Section 6 of the Tobacco' (Health Promotion' and Protection) Act 1988 provides as follows:-

" 6(1) Any person who imports, manufactures, sells or otherwise disposes of, or offers for sale or other disposal, or advertises, an oral smokeless tobacco product shall be guilty of an offence and shall be liable

1. on summary conviction, to a fine not exceeding œl,000, or
2. on conviction on indictment to a fine not exceeding œ10,000.

(2)In this section "oral smokeless tobacco product" means any product or substance, made wholly or partly from tobacco, which is intended for use, unlit, by being placed in the mouth and kept there for. a period, or by being placed in the mouth and sucked or chewed." 

The Plaintiffs' claim that this section is invalid as being in breach of Article 30 of the Treaty of Rome which is in the following form:-

"Quantitative restrictions on imports and all measures having equivalent effect shall, without prejudice to the following provisions, be prohibited between Member States." 

The Plaintiffs' claim in the alternative that Section 6 is unforceable by reason of non-compliance with two Directives of the Council of the European Community, being Directives 83/189/E.E.C. and 89/622/E.E.C. which were referred to in argument as the "notification" Directive and the "labelling" Directive. 

While the Plaintiffs' main claim is based on Article 30, the issue in the case is not in fact concerned with that Article as the Defendants (to whom I shall refer collectively as the State) concede that it is breached by Section 6. It would have been impossible to Argue otherwise as in Regina .v. Henn and Darby 1979 E.C.R. 3795 the Court of Justice of the European Communities held that a total ban contravened the Article. The Court said in its judgment at page 3812:'.The first question asks whether a law of a Member State which prohibits the import into that State of pornographic articles is a measure having equivalent effect to a quantitative restriction on imports within the meaning of Article 30 of the Treaty. 

That article provides that "quantitative restrictions on imports and all measures having equivalent effect" shall be prohibited between Member States.

It is clear that this provision includes a prohibition on imports inasmuch as this is the most extreme form of restriction. The expression used in Article 30 must therefore be understood as being the equivalent of the expression "prohibitions or restrictions on imports" occurring in Article 36." 

The main issue in the case arises under Articles 36 of the Treaty which provides as follows:-

"The provisions of Articles 30 to 34 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States."

The State's contention is that the ban on oral smokeless tobacco contained in Section 6 is justified on the grounds of the protection of health and life of humans. The Plaintiffs' answer to this is firstly, that the ban is not so justified, and secondly, that even if it could be, it offends the principle of proportionality, that is to say, that the objectives for which the ban was introduced could have been achieved by a measure which was less restrictive of the free circulation of goods in the Community. 

The Plaintiffs do not contend that the ban is either a means of arbitrary discrimination or a disguised restriction on trade between Member States.

Counsel stated a number of times in the course of his submissions that the Plaintiffs accept that the ban was enacted bona fide in the interests of public health. 

The Plaintiffs do not contend either that oral smokeless tobacco should be freely on sale, available to everyone without distinction of age, or that there should be no restrictions on its being advertised, or that they should not be obliged to have a warning on their products that they could be dangerous to health. As part of their argument on the principle of proportionality, it was submitted that the restrictions currently in force here in regard to cigarettes, pipe tobacco, cigars, cigarillos and chewing tobacco, under the Tobacco Products (Control Over Advertising, Sponsorship and Sales Promotion) No. 2 Regulation 1986 (S.I. No. 107 of 1986) and the Tobacco (Health Promotion and Protection) Regulations 1990 (S.I. No. 39 of. 1990) could be applied to oral smokeless tobacco and they would be adequate to achieve the State's objectives -to protect the health and life of the -citizens of this country.' 

One of the requirements of the 1986 Regulation is that advertisements for chewing tobacco, and the front of packages of chewing tobacco, should carry the statement "This product may cause oral cancer". It is part of the Plaintiffs' case, accordingly, that a statement in this form in advertisements for oral smokeless tobacco, and on packages of the product, and a prohibition on its sale to persons below the age of 16, would adequately protect the health and life of our citizens. Section 6 is being challenged, therefore, not so much on the ground that no protection is required against the Plaintiffs' product but rather on the ground that the ban contained in Section 6 goes beyond what is required to give the necessary protection and so offends against the principle of. proportionality. That was the principal issue argued in the case, and the principal issue which I now have to decide. In order to do so it is necessary to consider the law which is applicable and the evidence I heard as to the nature of oral smokeless tobacco and the effects it may have on the health of people who use it, but this must be prefaced by an outline of the circumstances in which the issue arises. 

