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Judgment of the Court (Grand Chamber) of 6 December 2005.#United Kingdom of Great Britain and Northern Ireland v European Parliament and Council of the European Union.#Foods - Regulation (EC) No 2065/2003 - Smoke flavourings - Choice of legal basis.#Case C-66/04.

ECLI:EU:C:2005:743

62004CJ0066

December 6, 2005
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(Foods – Regulation (EC) No 2065/2003 – Smoke flavourings – Choice of legal basis)

Summary of the Judgment

1. Approximation of laws – Foods – Regulation No 2065/2003 – Smoke flavourings – Legal basis – Article 95 EC – Measures for approximation – Discretion – Matter requiring evaluations relating to the safety of foods – Need to ensure, in the choice of harmonisation technique, a high level of protection of human health

(Art. 95 EC; European Parliament and Council Regulation No 2065/2003)

(Art. 95 EC; European Parliament and Council Regulation No 2065/2003)

1.By the expression ‘measures for the approximation’ in Article 95 EC the authors of the Treaty intended to confer on the Community legislature a discretion, depending on the general context and the specific circumstances of the matter to be harmonised, as regards the harmonisation technique most appropriate for achieving the desired result, in particular in fields which are characterised by complex technical features.

That discretion may be used in particular to choose the most appropriate harmonisation technique where the proposed approximation requires physical, chemical or biological analyses to be made and scientific developments in the field concerned to be taken into account. Such evaluations relating to the safety of products correspond to the objective imposed on the Community legislature by Article 95(3) EC of ensuring a high level of protection of health.

Consequently, Regulation No 2065/2003 on smoke flavourings used or intended for use in or on foods constitutes an appropriate harmonising measure, in that the matter harmonised requires such evaluations relating to the safety of products.

(see paras 45-46, 52)

2.Where the Community legislature provides for a harmonisation which comprises several stages, in particular where the harmonisation consists in drawing up a list of products authorised throughout the Community to the exclusion of all other products, two conditions must be satisfied. First, the legislature must determine in the basic act the essential elements of the harmonising measure in question. Second, the mechanism for implementing those elements must be designed in such a way that it leads to a harmonisation within the meaning of Article 95 EC. That is the case where the Community legislature establishes the detailed rules for making decisions at each stage of such an authorisation procedure, and determines and circumscribes precisely the powers of the Commission as the body which has to take the final decision.

Regulation No 2065/2003 on smoke flavourings used or intended for use in or on foods satisfies those two conditions, and may therefore be regarded as a harmonising measure within the meaning of Article 95 EC. It does not have the incidental effect of harmonising the conditions of the internal market, but is intended to approximate the laws, regulations and administrative provisions of the Member States in the field of smoke flavourings.

(see paras 47-49, 58-59, 64)

6 December 2005 (*)

(Foods – Regulation (EC) No 2065/2003 – Smoke flavourings – Choice of legal basis)

In Case C-66/04,

ACTION for annulment under Article 230 EC, brought on 11 February 2004,

United Kingdom of Great Britain and Northern Ireland, represented by R. Caudwell and M. Bethell, acting as Agents, and Lord Goldsmith QC, N. Paines QC and T. Ward, Barrister, with an address for service in Luxembourg,

applicant,

European Parliament, represented by K. Bradley and M. Moore, acting as Agents, with an address for service in Luxembourg,

Council of the European Union, represented by M. Sims, E. Karlsson and F. Ruggeri Laderchi, acting as Agents,

defendants,

supported by:

Commission of the European Communities, represented by J.-P. Keppenne and N. Yerrel, acting as Agents, with an address for service in Luxembourg,

intervener,

THE COURT (Grand Chamber),

composed of V. Skouris, President, P. Jann, C.W.A. Timmermans, A. Rosas and K. Schiemann, Presidents of Chambers, S. von Bahr, J.N. Cunha Rodrigues, R. Silva de Lapuerta (Rapporteur), K. Lenaerts, P. Kūris, E. Juhász, A. Borg Barthet and M. Ilešič, Judges,

Advocate General: J. Kokott,

Registrar: K. Sztranc, Administrator,

having regard to the written procedure and further to the hearing on 3 May 2005,

after hearing the Opinion of the Advocate General at the sitting on 8 September 2005,

gives the following

1.This request for a preliminary ruling concerns the interpretation of Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ 2012 L 26, p. 1), as amended by Directive 2014/52/EU of the European Parliament and of the Council of 16 April 2014 (OJ 2014 L 124, p. 1) (‘Directive 2011/92’).

