OPINION OF ADVOCATE GENERAL

GEELHOED

delivered on 7 September 2004 ( )

Case C-434/02

Arnold André GmbH & Co. KG

v

Landrat des Kreises Herford

(Reference for a preliminary ruling from the Verwaltungsgericht Minden – Germany)

(Validity of Article 8 of Directive 2001/37/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products – Prohibition of the placing on the market of tobacco for oral use – Maintenance of the sale of ‘snus’ in Sweden pursuant to Article 151(1) of the 1994 Act of Accession (Annex XV, Chapter X, ‘Miscellaneous’) – Proportionality of a complete ban on marketing (interpretation of Articles 28 EC and 95 EC)

and

Case C-210/03

Swedish Match AB andSwedish Match AB UK Ltd

v

Secretary of State for Health

(Reference for a preliminary ruling from the High Court of Justice of England and Wales, Queen's Bench Division (Administrative Court))

(Interpretation of Articles 28 EC, 29 EC and 30 EC – Compatibility of a national provision which prohibits the supply of tobacco products for oral use – Validity of Article 8 of Directive 2001/37/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products – Prohibition of the sale of tobacco for oral use – Maintenance of the sale of ‘snus’ in Sweden pursuant to Article 15(1) of the 1994 Act of Accession)





I – Introduction

1. The main issue that arises in these two cases is the validity of 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 (hereinafter ‘the 2001 Directive’). ( ) Case C‑434/02 stems from a reference by the Verwaltungsgericht (Administrative Court) Minden in Germany and Case C‑210/03 from a reference by the High Court of Justice of England & Wales, Queen´s Bench Division.

2. According to Article 8 of the Directive Member States are to prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden. In Sweden ‘snus’ may still be sold.

3. These cases can be regarded as a sequel to Case C‑491/01 British American Tobacco (Investments) and Imperial Tobacco, ( ) in which the Court examined the validity of the Directive in general. This examination did not disclose any factor of such a kind as to affect the validity of the Directive. However, given the request of the referring court in that case, the Court did not specifically consider Article 8 of the Directive.

4. Article 8 of the Directive prohibits the placing on the market of a tobacco product which is only used on a very small scale within the European Union, mainly within one MemberState (Sweden), whereas the marketing of all other more common tobacco products is still permitted, subject to a certain number of strict requirements. Moreover, as has been stated before the Court and is supported by many scientific reports, using tobacco for oral use is less harmful to health than smoking cigarettes and cigars.

5. Another important factor in this case is that the ban on tobacco for oral use was introduced in 1992 as part of a coherent package of measures aiming to combat the use of tobacco. The ban was justified on the ground that it concerned products which were not yet known on the Community market and could be attractive to young people. The ban was confirmed in the 2001 Directive, although a number of relevant changes had taken place in the context. Firstly, Sweden, where the use of snus is traditional and widespread, had acceded to the European Union. Secondly, Community policy on smokeless tobacco products other than tobacco for oral use was tending to become more flexible, contrary to the policy on cigarettes.

6. In this context the Court is required to answer the following questions:

– can a total ban on the marketing of certain products be based on Article 95 EC?

– is the ban on tobacco for oral use consistent with the principle of proportionality?

– to what extent does Community law require equal treatment of similar products?

– did the Community legislature comply with the obligation to state the reasons on which the prohibition is based?

7. In these cases the applicability of a number of other principles of law has been questioned as well, mainly by the claimants. I would mention in the first place the fundamental rights protected by the European Convention on Human Rights, more specifically the right of property and the freedom to pursue a trade or business and, in the second place, freedom of choice for the consumer, in so far as the consumer is denied the right to opt for less harmful tobacco products. These points can be assessed by simple reference to Case C‑491/01 and other case-law of the Court on restrictions on free movement of goods. I will not discuss them in my Opinion.

8. Another argument put forward by the claimants relates to the free movement of goods itself, in relation to the fact that snus can be lawfully marketed in one MemberState. As the claimants assert, the fact that snus is lawfully available only in Sweden is an impediment to the internal market. However, since this impediment is established at the level of a Treaty, in particular the Treaty of Accession of Sweden, the Court does not have to assess whether this impediment can be justified on public-interest grounds.

