CELEX: 62005CJ0319
Language: en
Date: 2007-11-15
Title: Judgment of the Court (First Chamber) of 15 November 2007.#Commission of the European Communities v Federal Republic of Germany.#Failure of a Member State to fulfil its obligations - Article 28 EC and Article 30 EC - Directive 2001/83/EC - Garlic preparation in capsule form - Preparation legally marketed as a food supplement in a number of Member States - Preparation classified as a medicinal product in the Member State of importation - Definition of ‘medicinal product’ - Obstacle - Justification - Public health - Proportionality.#Case C-319/05.

Case C-319/05
      Commission of the European Communities
      v
      Federal Republic of Germany
      (Failure of a Member State to fulfil its obligations – Articles 28 EC and 30 EC – Directive 2001/83/EC – Garlic preparation in capsule form – Preparation legally marketed as a food supplement in a number of Member States – Preparation classified as a medicinal product in the Member State of importation – Definition of ‘medicinal product’ – Obstacle – Justification – Public health – Proportionality)
      Opinion of Advocate General Trstenjak delivered on 21 June 2007 
      Judgment of the Court (First Chamber), 15 November 2007 
      Summary of the Judgment
      1.     Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal
            product by presentation – Criteria 
      (European Parliament and Council Directive 2001/83, Art. 1(2), first para.)
      2.     Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal
            product by function – Criteria 
      (European Parliament and Council Directive 2001/83, Art. 1(2), second para.)
      3.     Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal
            product by function – Criteria 
      (European Parliament and Council Directive 2001/83, Art. 1(2), second para.)
      4.     Free movement of goods – Quantitative restrictions – Measures having equivalent effect 
      (Arts 28 EC and 30 EC)
      1.     A product is ‘presented for treating or preventing disease’ within the meaning of Directive 2001/83 on the Community code
         relating to medicinal products for human use when it is expressly ‘indicated’ or ‘recommended’ as such, possibly by means
         of labels, leaflets or oral representation, or whenever any averagely well-informed consumer gains the impression, which,
         provided it is definite, may even result from implication, that the product in question should, having regard to its presentation,
         have the properties in question. 
      
      The criteria laid down in the first paragraph of Article 1(2) of Directive 2001/83 are not satisfied by a garlic preparation
         in capsule form which is neither indicated nor recommended as a product for treating or preventing disease, whether on the
         label, the information printed on the external packaging, or otherwise, and whose packaging displays nothing capable of inspiring
         in a reasonably well-informed consumer confidence like that usually inspired by medicinal products, with the result that presentation
         in capsule form is the only aspect likely to suggest classification of the product as a medicinal product by presentation.
         Such a preparation cannot be classified as a medicinal product by presentation for the purposes of that directive.
      
      The external form given to a product, although it may serve as strong evidence of the seller’s or manufacturer’s intention
         to market that product as a medicinal product, cannot be the sole or conclusive evidence, since otherwise certain food products
         which are traditionally presented in a similar form to medicinal products would also be covered. The capsule form is not exclusive
         to medicinal products, given that a large number of foodstuffs are in fact offered for sale in that form in order to facilitate
         their ingestion by consumers. Consequently, that evidence alone is not sufficient to confer the status of medicinal product
         by presentation on the product concerned.
      
      (see paras 44-46, 50-54, 78)
      2.     For the purposes of determining whether a product falls within the definition of a medicinal product by function within the
         meaning of Directive 2001/83 on the Community code relating to medicinal products for human use, the national authorities,
         acting under the supervision of the courts, must decide on a case-by-case basis, taking account of all the characteristics
         of the product, in particular its composition, its pharmacological properties to the extent to which they can be established
         in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity
         to consumers and the risks which its use may entail.
      
      The pharmacological properties of a product are the factor on the basis of which it must be ascertained, in the light of the
         potential capacities of the product, whether it may, for the purposes of the second subparagraph of Article 1(2) of Directive
         2001/83, be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying
         physiological functions in human beings.
      
      However, that criterion must not lead to the classification as a medicinal product by function of substances which, while
         having an effect on the human body, do not significantly affect the metabolism and thus do not strictly modify the way in
         which it functions. 
      
      Contrary to the definition of medicinal product by presentation, whose broad interpretation is intended to protect consumers
         from products which do not have the effectiveness they are entitled to expect, the definition of medicinal product by function
         is designed to cover products whose pharmacological properties have been scientifically observed and which are genuinely designed
         to make a medical diagnosis or to restore, correct or modify physiological functions.
      
      In those circumstances, and in order to preserve the effectiveness of that criterion, a product must not only have properties
         beneficial to health in general, but strictly speaking have the function of treating or preventing disease, especially since
         there are many products generally recognised as foodstuffs which may also serve therapeutic purposes. That fact is not sufficient
         to confer on them the status of medicinal product within the meaning of Directive 2001/83.
      
      Finally, the fact that ingesting a product could give rise to a health risk is not an indication that it is pharmacologically
         effective. Whilst the health risk must be taken into consideration in the classification of a product as a medicinal product
         by function, it is none the less an autonomous factor.
      
      (see paras 55, 59-61, 64-65, 69)
      3.     A garlic product in capsule form, whose effect on physiological functions is no more than the effects which a foodstuff consumed
         in a reasonable quantity may have on those functions, does not have a significant effect on the metabolism and cannot, therefore,
         be classified as a product capable of restoring, correcting or modifying physiological functions within the meaning of the
         second subparagraph of Article 1(2) of Directive 2001/83. Because the mentioned risks and contra-indications related to taking
         garlic preparations are limited and, more importantly, are no different from those linked to taking garlic as a foodstuff,
         and because the criterion of the method of using of the product concerned cannot be decisive, given that capsule form is not
         unique to medicinal products, such a preparation cannot be classified as a medicinal product by function within the meaning
         of the second subparagraph of Article 1(2) of Directive 2001/83.
      
