C-24/00

OPINION OF MR MISCHO — CASE C-24/00

OPINION OF ADVOCATE GENERAL MISCHO delivered on 26 June 2001 1

1. The Commission of the European Com- — the French authorities have impeded munities has applied for a declaration that the marketing of the above foodstuffs the French Republic has failed to fulfil its in France without establishing that they obligations under Article 30 of the EC would pose a risk to public health.' Treaty (now, after amendment, Article 28 EC) in so far as:

I — Legal background '— French legislation fails to guarantee the free movement of general foodstuffs and foodstuffs intended for special nutritional purposes, which are law- fully manufactured and/or marketed in other Member States but contain addi- tives (such as vitamins, minerals and Community law other ingredients) not provided for under that legislation;

2. There is no Community legislation gov- erning the addition of nutrients in general foodstuffs.

— in particular, French legislation fails to provide for a simplified procedure for having a substance entered on the national list of permitted additives, which is necessary if the above food- stuffs are to be marketed in France; 3. On the basis of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member 1 — Original language: English. States relating to foodstuffs intended for

National law

6. It may be concluded therefore that the present case is exclusively within the scope 8. The French legislation applicable to the marketing of food supplements and general 2 — OJ 1989 L 186, p. 27, the author's italics. foodstuffs fortified with vitamins, minerals 3 — OJ 1989 L 40, p. 27. and other nutrients such as amino acids is

I-1281

OPINION OF MR MISCHO — CASE C-24/00

the Decree of 15 April 1912 implementing for particular nutritional uses (JORF of the Law of 1 August 1905 on offences 29 August 1 9 9 1 , p. 11424) provides: relating to food standards and adulteration 'Foodstuffs are regarded as being intended of goods or services concerning foodstuffs, for particular nutritional uses if, as a result and in particular meat, prepared meat of their particular composition or of a products, fruit, vegetables, fish and pre- particular process in their manufacture, served foods. they are clearly different from foodstuffs for daily consumption, are suitable for the stated nutritional purpose and are mar- keted in such a way as to indicate that they fulfil that purpose.'

9. Article 1 of the Decree, as amended by Decree N o 73-138 of 12 February 1973 (JORF of 15 February 1973, p. 1728), provides: 11. Article 3 of the same decree reads as follows:

15. By nutrients, the Commission means vitamins, minerals, amino acids and other nitrogenous compounds and also other nutrients of the kind included in Annex III to Commission Directive 91/321/EEC of 13. The parties agree that, as stated by the 14 May 1991 on infant formulae and French Government, 'the French order follow-on formulae. 5 As regards other establishes a system of positive lists 4 and, ingredients, the complainants described in if a trader wishes to market in France a particular the difficulties linked to the foodstuff containing a substance not addition of caffeine to foodstuffs. included on the positive list, it must secure an amendment of the positive list of additives permitted in France'.

16. The first exchange of letters and dis- cussions having proved unfruitful, the Commission sent the French Republic, on 23 December 1997, a letter calling on it to submit its observations within two months. II — Facts

14. The Commission states that its atten- 17. The French Republic replied by letters tion was drawn, in particular by complaints of 9 March and 15 May 1998 stating that, by traders, to the French legislation on the in its opinion, the French legislation in addition of nutrients and certain ingredi- question complied with Community law.

4 — Italicised in the original text. 5 — OJ 1991 L 175, p. 35.

I - 1283

OPINION OF MR MISCHO — CASE C-24/00

I - 1284

COMMISSION v FRANCE

of process, on the ground that the Com- 25. Moreover, the sole fact that the Com- mission, at the same time as it makes public mission exercises two powers simulta- a draft directive on additives for specific neously in the same area, namely the power nutritional purposes, has brought an action to bring proceedings before the Court on for failure to fulfil obligations against one the basis of Article 226 EC and the power of the few Member States which has to set out legislative proposals, does not national legislation on the subject. prove in any way that the Commission has misused one of those two powers.

