant in the national proceedings (hereinafter the defendant) is the managing director of Arkopharma SA, a company which produces and distributes a variety of products including Arkotonic, Arkotonic capsules, Turbodiet 300, Turbodiet Fort, Elle Carnitine capsules and Elle Carnitine Forte (hereinafter the contested products), each of which contains L-Carnitine as a significant ingredient. It appears from the case-file that, in September 1994, the defendant was informed that the CSHPF had given an unfavourable opinion on his request for authorisation to use L-Carnitine in food supplements and L-tartrate of L-Carnitine in foodstuffs intended for particular nutritional uses.
5. In two sets of proceedings, one commenced before, and one after, the unfavourable opinion of the CSHPF, the defendant was prosecuted for having manufactured, and knowingly sold, adulterated foodstuffs for human consumption, in breach of Articles L 213-1 and L 213-3 of the Code de la Consommation (Consumer Protection Code). Foodstuffs which do not comply with the rules in force are considered to be adulterated (falsifiées) under French law.
6. The first legislative measure at the Community level adopted in this area was Council Directive 77/94/EEC of 21 December 1976 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses (hereinafter the 1977 Directive). This was transposed into French law by Decree No 81-574 of 17 May 1981 and by the Order of 4 August 1986 concerning the use of additives in the manufacture of foodstuffs intended for particular nutritional uses. In accordance with this Order, L-Carnitine is permitted as an additive in baby foods (maximum dose: 15.4 mg/litre) and in other foodstuffs for particular nutritional uses (maximum dose: 100 mg/1 000 KCal).
7. The 1977 Directive was replaced by 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. This was transposed into French law by Decree No 91-817 of 29 August 1991, which repealed Decree No 81-574; Article 9 of the 1991 Decree, however, provides that existing Orders concerning products intended for particular nutritional uses, including the Order of 4 August 1986, remain in force to the extent that they do not conflict with the present Decree.
8. Article 1(2)(a) of Directive 89/398/EEC lays down three criteria for foodstuffs to qualify as being for particular nutritional uses: they must, owing to their special composition or manufacturing process [be] clearly distinguishable from foodstuffs for normal consumption, they must be suitable for their claimed nutritional purpose and, finally, they must be marketed in such a way as to indicate such suitability. Article 1(2)(b) provides that:
[a] particular nutritional use must fulfil the particular nutritional requirements:
(i) of certain categories of persons whose digestive processes or metabolism are disturbed; or
(ii) of certain categories of persons who are in a special physiological condition and who are therefore able to obtain special benefit from controlled consumption of certain substances in foodstuffs; or
(iii) of infants or young children in good health.
9. Article 4 of Directive 89/398/EEC provides for the adoption of specific directives for certain groups of foods for particular nutritional uses listed in Annex I thereto. The list includes Low-energy and energy-reduced foods intended for weight control (group 4), Dietary foods for special medical purposes (group 5), and Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen (group 8). To date, three such specific directives have been adopted by the Commission: Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae, Directive 96/5/EC of 16 February 1996 on processed cereal-based foods and baby food for infants and young children, and Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction. L-Carnitine is amongst the nutritional substances permitted both in infant formulae and follow-on formulae, and in processed cereal-based foods and baby foods, by Annex III and Annex IV to Directives 91/321/EEC and 96/5/EC, respectively.
10. For foodstuffs intended for a particular nutritional use other than those listed in Annex I to Directive 89/398/EEC, Article 9 lays down monitoring provisions, and in particular the requirement that the manufacturer or importer, as the case may be, notify the competent national authority whenever such a product is first placed on the market or imported. Article 11 permits Member States temporarily to suspend or to restrict trade in such products, where it has detailed grounds for establishing that [a foodstuff] does not comply with Article 1(2) or endangers human health; the Commission and the other Member States are to be informed immediately, and the Commission may initiate a procedure with a view to the adoption of appropriate Community measures.
11. The key provisions of Directive 89/398/EEC for the present purposes are, however, Articles 10 and 15. These provide as follows:
Article 10
[1] Member States shall not, for reasons related to their composition, manufacturing specifications, presentation or labelling, prohibit or restrict trade in products referred to in Article 1 which comply with this Directive and[,] where appropriate, with Directives adopted in implementation of this Directive.
