1 By order of 6 August 1997, received at the Court on 16 September 1997, the Landskrona Tingsrätt (District Court, Landskrona) referred to the Court for a preliminary ruling under Article 177 of the EC Treaty (now Article 234 EC) three questions on the interpretation of Article 100a(4) of the EC Treaty (now, after amendment, Article 95(4) to (9) EC), and European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (OJ 1994 L 237, p. 13; hereinafter `the Directive').
2 Those questions were raised in criminal proceedings brought by the Swedish Public Prosecutor against Mr Kortas for infringement of provisions concerning the use of additives in the composition of foodstuffs.
3 Mr Kortas is charged with having sold in his shop, until 15 September 1995, confectionery products imported from Germany and containing a colorant called E 124 or `cochineal red'. Under Article 6 of the Livsmedelslag (1971:511) (Swedish Law on foodstuffs), the only substances which may be used as additives are those which have been approved specifically for the food product concerned. For the period between 1 January 1994 and 30 June 1996, approved additives were listed in the annexes to the Statens Livsmedelsverks Kungörelse (1993:33) om Livsmedelstillsatser (Notice on food additives issued by the National Food Administration). For the subsequent period, they were listed in the Statens Livsmedelsverks Kungörelse (1995:31) med Föreskrifter och allmänna Råd om Livsmedelstillsatser (Guidelines on food additives issued by the National Food Administration), which applied from 1 July 1996. According to those guidelines, the use of E 124 as an additive in confectionery is not permitted. Furthermore, pursuant to Article 30 of the Swedish Law on foodstuffs, contravention of that prohibition is a punishable offence.
4 However, E 124 is one of the colorants approved by the Directive for use in confectionery. Under Article 2(1) and (2) of the Directive, the substances listed in Annex I thereto may be used as colorants in foodstuffs under certain conditions, defined in Annexes III to V. E 124 is one of the substances which may be used up to a maximum level of 50 mg/kg or 50 mg/l.
5 Article 9 of the Directive provides that Member States are to bring into force, not later than 31 December 1995, the laws, regulations and administrative provisions necessary to comply with the Directive, which was adopted on the basis of Article 100a of the Treaty.
6 Article 100a(4) provides: `If, after the adoption of a harmonisation measure by the Council acting by a qualified majority, a Member State deems it necessary to apply national provisions on grounds of major needs referred to in Article 36, or relating to protection of the environment or the working environment, it shall notify the Commission of these provisions. The Commission shall confirm the provisions involved after having verified that they are not a means of arbitrary discrimination or a disguised restriction on trade between Member States. By way of derogation from the procedure laid down in Articles 169 and 170, the Commission or any Member State may bring the matter directly before the Court of Justice if it considers that another Member State is making improper use of the powers provided for in this Article.'
7 The Kingdom of Sweden joined the Community by virtue of the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and adjustments to the Treaties on which the European Union is founded (OJ 1994 C 241, p. 21, and OJ 1995 L 1, p. 1; hereinafter `the Act of Accession'), signed on 24 June 1994 with effect from 1 January 1995.
8 Under Article 151 of the Act of Accession, the new Member States may request certain temporary derogations from acts of the institutions adopted between 1 January 1994 and the date of signature of the Accession Treaty. Article 151(2) provides: `At the duly substantiated request of one of the new Member States, the Council, acting unanimously on a proposal from the Commission, may, before 1 January 1995, take measures consisting of temporary derogations from acts of the institutions adopted between 1 January 1994 and the date of signature of the Accession Treaty.'
9 In accordance with Article 151 of the Act of Accession, the Kingdom of Sweden submitted a request to the Commission on 26 July 1994 seeking permission to maintain the prohibition on the use of E 124 in foodstuffs. Apparently, discussions were held between the Swedish Government and the Commission, but the Kingdom of Sweden was not successful in obtaining the derogation.
10 On 5 November 1995 the Swedish Government notified to the Commission a request for derogation pursuant to Article 100a(4) of the Treaty, and advised the Commission of its intention to maintain in force the provisions of national law concerning E 124. In support of its request, it argued that in Sweden the use of certain colorants approved by the Directive could pose health risks. It is known that on occasion these substances cause allergic reactions in humans, such as urticaria and asthma, which is why Sweden adopts such a cautious approach in their regard.
11 The Commission did not reply to the Swedish Government's notification. In response to a question from the Court, it indicated by letter of 16 July 1998 that a decision would shortly be adopted.
