CELEX: 61997CC0328
Language: en
Date: 1998-10-01 00:00:00
Title: Opinion of Mr Advocate General Fennelly delivered on 1 October 1998. # Glob-Sped AG v Hauptzollamt Lörrach. # Reference for a preliminary ruling: Bundesfinanzhof - Germany. # Combined Nomenclature - Headings Nos 3004 and 2106 - Vitamin C-based preparations. # Case C-328/97.

Important legal notice

|

61997C0328

Opinion of Mr Advocate General Fennelly delivered on 1 October 1998.  -  Glob-Sped AG v Hauptzollamt Lörrach.  -  Reference for a preliminary ruling: Bundesfinanzhof - Germany.  -  Combined Nomenclature - Headings Nos 3004 and 2106 - Vitamin C-based preparations.  -  Case C-328/97.  

European Court reports 1998 Page I-08357

Opinion of the Advocate-General

Introduction 1 The present case concerns the tariff classification of two types of tablets, containing high concentrations of Vitamin C (ascorbic acid) and some calcium, as medicaments (heading No 3004), as food preparations (heading No 2106) or as provitamins and vitamins (heading No 2936). Legal and factual background 2 The present case concerns the Community's Combined Nomenclature (hereinafter `the CN'), in the version established by Commission Regulation (EEC) No 2505/92 of 14 July 1992 amending Annexes I and II to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff. (1)  The CN is based on the Harmonised Commodity Description and Coding System (hereinafter `the HS') of the Customs Cooperation Council. (2) 3 Within Chapter 30, `Pharmaceutical products', of the CN, heading No 3004 refers to `Medicaments (excluding goods of heading No 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses put up in measured doses or in forms or packings for retail sale'.  Subheading No 3004 50 refers to `Other medicaments containing vitamins or other products of heading No 2936'; its subdivision No 10 concerns such products `Put up in forms or in packings of a kind sold by retail'.  According to Note 1(a) in the introduction to Chapter 30 of the CN, that chapter does not cover `foods or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters)', which fall to be classified in Section IV of the CN. (3) 4 Subheading No 3004 50 of the HS is identical with its equivalent in the CN.  The Customs Cooperation Council's Explanatory Notes to the HS (hereinafter `the HSENs') concerning heading No 3004 of the HS state that it: `refers to products ... which, because of their packing and, in particular, the presence of appropriate indications (statement of disease or condition for which they are to be used, method of use or application, statement of dose, etc.) are clearly intended for sale directly to users (private persons, hospitals, etc.) without repacking, for the above purposes.  These indications (in any language) may be given by label, literature or otherwise ... .  On the other hand, even if no indications are given, unmixed products are to be regarded as being put up for retail sale for therapeutic or prophylactic use if they are put up in a form clearly specialised for such use.' (4) The HSENs also include text very similar to the above-quoted CN Note 1(a) and explain that the exclusion of foodstuffs and beverages applies `essentially ... as regards food preparations containing only nutritional substances.  The major nutritional substances in food are proteins, carbohydrates and fats.  Vitamins and mineral salts also play a part in nutrition'.  The HSENs add that heading No 3004 `excludes food supplements containing vitamins or mineral salts which are put up for the purpose of maintaining health or well-being but have no indication for the prevention or treatment of any disease of ailment', those being generally classified in heading No 2106 or Chapter 22 of the HS. 5 The Commission's Explanatory Notes to the CN (hereinafter `the CNENs'), (5) Chapter 30, `General', state: `The description of a product as a medicament in Community legislation (other than that relating specifically to classification in the combined nomenclature) or in the national legislation of the Member States, or in any pharmacopoeia is not the deciding factor in so far as its classification in this chapter is concerned.' 6 Within Section IV of the CN, Chapter 21 is entitled `Miscellaneous edible preparations'.  Heading No 2106 concerns `Food preparations not elsewhere specified or included'.  According to Note 1(g) to Chapter 21 of the CN, that chapter does not cover `yeast put up as a medicament or other products of heading No 3003 or 3004'.  The HSENs state that the identically worded heading of the HS includes, inter alia: `Preparations, often referred to as food supplements, based on extracts from plants, fruit concentrates, honey, fructose, etc. and containing added vitamins and sometimes minute quantities of iron compounds.  