Judgment — ECLI:EU:C:2005:743
Date: 2005-12-06
Language of the case: English
Court formation: Grand Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Concepts: Public health;General;Food safety
Procedure: Action for annulment - unfounded
Origin: United Kingdom

summary, then, the conclusion must be that Article 95(1) EC is the correct legal basis for the Regulation, since that provision allows the introduction of multi-stage normative procedures such as the Regulation that have the result of bringing about an approximation of the laws of the Member States. B – The United Kingdom’s other arguments 41. In the further course of the proceedings the United Kingdom developed arguments relating not to the legal basis of the Regulation but to its proportionality with reference to the powers of the Member States and the limits of delegation under Article 202 EC. 42. As the Commission and the Council submit with reference to delegation, however, those submissions are out of time in both respects, in accordance with Article 42(2) of the Rules of Procedure. They are new pleas which were adduced only in the reply and the response to the Commission’s statement in intervention. The application does not mention either proportionality or a possible infringement of the limits of possible delegation. If the United Kingdom had had such concerns, it would be incomprehensible how, in the application, it could have considered the adoption of the Regulation on the basis of Article 308 EC to be fully permissible. In so far as the United Kingdom has argued from the outset that a regulation based on Article 95 EC must prescribe material standards, that argument relates exclusively to the question whether the Regulation can be regarded as a measure for the approximation of laws. 43. I shall therefore consider the proportionality of the Regulation and the possibilities of delegation only in the alternative. 1. Proportionality of the Regulation 44. Article 5 EC, which lays down the principle of limited specific empowerment in its first paragraph and the principle of subsidiarity in its second paragraph, requires in its third paragraph that action by the Community must not go beyond what is necessary to achieve the objectives of that Treaty. This is an expression of the principle of proportionality in terms of the law of competence. In accordance with that principle, which is one of the general principles of Community law, the acts of the Community institutions must not exceed the limits of what is appropriate and necessary in order to attain the objectives legitimately pursued by the legislation in question. Where there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued. (15) 45. Since what is involved is the relationship between Community measures and competences of the Member States, it must be considered whether the aims of the Regulation could not be pursued by other equally effective provisions leaving more responsibility to the Member States. 46. It must be taken into account, however, that the Community legislature has a broad discretion when political, economic and social decisions requiring complex evaluations are to be made. (16) That is the case with the subject of legislation at issue here. Marketing authorisation for smoke flavourings for use in foods requires complex assessments which, in relation to the production and marketing of flavourings of a commercial nature and to the protection of human health, are of a scientific and social nature. 47. There is no indication to be seen in the present case that the Community legislature overstepped the limits of that discretion. On the contrary, everything suggests that the solution chosen is, of the various conceivable regulatory models, the most appropriate for achieving its aim. A directive prescribing standards for the Member States for the authorisation of smoke flavourings and providing for the mutual recognition of authorisations could not be adopted, since, according to recital 8 in the preamble to the Regulation, a uniform procedure for assessing the safety of primary products for smoke flavourings is impossible for scientific and objective reasons, so that toxicological evaluation must focus on the safety of individual smoke condensates. A ‘coordination solution’ (17) under which the Member States issue authorisations which are automatically recognised in all the other Member States if no objection is made would precisely, in the absence of common standards, have led to conflicts between Member States, which would then have had to be settled by the Commission. The immediate determination of a positive list in the co-decision procedure, that is, by the Parliament and the Council on a proposal by the Commission, as the United Kingdom ultimately recommends, would restrict the competences of the Member States just as much as the solution chosen, and would at the same time make the procedure for the authorisation of smoke flavourings considerably clumsier and if anything reduce the rights of participation of manufacturers. 