[2] Paragraph 1 shall not affect national provisions which are applicable in the absence of Directives adopted in implementation of this Directive.
Article 15
[1] Member States shall amend their laws, regulations and administrative provisions in such a way as:
- to permit trade in products complying with this Directive not later than 16 May 1990,
- to prohibit trade in products not complying with this Directive with effect from 16 May 1991.
They shall inform the Commission thereof.
[2] Paragraph 1 shall not affect those national provisions which in the absence of Directives referred to in Article 4 apply to certain groups of foodstuffs intended for particular nutritional uses.
12. Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products has also been referred to in the present proceedings. In the version as amended, in particular, by Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, the relevant provisions of Directive 65/65/EEC are as follows:
Preamble, first and second recitals
Whereas the primary purpose of any rules concerning the production and distribution of medicinal products must be to safeguard public health;
Whereas, however, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.
Article 1, 2nd definition
Medicinal product:
Any substance or combination of substances presented for treating or preventing disease in human beings or animals.
Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.
Article 3
No medicinal product may be placed on the market in a Member State unless an authorisation has been issued by the competent authority of that Member State.
13. In his defence before the Tribunal de Grande Instance (Regional Court), Grasse (hereinafter the national court), the defendant relied on the allegedly incomplete transposition into French law of Directive 89/398/EEC. By order of 16 June 1997, registered at the Court on 19 June 1997, the national court referred the following questions under Article 177 of the Treaty establishing the European Community:
1. Can a Member State correctly transpose a Community directive where in the national transposing measure it maintains in force previous provisions adopted on the basis of repealed national legislation transposing a previous, repealed directive, indicating in the new transposing measure merely that those provisions remain in force to the extent that they do not conflict with the new national legislation?
2. Do Articles 10(2) and 15(2) of 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) authorise a State to continue to apply rules which predate the directive and the measure transposing it?
3. Does the classification, by Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the [Member] States [relating to foodstuffs for particular nutritional uses], of foodstuffs intended for particular nutritional uses into nine groups (referred to in Annex I thereto), which are to be the subject of specific directives, and into foodstuffs not falling within those groups, for which there is no provision for such directives, allow a Member State to apply rules founded on a classification based on a distinction between dietary products and dietetic products or on a distinction between foodstuffs for infants and young children and foodstuffs other than those intended for infants and young children?
4. Do Articles 10(2) and 15(2) of 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, which do not affect the application of national measures in the event that specific directives as provided for in Article 4 of the directive are not adopted, preclude individuals from relying on the provisions of the directive in order to challenge the detailed measures of transposition adopted by the Member States and to have them declared inapplicable by the national courts to the extent that they conflict with the provisions of the directive?
5. Does not the fact that foodstuffs are controlled within the framework of Community directives imply that [Member] States must, when carrying out such control, observe the general Community principles, in particular the protection of legitimate expectations?
14. Written and oral observations have been submitted by the defendant, the French Republic and the Commission.
II - Analysis
(a) Admissibility
15. France has contested the admissibility of the questions referred on the grounds that L-Carnitine is a dietary supplement, that dietary supplements do not address a specific nutritional use within the meaning of Directive 89/398/EEC, that this Directive does not apply to such products, and hence that no answer the Court could provide to the questions would be necessary for the resolution of the main proceedings.
16. The Court has consistently held that it is solely for the national court before which the dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine in the light of the particular circumstances of the case both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court ... . Consequently, where the questions submitted by the national court concern the interpretation of Community law, the Court of Justice is, in principle, bound to give a ruling. In the present case, the national court has referred a number of questions concerning the interpretation of Community legislative provisions and of general principles of Community law.
