C-95/01

GREENHAM AND ABEL

OPINION OF ADVOCATE GENERAL MISCHO delivered on 16 May 2002 1

1. The Tribunal de grande instance (Re- of 3 May 1989 on the approximation of the gional Court), Paris (France), asks whether laws of the Member States relating to Articles 28 EC and 30 EC preclude national foodstuffs intended for particular nutri- legislation which prohibits the marketing of tional uses. 2These include products such a food supplement lawfully sold in another as baby foods, meal substitutes, gluten-free Member State. foods or foods for sportsmen.

I — Legal background

B — National provisions

A — Community law

'It is prohibited to possess with a view to sale, to make use of or to sell any goods and foodstuffs intended for human consump- tion to which chemical products have been added, other than those whose use is declared lawful by the orders made jointly by the Minister of Agriculture and Rural Development, the Minister of Economics and Finance, the Minister of Industrial and Scientific Development and the Minister of 7. Mr Greenham and Mr Abel, defendants Public Health, on the basis of the Opinion in the main proceedings and joint managers of the Conseil supérieur d'hygiène publique of the company NSA France SARL (here- de France (French public health authority, inafter 'NSA France'), are charged with hereinafter "the CSHPF") and the Aca- having, in Paris in 1998 and in any case on démie national de médecine (National the national territory during a period in Academy of Medicine).' respect of which criminal proceedings are not time-barred, committed two offences. First, they are charged with having dis- played and offered for sale adulterated foodstuffs by marketing food supplements 5. Decree N o 99-242 of 26 March 1999 ('JUICE + mélange de légumes et de fruits') amended that decree by substituting the to w h i c h were a d d e d the s u b s t a n c e opinion of the Agence de sécurité sanitaire 'coenzyme Q 1 0 ' , a chemical substance des aliments (food safety agency, the whose use in human food is not authorised AFSSA) for those of the CSHPF and the in France, and vitamins in amounts greater Académie national de médecine. than the daily recommended intake or in excess of the safety limits set by the CSHPF. They are also charged with having misled consumers in regard to product quality by marketing meal substitutes ('JUICE + Lite, 6. Decree N o 97-964 of 14 October 1997 arôme chocolate et arôme vanille') which was inserted into the Decree of 15 April do not comply with the requirements laid 1912 and for the first time defines food down in Commission Directive 96/8/EC of supplements as: 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction, 3 in particular because the energy they provide is below the threshold set in the legislation and they are deficient 'Products intended to be ingested as a in certain minerals. supplement to traditional foods in order to make up for the real or assumed insufficiency of daily intake.' 3 — OJ 1996 L 55, p. 22.

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14. Therefore, referring to the judgment in the assumption that the products were Rombi and Arkopharma, 5 where the Court imported from another Member State. held, in paragraph 72, that it 'is not in a position to determine whether the rules and principles relating to the free movement of goods apply to an activity of the kind at issue in the main proceedings', on the grounds that 'it is not apparent from the documents in the main proceedings that the 17. Second, the French Government and a c t i v i t y c a r r i e d on by A r k o p h a r m a the Commission point out — correctly, in involved either exporting or importing the my opinion — that although, in the case products concerned', the French Govern- which is the subject of the reference, the ment makes its observations subject to the proceedings relate to both food supple- referring court's verifying whether the ments and meal substitutes, the question abovementioned condition for the applica- asked by the referring court concerns only bility of Article 28 EC is satisfied. food supplements.

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20. I shall therefore not take a view on the The question referred for a preliminary interpretation of Articles 28 EC and 30 EC ruling in the light of national legislation such as that which applies in France to food supplements.

25. The referring court asks whether Articles 28 EC and 30 EC are to be 2 1 . Third, Mr Greenham and Mr Abel ask interpreted as prohibiting a Member State the Court to rule on the application to the from preventing the free movement and present case of Directive 96/8. marketing of a food supplement lawfully sold in another Member State.

