C-221/00

I — Introduction 2. Case C-221/00 concerns an action brought against the Republic of Austria by the Commission under Article 226 EC. The Commission received complaints that foodstuffs which had been lawfully manu- factured and put on the market in other Member States could not be sold in Austria because the health-related information affixed thereto was not authorised by the authorities. Such information included, for example, the statements 'for a cholesterol- 1. The cases covered by these combined conscious diet' on the labelling of salmon- Opinions essentially concern the question oil capsules; 'a contribution to healthy whether a national rule containing a gen- intestinal bacteria and healthy cells' on eral prohibition on health-related infor- the labelling of bread, and 'dietary fibre mation appearing on foodstuffs unless and bulking agent for sufferers of consti- prior authorisation has been granted is pation caused by diet' on the labelling of compatible with the provisions of Council linseed. 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 for sale to the ultimate consumer (here- inafter 'Directive 79/112') 2 and with Articles 28 and 30 EC relating to the free movement of goods. In particular, the Court is required to rule on the provisions of Directive 79/112 concerning the prohib- ition of disease-related information and misleading labelling (Article 2) and the right of Member States to prohibit the sale 3. After the Commission brought the of foodstuffs which comply with the direc- action, a number of courts in Austria tive by applying non-harmonised national referred questions to the Court of Justice labelling provisions (Article 15). for a preliminary ruling on the compatibil- ity of the same national rules with Com- munity law. The main proceedings concern 1 — Original language: Dutch. inter alia the statements 'a good name for 2 — OJ 1979 1. 33, p. 1. The directive lias been amended several tunes. On 20 March 2000 a consolidated text (Directive healthy enjoyment' on the labelling of pâté 2000/1 VEC, OJ 2000 L 109, p. 29; hereinafter 'Directive 2000/13') was adopted by the Council and the European (Case C-421/00) and the information 'for Parliament. the protection of the cell membrane against

5. Article 28 EC prohibits quantitative restrictions on imports and all measures having equivalent effect between Member States. Article 30 EC provides that (a) be such as could mislead the purchaser Article 28 EC does not preclude prohib- to a material degree, particularly: itions or restrictions on imports or goods in transit justified on grounds of inter alia the

3 — Case C-77/97 [1999] ECR I-431. With regard to the rules for cosmetic products, see the pending Case C-99/01 (i) as to the characteristics of the Unhart [2002] ECR I-9375, in which I delivered my Opinion on 7 March 2002. foodstuff and, in particular, as to

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its nature, identity, properties, Treaty, shall draw up a non-exhaustive list composition, quantity, durability, of the claims within the meaning of para- origin or provenance, method of graph 1, the use of which must at all events manufacture or production; be prohibited or restricted. 4

3. The prohibitions or restrictions referred to in paragraphs 1 and 2 shall also apply to: (ii) by attributing to the foodstuff effects or properties which it does not possess;

down in this Directive by the application of advertising (hereinafter 'Directive non-harmonised national provisions gov- 84/450'), 5Member States are to ensure erning the labelling and presentation of that 'adequate and effective means exist for certain foodstuffs or of foodstuffs in gen- the control of misleading advertising in the eral. interests of consumers as well as competi- tors and the general public'. Article 7 provides that Directive 84/450 does not preclude Member States from retaining or adopting provisions with a view to ensuring more extensive protection for the persons 2. Paragraph 1 shall not apply to non-har- concerned. monised national provisions justified on grounds of:

— protection of public health, B — National law

III — Facts and procedure (b) to refer to case histories, recommen- dations by doctors or expert medical opinions;

A — The infringement proceedings (c) to use health-related pictorial or sty- lised representations of organs of the human body, depictions of members of the health-care professions or of sana- toria or other pictures or illustrations referring to health-care activities.' 14. In the infringement proceedings, the Commission claims that the Court should:

12. Under Paragraph 9(3) of the LMG, the minister must, upon request and by decree, authorise the provision of health-related information in respect of certain foodstuffs or products intended for human consump- '(1) declare that, by interpreting and apply- tion where that is consistent with protect- ing Paragraph 9(1) of the Lebensmit- ing consumers against being misled. telgesetz ("the LMG") as meaning that health-related information on food- stuffs intended for human consumption is prohibited in a general and absolute manner, and by subjecting the affixing of such information to a prior auth- orisation procedure (Paragraph 9(3) of 13. According to Paragraph 74(1) of the the LMG)), the Republic of Austria has LMG, anyone who inter alia falsely failed to fulfil its obligations under

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Articles 2(1)(b) and 15(1) and (2) of described in that they bore the health- Directive 79/112 and under Article 28 related information 'ein guter Name für EC (ex Article 30 of the EC Treaty); gesunden Genuss' ('a good name for healthy enjoyment') and it is forbidden, in marketing foodstuffs, consumer products or additives, to refer to the prevention, relief or cure of illnesses or symptoms of illness, or to physiological or pharmaco- (2) order the defendant to pay the costs.' logical effects, or to create the impression of any such effect. She therefore acted in contravention of the provisions of Para- graph 9(1)(a) of the LMG and was ordered inter alia to pay fines pursuant to Para- graph 74(1) of the LMG. 15. The Republic of Austria contends that the action should be dismissed and that the Commission should be ordered to pay the costs.