      (see paras 68, 76-78)
      4.     Where a Member State decides to require marketing authorisation as a medicinal product for a garlic preparation in capsule
         form which does not satisfy the definition of a medicinal product within the meaning of Article 1(2) of Directive 2001/83
         on the Community code relating to medicinal products for human use, that requirement constitutes a measure having equivalent
         effect to a quantitative restriction on imports, prohibited by Article 28 EC.
      
      By so doing, the Member State creates an obstacle to intra-Community trade in so far as such a product, legally marketed in
         other Member States as a foodstuff, can be marketed in the said State only after having been subjected to the authorisation
         procedure for placing a medicinal product on the market.
      
      As to whether such a restriction may be justified under Article 30 EC by reasons relating to the protection of public health,
         it is true that Member States are entitled, in the absence of harmonisation and to the extent that uncertainties continue
         to exist in the current state of scientific research, to decide on their intended level of protection of human health and
         life and on whether to require prior authorisation for the marketing of foodstuffs, always taking into account the requirements
         of the free movement of goods within the Community. However, the means which they choose in that regard must be proportionate
         to the objective thus pursued. The issuing of a marketing authorisation under Article 8 of Directive 2001/83 is subject to
         particularly strict requirements, and the obligation to obtain such an authorisation before being able to market the product
         concerned in the territory of the Member State cannot be regarded as being in accordance with the principle of proportionality
         unless it is actually necessary to safeguard public health. Such a restriction on the free movement of goods must therefore
         necessarily be based on a detailed assessment of the risk alleged by the Member State.
      
      A generic reference to the risks that consuming the product may have for health in very specific circumstances is not sufficient
         to justify a measure such as making the product subject to the particularly strict procedure for a marketing authorisation
         for a medicinal product.
      
      (see paras 79, 81, 86-87, 89-91, 94, 97, operative part)
JUDGMENT OF THE COURT (First Chamber)
      15 November 2007 (*)
      
      (Failure of a Member State to fulfil its obligations – Article 28 EC and Article 30 EC – Directive 2001/83/EC – Garlic preparation in capsule form – Preparation legally marketed as a food supplement in a number of Member States – Preparation classified as a medicinal product in the Member State of importation – Definition of ‘medicinal product’ – Obstacle – Justification – Public health – Proportionality)
      In Case C‑319/05,
      ACTION under Article 226 EC for failure to fulfil obligations, brought on 19 August 2005,
      Commission of the European Communities, represented by B. Stromsky and B. Schima, acting as Agents, with an address for service in Luxembourg,
      
      applicant,
      v
      Federal Republic of Germany, represented by M. Lumma and C. Schulze-Bahr, acting as Agents,
      
      defendant,
      THE COURT (First Chamber),
      composed of P. Jann, President of the Chamber, R. Schintgen, A. Borg Barthet (Rapporteur), M. Ilešič and E. Levits, Judges,
      Advocate General: V. Trstenjak,
      Registrar: B. Fülöp, Administrator,
      having regard to the written procedure and further to the hearing on 19 April 2007,
      after hearing the Opinion of the Advocate General at the sitting on 21 June 2007,
      gives the following
      Judgment
      1       By its application, the Commission of the European Communities seeks a declaration from the Court that, by classifying as
         a medicinal product a garlic preparation in capsule form which does not fall under the definition of a medicinal product by
         presentation, the Federal Republic of Germany has failed to fulfil its obligations under Articles 28 EC and 30 EC.
      
       Legal background
       Directive 2001/83/EC
      2       The second to the fifth recitals in the preamble to Directive 2001/83/EC of the European Parliament and of the Council of
         6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67) state:
      
      ‘(2) The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard
         public health.
      
      (3) However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry
         or trade in medicinal products within the Community.
      
      (4) Trade in medicinal products within the Community is hindered by disparities between certain national provisions, in particular
         between provisions relating to medicinal products (excluding substances or combinations of substances which are foods, animal
         feeding-stuffs or toilet preparations), and such disparities directly affect the functioning of the internal market.
      
      (5) Such hindrances must accordingly be removed; whereas this entails approximation of the relevant provisions.’
      3       Under Article 1(2) of Directive 2001/83, ‘medicinal product’ must be construed as meaning:
      ‘Any substance or combination of substances presented for treating or preventing disease in human beings.
      Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis
         or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product
         …’
      
      4       Article 2 of Directive 2001/83 provides:
      ‘The provisions of this Directive shall apply to industrially produced medicinal products for human use intended to be placed
         on the market in Member States.’
      
      5       According to Article 6(1) of Directive 2001/83:
      ‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the
         competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance
         with Regulation (EEC) No 2309/93.’
      
       Directive 2002/46/EC
      6       Under Article 2(a) of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation
         of the laws of the Member States relating to food supplements (OJ 2002 L 183, p. 51), ‘food supplements’ means:
      
      ‘… foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other
         substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as
         capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles,
         and other similar forms of liquids and powders designed to be taken in measured small unit quantities’.
      