2.The request has been made in proceedings between, on the one hand, Waltham Abbey Residents Association and, on the other hand, An Bord Pleanála (Planning Board, Ireland; ‘the Board’), Ireland and the Attorney General (Ireland), concerning authorisation granted by the Board for a strategic residential housing development.

Legal context

European Union law

Directive 2011/92

3.Recitals 7 to 9 of Directive 2011/92 state:

‘(7) Development consent for public and private projects which are likely to have significant effects on the environment should be granted only after an assessment of the likely significant environmental effects of those projects has been carried out. …

(8) Projects belonging to certain types have significant effects on the environment and those projects should, as a rule, be subject to a systematic assessment.

ECLI:EU:C:2025:140

(9) Projects of other types may not have significant effects on the environment in every case and those projects should be assessed where the Member States consider that they are likely to have significant effects on the environment.’

4.Article 2(1) of that directive provides:

‘Member States shall adopt all measures necessary to ensure that, before development consent is given, projects likely to have significant effects on the environment by virtue, inter alia, of their nature, size or location are made subject to a requirement for development consent and an assessment with regard to their effects on the environment. Those projects are defined in Article 4.’

5.Under Article 3(1) of that directive:

‘The environmental impact assessment shall identify, describe and assess in an appropriate manner, in the light of each individual case, the direct and indirect significant effects of a project on the following factors:

(b) biodiversity, with particular attention to species and habitats protected under [Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ 1992 L 206, p. 7), as amended by Council Directive 2013/17/EU of 13 May 2013 (OJ 2013 L 158, p. 193) (“Directive 92/43”)] and Directive 2009/147/EC [of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ 2010 L 20, p. 7)];

…’

6.Article 4 of Directive 2011/92 provides:

‘1. Subject to Article 2(4), projects listed in Annex I shall be made subject to an assessment in accordance with Articles 5 to 10.

(a) a case-by-case examination;

(b) thresholds or criteria set by the Member State.

Member States may decide to apply both procedures referred to in points (a) and (b).

Where a case-by-case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2, the relevant selection criteria set out in Annex III shall be taken into account. Member States may set thresholds or criteria to determine when projects need not undergo either the determination under paragraphs 4 and 5 or an environmental impact assessment, and/or thresholds or criteria to determine when projects shall in any case be made subject to an environmental impact assessment without undergoing a determination set out under paragraphs 4 and 5.

Where Member States decide to require a determination for projects listed in Annex II, the developer shall provide information on the characteristics of the project and its likely significant effects on the environment. The detailed list of information to be provided is specified in Annex IIA. The developer shall take into account, where relevant, the available results of other relevant assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The developer may also provide a description of any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

The competent authority shall make its determination, on the basis of the information provided by the developer in accordance with paragraph 4 taking into account, where relevant, the results of preliminary verifications or assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The determination shall made available to the public and:

(a) where it is decided that an environmental impact assessment is required, state the main reasons for requiring such assessment with reference to the relevant criteria listed in Annex III; or

(b) where it is decided that an environmental impact assessment is not required, state the main reasons for not requiring such assessment with reference to the relevant criteria listed in Annex III, and, where proposed by the developer, state any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

Member States shall ensure that the competent authority makes its determination as soon as possible and within a period of time not exceeding 90 days from the date on which the developer has submitted all the information required pursuant to paragraph 4. In exceptional cases, for instance relating to the nature, complexity, location or size of the project, the competent authority may extend that deadline to make its determination; in that event, the competent authority shall inform the developer in writing of the reasons justifying the extension and of the date when its determination is expected.’

Annex II.A of that directive contains the list of ‘information to be provided by the developer on the projects listed in Annex II’. That list reads as follows:

‘1. A description of the project, including in particular:

(a) a description of the physical characteristics of the whole project and, where relevant, of demolition works;

(b) a description of the location of the project, with particular regard to the environmental sensitivity of geographical areas likely to be affected.

(a) the expected residues and emissions and the production of waste, where relevant;

(b) the use of natural resources, in particular soil, land, water and biodiversity.

Annex III to that directive sets out the ‘criteria to determine whether the projects listed in Annex II should be subject to an environmental impact assessment’.