12 Relying on Article 2(1) and (2) of the Directive, which authorise the use in certain circumstances of E 124 in confectionery, Mr Kortas argued that the proceedings brought against him were based on national legislation which was contrary to Community law and that they should therefore be discontinued. The Public Prosecutor contended, on the other hand, that the Kingdom of Sweden should be deemed to have obtained a derogation from the Directive in so far as the Commission has neglected, over a period of years, to respond to Sweden's notification.
13 The national court, hearing the case at first instance, was uncertain whether in such circumstances the Directive overrides provisions of national law and must be recognised as having direct effect. The events in respect of which Mr Kortas is being prosecuted occurred before the expiry on 31 December 1995 of the deadline for transposition of the Directive into national law, but effect must be given to the criminal law in force at the time of the judgment. Article 5 of the Lag (1964:163) om införande av brottsbalken (Swedish Law implementing the penal code) provides: `Penalties shall be fixed according to the statute in force on the date when the offence was committed. If another statute is in force at the time when judgment is given, whichever statute provides for exemption from punishment or provides for a lesser penalty shall prevail.' In so far as the provisions of the Directive are more favourable to Mr Kortas than those of the national law, it must therefore be determined whether the Directive has direct effect.
14 Those were the circumstances in which the Landskrona Tingsrätt decided to stay the proceedings and refer the following questions to the Court: `1. Can a directive adopted under Article 100a of the Treaty of Rome have direct effect? 2. If so, can such a directive have direct effect even if the State has made notification under Article 100a(4) of the Treaty of Rome? 3. If Question 2 is answered in the affirmative, how does the notification by the Member State affect the question of direct effect during the following periods: (a) between notification and reply? (b) from the reply?' Admissibility
15 The Danish and Dutch Governments maintain that the reply to the questions referred is not necessary for adjudication of the dispute in the main proceedings, since that dispute concerns events which occurred before the expiry of the deadline for transposition of the Directive into national law and Member States cannot assume, vis-à-vis their nationals, obligations under a Directive before the expiry of such a deadline.
16 In that regard it need only be stated that the national court, when called upon to adjudicate in criminal proceedings, must apply those provisions of law which are least harsh at the time when its decision is delivered. In so far as the provisions of the Directive are more favourable to Mr Kortas than the relevant provisions of national law, the questions referred for a preliminary ruling are objectively necessary in order to give judgment.
17 Consequently, the admissibility of the reference for a preliminary ruling cannot be disputed as regards the date of the entry into force of the Directive.
18 The French Government doubts whether the second question is admissible, maintaining that an answer is not necessary to enable the national court to give judgment in the main proceedings. It observes that the Kingdom of Sweden cannot rely on Article 100(4) of the Treaty because it did not participate in the procedure for adoption of the Directive, not being at that time a Member of the Community.
19 On that point, it need merely be stated that there is nothing in the wording of Article 100a(4) of the Treaty to suggest that a State which has joined the European Union after the adoption of a particular directive may not rely on that provision vis-à-vis that directive. Question 1
20 By its first question, the national court essentially asks whether a directive can have direct effect even though its legal basis is Article 100a of the Treaty and Article 100a(4) allows Member States to request a derogation from the implementation of that directive.
21 The Court has consistently held (see, inter alia, Case 8/81 Becker [1982] ECR 53, paragraph 25; Case 103/88 Fratelli Costanzo [1989] ECR 1839, paragraph 29; and Joined Cases C-246/94 to C-249/94 Cooperativa Agricola Zootecnica S. Antonio and Others [1996] ECR I-4373, paragraph 17) that, whenever the provisions of a directive appear, so far as their subject-matter is concerned, to be unconditional and sufficiently precise, they may be relied upon before the national courts by an individual against the State where that State has failed to implement the directive in national law by the end of the period prescribed or where it has failed to implement the directive correctly.
22 It is not decisive, in determining whether or not a directive has direct effect, that its legal basis allows Member States to apply to the Commission for a derogation from its implementation if they consider this necessary. The general potential of a directive to have direct effect is wholly unrelated to its legal basis, depending instead on the intrinsic characteristics referred to in paragraph 21 above.
23 The answer to the first question must therefore be that a directive can have direct effect even though its legal basis is Article 100a of the Treaty and Article 100a(4) allows Member States to request a derogation from the implementation of that directive. Questions 2 and 3
24 By its second and third questions, which it is appropriate to consider together, the national court essentially asks whether the direct effect of a directive, where the deadline for its transposition into national law has expired, is affected by the notification made by a Member State pursuant to Article 100a(4) of the Treaty, seeking confirmation of provisions of national law derogating from the directive.