The first named Plaintiff is a company incorporated in Ireland and is a wholly owned subsidiary of the second named Plaintiff which is an American Corporation and which in turn is a wholly owned subsidiary of United States Tobacco Inc., a large corporation with a number of other businesses as well as tobacco. The second named Plaintiff has had since 1985 a factory in Scotland for the manufacture of oral smokeless tobacco. Four different brands are manufactured Copenhagen, which has been manufactured by United States Tobacco Inc since 1822; two Skoal products, one long cut and one fine cut, which came on the market in 1934, and Skoal -Bandits which were first marketed in 1973. The first three products consist of finely cut loose tobacco packed in a tin.

They are used by a small portion of the tobacco being placed in the mouth between the gum and the lip and left there for a period which may vary from minutes to hours. The Skoal Bandits brand takes a different form though used in the same way. The tobacco, instead of being loose, is enclosed in small paper packages resembling tea bags. 

Oral smokeless tobacco is also known as moist snuff, and the practice of using it is called snuff dipping. in the western hemisphere the practice is to be found principally in the southern states of the United States of America and Scandinavia, and to a lesser extent in some other European countries. The practice does not exist in Ireland. It was accepted by the Plaintiffs that there is no evidence of any user of moist snuff in this country, but they submitted that this was not a factor which could be used as an argument in support of the ban. I shall consider this submission at a later stage when dealing with the principle or proportionality. 

I now turn to consider the law in regard to that principle and in regard to Article 36. Since what is involved is Community law, it was submitted on behalf of the Plaintiffs that I should consider a reference to the Court of Justice of the European Communities under Article 177 of the Treaty of Rome.

The State submitted that no such reference was necessary. Having carefully considered the question the view I take is that no reference is required. In my opinion the relevant law has been very clearly stated in a number of the decisions of the Court of Justice so that there is no doubt as to what the law is. The issue in the case is how the law should be applied to the particular facts. 

The case law to which I wish to refer covers three separate topics:

1. The construction of Article 36.
2. The principle of proportionality, and
3. The rights of Member States where there are uncertainties in the present state of scientific research. 

It will be seen, however, that the cases in the second category are not really distinct from those in the first as the principle of proportionality developed out of the construction of Article 36. 

1.the Construction Of Article 36. 

In Simmenthal SpA v. Italian Minister for Finance 1976 E.C.R. page 1871 the Court said in its judgment at page 1885 (paragraph 10):-

"Article 36 of the Treaty excepts from the prohibition, restrictions on imports, exports and goods in transit if measures of this nature are justified on grounds of the protection of health and life of humans and animals. Since the restrictions authorized by Article 36 derogate from the fundamental principle of the free movement of goods, they only comply with the Treaty in so far as they are justified, that is to say, necessary for attainment of the objectives referred to by this provision and in particular to ensure the protection of health and life of humans and animals."

and in the same case at page 1886 (paragraph 14) the Court said:- 

"Article 36 is not designed to reserve certain matters to the exclusive jurisdiction of Member States but permits national laws to derogate from the principle of the free movement of goods to the extent to which such derogation is and continues to be justified for the attainment of the objectives referred to in that article." 

In Commission of the European Communities v. Italian Republic 1982 E.C.R. 2187 the Court said in its judgment at page 2204 paragraph 27):- 

"It must be recalled that in accordance with the settled case-law of the Court, Article 36 must be strictly interpreted and the exceptions which it lists may not be extended to cases other than those which have been exhaustively laid down and, furthermore, that Article 36 refers to matters of a non-economic nature." 

2.the Principle Of Proportionality. 

In de Peijper 1976 E.C.R. 613, the Court said in its judgment at page 635/636 (paragraphs 15 to 17):-  

"15. Health and the life of humans rank first among the property or interests protected by Article 36 and it is for the Member States, within the limits imposed by the Treaty, to decide what degree of protection they intend to assure and in particular how strict the checks to be carried out are to be. 

16. Nevertheless it emerges from Article 36 that national rules or practices which do restrict imports of pharmaceutical products or-are capable of doing so are only compatible with the Treaty to the extent to which they are necessary for the effective protection of health and life of humans. 

17 National rules or practices do not fall within the exception specified in Article 36 if the health and life of humans can as effectively (be) protected by measures which do not restrict intra-Community trade so much." 

In the Commission v. the Kingdom of Belgium 1983 E.C.R. 531, the Court said in its judgment at page 543(parag37aph 12):-

"The principle behind the arguments put forward by the Belgian Gov6rnment can not be disputed, inasmuch as each Member State is entitled to take within its territory, in particular in a sphere in which the objective of the harmonization of health control measures has not yet been achieved, appropriate measures in order the ensure the protection of Public health. However, such measures are justified only if it is established that they are necessary in order to attain the objective of protection referred to in Article 36 and that such protection cannot be achieved by means which place less of a restriction on the free movement of goods within the Community." 

