Opinion of the Advocate General — ECLI:EU:C:2004:487
Date: 2004-09-07
Language of the case: German
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: External relations;Provisions governing the Institutions;Free movement of goods;Measures having equivalent effect;Commercial policy;Consumer protection;Approximation of laws;Quantitative restrictions;Acts of the institutions
Procedure: Reference for a preliminary ruling
Origin: Germany;United Kingdom

summary, it is the primary goal of the internal market provisions of the EC Treaty that one single market appear, that is not fragmented by divergent national rules. This goal does not have as a consequence that all possible products can be sold on that market, even if they harm the health of users. A provision that expressly forbids the marketing of a certain product might not contribute to the elimination of obstacles concerning that specific product but can nevertheless contribute to the establishment and functioning of the internal market for the purposes of Article 95 EC. E – Evaluation of the legality of Article 8 81. There is doubt as to whether Article 8 of the 2001 Directive must really be regarded as a total ban on a certain category of products, as was the case under the Directive on firearms, or whether the ban in Article 8 is comparable to a restriction on the composition of products, like Article 3 of the 2001 Directive. 82. Article 8 does not forbid the marketing of tobacco products in general. The ban only concerns tobacco products if they are intended to be used in a certain manner. Its scope does not differ substantially from that of a ban on products with a certain composition. On the other hand, one could defend the thesis that it forbids the marketing of a certain category of tobacco products which have a market that might well be distinguished from the market in other tobacco products (leaving aside the ‘substitution effect’, discussed elsewhere in this Opinion). 83. It is not necessary to develop the arguments put forward in the preceding paragraph. As stated above, the Community legislature is entitled to prohibit certain categories of products under Article 95 EC. Since the 2001 Directive bans only a specific, limited category of products – which differ from other permitted products not by virtue of their composition but by the way they are used – it is beyond doubt that Article 95 EC can serve as a legal basis. IX – How Community competence is used: the requirement of Article 95(3) EC and the principle of proportionality A – Introductory remarks 84. As stated above, the Community legislature may use its competence under Article 95 EC if obstacles (or at least seriously imminent obstacles) to free movement exist and the Community measure contributes to the elimination of these obstacles. The Community legislature has a broad discretion. However this discretion is not unlimited. In this section I will assess the limits on the Community legislature when it exercises this competence. 85. Firstly, Article 152(1) EC requires a high level of human health protection in the definition of all Community policies. Article 95(3) EC is even more specific when it comes to the use of the legislative power under Article 95 EC and refers to new developments based on scientific facts. Whereas the action of a national government which restricts the marketing of products in accordance with Articles 28 EC and 30 EC must be justified by imperative requirements in the general interest, the action of the Community legislature must ensure a high level of protection. As I stated in my Opinion in Case C‑491/01, (25) if an obstacle to free movement exists the protection of public health is dealt with by the Community legislature. Seen from the perspective of health protection, its action does not differ from the action of a national government that restricts the marketing of products in accordance with Articles 28 EC and 30 EC. 86. Secondly, the proportionality principle must be observed. According to Article 5 EC Community action is not to go beyond what is necessary, given the objectives pursued. If the main objective of a Community measure is the protection of public health – as under Article 8 of the 2001 Directive – the assessment of the proportionality principle does not differ from the assessment of a measure taken by a Member State aiming to protect public health in accordance with Articles 28 EC and 30 EC. It has to be determined whether the measure is appropriate to protect public health and whether the same result could not be reached by using less restrictive measures. 87. Thirdly, the Community legislature has to respect other principles of law that have been developed by the case-law of the Court or are mentioned in the Treaty, such as the principles that due care must be taken and legitimate expectations taken into account, and the duty to give reasons. As I stated in the introduction of this Opinion, I will not go into these principles of law, make an exception for the duty to give reasons (see below). B – A high level of human health protection 1. The particular nature of the case 88. The present cases are particular. It is beyond any doubt that the Community legislature, by banning snus, envisages a high level of health protection. However, it is uncertain whether the measure is appropriate to achieve this policy goal and it is even conceivable that the policy goal would have been better served if the Community legislature had allowed the marketing of snus. 89. The central issue in these cases is that Article 8 of the 2001 Directive bans a new product which is not yet marketed in the Member States, except for Sweden. The documents before the Court justify the assertion that the use of snus can cause oral cancer. Nevertheless this assertion alone does not justify the prohibition of snus. My second assertion is that the harmful effects of using snus are far less than the dangers caused by smoking. Last but not least, it is uncertain whether the main effect of providing snus on the market will be to encourage people to give up smoking (‘substitution effect’) or to make it easier to start using tobacco (‘stepping‑stone’). (26) 90. I will now discuss one by one the reference in Article 95(3) EC to new developments based on scientific facts, the precautionary principle in the absence of consensus on the effectiveness of a measure to benefit public health and the principle that preventive action should be taken. 