C-107/97

OPINION OF MR FENNELLY — CASE C-107/97

OPINION OF ADVOCATE GENERAL FENNELLY delivered on 22 October 1998 *

1. May a Member State prosecute, under 3. Under the relevant French legislation, in its consumer protection legislation, a pro- particular the Decree of 15 April 1912, 1 ducer of foodstuffs on the grounds that foodstuffs may only contain substances these contain higher doses of a substance whose addition has been authorised by than is permitted in the national legislation interministerial order adopted after a on foodstuffs intended for particular nutri- favourable opinion of the Conseil Supérieur tional uses, when the marketing of the same d'Hygiène Publique de France (hereinafter substance is authorised in other Member the 'CSHPF'), on the basis of information States? submitted by the applicant seeking to show that the substance is harmless at the recommended levels of use.

8. Article 1(2)(a) of Directive 89/398/EEC 6. The first legislative measure at the lays down three criteria for foodstuffs to Community level adopted in this area was qualify as being for 'particular nutritional Council Directive 77/94/EEC of 21 Decem- uses': they must, 'owing to their special ber 1976 on the approximation of the laws composition or manufacturing process [be] of the Member States relating to foodstuffs clearly distinguishable from foodstuffs for for particular nutritional uses (hereinafter normal consumption', they must be 'suita- 'the 1977 Directive'). 2This was transposed ble for their claimed nutritional purpose' into French law by Decree No 81-574 and, finally, they must be 'marketed in such of 17 May 1981 and by the Order of a way as to indicate such suitability'. 4 August 1986 concerning the use of addi- Article 1(2)(b) provides that: tives in the manufacture of foodstuffs intended for particular nutritional uses. 3 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). '[a] particular nutritional use must fulfil the particular nutritional requirements:

7. The 1977 Directive was replaced by (i) of certain categories of persons whose Council Directive 89/398/EEC of 3 May digestive processes or metabolism are 1989 on the approximation of the laws of disturbed; or the Member States relating to foodstuffs

4 — OJ 1989 1. 186, p. 27. 2 — OJ 1977 L 26, p. 55. 5 — The order for reference refers to 'Decree 91-174 of 17 May 3 — JORF, .50 August 1986. 1981', but this is clearly erroneous.

10. For foodstuffs intended for a particular nutritional use other than those listed in 9. Article 4 of Directive 89/398/EEC pro- Annex I to Directive 89/398/EEC, Article 9 vides for the adoption of specific directives lays down monitoring provisions, and in for certain groups of foods for particular particular the requirement that the manu- nutritional uses listed in Annex I thereto. facturer or importer, as the case may be, The list includes 'Low-energy and energy- notify the competent national authority reduced foods intended for weight control' whenever such a product is first placed on (group 4), 'Dietary foods for special med- the market or imported. Article 11 permits ical purposes' (group 5), and 'Foods inten- Member States temporarily to suspend or ded to meet the expenditure of intense to restrict trade in such products, where it muscular effort, especially for sportsmen' has 'detailed grounds for establishing that (group 8). To date, three such specific [a foodstuff] does not comply with Arti- directives have been adopted by the Com- cle 1(2) or endangers human health'; the mission: Directive 91/321/EEC of 14 May Commission and the other Member States 1991 on infant formulae and follow-on are to be informed immediately, and the formulae,6 Directive 96/5/EC of 16 Febru- Commission may initiate a procedure with ary 1996 on processed cereal-based foods 7 — OJ 1996 L 49, p. 17; this was amended by Commission Directive 98/36/EC of 2 June 1998, OJ 1998 L 167, p. 23. 6 — OJ 1991 L 175, p. 35. 8 — OJ 1996 L 55, p. 22.

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provisions laid down by law, regulation or Article 1, second definition administrative action relating to medicinal products 9has also been referred to in the present proceedings. In the version as amended, in particular, by Council Direc- tive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 'Medicinal product: 75/319/EEC on the approximation of pro- visions laid down by law, regulation or administrative action relating to proprie- tary medicinal products, 10 the relevant Any substance or combination of sub- provisions of Directive 65/65/EEC are as stances presented for treating or preventing follows: disease in human beings or animals.