Directive 2014/52

Recitals 11 and 29 of Directive 2014/52 state:

‘(11) The measures taken to avoid, prevent, reduce and, if possible, offset significant adverse effects on the environment, in particular on species and habitats protected under [Directive 92/43] and Directive 2009/147 …, should contribute to avoiding any deterioration in the quality of the environment and any net loss of biodiversity, in accordance with the [European] Union’s commitments in the context of the [United Nations Convention on Biological Diversity, signed in Rio de Janeiro on 5 June 1992,] and the objectives and actions of the Union Biodiversity Strategy up to 2020 laid down in the [Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions] of 3 May 2011 entitled ‘Our life insurance, our natural capital: an EU biodiversity strategy to 2020’ [(COM(2011) 244 final)]

(29) When determining whether significant effects on the environment are likely to be caused by a project, the competent authorities should identify the most relevant criteria to be considered and should take into account information that could be available following other assessments required by Union legislation in order to apply the screening procedure effectively and transparently. In this regard, it is appropriate to specify the content of the screening determination, in particular where no environmental impact assessment is required. Moreover, taking into account unsolicited comments that might have been received from other sources, such as members of the public or public authorities, even though no formal consultation is required at the screening stage, constitutes good administrative practice.’

Directive 92/43

Article 6(3) of Directive 92/43 provides:

‘Any plan or project not directly connected with or necessary to the management of the site but likely to have a significant effect thereon, either individually or in combination with other plans or projects, shall be subject to appropriate assessment of its implications for the site in view of the site’s conservation objectives. In the light of the conclusions of the assessment of the implications for the site and subject to the provisions of paragraph 4, the competent national authorities shall agree to the plan or project only after having ascertained that it will not adversely affect the integrity of the site concerned and, if appropriate, after having obtained the opinion of the general public.’

Article 12(1) of that directive provides:

‘Member States shall take the requisite measures to establish a system of strict protection for the animal species listed in Annex IV(a) in their natural range, prohibiting:

(a) all forms of deliberate capture or killing of specimens of these species in the wild;

(b) deliberate disturbance of these species, particularly during the period of breeding, rearing, hibernation and migration;

(c) deliberate destruction or taking of eggs from the wild;

(d) deterioration or destruction of breeding sites or resting places.’

Point (a) of Annex IV to that directive mentions ‘all species’ of bats belonging to the suborder of ‘microchiroptera’.

Irish law

The Parliament and the Council, supported by the Commission, contend that the application should be dismissed as unfounded and the United Kingdom ordered to pay the costs.

Arguments of the parties

18The United Kingdom submits that Article 95 EC does not provide a correct legal basis for the adoption of the contested regulation, as the regulation does not harmonise national laws but sets up a centralised procedure at Community level for the authorisation of smoke flavourings for foods. The legislative power conferred by Article 95 EC is a power to harmonise national laws, not a power to establish Community bodies or to confer tasks on such bodies, or to establish procedures for the approval of lists of authorised products.

19It accepts that a measure adopted under Article 95 EC may contain provisions which do not themselves harmonise national laws, where those provisions merely contain elements incidental to or constitute the implementation of the harmonising provisions.

20The United Kingdom further asserts that, while it is indeed permissible to harmonise national laws by a Community regulation, such a regulation must lead to a result which could have been achieved by the simultaneous enactment of identical legislation in each Member State. However, the system of evaluation of smoke flavourings laid down by the contested regulation is a Community mechanism which no Member State considered individually had the power to establish. Consequently, such a system cannot itself be regarded as a harmonisation measure.

21The United Kingdom considers that, even if the measures provided for by the contested regulation are ‘harmonisation measures’ within the meaning of Article 95 EC, they do not harmonise the ‘essential aspects’ or ‘standards’ for the use and marketing of smoke flavourings. The provisions of the regulation leave entirely open the question of which smoke flavourings are authorised and how they are to be evaluated. Thus, on the basis of the provisions of the regulation, neither a producer nor a national authority can determine whether or not a particular smoke flavouring is authorised.

22As regards the tasks conferred on the Commission in the regulatory procedure, the United Kingdom submits that under Article 202 EC the Commission may indeed play a part in the implementation of measures adopted under Article 95 EC, but only on condition that such action can be described as ‘implementation’ of those measures.

23The United Kingdom concedes that Articles 4 and 5 of the contested regulation, read together with Annex I to the regulation, contain some uniform conditions which smoke flavourings have to meet. However, those conditions do not amount to a set of standards for those substances, in the context of which the evaluation procedure consists solely of checking products against a list of conditions laid down by the regulation. The requirement in Article 4(1) of the regulation that the products must not present risks to human health is an important requirement but is not sufficiently precise. Similarly, the production methods listed in Annex I to the regulation are far from constituting an exhaustive list.