2. Remarks on the evidence 91. In the course of these proceedings before the Court a great deal of attention has been paid to the (scientific) evidence underlying the ban on snus. 92. Firstly, interesting legal arguments have been put forward by the claimants (and the Swedish Government) about the relevance of new scientific evidence. They state that the Community legislature is obliged to take into account scientific developments. The principle of proportionality involves a duty to review over time whether or not a measure has become disproportionate. (27) The applicants refer to Article 95(3) EC and also to the case-law of the Court. 93. In particular they mention the Community measures in the veterinary and zootechnical area, for example the measures taken to combat BSE, at issue in Case C‑180/96 United Kingdom v Commission. (28) In that case it was acknowledged that measures to be taken should be subjected to detailed scientific study and that new information should be taken into account. On the one hand, I agree with the claimants in so far as they state that legislation has to be reviewed when new scientific data raise doubts as to the benefits of that legislation. Continuous review is an obligation for every legislature. This obligation becomes even more important when a specific measure is included in a Community regulation or directive which is being amended because of new developments in the relevant area. In short, in the event of a fundamental amendment to the legislation on the use of tobacco products, all the measures related to the different tobacco products have to be reconsidered. 94. On the other hand, I do not agree that in the present case a review would necessarily have led to an amendment to the Community legislation on snus. The scientific reports presented to the Court show ‑ as I stated in point 47 of this Opinion ‑ the harmful effects of using snus and, contrary to what seems to be suggested by the claimants, do not express a fundamentally new point of view on the health risks. I would emphasise that it follows from the case-law of the Court on Article 30 EC that public health measures restricting the free movement of goods can be taken, even in the absence of scientific consensus. I would mention the judgments of the Court in De Peijper and NationalFarmers Union and Others. (29) In short, Community law recognises restrictive measures aiming to protect public health if they are based on proper and recent scientific studies. As a result of these studies unanimous scientific evidence on the health risks is not needed. Serious indications are sufficient. 95. Secondly, the evidence of the effectiveness of Article 8 itself. It is not scientifically proven that snus constitutes mainly a stepping‑stone to tobacco use rather than a substitute for smoking. In fact, the lack of evidence and the scientific uncertainty do not concern the banned substance itself, but expectations about people’s behaviour. The question to be answered is whether in these circumstances the ban on snus can be regarded as an effective measure to protect public health. It is precisely for this reason that I take into consideration the precautionary principle and the principle that preventive action should be taken. 3. The precautionary principle 96. As I emphasised above, the effectiveness of the ban on snus as a measure to protect public health is uncertain. I will discuss whether in such circumstances the Community legislature is obliged to abstain from action or whether it can base its action on the precautionary principle. 97. The precautionary principle is not defined in the Treaty, which refers to it only once, in relation to the Community policy on environmental protection in Article 174 EC. But the principle applies to much more than protecting the environment. On 2 February 2000, the Commission published a communication on the precautionary principle. (30) In this communication, the Commission considers that the precautionary principle is a general one which should in particular be taken into consideration in the fields of environmental protection and human, animal and plant health. According to the Commission, the precautionary principle comes into play only when a potential risk has been identified, it has been scientifically studied, and the results of scientific inquiries are mixed or inconclusive. 98. The precautionary principle mainly confers on the Community legislature broader, but not unlimited, discretion. When the legislature intends to use this extended discretion it is subject to a heavy burden of proof to make sure that the alleged risk is not merely hypothetical. 99. The Court has had several opportunities to review the application of the precautionary principle in cases concerning health issues and the free movement of goods. In Case C‑236/01 Monsanto AgricolturaItalia, (31) the dispute concerned Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, (32) in particular Article 12 thereof. In Cases C‑192/01 Commission v Denmark, C‑24/00 Commission v France and C‑95/01 Greenham and Abel, (33) the Court had to look at different national laws restricting additives in foodstuffs, like vitamins and minerals. 