I. INTRODUCTION
When we talk about harmonisation in the context of the World Trade Organisation (WTO) law, it is quite clear what we mean: firstly, harmonisation in the WTO is above all de-regulation. Article 2(6) of the Technical Barriers to Trade (TBT)-Agreement, which mentions harmonisation, provides what a European Union (EU) lawyer would call a general prohibition or restriction.Footnote 1 Secondly, where harmonisation in the WTO comes close to what we understand by this term in the EU – such as in Article 3 of the Application of Sanitary and Phytosanitary Measures (SPS) Agreement on international standards, guidelines and recommendations – standards are not imposed upon WTO members as they are by directives and regulations in the EU. Instead, these international standards serve as a ‘shield’ for national measures against challenges under the SPS Agreement or the General Agreement on Tariffs and Trade (GATT).Footnote 2 Instead of conferring legislative powers upon the WTO, Article 3(2) SPS Agreement applies a presumption of legality for sanitary or phytosanitary measures of WTO Members. Higher national standards, ie stricter national measures than those based on these standards must be scientifically justified, recalling Article 114(5) TFEU discussed below. Hence, harmonisation has a specific yet quite distinct meaning and function in WTO law.Footnote 3
In contrast, when we talk about harmonisation in the context of EU law, it is sometimes not entirely clear what precisely is meant. This is because a variety of terms are used for apparently very similar if not analogous concepts. In addition, the EU makes use of an increasing number of concepts and regulatory models besides, and within, harmonisation, and their relationship with each other often is vague. Finally, many years after some landmark judgments in this field, it still remains unclear what latitude the EU legislator has in drafting a new harmonisation measure. Different from the rules and principles that govern the scope of application of Article 114 of the Treaty on the Functioning of the European Union (TFEU) providing the competence to regulate the internal market, case law on harmonisation until now has been far from providing a drafting guide for the legislature.Footnote 4
The centre for harmonisation in EU law is Article 114 TFEU. If it is used for full harmonisation, it is unique in providing both substantial and procedural rules for Member States wishing to maintain or enact measures that are not genuine implementing acts. In this case, any deviation from the prescriptions of the harmonising act is exclusively governed by the ‘derogations’ in Article 114(4) and (5) TFEU. Article 114(5) TFEU not only limits the public reasons available to Member States, but in addition requires the existence of a specific problem for a Member State; a condition that has been notoriously difficult to satisfy.Footnote 5
If, in contrast, Article 114 TFEU is invoked as the basis for secondary law allowing for more stringent measures by Member States, different rules apply to national ‘reinforcements’, and questions of legality arise. This will be referred to as ‘legislative minimum harmonisation’, and will be distinguished from ‘constitutional minimum harmonisation’, where the Treaty allows Member States to pass more stringent measures in the areas of social policy, consumer policy, environmental policy and – since the Treaty of Lisbon – in the field of health policy. With these provisions, the right to national reinforcements is already built into primary law, prohibiting full harmonisation while offering no direction on the rules applying to (stricter) measures adopted by the Member States.
In this article it will be argued that minimum harmonisation under Article 114 TFEU differs from minimum harmonisation under legal bases such as Article 193 TFEU. Article 114(4) and (5) TFEU will only be considered as way of comparison, especially when discussing the increasing number of ‘tools’ the Union legislature uses in order to ensure compliance with its harmonisation instruments in a final part of this article. The main part of this article will discuss the different forms of harmonisation and their relation to other regulatory models, starting with full harmonisation.
II. FULL HARMONISATION
A. Introduction
I would suggest that it is useful to distinguish the scope of harmonisation measures from their intensity, bearing in mind that this article focuses on the intensity of harmonisation rather than its scope.Footnote 6 Harmonisation is ‘full’ in scope when there is comprehensive or exhaustive legislative harmonisation in a specific area; harmonisation will otherwise be said to be ‘partial’ in scope. But, distinct from the scope of harmonisation, the standard(s) set by European legislation may also vary in their intensity. They may provide for ‘full (or ‘maximum’, or ‘total’)’ harmonisation, in the sense of setting standards which Member States cannot derogate from, or they may provide for ‘minimum’ harmonisation only, leaving some discretion to Member States in, for example, setting a higher standard than the minimum standard(s) adopted under European law.