48. For the above reasons, the ‘disadvantages’ for the competences of the Member States are proportionate to the aims of Article 95(1) EC and of the Regulation. 49. The Regulation therefore complies with the requirements of proportionality. 2. The limits of delegation under Article 202 EC 50. In accordance with the third indent of Article 202 EC and the fourth indent of Article 211 EC, competence is normally to be conferred on the Commission to implement secondary law. (18) To assess the lawfulness of a delegation of powers to the Commission, the Court distinguishes between provisions that are essential for the matter to be regulated and must therefore be reserved to the basic instrument and provisions that are only of an implementing nature and can thus be left to the Commission to adopt. (19) Consequently, as the United Kingdom correctly assumes, the decisive point here is whether the delegated powers are to be reckoned to the ‘essential elements of the matter to be regulated’ or to the sphere of ‘implementation’. 51. The United Kingdom doubts that the essential elements of the matter to be regulated are, in the present case, determined in the basic regulation. It says that the Council and the Parliament did not lay down material standards for the approximation of laws, but only conferred on the Commission the task of elaborating the material criteria for regulating the matter. 52. Against that argument, it must be countered that the Court interprets the concept of ‘essential elements of the matter to be regulated’ very strictly, and regards as such only the provisions intended to give shape to the fundamental guidelines of Community policy. (20) Its settled case-law correspondingly interprets the concept of ‘implementation’ very widely (21) and thereby enables the Council to confer extensive powers on the Commission. (22) 53. In its wide interpretation of the concept of implementation, the Court relies firstly on the overall context of the EC Treaty and secondly on practical requirements, especially in the agricultural market and in connection with the law of foreign trade. It considers that only the Commission is in a position to track developments in agricultural or international markets, as the case may be, constantly and attentively and act with the swiftness called for by the situation. (23) 54. In accordance with that approach, the Court has so far as a rule required only very little as to the degree of definiteness of a delegation of powers to the Commission. Thus it has held that the Commission may be delegated a general power to regulate the detailed rules for the application of provisions. In particular, the essential elements of the delegated powers do not have to be specified precisely: provisions drafted in general terms have also provided a sufficient basis for authority to act in the particular case. (24) Such general conferments of power read, for example: ‘Detailed rules for the application of this Regulation … shall be adopted in accordance with the procedure …’. (25) 55. Such an indefinite delegation would not be acceptable in the present case. This case does not concern fields such as the agricultural market, which are fast-moving and at the same time characterised by intensive interventions on the part of the Community. Rather, on the basis of scientific assessments, a balance is to be struck, once only, for each primary product between the commercial freedom of action of undertakings and the protection of health and consumers in the internal market. This balancing exercise does not require flexibility and rapidity but a careful investigation and evaluation of all the relevant information. 56. Moreover, respect for the Parliament’s rights of participation, which even the Parliament itself may not relinquish unduly, and the danger of circumventing the legislative procedure prescribed in the Treaty argue in favour of stricter requirements for delegation. By contrast with the committee procedure (comitology) provided for here, in which the Parliament can participate only theoretically and in exceptional cases, (26) the procedure under Article 95 EC is characterised by greater transparency and markedly increased democratic legitimacy. 57. Even applying the stricter standards in certain sectors for which there are indications in the case-law, (27) the delegation in the present case is lawful. Articles 4 and 5 of the Regulation in particular, in conjunction with Annex I, state adequately the aims and subject-matter of the matter to be regulated. They thereby serve at the same time, as the institutions rightly submit, to implement the fundamental guidelines of Community policy in this field, and consequently determine the essential features of the matter to be regulated. Furthermore, the Regulation contains precise provisions as to how the delegated powers are to be exercised. 