100. A proper application of the precautionary principle presupposes in the first place the identification of the potentially negative consequences for health of a specific situation and in the second place a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research. (34) In other words, the existence of a health risk must be plausible. (35) According to the Court, ‘[w]here it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures’ (36) According to that judgment, the key element of the precautionary principle is scientific uncertainty. Measures can be taken when the desired level of protection for the environment or health is jeopardised. 101. In general the precautionary principle plays a role if government wants to regulate risk. The Declaration of Rio de Janeiro in the framework of the World Summit on Sustainable Development stated that the principle applies where there are threats of serious or irreversible damage but where there is scientific uncertainty over those threats. The fact that there is no evidence of harm should not be equated with no harm. (37) 102. It is uncertain whether the competence under the precautionary principle to regulate risk can be used in order to ban all risk. The Court of First Instance states in Case T‑13/99 Pfizer Animal Health v Council (38) that a Community measure under the precautionary principle may, on the one hand, not be based on a ‘zero-risk’-approach. On the other hand, the Community institutions must take account of their obligation under the first subparagraph of Article 152(1) EC to ensure a high level of human health protection. 103. It is in my view beyond doubt that the Community legislature can base its action on the precautionary principle if three cumulative conditions are fulfilled. There must be scientific uncertainty about the risk, the risk must be analysed and proved to be realistic and the risk must have substantial consequences for the public interest. When it comes to the substance of a measure, a measure relying on the precautionary principle may not go as far as banning all risk. 104. This brings me to the present cases. The claimants state that the precautionary principle does not apply. They refer to certain principles put forward by the Court of First Instance in Pfizer Animal Health v Council (39) that serve to ensure that the precautionary principle is not used in an arbitrary way. Moreover the precautionary principle would only be relevant in cases where scientific uncertainty exists about the effect of certain substances or behaviour. It is invoked where an analysis of all the available scientific data has been carried out, but uncertainty still remains. 105. The claimants deny the existence of any uncertainty about the health risks of snus. They emphasise that snus is not a new product, but a product that has traditionally been marketed in some Nordic countries. So, the health risks are known. I agree with these remarks by the claimants: the precautionary principle is not relevant in relation to the effects of snus itself, a traditional product in some Nordic countries. Although the scientific reports presented to the Court are not unanimous in their evaluation of the risks of using snus, as might be clear from my earlier remarks, there is no scientific uncertainty in the sense mentioned above. The Court can accordingly base its assessment on the assumption that the use of snus can provoke oral cancer. 106. However, the effect of marketing snus throughout the whole Community on the behaviour of – mainly young – people is highly uncertain. Here we come to the impact of the observations made above: the uncertainty of the effectiveness of the ban, whether the prohibition on marketing snus will stop smokers giving up smoking or dissuade young non-smokers from starting to use tobacco. 107. In my opinion the precautionary principle cannot be applied in these circumstances: – The uncertainty about the risk that justifies the prohibition depends on expectations about the use of snus. This is not a risk of a scientific nature that justifies the application of the precautionary principle. The source of the uncertainty has nothing to do with the precautionary principle. – As to the burden of proof, the damage to public health if snus appears on the market is not plausible. I would mention the substitution effect. (40). The Community legislature was not in a situation in which it could base its measures on the likelihood of real harm to public health, (41) without having unequivocal scientific evidence at its disposal. – However, the third condition mentioned in point 103 above is fulfilled: the risk, if it occurs, has substantial consequences for public health. 4. Preventive action 108. Title XIX of the EC Treaty on Environment also mentions the principle that preventive action should be taken. This principle as laid down in Article 174(2) EC has also been recognised in relation to the protection of human health, more specifically in the case‑law on BSE. (42) The principle is usually mentioned in connection with the precautionary principle. For instance, in the case-law on BSE the Court does not attribute a separate role to the principle that preventive action should be taken. 