61997C0319

1 This reference from a Swedish court raises once again the difficulty of interpreting Article 100a of the Treaty, specifically Article 100a(4). The specific subject to be addressed has already been touched on, both in an earlier judgment (1) and in my Opinion in Burstein, (2) namely, the relationship between Community harmonising measures designed to establish the internal market and domestic legislation which derogates from them.

The national legislation

2 Swedish law - specifically, Law No 511 of 1971 - lays down that, save where otherwise provided, additives may be used in foodstuffs only if specially authorised for use with the product in question. Breach of that rule constitutes a criminal offence attracting a heavier penalty if the quantities involved are significant.

3 The rules implementing Law No 511/1971 - in particular, Decree No 33 of 1993, which entered into force on 1 January 1994 - banned all use of the colorant known as E 124 or cochineal red in foodstuffs, save for alcoholic beverages. The same ban was imposed in an earlier measure, Decree No 1 of 1993, the provisions of which remained in force under transitional arrangements until June 1995.

On 1 December 1995 the competent administrative authority adopted Decree No 31 on food additives. This measure, which gave effect to European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (hereinafter `the Directive'), (3) confirmed the ban on the use of E 124 in foodstuffs.

The Community legislation

4 The Directive is intended to harmonise national laws governing the use of colorants in foodstuffs, given that the discrepancies in this area as between the various Member States impedes the free movement of foodstuffs and distorts competition. Accordingly, the legal basis of the Directive is Article 100a of the Treaty, the first paragraph of which empowers the Council, acting in accordance with the procedure referred to in Article 189b, to adopt `measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market'.

5 The substantive content of the rules introduced by the Directive is based principally on the need to protect and inform the consumer, permitting the use of additives only where this is shown to be technologically necessary and harmless to health. (4) That approach is reflected primarily in the fact that the Directive permits a fixed number of substances to be used as colorants in foodstuffs. Article 2(1) provides that `only the substances listed in Annex I may be used as colours in foodstuffs'. One of the substances listed in that Annex is E 124, the common name for which is `Ponceau 4R, Cochineal Red A'.

In addition to specifying the colours which may be used, the rules make very detailed provision. The permitted colorants (Annex I) may be used only in the foodstuffs listed in Annexes III, IV and V, subject to the conditions specified therein. It is not permitted to use colorants in the foodstuffs listed in Annex II, save in the cases specifically envisaged in the other annexes. Some colorants which may be used only for specific purposes are listed, together with their authorised uses, in Annex IV. Colorants which are generally permitted, that is to say, they may be used quantum satis (5) in all foodstuffs, except those listed in Annexes II and III, are listed in Annex V, Part 1. E 124 is not listed there. On the contrary, it may be used only up to a given level and only in the foodstuffs listed in Part 2 of Annex V.

6 Pursuant to Article 10 of the Directive, that measure entered into force on 10 September 1994, the date of its publication in the Official Journal. The Member States were required to adopt, by 31 December 1995 at the latest, the implementing measures necessary (a) to allow, not later than 31 December 1995, trade in and use of products conforming to the Directive and (b) to prohibit, not later than 30 June 1996, trade in and use of products not conforming to the Directive. (6) In other words, the use and marketing of products containing colorants approved by the Directive should have been permitted under the domestic law of the Member States by 31 December 1995.

The accession of Sweden

7 The Treaty of Accession of the Kingdom of Norway, the Republic of Austria, the Republic of Finland and the Kingdom of Sweden to the European Union and the Act concerning the conditions of accession and adjustments to the Treaties on which the European Union is founded entered into force on 1 January 1995. (7) In principle, both the Treaty and Community secondary legislation applied in full in the new Member States as from that date, with the exception of certain adjustments provided for by the instruments of accession. Under Article 151 of the Treaty of Accession, new Member States may request, between 1 January 1994 and the date of signature of the Accession Treaty, certain temporary derogations from acts of the institutions adopted. The Council, acting unanimously on a proposal from the Commission, is to take a decision on such requests. Sweden submitted such a request on 26 July 1994. In their respective observations, the Commission and the Swedish Government recount that, on learning through informal channels that its request would meet with a negative response, Sweden let it be known that it would waive its right to a formal decision.

In short, since Sweden had impliedly waived that right, it should have transposed the Directive into national law by 31 December 1995 in order to ensure that, by that date, products in conformity with that measure could be freely marketed and used.