24The United Kingdom submits that the Authority, when forming its opinion on whether a particular product is safe for human consumption, and the Commission, when taking a decision on this point, must not confine themselves to examining whether the production methods set out in Annex I to the contested regulation have been followed. In its view, it is necessary to provide information going well beyond a mere demonstration that that annex has been complied with, for example details of the chemical composition of the primary product and toxicological data.

25It observes in this respect that compliance with the methods of production laid down in that annex does not guarantee that the product is safe for human consumption. The Authority’s assessment of its safety and the Commission’s ‘risk management’ require a detailed analysis by experts in the field.

26The United Kingdom concludes that the only appropriate legal basis for the adoption of the contested regulation is Article 308 EC.

27The Parliament submits that the contested regulation harmonises the national provisions on smoke flavourings used in foods and that Article 95 EC constitutes a proper and sufficient legal basis for the establishment of the authorisation procedure laid down by the regulation.

28The Parliament observes that Article 95 EC does not require that the measures adopted themselves harmonise the relevant national provisions. A legal approximation of those provisions may be carried out by the legislation itself or by measures adopted under the legislation or both. Article 95 EC does not require the Community legislature to lay down all the details of measures ‘approximating’ the laws of the Member States, and leaves the legislature a discretion as to the legislative technique to be followed, in particular in the case of the establishment of a harmonised list of authorised products, provided that the essential elements of the matter to be regulated are contained in the basic act.

29It also observes that the Community legislature is not obliged to lay down exhaustively, in the primary legislation, a set of criteria which are precise enough to be able to be applied themselves.

30The Parliament points out that the contested regulation carries out an approximation of national legislation with regard to the most fundamental aspects of the use and marketing of smoke flavourings, namely the definition of the conditions under which those flavourings may be used in or on foods and the prohibition of the marketing of smoke flavourings which are not authorised or do not comply with those conditions.

31The Parliament submits that the absence of a common approach to evaluating the safety of smoke flavourings means that the Community legislature was unable, for objective scientific reasons, to draw up an exhaustive list of approved products in the text of the contested regulation itself. In those circumstances, and to ensure a high level of protection of human health and at the same time guarantee the free movement of products containing smoke flavourings, the Community legislature was forced to provide that the list of authorised products would be drawn up on the basis of a toxicological evaluation of each of the products concerned, and to entrust the Commission with that task.

32The Parliament considers that nothing in the contested regulation supports the view that the evaluation procedure is anything other than a means to an end, namely the establishment of a harmonised list of authorised primary products, valid throughout the Community, with the aim of improving the functioning of the internal market.

33The Council submits that the contested regulation falls within the scope of Article 95 EC, as it lays down harmonised substantive provisions on the content of smoke flavourings, by prescribing the type of primary products from which the smoke must be obtained. The regulation also lays down other harmonised rules concerning the identification of primary products, the harmonised substantive conditions governing the scientific evidence needed in order to apply for authorisation to add to the positive list primary products intended to be used in smoke flavourings, the effects of authorisations, and public access to the relevant data, confidentiality and data protection.

34The Council observes that the contested regulation does not therefore derogate from the principle governing Community law relating to food that there must be a separation between the provision of independent scientific expertise (risk assessment) and the making of decisions (risk management).

35The Council submits that authorisation for the entire Community of products such as smoke flavourings requires complex scientific evaluations. It would be practically impossible to draw up a legislative instrument in which all the technical parameters were described in such detail that all discretion could be ruled out in the making of those evaluations.

36The Council admits that, when implementing powers are delegated, it must be ensured that the conditions set out in Article 202 EC and in Decision 1999/468 are complied with. That applies in particular to the obligation to establish the ‘essential elements’ of the matter to be regulated. As regards technically complex issues, the legislature is entitled to confer extensive implementing powers on the Commission and, consequently, the concept of ‘essential elements’ should not be interpreted restrictively. In the present case, the authorisation procedure is no more than a procedure aimed at including in the positive list, by means of implementing measures, the substances which satisfy the substantive requirements laid down by the contested regulation.

37The Commission observes that Article 95 EC refers generally to ‘measures for the approximation’ of national provisions, rather than to ‘measures which approximate’. While the latter expression corresponds to provisions which directly carry out the approximation of national laws, the wording of the provision is much wider and leaves open the question of the legislative technique to be chosen to achieve that result. The only condition to which recourse to Article 95 EC is subject is that the measures adopted must be ‘for’ the approximation of national provisions, in that they must lead to an approximation, but as long as that criterion is complied with the Community legislature may choose the mechanism that is most appropriate to the specific circumstances.