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waltungssenat therefore referred the fol- the Court of Justice to give a ruling on the lowing question for a preliminary ruling: following questions:

'(1) Does Paragraph 9 of the LMG con- stitute an appropriate transposition of Article 2(1 )(b) of Council Directive 'Are Article 28 (ex Article 30) of the EC 79/112/EEC of 18 December 1978? Treaty as amended by the Treaty of Amsterdam and 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 for sale to the ultimate con- (2) Does Article 2(1 )(b) of Directive sumer (OJ 1979 L 33, p. 1) in the 79/112/EEC make exhaustive provi- applicable version to be interpreted as sion concerning unlawful labelling, or precluding national legislation prohibiting does that provision provide for a any health-related information from minimum level of regulation which appearing on the labelling and presentation may be supplemented by national of foodstuffs, products intended for human provisions? consumption and additives for general consumption, save if expressly authorised? (Paragraph 9(1 )(a), (b) and (c) and (3) of the LMG 1975, BGBl. No 1975/86 in the applicable version)?' (3) Is Article 2(1)(b) of Directive 79/112/EEC to be construed to mean that a restriction on labelling (such as that in Paragraph 9(1) of the LMG in regard to health-related information) is only permissible where a prohibition appears to be an unavoidable necessity in order to prevent consumers from being misled? 19. In the main proceedings in Case C-426/00, P.D. Haug was ordered by the city council of Vienna to pay fines for contravening the foodstuffs legislation. In an order for reference of 15 November 2000, which otherwise provides no insight into the factual background to the case in (4) Can Paragraph 9(1) of the LMG be the main proceedings, the Unabhängiger interpreted so as to comply with the Verwaltungssenat Wien (Independent directive and the restriction on label- Administrative Chamber, Vienna) requests ling mentioned therein be deemed to be

in conformity with Article 2(1)(b) of ideal for enhancing the nutritional level of Directive 79/112/EEC? This would be the daily food intake because they contain: possible inasmuch as an intention to a high level of linoleic acid, important as a m i s l e a d is n o t r e q u i r e d by constituent of the cell membrane; tocophe- Article 2(l)[(b)] as a whole but is a rols and carotenoids, important in protect- second criterion of the unlawfulness of ing the cell membrane against free radicals; a label.' the trace elements iron, copper, manganese, zinc and selenium, which are important for the functioning of many enzymes; the minerals calcium, magnesium and phos- phate, which are important for building bones and teeth; a high level of potassium, important in regulating the fluid balance (bladder functioning). Oil pumpkin seed capsules from Renatura not only contain 20. Finally, in the main proceedings in the valuable nutrients of Styrian oil pump- Case C-16/01, by judgment of the Unab- kin seeds, but are also enriched with added hängiger Verwaltungssenat Wien of Vitamin E. They can therefore be especially 12 October 1999, P.D. Haug was found recommended as a daily food supplement.' guilty, as the manager with general com- mercial power of representation of Renatura Naturheilmittel Ges.mb.H., of having been responsible for the company's supplying to DM-Zentrale in Enns, and thus putting on the market, the product 'Renatura Kürbiskernkapseln mit Vitamin E Blase und Prostata' purchased from Renatura Naturheilmittel Ges.m.b.H in Germany. Under the LMG, that consumer product was falsely described inasmuch as the accompanying leaflet contained the following health-related information in contravention of Paragraph 9(1) of the 21. In its case-law, the Verwaltungsgericht- LMG: 'for protection of the cell membrane shof has hitherto construed Paragraph 9(1) from free radicals'; 'important for the of the LMG as not distinguishing between functioning of many enzymes'; 'important health-related and disease-related infor- as a building block for bones and teeth'; mation, but as prohibiting generally all 'regulation of the fluid balance (bladder health-related information. In considering functioning)'. whether a specific piece of information is health-related, the Verwaltungsgerichtshof has always based its assessment on the generally prevailing view. Under the case- law of the Verwaltungsgerichtshof, the decisive factor is whether, in the case of the average consumer, a description is likely at first glance to convey the impres- sion that consumption of the foodstuff so That information was given in the follow- described has a favourable effect on health ing context: 'Styrian oil pumpkin seeds are (that is to say, at least the effect of

9 — The referring court cites as examples of descriptions which have been classified as prohibited health-related infor- mation: 'the healthy alternative'; 'only approx. 105kcal/100g — makes you fit, not fat'; 'Linusit Gold supplies roughage and bulking agent for constipation caused by diet'; and 'improves bladder function'. 10 — It is worth mentioning that the referring court states that it does not share the view expressed by the Austrian Government in the reply in Case C-221/00, and discussed (b) to refer to case-histories, recom- further on in this Opinion, that Paragraph 9(1) of the mendations made by doctors or LMG goes beyond the terms of Article 2(1)(b) of Directive 79/112. medical experts' reports;

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(c) to use health-related pictorial or IV — Pleas in law and main arguments of stylised representations of organs the parties of the human body, pictures of members of the health-care profes- sions or of sanatoria or other pictures or illustrations referring to health-care activities?

