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Súdny dvor Európskej únie·28.1.1999

C-319/97

ECLI:EU:C:1999:37

Súd
Súdny dvor Európskej únie
IČS
61997CC0319

KORTAS

OPINION OF ADVOCATE GENERAL SAGGIO delivered on 28 January 1999 *

1. This reference from a Swedish court 3 . The r u l e s i m p l e m e n t i n g Law raises once again the difficulty of interpret- No 511/1971 — in particular, Decree ing Article 100a of the Treaty, specifically No 33 of 1993, which entered into force Article 100a(4). The specific subject to be on 1 January 1994 — banned all use of the addressed has already been touched on, colorant known as E 124 or cochineal red both in an earlier judgment 1and in my in foodstuffs, save for alcoholic beverages. Opinion in Burstein,2 namely, the relation- The same ban was imposed in an earlier ship between Community harmonising measure, Decree No 1 of 1993, the provi- measures designed to establish the internal sions of which remained in force under market and domestic legislation which transitional arrangements until June 1995. derogates from them.

On 1 December 1995 the competent administrative authority adopted Decree No 31 on food additives. This measure, which gave effect to European Parliament The national legislation 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.

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 The Community legislation criminal offence attracting a heavier pen- alty if the quantities involved are signifi- cant. 4. The Directive is intended to harmonise national laws governing the use of color- * Original language: Italian. ants in foodstuffs, given that the discrepan- 1 — Case C-41/93 France v Commission [1994] ECR I-1829. cies in this area as between the various 2 — Case C-127/97 Burstein v Freistaat Bayern [1998] ECR Member States impedes the free movement 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.

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of foodstuffs and distorts competition. provision. The permitted colorants Accordingly, the legal basis of the Directive (Annex I) may be used only in the food- is Article 100a of the Treaty, the first stuffs listed in Annexes III, IV and V, paragraph of which empowers the Council, subject to the conditions specified therein. acting in accordance with the procedure It is not permitted to use colorants in the referred to in Article 189b, to adopt 'mea- foodstuffs listed in Annex II, save in the sures for the approximation of the provi- cases specifically envisaged in the other sions laid down by law, regulation or annexes. Some colorants which may be administrative action in Member States used only for specific purposes are listed, which have as their object the establish- together with their authorised uses, in ment and functioning of the internal mar- Annex IV. Colorants which are generally ket'. permitted, that is to say, they may be used quantum satis5 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 food- stuffs listed in Part 2 of Annex V.

5. The substantive content of the rules introduced by the Directive is based princi- pally on the need to protect and inform the consumer, permitting the use of additives only where this is shown to be technologi- cally 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 color- ants in foodstuffs. Article 2(1) provides that 'only the substances listed in Annex I 6. Pursuant to Article 10 of the Directive, may be used as colours in foodstuffs'. One that measure entered into force on 10 Sep- of the substances listed in that Annex is tember 1994, the date of its publication in E 124, the common name for which is the Official Journal. The Member States 'Ponceau 4R, Cochineal Red A'. were required to adopt, by 31 December 1995 at the latest, the implementing mea- sures 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

In addition to specifying the colours which may be used, the rules make very detailed 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 4 — See the second and third recitals in the preamble to the that the consumer is not misled. Directive. 6 — See Article 9(1) of the Directive.

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words, the use and marketing of products recount that, on learning through informal containing colorants approved by the channels that its request would meet with a Directive should have been permitted under negative response, Sweden let it be known the domestic law of the Member States by that it would waive its right to a formal 31 December 1995. 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, The accession of Sweden by that date, products in conformity with that measure could be freely marketed and used.

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 Article 100a(4) 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 8. Article 100a(4) of the Treaty provides: 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 'If, after the adoption of a harmonisation Member States may request, between measure by the Council acting by a quali- 1 January 1994 and the date of signature fied majority, a Member State deems it of the Accession Treaty, certain temporary necessary to apply national provisions on derogations from acts of the institutions grounds of major needs referred to in adopted. The Council, acting unanimously Article 36, or relating to protection of the on a proposal from the Commission, is to environment or the working environment, take a decision on such requests. Sweden it shall notify the Commission of these submitted such a request on 26 July 1994. provisions. In their respective observations, the Com- mission and the Swedish Government