These preparations are often put up in packagings with indications that they maintain general health or well-being.  Similar preparations, however, intended for the prevention or treatment of diseases or ailments are excluded (heading 3003 or 3004).' 7 Chapter 29 of the CN refers to `Organic Chemicals'. Heading No 2936 is entitled `Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent'. 8 Classification of products for the purposes of Community law is determined according to the terms of the headings in the CN and any relative section or chapter notes. (6)  As such, the chapter notes are a useful aid to the interpretation of the CN. (7)  The CNENs and HSENs may be an important aid to the interpretation of the scope of the various tariff headings but do not have legally binding force. (8) 9 The Commission has also adopted two detailed regulations which have been referred to the present case.  In Commission Regulation (EEC) No 2061/89 of 7 July 1989 concerning the classification of certain goods in the combined nomenclature, (9) reference is made to the following product: `Preparation[s] in the form of tablets put up in packages for retail sale with instructions on dosage and composition, to counter deficiency in vitamin C. Each tablet weighing 750 mg contains: - Ascorbic acid:  500 [m]g - Rose hip powder, cellulose, vegetable stearine, botanical oil solids, magnesium stearate, silicon dioxide and food glaze containing protein:  250 mg'. These tablets are classified under heading No 2106 90 91. 10 Commission Regulation (EEC) No 2723/90 of 24 September 1990 replacing the codes established on the basis of the Common Customs Tariff nomenclature in force on 31 December 1987 with those established on the basis of the Combined Nomenclature in certain Regulations concerning the classification of goods (10) classifies multivitamin pills and effervescent multivitamin pills containing, inter alia, 60 mg and 75 mg of Vitamin C respectively under CN heading No 2106 90 99 for the purposes of Commission Regulation (EEC) No 210/85 of 25 January 1985 classifying goods in subheading 21.07 G I d) 1 of the Common Customs Tariff. (11) 11 Reference should also be made to Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, (12) which provides that no proprietary medicinal products may be placed on the market in a Member State unless an authorisation has been issued by the competent authority of that Member State. (13)  The objective of the Directive is to remove hindrances to intra-Community trade in proprietary medicinal products arising from disparities between national provisions while respecting the primary goal of safeguarding public health. (14)  Article 1(2) of Directive 65/65/EEC defines a medicinal product as follows: `Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.' 12 To complete this overview of the relevant law, it is useful to summarise some of the recent case-law of the Court regarding the customs classification of products as medicaments.  `The decisive criterion', as stated, inter alia, in Bioforce (15) (hereinafter `Bioforce I'), `for the classification of goods for customs purposes is to be sought, regard being had to the requirements of legal certainty, in their objective characteristics and properties, as defined in the wording of the headings of the Common Customs Tariff'. (16)  The Court added that this was to be decided `in the light of medical developments'. That case concerned drops containing an extract of hawthorn with added alcohol which may be taken as a tonic for the heart.  It was agreed that the product was presented as a medicament. (17)  The Court accepted the scientific evidence that the drops at issue had `clearly defined therapeutic and, above all, prophylactic characteristics, the effect of which is concentrated on precise functions of the human organism, namely the cardiac, circulatory and neuro-vegetative functions'. (18) 13 Bioforce v Oberfinanzdirektion München (19) (hereinafter `Bioforce II') concerned the tariff classification of products consisting of a fresh herbal tincture of Echinacea purpurea which were offered for sale in packages mentioning their composition, spheres of application and recommended dosage, with a view to assisting the body in resisting or recovering from infection.  The competent customs authority took the view that the active substances in Echinacea had not as yet found general recognition and refused to classify the products as medicaments.  