1. By application lodged at the Court Registry on 31 May 2000, the Commission of the European Communities brought an action under Article 226 EC for a declaration that, by interpreting and applying Paragraph 9(1) and (3) of the Bundesgesetz über den Verkehr mit Lebensmitteln, Verzehrprodukten, Zusatzstoffen, kosmetischen Mitteln und Gebrauchsgegenständen (Lebensmittelgesetz 1975) (Federal Law on trade in foodstuffs, products intended for human consumption, additives, cosmetic products and consumer goods, "the LMG" ) of 23 January 1975 as meaning that health-related information on foodstuffs for general consumption is prohibited in a general and absolute manner, and by subjecting the affixing of such information to a prior authorisation procedure, the Republic of Austria has failed to fulfil its obligations under Articles 2(1)(b) and 15(1) and (2) of Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ 1979 L 33, p. 1), as amended by Directive 97/4/EC of the European Parliament and of the Council of 27 January 1997 (OJ 1997 L 43, p. 21) ( "Directive 79/112" ), and under Article 28 EC.
2. By order of the President of the Court of 20 November 2000, the Kingdom of Denmark was given leave to intervene in support of the form of order sought by the Republic of Austria. Legal background Community legislation
3. Article 28 EC provides: "Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States."
4. Article 30 EC reads as follows: "The provisions of Articles 28 and 29 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States."
5. Article 2(1) of Directive 79/112 provides: "The labelling and methods used must not: (a) be such as could mislead the purchaser to a material degree, particularly: (i) as to the characteristics of the foodstuff and, in particular, as to its nature, identity, properties, composition, quantity, durability, origin or provenance, method of manufacture or production; (ii) by attributing to the foodstuff effects or properties which it does not possess; (iii) by suggesting that the foodstuff possesses special characteristics when in fact all similar foodstuffs possess such characteristics; (b) subject to Community provisions applicable to natural mineral waters and foodstuffs for particular nutritional uses, attribute to any foodstuff the property of preventing, treating or curing a human disease, or refer to such properties. "
6. Article 15 of Directive 79/112 provides: "1. Member States may not forbid trade in foodstuffs which comply with the rules laid down in this Directive by the application of non-harmonised national provisions governing the labelling and presentation of certain foodstuffs or of foodstuffs in general. 2. Paragraph 1 shall not apply to non-harmonised national provisions justified on grounds of: ─ protection of public health, ─ prevention of fraud, unless such provisions are liable to impede the application of the definitions and rules laid down by this Directive, ─ protection of industrial and commercial property rights, indications of provenance, registered designations of origin and prevention of unfair competition. "
7. The first subparagraph of Article 4(1) of Council Directive 84/450/EEC of 10 September 1984 concerning misleading and comparative advertising (OJ 1984 L 250, p. 17), as amended by Directive 97/55/EC of the European Parliament and of the Council of 6 October 1997 (OJ 1997 L 290, p. 18) ( "Directive 84/450" ), reads as follows: "Member States shall ensure that adequate and effective means exist to combat misleading advertising and for the compliance with the provisions on comparative advertising in the interests of consumers as well as competitors and the general public."
8. Under Article 7(1) of Directive 84/450: "This Directive shall not preclude Member States from retaining or adopting provisions with a view to ensuring more extensive protection, with regard to misleading advertising, for consumers, persons carrying on a trade, business, craft or profession, and the general public." National legislation
9. Paragraph 9 of the LMG provides: "1. In marketing foodstuffs, products intended for human consumption or additives, it is prohibited: (a) to refer to the prevention, relief or cure of illnesses or symptoms of illness, or to physiological or pharmacological effects, in particular effects which prolong youthfulness, slow down the symptoms of ageing, lead to weight loss or preserve health or to create the impression of any such effect; (b) to refer to case histories, recommendations by doctors or expert medical opinions; (c) to use health-related pictorial or stylised representations of organs of the human body, depictions of members of the health-care professions or of sanatoria or other pictures or illustrations referring to health-care activities; 2. The prohibitions in subparagraph 1 do not apply to traditional designations which leave no doubt as to the characteristics of the product. 3. The Federal Minister for Health and the Environment shall authorise, by decree and upon request, health-related information for certain foodstuffs or consumer products where that is consistent with the protection of consumers against fraud. The decree shall be revoked where the conditions of the authorisation are no longer met. " The administrative procedure
10. Having found that various foodstuffs which are lawfully manufactured in other Member States and are in free circulation there could not be marketed in Austria, on the ground that the statements relating to the health of consumers had not been authorised by the competent authorities in the context of the prior authorisation procedure, the Commission on 16 February 1999 sent the Austrian Government a letter of formal notice informing it that that practice was contrary to Articles 2(1)(b) and 15(1) and (2) of Directive 79/112 and to the principle of the free movement of goods.