      7       Under Article 2(b) of Directive 2002/46, ‘nutrients’ means the following substances:
      ‘(i)      vitamins;
      (ii)      minerals’.
      8       Article 11 of Directive 2002/46 provides:
      ‘(1) Without prejudice to Article 4(7), Member States shall not, for reasons related to their composition, manufacturing specifications,
         presentation or labelling, prohibit or restrict trade in products referred to in Article 1 which comply with this Directive
         and, where appropriate, with Community acts adopted in implementation of this Directive.
      
      (2) Without prejudice to the EC Treaty, in particular Articles 28 and 30 thereof, paragraph 1 shall not affect national provisions
         which are applicable in the absence of Community acts adopted under this Directive.’
      
       Regulation (EC) No 178/2002
      9       According to Article 2 of 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, establishing the European Food Safety Authority and laying down
         procedures in matters of food safety (OJ 2002 L 31, p. 1), ‘food’ (or ‘foodstuff’) means:
      
      ‘… any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected
         to be ingested by humans.
      
      …’.
      10     Article 14(7) to (9) of Regulation No 178/2002 provide:
      ‘7. Food that complies with specific Community provisions governing food safety shall be deemed to be safe in so far as the
         aspects covered by the specific Community provisions are concerned.
      
      8. Conformity of a food with specific provisions applicable to that food shall not bar the competent authorities from taking
         appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market
         where there are reasons to suspect that, despite such conformity, the food is unsafe.
      
      9. Where there are no specific Community provisions, food shall be deemed to be safe when it conforms to the specific provisions
         of national food law of the Member State in whose territory the food is marketed, such provisions being drawn up and applied
         without prejudice to the Treaty, in particular Articles 28 and 30 thereof.’
      
       Pre-litigation procedure
      11     The Commission received a complaint from an undertaking whose application for authorisation to import and market a garlic
         preparation in capsule form was refused by the Federal Ministry for Health on the ground that the product was not a foodstuff
         but a medicinal product.
      
      12     The product concerned is marketed under the designation ‘garlic extract powder capsule’. According to the information provided
         by the parties, it is an extract obtained using ethanol and incorporated in an excipient (lactose) for the technological purpose
         of spray drying. Each capsule contains 370 mg of garlic powder extract with an allicin content of between 0.95% and 1.05%,
         which is the equivalent of 7.4 g of fresh raw garlic.
      
      13     After a lengthy informal exchange, the Commission sent a letter before action of 24 July 2001 to the Federal Republic of Germany
         in which it concluded that the classification of the garlic preparation concerned as a medicinal product on the basis of a
         justification such as that put forward when the complaint was being investigated was not compatible with the principle of
         free movement of goods under Article 28 EC and Article 30 EC and the relevant case-law. The Federal Republic of Germany replied
         to the letter of formal notice on 5 October 2001.
      
      14     In its reasoned opinion of 17 December 2002, the Commission called on the Federal Republic of Germany to put an end, within
         two months of receiving the reasoned opinion, to the administrative practices according to which products composed of dried
         garlic powder which are clearly not labelled or presented as medicinal products are treated as such.
      
      15     Since the Federal Republic of Germany, in its response to the reasoned opinion, stated that the classification of the product
         concerned as a medicinal product had been re-examined and had to be maintained, the Commission decided to bring the present
         proceedings. 
      
       The action
       Arguments of the parties
      16     The Commission observes, first of all, that, in addition to protecting human health, the Community provisions relating to
         medicinal products are intended to safeguard the free movement of goods, so that the interpretation of the provisions of Directive
         2001/83 in general and of the term medicinal product in particular cannot result in obstacles to the free movement of goods
         which are entirely disproportionate to the pursued aim of protecting health.
      
      17     The Commission then submits that, in order to classify the product concerned as a medicinal product by virtue of its function,
         account must be taken not only of the pharmacological effects but also the manner in which it is used, the extent of its distribution,
         its familiarity to consumers and the risks which its use may entail (Case C-60/89 Monteil and Samanni [1991] ECR I‑1547, paragraph 29).
      
      18     With regard to the pharmacological effects, the Commission does not dispute the fact that the product in question may serve
         to prevent arteriosclerosis, but points out that that effect may be achieved by taking a dose equivalent to 4 g of raw garlic
         each day. Therefore, where a product which is claimed to be a medicinal product does nothing more than a conventional foodstuff,
         it is clear that its pharmacological properties are insufficient for it to be accepted as a medicinal product. According to
         the Commission, a product which has no more effect on the body than a foodstuff has not reached the threshold above which
         it must be regarded as a medicinal product by function. In other words, substances which do not have a significant effect
         on the body and strictly speaking modify the way in which it functions cannot be treated as medicinal products.
      
      19     The Commission takes the view that the product concerned might at best be regarded as a food supplement within the meaning
         of Article 2(a) of Directive 2002/46, that is to say as a foodstuff which is a concentrated source of nutrients or other substances
         with a nutritional or physiological effect, alone or in combination, marketed in dose form. It states, nevertheless, that
         the attempt to deny that the product concerned is a foodstuff certainly does not justify its classification as a medicinal
         product.
      
      20      As regards the classification of a product as a medicinal product by virtue of its presentation, the Commission submits that
         that must be done on a case-by-case basis according to the specific characteristics of the product. A product might be regarded
         as a medicinal product by virtue of its presentation if its form and the manner in which it is packaged render it sufficiently
         similar to a medicinal product and, in particular, if on its packing and the information provided with it reference is made
         to research by pharmaceutical laboratories or to methods or substances developed by medical practitioners or even to testimonials
         from medical practitioners commending the qualities of the product in question (Case C-369/88 Delattre [1991] ECR I-1487, paragraph 41).
      