II – The legal framework

9. The ban on the marketing of tobacco for oral use was laid down in Council Directive 92/41/EEC of 15 May 1992 (hereinafter ‘the 1992 Directive’) amending Directive 89/622/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products (hereinafter ‘the 1989 Directive’). ( )

10. Article 8a of the 1989 Directive (as amended in 1992) provides that Member States are to prohibit the placing on the market of tobacco for oral use. According to Article 2(4), ‘tobacco for oral use’ means ‘all products for oral use, except those intended to be smoked or chewed, made wholly or partly of tobacco, in powder or particulate form or in any combination of these forms – particularly those presented in sachet portions or porous sachets – or in a form resembling a food product’. This definition remained unchanged under the 2001 Directive and includes snus. ( )

11. According to the preamble to the 1992 Directive the ban on tobacco for oral use is based on the following considerations related to the health risks of the products concerned:

– it has been proved that smokeless tobacco products are a major risk factor as regards cancer;

– scientific experts are of the opinion that the addiction caused by tobacco consumption constitutes a danger meriting a specific warning on every tobacco product;

– new tobacco products for oral use which have appeared on the market in certain Member States are particularly attractive to young people;

– there is a real risk that the new products for oral use will be used above all by young people, thus leading to nicotine addiction, unless restrictive measures are taken in time;

– in accordance with the conclusions of the studies conducted by the International Agency for Research on Cancer, tobacco for oral use contains particularly large quantities of carcinogenic substances and these new products cause cancer of the mouth in particular;

– the only appropriate measure is a total ban; however, such a ban should not affect traditional tobacco products for oral use.

12. Since Article 100a of the EC Treaty (now Article 95 EC) formed the legal basis of the 1992 Directive the preamble also refers to the internal market. In particular it is stated that ‘the sales bans on such tobacco already adopted by three Member States have a direct impact on the establishment and operation of the internal market’.

13. The 1989 Directive (as modified in 1992) was repealed and replaced by Directive 2001/37. As mentioned in the introduction of this Opinion, Article 8 of the Directive bans the placing on the market of tobacco for oral use, with a derogation for Sweden. The preamble to the Directive does not give reasons for this ban, apart from the reminder that Directive 89/622 prohibited the marketing of certain types of tobacco for oral use (with a derogation for Sweden).

14. In the Federal Republic of Germany Article 8a of Directive 89/622 is transposed into national law by Paragraph 5a of the German Regulation on Tobacco Products, ( ) which prohibits the commercial marketing of tobacco products that are intended for any oral use other than smoking or chewing.

15. In the United Kingdom the prohibition is implemented in the Tobacco for Oral Use (Safety) Regulations 1992 (hereinafter ‘the 1992 Regulations’), which provide that ‘no person shall supply, offer to supply, agree to supply, expose for supply or possess for supply any tobacco for oral use.’ The 1992 Regulations were enacted pursuant to powers in domestic law contained in the Consumer Protection Act 1987.

16. Finally I would mention the regulation of the labelling of smokeless tobacco products that are not covered by the ban on marketing. According to the 1992 Directive unit packets of smokeless tobacco products were to carry the following specific warning: ‘Causes cancer’. However, under the 2001 Directive a milder warning is sufficient. According to Article 5(4) of that Directive, ‘[t]obacco products for oral use, where their marketing is permitted under Article 8, and smokeless tobacco products shall carry the following warning: “This tobacco product can damage your health and is addictive.”’ The preamble to the 2001 Directive does not give reasons for this change.

III – Facts and procedure

A – Case C‑434/02

17. The claimant, Arnold André GmbH & Co. KG, which has its registered place of business in Germany, markets, in addition to cigars and pipe tobacco, smokeless tobacco products, including a variety of products coming under the designation of snus.

18. By decision of 12 September 2002 the Landrat des Kreises Herford, the defendant in the main proceedings, prohibited the claimant from engaging in the commercial marketing of tobacco products bearing the designations ‘Röda Lacket-Snus’, ‘Ljunglöf’s Ettan‑Snus’ and ‘General Snus’ of the importer Swedish Match. At the same time it instructed the claimant to carry out an internal recall , threatened to impose fines in the event of infringements, and ordered immediate compliance with its ruling. The claimant challenged that ruling on 27 September 2002.

19. By order of 14 November 2002, received at the Court Registry on 29 November 2002, the Verwaltungsgericht Minden referred a question for a preliminary ruling on the validity of Article 8 of the Directive.

B – Case C‑210/03

20. The first claimant, Swedish Match AB, is a Swedish manufacturer and distributor of tobacco products for oral use known as snus. The second claimant, Swedish Match AB UK Ltd, wholesales and retails tobacco products in the United Kingdom.