In the case of CMC Meikunie BV 1984 E.C.R. page 2367, the Court said in its judgment at page 2384 (paragraph 12):

"According to a consistent line of decisions of the Court, it follows from Article 36 that a national measure which has, or may have, a restrictive effect on trade is compatible with the Treaty only in so far as it is necessary for the purpose of effectively protecting human life and health. The proviso in Article 36 cannot therefore apply where human life and health can be protected just as effectively by measures less restrictive of intra-Community trade." 

And in Minister Public v. Claud Muller and Others 1984 E.C.R. page 1511, the Court said in its judgment at page 1528 (paragraph 23):-

"It follows that, as it stands at present, Community law does not prevent a Member State from prohibiting the marketing of food stuffs from other Member States to which such substances have been added. However, the principle of proportionality which underlies the last sentence of Article 36 of the Treaty requires that any such prohibition be restricted to what is necessary to attain the legitimate aim of protecting health. Consequently, authorisations to market such products should be granted when they are compatible with that aim."

 3.the Rights Of Member States Where There Are Uncertainties In The Present State Of Scientific Research. In Sandoz BV 1983 E.C.R. page 2445, the Court said in 16 to 18):- its judgment at page 2463 (paragraphs 16 to 18): 

16."As the Court found in its judgment of 17 December 1981 in Case 272/80.(Frans-Nederiandse Maatschappij voor Biologische Producten [1981] ECR 3277), in so far as there are uncertainties in the present state of scientific research it is for the Member States, in the absence of harmonisation, to decide what degree of protection of the health and life of humans they intend to assure, having regard however for the requirements of the free movement of goods within the Community. 

17.Those principles also apply to substances such as vitamins which are not as a general rule harmful in themselves but may have special harmful effects solely if taken to excess as .part of the general nutrition, the composition of which is unforeseeable and cannot be monitored. In view of the uncertainties inherent in the scientific assessment, national rules prohibiting, without prior authorization, the marketing of foodstuffs to which vitamins have been added are justified on principle within the meaning of Article 36 of the Treaty on grounds of the protection of human health. 

18.Nevertheless the principle of proportionality which underlies the last sentence of Article 36 of the Treaty requires that the power of the Member States to prohibit imports of the products in question from other Member States should be restricted to what is necessary to attain the legitimate aim of protecting health. Accordingly, national rules providing for such a prohibition are justified only if authorizations to market are granted when they are compatible with the need to protect health." 

In The State v. Leon Motte 1987 1 C.M.L.R. 663 the Court said in its judgment at page 680 (paragraph 19 and 20):- 

"19.As the Court held, inter alia in case 174/82 Sandoz, in so far as there are uncertainties in the present state of scientific research, it is for the Member States, in the absence of harmonization,, to decide what degree of protection of the health and life of humans they intend to assure, having regard however to the requirements of the free movement of goods within the Community. 

20.Although, for those purposes, Member States must take into account the results of international. scientific research and, in particular, the work of the Community's scientific committee for food, it must nevertheless be emphasized that the opinions of that committee do not have binding force." 

The principles set out in the passages cited might be summarized as follows. A prohibition or restriction on imports will come within one of the exceptions in Article 36 of the Treaty of Rome only insofar as it is justified, that is to say, insofar as it is necessary for the attainment of the objective for which it was introduced; if it was introduced for the protection of health-.and life of humans, it would be justified only insofar as it is necessary for the attainment of that objective. If the protection of the health and life of humans can be achieved by measures which place less of a restriction on the free movement of goods within the Community" the prohibition or restriction will not come within the exception in Article 36 because of the principle of proportionality. 

In the absence of the harmonization of measures for the protection of the health and life of humans against a particular product, insofar as uncertainties persist in the present state of scientific research in regard to that product, it is for the Member States to decide what degree of protection of health and life of humans they intend to insure, having regard, however, to the requirements of the free movement of goods within the Community. And where uncertainties persist the Member States must take into account the results of international research.

These are the principles of law which I propose to apply to the facts. 

I now turn to the evidence. It falls into two categories. On the one hand there are the conclusions of authoritative international bodies, and on the other the opinions of the experts called on behalf of both parties. I will begin with the former. 

Three publications in particular were referred to in the course of the evidence:-

1.Volume 37 of the IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans.

IARC stands for the International Agency for Research on Cancer which is a research agency set up by the World Health Organisation. It is probably the leading world agency in cancer research. The following are the conclusions, published in September 1985, of an IARC working group on the effects' of using oral snuff (page 116):- 

"There is sufficient evidence that oral use of snuffs of the types commonly used in North America and Western Europe is carcinogenic to humans. There is limited evidence that chewing tobacco of the types commonly used in these areas is carcinogenic. Epidemiological studies that did not. distinguish between chewing tobacco and snuff provide sufficient evidence for the carcinogenicity of oral use of smokeless tobacco products, as reported in these studies. In aggregate, there is sufficient evidence that oral use of smokeless tobacco of the above types is carcinogenic to humans. There is inadequate evidence to evaluate the carcinogenicity of chewing tobacco, snuff or nass to experimental animals." 