A — Infringement proceedings (Case C-221/00)

25. In its application, the Commission 2. Do Directive 79/112/EEC or Articles 28 makes a distinction between the prohib- and 30 EC preclude a national provi- ition of health-related information appear- sion which, on the placing into circu- ing on foodstuffs (Paragraph 9(1) of the lation of foodstuffs, permits health- LMG) and the requirement of prior auth- related information such as that orisation for health-related information to described in Question 1 to be affixed appear on foodstuffs (Paragraph 9(3) of the thereto only after prior authorisation LMG). by the competent federal minister, whereby a condition of authorisation is that the health-related information is consistent with protecting the con- sumer from being misled?'

sumer protection relied on by the Austrian be granted if the information in question is Government does not justify a general truthful and not misleading — as the Aus- prohibition of health-related information trian Government claims —, constitutes a since statements which are true and not measure having equivalent effect within the likely to confuse the average consumer are meaning of Article 28 EC. Under the also caught by the prohibition. 13 In that Court's settled case-law, obstacles to move- connection, the Commission points out ment within the Community resulting from that the law of a Member State must not disparities between national laws are cement given consumer habits with a view accepted in so far as those provisions are to preserving an advantage acquired by a necessary for reasons relating to the public domestic industry engaged in meeting the interest, such as consumer protection, pro- consumer demand when other measures are vided that they are proportionate to the available to protect consumers against the intended purpose and that purpose cannot risk of being misled. 14 The Court's case- be achieved by measures less restrictive of law confirms that it is not permitted to base free trade. 16 However, since the Commis- national rules for the protection of public sion considers that the general prohibition health and consumers only on the circum- of health-related information is not justi- stances prevailing in the Member State fied on grounds of consumer protection, concerned. According to the Commission, the same conclusion applies with regard to the view that a general prohibition such as the requirement of prior authorisation the one at issue finds no justification in connected with that prohibition. Moreover, Article 15(2) of Directive 79/112 is borne consumer protection can be ensured by out by the judgment in Unilever which measures having a less restrictive effect on concerned the same Austrian rules in so far the free movement of goods. Thus, for as they relate to cosmetic products. 15 example, targeted checks on the market could take place in order to identify products bearing descriptions likely to mislead the consumer, as the Court has already held in Unilever. 17 The Commis- sion further argues that the Austrian Gov- ernment has failed to show why the pro- cedure of prior examination is the least restrictive and most appropriate means of protecting the consumer against the risk of being misled. Moreover, the case-law under 27. The Commission assesses the condition which the marketing of foodstuffs may be of prior authorisation in the light of the made subject to prior authorisation is not Treaty provisions concerning the free relevant in the present case. 18 movement of goods (Articles 28 and 30 EC). The fact that authorisation must be applied for under Paragraph 9(3) of the LMG, even though such authorisation may

28. The Austrian Government acknowl- of the LMG, the Austrian Government then edges that the prohibition on health-related adds the following further points to those information exceeds the scope of arguments. It argues that Directive 79/112 Article 2(1)(b) of Directive 79/112 but does not make exhaustive provision. argues that it is covered by Article 15(2) Article 2 deals with the prohibition of of that directive for reasons connected with misleading and disease-related descriptions, the protection of public health and the but is silent on the permissibility of health- consumer. Any application for authori- related information and advertising which sation to use a health-related description are not misleading. For those reasons, the is granted if that description is truthful and Austrian Government — in contrast to the consistent with the requirement that the Commission — takes the view that in this consumer must be protected against the case account must also be taken of Direc- risk of being misled. That must not be left tive 84/450, as amended by Directive to the subjective judgement of a trader but 97/55. Article 2 of Directive 84/450, which must be verified on the basis of an objective also applies to foodstuffs, starts from a criterion. A misleading description which broad concept of deceptive advertising. attributes to a product a property which it That directive therefore also applies to does not possess (for example, 'beneficial to advertising on a product, the deceptive your health') may have adverse effects on a character of which stems from the wording patient's condition, in particular where an on the packaging. The Austrian Govern- effective treatment for a disease and its ment infers from the recitals in the pre- symptoms is disregarded because patients amble to Directive 84/450, and from the rely on the 'effect' of the product. The right of Member States, enshrined in Austrian Government is not convinced by Article 7, to adopt measures which afford the judgments cited by the Commission and consumers more extensive protection in its opinion the examples of health-re- against misleading advertising, that a lated descriptions mentioned in the appli- requirement of prior authorisation for cation 19 are not relevant. Those descrip- tions have either already been authorised foodstuffs carrying health-related infor- or, as medicinal claims, fall under mation is not contrary to Community law.