21. On 8 May 2002 the claimants brought judicial review proceedings against the defendant challenging the lawfulness of the prohibition on snus and sought a preliminary ruling pursuant to Article 234 EC on a number of questions concerning the grounds on which the challenge was based.

22. Following a hearing on 15 and 16 October 2002, the High Court of Justice of England and Wales (Queen’s Bench Division, Administrative Court) granted the claimants permission to apply for judicial review, and the parties subsequently agreed that a reference for a preliminary ruling was necessary. By order of 2 April 2003, received at the Court Registry on 15 May 2003, the High Court referred a range of questions for a preliminary ruling. In brief, those questions concern the interpretation of Articles 28 EC and 30 EC, the validity of the prohibition enacted by Article 8 of the 2001 Directive, and the consequences of the possible invalidity of the 1992 Regulations.

C – The two cases

23. On 8 June 2004 the Court held a joint hearing for both cases. At that hearing observations were made by the claimants in both cases, the defendant in Case C‑434/02, the United Kingdom, French, Irish and Finnish Governments, the European Parliament, the Council and the Commission. Written observations were furthermore submitted by the Belgian and Swedish Governments.

IV – First preliminary remark: the judgment in Case C‑491/01 does not give a definitive answer on the validity of Article 8

24. In its judgment in Case C‑491/01 the Court held – after an assessment of the Directive as a whole – that its consideration had not disclosed any factor of such a kind as to affect the validity of Directive 2001/37.

25. In its written observations the Commission explains that the objective of the Directive is to prevent various different standards for tobacco use being adopted at national level. In prohibiting snus, Article 8 simply reflects one aspect of the implementation of that objective. One could argue about whether this is really the main objective of the Directive, which provides for a set of measures to combat the use of tobacco products. However, such an argument is not relevant to the question raised by the Commission: did the Court, in assessing the Directive as a whole, also give an assessment of the validity of Article 8?

26. If it did, the validity of Article 8 of the Directive would be beyond any reasonable doubt. The Court could answer the questions of the national courts simply by referring to its judgment in Case C‑491/01.

27. However, in my opinion this is not how the Court should proceed. I accept that the questions in Case C‑491/01 concerned the Directive in general, as does the answer of the Court. But I attach more importance to the fact that the arguments put forward in that case relate almost exclusively to Articles 3, 5 and 7 of the Directive. The same is true of the Court’s assessment: it related almost exclusively to those three articles. What was at issue were the measures concerning the composition and labelling of cigarettes, which I consider to be at the heart of the Directive in terms of economic importance and significance for public health.

28. The Court did not assess Article 8 of the Directive, which must be regarded as a specific provision aiming to prohibit the marketing of a special product. In my view the validity of Article 8 can be assessed independently of the validity of the other provisions of the Directive. Although I consider the Directive to contain a coherent set of measures to combat tobacco use, each different measure can be effective without its being affected by the annulment of the other measures.

29. In short, it would not be appropriate to interpret the judgment in Case C‑491/01 in such a way that it relates to the validity of every single aspect of the Directive. I refer to the exact wording of the decision of the Court: ‘[c]onsideration of the first question has not disclosed any factor of such a kind as to affect the validity of Directive 2001/37.’

V – Second preliminary remark: Article 2(4) determines which products are banned

30. In the course of the proceedings before the Court the claimant in Case C‑434/02, in particular, questioned the preciseness of the definition of the products that are banned. Its doubts are based on:

– the preamble to the 1992 Directive, which states that the ban should not affect traditional products for oral use,

– the assertion that there is no difference between chewing tobacco and sucking tobacco,

– an inconsistency between the German and English language versions.

31. As regards the preamble to the 1992 Directive, the text, as stated above, is not reproduced in the 2001 Directive. Nevertheless, in the absence of appropriate reasons for the 2001 Directive, I regard the considerations that led to the text in the preamble to the 1992 Directive as still valid, but also irrelevant. After all, the definition of a product is not determined by a preamble but by a legal provision. The legal provisions concerned (Article 2(4) of the 1992 Directive and Article 2(4) of the 2001 Directive) do not distinguish between traditional and non-traditional products, but draw a distinction according to intended use.