Article 100a(4)

8 Article 100a(4) of the Treaty 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.'

9 On 5 November 1995 Sweden notified to the Commission the provisions of Swedish law relating to food additives (pursuant to which use of E 124 was prohibited) which it considered necessary to maintain in force for the protection of human health. The Commission did not respond.

Facts and questions referred for a preliminary ruling

10 The order for reference recounts that on 15 September 1995, in the course of inspecting business premises belonging to Mr Kortas, the competent national administrative authority came across a significant quantity of confectionery containing E 124. Mr Kortas was accordingly prosecuted for having marketed foodstuffs containing a colorant banned under Swedish legislation. Mr Kortas contended before the national court that E 124 was legally used in other Member States of the European Community, such as Germany, in accordance with Community law.

11 Taking cognisance of the Community Directive and of the fact that the more restrictive Swedish legislation had been notified to the Commission for the purposes of Article 100a of the Treaty, and noting the Commission's failure to respond, the national court referred the following questions to the Court for a preliminary ruling:

`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?'

Applicability of the Community legislation

12 One of the problems to be addressed in this context, although the order for reference is silent on the point, is the relevance ratione temporis of the Directive to the facts of the case. The offence was committed at the latest on 15 September 1995, the date on which it was discovered by the competent Swedish authorities. At that time, the deadline for transposing the Directive into national law had not yet expired, since Member States had until 31 December 1995 to comply. Nor, according to the case-law, can it be sustained that a Member State is under an obligation somehow to accord importance to the provisions of a directive before expiry of the deadline. (8) It was not until quite recently that the Court inferred, from Articles 5 and 189 of the Treaty read together, that Member States must refrain, during the period between the entry into force of a directive and the deadline for its implementation, from taking any measures liable seriously to compromise the result prescribed. (9) In the present case, however, Sweden did not adopt any new legislation inconsistent with the aims of the Directive; it merely continued to apply the existing legislation.

13 The true relevance of the Directive for the case before the national court lies in the fact that the legal system in Sweden, as in almost all the Member States, upholds the principle that an individual cannot be punished for something which under subsequent legislation is not an offence. (10) It follows that when, after the expiry of the deadline for the Directive's transposition into national law, primacy is accorded to the Directive and more lenient legislation applies to the facts of Mr Kortas' case, the national court will be bound accordingly in its determination of his culpability.

Question 1

14 The Directive has not been correctly transposed into Swedish law. Even Ministerial Decree No 31 of 1995 concerning food additives, albeit adopted in implementation of the Directive, confirmed the ban on the use of E 124. Thus, the relevance to be accorded to the divergent Community legislation depends on its direct effect in national law. However, the national court does not ask the Court whether the Directive - so far as concerns its specific substantive content - has direct effect. Rather, it questions, more generally, whether any directive adopted on the basis of Article 100a of the Treaty can have direct effect.

The question whether a provision of a directive may have direct effect has never been considered by the Court in terms of the legal basis in the Treaty which empowered the institution concerned to adopt that measure. The direct effect of such a provision depends exclusively on the characteristics of its substantive content, measured against a particular set of requirements. In particular, the rule in question must be clear, precise and capable of immediate application, that is to say, independently of formal implementing measures to be adopted at national level. (11) Another essential precondition is the fact that the directive in question must have run its term; in other words, the deadline for its transposition into national law must have expired. The legal basis on which the directive was adopted is wholly irrelevant. Furthermore, the fact that provisions of a harmonising directive adopted on the basis of Article 100a may be clear, precise and unconditional is confirmed by the wording of that provision, which does not require the Community legislature to adopt directives, but more generally, `measures for [...] approximation'. Arguably, therefore, the Community legislature could adopt measures such as regulations or `detailed' directives, which leave no margin of discretion within which the Member State may establish the mechanisms and timetables necessary to attain the result prescribed. Although, in theory, the lawfulness of such measures could be questioned where the Treaty - in Article 100, for example - prescribes use of a directive, it cannot be denied that detailed directives are entirely lawful where the relevant provision of the Treaty does not specify the form of legislative measure to be adopted, which is precisely the position in the case of Article 100a.

Incontestably, therefore, a directive adopted on the basis of Article 100a of the Treaty may have direct effect, provided that the conditions mentioned above are satisfied.