Some other distinctions must be mentioned. Vertical harmonisation and horizontal harmonisation are two concepts related to partial harmonisation (in scope), the former referring to harmonising rules for specific products or services and the latter referring to a legal act covering all or several different products and services. It has been argued that harmonisation is necessarily partial harmonisation and that it would be misleading to speak of full harmonisation in respect of a certain field.Footnote 7 It is however possible to regulate a precisely defined area exhaustively. Take the Tobacco Products Directive 2014/40/EU, which claims to regulate tobacco products and related products.Footnote 8 Take the Services Directive 2006/123/EC, where however there is a gap between assertion (at least in its title) of regulating ‘services’ and the reality of a rather curtailed scope of application.Footnote 9
In addition, the notion of targeted harmonisation refers to measures that provide only very selectively for harmonised rules. A case in point is the Consumer Credit Directive 2011/83/EU, which states in its Recital 9 that where it does not provide for harmonised rules, Member States are free to act, and clearly states which national rules this could concern.Footnote 10 The mentioned Tobacco Products Directive 2014/40/EU is another recent example for targeted full harmonisation, regulating tobacco products and nicotine containing products and explaining in Recital 55 that Member States ‘should remain free to maintain or introduce national laws applying to all products placed on its national market for aspects not regulated by this Directive, provided they are compatible with the TFEU and do not jeopardise the full application of this Directive’.Footnote 11 Also Chapter V on the quality of services in the Services Directive 2006/123/EC could be seen as a case of targeted harmonisation.
There are also, it is proffered, different ‘shades’ of the completeness of harmonisation. Whether a measure provides for minimum or full harmonisation can sometimes be unclear. In the Gallaher case, the Court found that text warnings on 6% of the surface of the cigarette pack did not breach the first Tobacco Products Directive, which allowed for warnings on ‘at least’ 4% of the surface.Footnote 12 In contrast, some directives such as the E-Money-Directive 2009/110/EC explicitly prohibit national measures other than implementing measures.Footnote 13 The most absolute form of full harmonisation occurs in blacklists such as Annex I of the Unfair Commercial Practices Directive 2005/29/EC, laying out business practices that must be banned by Member States without allowing recourse to justification.Footnote 14
B. A preference for minimum harmonisation?
In the field of consumer protection, ‘full’ legislative harmonisation has eclipsed ‘minimum’ legislative harmonisation as the ‘instrument of choice’ favoured especially by the European Commission. The Consumer Rights Directive 2011/83/EU has replaced a number of minimum harmonisation instruments such as the Doorstep Selling Directive 85/577/EEC – which had championed the right of Member States to foresee stricter measures in the interest of consumer protection – and is now clearly cast as a measure of ‘full’ harmonisation.Footnote 15 Earlier drafts had still argued for keeping the traditional ‘minimum’ approach while adding ‘full’ harmonisation only in a narrow technical area.Footnote 16
It is plain that national preferences and sensitivities are better served by ‘minimum’ harmonisation leaving Member States free to engage in ‘gold-plating’, in the sense of adding requirements that are not strictly necessary under the European harmonising instrument. However, it makes a difference whether ‘minimum’ harmonisation is applied to products or to selling arrangements, which are the subject of harmonisation of EU consumer law. Arguably, minimum harmonisation for products in general is considerably more disruptive to the functioning of the internal market than minimum harmonisation for directives on matters such as doorstep-selling. With product harmonisation, it would appear that the interest in preserving preferences of the Member States cannot outweigh the interest in furthering the internal market. These considerations will also play a role regarding the legality of minimum harmonisation (see Section III.B below). Thus, there doesn’t seem to be a case for generally preferring minimum harmonisation over full harmonisation. Yet it is true that the price of full harmonisation might be unclear language, because resistance to the loss of the right to determine one’s regulatory standards often translates into ambigious drafting.Footnote 17
If it is argued that full harmonisation would be radically less cooperative and thus more hierarchical than minimum harmonisation,Footnote 18 this can only be a difference of sorts. Intuitively, it seems ludicrous qualifying any form of harmonisation as a cooperative regulatory model. What could possibly be cooperative about an approach that prescribes uniform or at least approximated standards for all Member States? Yet if harmonisation is done by directives, then there is a cooperative element already built into the legal instrument used. Directives – at least as they were meant to be, and perhaps not as they are sometimes crafted in technical areas such as the energy marketFootnote 19 – are supposed to co-opt the Member States for the achievement of a certain objective. It is telling of the cooperative nature of directives how (literally) outgoing the European Commission has been in assisting the Member States on site fitting the – complex and fully harmonising – Patients’ Rights Directive 2011/24/EU on cross-border health-care into their national legal regimes.Footnote 20
C. Standard of review for reinforcements
It is plain that if matters are not covered by the scope of a directive or regulation, such as in the case of partial or targeted harmonisation, the fundamental freedoms continue to apply to national measures.Footnote 21 Conversely, this means that when a regulation or a directive governs a certain matter conclusively, divergent national measures cannot be justified under Article 36 TFEU. In Hedley Lomas, English authorities refused to grant the export of animal live-stock to Spain, arguing that while Spain had implemented Directive 74/577/EEC on the proper treatment of animals before slaughter, there would not be adequate controls and sanctions in case of infringements in Spain.Footnote 22 The Court held that Article 36 TFEU was not applicable, since the aim of protecting the health of animals in the context of slaughter was taken care of in the Directive. The lack of rules on enforcement and sanctions was held to be immaterial and the UK was referred to the principle of loyalty, requiring it to trust the Spanish authorities on controls.Footnote 23 This has been framed in the following words by the Court:Footnote 24
Article 36 of the Treaty allows the maintenance of restrictions on the free movement of goods, justified on grounds of the protection of the health and life of animals, which constitutes a fundamental requirement recognized by Community law. However, recourse to Article 36 is no longer possible where Community directives provide for harmonization of the measures necessary to achieve the specific objective which would be furthered by reliance upon this provision.