26. The action must therefore be held to be 22. The Commission replies that the exist- ence of projects for Community harmon- admissible. isation cannot relieve Member States of their obligation to comply with the Treaty. In addition, the Commission considers that the proposed directive does not cover the principal aspects of the failure to fulfil obligations alleged by the Commission in the context of the present action. The Commission s first plea

27. The precise scope of the Commission's first plea is not easy to grasp, which is why 23. I consider that the French Govern- I consider it necessary to quote fully what ment's objection cannot be upheld. the Commission has stated on that subject.

28. The first plea is entitled: 24. As stated in the judgment in Case 7/71 Commission v France, an action seeking to establish that a Member State has not complied with its obligations under the Treaty 'serves to ensure the application of the Treaty, and cannot constitute a misuse Trench legislation fails to provide for the of procedure'. 6 free movement of foodstuffs lawfully manufactured and/or marketed in other Member States but containing additives 6 — [1971] ECR 1003, paragraph 13. not provided for under that legislation.'

It would have been possible for French 31. If one relies solely on the title of the legislation to exempt from prior inclusion plea, it appears that the Commission wishes in the list of permitted substances additives to give the 'Cassis de Dijon' 7 case decisive permitted in another Member State, and influence, and that it is denying Member confine itself to requiring that the national States the right to rely on Article 36 of the authorities be notified, at the time of putting a food product on the market, of the use in this of a substance not permitted 7 — Case 120/78 Rewe-Zentral [1979] ECR 649.

I - 1286

COMMISSION v FRANCE

Treaty in order to retain a measure having 35. In the reply, the Commission stated equivalent effect to a quantitative restric- that 'under the "Foie gras" case the absence tion in the interest of 'the protection of in the legislation in question of provisions health and life of humans'. on the subject is sufficient to demonstrate the failure to fulfil obligations'.

36. During the hearing, finally, the Com- 32. Nonetheless, at the end of the first mission confirmed that this was indeed a paragraph of the plea, the Commission question of applying the findings of the refers to 'exceptions laid down in the Court in the judgment of 22 October 1998 Treaty'. This can only concern the excep- in Commission v France, known as 'Foie tions referred to in Article 36 of the Treaty gras', 8 to the present case. and also the 'overriding requirements' recognised by the Court.

I - 1287

OPINION OF M R MISCHO — CASE C-24/00

38. The operative part of the judgment 4 1 . The Court stated in paragraph 18 of reads: the judgment that 'national legislation pro- hibiting a product from a Member State which complies with the rules laid down by that State but which does not fully 1 1 satisfy the requirements imposed by that legis- lation from being marketed under a given trade description must be regarded as capable of hindering, at least potentially, inter-State trade'. 'By adopting Decree N o 93-999 of 9 August 1993 relating to preparations with foie gras as a base without including in it a mutual recognition clause for products from a Member State and complying with the rules laid down by that State, 1 0 the French Republic has failed to fulfil its obligations under Article 30 of the Treaty.'

49. It is immediately apparent that such a 45. However, that case is distinguished provision would give rise to great dif- from the present action on two important ficulties in interpretation. points.

50. Firstly, the provision would risk giving 46. Firstly, in the 'Foie gras' case, there was rise to disputes on the question of when the no question of the protection of public legislation of the country of origin of the health. product meets standards equivalent to those set in France for the protection of health, or to what extent those products may not 'wholly' satisfy the requirements of the French legislation.

47. Secondly, the French decree in question related to a group of clearly specified products (preparations with foie gras as a base). In the present action, however, the Commission alleges that the French Repub- 51. Consequently, should it be admitted lic has not included a provision for mutual that a foodstuff incorporating an additive recognition in two decrees, one of which not permitted in France, and which, there- relates to 'all goods and foodstuffs intended fore, clearly does not 'wholly' satisfy the for human consumption where chemical requirements of the French legislation, products have been added to them' and the meets none the less a 'standard of pro- other to 'foodstuffs intended for special tection' equivalent to that set in France? nutritional purposes'.