2. The Health Consequences of Using Smokeless Tobacco. 0A Report of the Advisory Committee to the Surgeon General. Published by the United States Department of Health and Human Services in April 1986. The Advisory Committee consisted of eleven experts supported by a large-number of scientists from different disciplines. Their conclusions were summarized as follows in the preface to the report (page vii): 

" The scientific evidence is strong that the use of snuff can cause cancer in humans. The evidence for causality is strongest for cancer of the oral cavity wherein cancer may occur several times more frequently in snuff dippers compared to non tobacco users. The excess risk of cancer of the cheek and gum may reach nearly fifty fold among long term snuff users. Experimental investigations reveal potent carcinogens in smokeless tobacco. These include nitrosamines, polycyclic aromatic hydrocarbons, and radiation-emitting polonium. The tobacco specific nitrosamines often have been detected at levels 100 or more times higher than government regulated levels of other nitrosamines permitted in foods eaten by Americans. Smokeless tobacco use can lead to the development of oral leukoplakias (white patches or plaques of the oral mucosa), particularly at the site of tobacco placement. Based on evidence from several studies, a portion of leukoplakias can undergo transformation to dysplasia and further to cancer. Gingival recession is a commonly reported outcome of smokeless tobacco use." 

3. Smokeless Tobacco Control. Report of a WHO study Group 1988. This is a report of a study group of nine experts who met in Geneva from the 1st to the 6th June 1987. The aim of the meeting, as set out in the report, was:- 

."To summarize existing knowledge concerning the prevalence of smokeless tobacco use and its harmful health effects, as well as to make recommendations and propose. strategy- guidelines for use by Governments in controlling such use where it already existed and in preventing the emergence of a new threat to health where it did not."

The report has this to say on the health effects of using smokeless tobacco (page 18): "There is conclusive scientific evidence that the use of smokeless tobacco causes cancer in humans. The evidence for causality is strongest for cancers of the oral cavity, but use of smokeless- tobacco has also been shown to increase the risk of cancer of the pharynx, larynx, oesophagus, pancreas and urinary tract. This conclusion is based on a number of findings, including the presence of high levels of carcinogens in smokeless tobacco, the metabolic conversion of smokeless Tobacco products into genotoxic agents, the fact that an association between oral cancer and smokeless tobacco has been consistently found in epidemiological investigations conducted- in a number of different places in the world, the tendency for oral cancer risks increased with duration of exposure, the strength of the association with oral cancer, and the association of the highest risk for cancers with the anatomical sites where tobacco exposures are the greatest."

A further report put in evidence was that of the first European conference on tobacco policy held in Madrid between the 7th and 11th November 1988. It is entitled "It Can Be Done" - A Smoke Free Europe. The conference was organised jointly by the WHO Regional Office for Europe; the Ministry for Health and Consumer Affairs of Spain and the Commission of the European Communities.

The following paragraph is taken from page 46 of the report:- 

"One of the most distinctly voiced concerns of conference participants was that the tobacco industry should not be allowed to encourage new forms of tobacco use such as smokeless tobacco. These products--ar6 associated with an increased risk of contracting oral cancer and other diseases of the mouth. While the use of oral snuff is traditional in some Scandinavian countries, Use of oral tobacco is almost unknown in most of Europe. Some participants, :particularly those -from countries such as Ireland, Norway, Sweden and the United Kingdom where the tobacco industry had made efforts to promote smokeless tobacco felt very strongly that pre-emptive action should be taken in Europe to prevent this novel form of nicotine administration." 

The expert evidence was extremely detailed. It lasted for approximately six days. It is not my intention to try to summarise it but simply to refer to such parts of it as are particularly relevant to the Plaintiffs' principal contention on this aspect of the case, namely, that there is a scientific controversy in regard to the effects of oral smokeless tobacco. 

I start with the experts called on behalf of the State as they gave evidence first since the onus of proof was on the State to prove that the ban came within Article 36. 

The witnesses called by the State were Dr. Alphonsus Walsh, the Chief Medical Officer of the Department of Health from 1983 to 1990. Dr. Bernard Eugene McCartan, the head of the division of oral surgery, oral medicine and oral pathology in the Dublin Dental Hospital and Consultant in oral medicine in the Dublin Skin and Cancer Hospital; Dr. O'Hickey, the Chief Dental Officer in the Department of Health; Dr. Gregory Connolly, Director of Dental Public Health in the State of Massachussets and Consultant t o the National Cancer Institute in the U.S.A.; and Miss Shane Allwright, Lecturer in epidemiology in Trinity College, Dublin.  