Recourse to ‘national’ interests of protection is thus no longer permissible when a directive harmonises those measures which are required for the attainment of the specific objective that would otherwise be protected by Article 36 TFEU. Protection is then afforded by the Union and there is no ‘mandate’ for the Member States, the public interest in need of protection having been ‘unionised’ or ‘harmonised’.
D. Mixing the models: the Services Directive
In the process leading to the Services Directive 2006/123/EC, several regulatory approaches were discussed, from the country of origin principle to mutual recognition and various forms of harmonisation.Footnote 25
Article 16 of the Commission proposal – the famous Bolkenstein/‘Frankenstein’ draft – provided for the country of origin principle.Footnote 26 This can be seen as a full harmonisation approach, if one considers that it leaves the host state with no right of reinforcement, since it has to apply the law of the Member State of origin to the service provider operating on its territory.Footnote 27 Full harmonisation and the country of origin principle as proposed by the European Commission may therefore be ‘close relatives’ as it has been put by Stephen Weatherill, but placing them under the same conceptual umbrella might be somewhat confusing. The country of origin principle as proposed did not provide for active, positive approximation of laws, but instead for a form of renvoi of law where the law of the home state of the service provider would be applied by the courts of the host state in case of a dispute. Thus, regulatory differences would not be affected as a matter of principle.
Moreover, even if we were to ignore this (highly practical) difference between full harmonisation and the country of origin principle as had been proposed by the Commission, we might just as well understand the latter as an option in the configuration of minimum harmonisation by considering the following: The proposal for the Services Directive – and this also counts for the adopted version – does have parts that harmonise national laws, such as on the quality of services requiring providers to furnish certain information to the recipient in Chapter V.Footnote 28 If national law were more stringent then these standards, these national standards would only apply to domestic service providers, while providers from other Member States would obtain market access by complying with the legal requirements in their home Member State. Since the home state would also have to implement the harmonised parts of the Directive, the outcome would not be any different from minimum harmonisation with market access for the foreign provider, discussed below.
The adopted version of the Services Directive, in place of this country of origin principle, provides a variation of the general prohibition of restrictions for services in its Article 16. While it is not based on Article 114 TFEU, Article 16 of the Services Directive curtails the ‘mandatory requirements’ Member States may invoke to justify national restrictions following the Cassis de Dijon case lawFootnote 29 over the full range of the parts of the directive pertaining to non-established service providers. However, on a substantive level, the Services Directive does not itself satisfy any of these public interests, except in the above mentioned Chapter on the quality of services. It does therefore, it is submitted, not follow the logic of Hedley Lomas.Footnote 30 This contributes to make the Services Directive a hotchpotch of regulatory models. It kept elements typical of full harmonisation from the proposal, such as the safety clause in Article 18, which allows taking protective measures against providers that are considered unreliable. Recital 7 of the Directive speaks of targeted harmonisation, but also of the freedom to provide services, and of coordination, and there are elements of mutual recognition.Footnote 31 The only qualification that can probably be excluded is that of minimum harmonisation, since neither Article 16 nor any other provision of the Services Directive provides a floor or a ceiling for standards on the provision of services.
III. LEGISLATIVE MINIMUM HARMONISATION
A. Introduction
I have suggested in Section II.A above, that the intensity of the harmonisation helps to distinguish between full (or maximum) harmonisation and minimum harmonisation. However, whether Member States have an absolute right to pass more stringent measures vis-à-vis other EU Member States or whether they must accept the harmonised standard for imports, adds the issue of market access to the equation. Market access clauses are something like ‘harm reduction’ from the perspective of the internal market, as they sustain regulatory differences but neutralise their practical consequences for market participants.