Any substance or combination of sub- stances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, Freamble, first and second recitals correcting or modifying physiological func- tions in human beings or in animals is likewise considered a medicinal product.'

'Whereas the primary purpose of any rules concerning the production and distribution of medicinal products must be to safeguard public health; Article 3

'No medicinal product may be placed on the market in a Member State unless an authorisation has been issued by the com- Whereas, however, this objective must be petent authority of that Member State.' attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.' 13. In his defence before the Tribunal de Grande Instance (Regional Court), Grasse 9 — OJ, English Special Edition, First Series 1965-1966, p. 20, as amended on a number of occasions. (hereinafter 'the national court'), the defen- 10 — OJ 1989 L 142, p. 11. dant relied on the allegedly incomplete I - 3374

3. Does the classification, by Council Directive 89/398/EEC of 3 May 1989 5. Does not the fact that foodstuffs are on the approximation of the laws of the controlled within the framework of [Member] States [relating to foodstuffs C o m m u n i t y directives imply t h a t

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[Member] States must, when carrying quent judicial decision, to determine in the out such control, observe the general light of the particular circumstances of the Community principles, in particular case both the need for a preliminary ruling the protection of legitimate expecta- in order to enable it to deliver judgment tions?' 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, 14. Written and oral observations have in principle, bound to give a ruling'. 11 In been submitted by the defendant, the the present case, the national court has French Republic and the Commission. referred a number of questions concerning the interpretation of Community legislative provisions and of general principles of Community law.

I I— Analysis

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18. Even if France were correct in its situation of an individual, he would not in submission that the contested products fall principle be affected by its incorrect trans- outside the scope of Directive 89/398/EEC, position. Thus, in concrete terms, if Arti- such a conclusion could only be reached by cles 10 and 15 of Directive 89/398/EEC interpreting the Directive and identifying were found to leave the Member States free the obligations which Community law to apply their national provisions to pro- imposes on the Member States in this ducts such as the contested products, the regard, which is the object of the first four incorrect transposition of other provisions questions referred. Moreover, France's of Directive 89/398/EEC would not avail argument on admissibility, even if it were the defendant. 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.

21. Though they raise a number of distinct issues, the second, third and fourth ques- tions essentially seek a ruling on whether, in 19. In the light of the foregoing, I am of the circumstances such as those of the main opinion that the questions referred are proceedings, Directive 89/398/EEC pre- admissible. vents a Member State from prosecuting an individual for manufacturing and distribut- ing products such as the contested pro- ducts. I propose therefore to deal with this matter first.

(b) The interpretation of Directive 89/398/ EEC

23. Clearly it makes no sense to speak of L- that there is at present no Community Carnitine as being, or not being, a dietary legislation specifically regulating the com- supplement, any more than it does to position or marketing of such products; 16 affirm or deny that it is an additive. Most that does not suffice, in my view, to edible and potable substances known to conclude that they are thereby outside the man can be harmful if taken in the wrong scope of Directive 89/398/EEC. Article 1 dose or under the wrong conditions; the of the Directive distinguishes between nor- observation of the sixteenth-century physi- mal foodstuffs and those for particular cian Paracelsus that 'solo dosis fecit vene- nutritional uses, which latter concept it num' ('only the dose makes the poison') is defines more closely in paragraph 2. While now widely accepted. L-Carnitine is merely the order for reference does not specify a nutritional substance which, in certain exactly for which nutritional uses the doses, and, possibly, combined with other contested products were intended, the substances, may be presented as a dietary defendant has argued that his products supplement, 13 while in other doses and in should be considered as belonging either to other contexts, it may be used as an group 8 of the list in Annex I to the additive, 14 or even as a medicinal pro- Directive (products for sporting activities) duct. 15 I might add that the Court has not or group 4 (weight reduction products). 17 been informed of the exact composition or The French authorities, in particular the presentation of any of the contested pro- Commission Interministérielle d'Étude des ducts; for the purposes of the present Produits destinés à une Alimentation Parti- proceedings, the products have been treated culière in 1993 and the CSHPF in 1994, by all parties as being essentially similar, appear to have examined the consumption and as having L-Carnitine as their princi- of L-Carnitine from both of these perspec- pal, or principal active, ingredient. In the tives. absence of more detailed information, I am obliged to base the present Opinion on those assumptions.