All of these witnesses were of the opinion that there is an association between oral smokeless tobacco and cancer. Each expressed it in a slightly different way. Dr. Walsh said he was satisfied that there is conclusive evidence that oral smokeless tobacco can cause oral cancer. Dr. McCartan believes that, there, is an overwhelming body of. opinion which associates the use of smokeless tobacco in both European societies and Asian societies with the development of cancer in the mouth. Dr. O'Hickey's opinion also was that the evidence is overwhelming because so many studies carried out under so many different circumstances and over different periods of time have come to roughly the same conclusion. Dr. Connolly's opinion was that oral snuff will increase the risk of cancer in humans. Finally, Miss Allwright, having made a rapid study within a week of most of the available literature, stated that in epidemiological terms the strength of the association between snuff and oral cancer would be considered quite strong. 

All of the witnesses were very thoroughly and expertly cross-examined by Mr. Fitzsimons on behalf of the Plaintiffs but their opinions were in no way undermined and I have no hesitation in accepting them. I have no doubt that their opinions are honestly held and were formed after careful consideration of the available data on the topic. 

Dr. Walsh gave evidence of other harmful effects also resulting from the use of oral smokeless tobacco: Leukoplakia which can be a pre-cancerous condition, developing into dysplasia and ultimately cancer, and gum recession. In addition both he and Dr. Connolly said that oral smokeless tobacco is addictive. And as regards the form of cancer which can develop, Dr. Walsh said that in the worst case it is squamous carcinoma which has a fifty per cent mortality rate in five years.  The witnesses called by the Plaintiffs were Dr. Kenneth MacRae, MaPh.D., F.I.S., who holds the post of Reader in Medical Statistics, Charing Cross and WestMinster Medical School, University of London;

Dr. Arthur Furst PhD ScD, DATS., a Toxicologist, retired Professor of Chemistry at the University of San Francisco; Torbjorn Malmfors, Toxicologist, Assistant Professor in Toxicology, Department of Toxicology, Karolinska Instituted, Stockholm; and Tony Axell, Chairman and acting full Professor Department of Oral Surgery and Oral Medicine and Head of Clinical Research Unit, Faculty of Dentistry, Land University, Malmo. 

Dr. MacRae said that in his opinion the claim that smokeless tobacco causes cancer in humans is totally unjustified from the epidemiological evidence available - it was just not defenceable on the basis of what had been published. He also said that in his opinion smokeless tobacco is not statistically associated with oral cancer. In a later part of his evidence he qualified this slightly and said that whether or not there is a statistical association in a general sense between snuff dipping and oral cancer is still unknown. Dr. MacRae criticized the epidemiological study of Dr. Deborah Winn, a summary of which appeared in the New England Journal of Medicine of March 1981, and which is one of the main studies supporting the association between oral snuff and cancer. He said that it did not give strong support to the suggestion that there is an association, but under cross-examination he said it tends in general to go in the positive direction and that it gives some support for the association. When asked if he held the view that smoking causes cancer, he said he did not. He qualified this later by saying that he was not saying that smoking does not cause cancer but that it is not established. When asked to draw the attention of the Court to any health institutes which denied the association between smokeless tobacco and cancer, he said that he could not. He has not published any paper setting out the views that he gave in evidence. 

Dr. Furst's evidence was mainly concerned with experiments on animals to see if smokeless tobacco caused cancer in animals and he said it was only in the area of animal evidence that he claimed expertise. His conclusion from a review of experiments carried out was that smokeless tobacco is not a carcinogenic substance to animals. When asked whether it causes cancer in humans, he said the question was wide open: "We don't know. I still think there is a major controversy. Some scientists say it is well known, established. I do not agree. I think we are in conflict." In cross-examination he agreed that the views he held are held by a small minority of people. The following sentences from page 89 of the report of the Advisory Committee to the Surgeon General were put to him and he agreed with them:  

"Bioassays of snuff have likewise generally shown no excess cancer, although some experiments suggest that it may cause oral tumours in rats and hamsters that are infected with herpes simplex virus. Among the chemical components of snuff, the tobacco-specific nitrosamines nnn and nnk are powerful carcinogens. The doses of nnn and nnk which produce tumours in experimental animals are close to the doses estimated from life-time exposure among human snuff dippers."  

But he said that nnk and nnn have been tested at various times -as carcinogens, and at no time have they produced oral cancer in experimental animals. Asked if smoking causes cancer, he said he did not think so because it had not been proven to him scientifically. Dr. Malmfors dealt with tobacco-specific nitrosamines which he said were a group of chemical compounds present in different tobacco products including smokeless tobacco. He described smokeless tobacco as being a complex mixture of compounds and said that the only way of making a toxicological evaluation of a complex mixture was to test the complete mixture itself. It was scientifically unsound to evaluate the separate compounds making up the mixture. In contrast with Dr. Furst's evidence, he said that nnn and nnk, tested on their own, had been shown to be animal carcinogenic. He said that he had considered the scientific literature dealing with nitrosamines and smokeless tobacco and his scientific evaluation was that nitrosamines in smokeless tobacco products do not cause adverse health effects to users of such products. In cross-examination he said he was dealing with the effect of nitrosamines on animals and animal experiments. He agreed with the following quotation from page 66 of the report of the Advisory Committee to the Surgeon General:- 

"The most prevalent organic carcinogens are the tobacco-specific n nitrosamines that are formed from the nicotiana alkaloids during the processing of tobacco leaves. Their concentrations in snuff exceed the level of nitrosamines in other consumer products by over 100 fold. During snuff dipping or chewing of tobacco, the nitrosation process continues within the mouth stimulated by oral bacteria." 