In that context, some authors have distinguished between ‘total’ and ‘optional’ harmonisation.Footnote 32 ‘Total’ harmonisation would oblige Member States to permit goods complying with a directive to be freely imported and marketed (under a free movement clause), but would prohibit the sale of goods not complying with a directive (under an exclusivity clause). By contrast, ‘optional’ harmonisation would require only the former with Member States being free to allow the sale of goods not meeting the standards laid down in the directive. By contrast, some others have defined ‘optional’ harmonisation as a model that leaves the producer the choice whether to comply with the national or with the harmonised rules.Footnote 33 The definition of ‘optional’ harmonisation becomes even more blurred when considering that others have introduced the notion of alternative/facultative harmonisation which would give Member States several options on how to reach a directive’s objective,Footnote 34 or would give producers the option to either follow the national or the harmonised rules.Footnote 35 That this may be confusing also becomes clear when we consider that in German literature ‘optional’ harmonisation has also been referred to as ‘minimum’ harmonisation without a market access clause, meaning that Member States could provide for stricter measures and also require imports to conform to these stricter standards.Footnote 36
It is suggested that, instead of using ambiguous terms such as ‘optional’, ‘facultative’ or ‘alternative’ harmonisation, focus should be put on the way ‘minimum’ harmonisation is drafted in a European legislative act. Arguably the most straight-forward manner is to stipulate that Member States are allowed to pass stricter measures than provided by the respective directive.Footnote 37 This may then be combined with a market access/free movement clause, which can bar Member States from denying the placing on the market of products in compliance with the directive.Footnote 38 To the same effect, such a clause can prohibit the Member States from restricting the application of the freedoms for products falling under the directive. Thus, Member States could pass stricter measures than foreseen under the directive, but these measures would need to comply with the fundamental freedoms and might eventually be set aside if in breach of the fundamental freedoms. A more indirect approach would have a clause inserted in the European legislative act, stating that Member States must take all necessary measures to ensure that only compliant products may be placed on the market.Footnote 39 This, it is submitted, can only mean that products that do not conform to the (environmental, safety, etc) standards set by the directive are not allowed on the market. It thus states the obvious for a binding legal act such as a directive, and if such a clause is missing, it doesn’t follow that either stricter standards are permitted or that Member States can allow products that do not conform to a directive’s rules. Equally, the mere inclusion of a clause providing for the free movement of goods complying with a directive cannot be taken to imply that Member States may pass more stringent measures.Footnote 40
The new Tobacco Products Directive 2014/40/EU, being the successor to the legal acts enticing some of the leading cases in this field (see Section III.B below), now provides for full harmonisation in its Article 24(1):
Member States may not, for considerations relating to aspects regulated by this Directive, and subject to paragraphs 2 and 3 of this Article, prohibit or restrict the placing on the market of tobacco or related products which comply with this Directive.
This is qualified by paragraph 2 reserving Member States the right ‘to maintain or introduce further requirements, applicable to all products placed on its market, in relation to the standardisation of the packaging of tobacco products ...’, and by paragraph 3 allowing them to prohibit a certain category of tobacco or related products, as already mentioned above. Article 24(1) thus prohibits national measures diverging from the Directive unless they are allowed under paragraphs 2 and 3. For products falling under these paragraphs, there is no market access and Member States with reinforcements may prohibit the placing on the market of products (from other Member States) that ‘merely’ comply with the Directive but not with these stricter measures.Footnote 41
B. Legality
Whereas the legality of ‘minimum’ harmonisation in general is not disputed, it has been unclear whether its legality is subject to the existence of a market access clause.
In Tobacco Advertising I, regarding the legality of Directive 98/43/EC, the Court criticised the absence of a free movement or market access clause in that Directive.Footnote 42 When it upheld the validity of the subsequently amended Directive, it pointed to the existence of such a provision.Footnote 43 It is more likely however, that in both cases the scope of the measures concerned was key to the Court’s judgments.Footnote 44 Also in the BAT case on the legality of the ‘old’ Tobacco Products Directive 2001/37/EC, the Court referred to the existence of a free movement clause only as a final argument and to confirm that ‘the Directive is fully effective in terms of its pursued aim of improving conditions for the functioning of the internal market’.Footnote 45 With its validity pending before the European Court of Justice, Directive 2014/40/EU is likely to prolong the tradition of tobacco regulation being a testing ground for the boundaries of harmonisation.Footnote 46
In a series of judgments on directives preceding the abovementioned Consumer Rights Directive 2011/83/EU, which were all based on Article 114 TFEU, the Court did not discuss the lack of a market access clause. These judgments are seen to confirm that at least under Article 114 TFEU the existence of such a clause is not crucial.Footnote 47 Then, however, the judgement in Laval again caused some uncertainty.Footnote 48 The minimum harmonisation clause in Article 3(7) of Directive 96/71/EC was interpreted by the Court so that for certain matters, Member States may not exceed the standards set in Article 3(1) of the Directive. Article 3(7) was thus made redundant by a judicial fiat. It is however suggested that Laval is a special case since the Directive primarily determined which national law should be applicable to posted workers.Footnote 49
Two different views can be taken on the legality of minimum harmonisation: on the one hand, full harmonisation, one could argue, is the rule provided in the Treaty for the core of the internal market. The Treaty does not allow for the ‘gold plating’ that is the hallmark of minimum harmonisation. Quite clearly, allowing Member States to provide for stricter measures means perpetuating regulatory divergences in the internal market and, thus, runs counter to the Treaty objectives. On the other hand, one could point to Article 114(4) and (5) TFEU explicitly allowing such divergences, albeit under strict scrutiny. One could also point to Article 114(3) TFEU demanding a high level of protection for proposals on this basis concerning health, safety, environmental protection and consumer protection.