109. In my opinion the principle plays a major role in the present cases. The Community legislature, faced with the potential health risks of the marketing of snus, does not have to wait until the ‘stepping‑stone’ theory has been proved to be true. It can act in a preventive manner. Moreover, let us consider the situation if the Community had not been allowed to act preventively. Snus would have appeared on the market and people would have started using it. After some years it might have become clear that snus was frequently used by young people who had not smoked before (and for whom the threshold to smoking had disappeared or diminished). It would have been the responsibility of the Community legislature to get rid of a product that had become attractive and addictive to consumers. It is questionable whether such a measure would have been as effective as a ban on a product that had not yet found its way to consumers. I would mention the risk of an emerging illegal market. In addition, a ban on a product that is already marketed can damage the legitimate expectations of the producer, and may lead to the payment of compensation and/or transitional measures. 110. In short, preventive action is needed because allowing snus onto the market could have irreversible effects. If governments allowed the marketing and promotion of snus for a certain period, an effective ban on snus would no longer be feasible. C – The proportionality principle 1. In general 111. In its judgment in Case C‑491/01 the Court deals with the principle of proportionality in relation to the 2001 Directive, bearing in mind the importance of adequate protection of public health by the Community legislature. I would refer to the extensive considerations of the Court. I mention here the crucial elements, specifically related to this case: – the measures should be appropriate for attaining the objective pursued, that is, protecting public health by making the use of tobacco products less attractive; – the Community legislature enjoys a broad discretion, which entails political, economic and social choices. The legality of a measure can only be affected if the measure is manifestly inappropriate, having regard to the objective pursued (see paragraph 123 of the judgment); – even some far-reaching measures like the ban on the manufacture of cigarettes containing certain yields and the prohibition of existing, but presumably misleading, statements are considered to be in conformity with the principle of proportionality. 112. It follows from these considerations of the Court that a Community provision on the use of tobacco, aiming to protect public health, will not easily be annulled because it does not comply with the principle of proportionality. As we know, the principle of proportionality is not to be confused with a comparative assessment of the protection of public health and the commercial interests of private companies. The ban on snus complies with the proportionality principle if: – the measure banning this product from the market is appropriate to remove or at least diminish the threat to public health; – a less restrictive measure would not guarantee the same level of health protection. 113. At the end of this section I will address an issue raised by the claimants, namely whether the measure imposes a disproportionate financial burden on specific undertakings. 2. Appropriateness: the competence to regulate when the benefits are uncertain 114. The uncertainty about the benefits of the ban to public health can be compared with the uncertainty that was dealt with by the Community legislature when opting for a ban on preventive vaccination in the fight against foot-and-mouth disease. In Case C‑189/01 Jippes, (43) the Court stated: – firstly, ‘[w]here the Community legislature is obliged to assess the future effects of rules to be adopted and those effects cannot be accurately foreseen, its assessment is open to criticism only if it appears manifestly incorrect in the light of the information available to it at the time of the adoption of the rules in question’; – secondly, the Community legislature ‘carried out a global assessment of the advantages and drawbacks of the system to be established and … that policy … was not on any view manifestly inappropriate in the light of the objective of controlling foot-and-mouth disease’; – thirdly, ‘[c]onsequently, having regard to the wide discretionary power conferred on the Council …, it must be concluded that the ban on preventive vaccination … does not exceed the limits of what is appropriate and necessary in order to attain the objective pursued by the Community rules.’ 115. The Court, in so holding, distinguishes three criteria. The legislature has a wide discretionary power; it must carry out a global assessment of the advantages and drawbacks of a planned system, but only in the case of a manifestly incorrect assessment may a Community measure be annulled. If we transpose these criteria to the present cases, it is obvious that the ban on snus must be considered to be appropriate. I would refer to my remarks on the principle that preventive action should be taken to show that the assessment by the Community legislature was not manifestly incorrect. Allowing snus onto the Community market would have irreversible effects. The precautionary principle is not relevant. 3. The effectiveness of less restrictive measures 116. The claimants have outlined a set of measures of a less restrictive nature. They refer to the imposition of technical standards, such as those in Canada or those based on the principles used by Swedish Match itself. Further, they mention labelling requirements, the possibility of introducing an age‑limit and restrictions on retail outlets. 