58. Article 4(1) defines the three essential conditions under which smoke flavourings may be authorised and used in connection with foods. They must not present risks to human health, must not mislead consumers, and must if appropriate comply with specific conditions of use. Article 4(2) accordingly prohibits the marketing of smoke flavourings which are not authorised or which do not adhere to the conditions of use. 59. The institutions which are parties to the proceedings correctly observe that Article 3 of the Regulation and recitals 7, 11 and 17 in its preamble make reference to Directive 88/388/EEC (28) and Regulation (EC) No 178/2002, (29) which give the general concepts in the Regulation a context that provides them with a technical background and thereby makes them specific. Article 4 of Directive 88/388/EEC and Articles 3, 5, 14 and 16 of Regulation (EC) No 178/2002 in particular offer more precise indications as to when a foodstuff does not present a risk to human health and when consumers are not misled. Whether these may actually be recognised as technical terms, as the Parliament submits, may be left open; in any event the terms are adequately defined. 60. Furthermore, the Commission has emphasised, without being contradicted, that the method of production of the primary products has decisive influence on the potential toxic effect of smoke flavourings. For the production of primary products, Article 5 therefore prohibits the use of chemically treated wood, unless it can be demonstrated that it is not dangerous. Annex I further specifies the conditions for the production of primary products, with respect to additives, heat treatment and chemical and physical processes for obtaining condensates and phases and their further treatment. Maximum contents are also given for two substances. Annex II gives further substantive indications in its references to the information relevant for the assessment. 61. The Regulation thus lays down specific, in any case sufficiently definite criteria for the method of production of the primary products, and regulates noticeably more than just the essential features of the matter. Everything else, in particular the elaboration of specific criteria of protection of health and consumers in the sphere of Article 4 of the Regulation, may very well – contrary to the United Kingdom’s view – be allocated to the broad area of ‘implementation’ as interpreted in the case-law of the Court. The implementing provisions and detailed rules of application which the Commission can adopt under delegated powers include precisely the determination of the preconditions, extent, and the other conditions for the application of general rules to individual cases. (30) 62. Moreover, the Commission has convincingly shown that practical and legal necessities prevented regulating in further detail in the Regulation itself, for example in the form of a positive list of all permissible primary products. Recital 8 in the preamble to the Regulation explains, to that effect, that a uniform procedure for the safety evaluation of primary products for smoke flavourings is not possible, for objective, scientific reasons. 63. In this respect, it must also be taken into account in particular that Article 95(3) EC and the first subparagraph of Article 152(1) EC demand a high level of protection of health. But if potential toxic effects of smoke flavourings depend so decisively on their components and proportions that what essentially matters are the primary products and their method of production, a list of authorised primary products can be drawn up only on the basis of toxicological evaluations in the individual case. (31) Since it is clear, furthermore, that every single one of the products may be specific in its method of production, chemical composition and toxicological characteristics, it is understandable that every authorisation must lay down individual conditions of use. 64. In the light of the information available on the purposes of the Regulation, its subject-matter and the relevant criteria, it is also unproblematic that under Article 9(1) the Commission has to take into account when making its assessment, as well as the requirements of Article 4(1) and Community law, also ‘other legitimate factors relevant to the matter’. What may legitimately be included under ‘factors’ can be sufficiently delimited by reference to the general main aims of the present basic regulation, the aims of the legal basis in Article 95(1) EC, the criteria laid down and the regulatory context. 65. In the two central material aspects of the matter to be regulated, the fundamental safety requirements for the use and marketing of smoke flavourings and the conditions of production, the Regulation consequently sets out the essential features of the measures of approximation of laws, with sufficient certainty as to the main elements of the delegated powers. 