32. Later on in this Opinion I will discuss the observations submitted to the Court on the difference in actual use between chewing tobacco and sucking tobacco. As has been stated, it cannot be excluded that chewing tobacco is often not chewed, but sucked. However, that is not relevant in determining the scope of the prohibition. The Directive distinguishes according to intended use, not actual use.

33. Finally, as regards the alleged difference between the English and German language versions, I deny the existence of such a difference. The German text uses the wording ‘die zum … Kauen bestimmt sind’ ‘which are intended to be chewed’.

34. I conclude that Article 2(4) determines the scope of the prohibition and that the text is sufficiently clear.

VI – Context: things to know about snus

A – A general remark

35. Evaluating the legal aspects of these cases makes sense only if one possesses some knowledge of the factual background. What is snus? Who uses it? What are the effects of the use of snus on public health? The importance of this factual background is shown by the number and volume of the documents lodged before the Court. These documents are supposed to act as the bases for the contrary viewpoints presented in this case. In fact they are supposed to prove either that the prohibition contributes to the improvement of public health or that the prohibition of snus is harmful to public health.

B – What is snus, how is it used and who uses it?

36. The order for reference in Case C‑210/03 describes the substance and physical appearance of snus as follows: ‘[t]obacco comes in a number of forms. The categories are normally subdivided into “smoking” tobacco and “smokeless” tobacco (which includes snus). “Smokeless” tobacco includes nasal snuff, moist snuff, “chewing tobacco” and a wide variety of other products. All of these products consist of ground or shredded tobacco leaf with some form of flavouring. In this respect, they are largely identical products. However, differences between products arise out of the type of tobacco used, its treatment, and the flavourings used which have a significant effect on the levels of tobacco-specific nitrosamines and benzopyrene, both of which are considered carcinogenic. Snus is recognised as having very low levels of nitrosamines and benzopyrene as compared with many of the permitted smokeless tobacco products’.

37. According to the Community legislation snus is a specific type of ‘tobacco for oral use’. ‘Tobacco for oral use’ is essentially the same substance as ‘chewing’ tobacco, except that it is not pressed into lumps and it has a different tobacco particle size. In addition, ‘tobacco for oral use’ contains more water.

38. Contrary to the order for reference in Case C‑210/03 it has been emphasised before the Court – and not refuted by the claimants – that the level of nitrosamines in snus is comparatively high. Nitrosamines are a carcinogenic substance. Moreover, it has been stated before the Court that the level of nicotine is also fairly high. For example, the Council states that 1 gram of snus contains 8‑10 milligrams of nicotine. Nicotine is toxic, particularly when in contact with skin, and it is addictive.

39. My second point concerns the use of snus. The claimants have asserted before the Court that snus is comparable to ‘Chewing tobacco products’, which are not covered by the prohibition in Article 8 of the 2001 Directive. These products often consist of shredded tobacco pressed into lumps which are placed in the mouth, more specifically in the oral cavity between the gum and lip. Many products sold under the heading of ‘chewing tobacco’ are not intended to be chewed at all, it is said, and some cannot be chewed at all. On some ‘chewing’ tobacco products the user is advised ‘don’t chew’. The tobacco is either kept between the lip and the gum or simply moved around the mouth. This pattern of consumption is also true for chewing tobacco products that come in a looser form.

40. The difference in use between snus and chewing tobacco has been thoroughly debated before the Court. In a nutshell, this debate concerned the claimants´ assertion that products which are sold as chewing tobacco are not chewed and might even not be intended to be chewed. In my view this debate has a limited relevance for the resolution of the present cases, given the product definition in the 2001 Directive. The determining factor is whether a tobacco product is intended to be chewed. If a smokeless tobacco product is marketed as ‘chewing tobacco’, but it is at the same time evident that the product is not meant to be chewed, it falls within the scope of the prohibition under Article 8 of the 2001 Directive. If it is meant to be chewed it is, according to the Directive, a different product that can lawfully be placed on the market.

41. In the third place, who are the users? Within the EC, snus may be marketed in Sweden alone. Approximately 20% of the male population in Sweden use snus regularly. Originally snus was not frequently used by women, but over recent years women have been using snus to an increasing extent. The key to attracting women was to package snus in little ‘tea bags’, to make its use cleaner. As regards the average age of users and their (former) smoking habits, the Commission has provided information. In 1976 moist snuff was used by 10% of Swedish males between 18 and 24 years old, whereas this percentage increased to 37% in 1986 for 16‑to‑24 year‑olds.