117. Given the policy goal of the ban – as explained in the preamble to the 1992 Directive – alternative measures could not be as effective as a total ban. Since the objective of the Community legislature is to prevent the introduction of new products onto the market, it is evident that this goal cannot be reached by measures less restrictive than a total ban. 118. I would emphasise that technical standards can limit the harmful effects of the use of certain products, but do not eliminate those effects completely unless all the dangerous substances have to be removed from the product, including the nicotine which makes the product attractive to the user. There is no indication that such a far‑reaching technical standard – which is not proposed by the claimants in the present cases – would be less restrictive on trade than the ban provided for under Community law as it stands. 119. The other alternatives mentioned above do not have the same effect as a ban. Since snus is considered to be an attractive product to young people, its mere availability on the market can incite them to use it. One could even take the view that legal restrictions like labelling provisions and age‑limits might make snus even more attractive. 4. The disproportionate charge on specific undertakings 120. My last point concerns the disproportionality of the charge on the manufacturers and sellers of snus. This point has been raised by the claimants in the present cases. As I stated before the ban on snus is a measure that can be taken under Article 95 EC and that – in itself – is in accordance with the proportionality principle. Nevertheless this does not exclude an obligation for the European Community to make good the damage caused by this act, according to the provision on non-contractual liability in the second paragraph of Article 288 EC. 121. However, this obligation arises only if there is substantial damage and/or if legitimate expectations have been harmed. I can be brief on these points. Snus is not yet placed on the Community market (except in Sweden) and the producers of snus could not have had the legitimate expectation that they would be allowed to manufacture and sell snus on the Community market. The ban on snus was already imposed under the 1992 Directive (before the accession of Sweden to the European Union). X – The principle of equal treatment 122. The principle of equal treatment is presented in these cases as a principle that should not be confused with that of proportionality, although in the circumstances the effect of their application is fairly similar. The ban on snus is regarded as disproportionate precisely because other equally or even more harmful products are tolerated on the market. 123. Nevertheless, the many observations made to the Court on this principle require a separate assessment. The principle of equal treatment mainly requires that comparable situations are not treated differently and that different situations are not treated in the same way unless such treatment is objectively justified. (44) 124. One could argue that this principle constitutes an essential limit to the discretionary powers of the Community legislature, more specifically in relation to measures aiming to restrict or even ban the marketing of specific products. If one pursues this argument even further it requires an assessment of the risks of marketing all other comparable products before adopting a Community measure. 125. I do not agree with the idea that the principle of equal treatment has such far‑reaching consequences. If, for example, on a certain market – let us limit ourselves to a well-defined market such as that for tobacco products – five different products create serious health risks, it is for the legislature in its discretion to decide which of these products – and in which order – should be banned from the market or subject to other restrictive measures. The only limit imposed on the legislature in this respect is that it may not make arbitrary choices. It has to give reasons why a specific product is the object of strict rules. Part of this reasoning could be a comparison with other products on the market. 126. This brings me to the two main objections put forward by the claimants, related to the principle of equal treatment. The first objection is that equivalent products are not prohibited. According to them chewing tobacco is not prohibited although in practice it is used in the same way as snus: although it is normally called ‘chewing tobacco’ the tobacco is quite often not chewed but sucked. 127. At this point the claimants could be right. The difference between the two products is not evident, although there might a slight difference in substance as regards the levels of nitrosamines and nicotine. (45) Even if the claimants’ statement about the use of chewing tobacco does not reflect reality, the health effects of the way it is used are comparable: as far as the harmful effects of using smokeless tobacco products are concerned, it does not make a fundamental difference whether they are sucked or chewed. But, this being said, the similarity of the products does not lead to a breach of the principle of equal treatment. After all, the difference in treatment is not based on the effect on the individual user, but on the difference in (potential) user groups. Whereas chewing tobacco is attractive mainly to well-defined socio-professional groups, snus is meant to be attractive to a broad range of users, as in Sweden. In short, the difference in treatment is not justified by the inherent characteristics of the products themselves but by the persons who (potentially) use them. 128. The second objection concerns the fact that contrary to the explanation of the Community legislature the product is not new, but is a traditional product, at least in some Nordic countries. The claimants use the term ‘new’ differently from the Community legislature and the other parties intervening before the Court. The claimants use the word in relation to the product as such, whereas the others use it in relation to the relevant market. 