      21     The Commission states that, in this case, the preparation is not presented or recommended for treating or preventing disease,
         either on the label, on the information printed on the packaging, or in any other way. Neither can the product's external
         packaging be regarded as typical of medicinal products. The capsule form is the only specific characteristic of the product
         that relates to medicinal products, although external form alone cannot be an exclusive and decisive indicator. No other element
         in this case indicates that the product is a medicinal product by virtue of its presentation. The Commission takes the view
         that consumers know exactly what is contained in the capsules, namely garlic, which they know as a foodstuff. Consumers can
         also see that the product does not make reference to any therapeutic effect.
      
      22     Finally, the Commission states that it is possible for Member States, under national law, to submit a product which is not
         a medicinal product within the meaning of Directive 2001/83 to the rules applying to medicinal products provided, however,
         that the measures to safeguard public health are proportionate (see Case C-387/99 Commission v Germany [2004] ECR I-3751, paragraph 72). In this case, the Federal Republic of Germany has not provided evidence that the prohibition
         on marketing the product concerned as a food supplement and the obligation to obtain authorisation for medicinal products
         are actually necessary for the protection of public health.
      
      23     For its part, the Federal Republic of Germany submits that only the provisions of Community law specific to medicinal products
         apply to a product which satisfies equally well the conditions for classification as a foodstuff and the conditions for classification
         as a medicinal product (Joined Cases C and-211/03, C-299/03 and C-316/03 to C-318/03 HLH Warenvertrieb and Orthica [2005] ECR I-5141, paragraph 43). It submits that, according to the case-law of the Court, the priority accorded to the regime
         governing medicinal products follows from Article 2, third paragraph, subparagraph (d) of Regulation No 178/2002 and from
         Article 1(2) of Directive 2002/46, which both exempt medicinal products from the scope of the rules on foodstuffs and on food
         supplements. That interpretation is also confirmed by Directive 2004/27/EC of the European Parliament and of the Council of
         31 March 2004 amending Directive 2001/83 (OJ 2004 L 136, p. 34) which inserts into Directive 2001/83 a new version of Article
         2, according to paragraph 2 of which, in cases of doubt, where a product is also covered by other Community legislation –
         such as the rules governing foodstuffs – it is always the provisions of Directive 2001/83 that apply.
      
      24     The Federal Republic of Germany submits that the garlic preparation in question is a medicinal product by function, primarily
         because it has pharmacological properties to which considerable importance is attached. In order to determine those pharmacological
         properties, the Federal Republic of Germany states that it is not only the effects of that preparation on health in general
         which is important, but also its pharmacological effectiveness (Case C-112/89 Upjohn [1991] ECR I-1703, paragraph 17). In this case, the product in question has therapeutic effects which prevent lesions occurring
         in the human body, and more specifically prevents arteriosclerosis. The Federal Republic of Germany relies on several studies
         and scientific reports in support of its argument.
      
      25     In answer to the Commission's argument that the effects of the preparation concerned on arteriosclerosis are limited, the
         Federal Republic of Germany states that neither Directive 2001/83 nor the case-law of the Court indicates a ‘materiality threshold’
         according to which a specific level of pharmacological effects has to be proven. Therefore, if pharmacological effectiveness
         is accepted in this case, it is irrelevant whether there is a slight or material reduction in the risk of arteriosclerosis.
      
      26     The Federal Republic of Germany also submits that the origin of the substances cannot be decisive in order to define a medicinal
         product, and states that the Court has held that vitamins in a particular form and in high doses could be classified as medicinal
         products (see Case 227/82 van Bennekom [1983] ECR 3883, paragraph 27, and Commission v Germany, paragraph 56). The fact that vitamins also occur in many foodstuffs thus does not prevent their classification as medicinal
         products. The same must apply to garlic and allicin, the active substance contained in it. Therefore, it is ultimately irrelevant
         whether or not an active substance with pharmacological properties also occurs in a foodstuff.
      
      27     The preparation concerned also has pharmacological properties that could cause health risks if taken (see Commission v Germany, paragraph 82). The fact that the consumption of certain other foodstuffs may also have negative effects on health cannot
         call into question the status of medicinal product. The Federal Republic of Germany states, however, that it is above all
         the pharmacological and/or therapeutic effects which play a crucial role.
      
      28     With regard to the methods of use, the Federal Republic of Germany states that the fact that the product concerned is offered
         for sale in capsule form also suggests that it should be classified as a medicinal product by function.
      
      29     As to the definition of medicinal products by presentation, the Federal Republic of Germany submits that a product may be
         regarded as such if its form and the manner in which it is packaged render it sufficiently similar to a medicinal product.
      
      30     In this case the form of capsule used suggests that it is intended to be marketed as a medicinal product, although the Federal
         Republic of Germany accepts that the external form alone cannot be a decisive indicator for classification as a medicinal
         product (see Delattre, paragraph 38).
      
      31     Furthermore, the Federal Republic of Germany points out that there are a large number of medicinal products containing active
         substances such as garlic bulb powder or oil on the German market, packaged in exactly the same way as the preparation concerned.
         The fact that they are all classified as medicinal products leans, according to commercial usage and consumer expectations,
         in favour of classification of the product in question as a medicinal product by virtue of its presentation.
      
      32     The Federal Republic of Germany also infers from the case-law of the Court that the national authorities have a broad discretion
         when deciding classification (see HLH Warenvertrieb and Orthica, paragraph 56). The Commission has not satisfied the burden of proof as it has not established that the exercise of discretion
         by the German authorities in classifying the preparation concerned as a medicinal product was defective.
      