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EEC Treaty was to be understood as itions or restrictions shall not, however, meaning that 'the fixing of a minimum constitute a means of arbitrary discrimi- alcohol content for alcoholic beverages nation or a disguised restriction on trade intended for human consumption by the between Member States'. legislation of a Member State also falls within the prohibition laid down in that provision where the importation of alco- holic beverages lawfully produced and marketed in another Member State is con- cerned.' However, that was because the Court had first established that the require- ment in question did not serve a purpose in 30. In the present case, the prohibition on the general interest such as to take preced- the marketing of the food supplements at ence over the requirements of the free issue appears to have been motivated movement of goods. specifically by a concern for 'the protection of health and life of humans' within the meaning of Article 30 EC.

in imposing a restriction on the free move- 35. It is also clear from the Court's case- ment of goods. law, especially the judgments in Sandoz, cited above, Motte, 11 Muller 12 and Com- mission v Germany, known as the 'Beer Purity Law' judgment, 1 3 that Community law does not preclude the adoption by the Member States of legislation whereby the use of additives is subjected to prior auth- orisation granted by a measure of general application for specific additives, in respect 33. I shall subsequently consider, in the of all products, for certain products only or alternative, whether the absence of a nutri- for certain uses. This is also true of the tional need can justify an import prohib- fixing of a maximum level for the use of an ition. Finally, I shall present some observa- additive in certain products. Such legis- tions on two other questions which have lation meets a legitimate need of health arisen in the course of the present proceed- policy, namely that of restricting the ings. uncontrolled consumption of food addi- tives.

1. The protection of the health and life of 36. Nevertheless, the principle of propor- persons tionality which underlies the last sentence of Article 30 EC requires that the power of the Member States to prohibit imports of products from other Member States should be restricted to what is necessary to attain the objectives of protection being legit- imately pursued. 1 4

34. It is clear from the Court's case-law 1 0 that, inasmuch as there are uncertainties in the present state of scientific research with regard to the harmfulness of food additives, it is for the Member States, in the absence of full harmonisation, to decide what 37. The case-law of the Court also makes degree of protection of the health and life clear that it is the responsibility of the of humans they intend to assure, having competent national authorities to prove regard for the requirements of the free that a substance is harmful. It is for them movement of goods within the Community.

to demonstrate, in each case, that their 39. There are areas in which scientific legislation is necessary in order effectively research is not yet sufficiently advanced to protect the interests referred to in for it to be possible to determine with Article 30 EC and, in particular, that the certainty the quantities and concentrations marketing of the product in question poses at which certain substances might become a risk to public health. 1 5 In so doing, they harmful and the exact effects to which they are to take account of the findings of might give rise. international scientific research, and in particular of the work of the Community's Scientific Committee for Food, the Codex Alimentarius Committee of the FAO [Food and Agriculture Organisation (of the United Nations)] and the World Health Organisation, and of the eating habits 1 6 prevailing in the i m p o r t i n g M e m b e r State. 1 7 40. Scientific uncertainty, inter alia in the field of vitamins, 1 9 has, moreover, led the Court to allow the Member States consider- able latitude.

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vitamins meets a real need, especially a instructions provided by the manufacturer technical or nutritional one'. is w i t h o u t d a n g e r to the c o n s u m e r ' (point 13 of the preamble).

42. Since then, that prudent approach has been confirmed by the Commission and the C o u n c i l . C o m m o n P o s i t i o n (EC) N o 18/2002 adopted on 3 December 2001 by the Council, with a view to adopting a 43. Until that directive has been adopted Directive of the European Parliament and and maximum limits set by the Commis- of the Council on the approximation of the sion under the relevant legislation, Member laws of the Member States relating to food States are obviously entitled to apply those supplements, 20reads as follows: criteria in their national legislation.