However, it is submitted that a more nuanced argument can be made beyond those two views if we draw analogies with the Court of Justice’s case law on national restrictions to the fundamental freedoms.Footnote 50 It is suggested that the more intrusive a European Union measure is for the functioning of the internal market, the more a European legislation is liable to affect market access, the harder it will be to justify permitting national stricter measures without allowing products from other Member States on the market.Footnote 51 Thus, we might argue that market access would have to play a role if the regulation of rules on the sale of products is highly disruptive to trade in the Union, as is the case with full bans of certain forms of advertising as was the case in Tobacco Advertising I and II. In such case, the above-mentioned cases on consumer law would only prove that the minimum harmonisation of (sales-related) rules must not go hand in hand with the granting of market access, unless it is potentially disruptive to intra-Community trade. In contrast, market access would generally have a greater role to play in genuine product regulation, such as on the regulation of ingredients or packaging of tobacco products, as in the BAT case.
Moreover, one might wonder whether social policy, environment and consumer policy stand apart, because they are shared competences. Also, the protection and improvement of human health mentioned in Article 6 TFEU is a mere supporting competence. It is possible to argue that if harmonisation based on Article 114 TFEU involves objectives of public health (provided that the conditions for invoking Article 114 TFEU are satisfied), then harmonisation must be more considerate of national souvereignty, as it would have to be in areas of shared competence. This argument however goes against the existence of market access clausesFootnote 52 with market/health-measures and would thus not support a consistent reading of the case law on tobacco regulation, which has made a point of the existence of such clauses in that field. Minimum harmonisation coupled with market access, after all, means ‘more harmonisation’ rather than less, as explained above.
C. Mutual recognition versus (minimum) harmonisation
Mutual recognition is a regulatory technique that is also a darling of European studies.Footnote 53 As catchy as it is as a concept, its contours are blurred in European Union law.Footnote 54 In positive terms, the ‘flexibility’ introduced under mutual recognition has been considered to be one of the principle’s main virtues.Footnote 55 But it is so flexible that there are several ways to understand its relation with harmonisation in general, and with minimum harmonisation specifically.
First, minimum harmonisation can be seen as a form of mutual recognition if minimum harmonisation is combined with a market access clause. In this case, the standard harmonised by EU law must be recognised by the Member State that is imposing stricter measures – albeit lawfully because this is allowed by the EU directive. Second, a more general way of framing the relation between harmonisation and mutual recognition is that, in order to be acceptable/legitimate, the latter requires some degree of harmonisation of standards.Footnote 56 If standards between Member States are comparable/equivalent, conversely, this then cannot be ignored when considering what legitimate regulatory controls may be applied in the host state.Footnote 57
It is plain that both harmonisation and mutual recognition entail a loss of regulatory autonomy for Member States.Footnote 58 With harmonisation, standards are imposed that are created by a norm-setting authority outside the Member State. With mutual recognition, standards set and administered by another Member State must be recognised by the Host Member State (provided they are substantially equivalent). Mostly, however, mutual recognition is seen as somewhat ‘inferior’ to harmonisation. Thus, it has been argued that mutual recognition is chosen when substantive harmonisation is not available.Footnote 59 Conversely but in the same vein, mutual recognition has been seen as an instrument of last resort when harmonisation has failed.Footnote 60 The underlying concern here seems to be the perceived limitations of mutual recognition and the assumption that the development of the internal market ultimately requires the intervention of the European legislator.Footnote 61 A slightly different way to come to the same conclusion is to argue that mutual recognition enables trade and, by doing so, creates a situation in which harmonisation is ‘politically necessary and possible’, whereby successful mutual recognition gradually leads to harmonisation.Footnote 62 I have argued elsewhere that this may be true for the goods market (even though the evidence seems patchy), but that it is not a convincing story for services, where harmonisation often is not politically viable.Footnote 63
European secondary law however also shows that mutual recognition and harmonisation can work hand in hand without any antagonistic element. Article 126 of the Medicinal Products Directive 2001/83/EC fully harmonises the reasons for refusing the marketing of pharmaceuticals:Footnote 64
An authorization to market a medicinal product shall not be refused, suspended or revoked except on the grounds set out in this Directive. No decision concerning suspension of manufacture or of importation of medicinal products coming from third countries, prohibition of supply or withdrawal from the market of a medicinal product may be taken except on the grounds set out in Articles 117 and 118.