United States. In that connection, it also 29. With regard to the requirement of prior points out that the legal framework result- authorisation laid down by Paragraph 9(3) ing from the Unilever judgment, which relates to cosmetic products, is different

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appearing on foodstuffs, even if the descrip- is positioned within the scheme of Directive tion in itself is true. Under the case-law of 79/112. That analysis is technical and legal the Verwaltungsgerichtshof, the decisive in nature. Nevertheless, a number of ques- factor for classifying a description as tions of principle arise in this regard, which 'health-related information' is whether, it are relevant to the further development of is likely at a glance to convey to the mind of law in the field of information about, and an average consumer the impression that labelling of, foodstuffs. consumption of the foodstuff so described has a beneficial effect on health. However, the prohibition on such information is not absolute. Under Paragraph 9(3) of the LMG, a trader may apply for prior auth- orisation to show health-related infor- mation on foodstuffs. The minister respon- sible must grant authorisation if the claims are truthful and do not mislead the con- 35. I shall examine below, first, the Com- sumer. mission's application in Case C-221/00. The assessment of that case will then provide the basis for answering the ques- tions referred by the Austrian courts. Where appropriate, submissions made in connection with the proceedings for pre- liminary rulings will be assessed in the course of considering the infringement proceedings.

and (2) of Directive 79/112, 22 and the Directive 79/112. Article 15(1) contains a requirement of prior authorisation, which market access clause: Member States may the Commission examines under Articles 28 not forbid trade in foodstuffs which comply and 30 EC, is not tenable. That separate with the provisions of the directive by assessment of the provisions of Paragraph applying national foodstuffs legislation in 9(1) and Paragraph 9(3) of the LMG is so far as such legislation consists of 'non- functionally illogical. It is also inconsistent harmonised national provisions'. If a with the scheme of Directive 79/112. national provision is harmonised, it must be assessed on the basis of the correspond- ing provision of the directive. 23 If a national provision is not harmonised, but falls within the material scope of Directive 79/112, it may be justified only by virtue of Article 15(2). Under that provision, Article 15(1) does not apply to 'non-har- 37. First, there is an obvious and indis- monised national provisions' justified on soluble connection between the general grounds of inter alia the protection of prohibition in Paragraph 9(1) of the LMG public health and the prevention of fraud and the authorisation requirement in Para- and unfair competition. In SARPP, the graph 9(3) of the LMG. The Austrian Court held that the limits of the power of Government has rightly pointed out that the Member States to maintain or adopt the system of authorisation in Paragraph rules in addition to those laid down by the 9(3) of the LMG presupposes the general directive are 'set by the directive itself in so prohibition in Paragraph 9(1) of the LMG. far as it lists exhaustively, in Article 15(2), Without such a prohibition, the system of the grounds on which the application of authorisation could not work. By means of non-harmonised national provisions... may the functional correlation between them, be justified.'24 the two provisions are designed to ensure effective control of health-related infor- mation.

national laws and attaches different legal that not all national labelling requirements consequences to them. However, there is are fully covered by the directive. Thus, for yet a third possibility. If a national provi- example, there are no specific provisions on sion is not harmonised, but also falls health-related descriptions and the matter outside the scope of the directive, the of authorisation requirements is not provision in question must, where appro- covered. Moreover, the directive allows priate, be examined in the light of the the Member States to adopt certain deroga- general provisions of the Treaty. Thus, ting measures in the field of labelling. according to the Court in the judgment in Nevertheless, national labelling rules per- SARPP, Directive 79/112 makes a distinc- taining to areas harmonised by the directive tion between the rules for labelling and must be assessed within the scheme of the advertising. As far as labelling is concerned, directive — namely, Article 15(2) — and the limit of the powers of the Member not in the light of Articles 28 and 30 EC. 27 States is set by the directive itself. That also With regard to the legislation on labelling, applies to national rules which lay down the system of the directive is conclusive. 28 conditions which, as such, are not covered by the directive. On the other hand, national rules which make advertising sub- ject to conditions in addition to those laid down by the directive must be considered in the light, in particular, of the provisions of the Treaty on the free movement of goods and especially Articles 28 and 30 EC. 25

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the remaining provisions of the directive, state any clear criteria on the basis of which and Articles 28 and 30 EC is not notable it makes such a distinction. 31 for its high degree of consistency. In a number of judgments, alleged infringe- ments of specific provisions of the directive are assessed solely in the light of the relevant provisions of the directive, without reference to primary Community law on the free movement of goods. In another part of the case-law, the Court takes as its basis both the directive and Articles 28 and 30 EC. 30 On no occasion does the Court