52. As the French Government rightly 48. The Commission's argument therefore argued, 'the point of reference' is missing effectively claims that even such general in relation to which the equivalent standard legislation should lay down a provision of protection should be assessed.

54. Moreover, one cannot maintain that the necessity of including such a provision 58. However, the Commission's first plea is apparent from the inherent logic of the includes two additional arguments. relevant articles of the Treaty or that it is vital to make those articles fully oper- ational. The articles are sufficient as they stand. Article 30 of the Treaty lays down a clear rule: the prohibition of measures having equivalent effect, and Article 36 of the Treaty allows certain exceptions. 59. In the third paragraph of its arguments, the Commission states that 'it would have been possible for French legislation to exempt from prior inclusion in the list of permitted substances additives permitted in another Member State, and confine itself to requiring that the national authorities 55. Therefore, it is sufficient, in my should be notified, at the time of putting opinion, to confine ourselves to the Court's a foodstuff on the market, 1 4 of the use in case-law, under which it is for the impor- this of a substance not permitted in ting Member State to establish, by means of France...'. relevant arguments and scientific reports, what in its view are the risks to health involved in the use of a particular sub- stance, or to explain, on the basis of a detailed statement of reasons, why con- sumers may be misled as to the precise 60. That would thus mean that where they nature of the properties or effects of the consider that the foodstuff in question foodstuff concerned. would involve a risk to health, the French authorities would be obliged to embark on a nationwide action, in order to obtain the withdrawal of that product from shops where, in the extreme case, damage to health could have already occurred. I do not see on what basis such a system could 56. The importer must then be able to be imposed on a Member State. challenge the decision of the competent authority. That is all that is required to ensure the free movement of goods. 14 — The author's italics.

I - 1291

OPINION OF MR MISCHO — CASE C-24/00

67. Given that the procedure is a particu- mission argues that that condition is not larly onerous one, the Commission con- satisfied in the present case, as the relevant siders that 'applications for authorisation provisions do not specify any time-limit for of additives or other ingredients in tradi- granting applications. tional foodstuffs or those intended for special nutritional purposes should be sub- ject to a simplified procedure in the case of foodstuffs lawfully marketed in another Member State, or at the very least one including an express provision allowing authorisations already issued and the 70. Finally, the Commission makes clear results of analysis already carried out in that the French legislation does not satisfy another Member State to be taken into the requirement that any refusal of auth- account'. orisation must be made in accordance with formal requirements ensuring in fact that it is capable of being challenged before the courts by the trader concerned.

use of additives in order to make the if it leads to a rejection, that rejection must procedure completely transparent. How- be open to challenge before the courts'. 1 6 ever, the French Government states that in the absence of a favourable response from the Commission, it has not been possible to publish the notice. 75. That judgment is particularly interest- ing because it concerned the same Decree of 15 April 1912 and therefore the same kind of authorisation procedure as the pro- cedure at issue in the present case. In that judgment, the Court dismissed the action for failure to fulfil obligations because the 73. Finally, the French Government con- Commission had not argued that the pro- siders that the Court 'in general supports cedure imposed by the decrees in question simplified procedures where the product in was contrary to Community law. By question is already permitted on the contrast, in the present case, the Commis- national export market and where an sion does criticise that procedure in the operator wishes to make a parallel import light of Community law. of a product identical or similar to another product already permitted in the Member State concerned. That does not appear to be the situation in the present case, because the specific circumstances referred to by the Commission relate to other additives which 76. The procedure for authorisation must were not yet permitted in France.' The therefore be examined by reference to the French Government concludes that the conditions set out in the judgment in Commission has not established that the Commission v France. procedure is not in fact simplified for a product which is already lawfully marketed in another Member State.