15 In the case of the Directive under consideration, there is no doubt that this lays down rules the content of which is clear, precise and unconditional with respect to the specification of colorants which may be used in foodstuffs. A clear illustration of such a provision is provided by Article 2, referred to above, which states that `only the substances listed in Annex I may be used as colours in foodstuffs'. While that rule prohibits the use of other substances, it authorises the use of the substances expressly named, provided that the detailed rules as to types of product and quantities are complied with. It cannot be sustained either that the rule which prohibits the use of unlisted substances may be interpreted more widely, at the discretion of the Member States. Indeed, that would wholly frustrate the aim of harmonising the legislation and permitting the free movement of the products concerned.

On the basis of the Directive, therefore, individuals are entitled to use the colorant E 124 in accordance with the detailed rules and may rely upon that right before the national courts, which as a consequence must disapply any conflicting provision of national law.

Questions 2 and 3

16 The second and third questions - the latter comprising two limbs - raise the issue of the relationship between harmonisation measures which may have direct effect and conflicting provisions of national law, where the Member State wishes to maintain the latter in force by availing itself of the safeguard clause provided in Article 100a(4) of the Treaty.

Admissibility of the questions

17 I do not regard as well founded the objection as to admissibility raised by the French Government, according to which only the States which took part in the negotiations within the Council regarding the adoption of the harmonisation measure - to the exclusion of States which have newly acceded to the Community thereafter - may avail themselves of the procedure provided for in Article 100a(4) of the Treaty. In the first place, that objection finds no support in the wording of the provision at issue. Article 100a(4) essentially serves to offset the mechanism requiring a qualified majority, which, although it has led to a notable increase in the efficiency of the decision-making process for establishing the internal market, has on the other hand entailed a sacrifice of national interests which merit protection. Thus, Article 100a(4) permits a Member State which so desires to continue to apply, in the wake of a harmonising measure, provisions of national law which are justified in terms of the important (non-economic) needs contemplated by Article 36 or which are necessary to protect the environment or the working environment, provided that a certain procedure is followed, and subject to both administrative checks (entrusted to the Commission) and judicial review.

18 To my mind, this is clearly a need which arises both in the case of States which have participated in the negotiations and in the case of States which had no opportunity to do so because at the material time they had not yet acceded to the Community. In any event, the latter States find themselves faced with a harmonising measure which may compromise important considerations. Arguably, in fact, this is all the more likely in the case of new Member States. Existing Member States will have had every opportunity during the adoption procedure to draw attention to their special needs.

19 What is more, if the jurisprudential view is that recourse to Article 100a(4) is to be permitted even in the case of States which voted in favour of the harmonising measure from which they seek derogation, it can scarcely be denied to States which were unable to play any role in the adoption process. In the case of Sweden, it must also be emphasised that it did attempt - unsuccessfully - to obtain a derogation under the instruments of accession, using the procedure provided for in Article 151 of the Treaty of Accession. The negative response of the Community institutions cannot, however, prevent the new Member State from directing their attention once again - in a much more `institutionalised' context - to those needs by availing itself of the derogation procedure provided for in Article 100a(4).

Substance

20 The substantive issue raised by the second and third questions concerns the fate of provisions of national law which conflict with the harmonisation measure but which the State wishes to apply for the protection of important national needs. In particular, the Court is asked whether, once the State has notified that legislation to the Commission, it can be immediately applied or whether its applicability is conditional upon the Commission's approval. In the event that the Court finds the latter approach to be correct, it is also asked to clarify the implications for that approach if there is a delay (as is the case here) before the Commission confirms or disapproves the national legislation notified.

21 In my view, in this case - as in Burstein - the only way to resolve the issues raised is through analysis of the ratio of Article 100a, particularly of Article 100a(4), in conjunction with other provisions of the Treaty.

Article 100a has provided the Community institutions with a mechanism for `the achievement of the objectives set out in Article 7a', hence for the establishment of the internal market, that is to say, an area without internal frontiers in which the fundamental freedoms conferred by Community law are ensured. In practice, Article 100a has proved to be vital to the attainment of the objective set out in Articles 3(c) and 7a of the Treaty, so much so that in various quarters regret has been expressed that Article 100a cannot be used in other fields, such as direct taxation, the importance of which has grown with increased integration (12) but in respect of which the harmonisation of the relevant legislation still depends on the less efficient mechanism provided for in Article 100.