In infringement proceed- ings against Germany, the Court gave judgment on assessing it under the provisions of the national rules under which foodstuffs containing an ingredient which is not in conformity with the traditional national recipe must carry a trade description with an additional statement indicating that the substance in question has been used, even if that substance is already 31 — An illustrative example of this is the case-law concerning included in the list of ingredients. The Commission had language requirements which a Member State may impose based its complaints both on Article 5 of Directive 79/112 in the field of labelling. In the judgment in Piageme I, the and on Article 28 EC. The Court held as follows in that Court declared that a national rule requiring the exclusive regard: 'In that connection, it is sufficient to note that the use of a specific language for the labelling of foodstuffs, requirement laid down in Article 5(1) of the Directive to without allowing for alternative methods of informing the the effect that any additional particulars accompanying the purchaser, was contrary to Article 28 EC and to the rules trade description must be necessary for the information of on the use of languages under Article 14 of Directive consumers also follows from Article [28 EC] and that, 79/112, which were applicable at that time (Case C-369/89 consequently, this point cannot constitute a separate [1991] ECR I-2971). In Piageme 11, on the other hand, a ground of challenge' (Case C-51/94 Commission v Ger- question concerning the same national rule was disposed of many [1995] ECR I-3599, paragraph 40, italics added). In solely on the basis of Article 14 (Case C-85/94 [1995] ECR the Bellamy and English Shop Wholesale case, a Belgian I-2955). Similarly, in the judgment in the related Goerres court sought to ascertain whether Article 28 EC precludes case, there is no reference to Article 28 EC, perhaps a national rule which prohibits giving the impression that a because the national court had not mentioned that branded product possesses particular qualities when in fact provision in its questions (Case C-385/96 [1998] ECR all similar foodstuffs display the same qualities and, if so, I-4431). In the recent judgment in Geffroy, however, the

21). It is remarkable that the Court implicitly gave and in the light of Article 28 EC. That twofold examin- judgment by reference to primary Community law, ation occurs only by virtue of a reference to the above- whereas in fact the case concerned the transposition of a mentioned three judgments in Piageme J, Piageme II and provision of a directive. In Darbo, cited in footnote 23, the Goerres (Case C-366/98 [2000] ECR I-6579, paragraphs Court was asked whether Article 2(1)(a)(i) of Directive 24 to 28). 79/112 precludes use of the words 'naturally pure' to describe a strawberry jam which contains the gelling agent 32 — As recently held in Case C-324/99 DaimlerChrysler [2001] pectin and traces or residues of lead, cadmium and ECR 1-9897, paragraph 32. See also in this respect, as

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Treaty. In my opinion, no such possibility 79/112, Directive 84/450 (as amended) is arises in this case. also relevant for the purpose of assessing the authorisation requirement laid down by Paragraph 9(3) of the LMG must also be examined.

46. However, that does not alter the fact that the provisions of Directive 79/112 must, as must any provisions of secondary 48. Even assuming that Directive 84/450 law, be interpreted in the light of the covers the labelling of foodstuffs, that provisions of the Treaty relating to the free directive cannot be relied on successfully movement of goods. 33 That applies a in the present proceedings. In so far as the fortiori in the present case, where the scope issue in the labelling of foodstuffs is that of Article 15(2) of Directive 79/112 dis- the consumer may be misled, Directive plays features in common with the grounds 79/112 lays down specific provisions in of justification under Article 30 EC (pro- Articles 2 and 15. Here the principle lex tection of public health) and the Cassis de specialis derogat legi generali applies, so Dijon case-law (consumer protection and that that directive takes precedence over a fair trade). 34 A consequence of that affinity set of general rules such as Directive is that the principle of proportionality also 84/450. In view of the exhaustive nature applies when examining national rules in of the harmonisation of national labelling the light of Article 15 of Directive provisions, Member States may not dero- 79/112. 35 Viewed thus, those consider- gate from the requirements laid down in ations do not affect the issues in these those rules. That applies in particular to proceedings. The Commission's action Article 7 of Directive 84/450, which allows seeks a declaration that the national rules more extensive protection for consumers in question are in any event contrary to against misleading advertising. 36 Article 15(1) and (2) of the directive. In so far as the Commission's action also seeks a finding of infringement of Articles 28 and 30 EC, that complaint no longer has any independent significance.

50. The Commission points out in its application that the recitals in the preamble to the directive (now recital 14) state that the rules on labelling should also prohibit the use of information that would 'attribute 52. The Commission concedes, in its medicinal properties to foodstuffs'. It adds written observations in Case C-16/01, that that that function is reserved to medicinal Article 2(l)(b) does not make an express products within the meaning of Directive distinction between health-related and dis- 65/65. 37 ease-related information. In its opinion, the directive seeks to keep the consumer, when ill or in order to prevent disease, from resorting to foodstuffs which are not intended for that purpose. Under the defi- nition in Directive 65/65, a medicinal product has the property of restoring, 51. That narrow view is disputed by the correcting or modifying physiological func- Danish Government. According to the tions in human beings. If, on the other latter, health-related statements are also hand, a product is merely 'healthy', such covered by Article 2(l)(b) of Directive properties cannot be ascribed to it. A 79/112. The Verwaltungsgerichtshof, distinction between the two kinds of infor- which is the referring court in Case mation must therefore be made, even C-16/01, likewise points out that that though the dividing line is sometimes dif- provision makes no distinction between ficult to draw. health-related and disease-related infor- mation. A workable criterion for distin- guishing between health-related and dis- ease-related information cannot be found, and the consumer would also be unable to make a distinction between health-related and disease-related information. In the 53. I agree with the view that a distinction view of the Verwaltungsgerichtshof, all must certainly be made here, a view which information which is in any way related was in any case not contradicted by the Austrian Government in the main proceed- ings. Article 2(l)(b) states unequivocally 37 — Council Directive 65/6J/EEC of 26 January 1965 on the that the prohibition relates to labelling approximation of provisions laid down by law, regulation which is directly or indirectly connected or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 24). It with a human disease. Disease is a con- has since been replaced by Directive 2001/83/EC of the European Parliament and of the Council of 6 November dition in which a person's organs and vital 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67). The processes do not function properly and definition of 'medicinal product' has remained unchanged. normally. Disease is contrasted with a