7 — Both instruments were signed in Corfu on 24 June 1994 (OJ 1994 C 241), and subsequently amended — following The Commission shall confirm the provi- the failure of the Kingdom of Norway to ratify them by sions involved after having verified that 31 December 1994 — by decision of the Council of 1 December 1994 (OJ 1995 L 1). they are not a means of arbitrary discrimi-

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nation or a disguised restriction on trade 11. Taking cognisance of the Community between Member States.' Directive and of the fact that the more restrictive Swedish legislation had been notified to the Commission for the pur- poses 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: 9. On 5 November 1995 Sweden notified to the Commission the provisions of Swed- ish law relating to food additives (pursuant to which use of E 124 was prohibited) which it considered necessary to maintain '1. Can a directive adopted under Arti- in force for the protection of human health. cle 100a of the Treaty of Rome have The Commission did not respond. 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 ? Facts and questions referred for a prelimin- ary ruling

3. If Question 2 is answered in the affirmative, how does the notification by the Member State affect the ques- 10. The order for reference recounts that tion of direct effect during the follow- on 15 September 1995, in the course of ing periods: inspecting business premises belonging to Mr Kortas, the competent national admin- istrative authority came across a significant quantity of confectionery containing E 124. Mr Kortas was accordingly prose- cuted for having marketed foodstuffs con- (a) between notification and reply? taining 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 accor- dance with Community law. (b) from the reply?'

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Applicability of the Community 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 sub- sequent legislation is not an offence.10 It follows that when, after the expiry of the deadline for the Directive's transposition 12. One of the problems to be addressed in into national law, primacy is accorded to this context, although the order for refer- the Directive and more lenient legislation ence is silent on the point, is the relevance applies to the facts of Mr Kortas' case, the ratione temporis of the Directive to the national court will be bound accordingly in facts of the case. The offence was commit- its determination of his culpability. ted 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, accord- ing 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 Question 1 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 14. The Directive has not been correctly prescribed. 9 In the present case, however, transposed into Swedish law.

Even Minis- Sweden did not adopt any new legislation terial Decree No 31 of 1995 concerning inconsistent with the aims of the Directive; food additives, albeit adopted in implemen- it merely continued to apply the existing tation of the Directive, confirmed the ban legislation. on the use of E 124. Thus, the relevance to be accorded to the divergent Community legislation depends on its direct effect in 8 — The judgment given in Case 148/78 Ratti [1979] ECR 1629 national law. However, the national court 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). 10 — Article 5 of the Law introducing the Penal Code (Lag 9 — See Case C-129/96 inter-Environnement Wallonie |1997] (1964:163) om införande av brottsbalken) is based on that ECR I-7411. On that point, the Court appears to advert to principle, as is Article 2(2) of the Italian Penal Code.

In the principle of international law in accordance with which international law, see also Article 15 of the International a State must refrain from acts which would defeat the object Agreement on Civil and Political Rights of 15 December and purpose of a treaty before it enters into force (see 1966. The principle is founded on the fact that it would be Article 18 of the Vienna Convention on the law of treaties, unreasonable and contradictory to punish a person for an concluded on 23 May 1969). act which is now tolerated by the legal system in question.

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does not ask the Court whether the Direc- cretion within which the Member State tive — so far as concerns its specific may establish the mechanisms and time- substantive content — has direct effect. tables necessary to attain the result pre- Rather, it questions, more generally, scribed. Although, in theory, the lawfulness whether any directive adopted on the basis of such measures could be questioned of Article 100a of the Treaty can have where the Treaty — in Article 100, for direct effect. 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.