22 A feature of measures `which have as their object the establishment and functioning of the internal market' (Article 100a(1)) is that they tend to have cross-disciplinary effects, with the result that harmonisation measures may affect other areas, such as environmental matters, which are governed by special Community policies. That consideration, given the priority accorded to the establishment of the internal market, does not alter the choice of legal basis which remains, even in such cases, Article 100a of the Treaty. (13)

23 In that context, the `compensatory' mechanism provided for by Article 100a(4) can only be intended to be by way of exception in relation to the aim pursued by the other provisions laid down in Article 100a. Like all exceptions to fundamental principles underlying Community integration, (14) Article 100a(4) must be narrowly construed, and its operation must be subject to stringent conditions both with respect to the scope of the justifications provided for, and to the procedure for administering this safeguard clause, in which the role played by the Commission, far from being viewed as a matter of `rubber-stamping', must be accorded substantive importance so that the preconditions for invoking the derogation are properly monitored.

24 Underlying all this is the need to safeguard the uniform application of Community law, which represents the principal means of creating and maintaining an internal market, an area primarily characterised by legal homogeneity. Running counter to that endeavour is the power of the Member States to introduce unilateral derogations independently of the monitoring procedure provided for. If the ratio of the rule is to be respected, therefore, the confirmatory decision - which is to be adopted by the Commission after verifying that the national measures notified to it do not constitute `a means of arbitrary discrimination or a disguised restriction on trade between Member States' - must be a conditio sine qua non of the applicability of any provisions of national law which are more restrictive than the corresponding Community legislation. Although Article 100a(4) answers the need to balance opposing interests - on the one hand, the harmonisation of laws directly affecting the operation of the internal market and, on the other, the protection of values on which Member States place particular importance - the truth is that Community law requires adequate protection to be given to many of the States' priorities (health, safety, environmental protection and consumer protection) at the stage when harmonisation measures are being drafted, the Commission being under a duty, in its proposals concerning those sectors, to take as a base `a high level of protection' (Article 100a(3)). (15) This factor lends further justification to the need to construe the safeguard narrowly - if the harmonising legislation already accommodates a high level of protection in a particular area, there is no need to allow the States added powers in that respect.

25 That observation is fully consistent with the location of Article 100a(4) in the conceptual structure of the Treaty. The Chapter of the Treaty dealing with the approximation of laws is juxtaposed with the rules on competition, comprising inter alia the rules governing State aid, in respect of which analogous difficulties may arise. State aid may be granted in derogation from the competition rules and is permissible only where particular needs are identified, which the aid is designed to meet (Article 92(2) and (3) of the Treaty) and subject to supervision by the Commission. Article 93(3) provides, in respect of plans to grant new aid, for a procedure not unlike the procedure laid down in Article 100a(4). The State must notify such plans to the Commission in sufficient time to enable it to submit its comments. If the Commission considers that such plans are not compatible, it must `without delay' initiate the procedure provided for in Article 93(2), but, pending a final decision, the Member State concerned must not put its proposed measures into effect. The fact that it is forbidden to grant the aid medio tempore is attributable to a ratio not unlike that underlying the mechanism provided for in Article 100a(4). Accordingly, it is not unreasonable to apply that more restrictive approach to the interpretation of the latter provision, too.

26 Of course, my remarks in favour of a narrow interpretation of safeguard clauses are confined to the context of the internal market, in respect of which priority is to be accorded to harmonisation. In other contexts, safeguard clauses may operate differently. This implicitly confirms that a more stringent approach is appropriate in the context of the relationship between harmonising measures and the unilateral derogation governed by Article 100a(4).

This is illustrated by the protection measures to be adopted by the Council in furtherance of Community environmental policy pursuant to Article 130s of the Treaty. In that context, notwithstanding harmonisation measures, Member States retain under Article 130t the option of `maintaining or introducing more stringent protective measures'. They need only notify such measures to the Commission, and further intervention by the Community institutions is not contemplated. In this context, by contrast with the internal market, the harmonising measure and the more restrictive national legislation share a common objective - protection of the environment. This both explains the different approach and further illustrates the differences between environmental legislation and laws designed to establish the internal market.

27 The Court has already ruled that the national legislation cannot apply before confirmation is received from the Commission. In France v Commission, (16) the Court stated that `a Member State is not [...] authorised to apply the national provisions notified by it until after it has obtained a decision from the Commission confirming them'. The Court indicated that otherwise the harmonisation of laws would be rendered ineffective, thereby compromising the establishment of the internal market.