17. As noted above, the order of 4 August 1986 was adopted on the basis of Decree No 81-574, which sought to transpose the 1977 Directive into French law, and was maintained in force by Decree No 91-817, which sought to transpose Directive 89/398/EEC. It follows from the consistent case-law of the Court that, when applying domestic law, whether adopted before or after the directive, the national court that has to interpret that law must do so, as far as possible, in the light of the wording and purpose of the directive so as to achieve the result it has in view and thereby comply with the third paragraph of Article 189 of the Treaty. Contrary to the view put by France, the answers to the questions referred would, in principle, assist the national court in interpreting the national provisions in accordance with Directive 89/398/EEC.
18. Even if France were correct in its submission that the contested products fall outside the scope of Directive 89/398/EEC, such a conclusion could only be reached by interpreting the Directive and identifying the obligations which Community law imposes on the Member States in this regard, which is the object of the first four questions referred. Moreover, France's argument on admissibility, even if it were well founded, quod non, would not affect the fifth question, which seeks guidance on the application of the general principles of Community law in circumstances such as those in the main proceedings.
19. In the light of the foregoing, I am of the opinion that the questions referred are admissible.
(b) The interpretation of Directive 89/398/EEC
20. The first question concerns the duties of transposition which arise for the Member States as a result of Directive 89/398/EEC. However, rather than seeking to provide a ruling in abstracto on the Member States' duties in this regard, it appears more appropriate to identify their substantive obligations in relation to the regulation of the contested products. Logically, where the correct transposition of the provisions of a directive would not affect the legal situation of an individual, he would not in principle be affected by its incorrect transposition. Thus, in concrete terms, if Articles 10 and 15 of Directive 89/398/EEC were found to leave the Member States free to apply their national provisions to products such as the contested products, the incorrect transposition of other provisions of Directive 89/398/EEC would not avail the defendant.
21. Though they raise a number of distinct issues, the second, third and fourth questions essentially seek a ruling on whether, in circumstances such as those of the main proceedings, Directive 89/398/EEC prevents a Member State from prosecuting an individual for manufacturing and distributing products such as the contested products. I propose therefore to deal with this matter first.
22. As noted above, France doubts that Directive 89/398/EEC can have any application to what it describes as dietary supplements. In the order for reference, the national court expressly described Arkotonic as a dietary supplement, though it made no such finding in relation to the other products in question. The Commission proceeded in its written submissions on the assumption that all the contested products are dietary supplements, while the defendant denied at the oral hearing that L-Carnitine is such a product.
23. Clearly it makes no sense to speak of L-Carnitine as being, or not being, a dietary supplement, any more than it does to affirm or deny that it is an additive. Most edible and potable substances known to man can be harmful if taken in the wrong dose or under the wrong conditions; the observation of the sixteenth-century physician Paracelsus that solo dosis fecit venenum (only the dose makes the poison) is now widely accepted. L-Carnitine is merely a nutritional substance which, in certain doses, and, possibly, combined with other substances, may be presented as a dietary supplement, while in other doses and in other contexts, it may be used as an additive, or even as a medicinal product. I might add that the Court has not been informed of the exact composition or presentation of any of the contested products; for the purposes of the present proceedings, the products have been treated by all parties as being essentially similar, and as having L-Carnitine as their principal, or principal active, ingredient. In the absence of more detailed information, I am obliged to base the present Opinion on those assumptions.
24. It may be true that the contested products, or some of them, are marketed as food supplements, and it is certainly true that there is at present no Community legislation specifically regulating the composition or marketing of such products; that does not suffice, in my view, to conclude that they are thereby outside the scope of Directive 89/398/EEC. Article 1 of the Directive distinguishes between normal foodstuffs and those for particular nutritional uses, which latter concept it defines more closely in paragraph 2. While the order for reference does not specify exactly for which nutritional uses the contested products were intended, the defendant has argued that his products should be considered as belonging either to group 8 of the list in Annex I to the Directive (products for sporting activities) or group 4 (weight reduction products). The French authorities, in particular the Commission Interministérielle d'Étude des Produits destinés à une Alimentation Particulière in 1993 and the CSHPF in 1994, appear to have examined the consumption of L-Carnitine from both of these perspectives.