66. Finally, the Regulation lays down in Articles 6, 8 to 12 and 19 how the Commission is to exercise the delegated powers. Its task is to draw up a positive list of authorised primary products. The procedural provisions provide that the Commission is to evaluate the primary products on the basis of the material criteria with the assistance of the Food Safety Authority, and to decide on inclusion in the list with the participation of the regulatory committee. The type, effects, duration, modification, suspension, revocation and renewal of authorisations are referred to, as are the effects of a refusal. C – Summary conclusions 67. In conclusion, then, it may be stated that Article 95(1) EC is an adequate legal basis for the Regulation, its regulatory model is proportionate, and the delegation of implementing powers to the Commission is within the sphere of what is permissible under the third indent of Article 202 EC. The action must therefore be dismissed. V – Costs 68. Under Article 69(2) of the Rules of Procedure, the unsuccessful party must pay the costs if they have been applied for in the other party’s pleadings. Since the Parliament and the Council have in the present case made an application within the meaning of Article 69(2) of the Rules of Procedure and the United Kingdom, in accordance with the foregoing considerations, is unsuccessful, the United Kingdom must be ordered to pay the costs. 69. Under Article 69(4) of the Rules of Procedure, institutions which intervene in the case are to bear their own costs. The Commission must therefore bear its own costs. VI – Conclusion 70. On the basis of the foregoing considerations, I propose that the Court should: (1) Dismiss the action; (2) Order the United Kingdom to pay the costs, except for those incurred by the Commission, and order the Commission to bear its own costs. 1 – Original language: German. 2 – OJ 2003 L 309, p. 1. 3 – See Article 5 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (the comitology decision), OJ 1999 L 184, p. 23: The committee consists of representatives of the Member States. If the Commission’s planned measure is not supported in that committee by a qualified majority, the Commission must refer it to the Council. The Council can reject the measure or adopt it. If the Council is silent, the Commission can adopt the implementing measure itself after the expiry of a period of three months. 4 – The Food Safety Authority was created by 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). 5 – Case C‑300/89 Commission v Council (Titanium dioxide) [1991] ECR I‑2867, paragraph 10, and Case C‑110/03 Belgium v Commission [2005] ECR I‑0000, paragraph 78. 6 – See Case C‑376/98 Germany v Parliament and Council (Tobacco advertising) [2000] ECR I‑8419, paragraphs 84 and 85. 7 – See Wyatt, D. and Dashwood, A., European Union Law, 4th ed., Sweet & Maxwell, London 2000, p. 521; Müller-Graff, P.-C., ‘Die Rechtsangleichung zur Verwirklichung des Binnenmarktes’, Europarecht, Beck, Munich 1989, p. 107, 129; von Borries, R., ‘Verwaltungskompetenzen der Europäischen Gemeinschaft’, Festschrift für Ulrich Everling, vol. 1, 1995, p. 127, 128 ff.; Ludwigs, M., Rechtsangleichung nach Artikel 94, 95 EG-Vertrag, Nomos, Baden-Baden 2004, pp. 236 ff.; Schreiber, S., Verwaltungskompetenzen der Europäischen Gemeinschaft, Nomos, Baden-Baden 1997, pp. 122 ff.; Biervert, B., Der Missbrauch von Handlungsformen im Gemeinschaftsrecht, Nomos, Baden-Baden 1999, pp. 146 ff.; Klepper, M., Vollzugskompetenzen der Europäischen Gemeinschaft aus abgeleitetem Recht: Zulässigkeit, Modalitäten, Rechtsfolgen, Nomos, Baden-Baden 2001, pp. 62 ff.; and Wahl, R. and Groß, D., ‘Die Europäisierung des Genehmigungsrechts am Beispiel der Novel Food-Verordnung’, Deutsches Verwaltungsblatt, Rechts- und staatswissenschaftlicher Verlag, Hamburg 1998, pp. 2 ff. 8 – See Pipkorn, J., Bardenhewer-Rating, A. and Taschner, H.-C., ‘Artikel 95 EG – Angleichung von Vorschriften mit Bezug auf den Binnenmarkt’, in von der Groeben, H. and Schwarze, J., Kommentar zum Vertrag über die Europäische Union und zur Gründung der Europäischen Gemeinschaften, vol. 2, 6th ed., Nomos, Baden-Baden 2003, paras 36 ff.; Herrnfeld, H.-H., ‘Artikel 95 EGV – Angleichung der Rechtsvorschriften’, in Schwarze J., EU-Kommentar, Nomos, Baden-Baden 2000, paras 23 and 37; Leible, S., ‘Artikel 95 EGV’, in Streinz, R., EUV/EGV – Vertrag über die Europäische Union und Vertrag zur Gründung der Europäischen Gemeinschaft, Beck, Munich 2003, paras 28 f.; and Streinz, R., ‘Die EG-Verordnung über neuartige Lebensmittel und neuartige Lebensmittelzusätze – Eine Analyse der Novel Food-Verordnung’, Europäische Zeitschrift für Wirtschaftsrecht, Beck, Munich 1997, p. 487, 490. 9 – See Case C‑377/98 Netherlands v Parliament and Council [2001] ECR I‑7079, paragraphs 24 and 25; Case C‑350/92 Spain v Council [1995] ECR I‑1985, paragraph 23; and Opinion 1/94 (Competence of the Community to conclude international agreements concerning services and the protection of intellectual property) [1994] ECR I‑5267, paragraph 59. 10 – In French the passage is ‘mesures relatives au rapprochement’, in English ‘measures for the approximation’, in Spanish ‘medidas relativas a la aproximación’, in Italian ‘misure relative al ravvicinamento’, and in Portuguese ‘medidas relativas à aproximação’. 