D — Assessment under Article 15 of Directive 79/112

54. The prohibition laid down by Article 2(1 )(b) of Directive 79/112 is abso- lute, which means that what are described as disease-related claims are by definition 56. It should be pointed out from the outset prohibited regardless of whether they are that Article 15(1) precludes the application accurate or whether they mislead the con- sumer. That provision requires Member States to prohibit disease-related infor- 38 — By analogy with the way in winch the Court regards products possessing properties or hoth mediami! products mation, but by contrary inference is not and. for example, cosmetic products as subiect to the more concerned with health-related information, rigorous Community rules applicable to medicinal prod- ucts (sec Case C-.Ï69/88 Dclutrc |1991] ICR I-I48~. which is thus not prohibited by virtue of paragraphs 20 to 22).

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of Paragraph 9(1) and (3) of the LMG in so relies on consumer protection and the far as those provisions are wider in scope protection of public health. Both interests than the prohibitions laid down by are mentioned in Article 15(2) of Directive Article 2(1)(a) or Article 2(1)(b) of Direc- 79/112. tive 79/112. With regard to foodstuffs which in other respects satisfy the labelling requirements of Directive 79/112 and have been marketed lawfully in another Member State, both requirements amount de facto to a prohibition of trade in Austria.

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neglect to change his dietary habits or to Article 2(1 )(b) of Directive 79/112, also seek medical help. applies to non-misleading health-related information may, in principle, be justified on the ground of protection of public health.

60. In the light of the foregoing, the scheme of the directive makes it impossible, in my view, for Austria to rely, as justification for 62. In infringement proceedings it is for the the prohibition at issue, on protection of Member State to prove that a general the consumer against confusion as referred prohibition on non-misleading health-re- to in Article 15(2) of Directive 79/112. lated information is necessary for the pro- Article 2(1 )(a) of Directive 79/112 already tection of public health. The Austrian prohibits all labelling which misleads or Government argues that such information could mislead the consumer. A general may endanger the health of consumers prohibition on misleading health-related since they may wrongly rely on the effect information cannot be justified on the basis of a health-related statement. The Com- of Article 15(2) of Directive 79/112 since mission counters that by submitting that the interest in question — consumer pro- nothing is gained by prohibiting the tection — is already covered by description 'healthy', since foodstuffs Article 2(1 )(a) of Directive 79/112. harmful to health may not lawfully be marketed.

exemption is then appropriate, in principle, 66. In the absence of specific Community in order to eliminate or limit that risk. rules, Community law allows the Member Whether such a measure, which is effective States a relatively wide margin of discretion in principle, misses its target and therefore where public health is at stake. 41 Never- infringes the principle of proportionality is theless, even then the principle of propor- another question, which must be examined tionality requires that the objective should in more detail. not be achievable by less restrictive means. In view of the general application of the prohibition laid down by Paragraph 9(1) of the LMG, the abovementioned case-by- case approach can be adopted only in the context of the authorisation procedure under Paragraph 9(3) of the LMG. Accord- ing to the Austrian Government, that procedure is necessary since only the public authorities are capable of acting reliably in 64. It is not easy to state precisely the a supervisory capacity. circumstances in which the health of a consumer may be endangered. The only example which the Austrian Government has given, the claim 'good for your health', is difficult to assess without knowing the context of those words. If that information occurs on the labelling of a bag of apples, I really do not see how even a vulnerable consumer could suppose that a visit to the doctor can be postponed simply by eating apples. If the claim appears on the packag- ing of a food supplement which may be marketed as a foodstuff, such an effect can more readily be envisaged. However, even 67. The combination of a far-reaching in that situation health will only be at risk if general prohibition of any health-related consumption of such supplements is at the information and an onerous authorisation expense of a balanced diet. procedure is not, in my view, proportionate to the desired objective. I would point out in this connection that the risks to public health to be prevented are residual risks. Article 2(1)(a) and (b) of Directive 79/112 already prohibits incorrect or misleading information on health effects and any disease-related information. Moreover, as the Commission has rightly stated, it must be borne in mind that the foodstuffs in 65. It will therefore be necessary to deter- question may on no account constitute a mine, taking into account all the relevant circumstances of the case, whether a par- ticular statement constitutes a genuine risk 41 — See, for example, the case-law on additives, as set out in Müller and Others and Beer Purity, cited in footnotes 24 to public health. and 14 respectively.