meaning of Article 1(2) of Direc- and fourth questions 18 is that, in the tive 89/398/EEC. Groups 4 and 8 of present state of Community law, the Mem- Annex I to the Directive expressly recog- ber States enjoy the power to enforce nise, respectively, that weight control and 'national provisions which are applicable the expenditure of intense muscular effort in the absence of' such directives, in accor- are such uses. The Commission's descrip- dance with Articles 10(2) and 15(2); the tion at the hearing of the contested pro- application of such national provisions is ducts as being 'very low-energy foods' none the less subject to the obligations seems to me to be consistent with the which arise for the Member States under properties generally claimed for L-Carni- the Treaty rules on the free movement of tine in transforming existing fat into goods. I might add that this is the same energy. I have, therefore, little doubt that situation as would obtain if the Court were those of the contested products presented not to follow my recommendation to for use as slimming aids could in principle consider the contested products as being be classified within group 4 of Annex I to within Directive 89/398/EEC. Before the Directive. This interpretation of the examining the application of the Treaty relevant wording of Annex I is also con- rules on the free movement of goods, sistent with that adopted by the Commis- however, it is necessary to consider the sion in Directive 96/8/EC, which applies to possible relevance for the present case of certain categories of 'foods intended for use Directive 65/65/EEC. in energy-restricted diets for weight reduc- tion'. 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 proper- ties of the contested products, to decide whether they fall within the scope of (c) The possible relevance of Direc- Directive 89/398/EEC thus interpreted. tive 65/65/EEC

relied upon this fact to argue that there was to an erroneous understanding of the therefore no obstacle to the marketing of L- applicable provisions of Community law. Carnitine products relating to their compo­ Furthermore, the Court has long recognised sition, while, at the hearing, he informed that it may take into consideration provi­ the Court that Arkopharma itself had sions of Community law other than those received a marketing authorisation for mentioned in the questions referred. 20 In 'Elle-Carnitine', which, he declared, is any case, as will appear later, the classifica­ neither more nor less than the presentation tion of the products in the light of Direc­ as a medicinal product of the dietary tive 65/65/EEC is, in my view, relevant to products 'Carnivit' and 'Turbodiet' which the issue of the application of Article 36 of were amongst those which had given rise to the Treaty. the proceedings. 19 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.

19 — 'Carnivit' is not amongst the contested products listed in the order for reference, though two presentations each of Turbodieť and 'Elle-Carnitine' are. 20 — Case C-241/89 SARPP [1990] ECR I-4695, paragraph 8.

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inal product' set out in Article 1(2) of ber State both as a medicinal product and Directive 65/65/EEC, as a 'substance ... - as a cosmetic product. 23 On a reference in which may be administered to human unfair competition proceedings between beings ... with a view to ... modifying phy- the companies marketing the respective siological functions'.21 In these circum- products, the Court held that, even though stances, the Member State concerned the product might fall under the definition would be obliged by Article 3 of Direc- of a cosmetic product, it was nevertheless tive 65/65/EEC to prohibit the placing of to be treated as a medicinal product if such products on the market in their it came within Article 1(2) of Direc- territory unless an authorisation in accor- tive 65/65/EEC: dance with Chapter II of this Directive has been granted.