42. The main relevant factor about the use of snus is that – in Sweden – it is widespread amongst the population and the product is attractive to young people. It has, as the European Parliament stated at the hearing in these cases, a ‘cool factor’. In this respect, it is different from other nasal and chewing tobacco products, since – to quote a statement of the Commission which was not refuted – these products have ‘virtually no market outside certain socio-professional groups (seafarers, miners and sectors of the army) and regions’. Moreover, this market steadily declined throughout the 20th century.

43. To summarise, snus can be compared to other smokeless tobacco products, from the point of view of its substance and its physical appearance, as well as the way it is used. The main difference relates to the user groups.

C – How dangerous is snus?

44. Here we come to a point where the submissions made before the Court diverge. In my view we should distinguish three things:

– the health consequences in themselves: does the use of snus provoke serious diseases such as cancer?

– a comparison with the health risks of other tobacco use, namely smoking and the use of chewing tobacco, a smokeless tobacco product that is not banned;

– substitute or stepping stone? Does the availability of snus encourage people to give up smoking, is the use of snus unrelated to smoking habits or, worse, does snus attract mainly young people who do not smoke and does it lower for them the barrier to nicotine use and addiction?

45. Let us start with the health consequences in themselves. In the documents submitted to the Court various diseases are mentioned in relation to the use of snus. In particular, snus is associated with cancer of the mouth. According to the reasons presented by the Community legislature, it was inter alia this association that led to the ban on snus. The preamble to the 1992 Directive refers to studies conducted by the International Agency for Research on Cancer (the IARC).

46. The claimants deny the accuracy of these studies since, they say, the studies considered mainly products from the USA and Asia. The IARC Report was based primarily on a study concerning ‘dry’ snuff which is not comparable to snus because of differences in patterns of use and product characteristics arising primarily from the method of curing the tobacco. The IARC Report did not take into account the effect of snus, because at that time there were no comprehensive studies on possible links between snus and oral cancer. On the contrary, according to the claimants’ more recent reports deny the relationship between the use of snus and oral cancer.

47. It should be noted that this evaluation by the claimants is not shared by the other parties which have made submissions to the Court, nor did it find any support at the hearing. In brief, the reports referred to by the claimants should be interpreted in a more balanced way: they do contain statements acknowledging the increased risk of oral cancer following intensive use of snus. Additionally, the Commission refers to a recent report from the University of Uppsala ( ) stating that mouth cancers observed in certain patients undergoing treatment for the disease had indeed been caused by the use of snus. Moreover, documents have been submitted to the Court stating that smokeless-tobacco users face a higher risk of, inter alia, cardiovascular death than non‑tobacco‑users. In addition, no one expressly states that snus is harmless. It contains fairly high quantities of nicotine. The presence of these quantities of nicotine makes the product addictive.

48. The second aspect requires a comparison with the health risks of other tobacco products that are not banned. There is no doubt about the harmful effects of smoking on the health of the user. The claimants state that all available data clearly show that cigarettes are far more harmful than snus. They refer to estimates that cigarettes are 100 times more hazardous than snus, and that Scandinavian smokeless tobaccos are 90‑99% less hazardous than cigarette smoking. They mention a recent report by the members of the Tobacco Advisory Group of the Royal College of Physicians of London (2002) which states that smokeless tobacco is ‘in the order of 10‑1,000 times less hazardous than smoking’. Although the accuracy of those figures can be questioned, there seems to be no difference of opinion on the correctness of the statement itself, namely that cigarettes are far more harmful than snus. According to a scientific report cited by the claimants in Case C‑210/03, ‘Snuff is a mini-monster in comparison to cigarettes.’

49. To summarise the first two aspects mentioned above, snus is a product that is in itself harmful to the health of the user, but less harmful by far than cigarettes.

50. This brings me to the third aspect. To determine whether the prohibition on snus is an appropriate contribution to public health it is crucial to look in greater detail at the relationship between the use of snus and cigarette smoking. In the words used above, is snus a substitute for smoking or does it provide a stepping‑stone?

51. One could argue that snus serves mainly as a substitute for smoking. Since giving up smoking is not easy, as many people know from personal experience, addicts can be encouraged if the market provides an attractive alternative. In that respect the presence of nicotine in snus might even be advantageous to public health. It is to that effect that the claimants argue. They provided the Court with figures showing that Sweden, where the use of snus is widespread amongst males, has internationally low rates of tobacco-related illnesses among men. They also point out that the percentage of smokers in Sweden is extremely low compared with other MemberStates and claim that there is a direct link with the Swedish habit of using snus. However, the validity of this last claim is questionable since, as the Finnish Government points out, smoking figures in Finland are comparatively low, although the use of snus or a similar alternative is not widespread.