O n l y vitamins and minerals normally found in, and consumed as part of, the diet should be allowed to be present in food supplements, although this does not mean 44. In that context, reference can also be that their presence therein is necessary. made, as has been done by several partici- Controversy as to the identity of those pants in the present proceedings, to the nutrients that could potentially arise should judgment of the Court of the European Free be avoided. Therefore it is appropriate to Trade Association ('the EFTA Court') of establish a positive list of those vitamins 5 April 2001, 2 1 which appears to me to and minerals' (point 9 of the preamble) confirm the prudent approach advisable in the matter. In paragraphs 29 to 31 of its judgment, that court held as follows:

In many cases, the assessment of such questions will show that there is a great measure of scientific and practical uncer- tainty linked to the issue under consider- 46. In carrying out that assessment, the ation. A proper application of the pre- national court must take into consideration cautionary principle presupposes, firstly, an the fact that the national authorities are identification of potentially negative health entitled to refer to the precautionary prin- consequences arising, in the present case, ciple. That means that a Member State may from a proposed fortification, and, sec- have recourse to Article 30 EC where it has ondly, a comprehensive evaluation of the serious suspicions but no certainty as to the risk to health based on the most recent danger posed by a substance, but where scientific information. serious harm could occur if the suspicion proved to be correct.

When the insufficiency, or the inconclusive- ness, or the imprecise nature of the con- 47. Mr Greenham and Mr Abel also refer clusions to be drawn from those consider- to several factual elements which they ations make it impossible to determine with claim demonstrate that the prohibition at certainty the risk or hazard, but the likeli- issue is not justified by the protection of hood of considerable harm still persists public health, and they ask the Court to were the negative eventuality to occur, the find that such is the case. precautionary principle would justify the taking of restrictive measures.'

48. However, such an assessment goes beyond the framework of the present 45. It follows from all the foregoing con- reference, which concerns only the inter- siderations that it is for the referring court pretation of the Community provisions on to determine w h e t h e r the c o m p e t e n t which the national court has put its ques-

5 0 . T h e C o m m i s s i o n , h o w e v e r , also touches on the question whether a restric- tion on the free movement of a foodstuff may be justified by the absence of nutri- 'The need to safeguard public health has tional need relating to one or more of the been recognised as, and remains, a primary substances incorporated in that foodstuff, concern, and the level of protection chosen and it proposes that the Court should rule by the Contracting Parties should not be on that point in its reply to the question placed in question. However, the principle referred for a preliminary ruling. of proportionality must be respected. In that process, the question of nutritional need with regard to additives to foodstuffs in any given population may have a proper place. Indeed, the most authoritative defi- nition of "fortification and enrichment" is directly linked to this element (See Codex 51. Referring to the judgment of the EFTA Alimentarius General Principles for the Court, cited above, the Commission con- Addition of Essential Nutrients to Food...). siders that only the existence of a risk to However, under the requirement of pro- public health, and not the mere fact that the portionality, the need to safeguard public

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health must be balanced against the prin- — it did not carry out a comprehensive ciple of the free movement of goods. The assessment of the risk which the addi- mere finding by a national authority of the tion of iron to foodstuffs might entail. absence of nutritional need will not justify an import ban, a most restrictive measure, on a product which is freely traded in other EEA States'. 2 2

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products on the market in France which are subjected to prior authorisation granted by also of lower nutritional value or are a measure of general application for spe- composed substantially of the same fats cific additives, in respect of all products, for used in milk substitutes yet there is no ban certain products only or for certain uses. on marketing them...'. 2 6 This is also true of the fixing of a maximum level for the use of an additive in certain products. Such legislation meets a legit- imate need of health policy, namely that of restricting the uncontrolled consumption of food additives'. 2 7

59. At issue in that case was a product obtained from natural substances whose nutritional value was simply lower than that of competing products. It was totally inconceivable that that could constitute a valid ground for prohibiting imports. 62. It unquestionably follows from that case-law that the M e m b e r States are entitled to control and, in so far as is necessary, restrict the use of additives in foodstuffs and that they can do so by means of a system based on the principle that everything which is not authorised is pro- hibited. 60. In a whole series of other cases, in contrast, the Court was confronted with chemical substances which had been added to foodstuffs on the ground that this met a real need, in particular a technological or dietary need.