The Court noted, on the basis of the documents and observations, that it was clear that the use of the products in question was recommended in appropriate dosages `in particular, to strengthen the body's defences against feverish colds and, more particularly in the case of "Echinaforce", against chronic inflammations and infections, cases of increased risk of infection and debility after infectious diseases and also against skin diseases'. (20)  It continued, in a passage which has been misunderstood: `Whatever the actual therapeutic or prophylactic value of the products in question, it must be held that the description of the curative or prophylactic properties of those products as well as the way in which they are packaged, dispensed and marketed is in itself such as to cause them to be regarded as products possessing the characteristic properties of a medicament and, by correlation, to exclude the possibility that they might be used for purposes other than those of a therapeutic or prophylactic nature.' (21) The Court added that the fact that the products in question were authorised to be put on the market as medicaments in the Member States in which they were marketed, or had been the subject of an application for authorisation to that end, `constitutes further evidence that they possess the objective characteristics and properties defined in heading 3004 of the CCT'. (22) 14 In LTM, (23) the Court was asked about the tariff classification of two products, one of which contained certain vitamins in amounts several times higher than the levels of the Reference Intake for a Population and which was stated to be recommended for the prevention or correction of vitamin deficiencies linked to an inadequate or unbalanced diet, the other of which was a combination of amino acids, mineral salts and trace elements and was stated to be recommended in cases of debility, convalescence, overwork, poor appetite, weight loss and ageing.  The Court found that neither product had clearly defined therapeutic or prophylactic characteristics with an effect concentrated on precise functions of the human organism and that neither was capable of being applied in the prevention or treatment of diseases or ailments, as required by the judgment in Bioforce I. (24)  The fact that the products in question were the subject of an authorisation to be marketed in France as medicinal products, (25) that they were presented as medicinal products and that they were distributed exclusively in pharmacies could provide a strong indication but did not compensate for the lack of these essential characteristics. (26)  The Court noted, in particular, that the objectives of Directive 65/65/EEC - of eliminating obstacles to trade while protecting public health - were different from those of the Combined Nomenclature, and that the classification of a product as a medicinal product for the purposes of that Directive was wide and could vary as between Member States. (27)  The Combined Nomenclature, on the other hand, was to be applied in a uniform manner by all the Member States. (28) 15 Glob-Sped AG (hereinafter `the applicant') requested the Hauptzollamt Lörrach (Principal Customs Office, Lörrach, hereinafter `the defendant') on 26 January 1993 to admit the two products in question in the present case into free circulation as medicaments.  The two products are Taxofit Vitamin C + Ca Brausetabletten, soluble tablets containing 1 000 mg of Vitamin C, and Taxofit Vitamin C Kautabletten, chewable tablets containing 500 mg of Vitamin C.  These quantities appear to be greatly in excess of that recommended for normal dietary purposes (on average 75 mg per day). (29)  The packaging of both products states that they are to be taken to reinforce the immune system in cases of heightened risks of infectious illnesses, such as colds or flu, or in cases of overwork, tiredness or (in the case of the Brausetabletten) allergic reactions.  Both are stated to be traditionally used for strengthening and fortification (`zur Stärkung und Kräftigung'), in the case of the Kautabletten as a prophylactic measure.  The posology provides for a certain number of tablets to be taken daily, depending on the circumstances, in the absence of a contrary prescription.  There is also a warning on the packaging, in both cases, that the product is a medicament, to be kept with care and out of the reach of children, and that persons using the products should refer to the instructions.  Authorisation has been granted pursuant to Directive 65/65/EEC to market both products in Germany as medicaments. 16 The defendant took the view, following an expert study, that the products should be classified as `other food preparations not elsewhere specified or included' (heading No 2106 90 99 of the CN).  The Finanzgericht (Finance Court) rejected the case claim of the applicant, on the grounds that there was no indication on the pack of the tablets' specific effectiveness against defined illnesses (30) and that the products in question should, therefore, be classified as vitamins.  