129. I accept that when the Community legislature referred to new products in the preamble to the 1992 Directive it did not make any reference to the internal market. However, it is obvious that it referred to products not yet available on the Community market and not to new products as such, since the 1992 Directive – like the current directive – deals only with the internal market in tobacco products, and does not concern products manufactured and available in third countries. More specifically, the term ‘new’ was used in the context of the policy objective to prevent young inhabitants of the European Union from starting to use tobacco products or – even worse – starting to use tobacco products which were not available to them before. Snus was not available to young people within the European Union. It was comparable to tobacco products frequently used in other continents, but not in Europe. 130. Since the Kingdom of Sweden was not yet a Member State when the 1992 Directive was adopted, the Community legislature could use the term ‘new’ in an unconditional way, because the products were not marketed at all within the territory of the European Community. Only later, when the Kingdom of Sweden acceded to the Community, did this context change. None the less, the difference remained, since snus is not prohibited in the only MemberState where it is traditionally used. 131. I conclude that neither of the two objections points to a breach of the principle of equal treatment. As stated above, the principle of equal treatment plays a role in so far as it requires the Community legislature to give reasons for the different treatment of comparable products. 132. It is beyond any doubt that valid reasoning was given by the Community legislature in the preamble to the 1992 Directive, cited in point 5 of this Opinion. In their submissions the Commission, the Council and the European Parliament give some additional explanations for the prohibition of snus. Firstly, they mention considerations based on the functioning of the internal market, since three Member States considered banning snus, or have already imposed such a ban. Secondly, they mention rapidly increasing trends in consumption. Thirdly, they substantiate the health risks and fourthly they mention the relatively small economic costs of a ban. 133. Given my considerations above Article 8 of the 2001 Directive satisfies the principle of equal treatment. XI – The duty to give reasons under Article 253 EC A – Change of context 134. The ban on tobacco for oral use was introduced under the 1992 Directive and was based on the considerations that it concerned products that were not yet known on the Community market and could be attractive to young people. Given my views expressed in this Opinion this reasoning could sustain the ban. However, when the ban was confirmed under the 2001 Directive, no substantive reasoning was given. The preamble simply refers to the ban that existed under the 1992 Directive. 135. According to the case-law of the Court the obligation to provide a statement of reasons is an essential formal requirement that must be distinguished from the question of the correctness of that statement, which concerns the substantive lawfulness of the contested act. The statement of reasons must be appropriate to the act at issue and must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted the measure in question in such a way as to enable the persons concerned to ascertain the reasons for the measure and to enable the Court to carry out its review. It is not necessary for the reasoning to go into all the relevant facts and points of law, since the question whether the statement of reasons meets the requirements of Article 253 EC must be assessed with regard not only to its wording but also to its context and to all the legal rules governing the matter in question. (46) 136. I would emphasise that the obligation under Article 253 EC is more than just a formality, as has been contended by the United Kingdom Government in the present cases. The Court must be able to review whether or not a decision can be justified by the reasons given. Moreover, more detailed reasons are required where a decision deviates from usual practice or where other circumstances require more detailed reasoning so as to make sure that the Court can carry out its review. 137. According to the case-law of the Court on Article 253 EC the requirements of this article must be assessed with regard not only to their wording but also to their context. To me it is evident that the reasoning should not only be seen in the context as it was when the provision was adopted but also pay attention to substantial changes of context. This requirement is even more important when the whole policy in a certain area is subject to review. However, in the present cases the Community legislature did not pay attention to the change of context. 138. In the present cases I would point out two substantial changes of context: – the Kingdom of Sweden acceded to the European Union; – the Community policy on tobacco products was fundamentally modified. B – The accession of Sweden 139. In the first place, the accession of Sweden involved the accession of a country where the use of snus is traditional and widespread. This being the case, the reasoning given in the preamble to the 1992 Directive, namely that the ban should not affect traditional tobacco products for oral use, needs further consideration. After all, the premiss of this reasoning was that snus is a product that should be regarded as a product without any tradition on the internal Community market. 