He also agreed with the following quotation from page 75 of the same report:- 

"Persuasive evidence exists that the carcinogenic nitrosamines that are present in high quantities of snuff and other forms of smokeless tobacco are metabolized by target tissues of experimental animals and by human tissues to intermediates that can modify the genetic material of the cell." 

Dr. Maimfors said he had been working as a consultant for United States Tobacco for three years doing scientific evaluations of smokeless tobacco. He had been asked to give his independent scientific view on the scientific issues with regard to smokeless tobacco, which were to evaluate the health effects. Asked what these health effects were, he said it was the possible carcinogenic effect. He had not published on the question of toxicology and tobacco use, nor had he done any research on it.  Dr. Axell said that in Sweden about ten per cent of the adult population use moist snuff, that is, about seven or eight hundred thousand people. His conclusion from his own studies, and from the literature in Sweden and Scandinavia, is that it does not cause oral cancer. There are 400 cases of oral cancer in Sweden every year and since ten per cent of the adult population use oral snuff you would be very surprised if some oral snuff users did not contract cancer. He said that four per cent of leukoplakias develop into cancer in 10 to 20 years. There are a couple of studies showing that there is a higher frequency of leukoplakias in non -users developing into cancer than leukoplakias -in users. Dr. Axell did not agree with the conclusions in either the IARC report or in the report of the Advisory Committee to the Surgeon General. He said the reason he did not agree was related to his own personal experience. He agreed that in a published work of his in the mid 1970's he had said there could be some association between oral snuff and cancer. He said that this was because he did not at all know at that time. Asked if smoking causes cancer in the lungs, he said he was not an expert in the field but there could be a relationship. 

In cross-examination Dr. Axell said that he was the author of a programme on smokeless tobacco used in all the schools in Sweden, which advised the children that using smokeless tobacco was something they. should not do. It discouraged them from starting and advised them against starting. He said he hoped the effect of the programme would be that the habit would be reduced, like all other tobacco habits. Dr. Axell said he had produced a four point scale of the changes in the oral mucosa brought about by the use of oral snuff. At the fourth point on the scale, the changes were thickening of the mucosa with intervening furrows, and there m.4Lght be some sores and ulceration. Other changes which might or might not appear were gingival recession and gingivitis. In re-examination he said the changes were not part of a malignant process and that they were reversible if the subject stopped using the snuff.

Some patients had a normal tissue three months after they stopped. In assessing the evidence it seems to me that the relevant questions I have to answer are the following:-

1. Was the ban contained in Section 6 justified when introduced in July 1988?
2. If so, is it still justified?
3. If both of the previous questions are answered in the affirmative, could the objectives of the ban have been achieved by a means which would not have restricted as much the free circulation of goods in the Community?

In considering the first question, two principles laid down by the Court of Justice are particularly relevant: firstly, that in so far as uncertainties prevail in the present state of scientific research, it is for the Member States to decide what degree of protection of health and life they intend to assure, having regard however to the requirements of the free movement of goods within the Community; and secondly, that where uncertainties persist, the Member States must take into account the results of international research.

In regard to the first of these principles, counsel for the Plaintiffs laid stress on the fact that Member States, in deciding what degree of protection of health and life they intend to assure, had still to have regard to the requirements of the free movement of goods within the community. That is undoubtly correct and it is because of this that measures which might prima facie be justified may be invalidated as contravening the principle of proportionality. I will deal more fully with this submission when considering that that principle. 

As regards the first question, I am satisfied that the ban contained in Section 6 was fully justified when it was introduced in 1988. At that time the results of international research were to be found in the IARC monograph, published in 1985, the 1986 report of the Advisory Committee to the United States Surgeon General, and the 1988 report of the WHO study group- The view expressed in these three publications was that there was sufficient evidence to conclude that using oral smokeless tobacco could cause oral cancer. From the point of view of the individual this meant that if he should use oral smokeless tobacco he would be at risk of developing oral cancer. Clearly this was a serious risk against which people had to be protected. And how were they to be protected effectively? In my opinion by ensuring that the product would not be available. If it was available, obviously some people would use it, so nothing short-o" total ban would achieve the necessary protection. In my opinion such a ban was necessary and so was justified. 