11. By letter of 15 April 1999, the Austrian authorities replied to the Commission that, while the prohibition in Paragraph 9(1) of the LMG did indeed go beyond that in Article 2(1)(b) of Directive 79/112, it was nevertheless justified by Article 15(2) of that directive. Moreover, the Austrian legislation was also compatible not only with Directive 84/450 but also with the case-law of the Court of Justice, in particular Case 120/78 Rewe-Zentral ( "Cassis de Dijon" ) [1979] ECR 649.
12. Since it considered that the Republic of Austria had not taken any measures from which it could be concluded that an end had been put to the infringements referred to in the letter of formal notice, the Commission on 9 November 1999 sent that Member State a reasoned opinion, stating that the procedure for failure to fulfil obligations concerned the general prohibition of placing health-related information on the labelling of foodstuffs and the need to submit products bearing such information to a prior authorisation procedure.
13. By letter of 23 December 1999, the Austrian Government replied to the Commission that the national legislation did not apply a general prohibition of health-related information on the labelling of foodstuffs, but on the contrary a system of prohibition subject to authorisation. It also stated that the object of the administrative procedure was to ensure that every applicant was entitled to obtain authorisation to display health-related information if it was compatible with the protection of consumers against fraud and was strictly accurate.
14. Since it considered that the Republic of Austria had not complied with the reasoned opinion within the time-limit set, the Commission decided to bring the present action. Substance Arguments of the parties
15. The Commission submits that the general and absolute prohibition of health-related information on the labelling of foodstuffs is contrary to Articles 2(1)(b) and 15(1) and (2) of Directive 79/112 and that the prior authorisation procedure laid down for such information is incompatible with Articles 28 EC and 30 EC.
16. Article 2(1)(b) of Directive 79/112 only allows the Member States to prohibit statements relating to diseases. It leaves room, however, for health-related information on the labelling of foodstuffs, subject to compliance with the other conditions laid down by that directive, in particular the condition that such information must not mislead the purchaser.
17. According to the Commission, in addition to the prohibition of placing information relating to diseases on the labelling of foodstuffs, Paragraph 9(1)(a) to (c) of the LMG also prohibits the use of health-related information, for example references to physiological or pharmacological effects, in particular effects which prolong youthfulness, slow down the symptoms of ageing, lead to weight loss or preserve health. Such a prohibition cuts down the scope of Article 2(1)(b) of Directive 79/112.
18. On this point, the Commission submits that, according to the Court's case-law (Case C-241/89 SARPP [1990] I-4695, paragraph 15), because Directive 79/112 is general and applicable horizontally, it allows the Member States to maintain or adopt rules in addition to its own provisions. However, the directive lists exhaustively, in Article 15(2), the grounds on which the application of national provisions may be justified.
19. It follows, according to the Commission, that the general and absolute prohibition in Paragraph 9 of the LMG of displaying health-related information must be regarded as a non-harmonised national provision which may be applied only in cases in which it is justified on one of the grounds listed in Article 15(2) of Directive 79/112, namely protection of public health, protection of consumers and prevention of unfair competition.
20. According to the Commission, contrary to the submissions of the Austrian Government, the protection of consumers may not be relied on to justify the prohibition in question, given that it extends also to correct statements which are not liable to mislead a reasonably well-informed consumer.
21. A foodstuff whose labelling carries a health-related statement and which is lawfully marketed in another Member State with respect to Directive 79/112 cannot therefore, in the Commission's view, constitute fraud within the meaning of Article 15(2) of that directive and thus justify the application of non-harmonised national provisions.
22. As regards the procedure for prior authorisation to place health-related information on the labelling of foodstuffs provided for in Paragraph 9(3) of the LMG, the Commission considers, first, that it is not covered by Directive 79/112 and, second, that it constitutes a measure having equivalent effect within the meaning of Article 28 EC.
23. In the Commission's view, the legislation has the consequence that products bearing health-related information which are lawfully produced or marketed in another Member State may be marketed in Austria only on condition of obtaining prior authorisation.
24. Moreover, the Commission submits that such an administrative procedure cannot be justified with respect to Directive 84/450 either, since the labelling and presentation of foodstuffs is definitively regulated by Directive 79/112. Article 2(1)(a) of the latter directive prohibits statements on the labelling of foodstuffs which mislead the purchaser.