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 empow- ered the institution concerned to adopt that measure. The direct effect of such a provi- Incontestably, therefore, a directive sion depends exclusively on the character- adopted on the basis of Article 100a of istics of its substantive content, measured the Treaty may have direct effect, provided against a particular set of requirements. In that the conditions mentioned above are particular, the rule in question must be satisfied. clear, precise and capable of immediate application, that is to say, independently of formal implementing measures to be adopted at national level. 11 Another essen- tial precondition is the fact that the direc- tive in question must have run its term; in other words, the deadline for its transposi- 15. In the case of the Directive under tion into national law must have expired. consideration, there is no doubt that this The legal basis on which the directive was lays down rules the content of which is adopted is wholly irrelevant. Furthermore, clear, precise and unconditional with the fact that provisions of a harmonising respect to the specification of colorants directive adopted on the basis of Arti- which may be used in foodstuffs. A clear cle 100a may be clear, precise and uncon- illustration of such a provision is provided ditional is confirmed by the wording of that by Article 2, referred to above, which states provision, which does not require the that 'only the substances listed in Annex I Community legislature to adopt directives, may be used as colours in foodstuffs'. but more generally, 'measures for [...] While that rule prohibits the use of other approximation'. Arguably, therefore, the substances, it authorises the use of the substances expressly named, provided that Community legislature could adopt mea- the detailed rules as to types of product and sures such as regulations or 'detailed' quantities are complied with. It cannot be directives, which leave no margin of dis- sustained either that the rule which prohi- bits the use of unlisted substances may be interpreted more widely, at the discretion of 11 — From the wide range of cases on this point, see Joined the Member States. Indeed, that would Cases C-6/90 and C-9/90 Francovich [1991] ECR I-5357.

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wholly frustrate the aim of harmonising the the adoption of the harmonisation mea- legislation and permitting the free move- sure — to the exclusion of States which ment of the products concerned. 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 On the basis of the Directive, therefore, of the provision at issue. Article 100a(4) individuals are entitled to use the colorant essentially serves to offset the mechanism E 124 in accordance with the detailed rules requiring a qualified majority, which, and may rely upon that right before the although it has led to a notable increase national courts, which as a consequence in the efficiency of the decision-making must disapply any conflicting provision of process for establishing the internal market, national law. 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 justi- fied in terms of the important (non-eco- nomic) needs contemplated by Article 36 Questions 2 and 3 or which are necessary to protect the environment or the working environment, provided that a certain procedure is fol- 16. The second and third questions — the lowed, and subject to both administrative latter comprising two limbs — raise the checks (entrusted to the Commission) and issue of the relationship between harmoni- judicial review. sation 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 Arti- cle 100a(4) of the Treaty.

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 Admissibility of the questions opportunity to do so because at the mate- rial time they had not yet acceded to the Community. In any event, the latter States find themselves faced with a harmonising 17. I do not regard as well founded the measure which may compromise important objection as to admissibility raised by the considerations. Arguably, in fact, this is all French Government, according to which the more likely in the case of new Member only the States which took part in the States. Existing Member States will have negotiations within the Council regarding had every opportunity during the adoption

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procedure to draw attention to their special or whether its applicability is conditional needs. 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 19. What is more, if the jurisprudential the national legislation notified. 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 21. In my view, in this case — as in adoption process. In the case of Sweden, Burstein — the only way to resolve the it must also be emphasised that it did issues raised is through analysis of the ratio attempt — unsuccessfully — to obtain a of Article 100a, particularly of Arti­ derogation under the instruments of acces­ cle 100a(4), in conjunction with other sion, using the procedure provided for in provisions of the Treaty. Article 151 of the Treaty of Accession. The negative response of the Community insti­ tutions cannot, however, prevent the new Member State from directing their atten­ tion once again — in a much more 'insti­ tutionalised' context — to those needs by availing itself of the derogation procedure Article 100a has provided the Community provided for in Article 100a(4). 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 Com­ munity law are ensured. In practice, Arti­ cle 100a has proved to be vital to the Substance 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 20. The substantive issue raised by the importance of which has grown with 12 second and third questions concerns the increased integration but in respect of fate of provisions of national law which conflict with the harmonisation measure but which the State wishes to apply for the 12 — The importance of taxation in relation to the attainment of the fundamental freedoms is alluded to with increasing protection of important national needs. In frequency in the case-law of the Community judicature. See, inter alia, Case C-204/90 Bachmann [1992] ECR particular, the Court is asked whether, once 1-249; Case C-300/90 Commission ν Belgium [1992] ECR the State has notified that legislation to the I-305; Case C-279/93 Schumacker [1995] ECR I ; Case C-80/94 Wielcockx [1995] ECR I-2493; and Case Commission, it can be immediately applied C-264/96 ¡CI [1998] ECR 1-4695.

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which the harmonisation of the relevant be subject to stringent conditions both with legislation still depends on the less efficient respect to the scope of the justifications mechanism provided for in Article 100. 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 sub- stantive importance so that the precondi- tions for invoking the derogation are prop-

22. A feature of measures 'which have as erly monitored. their object the establishment and function- ing of the internal market' (Article 100a(l)) 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 con- sideration, given the priority accorded to 24. Underlying all this is the need to safe- the establishment of the internal market, guard the uniform application of Commu- does not alter the choice of legal basis nity law, which represents the principal which remains, even in such cases, Arti- means of creating and maintaining an cle 100a of the Treaty. 13 internal market, an area primarily charac- terised by legal homogeneity.