This full harmonisation approach is coupled with Chapter 4 of the Directive titled ‘Mutual recognition procedure and decentralised procedure’. Pursuant to Article 28 of the Directive, in order to gain a marketing authorisation for a medicinal product in more than one Member State, an applicant must submit an application based on an identical dossier in his/her chosen Member States, including a list of Member States concerned with the application. One Member State then acts as a ‘reference Member State’. Alternatively, where the medicinal product has already received a marketing authorisation at the time of application, the concerned Member States must recognise the marketing authorisation granted by the reference Member State.Footnote 65 The quintessentially centralised regulatory model of harmonisation on standards is thus combined with a decentralised approach of mutual recognition on procedures.
IV. CONSTITUTIONAL MINIMUM HARMONISATION
A. Introduction
In the areas of health, environment and consumer protection, the Treaty prohibits full harmonisation, which also cannot be achieved by resorting to Article 114 TFEU. While the Treaty prescribes a high standard of protection, it therefore does not require EU law to set the highest possible standard of protection – hence the reference to ‘constitutional’ (ie Treaty-based) minimum harmonisation.Footnote 66 Article 153(4) TFEU on social policy states that it ‘shall not prevent any Member State from maintaining or introducing more stringent protective measures compatible with the Treaties’. Article 169(4) TFEU on consumer policy and Article 193 TFEU on environmental policy ‘shall not prevent any Member State from maintaining or introducing more stringent protective measures. Such measures must be compatible with the Treaties. The Commission shall be notified of them.’ Regarding health policy, there is no general requirement of minimum harmonisation. However, Article 168(4)(a) TFEU on measures setting high standards of quality and safety of organs and substances of human origin provides that ‘these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures’. The Blood Directive 2002/98/EC, one of the legal acts applying this legal basis, repeats this limitation.Footnote 67
Hence, full harmonisation is constitutionally ruled out for measures passed under those legal bases. Could a market access clause apply to a European measure in those areas? In the Blood Directive 2002/98/EC, for example, a market access clause would mean that stricter national standards would not apply to blood imported from other Member States. It arguably is doubtful whether that would be compatible with the telos of Article 168 TFEU.
Another question in this context is whether constitutional minimum harmonisation could somehow ‘trump’ legislative full harmonisation. This was argued by France in defence of its national monopoly for the marketing of plasma in Octapharma.Footnote 68 Plasma fell under both the Blood Directive 2002/98/EC – adopted on the basis of Article 168(4)(a) TFEU, thereby requiring minimum harmonisation only – and under the Medicinal Products Directive 2001/83/EC, which anticipates full harmonisation as discussed above (Section III.C). France argued that constitutional minimum harmonisation represented by the Blood Directive 2002/98/EC should take priority over the European legislator’s decision to require full harmonisation in the area of medicinal products. The Court in Octapharma however did not have to decide this issue, as both Directives quite clearly regulate their relationship to each other regarding the relevant plasma. In the Octapharma case, the plasma was held to fall under the Blood Directive ‘solely with respect to its collection and testing’.Footnote 69
B. Standard of review for reinforcements
Member States can have the right to take more stringent measures either on the basis of Treaty provisions (constitutional minimum harmonisation) or by European legislative choice (minimum harmonisation). One may think that the standard of scrutiny of those more stringent measures would be the same in either situation: Member States must provide a valid reason or justification for their restriction(s) to the fundamental freedoms, and they must comply with the principle of proportionality. However, the current case law suggests otherwise.
The Borsana case dealt with Directive 90/394/EEC on the protection of workers from the risks related to exposure to carcinogens at work, based on (now) Article 153 TFEU for social policy (formerly Article 118a EEC).Footnote 70 In line with (now) Article 153 TFEU, the Directive allowed for more stringent measures to be taken by Member States.Footnote 71 An Italian law obliged employers to reduce workers’ exposure to carcinogens irrespective of the assessment of risk and thus constituted a more stringent measure for the protection of working conditions. The Court held that the Italian legislation was confined to reinforcing the obligation of protection laid down in Article 5 of Directive 90/394 and that it therefore would not ‘undermine the coherence of Community action in the area of workers’ health and safety’.Footnote 72 Moreover, it would apply in a non-discriminatory manner and would not hinder the exercise of the fundamental freedoms guaranteed by the Treaty. The Court concluded its examination as follows:Footnote 73
Since the legislation at issue is a more stringent measure for the protection of working conditions compatible with the Treaty and results from the exercise by a Member State of the powers it has retained pursuant to Article 118a(3) of the Treaty, it is not for the Court to rule on whether such legislation and the penalties imposed therein are compatible with the principle of proportionality.