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interpretation of the notion 'medicinal — '[i]t is for the national courts to deter- p r o d u c t ' in Article 1(2) of Direc- mine on a case-by-case basis the classi- tive 65/65/EEC and on the identification fication of each product having regard of such products: 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.' 25

— 'products which alter physiological functions in the absence of disease fall within the scope of that definition';

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proceedings, though the effect of the tive restrictions on trade between Member Decree of 15 April 1912 is to prevent the States. The scope of this provision has been marketing without authorisation of any interpreted in the Court's established case- foodstuffs, including those which might be law to include 'all commercial rules of the classified as medicinal products. Be that as Member States likely to impede directly or it may, it is settled case-law that 'a directive indirectly, actually or potentially, intra- cannot, of itself and independently of a Community trade'. 27 More specifically, in national law adopted by a Member State Keck and Mithouard, the Court held to for its implementation, have the effect of constitute such measures the application 'to determining or aggravating the liability in goods coming from other Member States criminal law of persons who act in contra­ where they are lawfully manufactured and vention of the provisions of that direc­ marketed, of rules that lay down require­ tive.' 26 Equally, in the present case, Direc­ ments to be met by such goods (such as tive 65/65/EEC cannot, in my view, be those relating to designation, form, size, taken as determining or aggravating the weight, composition, presentation, label­ d e f e n d a n t ' s c r i m i n a l liability u n d e r ling, packaging) [and that this] is so even if national provisions which, like those at those rules apply without distinction to all issue in the present case, were not adopted products unless their application can be to implement it. The fact that the French justified by a public-interest objective tak­ authorities might, subject to the determina­ ing precedence over the free movement of tion of the national court on this point, goods'. 28 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.

not the same as those applicable in France', my view, that the application, in circum- and that Article 30 of the Treaty is there- stances such as those which gave rise to the fore potentially relevant. 31 In the main main proceedings, of the national provi- proceedings, the French authorities appear sions upon which the prosecuting authority to be applying to the contested products relies constitutes a measure having an national rules concerning the composition equivalent effect to a quantitative restric- of foodstuffs intended for a particular tion on trade in the contested products nutritional use, which come within the within the meaning of Article 30 of the scope of Article 30 as identified in Keck Treaty. 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 estab- lished by the Decree of 15 April 1912, which is at the origin of the main proceed- ings, constitutes an obstacle to the free movement of foodstuffs. 32

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proceedings, France appears to be relying discretion to the Member States in relation primarily on considerations of public to such additives,' 36 including the possibi- health, though it has also mentioned con- lity of requiring an administrative autho- sumer protection. risation prior to marketing the foodstuffs in question. In the absence of Community harmonisation, the Member States arc thus free to decide on the degree of health protection which they intended to assure.

34 — Case 174/82, cited in footnote 27 above. 36 — Ibid., paragraph 15. 35 — Ibid., paragraph 11. 37 — Ibid., paragraphs 18 and 19).

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protection, the Member States 'must take judgment, the Court added that a failure to into account the results of international grant authorisation must be amenable to scientific research and, in particular, the judicial review. work of the Community's 38 Scientific Committee for Food', 39 though the opi- nions 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'. 40 As regards additives in particular, the Court accepted the view of the SCF that sub- 41. As regards the protection of public stances should only be authorised as addi- health, the contested products in the pre- tives to fulfil a need, 'which may be sent case differ in a number of respects technological or economic or again, as far from those considered by the Court in the as flavouring and colouring matters are cases mentioned above, which prevent this concerned, organoleptic or psychological', case-law from being applied to the present the existence of such a need to be assessed case without more. In particular, as the 'in the light of the eating habits of that Commission pointed out at the hearing, it State'. 41 This approach was confirmed in is not particularly appropriate to treat the Muller, 42 where the Court also laid down L-Carnitine present in the contested pro- the requirement that the Member States ducts as an additive, when the L-Carnitine make available to traders an easily acces- appears to be the, or a, main ingredient of sible authorisation procedure, operating the products in question. This view is within a reasonable time, and in the 'Ger- confirmed by Article 1(2) of Council Direc- man beer' case and Bellon; 43 in the latter tive 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. 44 This defines the term 'food additive' as follows:

It appears, in my view, from the facts as stated in the order for reference and in the observations of the parties that the con- tested products contain L-Carnitine 'as a characteristic ingredient', rather than its 43. The state of scientific knowledge con- being added to these products 'for a cerning possible negative effects on human technological purpose'. health of the ingestion of supplementary doses of L-Carnitinc docs 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 mar- 42. The second material difference is that keting authorisation, notwithstanding the the additives in question in the case-law findings of the CSHPF, which, according to outlined above were already all subject to France's own submissions, had based its some form of Community regulation, prior negative opinion on tests involving the to the facts giving rise to the dispute; as a daily ingestion of doses of 900 mg or less. result (or perhaps, as a necessary precondi- At the hearing, the Commission informed tion), there existed some degree of scientific the Court that it was unaware of any consensus concerning the effects of adding evidence that the use of L-Carnitine con- the particular substances to foodstuffs. This stituted a particular danger for public enabled the Court to conclude, for example health, while it is common ground that in Sandoz, that the concentration of the products containing or mainly comprising vitamins in the products in question in that this substance arc freely available in other case was 'far from attaining the critical Member States. threshold of harmfulness so that excessive consumption thereof cannot in itself con- stitute a risk to public health' but that 'such 45 — Case 174/82, cited in f o o t n o t e 2 7 above. paragraph 12.

44. I am none the less satisfied that the those at issue, Article 4(1)(a) of Direc- French authorities are entitled to rely on tive 89/398/EEC recognises that Member the derogation allowed by Article 36 of the States may lay down national provisions Treaty, even where they have treated the regulating this matter, which the directives contested products as foodstuffs for a would harmonise in the interests of facil- particular nutritional use. Firstly, if they itating the free movement of such goods. 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 protec- tion they intend to assure'. 46In this regard, the fact that a product containing a parti- cular active substance has been authorised as a medicinal product, whose consump- tion 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 necessa- 45. While recourse to Article 36 of the rily be authorised either for different pur- Treaty may be justified in principle in the poses and under different conditions, or present case, the national authorities without any such restrictions. 47Secondly, responsible for the authorisation of market- just as with additives, the protection of ing of foodstuffs must have regard to the public health may justify national measures principle of proportionality reflected in the seeking to avoid any harmful effects of an second sentence of this provision. They excessive consumption of a substance must show, in particular, that their national which, as has been noted, already occurs rules are 'necessary to give effective protec- in various foodstuffs, whether or not the tion to the interests referred to in Arti- substance taken on its own is harmful or cle 36 ... and ... to show that the market- not; such caution seems to me to be ing of the product in question creates a particularly justified in the present state of serious risk to public health'. 4 8Further- scientific uncertainty regarding the public more, 'traders must also be able to apply, health implications of the consumption of under a procedure which is easily accessible L-Carnitine. Furthermore, in providing for to them and can be concluded within a the adoption of specific directives govern- reasonable time' for authorisation to dis- ing the composition of products such as tribute the particular product. 49Under the division of competences between the Court and the national court in the preliminary 46 — Case C-347/89 Eurim-Pharm [1991] ECR I-1747, para- graph 26. 47 — The defendant implicitly recognised as much at the 48 — Case 227/82 Van Bennekom [1983] ECR 3883, para- hearing, in arguing that any medicinal product could be graph 40. dangerous depending on the quantity taken, the context, 49 — Case C-42/90 Bellon, cited in footnote 32 above, para- the age and state of health of the patient, and so forth. graphs 14 and 16.

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

51 — Though this may be relevant to its classification as a 50 — The Commission stated at the heating that there was no medicinal product, unless carried out completely indepen- such procedure for the authorisation of substances not dently of tne manufacturer or seller of the product: Case permitted by the Decree of 4 August 1986, while France C-219/91 Ter Voort [1992] ECR I-5485, paragraph 31. stated that under the Decree of 15 April 1912 traders could apply for authorisation to the Directorate-General 52 — Case 72/83 Campus Oil [1984] ECR 2727, paragraph 44. for Competition, Consumer Affairs and the Suppression of 53 — Joined Cases C-34/95, C-35/95 and C-36/95, KO v De Fraud which in turn refers the matter to the CSHPF. Agostini and TV-Shop [1997] ECR I-3843, paragraph 31.

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I I I— 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:

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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;