81. Furthermore, the draft notice, as men- tioned in its title, concerns only additives in general foodstuffs. The notice, if it was adopted, therefore would not cover in any event additives in foodstuffs intended for 79. The examples provided by the Com- special nutritional purposes, which are also mission confirm the absence of a procedure the subject of these proceedings. such as that envisaged by the Court. The Commission refers, without being chal- lenged by the French Government, to the case of the manufacturer of the 'Red Bull' drink, which waited seven months for acknowledgment of its application for authorisation to market its product, and more than two years for the refusal. One 82. Finally, the French Government's argu- cannot consider that to be a procedure ment that it follows from case-law that the which can be completed within a reason- procedure is required only where the prod- able time. uct in question is already permitted on the national export market and where an operator wishes to make a parallel import of a product identical or similar to one which is already permitted in the national territory concerned cannot be upheld.

80. As regards the draft 'notice to traders on the conditions for incorporation of additives in general foodstuffs' which the French Government sent to the Commis- sion, it should be noted, in so far as that 83. That situation, as described by the notice satisfies the conditions of procedure French Government, is not the same as referred to by the Court, that it has not that in Commission v France, in which the been shown that it was in force on the Court specifically set out the requirement expiry of the time-limit set in the reasoned of an appropriate procedure. By contrast, opinion. The mere fact that the Commis- the situation in that case, namely the sion has not approved such a draft — a addition of nitrate to cheese, is by its very fact which the French Government com- nature almost identical to the problem in plained of only at the stage of the the present case.

88. That said, it follows from the foregoing arguments that the French Republic has failed to fulfil its obligations under Article 30 of the Treaty, by not having provided for a procedure which is readily 85. In p a r a g r a p h 31 of the reasoned accessible, can be completed within a opinion, the Commission stated that it reasonable time and is capable of being considers that the expression means that, challenged before the courts if it has led to in the case of foodstuffs which have already a refusal, with a view to having additives been put on sale in another Member State included on the list laid down by national in compliance with that State's legislation, legislation, as is required for marketing in 'it is not necessary that the product should France general foodstuffs and foodstuffs still be subject to the full procedure, includ- intended for special nutritional purposes ing the successive opinions of the CSHPF which are lawfully manufactured and/or and the Academie Nationale de Médecine.' marketed in other Member States of the European Community but contain those substances.

86. Although I agree that for products The third plea, relating to the application lawfully put on the market in another of national legislation to individual Member State the competent authorities requests must begin by 'taking that fact into account' and enquire whether there is still room for doubt as to the innocuousness of the substance in question, it is possible that such doubts remain, or that the possible effects of the substance have not been the 89. In the third plea, the Commission subject of any analysis in the country of alleges that the French Republic has manufacture of the foodstuff, or even that impeded the marketing in France of the in that country there is no legislation on the foodstuffs which are the subject of this matter and no relevant procedure. action for failure to fulfil obligations with-

91. The Commission recognises that con- sumer protection and efforts to curb mis- leading practices amount to an overriding requirement which merits protection. None the less, the Court has established that 94. As regards the Commission's argument labelling suffices to ensure such protection. that the French authorities have not relied on any genuine reasons based on public health for not permitting the marketing of products from another Member State, the French Government notes that the effec- tiveness of the product or of the additive is also taken into account by numerous Community directives which target public 92. Finally, in the reply, the Commission health. It adds that the criteria of effective- submits that 'neither the Decree of 15 April ness and fairness allow national measures 1912 nor that of 29 August 1991 makes the to be justified in terms of the overriding innocuousness of a substance a condition requirements recognised by the Court as which must be satisfied in order for that being in respect of public health under substance to be entered on the positive Article 36 of the Treaty. In its opinion, the lists.' The Commission infers from this that Commission has therefore failed to fulfil its the French authorities need not show that obligation to prove that the disputed legis- the products placed on the market are lation does not serve aims of public health dangerous to health. and/or consumer protection.