63. In addition, as regards chemical sub- stances, it appears to follow from the Court's case-law that the existence of a genuine threat to public health is not the only factor which a Member State can take 61. It should be recalled that, in particular into account. In paragraph 17 of Debus, in Debus, cited above, the Court held that cited above, the Court made clear that '... 'Community law does not preclude the the use of a specific additive which is adoption by the Member States of legis- authorised in another Member State must lation whereby the use of additives is

65. The Court therefore appears to con- sider that, even if a substance does not 68. Finally, it should be observed that the present a risk to public health, the market- concept of 'nutritional need' is no stranger ing of the foodstuff in which it is incor- to the positive law of the Community now porated can nevertheless be prohibited if in f o r c e . A r t i c l e 1(3) of D i r e c t i v e that substance does not meet a genuine 2 0 0 1 / 1 5 / E C of t h e C o m m i s s i o n of need. 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses 3 2 28 — Emphasis added. See also the judgments in Muller, cited reads as follows: above, paragraph 25, Beer Purity Law, cited above, paragraph 44 and Bellon, cited above, paragraph 14. 29 — Case C-344/90 Commission v France [1992] ECR I-4719. 30 — Commission v France, cited above, paragraph 10. Empha- 31 — Emphasis added. sis added. 32 — OJ 2001 L 52, p. 19.

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'The use of nutritional substances in foods ible, be avoided, even if the harmfulness of for particular nutritional uses shall result in a given substance is not proven. It is as if the manufacture of safe products that fulfil they were all potentially dangerous. the particular nutritional requirements of the persons for whom they are intended as established by generally accepted scientific data.' 3 3

72. One might, therefore, be tempted to 69. The two texts which I have just cited conclude that, until a positive list of auth- tend to confirm the conclusion which I orised substances has been drawn up at think can be drawn from the Court's Community level, national authorities are judgment in Case C-344/90 Commission v entitled to prohibit not only dangerous France, cited above: namely, that artificial substances (including those to be treated as substances incorporated in foodstuffs must such in the application of the precautionary not only be risk-free but must also serve a principle) but also those which can be useful purpose. proved not to satisfy any genuine nutri- tional need.

74. Mr Greenham and Mr Abel also request the Court to find that the national 4. The mutual recognition clause legislation at issue infringes Articles 28 EC and 30 EC in that traders cannot obtain an authorisation under a procedure which is easily accessible and which can be con- cluded within a reasonable time. Conclusion

75. It does indeed follow from the case-law of the Court that authorisation to market 78. Finally, Mr Greenham and M r products is to be granted according to a procedure which is easily accessible to Abel, referring to Case C-184/96 Com- traders, can be completed within a reason- mission v France, 36 request the Court able period and which, if it leads to a to find that the French Republic has rejection, enables that rejection to be failed to include in its legislation any challenged before the courts. 35 mutual recognition clause which would allow the marketing on French terri- tory of food supplements freely mar- keted in other Member States.

76. Nevertheless, as can be inferred from the order for reference and as the French Government confirms in the present case, Mr Greenham and Mr Abel marketed the products at issue without having first 79. In that regard, I should like to refer lodged an application which could have to my Opinion of 26 June 2 0 0 1 , cited been investigated by the French competent above, where I concluded that authorities. Articles 28 EC and 30 EC do not impose the inclusion of a mutual recognition clause in national legis- lation such as Decree N o 73-138, which refers to 'all goods and food- 77. The detailed rules of the French auth- stuffs intended for human consump- orisation procedure are thus not at issue in tion to which chemical products have the main proceedings and it is therefore not been added'. 37

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