52. The opposite reasoning is based on the premiss that the substitution effect does not play a substantial role. The use of snus does not prevent people from smoking and – even worse – the availability on the market of snus attracts (young) people who in other circumstances would abstain from tobacco use. In this view, snus lowers the threshold to tobacco use. As the Commission contends in its written observations, snus should be regarded as a stepping-stone to smoking tobacco products.

53. Both points of view have been defended before the Court in the present cases. The claimants in both cases, as well as the Swedish Government, defend the first point of view, whilst the other intervening Governments and the Community institutions defend the second. In my view both points of view can be defended at the same time. They are not mutually exclusive. Snus can be regarded as a substitute for smoking in so far as it helps people to give up smoking, but at the same time it attracts young people who do not (yet) smoke and do not intend to start smoking. Moreover, both points of view are supported by the fact that snus is marketed as an attractive product to young consumers, contrary to traditional chewing tobacco.

54. It is not easy to determine which is the predominant effect. Particularly when young people are attracted by snus and refrain from cigarette smoking, this does not mean that they would otherwise – if snus were not available on the market – start smoking. Some indications can be drawn from the experience in Sweden, but they are not unequivocal, as has been shown by the figures on cigarette smoking in Sweden and Finland.

VII – The tobacco policy of the European Union (and the MemberStates)

55. The policy on the control of tobacco use is, as has been repeatedly emphasised by the Council, ( ) based on an overall policy aiming to combat effectively all kinds of tobacco use by taking several comprehensive measures. The actions of the European Community and the MemberStates are meant to complement each other.

56. The emphasis of tobacco policy is of course on smoking, not smokeless tobacco. Tobacco policy is mainly an anti-smoking policy. The measures taken against smoking have become more and more restrictive as the years have gone by. This tendency is due to increased knowledge of the harmful effects of smoking, but also to changing attitudes in society towards smoking and smokers.

57. In my Opinion in Case C‑491/01 British American Tobacco, ( ) I pointed out that Government policy is at present based on two pillars. The first pillar comprises measures designed to discourage smoking as much as possible, with particular emphasis on young people, whilst the second concerns measures to limit as much as possible the deleterious effects which smoking can have.

58. As regards the first pillar, the objective to discourage smoking is in the first place implemented in Article 5 of the 2001 Directive, containing provisions on the labelling of smoking tobacco products. As we know, packets of tobacco products must carry serious warnings. Furthermore, Directive 2003/33 ( ) limits the advertising of tobacco products and their promotion. Article 3 of the 2001 Directive is an example of the second pillar of the Community policy: maximum tar, nicotine and carbon monoxide yields are imposed.

59. The scope of the Community policy on smoking has limits since it is subject to the principles of subsidiarity and proportionality and the conditions laid down by the Court in the Tobacco advertising case. ( ) In addition to the Community policy, the Member States have developed their own policies and inter alia imposed limitations on the selling of tobacco products and limited the areas where smoking is still allowed.

60. It is important to note that the Community as well as the MemberStates are steadily strengthening the measures on the use of tobacco products. Nevertheless, the most restrictive of all possible measures – a total ban on tobacco products – is not considered. As the Commission stated, this measure might well be justified by the dangers represented by smoking but would not be feasible on practical grounds and for fiscal and political reasons. I would modify that statement: a total ban on tobacco products would not yet be feasible. However, given the evolving attitudes in society towards smoking and smokers, this might change over the coming years.

61. In short, the Commission gives two sets of reasons as to why the Community legislature would not be doing what it was supposed to do if consideration were given only to the protection of the health of tobacco users (and the health of ‘passive’ smokers).

62. The alleged practical grounds are clear. A total ban on tobacco products would lead to unreasonable compliance costs, but would also not have the effect of stopping people smoking. An illegal market would appear.

63. In the context of the present cases, I consider the second set of arguments (the fiscal and political reasons) to be more interesting. As we know, Government policy towards tobacco has, to a certain extent, always been ambiguous. The excises on tobacco products are a source of public revenue; the manufacture and distribution of tobacco products is a source of employment. Of course, these arguments play a far less important role when it comes to products of small economic importance. Under those circumstances, the legislature does not have to consider the high economic costs of a far-reaching policy option such as a total ban on the products. It can abstain from a difficult cost-benefit analysis and can restrict itself to an assessment of the health effects of the intended measure, of course within the boundaries of the principle of proportionality.