11 – Case C‑209/97 Commission v Council [1999] ECR I‑8067, paragraph 35 et seq. 12 – Whether Article 95 EC makes it possible to create new Community bodies is to be clarified in the pending Case C‑217/04 United Kingdom v Parliament and Council concerning the European Network and Information Security Agency. 13 – On this argument, see point 23 above. 14 – A negative answer is given by the judgment in Case C‑359/92 Germany v Council [1994] ECR I‑3681, paragraph 38. 15 – See Joined Cases C‑96/03 and C‑97/03 Tempelman and van Schaijk [2005] ECR I‑0000, paragraph 47; Case C‑189/01 Jippes and Others [2001] ECR I‑5689, paragraph 81; Joined Cases C‑27/00 and C‑122/00 Omega Air and Others [2002] ECR I‑2569, paragraph 62; Case C‑112/00 Schmidberger [2003] ECR I‑5659, paragraph 79; and Case C‑220/01 Lennox [2003] ECR I‑7091, paragraph 76. 16 – See most recently Case C‑210/03 Swedish Match [2004] ECR I‑0000, paragraph 47 et seq. 17 – See Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs (OJ 1996 L 299, p. 1); 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); Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ 1998 L 123, p. 1); Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ 2004 L 104, p. 1); Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1); 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); and European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (OJ 1994 L 237, p. 3). 18 – The Court has made it clear that the new version of the wording now provides for this normal delegation: see Case 16/88 Commission v Council [1989] ECR 3457, paragraph 10. 19 – See Case C‑240/90 Germany v Commission [1992] ECR I‑5383, paragraph 36; Joined Cases C‑63/90 and C‑67/90 Portugal and Spain v Council [1992] ECR I‑5073, paragraph 14; Case 46/86 Romkes [1987] ECR 2671, paragraph 16; Case 230/78 Eridania [1979] ECR 2749, paragraph 7; and Case 25/70 Köster [1970] ECR 1161, paragraph 6. 20 – See Case C‑356/97 Molkereigenossenschaft Wiedergeltingen [2000] ECR I‑5461, paragraph 21, and Germany v Commission, cited in footnote 19, paragraphs 36 and 37. 21 – See Case C‑159/96 Portugal v Commission [1998] ECR I‑7379, paragraph 40; Case 23/75 Rey Soda [1975] ECR 1279, paragraph 10; Joined Cases C‑9/95, C‑23/95 and C‑156/95 Belgium and Germany v Commission [1997] ECR I‑645, paragraph 36; Case 22/88 Vreugdenhil [1989] ECR 2049, paragraph 16; Case C‑478/93 Netherlands v Commission [1995] ECR I‑3081, paragraph 30; and Joined Cases 279/84, 280/84, 285/84 and 286/84 Walter Rau [1987] ECR 1069, paragraph 14. 22 – See Belgium and Germany v Commission, cited in footnote 21, paragraph 36; Vreugdenhil, cited in footnote 21, paragraph 16; Netherlands v Commission, cited in footnote 21, paragraph 30; and Walter Rau, cited in footnote 21, paragraph 14. 23 – See, on the agricultural market, Belgium and Germany v Commission, cited in footnote 21, paragraph 36, Vreugdenhil, cited in footnote 21, paragraph 16, and Rey Soda, cited in footnote 21, paragraph 11; and, on the law of foreign trade, Portugal v Commission, cited in footnote 21, paragraph 40 et seq. 24 – See Case C‑374/96 Vorderbrüggen [1998] ECR I‑8385, paragraph 36; Germany v Commission, cited in footnote 19, paragraph 41; Case C‑48/98 Söhl & Söhlke [1999] ECR I‑7877, paragraph 34; and Molkereigenossenschaft Wiedergeltingen, cited in footnote 20, paragraph 23. 25 – See, for instance, Article 12 of Council Regulation (EEC) No 768/89 of 21 March 1989 establishing a system of transitional aids to agricultural income (OJ 1989 L 84, p. 8), which was the basis of the judgment in Germany v Commission, cited in footnote 19. 26 – See Article 8 of the comitology decision, cited in footnote 3, according to which the Parliament can call on the Commission to re-examine draft implementing measures on the ground that the limits of delegation have been exceeded. In 2000 and 2001 the Parliament made use of this possibility only once, in 2000 (see the Reports from the Commission on the working of the committees during 2000 and 2001, COM(2001) 783 final of 20 December 2001, p. 6 et seq., and COM(2002) 733 final of 13 December 2002, p. 4 et seq.). 27 – See Case 291/86 Central-Import [1988] ECR 3679, paragraph 13; Vreugdenhil, cited in footnote 21, paragraph 17; and the reinforcement of the normative content of the comitology decision, cited in footnote 3, by the judgment in Case C‑378/00 Commission v Parliament and Council [2003] ECR I‑937, paragraph 40 et seq., Article 1(1) of which requires the basic instrument to stipulate the essential elements of the powers conferred. 28 – Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production, OJ 1988 L184, p. 61. 29 – 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. 30 – See Commission v Council, cited in footnote 18, paragraphs 10 and 11, and Söhl & Söhlke, cited in footnote 24, paragraph 34. 31 – For that reason, it is said, it was also necessary to call on undertakings to submit detailed applications for their products available on the market, which incidentally also reduces the anticipated number of such products to fewer than 20.