      33     Alternatively, the Federal Republic of Germany states that in the event that the Court takes the view that the principle of
         free movement of goods is applicable and considers the classification of the product in question as a medicinal product to
         be a restriction on that principle, the decision is justified in any event in order to protect an overriding public interest,
         namely the protection of public health.
      
       Findings of the Court
      34     It is clear from Articles 2 and 6(1) of Directive 2001/83 that no industrially produced medicinal product may be placed on
         the market in a Member State unless a marketing authorisation has been issued by the competent authorities of that Member
         State or an authorisation has been granted in accordance with Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down
         Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing
         a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1).
      
      35     It follows that if a product produced industrially comes within the definition of medicinal product in Article 1(2) of Directive
         2001/83, the obligation on the importer of that product to obtain a marketing authorisation in accordance with that directive
         prior to marketing it in the Member State of importation cannot in any event constitute a restriction on trade between Member
         States prohibited by Article 28 EC (see, to that effect, Case C-150/00 Commission v Austria [2003] ECR I-3887, paragraph 57).
      
      36     Furthermore,  although the essential purpose of Directive 2001/83 is to remove obstacles to trade in medicinal products within
         the Community, and although for that purpose Article 1 gives a definition of medicinal products, it nevertheless constitutes
         merely a first stage in the harmonisation of national legislation on the production and distribution of such products (see,
         to that effect, Commission v Austria, paragraph 58).
      
      37     In those circumstances, so long as harmonisation of the measures necessary to ensure the protection of health is not more
         complete, it is difficult to avoid the existence of differences in the classification of products as medicinal products or
         foodstuffs between Member States. Thus, the fact that a product is classified as a foodstuff in another Member State cannot
         prevent it from being classified as a medicinal product in the Member State of importation, if it displays the characteristics
         of such a product (see HLH Warenvertrieb and Orthica, paragraph 56).
      
      38     The fact remains that a product which satisfies the definition of ‘medicinal product’ within the meaning of Directive 2001/83
         must be held to be a medicinal product and be made subject to the corresponding rules even if it comes within the scope of
         other, less stringent Community rules (see, to that effect, Case C-219/91 Ter Voort [1992] I‑5485, paragraph 19 and the case-law cited).
      
      39     In those circumstances it is appropriate to determine, first of all, whether the product concerned is a medicinal product
         within the meaning of Directive 2001/83.
      
      40     Under the first subparagraph of Article 1(2) of Directive 2001/83, a medicinal product is ‘[a]ny substance or combination
         of substances presented for treating or preventing disease in human beings’, and according to the second subparagraph thereof,
         ‘[a]ny substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis
         or to restoring, correcting or modifying physiological functions in human beings’ is likewise to be considered a medicinal
         product.
      
      41     The directive thus gives two definitions of medicinal product, one ‘by presentation’ and one ‘by function’. A product is a
         medicinal product if it falls within either of those definitions (HLH Warenvertrieb and Orthica, paragraph 49).
      
      42     In that connection, it must be observed that although the Commission expressly refers to the definition of medicinal product
         by presentation in its arguments, it makes no reference to the definition of medicinal product by function. In the grounds
         of its application, however, and throughout the pre-litigation procedure, the Commission formulated arguments relating to
         those definitions. In its defence, both in the pre-litigation procedure and in these proceedings, the Federal Republic of
         Germany also put forward arguments regarding those two definitions. Therefore, the Commission's application must be interpreted
         as denying the product the status of both medicinal product by presentation and medicinal product by function.
      
       The definition of medicinal product by presentation
      43     According to settled case-law, the term ‘presentation’ of a product must be interpreted broadly. It must be recalled, in that
         connection, that by basing its arguments on the criterion of the ‘presentation’ of the product, Directive 2001/83 intends
         to cover not only medicinal products having a genuine therapeutic or medical effect, but also those which are not sufficiently
         effective or do not have the effect which consumers would be entitled to expect from the way in which they are presented.
         The directive thereby intends to protect the consumer not only from harmful or toxic medicinal products, but also from a variety
         of products used instead of the proper remedies (van Bennekom, paragraph 17).
      
      44     In that context, a product is ‘presented for treating or preventing disease’ within the meaning of Directive 2001/83 when
         it is expressly ‘indicated’ or ‘recommended’ as such, possibly by means of labels, leaflets or oral representation (see, to
         that effect, van Bennekom, paragraph 18, and Monteil and Samanni, paragraph 23).
      
      45     In this case, it is clear from the file that the preparation concerned is not indicated or recommended as a product for treating
         or preventing disease, whether on the label, the information printed on the external packaging, or in any other way.
      
      46     A product is also ‘presented for treating or preventing disease’ whenever any averagely well-informed consumer gains the impression,
         which, provided it is definite, may even result from implication, that the product in question should, having regard to its
         presentation, have the properties in question (see, to that effect, van Bennekom, paragraph 18, and Monteil and Samanni, paragraph 23).
      
      47     In that regard, account must be taken of the attitude of an averagely well-informed consumer, in whom the form given to a
         product may inspire particular confidence similar to that normally inspired in him by proprietary medicinal products, having
         regard to the safeguards normally associated with their manufacture and marketing. Although the external form given to the
         product may serve as strong evidence of its classification as a medicinal product by presentation, the ‘form’ must be taken
         to mean not only the form of the product itself but also that of its packaging, which may, for reasons of marketing policy,
         tend to make it resemble a medicinal product (see, to that effect, van Bennekom, paragraph 19, and Monteil and Samanni, paragraph 24). 
      