38In the Commission’s view, it follows that a measure adopted on the basis of Article 95 EC may perfectly well include a two-stage process such as that introduced by the contested regulation, in which an authorisation procedure is set up only in order to create a harmonised list of authorised primary products as its end result, since this is a measure leading directly to an approximation of the national rules relating to those products.

39The Commission emphasises that this two-stage process constitutes in the present case a proportionate and scientifically founded approach, since it is necessary to draw up a list which is both detailed and open-ended and capable of being amended in the light of scientific and technical developments. It would have been impossible – and nonsensical – to include in the actual text of the contested regulation a list of all the authorised primary products.

40The Commission concludes that, having regard to the many technical constraints of the necessary toxicological evaluations, the Community legislature was obliged to provide for a system incorporating a case-by-case evaluation of the safety of primary products and the progressive establishment of a harmonised list, on the basis of the substantive criteria set out in the contested regulation.

Findings of the Court

The scope of Article 95 EC

41To begin with, it should be recalled that, according to the Court’s case-law, where there are obstacles to trade, or it is likely that such obstacles will emerge in the future, because the Member States have taken, or are about to take, divergent measures with respect to a product or a class of products which bring about different levels of protection and thereby prevent the product or products from moving freely within the Community, Article 95 EC authorises the Community legislature to intervene by adopting appropriate measures, in compliance both with Article 95(3) EC and with the legal principles mentioned in the EC Treaty or identified in the case-law (Case C‑434/02 Arnold André [2004] ECR I‑11825, paragraph 34; Case C‑210/03 Swedish Match [2004] ECR I‑11893, paragraph 33; and Joined Cases C‑154/04 and C‑155/04 Alliance for Natural Health and Others [2005] ECR I‑0000, paragraph 32).

42In the present case, according to the statements in the fifth recital in the preamble to the regulation which have not been disputed by the United Kingdom, at the time when the regulation was adopted there were differences between national laws, regulations and administrative provisions concerning the evaluation and authorisation of smoke flavourings which could hinder their free movement, creating conditions of unequal and unfair competition.

43In those circumstances, action by the Community legislature on the basis of Article 95 EC was justified with respect to smoke flavourings used or intended for use in or on foods.

44It must also be emphasised that, as the Advocate General observes in point 18 of her Opinion, that provision is used as legal basis only where it is actually and objectively apparent from the legal act that its purpose is to improve the conditions of the establishment and functioning of the internal market.

45Next, it should be observed that by the expression ‘measures for the approximation’ in Article 95 EC the authors of the Treaty intended to confer on the Community legislature a discretion, depending on the general context and the specific circumstances of the matter to be harmonised, as regards the harmonisation technique most appropriate for achieving the desired result, in particular in fields which are characterised by complex technical features.

46That discretion may be used in particular to choose the most appropriate harmonisation technique where the proposed approximation requires physical, chemical or biological analyses to be made and scientific developments in the field concerned to be taken into account. Such evaluations relating to the safety of products correspond to the objective imposed on the Community legislature by Article 95(3) EC of ensuring a high level of protection of health.

47Finally, it should be added that where the Community legislature provides for a harmonisation which comprises several stages, for instance the fixing of a number of essential criteria set out in a basic regulation followed by scientific evaluation of the substances concerned and the adoption of a positive list of substances authorised throughout the Community, two conditions must be satisfied.

48First, the Community legislature must determine in the basic act the essential elements of the harmonising measure in question.

49Second, the mechanism for implementing those elements must be designed in such a way that it leads to a harmonisation within the meaning of Article 95 EC. That is the case where the Community legislature establishes the detailed rules for making decisions at each stage of such an authorisation procedure, and determines and circumscribes precisely the powers of the Commission as the body which has to take the final decision. That applies in particular where the harmonisation in question consists in drawing up a list of products authorised throughout the Community to the exclusion of all other products.

50Such an interpretation of Article 95 EC is also borne out by the fact that, according to their very wording, paragraphs 4 and 5 of that article recognise that the Commission has power to adopt harmonisation measures. The reference to that power of the Commission in those paragraphs, read in conjunction with paragraph 1 of that article, indicates that an act adopted by the Community legislature on the basis of Article 95 EC, in accordance with the codecision procedure referred to in Article 251 EC, may be limited to defining the provisions which are essential for the achievement of objectives in connection with the establishment and functioning of the internal market in the field concerned, while conferring power on the Commission to adopt the harmonisation measures needed for the implementation of the legislative act in question.