I - 1296

COMMISSION v FRANCE

95. The question is whether the Commis- — "tiredness", and especially, circum- sion has proved, as is incumbent upon it, 1 7 stances where there may be a "reduc- the allegation that the French Republic has tion in the pool of carnitine in the failed to fulfil its obligations. body, such as an unbalanced diet, a drop in carnitine synthesis or intense physical exercise";

I - 1297

OPINION OF MR MISCHO — CASE C-24/00

referring to 'Cassis de Dijon', points out necessary in order to satisfy mandatory that 'consumer protection is one of the requirements relating in particular to... the overriding requirements added to the list of defence of the consumer'. 2 0 exceptions laid down in Article 30 EC'.

103. I consider that consumer protection is in fact at stake where there is no proof, as it follows from the above Opinion, the con- 101. As a preliminary matter, it is useful to tent of which has not in any case been note the judgment in Rombi and Arkoph- challenged by the Commission, that a arma, 1 8 in which the Court ruled that, 'in substance has the effect that it is stated to the absence, first, of Community rules on have. the authorisation of additives in general in foodstuffs intended for particular nutri- tional uses, and in particular on L-carni- tine, 1 9 and, second, of rules on the com- position of such foodstuffs, Community law does not preclude national legislation on additives authorised in the manufacture of this type of foodstuff such as the legis- 104. The Commission's argument that lation at issue in the main proceedings'. labelling is in such a case a measure less disproportionate than prohibition does not persuade me, since I do not see what information it would involve disclosing. Would a product surrounded in publicity drawing attention to the fact that it stimu- lates the metabolism of persons lacking in energy still be marketable if it carried the label: 'Caution, it is not proved that this product stimulates your metabolism'? 102. Finally, as suggested by the French Government, reference should be made to 'Cassis de Dijon', cited above, in which the Court ruled that 'obstacles to movement within the Community resulting from dis- parities between the national laws relating to the marketing of the products in ques- tion must be accepted in so far as those 105. I therefore consider that the Commis- provisions may be recognised as being sion has not proved that there is a failure to fulfil obligations in those circumstances.

— untrue claim as to the "energising" — risks linked to excess consumption of nature of the product, caffeine: c a r d i o v a s c u l a r ( c a r d i a c arrhythmia, increase in blood press- ure), neuropsychological (hyperkinesis, aggression, insomnia, source of seda- tive consumption), risks related to phosphorous and calcium metabolism — risk of a positive anti-drugs test for (loss of calcium). sportsmen.

I - 1299

OPINION OF MR MISCHO — CASE C-24/00

The [CSHPF] considers that the maximum health. On the contrary, it follows from level of caffeine in drinks must not exceed information supplied by the French Repub- 150 mg/l in drinks and notes that caffeine lic and which has not been challenged by consumption should not exceed 200 mg/ the Commission that the latter received on day.' 21 January 1999 from the Comité Scienti- fique de l ' A l i m e n t a t i o n H u m a i n e an Opinion adverse to the presence of certain additives in energy drinks.

108. It appears beyond question that by listing the specific risks linked to excess consumption of caffeine the CSHPF, as a scientific authority, has shown that the drinks in question present public health problems. The same applies where it states 111. In so far as the Opinion refers, at the that that kind of drink contains an 'excess- same time, to the 'untrue claim as to the ive concentration of caffeine (300 mg/l), "energising" nature of the product', it takes greater than that authorised (150 mg/l)'. account, in my opinion, of the criterion of consumer protection which is justified in the light of 'Cassis de Dijon', as I have set out above.

116. In that context, the French Govern- ment draws our attention to the Opinion of the CSHPF of 12 September 1995 'on safe 114. I am therefore of the opinion that the limits in food for vitamins and certain Commission has not proved that the French minerals'. The preamble to that Opinion Republic has failed to fulfil its obligations indicates that the CSHPF set the safe limits in the present case. for daily consumption of vitamins and minerals on the basis of 'bibliographical reviews and reports presented to the [CSHPF] on medical publications of the observations of secondary effects in man linked to the consumption of vitamins and minerals below,... the food toxicology 115. As regards the Opinion on sweets and rules,... the recommendations by French drinks fortified with vitamins, the follow- nutritional experts... [and] studies carried ing is stated in particular: out in France to date'.