      48     According to the information submitted to the Court, the product concerned is a garlic powder extract marketed in capsule
         form. On the product's external packaging there is, inter alia, a photograph of a head of garlic next to which are two capsules.
      
      49     In that connection, the fact, relied on by the Federal Republic of Germany, that there are a large number of products containing
         active substances such as garlic bulb powder or oil on the German market, packaged in a similar manner to the product concerned
         and classified as medicinal products, is not sufficient to confer on that product the status of a medicinal product by presentation.
         The Federal Republic of Germany has not provided any specific evidence in support of that argument.
      
      50     In those circumstances, taking account of the information before the Court, it must be held that no aspect of its packaging
         tends to make the product concerned resemble a medicinal product other than the photograph or of a head of garlic on the product's
         external packaging, as such an image also features on a number of products marketed as medicinal products in Germany. The
         photograph of a plant on the external packaging of a product is not, however, sufficient to inspire in a reasonably well-informed
         consumer confidence like that usually inspired by medicinal products.
      
      51     Therefore, presentation in capsule form is the only aspect likely to suggest classification of the product as a medicinal
         product by presentation.
      
      52     However, it must be recalled that, according to settle case-law, the external form given to a product, although it may serve
         as strong evidence of the seller's or manufacturer's intention to market that product as a medicinal product, cannot be the
         sole or conclusive evidence, since otherwise certain food products which are traditionally presented in a similar form to
         medicinal products would also be covered (see, to that effect, van Bennekom, paragraph 19, and Delattre, paragraph 38).
      
      53     As the Advocate General noted, in point 51 of her Opinion, the capsule form is not exclusive to medicinal products. A large
         number of foodstuffs are in fact offered for sale in that form in order to facilitate their ingestion by consumers. In that
         connection, it must be observed that Article 2(a) of Directive 2002/46 expressly refers, among the criteria used to define
         ‘food supplement’, to its presentation in capsule form. Consequently, that evidence alone is not sufficient to confer the
         status of medicinal product by presentation on the product concerned.
      
      54     In those circumstances, it must be held that the product concerned does not satisfy the criteria laid down in the first paragraph
         of Article 1(2) of Directive 2001/83. Therefore it cannot be classified as a medicinal product by presentation within the
         meaning of that directive.
      
       Definition of medicinal product by function
      55     For the purposes of determining whether a product falls within the definition of a medicinal product by function within the
         meaning of Directive 2001/83, the national authorities, acting under the supervision of the courts, must decide on a case-by-case
         basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological properties
         to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used,
         the extent of its distribution, its familiarity to consumers and the risks which its use may entail (HLH Warenvertrieb and Orthica, paragraph 51).
      
      56     In this case, in order to justify the classification of the product concerned as a medicinal product by function, the Federal
         Republic of Germany relies essentially on its allicin content, its effect on blood pressure and lipid levels, the capsule
         form used and the risks related to its ingestion.
      
      57     It is apparent from the file that the product in question is a garlic powder extract, the allicin content of which is between
         0.95% and 1.05%, each capsule containing the equivalent of 7.4 g of fresh raw garlic. Allicin, the principal active ingredient,
         which is obtained from crushed garlic, is the result of the transformation of alliin, an amino acid naturally present in garlic,
         when it is mixed with the natural enzyme allinase.
      
      58     Therefore, it must be held that, apart from the excipient into which the garlic extract was incorporated before being powdered,
         the product concerned is obtained entirely from garlic, and does not contain any substance which is not itself in garlic in
         its natural state.
      
      59     The pharmacological properties of a product are the factor on the basis of which it must be ascertained, in the light of the
         potential capacities of the product, whether it may, for the purposes of the second subparagraph of Article 1(2) of Directive
         2001/83, be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying
         physiological functions in human beings (HLH Warenvertrieb and Orthica, paragraph 52).
      
      60     Although, as the Advocate General observed in paragraph 58 of her Opinion, that definition is broad enough to include products
         which, although they are capable of having an effect on bodily functions have in fact another purpose, that criterion must
         not lead to the classification as a medicinal product by function of substances which, while having an effect on the human
         body, do not significantly affect the metabolism and thus do not strictly modify the way in which it functions (Upjohn, paragraph 22).
      
      61     Contrary to the definition of medicinal product by presentation, whose broad interpretation is intended to protect consumers
         from products which do not have the effectiveness they are entitled to expect, the definition of medicinal product by function
         is designed to cover products whose pharmacological properties have been scientifically observed and which are genuinely designed
         to make a medical diagnosis or to restore, correct or modify physiological functions.
      
      62     Such an interpretation is in accordance with the aims of Directive 2001/83 which, as is clear from the second to the fifth
         recitals in the preamble, seeks to reconcile the aim of protection of public health with the principle of free movement of
         goods.
      
      63     Furthermore, although only the provisions of Community law specific to medicinal products apply to a product which satisfies
         the conditions for classification a medicinal product,  even if it comes within the scope of other, less stringent Community
         rules (see, to that effect, Delattre, paragraph 22, Monteil and Samanni, paragraph 17, Ter Voort, paragraph 19, and HLH Warenvertrieb and Orthica, paragraph 43 ), it must be stated, as is shown by a reading of Article 1(2) of Directive 2001/83 in conjunction with Article
         2 of Directive 2002/46, that the physiological effect is not specific to medicinal products but is also among the criteria
         used for the definition of food supplements.
      