This, to my mind, is the correct approach in the present case, even though it is not clearly indicated in the wording of Article 100a(4). Admittedly, the verb `confirm' is used to describe the content of the Commission decision, but that confirmation is nevertheless conditional upon the Commission having `verified' the legislation notified and its impact on trade between Member States. By definition, verification entails the evaluation of that impact on the operation of the internal market and the national legislation may apply only if its effects are found by the Commission to be positive. Otherwise, the State would be the sole arbitrator and would be able to apply its legislation as soon as it had discharged the obligation to notify it to the Commission. As a consequence, the internal market would be paralysed and, most importantly, the free movement of goods would be frozen, being dependent on unilateral decisions taken a posteriori, with grave implications for the expectations of traders, who would ultimately be faced with a panoply of divergent choices made by the various legal systems. Consider, for example, the situation where a Member State waits until the last day of the period prescribed for implementation of a directive, (17) before notifying the Commission of more restrictive legislation which it wishes to maintain in force: in such circumstances, were the Court to espouse the approach advocated by the States which have intervened in this case, it would be impossible to prevent the application of that legislation. As a result, the legal homogeneity of the internal market, which the directive seeks to promote, would be fragmented.

Although such an interpretation may be compatible with the wording of Article 100a(4), it should not be forgotten that this provision arises in the context of legislation which is primarily directed towards harmonisation (Article 100a(1)), not the protection of Member States' powers of derogation.

In reply to the second question referred by the national court, the need for confirmation by the Commission must be affirmed, so that mere notification of measures cannot suffice for their application after the expiry of the deadline set by a directive for its implementation. It follows that provisions of a directive which are capable of direct effect must be accorded that authority even after the notification of conflicting provisions of national law.

The Commission's delay in adopting a confirmatory decision

28 The most important aspect of this case, which is referred to in the third question referred by the national court and emphasised in the various observations submitted to the Court, concerns the reasonableness of the approach advocated above in cases where the Commission delays, perhaps considerably, in adopting a decision on the national legislation notified. The intervening States have all expressed the opinion that, if the Commission delays beyond a reasonable length of time, it should be possible to apply the national legislation notified, on the ground that silence on the part of the Commission should be construed as assent.

The justification of such an approach is essentially based on the principles of legal certainty and the protection of legitimate expectations. Both principles are wholly frustrated where the Commission delays unreasonably, especially where important interests are at stake, such as those referred to in Article 100a(4).

29 In an attempt to set a reasonable time-limit within which the Commission must take such a decision, a variety of suggestions has been put forward, ranging from a two-month time-limit - inferred from the case-law, and analogous to the situation in which the Commission must decide on the compatibility of State aid under the Article 93 procedure (18) - to the generic `as soon as possible' prescribed by 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, (19) up to the six-month period prescribed in the new version of Article 100a, as amended by the Treaty of Amsterdam, on expiry of which, in the absence of a decision by the Commission, `the national provisions [...] shall be deemed to have been approved'. (20)

The variety of proposals reflects the fact that use of the interpretative method may lead to the creation of a provision which does not, in fact, exist. Article 100a(4) of the Treaty sets no express limit on the time within which the Commission must verify the national provisions notified. Of course, the Commission is under a duty to act quickly to verify national legislation, just as the State must notify such legislation as quickly as possible if it wishes to maintain it in force. (21) From this point of view - the physiological, so to speak - of the interaction between State and Commission in the application of a directive adopted under Article 100a, the period within which the Commission must evaluate the legislation notified could reasonably be said to expire on the date by which the directive must be implemented. This would avoid uncertainty, since, up to that date, the State could lawfully apply its own legislation. As from that date, it would have to apply the harmonising measures if the Commission's findings were negative, but if, on the other hand, the Commission adopted a confirmatory decision, the State could continue to apply the legislation notified.

30 The Commission's inaction, which persisted after the deadline for transposition of the Directive into national law, may constitute an infringement of the Treaty; in particular, it might constitute failure to act within a reasonable time in terms of Articles 5 and 100a(4) of the Treaty. However, failure to fulfil obligations under the Treaty cannot be remedied by the distortion of the proper relationship between Member State and Community institutions or by stripping a body of competence attributed to it by the Treaty - which would be the effect if it were found that the national legislation notified should be deemed to be impliedly confirmed.