This deference to the national legislator is put in even clearer terms in the case Deponiezweckverband.Footnote 74 It concerned the Waste Directive 1999/31/EC based on (now) Article 193 TFEU (formerly Article 176 EC).Footnote 75 Under Article 5(1) of the Directive, Member States were to set up national strategies in order to reduce the amount of biodegradable waste going to landfills by certain percentages before certain fixed dates. This was a case where the minimum harmonising nature of the measure was found by interpretation. The Court held that the ‘wording and broad logic of those [Directive] provisions make it clearly apparent that they set a minimum reduction to be achieved by the Member States and they do not preclude the adopting by the latter of more stringent measures’.Footnote 76 While these stricter measures would have to be compatible with the Treaty, it would fall to the Member States to define the extent of the reduction of biodegradable waste going to landfills. The Court in two sentences only then excludes the application of the proportionality principle:Footnote 77
In that context, in so far as it is a matter of ensuring that the minimum requirements laid down by the Directive are enforced, the Community principle of proportionality demands that measures of domestic law should be appropriate and necessary in relation to the objectives pursued.
In contrast, and inasmuch as other provisions of the Treaty are not involved, that principle is no longer applicable so far as concerns more stringent protective measures of domestic law adopted by virtue of Article 176 EC and going beyond the minimum requirements laid down by the Directive.
It is not that proportionality would otherwise play a prominent role in policing the exercise of Union competence by the EU legislator.Footnote 78 This statement, curt as it is, is nonetheless striking. As is visible from the quote above, the Court does not explain why proportionality is not relevant in the scrutiny of national measures taken on the basis of constitutional minimum harmonisation, when proportionality applies in the scrutiny of national measures adopted under legislative minimum harmonisation.Footnote 79 This would suggest that legislative minimum harmonisation and constitutional minimum harmonisation are two different animals, with the former conferring less legitimacy to the national legislator when it passes stricter measures than those required under EU law. That the proportionality principle did not apply in Deponiezweckverband is also striking because the Court is less benevolent towards the Member States regarding ‘sovereignty clauses’ in other areas such as in Articles 166 and 167 TFEU on national education systems. Those Articles would seem much better suited to show deference to the national legislator, but so far have not served that pupose at all.Footnote 80
C. (Minimum) harmonisation and pre-emption
If a directive provides for full harmonisation, Member States are fully pre-empted from passing (conflicting) laws and regulations, whereas there is no such pre-emption with either partial or minimum harmonisation.Footnote 81 It has been argued that, in the case of full harmonisation, pre-emption would already have been triggered by the Commission proposal for a legislative act.Footnote 82 It has also been submitted that the prohibition of frustration pursuant to the Inter-Environnement Wallonie case law should generally set in with the entry into force of a directive because there would be no situations imaginable where national measures after that point would not jeopardise the attainment of the directive’s objective.Footnote 83 Both positions seem too far-reaching. The Commission proposal would have a pre-emption effect only under very narrow circumstances, and the Court has carefully subjected the prohibition of frustration to precise conditions in Inter-Environnement Wallonie and Adenlener.Footnote 84
The implications of the passing of a directive on the rights of Member States to enter into international agreements with third states, in contrast, are a somewhat different matter. While the ERTA doctrine is based on the correspondence between the scope of the ‘common rule’ and the envisaged international agreement, there is no such strict correlation between the scope of a directive and the extent to which Member States are pre-empted in the external sphere under other grounds for establishing external competences.Footnote 85 This is because the Court has ruled that Member States are also prohibited from acting when Union exclusive competence is necessary to exercise its internal competence, or when the EU has largely (but not exhaustively) regulated an area.Footnote 86
What happens if we add minimum harmonisation to this equation? In Opinion 2/91, the Court had to decide whether the Union had exclusive competence to conclude Convention No 170 of the International Labour Organization (ILO) concerning safety in the use of chemicals at work.Footnote 87 Community competence in general terms was conferred in (now) Article 153 TFEU (formerly Article 118a EEC), which provides for constitutional minimum harmonisation. However the ILO Convention equally allowed its Members to adopt more stringent measures.Footnote 88 The Court held that the provisions of Convention No 170 could not affect rules adopted under (formerly) Article 118a EEC (now Article 153 TFEU).Footnote 89 Notably, this statement is not yet about ERTA; the ERTA principle concerns an international agreement to be concluded on the one hand and Union measures on the other hand. Put shortly, if the former might affect the latter, Union competence is exclusive.
In Opinion 2/91, the Court goes on to distinguish between two situations.Footnote 90 Firstly, when the Union adopts less stringent rules than those in a convention, then Member States can adopt more stringent measures then those provided in EU secondary law, by applying the (stricter measures of) the international agreement. Secondly, if the Union passes more stringent measures than those of the (minimum standard setting) international agreement, that agreement does not prevent the full application of the more stringent Union measures by the Member States. It could be added that in the second case, neither the agreement nor the Union measures would bar Member States to regulate even stricter measures than foreseen by both acts. Thus, the ERTA pre-emption principle does not apply if both the international agreement and the provisions of Union law provide minimum standards.Footnote 91 Opinion 2/91 however still concluded by acknowledging the exclusive competence of the EU on the basis that a number of directives in that field were fully harmonising and, while not correlating entirely with the scope of the Convention, covered the area to a large extent.Footnote 92
V. PROCEDURAL VARIANTS
A wide range of instruments are available to the European legislature for exercising control over Member States within the scope of directives.