68. Since inherently correct information on health effects may result in health risks only in a stated context and with regard to specific cases or products, the rules con- tained in Paragraph 9(1) and (3) of the LMG are disproportionate. They go beyond that which is permitted by 70. I would further point out in this con- Article 15(2) of Directive 79/112. Less nection that traders who place products on restrictive solutions for the prevention of the market bearing health-related state- such residual risks do exist. ments which could not in any way endan- ger public health are nevertheless caught by the prohibition and made subject to an 42 — See, as an example of a general provision, Article 3 of authorisation requirement which is Council Directive 92/59/EEC of 29 June 1992 on general unnecessary for their products. If a product safety (OJ 1992 L 228, p. 24). On 15 January 1994 that directive was replaced by Directive 2001/95/EC Member State finds it necessary, in a of the European Parliament and of the Council of 3 December 2001 (OJ 2002 L 11, p. 4). Article 14 of specific context, to adopt special rules Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, estab- lishing the European Food Safety Authority and laying 44 — In the manner provided for by Article 6(a) of Directive down procedures in matters of food safety (OJ 2002 L 31, 84/450, as held by the Court in Unilever, cited in footnote p. 1) enters into force on 1 January 2005. Paragraph 1 of 3, paragraphs 34 and 35. That provision requires Member that provision prohibits in general terms the placing on the States to confer upon the courts or administrative auth- market of food if it is unsafe, and will apply in addition to orities powers enabling them in proceedings concerning existing specific Community provisions on food safety. misleading advertising to require the advertiser to prove 43 — Darbo, cited in footnote 23, paragraph 22. the accuracy of factual claims in advertising.

72. In my opinion, neither a general pro- hibition on health-related information appearing on the labelling of foodstuffs nor a requirement of prior authorisation can therefore be justified by reference to Article 15(2) of Directive 79/112. That view accords mutatis mutandis with the case-law concerning statements appearing on cosmetic products, in which the Court has specifically criticised the authorisation requirement under the LMG. 46 The Aus- trian Government's argument that food- stuffs must be distinguished from cosmetic products cannot be accepted. The nature of the interests to be protected — consumer protection and public health — and there- fore the objective of the LMG, is identical in both cases. In this connection, as the Commission has rightly pointed out, the 71. The Court's case-law cited by the Court's case-law also allows no differenti- Austrian Government, according to which ation according to product category. In prior authorisation may be required for the protecting the consumer against being marketing of additives, does not apply in misled, the basic yardstick, in the case of this case. The Court has also, in that both foodstuffs and cosmetic products, is case-law, laid down conditions for the the model of the average consumer. 47 introduction of a system of authorisation Moreover, the damage to health caused which are based on the principle of pro- portionality. Moreover, because of their inherent characteristics, additives in food- 46 — See Unilever, cited in footnote 3. In the pending Linhart stuffs may constitute a danger to public case, cited in footnote 3, the Court has before it a reference health. That warrants stricter measures from the Verwaltungsgerichtshof for a ruling on the compatibility with Community law of a prohibition on the statement 'dermatologically tested' appearing on soaps and shampoos. 47 — Aptly cited in Case C-220/98 Estéé Lauder [2000] ECR 45 — The argument put forward by the Austrian Government, 1-117 which, like Unilever (cited in footnote 3), relates to that there has been negative experience of this form of cosmetic products and where the Court refers, in para- self-regulation in the United States, is not substantiated in graph 27, to the judgment in Gut Springenheide and any way by it. Tusky, which concerns foodstuffs (eggs).

48 — It is apparent from the order for reference that in the main proceedings Haug was held responsible tor placing on the market the product 'Renatura Casterenum-Kapseln' which had been imported from Germany. It would not surprise me if the questions referred have some connection with the criminal proceedings against Mr Haug in Case C-16/01, (3) order the Kingdom of Denmark to bear but that cannot be stated with any certainty on the basis of its own costs. the information made available.

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as embodied in the labelling Directive. The that the Court must declare the reference Unabhängiger Verwaltungssenat also refers from the Unabhängiger Verwaltungssenat to the action brought by the Commission Wien inadmissible. against Austria under Article 226 EC.

— Case C-421/00

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restrictive instruments, such as regular court with any relevant criteria for the monitoring of the market, could be used interpretation of Community law. 50 I am to verify whether statements appearing on of the opinion that that case-law also foodstuffs are in accordance with those applies to the question whether a particular provisions. statement constitutes a danger to public health. In this case, the referring court has formulated its questions in the abstract, but the account of the facts in the main proceedings enables me to make the follow- ing observations.

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non' and 'Tartex veget. Pastete Kräuter'. 83. The abbreviation 'veget.' in the state- Having regard to the Court's case-law, it ment suggests that it describes a pâté which must be examined, taking all relevant has been made without meat. However, factors into account, whether an average without needing know the exact composi- consumer who is reasonably well informed tion of the products 'Tartex veget. Pastete and reasonably observant and circumspect Champignon' and 'Tartex veget. Pastete would construe the statement in question, Kräuter', it is difficult on the face of it to viewed in the context as a whole, as it is see how the words 'healthy enjoyment' intended to be construed. 51 The Court is could create false expectations in the mind critical of excessively paternalistic interpre- of the average consumer when purchasing tations: the existence of a group of con- those foodstuffs. The situation would only sumers which may be misled by a claim is be different if it could not be stated with not in itself sufficient to justify a barrier to certainty in relation to the foodstuff in the free movement of goods. 52 There must question that it was also a healthy product. be a real risk that the average consumer To that end it could be examined whether, would be confused or misled and that his in nutritional terms, the products possessed economic behaviour would be affected as a recognised positive properties in relation to result. 53 The fact that certain consumers the promotion or maintenance of health. may not be aware of the meaning of the Moreover, even if that were the case, the claims being made and may thereby be statement could still be said to be mislead- misled is not a sufficient justification for ing if similar products which met a com- characterising the statements in question as parable demand had a healthier composi- misleading and for prohibiting them on tion. that basis. 54