Community law provides the mechanisms for the proper `management' of such a situation. The Commission's omission entails a failure to act, which may be appraised in the light of Article 175 of the Treaty and disciplined by the Court of Justice if a Member State brings proceedings. The judicial mechanism ensures that the system retains a certain `flexibility', since the Court can assess whether the time which has elapsed without any decision from the Commission being forthcoming is unreasonable in the light of Articles 5 and 100a(4), with the consequence that the Commission is at fault for the purposes of an action for failure to act. The inevitable discretion accruing to the Court in such cases from the need to interpret the concept of reasonableness in that context enables it to take proper account of the circumstances of the individual case and, in particular, the rapidity with which, in its turn, the Member State acted when notifying the legislation. This avoids the kind of rigid automatism which might have heralded the beginning of a process in which harmonisation - which the correct application of directives should ensure - would have been compromised by restrictions which might not always have been justifiable.

31 It is true that certain needs, which under Article 100a(4) may justify a derogation from a harmonising measure, relate to vital considerations which, in theory, are not amenable to compromise. However, in such cases, it is open to Member States to apply as a matter of urgency, in the context of a direct action against the Commission for failure to act, for interim measures necessary for the protection of those priorities, on the basis of the safeguards provided for in Articles 185 and 186 of the Treaty. Thus, it is not inconceivable that operation of the Directive might be suspended in the case of that State.

Of course, when assessing the periculum, a necessary precondition if urgency is to be proved, it is necessary to balance the interests at stake which entails the need to consider the level of protection guaranteed by a Directive. In cases such as this, in which the harmonising directive itself protects human health, it cannot be assumed that the needs of the State necessarily merit protection at the expense of market homogeneity. Judicial proceedings therefore appear to be an appropriate means of resolving this issue, which arises only in `abnormal' circumstances and must not therefore be treated as anything other than an exception in the context of the safeguard clause in question.

32 Admittedly, this approach would lead to inconsistency in the legal rules governing these matters within the national legal system in question. Up until the expiry of the deadline for implementing the directive, the national legislation would apply; subsequently, the directive - duly transposed into national law - would apply; then, if the Commission belatedly confirms the national legislation notified, the latter would again apply. However, such inconsistency can be limited if recourse is made to the judicial remedy proposed above. Moreover, if the contrary approach is adopted, it would lead to a similar situation. If a reasonable period must elapse after the final date for transposition of a directive into national law so that the national legislation can be said to be confirmed by implication, during that period the State ought to implement that directive, except that - and this, for the reasons given above, would be inconsistent with the underlying rationale - expiry of the deadline would automatically revive application of the national legislation notified.

Consequently, this Directive would have direct effect - provided that the relevant preconditions are satisfied - during the period following notification of the more restrictive national legislation and could therefore be relied upon by the individual against whom criminal proceedings are being brought on the basis of that legislation. Of course, in the event that the Commission later adopts a confirmatory decision, the direct effect of the Directive will be frozen and the national legislation will apply.

Conclusion

33 In the light of the above considerations, I therefore propose that the Court reply as follows to the questions referred for a preliminary ruling by the Landskrona Tingsrätt:

(1) A directive adopted on the basis of Article 100a of the Treaty may have direct effect in national law, provided that its provisions are clear, precise and unconditional and that the deadline for transposition of that directive into national law has expired.

(2) Notification by a Member State, in accordance with Article 100a(4) of the Treaty, of provisions of national law which it wishes to maintain in force does not preclude the direct effect of a Community directive adopted on the basis of Article 100a, provided that the conditions set out in paragraph (1) above are satisfied.

(3) The direct effect of a Community directive does not lapse during the period between notification by the Member State and the decision adopted by the Commission, unless the Court of Justice makes a contrary assessment, when considering the merits of an action or when hearing an application for interim relief [Question 3(a)]; in the period following the Commission's decision, direct effect will lapse only if the Commission has confirmed the provisions of national law notified to it [Question 3(b)].

(1) - Case C-41/93 France v Commission [1994] ECR I-1829.

(2) - Case C-127/97 Burstein v Freistaat Bayern [1998] ECR I-6005. In the related judgment, the Court did not have an opportunity to address the problem of Article 100a(4) of the Treaty since it had decided, in line with my general proposal, that the national legislation fell outside the scope of the harmonising directive in question.

(3) - OJ 1994 L 237, p. 13.

(4) - See the second and third recitals in the preamble to the Directive.

(5) - Article 2(7) provides that the term quantum satis indicates that no maximum level is specified. However, even in such cases, the colorant must be used in accordance with proper manufacturing practice at a level not higher than is necessary to achieve the intended purpose and provided that the consumer is not misled.