VIII – Assessment: can the total ban on certain products be based on Article 95 EC?

A – Scope of the Community competence under Article 95 EC

64. Article 95 EC is the general legal basis for measures which have as their object the establishment and functioning of the internal market. As the Court has held, Article 95 EC does not vest in the Community legislature a general power to regulate the internal market. Moreover, a measure adopted on the basis of Article 95 EC must genuinely have as its object the improvement of the conditions for the establishment and functioning of the internal market. According to the Court’s judgment in Case C‑491/01, the measure must actually contribute ‘to the elimination of obstacles to the free movement of goods or to the freedom to provide services, or to the removal of distortions of competition. Also, while recourse to Article 95 EC as a legal basis is possible if the aim is to prevent the emergence of future obstacles to trade resulting from multifarious development of national laws, the emergence of such obstacles must be likely and the measure in question must be designed to prevent them ….’ ( )

65. Essentially it follows from this reasoning that two requirements apply. Obstacles (or at least seriously imminent obstacles) to free movement must exist and the Community measure must contribute to the elimination of these obstacles. If one looks in more depth at these two requirements one sees a parallel with the criteria which the Court uses when assessing the competences of a Member State under Articles 28 EC and 30 EC to prohibit or restrict the free movement of goods (or under Articles 52 EC and 59 EC in respect of services). The measures must be justified by imperative requirements in the general interest and must be suitable for securing the attainment of the objective which they pursue. ( ) However, the competence under Article 95 must be justified by shortcomings in the internal market itself.

66. In the present cases it is beyond doubt that the first requirement is met, since it is evident that a serious risk of multifarious development of national laws exists. As was stated in the preamble to the 1992 Directive, three Member States ( ) had already adopted sales bans on such tobacco products. If the ban had been lifted at Community level when the 2001 Directive was adopted, Member States themselves might have prohibited snus autonomously, but there would have been no guarantee that the Member States would have used their autonomous competences in a coordinated way.

67. In this part of my Opinion I will now analyse the second requirement, tailored to the ban on the marketing of certain products under Article 95 EC. I will discuss:

– legislative practice;

– the limits following the Tobacco advertising judgment;

– the prohibition of products;

– the legality of Article 8 of the 2001 Directive.

B – The legislative practice of the Community

68. It has been rare for the Community legislature to impose a total prohibition on the marketing of certain products. In its written and oral observations, the French Government puts forward three examples. Firstly it mentions Directive 76/768 on cosmetic products. ( ) This directive bans the marketing of cosmetic products containing certain substances or colouring agents. It does not generally prohibit the marketing of certain types of cosmetic products, for instance those that are intended to be applied in a certain manner. Nevertheless, the directive provides for the adaptation of the requirements following technical progress. A consequence of this adaptation might be that products have to be withdrawn from the market. A system having a similar effect on the marketing of products is introduced by Directive 76/769 on certain dangerous substances and preparations. ( )

69. The third example mentioned by the French Government is Directive 2001/83 on medicinal products for human use. ( ) This directive mainly regulates the conditions to be fulfilled prior to the marketing of medicinal products: no medicinal product may be placed on the market of a MemberState unless a marketing authorisation has been issued. This marketing authorisation can only be issued following a product assessment, concerning different aspects of the products.

70. The directives cited by the French Government concern inter alia the substance of the products. They (can) lead to the prohibition of the marketing of certain products, if they contain illicit substances. Although none of the provisions mentioned expressly prohibits any specific category of products, all are, as to their result, comparable to Article 8 of the 2001 Directive. They prevent the lawful marketing of categories of products if certain conditions are fulfilled.