      64     In those circumstances, and in order to preserve the effectiveness of that criterion, it is not sufficient that product has
         properties beneficial to health in general, but it must strictly speaking have the function of treating or preventing disease.
      
      65     That statement is even more relevant in the case of products which, in addition to being food supplements, are recognised
         as having beneficial effects on health. As the Advocate General observed, in point 60 of her Opinion, there are many products
         generally recognised as foodstuffs which may also serve therapeutic purposes. That fact is not sufficient however to confer
         on them the status of medicinal product within the meaning of Directive 2001/83.
      
      66     In this case, the Federal Republic of Germany does not dispute that the physiological effects that it relies on, essentially
         with respect to the prevention of arteriosclerosis, may also be obtained by ingesting 7.4 g of garlic as a foodstuff. It is
         significant in that regard that the fact that the studies on which the Federal Republic of Germany bases its arguments relate
         both to the potential effects of ingesting garlic preparations in the form of capsules, powders or solutions, and to the potential
         effects of consuming garlic in its natural state.
      
      67     It is also common ground that the disputed product does not have any additional effects as compared to those which derive
         from the consumption of garlic in its natural state and, as the Advocate General observed in point 62 of her Opinion, those
         effects should not be regarded as any greater than, or different from, those of other vegetable or animal products which are
         taken as part of the daily diet.
      
      68     In those circumstances, it must be held that the product concerned, whose effect on physiological functions is no more than
         the effects of a foodstuff consumed in a reasonable quantity may have on those functions, does not have a significant effect
         on the metabolism and cannot, therefore, be classified as a products capable of restoring, correcting or modifying physiological
         functions within the meaning of the second subparagraph of Article 1(2) of Directive 2001/83.
      
      69     Finally, and contrary to the Federal Republic of Germany's submissions, the fact that ingesting the product concerned could
         give rise to risks to health is not an indication that it is pharmacologically effective. It is clear from the case-law that
         the risk to health, although it must be taken into consideration in the classification of a product as a medicinal product
         by function, is none the less an autonomous factor (HLH Warenvertrieb and Orthica, paragraph 53).
      
      70     The assessment of the potential risks related to the use of the product concerned must be undertaken in the context of Directive
         2001/83 and in the light of the principles of Community law in general.
      
      71     As the Commission has observed, the Community provisions relating to medicinal products must ensure, in addition to the protection
         of human health, the free movement of goods, so that the interpretation of the provisions of Directive 2001/83 in general,
         and the definition of medicinal products in particular, cannot result in obstacles to the free movement of goods which are
         entirely disproportionate to the pursued aim of protecting health.
      
      72     In this case, the Federal Republic of Germany cites cases of spontaneous post-operative bleeding occurring after excessive
         consumption of garlic as a foodstuff or in the form of a preparation, the suppression of the effects of certain anti-retroviral
         drugs and an interaction with some anticoagulants.
      
      73     In that connection, it must be observed, first of all, that those risks arise from the absorption of garlic in general and
         not specifically from the ingestion of the disputed preparation.
      
      74     Furthermore, it is clear from the examples cited by the Federal Republic of Germany that it is only the interaction with certain
         medicinal products or excessive intake of garlic or a garlic preparation in specific circumstances such as an operation that
         risks to health may arise.
      
      75     As the Advocate General observed in point 65 of her Opinion, it is clear from those examples that the risks and contra-indications
         related to taking garlic preparations mentioned are limited and, more importantly, are no different from those linked to taking
         garlic as a foodstuff.
      
      76     As regards the criterion for the method of use of the product concerned, it cannot be decisive in this case for the reasons
         set out in paragraph 53 of this judgment.
      
      77     In those circumstances, it must be held, having regard to all its characteristics, that the product concerned cannot be classified
         as a medicinal product by function within the meaning of the second subparagraph of Article 1(2) of Directive 2001/83.
      
      78     It is clear from all the foregoing that the product concerned does not satisfy either the definition of medicinal product
         by presentation or the definition of medicinal product by function. Therefore, it cannot be classified as a medicinal product
         within the meaning of Directive 2001/83.
      
       Infringement of Article 28 EC and Article 30 EC
      79     It is now appropriate to ascertain whether, as the Commission submits, the requirement for a marketing authorisation as a
         medicinal product, as it appears from the decision taken by the Federal Republic of Germany, is a measure having equivalent
         effect to a quantitative restriction on imports prohibited by Article 28 EC.
      
      80     The prohibition on measures having equivalent effect to quantitative restrictions, set out in Article 28 EC, covers all measures
         which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade (see, in particular,
         Case 8/74 Dassonville [1974] ECR 837, paragraph 5, and Commission v Austria, paragraph 81). 
      
      81     In this case, the Federal Republic of Germany's decision creates an obstacle to intra-Community trade in so far as the products
         concerned, legally marketed in other Member State as a foodstuff, can be marketed in Germany only after having been subjected
         to the authorisation procedure for the placing on the market of a medicinal product.
      
      82     In that connection, the Federal Republic of Germany submits that its decision is justified by reasons relating to the protection
         of public health, in accordance with Article 30 EC.
      
      83     Whilst Article 30 EC allows the maintenance of restrictions on the free movement of goods justified on grounds of the protection
         of the health and life of humans, which are fundamental requirements recognised by Community law, it must be recalled that
         that provision cannot be applied where Community directives provide for harmonisation of the measures necessary to achieve
         the specific objective which would be furthered by reliance upon it (see, to that effect, Case C-102/96 Commission v Germany [1998] ECR I‑6871, paragraph 21).
      