Classification of the contested regulation as a harmonisation measure within the meaning of Article 95 EC

51In the light of the above considerations, it must be determined whether the contested regulation satisfies the two conditions recalled in paragraphs 48 and 49 above, so as to be regarded as a harmonisation measure within the meaning of Article 95 EC.

52It must be stated, first of all, that the matter harmonised by the contested regulation has the features referred to in paragraph 46 above. The sixth to ninth recitals in the preamble to the regulation refer to special features of smoke flavourings used for foods, in particular the complexity of the chemical composition of the smoke, the possible toxic properties of those substances, and the methods of production concerned.

53As to the first condition stated in paragraph 48 above, it must be examined whether that regulation contains the essential elements concerning the approximation of the laws, regulations and administrative provisions of the Member States that regulate the characteristics of smoke flavourings used or intended for use in or on foods.

54It should be recalled here that, as its Article 1(2) states, the contested regulation defines the parameters for the evaluation and authorisation of primary smoke condensates and primary tar fractions used or intended for use as such in or on foods or in the production of derived smoke flavourings used or intended for use in or on foods.

55Moreover, as is apparent from Article 4(1) of the regulation, the two fundamental safety rules set out in that provision must be observed before smoke flavourings can be the subject of an authorisation valid throughout the Community. Their use in or on foods can be authorised only if it has been demonstrated that there are no risks to human health. In addition, authorisation is granted only if the use of those substances does not mislead consumers.

56It should also be noted that Article 5(1) of the contested regulation lays down a large number of conditions which must be satisfied by the wood used for the production of the primary products. As to the conditions for the production of primary products, Article 5(2) states that they are laid down in Annex I to the regulation, which defines the type of products from which the smoke must be obtained, the ingredients allowed in the combustion process, the combustion technique, the environment required, the maximum combustion temperature, the way in which the smoke is condensed, the chemical composition of the condensates, the maximum content of certain substances, and other factors which influence the production process.

57The information relating to the scientific evaluation of primary products must, moreover, be included in the application for authorisation made under Article 7 of the regulation read together with its Annex II. In addition, Articles 9(4) to (6) and 13 to 16 of the contested regulation lay down harmonised rules concerning the effects of authorisations granted, the consequent rights and obligations, the identification and traceability of primary products, as well as public access, the confidentiality of certain information and data protection.

58It follows from all those factors that the contested regulation contains the essential elements typifying a harmonisation measure.

59It also follows that, contrary to the United Kingdom’s submissions, the regulation does not have the incidental effect of harmonising the conditions of the internal market (see on this point Case C‑209/97 Commission v Council [1999] ECR I‑8067, paragraph 35), but is intended to approximate the laws, regulations and administrative provisions of the Member States in the field of smoke flavourings.

60As to the second condition stated in paragraph 49 above, it must be recalled that the Community authorisation procedure provided for in the contested regulation is defined in Article 19(2) of the regulation, referring to Articles 5 and 7 of Decision 1999/468, as a ‘regulatory procedure’.

61Under Articles 7 to 9 of the contested regulation, after an application has been made for a primary product to be included in the positive list and the application has been transmitted to the Authority by the competent national authority, it is for the Authority and the Commission to apply to that product the evaluation criteria set out in Articles 4 and 5 of the regulation in conjunction with Annexes I and II to the regulation.

62It follows from such a legal framework that not only are the tasks conferred on the Authority and the Commission clearly defined by the provisions of the contested regulation, the procedure provided for therein also leads to the adoption of the positive list of substances authorised throughout the Community.

63The procedure provided for by the regulation thus constitutes an appropriate means for achieving the desired approximation, namely the establishment of a positive list of substances authorised throughout the Community.

64Having regard to all the foregoing considerations, the conclusion must be that the contested regulation was rightly based on Article 95 EC. The action must therefore be dismissed.

Costs

65Under 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 Parliament and the Council have applied for costs and the United Kingdom has been unsuccessful, the latter must be ordered to pay the costs. In accordance with Article 69(4), the Commission must bear its own costs.

On those grounds, the Court (Grand Chamber) hereby:

Dismisses the action;

Orders the United Kingdom of Great Britain and Northern Ireland to pay the costs;

Orders the Commission of the European Communities to bear its own costs.

[Signatures]

*

Language of the case: English.

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