Running counter to that endeavour is the power of the Member States to introduce unilateral derogations independently of the monitor- ing procedure provided for. If the ratio of the rule is to be respected, therefore, the 23. In that context, the 'compensatory' confirmatory decision — which is to be mechanism provided for by Article 100a(4) adopted by the Commission after verifying can only be intended to be by way of that the national measures notified to it do exception in relation to the aim pursued by not constitute 'a means of arbitrary discri- the other provisions laid down in Arti- mination or a disguised restriction on trade

cle 100a. Like all exceptions to fundamen- between Member States' — must be a tal principles underlying Community inte- conditio sine qua non of the applicability gration, 14 Article 100a(4) must be nar- of any provisions of national law which are rowly construed, and its operation must more restrictive than the corresponding Community legislation. Although Arti- cle 100a(4) answers the need to balance 13 — See Case C-70/88 Parliament v Council [1991] ECR opposing interests — on the one hand, the I-4529, paragraph 17, and Case C-155/91 Commission v Council [1993] ECR I-939, paragraph 19. harmonisation of laws directly affecting the 14 — Exceptions to the rules on the free movement of goods, operation of the internal market and, on consolidated in Article 36 of the Treaty, are to be narrowly construed (see Case 46/76 Bauhuis [1977] ECR 5, the other, the protection of values on which paragraphs 5 to 12, and Case 103/84 Commission v Italy [1986] ECR 1759, paragraphs 21 and 22).

Identical Member States place particular impor- considerations weigh in the case of the exceptions to the tance — the truth is that Community law rules on freedom of movement for employed workers, provided for in Article 48(3) of the Treaty, or of self- requires adequate protection to be given to employed workers, on the basis of Article 56 thereof, many of the States' priorities (health, safety, referred to again in Article 66 in the context of the freedom to provide services. environmental protection and consumer

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protection) at the stage when harmonisa- State concerned must not put its proposed tion measures are being drafted, the Com- measures into effect. The fact that it is mission being under a duty, in its proposals forbidden to grant the aid medio tempore is concerning those sectors, to take as a base attributable to a ratio not unlike that 'a high level of protection' (Arti- underlying the mechanism provided for in cle 100a(3)). 15 This factor lends further Article 100a(4). Accordingly, it is not justification to the need to construe the unreasonable to apply that more restrictive safeguard narrowly — if the harmonising approach to the interpretation of the latter legislation already accommodates a high provision, too. level of protection in a particular area, there is no need to allow the States added powers in that respect.

26. Of course, my remarks in favour of a narrow interpretation of safeguard clauses 25. That observation is fully consistent are confined to the context of the internal with the location of Article 100a(4) in the market, in respect of which priority is to be conceptual structure of the Treaty. The accorded to harmonisation. In other con- Chapter of the Treaty dealing with the texts, safeguard clauses may operate differ- approximation of laws is juxtaposed with ently. This implicitly confirms that a more the rules on competition, comprising inter stringent approach is appropriate in the alia the rules governing State aid, in respect context of the relationship between harmo- of which analogous difficulties may arise. nising measures and the unilateral deroga- State aid may be granted in derogation tion governed by Article 100a(4). from the competition rules and is permis- sible only where particular needs are iden- tified, 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). This is illustrated by the protection mea- The State must notify such plans to the sures to be adopted by the Council in Commission in sufficient time to enable it furtherance of Community environmental to submit its comments. If the Commission policy pursuant to Article 130s of the considers that such plans are not compa- Treaty. In that context, notwithstanding tible, it must 'without delay' initiate the harmonisation measures, Member States procedure provided for in Article 93(2), retain under Article 130t the option of but, pending a final decision, the Member 'maintaining or introducing more stringent protective measures'. They need only notify such measures to the Commission, and 15 — The Directive at issue in the present case is in large measure based on the need to protect human health, that is further intervention by the Community to say, it seeks to protect the very priority given as justification for the request for derogation under Arti- institutions is not contemplated. In this cle 100a(4). context, by contrast with the internal