25. In my opinion, whether the contested products are intended for sportsmen or weight-watchers, they may be considered as being, in principle, intended for a particular nutritional use within the meaning of Article 1(2) of Directive 89/398/EEC. Groups 4 and 8 of Annex I to the Directive expressly recognise, respectively, that weight control and the expenditure of intense muscular effort are such uses. The Commission's description at the hearing of the contested products as being very low-energy foods seems to me to be consistent with the properties generally claimed for L-Carnitine in transforming existing fat into energy. I have, therefore, little doubt that those of the contested products presented for use as slimming aids could in principle be classified within group 4 of Annex I to the Directive. This interpretation of the relevant wording of Annex I is also consistent with that adopted by the Commission in Directive 96/8/EC, which applies to certain categories of foods intended for use in energy-restricted diets for weight reduction. The situation is even clearer as regards those of the contested products presented as energy-providing products for sportsmen which in principle fall within group 8. In line with the distribution of competences operated by Article 177 of the Treaty, it falls to the national court, in the light of the composition and other properties of the contested products, to decide whether they fall within the scope of Directive 89/398/EEC thus interpreted.
26. Even if the contested products are considered as falling within Directive 89/398/EEC, none of the specific directives within the meaning of Article 4 adopted to date governs the conditions under which these products may be produced and distributed. In such circumstances, the answer to the second, third and fourth questions is that, in the present state of Community law, the Member States enjoy the power to enforce national provisions which are applicable in the absence of such directives, in accordance with Articles 10(2) and 15(2); the application of such national provisions is none the less subject to the obligations which arise for the Member States under the Treaty rules on the free movement of goods. I might add that this is the same situation as would obtain if the Court were not to follow my recommendation to consider the contested products as being within Directive 89/398/EEC. Before examining the application of the Treaty rules on the free movement of goods, however, it is necessary to consider the possible relevance for the present case of Directive 65/65/EEC.
(c) The possible relevance of Directive 65/65/EEC
27. The national court has noted that marketing authorisations for two products containing L-Carnitine were granted, presumably in France and in accordance with Directive 65/65/EEC, in 1975 and 1985. In his written observations, the defendant relied upon this fact to argue that there was therefore no obstacle to the marketing of L-Carnitine products relating to their composition, while, at the hearing, he informed the Court that Arkopharma itself had received a marketing authorisation for Elle-Carnitine, which, he declared, is neither more nor less than the presentation as a medicinal product of the dietary products Carnivit and Turbodiet which were amongst those which had given rise to the proceedings. France, on the other hand, informed the Court at the hearing that marketing authorisations had been granted for Carnitine Arkopharma 300mg, in boxes of 12 and 24 tablets, for treating momentary bouts of fatigue.
28. While the national court has not submitted any specific question to the Court concerning the possible relevance of Directive 65/65/EEC in the present proceedings, it has relied on the marketing authorisations as part of the factual background. Furthermore, the fifth question refers to foodstuffs ... controlled within the framework of Community directives, without specifying which measures are intended, which, in line with the Court's case-law, examined below, could include Directive 65/65/EEC. More importantly, for the Court to ignore Directive 65/65/EEC in responding to the national court would, in my view, undermine the utility of the answers it is to provide, and may even lead to an erroneous understanding of the applicable provisions of Community law. Furthermore, the Court has long recognised that it may take into consideration provisions of Community law other than those mentioned in the questions referred. In any case, as will appear later, the classification of the products in the light of Directive 65/65/EEC is, in my view, relevant to the issue of the application of Article 36 of the Treaty.
29. The fact that product A, which is identical to product B, has received a marketing authorisation as a medicinal product, seems to me to be relevant to the classification under Community law of product B, though perhaps not in the way that the defendant intended. In the first place, it is to my mind difficult to escape the conclusion that, if Elle-Carnitine is treated as a medicinal product in France, then other products which are identical, or materially similar, as regards their composition or pharmacological effects should equally be treated as medicinal products. Furthermore, given the physiological function of L-Carnitine of transforming bodily fat into energy, which is not in dispute between the parties to the present proceedings, I do not see how products containing L-Carnitine as the principal active ingredient, or one of the principal such ingredients, could escape the definition of medicinal product set out in Article 1(2) of Directive 65/65/EEC, as a substance ... which may be administered to human beings ... with a view to ... modifying physiological functions. In these circumstances, the Member State concerned would be obliged by Article 3 of Directive 65/65/EEC to prohibit the placing of such products on the market in their territory unless an authorisation in accordance with Chapter II of this Directive has been granted.