Article 114 TFEU is not only unique in substantive terms as discussed above; it is also exceptional in the force of its procedural prescriptions. In a measure providing for full harmonisation, the validity of national derogations is subject to the notification duties in Article 114(4) and (5) TFEU.Footnote 93 This stands in conspicuous contrast to the notification obligations provided in the Treaty rules providing constitutional minimum harmonisation, such as in the area of consumer policy or environmental policy. In those areas, the failure to notify the Commission of stricter measures does not have any explicit implications for the Member State concerned.
There is however a middle ground between the maximum approach to policing Member States in Article 114 TFEU and the minimum approach chosen, eg in Article 153 TFEU. The best known example is the Technical Standards and Regulations Directive 98/34/EC based on Article 114 TFEU.Footnote 94 Its Article 9(3) requires Member States to postpone the adoption of a draft technical regulation for 12 months from the date of receipt by the Commission of the notification, if either the Commission announces its intention to propose or adopt a measure, or announces its finding that the draft technical regulation concerns a matter which is already covered by secondary law. The Commission must make this declaration within three months of the notification. Paragraph 5 explicity calls this a ‘standstill period’ and extends it to 18 months if the Council adopts a common position during that time. This strict regime has been given even more bite by the Court, which gave direct effect to that standstill obligation.Footnote 95
One step down the ladder, the Services Directive 2006/123/EC provides a duty of notification for what it calls requirements under the principle of freedom of establishment as well as a right of examination for the Commission, without however any standstill obligation. Thus, Article 15(7) of the Services Directive provides that Member States shall notify the Commission of any new laws, regulations or administrative provisions falling under a list of supect requirements together with the reasons for those requirements. The Commission shall then communicate the provisions concerned to the other Member States. Such notification shall however not prevent Member States from adopting the provisions in question. Within a period of three months from the date of receipt of the notification, the Commission shall examine the compatibility of any new requirements with Union law and, where appropriate, shall adopt a decision requesting the Member State in question to refrain from adopting them or to abolish them.
The latest addition to the arsensal of control instruments provided in secondary law is a tacit approval regime in Article 24(3) of Tobacco Products Directive 2014/40/EU. According to this, a Member State may prohibit a certain category of tobacco or related products. Such prohibition must be notified to the Commission together with the grounds for introducing them. The Commission then must, within six months of the date of receiving the notification, approve or reject the national provisions. In the absence of a Commission decision within this period, the ‘national provisions shall be deemed to be approved’.Footnote 96 Thus, in contrast to the above-mentioned legal acts, the new Tobacco Products Directive establishes a quite distinct supervision mechanism paired with a minimum harmonisation approach.
VI. FINAL REMARKS
In this piece I have aimed to show that when we talk about harmonisation, we may mean quite different things. This is true for the use of the concept within the EU and the WTO, but also for the variety of terms available within the EU law discourse. This article has argued for a distinction between full and partial harmonisation in scope, and between full and minimum harmonisation in standards reflecting the necessary distinction between the scope and the intensity of harmonisation. I have also argued that there is a close yet often unclear relation between minimum harmonisation and mutual recognition on the one hand, and between full harmonisation and the country of origin principle on the other hand. As a result, classifying legal acts by reference to a particular approach to harmonisation becomes increasingly difficult. Thus, the Services Directive could be described as an instrument of targeted full harmonisation coupled with a general prohibition of restrictions and mutual recognition. The new Tobacco Products Directive, in contrast, could be seen as combining targeted minimum harmonisation with full harmonisation.
Fundamentally, there is always the search for a balance between market integration and respect for the Member States’ preferences. If minimum harmonisation is the safety valve for the regulatory autonomy of Member States, then as a counterbalance market access clauses in European legislation provide some harm reduction from the perspective of the functioning of the internal market. I have also suggested that the legal necessity of a market access clause is determined by the potential effect of the harmonised rules on intra-Community trade, which tends to be less with sales-related rules. While this cannot be deduced from case law with certainty, it would at least give a generally opaque case law a semblance of inner logic. There is less logic, in contrast, in the nearly complete deference to the national legislator when constitutional minimum harmonisation applies.
It is striking that what is the butter and bread of market integration in the EU continues to be shrouded in ambiguity in so many different ways. It is less surprising that tobacco regulation may again be the testing ground for further elucidation of these matters.