I would point out that neither in 1988 nor at the date of the date of the hearing of the action was there any published .Scientific opinion which was at variance with the conclusions expressed in the three publications I have referred to, so the -evidence before the State at the time Section 6 was enacted pointed in one direction.

Is the ban still justified? Is it still necessary? In my opinion it is. On behalf of the Plaintiffs it was submitted that there is a scientific controversy in regard to the effects caused by the use of oral smokeless tobacco. That was the evidence of some of their witnesses. But in my opinion it was not proved. All -that was established was that the witnesses who gave evidence disagree with the conclusions of the IARC and Surgeon General reports. But there was no evidence that any responsible body of scientific opinion agrees with them. In fact the evidence was the other way. Dr. Furst said that the views he held were shared by a small minority of people, and Dr. MacRae could not point to any health institute which denied the association between oral smokeless tobacco and cancer. 

If there was any scientific controversy, one would have expected that it would have been the subject of contributions to scientific journals, but none such were put in evidence. So the only evidence was the views of the witnesses called, and apart from the question of whether they established the existence of a scientific controversy, the question to be considered is whether the evidence was such that the State could now safely take the view that the use of oral smokeless tobacco does not involve any risk of developing cancer. In my opinion the evidence fell far short of establishing this. Dr. MacRae's evidence has to be looked at in the light of his statement that in his view it has not been established that smoking causes cancer. Any scientist with such a view must require exceptionally high standards of proof before accepting any proposition. A statement that the claim that smokeless tobacco causes cancer in humans is totally unjustifiable from the epidemiological evidence available has to be looked at in that light. -It must also be borne in mind that what he was rejecting was the claim that oral smokeless tobacco causes cancer. But for the State to be justified in imposing a ban, it is not necessary to prove that it causes -cancer, it is sufficient that there should be evidence that it may cause cancer or that it increases the risk of oral cancer developing, and in that regard it is significant that Dr. MacRae agreed that the research of Dr. Deborah Winn, whose work in this field is one of the most important, gave some support to the association between oral smokeless tobacco and cancer. I am satisfied that there was nothing in Dr. MacRae Is evidence -which would require me to come to the conclusion that the ban is no longer justified.

The evidence of Dr. Furst and Dr. Maimfors was concerned principally with the result of experiments carried out on animals. They said it had not been established that oral snuff was carcinogenic to animals. But that was accepted in the conclusion in the IARC monograph. One of the conclusions was that "There is inadequate evidence to evaluate the carcinogenisity of chewing tobacco, snuff or nass to experimental animals In spite of having come to this conclusion the IARC scientists were nonetheless of the opinion that there was "sufficient evidence that oral use of snuff of the type commonly used in North America and Western Europe is carcinogenic to humans". So the fact that Dr. Furst and, Dr. Malmfors found no evidence of its carcinogenisity to animals did not take away from the IARC conclusion. Their conclusion was not based on smokeless tobacco being carcinogenic to animals, so experiments showing that it is not are not inconsistent with it. For this reason the evidence of Dr. Furst and Dr. Maimfors did not persuade me either that the ban was no longer justified.

Finally, Dr. Axell's evidence. While he said he disagreed with the conclusions in the IARC monograph and the Surgeon Generals. report, parts of his evidence could only be regarded as supporting the attitude of the State. He is the author of a programme used in all the schools in Sweden, the purpose of which is to prevent children starting to use oral snuff. The programme advises them against using it and encourages them not to start. Dr. Axell was extremely evasive when asked why he had put together such a programme. He said that it was because using oral snuff was expensive and because it was something that it was not necessary to do. But Dr. Axell is neither an economist nor a moral theologian. He is a dentist and a professor of oral surgery and oral medicine, and it is in that capacity that he composed the programme. So its purpose clearly was connected with oral health, to try to ensure that children would avoid the health risks associated with using oral snuff. He did not agree it could cause cancer, but he described how it could effect changes in the oral mucosa, and said he had produced a four point scale of the changes, the fourth of which could give rise to sores and ulcers. In my opinion his evidence confirms rather than disputes that the ban is still justified. One of the submissions most strongly advanced by the Plaintiffs was that there is a scientific controversy in regard to the effects of smokeless tobacco and that because of this the ban is not justified. As I said earlier, I do not accept that there is such a controversy. But even if the fact that some scientists disagree with the conclusions in the IARC monograph and the Surgeon General's report could be termed a scientific controversy, I do not think that that would effect the position. One has to look at the underlying facts which are said to support the existence of a controversy. And the underlying facts are that IARC, the premier international agency for cancer research; the scientists who prepared the Surgeon General's report, and the experts in the WHO study group, all take the view that using oral snuff can cause cancer.