30. A number of consequences would flow from the classification of the contested products, or some of them, as medicinal products. In the first place, the fact that they might be considered as foodstuffs in other Member States would not prevent the French authorities from treating them as medicinal products, so long as they display the characteristics of medicinal products. Similarly, the fact that they might otherwise be considered as falling in principle within the scope of Directive 89/398/EEC does not mean that they can escape the authorisation requirements of Directive 65/65/EEC, if they fall within the scope of application of the latter. Thus in Upjohn, exactly the same product, a treatment for natural baldness, was marketed in the same Member State both as a medicinal product and as a cosmetic product. On a reference in unfair competition proceedings between the companies marketing the respective products, the Court held that, even though the product might fall under the definition of a cosmetic product, it was nevertheless to be treated as a medicinal product if it came within Article 1(2) of Directive 65/65/EEC:
[t]hat is ... the only conclusion consistent with the aim, pursued by the directives, of protecting public health, since the legal rules governing proprietary medicinal products are stricter than those governing cosmetic products, in view of the particular risks to public health which the former may represent and which are generally not displayed by cosmetic products.
31. In the same judgment, the Court provided a number of indications on the interpretation of the notion medicinal product in Article 1(2) of Directive 65/65/EEC and on the identification of such products:
- products which alter physiological functions in the absence of disease ... fall within the scope of that definition;
- the fact that the provision uses the expression "with a view to" means that the definition of a medicinal product may include not only products which have a real effect on physiological functions but also those which do not have the advertised effect, thereby enabling public authorities to prevent the marketing of such products in order to protect consumers;
- [the phrase] "restoring, correcting or modifying physiological functions" ... must be given a sufficiently broad interpretation to cover all substances capable of having an effect on the actual functioning of the body, though excluding substances such as cosmetics which, while having an effect on the human body, do not significantly affect the metabolism and thus do not strictly [speaking] modify the way in which it functions;
- [i]t is for the national courts to determine on a case-by-case basis the classification of each product having regard to its pharmacological properties as they may be ascertained in the current state of scientific knowledge, to the way in which it is used, to the extent to which it is sold and to consumers' familiarity with it.
32. It therefore follows that, should the national court find that the contested products, or some of them, fall within the definition of medicinal products, then the French authorities would not only be empowered, but would, in principle, be obliged, under Directive 65/65/EEC, to prohibit their marketing in the absence of the necessary authorisation. On this point, the inconsistency of the French authorities would therefore stem, not from prohibiting the marketing of the contested products while authorising them or identical products as medicinal products, as the defendant has suggested, but from their failure to treat as medicinal products those of the contested products which are identical to the products authorised under Directive 65/65/EEC.
33. The French authorities have not invoked Directive 65/65/EEC in the main proceedings, though the effect of the Decree of 15 April 1912 is to prevent the marketing without authorisation of any foodstuffs, including those which might be classified as medicinal products. Be that as it may, it is settled case-law that a directive cannot, of itself and independently of a national law adopted by a Member State for its implementation, have the effect of determining or aggravating the liability in criminal law of persons who act in contravention of the provisions of that directive. Equally, in the present case, Directive 65/65/EEC cannot, in my view, be taken as determining or aggravating the defendant's criminal liability under national provisions which, like those at issue in the present case, were not adopted to implement it. The fact that the French authorities might, subject to the determination of the national court on this point, have been able to rely upon the national provisions implementing Directive 65/65/EEC is none the less relevant, in deciding on the application of the Treaty rules on the free movement of goods.