140. However, I attach even more importance to the impact of the accession of Sweden on the internal market of tobacco products for oral use. The Community reacted to the consequences of the accession of Sweden by compartmentalising this market. The Swedish market is separated from the internal market for these products. Moreover, the Swedish authorities are obliged to take the steps necessary to prevent products that are lawful on the Swedish market, but banned from the market of the remainder of the European Community, from being exported to the latter market. 141. This choice of the legislature offends against the concept of the internal market, by allowing a compartmentalisation of this market. At this point I should stress the importance of the establishment and functioning of the internal market as an instrument of European integration. In the present cases such a compartmentalisation is even more significant since: – the 2001 Directive has precisely as its object the establishment and functioning of the internal market, by taking away impediments to the free movement of tobacco products. However, the exception for Sweden creates a new impediment; – this compartmentalisation is not limited to a transitional period. An exception for Sweden at the time of the accession made sense, since it might have been difficult for the Swedish Government to stop the use of snus at once. However, a temporal limitation of this effect on the internal market would have been more in accordance with the importance of the internal market. One of the normal consequences of accession to the European Union is the adaptation of legislation to European Union standards. 142. In short, the absence of any reasoning related to the accession of Sweden creates two gaps. In the first place, the Community legislature should have paid attention to the effect of the ban on tobacco products that are traditional in one MemberState. In the second place, it should have paid attention to the consequences of the accession for the establishment and functioning of the internal market for tobacco products. C – Modification of Community policy on tobacco products 143. This brings me to the fundamental modification of the Community policy on tobacco products. In general, the 2001 Directive is an expression of a tobacco policy that has become more and more restrictive as the years have gone by. As stated above, this policy is mainly an anti-smoking policy. 144. Nevertheless, contrary to the general trend in the policy on cigarettes, it seems that the policy on smokeless tobacco products (other than snus) has tended to become more flexible. I would recall the rules on the labelling of smokeless tobacco products other than snus. Packets need no longer carry the warning ‘Causes cancer’; it is sufficient if it is stated on packets that ‘This tobacco product can damage your health and is addictive.’ At the same time, the warnings appearing on packets of cigarettes have become much stricter, both in respect of their size and their substance. They include a warning such as ‘smoking kills’. 145. To summarise, the general tendency is to make legislation on tobacco products more restrictive. The legislature provides for an exception for a specific category of tobacco products (smokeless tobacco). It would have been logical if this exception had applied to all the products belonging to this category. However, the legislature did the opposite and confirmed the strictest measure of all in relation to a specific sub-group of products belonging to this category. 146. I would emphasise that under these circumstances the preservation of the ban on snus cannot be regarded as a mere continuation of existing policy. We should recall the Court’s case-law stating that a decision deviating from usual practice requires more detailed reasoning so as to make sure that the Court can carry out its review. Moreover, interested parties have a right to know on what grounds the Community legislature has decided to limit their freedom. D – The consequences 147. The more a decision deviates from normal practice, the more explicit must be the grounds stated by the Community legislature. Given the important changes of context, the choice of the legislature to maintain the ban on snus, which in itself does not exceed its discretion, requires solid reasoning. The absence of any reasoning constitutes a clear and manifest breach of the obligation of the Community under Article 253 EC. 148. I conclude furthermore that this absence of any reasoning taking into account the change of context must be considered to be an infringement of an essential procedural requirement, leading to the invalidity of Article 8 of the 2001 Directive. Therefore I propose that the Court declare Article 8 of the 2001 Directive invalid. 149. Nevertheless, one should keep in mind that the assessment of the present cases has proven that the Community legislature had – in 1992 – valid reasons for the ban on snus. Furthermore, it must be observed that outright annulment of the contested provision would be likely to undermine the main effect of the ban and would seriously hamper the policy goal to prevent new and potentially attractive tobacco products from appearing on the market. Account must also be taken of the fact that, as is apparent from my observations above, the essential legislative content of the directive is valid. 