The applicant appealed to the Bundesfinanzhof (Federal Finance Court, hereinafter `the national court'), seeking the quashing (Revision) of the decision of the Finanzgericht.  The applicant invoked the judgment in Bioforce II (31) and argued that the tablets in question should be classified as medicaments on the basis of their objective characteristics and effects on certain illnesses and/or of their external presentation and the marketing authorisation.  The applicant cited a publication of the Bundesgesundheitsamt (Federal Health Authority) recommending 50 to 225 mg of Vitamin C per day as a prophylactic, depending on the circumstances, and 225 to 1 000 mg per day as treatment of diseases such as scurvy, Moeller-Barlow disease, malnutrition, severe trauma and infectious diseases. (32)  The defendant conceded that concentrated Vitamin C was suited to combating certain illnesses, but countered that the information provided on the packaging should enable the product to be used properly as a medicament and to be identified as such, and that such specific information was lacking in the present case. 17 The national court took the view that a product is not a medicament if it merely combats a deficiency, even if it thus indirectly counteracts deficiency diseases.  The product must act both as a replacement in case of deficiency and as a treatment or prophylactic for non-deficiency diseases.  It suggested that Bioforce II attached greater importance than previous cases to the presentation of products, with the result that the tablets in question could probably be deemed to be medicines on the basis of the package indications;  but that the applicant had gone even further by arguing that the products could be classified as medicaments on the basis of the packaging alone.  In order to resolve this issue, the national court referred the following questions to the Court for a preliminary ruling pursuant to Article 177 of the Treaty establishing the European Community (hereinafter `the Treaty'): `1. Are the comments of the Court of Justice in paragraph 15 of its judgment of 15 May 1997 in Case C-405/95 Bioforce v Oberfinanzdirektion München to be interpreted as meaning that, in order for a preparation to be regarded as a product possessing the characteristic properties  of a medicament for the purposes of heading No 3004 of the Combined Nomenclature, it does not have to possess any objective qualities making it suitable for therapeutic or prophylactic uses, but that just the overall presentation of the preparation (information on its use, and its packaging, dispensation and marketing), that is to say its subjective purpose, is sufficient for such a classification? 2. If Question 1 is answered in the negative: Is the Combined Nomenclature for 1993 to be interpreted as meaning that vitamin pills such as "Taxofit Vitamin C + Ca effervescent pills" and "Taxofit Vitamin C chewable pills" are to be assigned to heading No 3004 ("medicaments ... consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in ... forms or packings for retail sale"), when they contain 1 000 mg and 500 mg of Vitamin C (ascorbic acid) per pill respectively, are imported in packings for retail sale, are to be used - according to the information on use which is contained in the leaflets enclosed with the packs and indicates a specific dose - inter alia "to build up resistance:  for colds and influenza infections, ... and allergic processes" and "as a prophylactic at times of increased risk of infection" respectively, and are authorised as medicinal products in the Federal Republic of Germany?' Submissions 18 Written and oral observations were submitted by the applicant, the French Republic and the Commission. 19 The applicant states that the Finanzgericht accepted that the products in question have prophylactic and therapeutic functions, so that there is no need to answer the first question.  Provided specific instructions are given for the use of the products for medicinal purposes, the fact that the product is also stated to have other, merely fortifying qualities cannot alter its CN classification as a medicament.  The subjective intention with which a product is marketed can affect its objective characteristics, through the choice of packaging and of the language used thereon.  Thus, if the Court decides to answer the first question, the applicant submits, in reliance on the judgment in Bioforce II, that it should be answered in the affirmative, resulting in parallelism between the CN classification and the scope of Directive 65/65/EEC, which is principally based on the presentation of products. 