(d) The application of the Treaty rules on the free movement of goods
34. Article 30 of the Treaty prohibits measures having equivalent effect to quantitative restrictions on trade between Member States. The scope of this provision has been interpreted in the Court's established case-law to include all commercial rules of the Member States likely to impede directly or indirectly, actually or potentially, intra-Community trade. More specifically, in Keck and Mithouard, the Court held to constitute such measures the application to goods coming from other Member States where they are lawfully manufactured and marketed, of rules that lay down requirements to be met by such goods (such as those relating to designation, form, size, weight, composition, presentation, labelling, packaging) [and that this] is so even if those rules apply without distinction to all products unless their application can be justified by a public-interest objective taking precedence over the free movement of goods.
35. In the present case, France has not disputed that products containing L-Carnitine are manufactured and are available in other Member States, as it euphemistically notes, under conditions which are not the same as those applicable in France, and that Article 30 of the Treaty is therefore potentially relevant. In the main proceedings, the French authorities appear to be applying to the contested products national rules concerning the composition of foodstuffs intended for a particular nutritional use, which come within the scope of Article 30 as identified in Keck and Mithouard; it was not suggested at any point that such rules should be considered selling arrangements which fall outside the scope of that provision. Moreover, the Court has already found in a number of cases that the authorisation system established by the Decree of 15 April 1912, which is at the origin of the main proceedings, constitutes an obstacle to the free movement of foodstuffs.
36. At the hearing, France was at pains to argue that the contested products were not prohibited, but had instead given rise to a procedure. That argument is devoid of merit; the fact that the distribution of such products leaves the distributor open to criminal sanctions under consumer protection legislation must be considered, from the perspective of Article 30, as having an effect equivalent in all material respects to an express prohibition on distribution. Furthermore, it is clear that the relevant French provisions do not authorise the use of L-Carnitine in doses greater than 100 mg/1000 Kcal in foodstuffs intended for particular nutritional uses. It follows, in my view, that the application, in circumstances such as those which gave rise to the main proceedings, of the national provisions upon which the prosecuting authority relies constitutes a measure having an equivalent effect to a quantitative restriction on trade in the contested products within the meaning of Article 30 of the Treaty.
37. There remains the question of the existence of a public-interest objective which might justify the effective prohibition on the distribution of the contested products. Article 36 of the Treaty expressly allows restrictions on trade between Member States justified on grounds of public health, while the Court's case-law has recognised that in the absence of common rules relating to the marketing of the products concerned, obstacles to free movement within the Community resulting from disparities between the national laws must be accepted in so far as such [national] rules, applicable to domestic and to imported products without distinction, may be recognised as being necessary in order to satisfy mandatory requirements relating inter alia to consumer protection. In its observations in the present proceedings, France appears to be relying primarily on considerations of public health, though it has also mentioned consumer protection.
38. On a number of occasions, the Court has analysed the compatibility with Article 36 of national restrictions on the importation of foodstuffs containing additives the use of which was prohibited under national legislative provisions. Thus, in Sandoz, the defendant had been prosecuted for importing vitamin-enriched food and drinks intended for sportsmen without the authorisation required under Netherlands law for adding vitamins to foodstuffs. The Court first noted that vitamins are not in themselves harmful substances but on the contrary are recognised by modern science as necessary for the human organism ... [but recognised that] excessive consumption of them over a prolonged period may have harmful effects. The relevant legislative provisions, including the 1977 Directive, showed that the Community legislature accept[ed] the principle that it is necessary to restrict the use of food additives to the substances specified, whilst leaving the Member States a certain discretion to adopt stricter rules; the Court added that [t]he [Community] measures thus testify to a great prudence regarding the potential harmfulness of additives, the extent of which is still uncertain in respect of each of the various substances, and leave a wide discretion to the Member States in relation to such additives, including the possibility of requiring an administrative authorisation prior to marketing the foodstuffs in question. In the absence of Community harmonisation, the Member States are thus free to decide on the degree of health protection which they intended to assure.
39. The exercise of the discretion of the Member States in this regard is subject to the principle of proportionality underlying the second sentence of Article 36. This requires that national measures be restricted to what is necessary to attain the legitimate aim of protecting health, and that marketing must be authorised when the addition of the vitamins to foodstuffs meets a real need, especially a technical or nutritional one. Furthermore, in any marketing authorisation procedure, the national authority bears the onus of proving that the product is harmful to health, though it may of course request the importer to supply it with all the necessary information at his disposal.