150. Given these considerations, important reasons of legal certainty, comparable to those which operate in cases where certain regulations are annulled under the second paragraph of Article 231 EC, justify the Court’s limiting the effects of the annulment. (47) Therefore I suggest that the Court decide in the particular circumstances of these cases to maintain for the time being all the effects of Article 8 of the 2001 Directive, until such time as the Council and the European Parliament have replaced it with a new provision based on proper reasoning. XII – Conclusion 151. In the light of the foregoing I propose that the Court reply as follows to the questions referred to it by the Verwaltungsgericht (Administrative Court) Minden in Case C‑434/02 and by the High Court of Justice of England & Wales, Queen’s Bench Division in Case‑210/03: – Article 8 of Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products, containing a total ban on the marketing of tobacco products for oral use can be based on Article 95 EC. – The ban on tobacco for oral use in Article 8 of Directive 2001/37/EC is consistent with the principle of proportionality. – – The ban on tobacco for oral use in Article 8 of Directive 2001/37/EC is consistent with the principle of equal treatment of similar products. – The Community legislature did not comply with the obligation to state the reasons on which the prohibition is based and therefore Article 8 should be declared invalid. – For the time being all the effects of Article 8 of Directive 2001/37/EC will be maintained, until such time as the Council and the European Parliament have replaced it with a new provision based on proper reasoning. 1 – Original language: English. 2 – OJ 2001 L 194, p. 26. 3 – [2002] ECR I‑11453. 4 – OJ 1992 L 158, p. 30. 5 – See Article 2(4) of the 2001 Directive. 6 – Verordnung über Tabakerzeugnisse (Tabakverordnung). 7 – Jan-M. Hirsch et al., Oral Cancer in Swedish Snuff‑Dippers, submitted by the Commission to the Court. 8 – Council Recommendation of 2 December 2002 on the prevention of smoking and on initiatives to improve tobacco control, OJ 2003 L 22, p. 31, and the earlier Council documents to which it refers. 9 – Case referred to in footnote 3, point 60 of the Opinion. 10 – Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products, OJ 2003 L 152, p. 16. This directive replaces Directive 98/43/EC of the European Parliament and of the Council of 6 July 1998 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products (OJ 1998 L 213, p. 9), which was annulled by the Court in Case C‑376/98 Germany v Parliament andCouncil, ‘Tobacco advertising’ [2000] ECR I‑8419. 11 – Case, referred to in footnote 10. 12 – Paragraphs 60 and 61 of the judgment in Case C‑491/01. 13 – See the criteria taken from Case C‑55/94 Gebhard [1995] ECR I‑4165. 14 – These are Belgium, Ireland and the United Kingdom. 15 – Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, OJ 1976 L 262, p. 169. 16 – Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations, OJ 1976 L 262, p. 201. 17 – Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ 2001 L 311, p. 67. 18 – Council Directive 92/109/EEC of 14 December 1992 on the manufacture and the placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances, OJ 1992 L 370. 19 – Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions relating to the placing on the market and supervision of explosives for civil uses OJ 1993 L 121. 20 – Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons, OJ 1991 L 256, p. 51. 21 – See the preamble to Council Directive 91/477. 22 – Case C‑376/98, referred to in footnote 10, paragraph 83. 23 – Paragraph 99 of the judgment. 24 – Case C‑376/98, referred to in footnote 10, paragraphs 95 to 100. 25 – In particular point 106 of the Opinion. 26 – See points 44 to 54 of this Opinion. 27 – In this respect the claimants draw comparisons with the case-law on social policy, in which the Court has recognised a duty to assess periodically the activities concerned in order to decide whether, in the light of social developments, a derogation may still be maintained (Case C‑285/98 Kreil [2000] ECR I‑69). 28 – [1998] ECR I‑2265, paragraph 101. 29 – Case 104/75 De Peijper [1976] ECR 613 and Case C‑157/96 National Farmers’ Union and Others [1998] ECR I‑2211. 30 – Communication from the Commission on the precautionary principle, COM/2000/0001 final. The aim of the communication is to outline the Commission’s approach to using the precautionary principle, establish Commission guidelines for applying it, build a common understanding of how to assess, appraise, manage and communicate risks that science is not yet able to evaluate fully, and avoid unwarranted recourse to the precautionary principle as a disguised form of protectionism. 31 – Judgment of 9 September 2003, paragraph 113. 32 – OJ 1997 L 43, p. 1. 33 – Case C‑192/01, judgment of 23 September 2003, Case C‑24/00, judgment of 5 February 2004, Case C‑95/01, judgment of 5 February 2004. 34 – According to the Court’s reasoning in Case C‑192/01 Commission v Denmark, cited in footnote 33, paragraphs 51 to 55. 35 – See the Opinion of Advocate General Mischo in Case C‑192/01 Commission v Denmark, cite in footnote 33, point 102. 36 – Paragraph 52 of the judgment. 37 – See for more detail: ‘Is the precautionary principle justiciable?’, E. Fischer, Journal of Environmental Law, Vol. 13, no 3, p. 315. 38 – [2002] ECR II‑3305, paragraph 152. 39 – Case referred to in footnote 38. 40 – See points 50 to 53 above. 41 – Criterion formulated by the Court and cited in point 100 above. 42 – Case C‑180/96 United Kingdom v Commission [1998] ECR I‑2265, and CaseC‑157/96 referred to in footnote 29. 43 – [2001] ECR I‑5689, mainly paragraphs 84, 85, 95 and 100. 44 – See for example Case C‑292/97 Kjell Karlsson and Others [2000] ECR I‑2737, paragraph 39. 45 – See point 38 above. 46 – See my Opinion in Case C‑278/00 Greece v Commission, judgment of 29 April 2004, point 182 and the case‑law of the Court cited in footnote 42 of that Opinion. 47 – The reasoning for the limitation of the effects can be highly similar to the reasoning given by the Court in its judgment in Case C‑295/90 Parliament v Council [1992] ECR I‑4193.