71. It is remarkable that an express prohibition on the marketing of certain products cannot be found even in specific product schemes under Article 95 EC dealing with dangerous goods like narcotic drugs and psychotropic substances ( ) or explosives intended for civil use. ( ) However, in the case of firearms Member States are, according to a directive based solely on Article 95 EC, ( ) to take all appropriate steps to prohibit the acquisition and the possession of the firearms and ammunition classified in a certain category. The Community legislature explains the use of Article 95 EC as a legal basis by referring to the total abolition of controls and formalities at intra‑Community frontiers as a fundamental condition to be fulfilled in order to establish an internal market. ( )

C – The limits according to the Tobacco advertising case

72. In the Tobacco advertising case ( ) the Court stated that Article 95 EC does not vest in the Community legislature a general power to regulate the internal market. A general power would be contrary to the express wording of Article 95 and furthermore incompatible with the principle embodied in Article 5, first paragraph EC. According to paragraph 95 of that judgment it is necessary to verify whether a provision actually contributes to eliminating obstacles to the free movement of goods and to the freedom to provide services, and to removing distortions of competition. The Court stated furthermore that the prohibition of advertising on posters, parasols, ashtrays and other articles used in hotels, restaurants and cafés, and the prohibition of advertising spots in cinemas could in no way help to facilitate trade in the products concerned. ( )

73. It should be borne in mind that the Court considers Article 95 EC as conferring – this is my terminology – a functional competence. It is not of any importance whether the ultimate goal of a measure is to facilitate trade; what matters is whether a measure is appropriate to facilitate trade. The predominant policy goal can very well be the protection of public health.

74. The Court thus provides us with some key elements of this functional competence: (1) the object must be the improvement of the conditions for the establishment and functioning of the internal market, (2) the provisions must contribute to the elimination of obstacles, (3) distortions of competition must be removed and (4) the provisions must facilitate trade.

D – The prohibition of products

75. According to Article 14(2) EC, the internal market is to comprise an area without internal frontiers. It is essential to the functioning of this market that the conditions for the marketing of products are equal in the different Member States. Only if this equality is achieved can internal frontiers be removed.

76. That is the fundamental reason for the competence of the Community legislature to harmonise diverging legislation of the Member States. However, the responsibility of the Community legislature goes even further. It not only has to create the conditions for an internal market of products, but also has to guarantee that the products that appear on this market do not harm other public interests such as health, safety, environmental protection and consumer protection. This responsibility of the Community legislature has been made explicit in Article 95(3) EC, which requires a high level of protection.

77. If one or more Member States prohibit the marketing of certain products for reasons of public health whilst other Member States allow the sale of those products, internal frontiers come into being and the functioning of the internal market is affected. Intervention by the Community legislature, aiming to harmonise the divergent national legislation, can lead to the removal of obstacles at the internal frontiers of the Community. Given the divergence of national legislation, it is within the discretion of the Community legislature to decide whether to provide for restrictions on the composition of certain products or for legislation totally banning the marketing of those products. If a high level of human health protection, as also required by Article 152(1) EC, can be ensured only by a total ban, the Community legislature is definitely obliged to choose this option.

78. Of course one can object that a prohibition on selling a product cannot itself improve the conditions for the marketing of that product. In fact, the product is excluded from the market. As the claimants stated in their written observations, it is questionable whether a total ban of this kind could ever contribute to the establishment and functioning of the internal market. Such a ban can hardly be regarded as the removal of barriers to the marketing of these products, since it makes the existence of a market impossible. In other words, it prevents a lawful market from coming into being and, by so doing, establishes a barrier to trade. The claimants even seem to interpret the judgment of the Court in the Tobacco advertising case ( ) to that effect, by claiming that an absolute prohibition on advertising of certain products cannot in any way be considered to be facilitating trade in those products.

79. However, this objection does not reflect the proper meaning of Article 95 EC. Although Community measures must improve the conditions for the establishment and functioning of the internal market and must facilitate trade, this does not imply that they have to do so in respect of every individual product. The Community legislature may prohibit the marketing of a product, as I stated above. In those circumstances such products cannot lawfully appear on the market within the territory of the European Community This diminishes enforcement costs and can even diminish the costs of the enforcement of regulations on related products. In short, if snus is not on the market of the European Union, the effort to control the marketing of other smokeless tobacco products can be reduced. In this respect, one can say that Article 8 of the 2001 Directive contributes to the removal of barriers to trade in other products.

80. In 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, ( ) 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’). ( )

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. ( ) 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. ( ) 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. ( ) 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. ( ) 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, ( ) 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, ( ) 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, ( ) 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. ( ) In other words, the existence of a health risk must be plausible. ( ) 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’ ( ) 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. ( )

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 ( ) 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 ( ) 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. ( ). The Community legislature was not in a situation in which it could base its measures on the likelihood of real harm to public health, ( ) 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. ( ) 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, ( ) 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. ( )

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. ( ) 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. ( )

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. ( ) 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.