40. Later cases show that, in exercising their discretion in relation to public health protection, the Member States must take into account the results of international scientific research and, in particular, the work of the Community's Scientific Committee for Food, though the opinions of this committee cannot abrogate the responsibilities of national authorities for the protection of health in the absence of binding rules and effective supervisory measures at the Community level. As regards additives in particular, the Court accepted the view of the SCF that substances should only be authorised as additives to fulfil a need, which may be technological or economic or again, as far as flavouring and colouring matters are concerned, organoleptic or psychological, the existence of such a need to be assessed in the light of the eating habits of that State. This approach was confirmed in Muller, where the Court also laid down the requirement that the Member States make available to traders an easily accessible authorisation procedure, operating within a reasonable time, and in the German beer case and Bellon; in the latter judgment, the Court added that a failure to grant authorisation must be amenable to judicial review.
41. As regards the protection of public health, the contested products in the present case differ in a number of respects from those considered by the Court in the cases mentioned above, which prevent this case-law from being applied to the present case without more. In particular, as the Commission pointed out at the hearing, it is not particularly appropriate to treat the L-Carnitine present in the contested products as an additive, when the L-Carnitine appears to be the, or a, main ingredient of the products in question. This view is confirmed by Article 1(2) of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption. This defines the term food additive as follows:
any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food whether or not it has a nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may reasonably be expected to result, in it or its by-products becoming directly or indirectly a component of such foods.
It appears, in my view, from the facts as stated in the order for reference and in the observations of the parties that the contested products contain L-Carnitine as a characteristic ingredient, rather than its being added to these products for a technological purpose.
42. The second material difference is that the additives in question in the case-law outlined above were already all subject to some form of Community regulation, prior to the facts giving rise to the dispute; as a result (or perhaps, as a necessary precondition), there existed some degree of scientific consensus concerning the effects of adding the particular substances to foodstuffs. This enabled the Court to conclude, for example in Sandoz, that the concentration of the vitamins in the products in question in that case was far from attaining the critical threshold of harmfulness so that excessive consumption thereof cannot in itself constitute a risk to public health but that such a risk cannot be excluded in so far as the consumer absorbs with other foods further quantities of vitamins which it is impossible to monitor or foresee.
43. The state of scientific knowledge concerning possible negative effects on human health of the ingestion of supplementary doses of L-Carnitine does not appear to be very advanced. France relied upon the opinions of two national authorities to argue that the ingestion of the contested products could cause digestive problems for a significant percentage of the population. However, it was unable to corroborate this with international scientific research, or to explain how similar products in similar or identical doses could have received a marketing authorisation, notwithstanding the findings of the CSHPF, which, according to France's own submissions, had based its negative opinion on tests involving the daily ingestion of doses of 900 mg or less. At the hearing, the Commission informed the Court that it was unaware of any evidence that the use of L-Carnitine constituted a particular danger for public health, while it is common ground that products containing or mainly comprising this substance are freely available in other Member States.
44. I am none the less satisfied that the French authorities are entitled to rely on the derogation allowed by Article 36 of the Treaty, even where they have treated the contested products as foodstuffs for a particular nutritional use. Firstly, if they have the properties ascribed to them, products containing L-Carnitine as a main active ingredient should, in principle (though not in fact in the present case), be considered as medicinal products for the purposes of Directive 65/65/EEC; the Court has consistently held that the health and the life of humans rank foremost among the property or interests protected by Article 36 and it is for the Member States ... to decide what degree of protection they intend to assure. In this regard, the fact that a product containing a particular active substance has been authorised as a medicinal product, whose consumption is proven to have a certain therapeutic effect if taken under certain conditions, does not, in my view, mean that its manufacture or distribution must necessarily be authorised either for different purposes and under different conditions, or without any such restrictions. Secondly, just as with additives, the protection of public health may justify national measures seeking to avoid any harmful effects of an excessive consumption of a substance which, as has been noted, already occurs in various foodstuffs, whether or not the substance taken on its own is harmful or not; such caution seems to me to be particularly justified in the present state of scientific uncertainty regarding the public health implications of the consumption of L-Carnitine. Furthermore, in providing for the adoption of specific directives governing the composition of products such as those at issue, Article 4(1)(a) of Directive 89/398/EEC recognises that Member States may lay down national provisions regulating this matter, which the directives would harmonise in the interests of facilitating the free movement of such goods.