25. In addition, the Commission submits that the protection of consumers can be ensured by means which are less restrictive of the free movement of goods than the requirement of prior authorisation. Thus provision could be made for checks to identify in the market products carrying statements liable to mislead the purchaser.
26. The Austrian Government concedes that the prohibition of health-related information laid down in Paragraph 9(1) of the LMG goes beyond the content of the prohibition in Article 2(1)(b) of Directive 79/112. It argues, however, that such a prohibition is compatible with Article 15(2) of that directive, as it pursues the objective of the protection of public health or of consumers.
27. It submits that the national law authorises, in an administrative procedure applicable to both domestic and imported goods, health-related information on the labelling of foodstuffs if it is accurate and liable to ensure the protection of consumers against fraud. The determination of whether or not such information is accurate cannot, however, be left to the subjective assessment of the party applying for authorisation to use it.
28. Moreover, according to the Austrian Government, protection of consumers may lead to protection of health. Misleading statements on the labelling of a product, ascribing qualities to it which it does not possess, may have negative consequences for the condition of sick persons, in particular where an effective treatment for the diseases they suffer from is neglected because they have relied on the effect of a product so labelled.
29. As regards the prior authorisation procedure laid down in Paragraph 9(3) of the LMG, the Austrian Government submits that Directive 79/112 does not regulate exhaustively the question of the labelling and presentation of foodstuffs.
30. It considers that Article 2 of Directive 79/112 is silent as regards the authorisation of health-related statements or advertisements which are not misleading, so that it is necessary to refer to Directive 84/450 on this point. That directive, Article 2 of which adopts a broad interpretation of misleading advertising, applies also to advertising for a product whose misleading effect derives from the wording printed on the labelling of the product concerned.
31. It argues that it may be inferred from the preamble to Directive 84/450 in combination with Article 7 of that directive, which allows Member States to adopt provisions with a view to ensuring more extensive protection of consumers, with regard to misleading advertising, that a prior control of foodstuffs carrying health-related information is not contrary to Community law.
32. Moreover, the Austrian Government considers that the system of prior authorisation may be applied, as a non-harmonised national provision, if it is justified on one of the grounds set out in Article 15(2) of Directive 79/112. The ground of protection of consumers is expressly mentioned in that provision.
33. Finally, the Austrian authorities submit that the obligation of prior authorisation constitutes the least severe means of ensuring the necessary protection of the health of consumers, since the system of control a posteriori of foodstuffs already on the market is not capable of ensuring such protection. Findings of the Court
34. It should be noted, first, that Article 2(1)(a) of Directive 79/112 prohibits the labelling of foodstuffs and the methods used being such as could mislead the purchaser. Second, Article 2(1)(b) of that directive prohibits, subject to the provisions applicable to foodstuffs for particular nutritional uses, the labelling attributing to a foodstuff the property of preventing, treating or curing a disease.
35. It follows that Directive 79/112 prohibits all statements relating to human diseases, regardless of whether or not they are liable to mislead the consumer, as well as statements which, although not containing any reference to diseases but referring rather to health, for example, prove to be misleading.
36. It must also be noted that Article 15(1) of Directive 79/112 prevents Member States from enacting measures prohibiting trade in foodstuffs which comply with the rules laid down in that directive.
37. Consequently, foodstuffs whose labelling contains non-misleading health-related information must be regarded as complying with the rules of Directive 79/112, since Member States may not prohibit their marketing on grounds of a possible irregularity of that labelling.
38. However, as is apparent from the ninth recital in its preamble, because Directive 79/112 is general and applicable horizontally, it allows the Member States to lay down rules in addition to those of the directive. The limits of the power retained by the Member States are fixed by the directive itself inasmuch as it lists exhaustively, in Article 15(2), the grounds on which the application of non-harmonised national provisions prohibiting trade in foodstuffs which comply with the directive may be justified (see, to that effect, SARPP , paragraph 15). Those grounds include inter alia the protection of health and consumers.
39. Paragraph 9(1) of the LMG prohibits, in connection with the marketing of foodstuffs, not only statements referring to diseases but also those relating to health. It appears from the documents in the case that the Austrian courts interpret that provision as meaning that the prohibition applies even if the information concerning health is accurate.
40. Under Paragraph 9(3) of the LMG, all statements relating to health are subject to a prior authorisation procedure which is intended to differentiate accurate information from information which is liable to mislead the consumer. Authorisation or prohibition of marketing the foodstuffs concerned depends on the differentiation operated by the competent national authorities.