25 It should be noted at the outset that where, after the expiry of the deadline for transposition into national law or after the entry into force of a harmonisation measure under Article 100a(1) of the Treaty, Member States intend to continue to apply provisions of national law derogating from that measure, they must notify those provisions to the Commission.
26 Also, the Commission must make sure that all the conditions for a Member State to rely on the exception provided for in Article 100a(4) are satisfied. This means that it must verify that the provisions at issue are justified by major needs, as referred to in Article 100a(4), first paragraph, and are not a means of arbitrary discrimination or a disguised restriction on trade between Member States.
27 The aim of the procedure under that provision is to ensure that no Member State applies national rules derogating from the harmonised legislation without obtaining due confirmation from the Commission.
28 As the Court has consistently held (Case C-41/93 France v Commission [1994] ECR I-1829, paragraphs 29 and 30), measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which are such as to hinder intra-Community trade would be rendered ineffective if Member States retained the right unilaterally to apply national rules derogating from those measures and a Member State is not, therefore, authorised to apply the national provisions notified by it under Article 100a(4) until after it has obtained a decision from the Commission confirming them.
29 The national court asks whether an exception to that principle arises where the Commission does not respond to the notification of measures by a Member State.
30 On that point, the Swedish, Danish, French, Netherlands and Austrian Governments maintain that the principle laid down by the Court in Case C-41/93, cited above, cannot apply when the Commission's reply is not given as quickly as possible or within a reasonable period of time. Since the Kingdom of Sweden notified the Commission in 1995 and to this day has received no reply, the principles of legal certainty and protection of legitimate expectations require that, where so much time has elapsed, confirmation of the national measures by the Commission should be deemed to have been acquired.
31 According to the Swedish and Austrian Governments, the two-month period which the Court considered to be reasonable in relation to the procedure under Article 93 of the EC Treaty (now Article 88 EC) concerning State aid (see Case 84/82 Germany v Commission [1984] ECR 1451, paragraph 11) could provide guidance as to the length of time which should properly be available to the Commission in the present context. The French Government, on the other hand, suggests that, as in the implementation of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (OJ 1989 L 40, p. 27), the Commission must respond without delay.
32 The Dutch Government proposes a six-month time-limit, as provided for in Article 95(6) EC. Under this provision, which amends and replaces Article 100a(4) of the Treaty, if the Commission has not expressed a view within six months of notification of provisions of national law, those provisions shall be deemed to have been approved.
33 It must be noted that Article 100a(4) of the Treaty is silent as to the time within which the Commission must adopt a position with regard to provisions of national law which have been notified. The Commission's freedom from temporal constraints is further substantiated by the fact that the Community legislature found it necessary, in the Treaty of Amsterdam, to limit to six months the time available to the Commission for verification of such provisions. However, it is common ground that no such time-limit was in operation at the time when the Kingdom of Sweden notified to the Commission its request for derogation from the Directive.
34 However, the fact that there was no time-limit could not absolve the Commission from the obligation to act with all due diligence in discharging its responsibilities, particularly as Article 100a(4), first paragraph, of the Treaty concerns provisions of national law which a Member State considers to be justified by major needs referred to in Article 36 of the Treaty or relating to protection of the environment or the working environment.
35 In those circumstances, implementation of the notification scheme provided for in Article 100a(4) requires the Commission and the Member States to cooperate in good faith. It is incumbent on Member States under Article 5 of the EC Treaty (now Article 10 EC) to notify as soon as possible the provisions of national law which are incompatible with a harmonisation measure and which they intend to maintain in force. The Commission, for its part, must demonstrate the same degree of diligence and examine as quickly as possible the provisions of national law submitted to it. Clearly, this was not the case with respect to the examination of the notified provisions at issue in the main proceedings.
36 Although failure on the part of the Commission to act with due diligence following a notification effected by a Member State under Article 100a(4) of the Treaty may therefore constitute a failure to fulfil its obligations, it cannot affect full application of the directive concerned.
37 If the Member State considers the Commission to be in breach of its obligations, it may, in accordance with the provisions of the Treaty, in particular Article 175 of the EC Treaty (now Article 232 EC), bring proceedings before the Court for a declaration to that effect and, where appropriate, may apply for interim relief.
38 The answer to the second and third questions must therefore be that the direct effect of a directive, where the deadline for its transposition into national law has expired, is not affected by the notification made by a Member State pursuant to Article 100a(4) of the Treaty seeking confirmation of provisions of national law derogating from the directive, even where the Commission fails to respond to that notification.