45. While recourse to Article 36 of the Treaty may be justified in principle in the present case, the national authorities responsible for the authorisation of marketing of foodstuffs must have regard to the principle of proportionality reflected in the second sentence of this provision. They must show, in particular, that their national rules are necessary to give effective protection to the interests referred to in Article 36 ... and ... to show that the marketing of the product in question creates a serious risk to public health. Furthermore, traders must also be able to apply, under a procedure which is easily accessible to them and can be concluded within a reasonable time for authorisation to distribute the particular product. Under the division of competences between the Court and the national court in the preliminary ruling procedure, it falls to the latter to determine whether the French authorities could have protected human health against any scientifically-demonstrated dangers from ingestion of supplementary L-Carnitine without recourse to what amounts in effect to a prohibition backed by criminal sanctions, and whether or not there exists such an authorisation procedure.
46. France also relied upon consumer protection as justifying the effective prohibition on the manufacture and distribution of products containing L-Carnitine. In particular, it referred to misleading information which, though not on the packaging of the product, was widely available in print or on the Internet, and which might induce consumers to adopt abnormal alimentary behaviour.
47. While a determination on this matter falls once again to the national court, it is difficult to see how the fact that misleading information concerning the consumption of a particular product might be disseminated by third parties could be relied upon to justify the restrictions on the free movement of such products which result from the provisions of French law being applied in the main proceedings. It is well established in the case-law that a Member State may have recourse to Article 36 to justify a measure having equivalent effect to a quantitive restriction on imports only if no other measure, less restrictive from the point of view of the free movement of goods, is capable of achieving the same objective. Furthermore, the Community principle of proportionality requires that the national measure be appropriate and necessary to attain the objective sought. In order to rely on consumer protection in circumstances such as those in the main proceedings, France would need to show that it is unable to prevent abnormal alimentary behaviour induced by misleading information by means less restrictive of the free movement of goods than the criminal prosecution of those responsible for the manufacture and distribution of the product, such as, for example, action against those responsible for the dissemination of the information. Should it succeed in doing so, it would still need to demonstrate that the prosecution of parties who are not responsible for disseminating such information is an appropriate and effective response to preventing abnormal alimentary behaviour.
III - Conclusion
48. In the light of the foregoing, I propose that the questions submitted by the Tribunal de Grande Instance, Grasse, be answered as follows:
(1) In the present state of Community law, 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 must be interpreted as permitting the Member States to apply national provisions relating to the composition of foodstuffs to products such as those whose manufacture and distribution gave rise to the main proceedings, subject to the rules established by the Treaty concerning the free movement of goods.
(2) The application to such products of an authorisation procedure for foodstuffs constitutes a measure having equivalent effect to a quantitative restriction on the free movement of goods within the meaning of Article 30 of the Treaty.
(3) In so far as such products, though treated under national law as foodstuffs, are materially identical in their composition or pharmacological effects to products whose marketing has been authorised in accordance with the procedure established by Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended, the Member States are entitled to prohibit their manufacture and marketing in their territory, in accordance with the conditions laid down in Article 36 of the Treaty, subject to the proviso that a directive cannot, of itself and independently of national laws, whether or not these have been adopted for its implementation, have the effect of determining or aggravating the liability in criminal law of persons who act in contravention of the provisions of that Directive.
(4) In order for Member States to rely on the derogation allowed by Article 36 of the Treaty in circumstances such as those in the main proceedings:
- the national measures they apply in this regard must be restricted to what is necessary to protect public health, and must be appropriate to this purpose;
- they must make available to traders an easily accessible authorisation procedure, operating within a reasonable time and subject to judicial review;
- in any marketing authorisation procedure, the national authority bears the onus of proving that the product is harmful to health;
- in deciding on the application of such measures, the Member States must take into account the results of international scientific research.
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