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market, the harmonising measure and the Commission to be positive. Otherwise, the more restrictive national legislation share a State would be the sole arbitrator and common objective — protection of the would be able to apply its legislation as environment. This both explains the differ- soon as it had discharged the obligation to ent approach and further illustrates the notify it to the Commission. As a conse- differences between environmental legisla- quence, the internal market would be tion and laws designed to establish the paralysed and, most importantly, the free internal market. movement of goods would be frozen, being dependent on unilateral decisions taken a posteriori, with grave implications for the expectations of traders, who would ulti- mately be faced with a panoply of divergent choices made by the various legal systems. Consider, for example, the situation where 27. The Court has already ruled that the a Member State waits until the last day of national legislation cannot apply before the period prescribed for implementation of confirmation is received from the Commis- a directive, 1 7 before notifying the Commis- sion. In France v Commission,16 the Court sion of more restrictive legislation which it stated that 'a Member State is not [...] wishes to maintain in force: in such cir- authorised to apply the national provisions cumstances, were the Court to espouse the notified by it until after it has obtained a decision from the Commission confirming approach advocated by the States which them'. The Court indicated that otherwise have intervened in this case, it would be the harmonisation of laws would be ren- impossible to prevent the application of dered ineffective, thereby compromising that legislation. As a result, the legal the establishment of the internal market. homogeneity of the internal market, which the directive seeks to promote, would be fragmented.

This, to my mind, is the correct approach in the present case, even though it is not clearly indicated in the wording of Arti- cle 100a(4). Admittedly, the verb 'confirm' is used to describe the content of the Commission decision, but that confirma- tion is nevertheless conditional upon the Commission having 'verified' the legisla- Although such an interpretation may be tion notified and its impact on trade compatible with the wording of Arti- between Member States. By definition, cle 100a(4), it should not be forgotten that verification entails the evaluation of that this provision arises in the context of impact on the operation of the internal legislation which is primarily directed market and the national legislation may towards harmonisation (Article 100a(l)), apply only if its effects are found by the

17 — In the present case, Sweden notified the legislation to the Commission on 2 November 1995, whereas the deadline 16 — Case C-41/93, cited in footnote 1; see, in particular, for transposing the Directive into national law expired on paragraphs 29 and 30. 31 December 1995.

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not the protection of Member States' The justification of such an approach is powers of derogation. 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). In reply to the second question referred by the national court, the need for confirma­ tion 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.

29. In an attempt to set a reasonable time- The Commission's delay in adopting a limit within which the Commission must confirmatory decision take such a decision, a variety of sugges­ tions 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 28. The most important aspect of this case, compatibility of State aid under the Arti­ which is referred to in the third question 18 cle 93 procedure — to the generic 'as referred by the national court and empha­ sised in the various observations submitted soon as possible' prescribed by Council to the Court, concerns the reasonableness Directive 89/107/EEC of 21 December of the approach advocated above in cases 1988 on the approximation of the laws of where the Commission delays, perhaps the Member States concerning food addi­ considerably, in adopting a decision on tives authorised for use in foodstuffs inten­ the national legislation notified. The inter­ ded for human consumption, 1 9 up to the vening States have all expressed the opinion six-month period prescribed in the new that, if the Commission delays beyond a version of Article 100a, as amended by the reasonable length of time, it should be Treaty of Amsterdam, on expiry of which, possible to apply the national legislation in the absence of a decision by the Corn- notified, on the ground that silence on the i s — See Case 84/82 Germany ν Commission [1984] ECR 1451, part of the Commission should be con­ paragraph 11. strued as assent. 19 — OJ 1989 L 40, p. 27.

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mission, 'the national provisions [...] shall tainty, since, up to that date, the State could be deemed to have been approved'. 20 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 confir- matory decision, the State could continue to apply the legislation notified.