      84     In this case, it is not necessary to examine whether the product concerned may be classified as a food supplement within the
         meaning of Article 2 of Directive 2002/46 or as a foodstuff within the meaning of Article 2 of Regulation No 178/2002. It
         is sufficient to hold that, according to Article 11(2) of Directive 2002/46 and Article 14(9) of Regulation No 178/2002, in
         the absence of specific Community rules laid down in those provisions, national rules may be applied without prejudice to
         the provisions of the Treaty.
      
      85     In those circumstances, it is appropriate to ascertain whether the German practice concerned may be justified on the basis
         of Article 30 EC.
      
      86     In that connection, it must be recalled that it is for the Member States, in the absence of harmonisation and to the extent
         that uncertainties continue to exist in the current state of scientific research, to decide on their intended level of protection
         of human health and life and on whether to require prior authorisation for the marketing of foodstuffs, always taking into
         account the requirements of the free movement of goods within the Community (Case 174/82 Sandoz [1983] ECR 2445, paragraph 16; van Bennekom, paragraph 37; and Joined Cases C-158/04 and C-159/04 Alfa Vita Vassilipoulos and Carrefour-Marinopoulos [2006] ECR I-8135, paragraph 21).
      
      87      However, in exercising their discretion relating to the protection of public health, the Member States must comply with the
         principle of proportionality. The means which they choose must therefore be confined to what is actually necessary to ensure
         the safeguarding of public health; they must be proportional to the objective thus pursued, which could not have been attained
         by measures which are less restrictive of intra-Community trade (see Sandoz, paragraph 18, van Bennekom, paragraph 39; Case C-192/01 Commission v Denmark [2003] ECR I‑9693, paragraph 45; and Case C-24/00 Commission v France [2004] ECR I-1277, paragraph 52).
      
      88      Furthermore, since Article 30 EC provides for an exception, to be interpreted strictly, to the rule of free movement of goods
         within the Community, it is for the national authorities which invoke it to show in each case, in the light of national nutritional
         habits and in the light of the results of international scientific research, that their rules are necessary to give effective
         protection to the interests referred to in that provision and, in particular, that the marketing of the products in question
         poses a real risk for public health (Sandoz, paragraph 22; van Bennekom, paragraph 40; Commission v Denmark, paragraph 46; and Commission v France, paragraph 53).
      
      89      Although, as was noted in paragraph 86 of this judgment, Community law does not, in principle, preclude a system of prior
         authorisation, it must however be stated that the issue of a marketing authorisation under Article 8 of Directive 2001/83
         is subject to particularly strict requirements.
      
      90     In those circumstances, the obligation to obtain a marketing authorisation for a medicinal product before being able to market
         the disputed product on German territory may be regarded as in accordance with the principle of proportionality only if it
         is actually necessary to safeguard public health.
      
      91     Such a restriction on the free movement of goods must therefore necessarily be based on a detailed assessment of the risk
         alleged by the Member State invoking Article 30 EC (see, to that effect, Commission v Denmark, paragraph 47, and Commission v France, paragraph 54).
      
      92     In this case, the Federal Republic of Germany merely refers to its arguments on the risks to health which derive from the
         preparation concerned in order to justify the restriction on the free movement of goods.
      
      93     As was stated in paragraphs 73 to 75 of this judgment, it must be recalled, first, that those arguments relate principally
         to the effect of garlic taken as a foodstuff and not specifically to those of the product concerned and, second, that such
         risks arose in very specific circumstances.
      
      94     The generic reference made by the Federal Republic of Germany to the risks that taking garlic may have for health in very
         specific circumstances is not sufficient, as the Advocate General observed in point 79 of her Opinion, to justify a measure
         such as making the product subject to the particularly strict procedure for a marketing authorisation for a medicinal product.
      
      95     Furthermore, the Member State, instead of making the product concerned subject to such a procedure, could have prescribed
         suitable labelling warning consumers of the potential risks related to taking this product. The protection of public health
         would thus have been ensured without such serious restrictions on the free movement of goods (see, to that effect, Case C-17/93
         van der Veldt [1994] ECR I-3537, paragraph 19). 
      
      96     It follows from the foregoing considerations that the Federal Republic of Germany has failed to prove that the legislation
         at issue is necessary in order to protect consumer health and that it goes no further than is necessary in order to achieve
         that aim. The decision of that Member State does not therefore satisfy the principle of proportionality. 
      
      97     It follows from all the foregoing considerations that, by classifying as a medicinal product a garlic preparation in capsule
         form not satisfying the definition of a medicinal product within the meaning of Article 1(2) of Directive 2001/83, the Federal
         Republic of Germany has failed to fulfil its obligations under Article 28 EC and Article 30 EC.
      
       Costs
      98     Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been
         applied for in the successful party’s pleadings. Since the Commission has applied for costs and the Federal Republic of Germany
         has been unsuccessful, the latter must be ordered to pay the costs.
      
      On those grounds, the Court (First Chamber) 
      hereby:
      1.      Declares that, by classifying as a medicinal product a garlic preparation in capsule form not satisfying the definition of
            a medicinal product within the meaning of Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council
            of 6 November 2001 on the Community code relating to medicinal products for human use, the Federal Republic of Germany has
            failed to fulfil its obligations under Article 28 EC and Article 30 EC;
      2.      Orders the Federal Republic of Germany to pay the costs.
      [Signatures]
      * Language of the case: German.