(6) - See Article 9(1) of the Directive.

(7) - Both instruments were signed in Corfu on 24 June 1994 (OJ 1994 C 241), and subsequently amended - following the failure of the Kingdom of Norway to ratify them by 31 December 1994 - by decision of the Council of 1 December 1994 (OJ 1995 L 1).

(8) - The judgment given in Case 148/78 Ratti [1979] ECR 1629 remains of immediate relevance today. In that judgment, the Court rejected the argument that individuals may rely on the principle of the protection of legitimate expectations in relation to a period before expiry of the deadline for transposing a directive into national law (see paragraph 46).

(9) - See Case C-129/96 Inter-Environnement Wallonie [1997] ECR I-7411. On that point, the Court appears to advert to the principle of international law in accordance with which a State must refrain from acts which would defeat the object and purpose of a treaty before it enters into force (see Article 18 of the Vienna Convention on the law of treaties, concluded on 23 May 1969).

(10) - Article 5 of the Law introducing the Penal Code (Lag (1964:163) om införande av brottsbalken) is based on that principle, as is Article 2(2) of the Italian Penal Code. In international law, see also Article 15 of the International Agreement on Civil and Political Rights of 15 December 1966. The principle is founded on the fact that it would be unreasonable and contradictory to punish a person for an act which is now tolerated by the legal system in question.

(11) - From the wide range of cases on this point, see Joined Cases C-6/90 and C-9/90 Francovich [1991] ECR I-5357.

(12) - The importance of taxation in relation to the attainment of the fundamental freedoms is alluded to with increasing frequency in the case-law of the Community judicature. See, inter alia, Case C-204/90 Bachmann [1992] ECR I-249; Case C-300/90 Commission v Belgium [1992] ECR I-305; Case C-279/93 Schumacker [1995] ECR I-225; Case C-80/94 Wielcockx [1995] ECR I-2493; and Case C-264/96 ICI [1998] ECR I-4695.

(13) - See Case C-70/88 Parliament v Council [1991] ECR I-4529, paragraph 17, and Case C-155/91 Commission v Council [1993] ECR I-939, paragraph 19.

(14) - Exceptions to the rules on the free movement of goods, consolidated in Article 36 of the Treaty, are to be narrowly construed (see Case 46/76 Bauhuis [1977] ECR 5, paragraphs 5 to 12, and Case 103/84 Commission v Italy [1986] ECR 1759, paragraphs 21 and 22). Identical considerations weigh in the case of the exceptions to the rules on freedom of movement for employed workers, provided for in Article 48(3) of the Treaty, or of self-employed workers, on the basis of Article 56 thereof, referred to again in Article 66 in the context of the freedom to provide services.

(15) - The Directive at issue in the present case is in large measure based on the need to protect human health, that is to say, it seeks to protect the very priority given as justification for the request for derogation under Article 100a(4).

(16) - Case C-41/93, cited in footnote 1; see, in particular, paragraphs 29 and 30.

(17) - In the present case, Sweden notified the legislation to the Commission on 2 November 1995, whereas the deadline for transposing the Directive into national law expired on 31 December 1995.

(18) - See Case 84/82 Germany v Commission [1984] ECR 1451, paragraph 11.

(19) - OJ 1989 L 40, p. 27.

(20) - For purposes of clarity, I shall quote the relevant provision of Article 100a (now, after amendment, Article 95), as amended by the Treaty of Amsterdam: `The Commission shall, within six months of the notifications as referred to in paragraphs 4 and 5, approve or reject the national provisions involved after having verified whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between Member States and whether or not they shall constitute an obstacle to the functioning of the internal market.

In the absence of a decision by the Commission within this period the national provisions referred to in paragraphs 4 and 5 shall be deemed to have been approved'. It should be noted that the new version of this provision expressly states whether the Commission's decision is essential or not. The above considerations are therefore valid also in respect of the new Treaty.

(21) - The obligation to act quickly stems from the duty of cooperation in the fulfilment of obligations under the Treaty, provided for in Article 5 thereof. On the subject of the implications of Article 5 for the institutions, see Case C-2/88 Imm. Zwartveld [1990] ECR I-3365; Case C-349/93 Commission v Italy [1995] ECR I-343; and Case T-16/90 Panagiotopoulou v Parliament [1992] ECR II-89, paragraph 51.