20 The Commission proposes a negative answer to the first question.  It contends that the judgment in Bioforce II did not depart from pre-existing case-law regarding the use of objective factors to determine customs classification.  The description used on the packaging in that case merely underlined the objective qualities of the product in question.  As emerges clearly from LTM, the manner of presentation and marketing of a product can, in addition, have indicative value for CN classification purposes, but parallelism between the CN and Directive 65/65/EEC is inappropriate because of their different objectives.  The Commission accepts that the products in question have a specific medicinal function, which is not contradicted by other, more general indications regarding their use as a strengthener.  Neither Regulation No 2061/89 nor Regulation No 2723/90 applies directly to the products at issue in the present case, due to their different composition.  In the wake of the judgment in Bioforce II, the Commission would not recommend reliance on Regulation No 2061/89 to determine, by analogy, the classification of products outside its immediate scope. (33) 21 France submits that the manner in which a product is presented and the grant of a marketing authorisation are merely complementary indices for customs classification purposes;  the product's objective characteristics remain central.  On the facts of the case, both the product's objective characteristics and its presentation point towards its classification as a medicament. Analysis 22 The first question referred by the national court requires to be addressed only if a negative answer is given to the second, that is, if the products in question in this case possess no objective qualities or properties making them suitable for therapeutic or prophylactic purposes. For that reason, I shall commence with the second question. 23 The decisive criterion based on `objective characteristics' is the basis of the reasoning in all the cases. (34)  In the case of medicaments, this entails interpretation in the light of `medical developments', or, as stated in Bioforce I, that the product have `clearly defined therapeutic [or] prophylactic characteristics, the effect of which is concentrated on precise functions of the human organism'. (35)  This requirement should not be construed too strictly.  Thus, in Bioforce I, the Court deemed it to be satisfied by drops which eased minor cardiac difficulties caused by ageing, contrary to the suggestion of Advocate General Gulmann, who took the view that the drops were not designed for a specific illness and that their effect was not sufficiently specific. (36)  In Bioforce II, the Court characterised as medicaments products designed to strengthen the body's resistance to colds and other infections, to promote recovery after infection and to treat certain skin conditions.  The Court's reference in Bioforce I to `precise functions of the human organism' (37) is, in my view, to be understood as referring to identifiable functions of the body;  this is the application to the facts of that case of its view that the heading was to be interpreted in the light of `medical developments'.  This is also consistent with the approach taken on this point by Advocate General La Pergola in Bioforce II.  In response to the Commission's argument that the products at issue merely performed a generic prophylactic function, and should not be classed as medicaments, he observed that such a condition would exclude from heading No 3004 of the CN `a whole series of substances which are undeniably medicaments and which have a definite broad-spectrum prophylactic and/or preventive function, such as antibiotics or immunising substances, or which, like aspirin, have various functions'. (38) 24 On the other hand, products containing substances with potential prophylactic or therapeutic functions will not merit customs classification as medicaments if those substances are present in insufficient quantities to have such effects.  This was the case in Colin and Dupré, where the substances in question, present in throat pastilles, acted merely as flavouring agents; (39)  and in LTM, the multivitamin tablets under consideration could not be used to combat specific deficiencies of a particular vitamin without risk of overdose of other vitamins, so that they were of use only as a daily dietary supplement intended to maintain general health and well-being.  The other product at issue in that case, which combined amino acids, mineral salts and trace elements, had extremely general effects in cases of debility, convalescence, overwork, poor appetite, weight loss and ageing. 