relevant circumstances, to examine 87. The Commission observes that those whether the statement concerned is actually claims may give the average consumer the misleading. I propose that the Court impression that the product has properties answer the questions referred by the Unab- of preventing, treating or curing a disease, hängiger Verwaltungssenat für Kärnten as thereby falling, in its view, within the scope follows: of the prohibition laid down in Article 2(1 )(b) of Directive 79/112. In particular, that is the case because of the reference to specific human organs, the bladder and the prostate. Furthermore, it is not clear what the link is between those organs and the claims 'for protection of the 'Articles 2(1)(b) and 15(1) and (2) of cell membrane from free radicals'; 'import- Directive 79/112 preclude national legis- ant for the functioning of many enzymes' lation which prohibits, generally and abso- and 'important as a building block for lutely, any health-related information from bones and teeth'. Those statements may appearing on foodstuffs intended for gen- therefore also be misleading for the pur- eral consumption and makes health-related chaser and for that reason not permitted information subject to a prior authorisation under Directive 79/112. The same applies, procedure.' according to the Commission, to the claims concerning linoleic acid, tocopherols, trace elements, minerals and potassium, which are also clearly made in connection with the organs 'bladder and prostate'.

— Case C-16/01

sense, the claims 'regulation of the fluid 91. Since the national court has not sub- balance' or 'important as a building block mitted a question on the matter, I shall for bones and teeth', for example, are assume in the first place that the pumpkin permissible, according to the Commission. seed capsules referred to in the main proceedings must be characterised as a foodstuff within the meaning of Directive 79/112. 56 It must also be assumed that a statement appearing on or accompanying pumpkin seed capsules falls, as labelling of foodstuffs, within the scope of Article 1 of Directive 79/112. The term 'labelling' in Article 1(3) of Directive 79/112 covers inter alia any words placed on notices accom- 89. The Commission also has difficulty panying the foodstuff, so that the infor- with the phrase 'physiological or phar- mation in the accompanying leaflet falls macological effects' in the referring court's within the scope of the directive. first question, because it is unclear. The decisive consideration is always the context in which claims are made. The Commission therefore disputes the assertion that infor- mation on matters such as 'preserving youthfulness, inhibiting signs of ageing, promoting slimming or maintaining health' is automatically connected with preventing, treating or curing a disease. An assessment of whether information is actually mislead- ing can only be made in relation to an individual case.

93. Thirdly, in this case the claims at issue associations with the control or prevention can be regarded as functional, which means of diseases, and in so far as it can accept that the words indicate the purpose of the that the labelling does not generate any product or of an ingredient. Thus, for misconceptions as to the characteristics of example, potassium is important in regulat- the product, it may consider whether the ing the fluid balance and the title 'Renatura claims involved are prejudicial to public Kürbiskernkapseln mit Vitamin E Blase health. It is for the trader or manufacturer und Prostata', makes, as the Commission responsible to demonstrate, on the basis of rightly states, a connection between vit- international scientific information, that amin E and the bladder and prostate the product possesses the properties functions. The statement that the oil pump- attributed to it, in particular that the kin seeds are enriched with extra vitamin E pumpkin seed capsules help to protect the also makes it a composition-related claim. cell membrane against free radicals and to In so far as the prostate and bladder are ensure the functioning of many enzymes, mentioned, that is an allusion to a specific and that they are important as a building disorder, namely prostate and bladder block for bones and teeth and for regulat- cancer, which in my view gives grounds ing the fluid balance. for regarding those statements as pro- hibited disease-related statements as referred to in Article 2(1 )(b) of Directive 79/112. Contrary to the Commission's argument put forward in its written obser- vations both in Case C-221/00 and in the proceedings for preliminary rulings under consideration here, the scope of the pro- hibition on disease-related claims in Direc- tive 79/112 may, in my opinion, extend beyond a mere connection with medicinal 95. In this case also, I propose that the products within the meaning of the Com- questions referred for a preliminary ruling munity legislation governing the latter. be answered as follows:

(1) declare that, by interpreting and applying Paragraph 9(1) of the Leben- smittelgesetz (LMG) as meaning that health-related information is prohibited, in a general and absolute manner, from appearing on foodstuffs intended for general consumption, and by subjecting the affixing of health-related information to a prior authorisation procedure (Paragraph 9(3) of the LMG), 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 for sale to the ultimate consumer;

(2) order the Republic of Austria to pay the costs;

(3) order the Kingdom of Denmark to bear its own costs. I - 1042

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in Case C-426/00:

declare the reference for a preliminary ruling submitted by the Unabhängiger Verwaltungssenat Wien to be inadmissible;

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