41. The system thus laid down in Paragraph 9(1) and (3) of the LMG, which is characterised by a general prohibition subject to prior authorisation for health-related information, is more restrictive than that under Article 2(1) of Directive 79/112. Its lawfulness therefore depends on an assessment of the grounds on which it is based.
42. On this point, it must be observed that, since Article 15(2) of Directive 79/112 carried out an exhaustive harmonisation of the grounds on which the application of national rules raising obstacles to trade in foodstuffs complying with the directive may be justified, any national measure relating thereto must be assessed in the light of the provisions of that harmonising measure and not of Articles 28 EC and 30 EC (see, inter alia , Case C-37/92 Vanacker and Lesage [1993] ECR I-4947, paragraph 9; Case C-324/99 DaimlerChrysler [2001] ECR I-9897, paragraph 32; and Case C-99/01 Linhart and Biffl [2002] ECR I-9375, paragraph 18).
43. It must also be noted that Articles 2 and 15 of Directive 79/112 prohibit statements liable to mislead the purchaser. This is a specific provision intended to prevent fraud which must be interpreted as a special rule in relation to the general provisions on protection against misleading advertising laid down in Directive 84/450 (see, to that effect, Linhart and Biffl , paragraphs 19 and 20).
44. In those circumstances, the compatibility of the national provisions in question with Community law must be assessed solely by reference to Directive 79/112.
45. It is common ground that the system established by the LMG is based on the consideration that the protection of consumers against fraud necessarily requires that whether or not health-related information on the labelling of foodstuffs is misleading should be the subject of prior examination by the competent national authorities.
46. It must therefore be ascertained whether the prior authorisation system laid down in Paragraph 9(3) of the LMG may be regarded as compatible with Article 15(2) of Directive 79/112, in so far as that provision authorises non-harmonised national provisions which are justified on grounds of the protection of public health and the prevention of fraud.
47. For that to be the case, the system must be appropriate for securing the attainment of the objective which it pursues and must not go beyond what is necessary in order to attain it.
48. While Article 2(1) of Directive 79/112 prohibits, first, all statements relating to the preventing, treating and curing of a human disease, even if they are not liable to mislead the purchaser, and, second, misleading statements relating to health, it is clear that the protection of public health, assuming that risks relating thereto are nevertheless conceivable in a particular situation, cannot justify a system as restrictive of the free movement of goods as that which results from a procedure of prior authorisation for all health-related information on the labelling of foodstuffs, including those which are manufactured lawfully in other Member States and are in free circulation.
49. Less restrictive measures exist for the prevention of such residual risks to health, such as, for example, an obligation on the manufacturer or distributor of the product in question, in the event of any uncertainty, to furnish evidence of the accuracy of the facts mentioned on the labelling (see, to that effect, Case C-77/97 Unilever [1999] ECR I-431, paragraph 35).
50. The Austrian Government's argument based on the protection of consumers cannot be accepted either.
51. The system established by Paragraph 9(1) and (3) of the LMG, which is intended to prohibit misleading statements relating to health, has the consequence in practice that foodstuffs bearing health-related information may not be marketed freely in Austria, even if the information is not liable to mislead the consumer.
52. The Austrian Government has not produced any evidence to establish its claim that the system of control a posteriori of foodstuffs already on the market, such as that referred to in paragraph 49 above, would be ineffective. It has confined itself to stating, without giving reasons, that such a system had negative results in the United States and would not be suited to the European approach to the protection of health and of consumers. The general prohibition established by Paragraph 9(1) and (3) of the LMG cannot therefore be regarded as proportionate to the aim pursued.
53. It should be added that, in similar cases concerning information on the packaging of certain cosmetic products, in which the Austrian authorities likewise relied on the protection of the health of consumers and the prevention of fraud, the Court held that the need to obtain the authorisation laid down in Paragraph 9(3) of the LMG constituted a wholly unjustified obstacle to the free movement of the products in question (Unilever , paragraph 34, and Linhart and Biffl , paragraph 45).
54. Paragraph 9(1) and (3) of the LMG consequently establishes a system which goes beyond what is necessary to attain the objective pursued by that national legislation, and therefore does not comply with the principle of proportionality.
55. Having regard to the above considerations, it must be held that, by laying down a general prohibition of health-related information on the labelling of foodstuffs for general consumption and by subjecting the display of such information to a prior authorisation procedure, the Republic of Austria has failed to fulfil its obligations under Articles 2(1)(b) and 15(1) and (2) of Directive 79/112.