25 In my view, the high-dosage Vitamin C tablets which are the subject of the present case have clearly defined therapeutic and prophylactic characteristics.  First of all, the dosage of Vitamin C is far higher than is needed or recommended for normal daily intake as a dietary supplement.  More importantly, in addition to assisting the body's immune system to resist infection at times of debility, overwork and so on, such high concentrations of Vitamin C are also recommended in response to allergic reactions and severe traumas, such as may arise from an injury or surgical operation, as well as to at least two specific (if rare) illnesses, scurvy and Moeller-Barlow disease. 26 This assessment of the objective characteristics of the products in question is not affected by the classification of certain tablets containing 500 mg of Vitamin C as food supplements by Regulation No 2061/89.  That regulation states no more than that a specific product with a specific composition is covered by heading No 2106 of the CN, and it does not indicate the heading under which products with a different composition are to be classified. (40)  The products at issue do not fall within the scope of that regulation as they do not contain the other ingredients mentioned therein, or do not do so in the same proportions. 27 It should be noted that the packaging of the products in question does not refer to the two illnesses mentioned above.  It concentrates instead on the products' more general effects on the body's immune system.  It also refers to their traditional use as a strengthener, which use, taken on its own, would not be sufficient to qualify the products as a medicament, in my view, regard being had to the judgment in LTM.  At the same time, it is clearly stated that the products are medicaments, to be handled with care and in accordance with the posology and instructions given.  It might be concluded from this that the manufacturer wished simultaneously to enhance the potential market for these products among persons generally interested in their own health and to present them, as is justified by their objective characteristics, as medicaments suitable for treatment of particular conditions or ailments.  The presentation of the products can thus be concluded to be ambiguous. 28 However, I do not think that ambiguity in the presentation of products is sufficient to overturn their characterisation as medicaments in the light of their objective prophylactic or therapeutic qualities. 29 This leads me to make a few closing remarks concerning the first question.  The national court refers in particular to the statement in paragraph 15 of the judgment in Bioforce II that the description, packaging and manner of marketing the drops at issue in that case could cause them to be regarded as medicinal products, `[w]hatever the actual therapeutic or prophylactic value of the products in question'. (41)  It infers from this statement the possibility that the presentation of products could in itself, without regard to their objective characteristics, permit them to be classified as medicaments.  This was also suggested by Advocate General La Pergola, who argued for the concept of a medicinal product to be similarly defined for the purposes of customs classification and of Directive 65/65/EEC by reference to the criteria set out in that Directive. (42) 30 However, I do not think such an inference is justified. The Court's statement in paragraph 15 of its judgment in Bioforce II must be read in the light of its earlier reference to the product's objective characteristics and properties as the decisive criterion for customs classification. (43)  There is nothing in Bioforce II to detract from the Court's consistent statement that presentational and marketing aspects of products, whatever their effect on the perception of a product by consumers, are merely complementary to that decisive criterion.  Thus, the Court referred to authorisation to market a product as a medicament as evidence of its objective characteristics and properties, (44) thereby confirming the centrality of that criterion.  Similarly, statements in the packaging or instructions of a product can also constitute complementary evidence that it possesses any objective prophylactic or therapeutic properties claimed, on the assumption that such statements are correct. 31 This conclusion is not contradicted, in my view, by the HSENs concerning heading No 3004 of the HS. (45)  Those explanatory notes merely serve to distinguish medicinal products put up in measured doses or in forms or packings for retail sale from those not so put up, which fall under heading No 3003, and do not  affect the dividing line between medicinal and other products, such as food preparations.  