' 3 . The French population is at risk of an 117. Having regard to Harpegnies, it can- excessive intake of a certain number of not be denied that the French Republic has vitamins for a minimal, but significant the power to set those safe limits and to proportion of its distribution. ensure that those limits are not exceeded.

4. The distribution of that kind of prod- uct may lead to the overstepping of safe 118. Moreover, the Commission does not limits for intake of certain vitamins. It show that it would have been more pro- is important to consider that an indi- portionate to the aim pursued — the pro- vidual might be encouraged to con- tection of health — to label sweets and sume numerous products fortified with drinks fortified with vitamins instead of

'36 As the Court has had occasion to affirm in its judgment of 14 July 1983 (Officier Van Justitie v Sandoz, Case 174/82, [1983] ECR 2445), the excess- ive consumption of vitamins over a prolonged period may have harmful 1 2 0 . T h e C o m m i s s i o n has p r o d u c e d effects, the extent of which varies n o t h i n g to s h o w t h a t the c o n c e r n s according to the type of vitamin, there expressed in 1983 are no longer scientifi- being generally a greater risk with cally valid today. vitamins soluble in fat than with those soluble in water. It is further apparent that it is principally in high concen- trations that vitamins constitute a seri- ous risk to health. According to the observations submitted to the Court, however, scientific research does not appear to be sufficiently advanced to be able to determine with certainty the 121. I am therefore of the opinion that, in critical quantities and the precise the case of vitamin-fortified sweets and effects. drinks also, the Commission has not proved to the requisite legal standard that the French Republic has failed to fulfil its 23 — Case 227/82 [1983] ECR 3883, paragraphs 36 to 38. obligations under Article 30 of the Treaty.

I - 1302

COMMISSION v FRANCE

123. I consider that the Commission's plea is unfounded. As pointed out by the French Government, under the procedure provided for by the Decrees of 15 April 1912 and 29 August 1991 the substances are auth- orised by order after an opinion has been obtained from 'the scientific authorities'. That means the CSHPF, whose role was 126. It should be noted, finally, that it was taken over after the Law of 98-585 of 1 July concluded above that a Member State may 1998 by the Agence Française de Sécurité also prohibit the marketing of a foodstuff des Aliments, and the Académie Nationale where it is not an immediate danger to de Médecine. The role of those authorities health, but where it is presented in such a is specifically to assess the innocuousness of way as to make the consumer believe that it new substances for which authorisations has a beneficial effect which, in reality, it for use are sought. has not.

I - 1303

OPINION OF MR MISCHO — CASE C-24/00

127. Lastly, the parties have also debated the standard of protection which they wish the question of whether the mere absence to ensure in the areas in which harmon- of nutritional value may also be a criterion isation has not occurred, which means justifying restriction of free movement. necessarily that they may consider that there is a risk where other Member States do not or are not concerned even to analyse the effect of a given substance.

128. I consider that the discussion is no longer relevant since, in my opinion, the French Republic has proved that the mar- keting of the products in question posed a risk to public health and/or to consumer protection.

IV — Conclusion

134. I propose that the Court should:

— find that the French Republic has failed to fulfil its obligations under Article 30 of the EC Treaty (now, after amendment, Article 28 EC) by not having provided for a procedure which is readily accessible, can be completed within a reasonable time and is capable of being challenged before the courts, if it leads to a refusal, for the purpose of having an additive entered on the list provided for by national legislation, which is necessary for marketing in France general foodstuffs and foodstuffs intended for special nutritional purposes, which are lawfully manufactured and/or marketed in other Member States of the European Community and which contain those substances;

— dismiss the remainder of the action;

— order each party to pay its own costs.

I - 1305