The variety of proposals reflects the fact that use of the interpretative method may 30. The Commission's inaction, which per- lead to the creation of a provision which sisted after the deadline for transposition of does not, in fact, exist. Article 100a(4) of the Directive into national law, may con- the Treaty sets no express limit on the time stitute an infringement of the Treaty; in within which the Commission must verify particular, it might constitute failure to act the national provisions notified. Of course, within a reasonable time in terms of the Commission is under a duty to act Articles 5 and 100a(4) of the Treaty. How- quickly to verify national legislation, just as ever, failure to fulfil obligations under the the State must notify such legislation as Treaty cannot be remedied by the distortion quickly as possible if it wishes to maintain of the proper relationship between Member it in force. 21 From this point of view — the State and Community institutions or by physiological, so to speak — of the inter- stripping a body of competence attributed action between State and Commission in to it by the Treaty — which would be the the application of a directive adopted under effect if it were found that the national Article 100a, the period within which the legislation notified should be deemed to be Commission must evaluate the legislation impliedly confirmed. notified could reasonably be said to expire on the date by which the directive must be implemented. This would avoid uncer-

20 — For purposes of clarity, I shall quote the relevant provision Community law provides the mechanisms of Article 100a (now, after amendment, Article 95), as for the proper 'management' of such a amended by the Treaty of Amsterdam: 'The Commission shall, within six months of the notifications as referred to situation. The Commission's omission in paragraphs 4 and 5, approve or reject the national entails a failure to act, which may be provisions involved after having verified whether or not they are a means of arbitrary discrimination or a disguised appraised in the light of Article 175 of the restriction on trade between Member States and whether or not they shall constitute an obstacle to the functioning Treaty and disciplined by the Court of of the internal market. Justice if a Member State brings proceed- In the absence of a decision by the Commission within this period the national provisions referred to in paragraphs 4 ings. The judicial mechanism ensures that and 5 shall be deemed to have been approved'. It should be noted that the new version of this provision expressly the system retains a certain 'flexibility', states whether the Commission's decision is essential or since the Court can assess whether the time not. The above considerations are therefore valid also in respect of the new Treaty. which has elapsed without any decision 21 — The obligation to act quickly stems from the duty of cooperation in the fulfilment of obligations under the from the Commission being forthcoming is Treaty, provided for in Article 5 thereof. On the subject of unreasonable in the light of Articles 5 and the implications of Article 5 for the institutions, see Case C-2/88 Imm. Zwartveld [1990] ECR I-3365; Case 100a(4), with the consequence that the C-349/93 Commission v Italy (1995] ECR I-343; and Commission is at fault for the purposes of Case T-16/90 Panagiotopoulou v Parliament [1992] ECR II-89, paragraph 51. an action for failure to act. The inevitable

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discretion accruing to the Court in such protection at the expense of market homo- cases from the need to interpret the concept geneity. Judicial proceedings therefore of reasonableness in that context enables it appear to be an appropriate means of to take proper account of the circumstances resolving this issue, which arises only in of the individual case and, in particular, the 'abnormal' circumstances and must not rapidity with which, in its turn, the Mem- therefore be treated as anything other than ber State acted when notifying the legisla- an exception in the context of the safeguard tion. This avoids the kind of rigid auto- clause in question. matism which might have heralded the beginning of a process in which harmoni- sation — which the correct application of directives should ensure — would have been compromised by restrictions which might not always have been justifiable. 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; sub- 31. It is true that certain needs, which sequently, the directive — duly transposed under Article 100a(4) may justify a dero- into national law — would apply; then, if gation from a harmonising measure, relate the Commission belatedly confirms the to vital considerations which, in theory, are national legislation notified, the latter not amenable to compromise. However, in would again apply. However, such incon- such cases, it is open to Member States to sistency can be limited if recourse is made apply as a matter of urgency, in the context to the judicial remedy proposed above. of a direct action against the Commission Moreover, if the contrary approach is for failure to act, for interim measures adopted, it would lead to a similar situa- necessary for the protection of those prio- tion. If a reasonable period must elapse rities, on the basis of the safeguards pro- after the final date for transposition of a vided for in Articles 185 and 186 of the directive into national law so that the Treaty. Thus, it is not inconceivable that national legislation can be said to be operation of the Directive might be suspen- confirmed by implication, during that ded in the case of that State. 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 noti- Of course, when assessing the periculum, a fied. 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 pro- Consequently, this Directive would have tects human health, it cannot be assumed direct effect — provided that the relevant that the needs of the State necessarily merit preconditions are satisfied — during the

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KORTAS

period following notification of the more tion. Of course, in the event that the restrictive national legislation and could Commission later adopts a confirmatory therefore be relied upon by the individual decision, the direct effect of the Directive against whom criminal proceedings are will be frozen and the national legislation being brought on the basis of that legisla- 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)].

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