This is most clearly demonstrated by the reference to sale directly to users without repacking and by the last sentence of the HSENs quoted above. 32 I am unable to accept that the definition provided in Directive 65/65/EEC should be used in this context.  I concur entirely with the reasons given by the Court in LTM for this conclusion, (46) which are further supported by reference to the CNENs to Chapter 30. (47) 33 In the light of my proposed answer to the second question, I do not think, however, that it is necessary to respond directly to the first question referred by the national court.  It should be clear, however, that if I were to recommend a response, it would be in the negative. Conclusion 34 In the light of the foregoing, I recommend that the Court respond as follows to the questions referred by the national court: Products such as those described in the order for reference are to be classified under heading No 3004 50 10 of the Combined Nomenclature, in the version established by Commission Regulation (EEC) No 2505/92 of 14 July 1992 amending Annexes I and II to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff. (1) - OJ 1992 L 267, p. 1. (2) - Since 1994, the Customs Cooperation Council is unofficially known as the World Customs Organisation. (3) - Such chapter notes form part of the combined nomenclature;  see Article 1(2)(c) of Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff, OJ 1987 L 256, p. 1. (4) - See, most recently, World Customs Organisation, Harmonised Commodity Description and Coding System: Explanatory Notes, 2nd. ed. (Brussels, 1996). (5) - The CNENs are adopted by the Commission pursuant to Article 9(1)(a) of Regulation No 2658/87, loc. cit.  They are stated to be complementary to the HSENs, to which they make frequent reference.  For a consolidated version of the CNENs, see OJ 1994 C 342, p. 1.  The most recent version was published after the hearing in this case, OJ 1998 L 287, p. 1. (6) - See Rule 1 of Part One.I.A of the CN, General rules for the interpretation of the combined nomenclature. (7) - Case 200/84 Daiber v Hauptzollamt Reutlingen [1985] ECR 3363, paragraph 14. (8) - Ibid.;  Case C-35/93 Develop Dr Eisbein [1994] ECR I-2655, paragraph 21;  Joined Cases C-106/94 and C-139/94 Colin and Dupré [1995] ECR I-4759, paragraph 21;  Case C-201/96 LTM v FIRS [1997] ECR I-6147 (hereinafter `LTM'), paragraph 17. (9) - OJ 1989 L 196, p. 5. (10) - OJ 1990 L 261, p. 24. (11) - OJ 1985 L 24, p. 11. (12) - OJ, English Special Edition, First Series (1965-1966), p. 20. (13) - Article 3 of the Directive. (14) - First and third recitals in the preamble to the Directive;  Case 227/82 Van Bennekom [1983] ECR 3883. (15) - Case C-177/91 Bioforce [1993] ECR I-45. (16) - Ibid., paragraphs 8 and 9.  The Court cited Case C-338/90 Hamlin Electronics v Hauptzollamt Darmstadt [1992] ECR I-2333, paragraph 8. (17) - Opinion of Advocate General Gulmann, paragraph 5. (18) - Loc. cit., paragraph 12. (19) - Case C-405/95 [1997] ECR I-2581. (20) - Ibid., paragraph 14. (21) - Ibid., paragraph 15. (22) - Ibid., paragraph 16. (23) - Loc. cit. (24) - Paragraphs 37 and 45 of the judgment in LTM, loc. cit.  See Bioforce I, loc. cit., paragraph 12. (25) - See paragraph 26. (26) - LTM, loc. cit., paragraphs 38 and 46. (27) - Ibid., paragraph 24.  See also the Opinion of Advocate General Elmer, paragraph 16, and his Opinion in Colin and Dupré, loc. cit., paragraphs 15 and 16;  the Opinion of Advocate General Gulmann in Bioforce I, loc. cit., paragraph 7;  Van Bennekom, loc. cit.; and the CNENs to Chapter 30 of the CN.  Cf. the Opinion of Advocate General La Pergola in Bioforce II, loc. cit., paragraphs 12 and 13. (28) - Ibid., paragraph 25;  see the eighth recital in the preamble to Regulation No 2658/87. (29) - See paragraph 16 below. (30) - The Finanzgericht relied upon Bioforce I and Colin and Dupré, loc. cit. (31) - Loc. cit. (32) - Bundesanzeiger No 97, 29 May 1991. (33) - See paragraphs 9 and 10 above. (34) - Bioforce I, loc. cit., paragraph 8;  Colin and Dupré, loc. cit., paragraph 22;  Bioforce II, loc. cit., paragraph 12;  LTM, loc. cit., paragraph 17. (35) - Bioforce I, loc. cit., paragraphs 9 and 12. (36) - Ibid., paragraph 9 of the Opinion. (37) - Emphasis added. (38) - Loc. cit., paragraph 14 of his Opinion. (39) - Loc. cit., paragraph 26. (40) - See the Opinion of Advocate General Elmer in Colin and Dupré, loc. cit., paragraph 17. (41) - Loc. cit. (42) - Ibid., paragraphs 12 and 13 of his Opinion. (43) - Ibid., paragraph 12. (44) - Ibid., paragraph 16. (45) - Quoted in paragraph 4 above. (46) - Loc. cit., paragraphs 24 to 27.  See my summary at paragraph 14 above. (47) - Quoted in paragraph 5 above.