The State had that evidence before it and clearly had to take it into account in deciding what action it would take. And is that evidence any the less to be taken into account because there is a minority of scientists who disagree with it? In my opinion, no, because the State is obliged to protect its citizens against the risk of the majority authoritative view being correct, particularly when what is involved is a risk to life. it seems to me that the State would be failing in its duty to its citizens if it were to act otherwise. 

The final question on this issue is as to whether the ban offends against the principle of proportionality. The Plaintiffs submitted that it did; that it went beyond what was necessary to achieve the State's objective and that measures less restrictive of the free circulation of goods would be adequate. In order to consider this submission, it is necessary to start by setting out again the relevant principles as enunciated by the Court of Justice. "According to a consistent line of decisions of the Court, it follows from Article 36 that a national measure which has, or may have, a restrictive effect on trade is compatible with the Treaty only in so-far as it is necessary for the purpose of effectively protecting human life and health. The proviso in Article 36 cannot therefore apply where human life and health can be protected just as effectively by measures less restrictive of "intra-Community trade." (CMC Melkunie BV 1984 ECR page 2384 (paragraph 12)) 

"However, such measures are justified only if it is established that they are necessary in order to attain the objective of protection referred to in Article 36 and that such protection cannot be achieved by means which place less of a restriction on the free movement of goods within the Community." (Commission v. Belgium 1983 ECR 531 at page 543 (paragraph 12)) 

"Nevertheless the principle of proportionality which underlies the last sentence of Article 36 of the Treaty requires that the power of the Member States to prohibit imports of the products in question from other Member States should be restricted to what is necessary to attain the legitimate aim of protecting health."(Sandoz 1983 ECR page 2445 at page 2463 (paragraph 18)) 

The Plaintiffs submitted that the regulations in force in regard to cigarettes - restrictions on advertising, sponsorship and sale to persons under 16 years of age, and requirements of a health warning to be included in advertisements and printed on packets - must be taken to be adequate to deal with the health risks involved, and so should be adequate to deal with the health risks involved in the use of oral smokeless tobacco also. In my opinion this submission is unsound. To start with, it should be noted that even if it were factually correct it does not satisfy the requirements laid down by the Court of Justice. For a measure to be held to contravene the principle of proportionality, it must be shown that human life and health can be protected just as effectively by a less restrictive measure. But this is not what is submitted. All that is submitted is that the existing regime of restrictions would be adequate. It was not submitted that it would be effective, and certainly not that it would be as effective as the ban.

Apart from this, I am satisfied that the submission is not factually sound. There was no evidence that the regulations in force in regard to cigarettes are adequate to deal with the health risk involved. On the contrary, Dr. Walsh said that they were a second best and Dr. O'Hickey said that the prohibitions are not observed, that around the city one can see children of the ages of eight or ten smoking. So clearly the current regulations are not sufficient to prevent children under the age of 16 from starting to smoke. And if they are not sufficient to prevent children from starting to smoke there is no reason to believe that they would be sufficient to stop children using oral smokeless tobacco either. So the only conclusion one can come to is that the current regulations, if applied to oral smokeless tobacco, would not be as effective as a total ban on the import of the product. 

In these circumstances I am satisfied that the ban contained in Section 6 does not-offend against the principle of proportionality. It would only do so if the measures favoured by the Plaintiffs would have been as effective as the ban, and I am satisfied that they would not.  

The Plaintiffs also submitted that the non-existence of smokeless tobacco on the market in Ireland should not give the State greater powers under Article 36 than those possessed by other Member States. Article 36 would operate in a discriminatory fashion if one Member State had greater powers under it because a product was not in free circulation on its market. In my opinion this submission is based on a false hypothesis. It assumes that a State could not under Article 36 impose an import ban on a product which up to then had been freely available on the market. Such an assumptionis without foundation.

The right of a Member State to impose an import ban is in no way dependent on whether the product in question is already being imported or not. The sole issue is whether the ban is justified on grounds of the protection of the life and health of humans. Whether the product is or is not being imported at the time is a neutral factor. A Member State in which smokeless tobacco is in circulation has no less of a right to impose an import ban than a State which has never previously imported it. 

Related to this submission was another contention of the Plaintiffs, namely, that the State's case was based on the fact that smokeless tobacco had not up to now been imported into Ireland, and they claimed that this fact was no justification for the ban. But this was not the basis of the State's case. The State's defence of Section 6 is-grounded on Article 36: that the ban is justified on grounds of the protection of the health and life of humans. The only relevance of smokeless tobacco not having previously been on the market here is that it makes the ban practicable. If smoking tobacco was in the same situation, it also would have been banned. The reason it has not been, is not because it is thought that a ban would not be justified, but because it is believed that it would not be effective. The fact that smoking tobacco is freely available on the market here does not effect the State's right to impose an import ban, it only effects the advisability of taking such a decision. As I said earlier, insofar as the State's right is concerned, it is a neutral factor. 

I am satisfied accordingly that the State has established that Section 6 comes within Article 36 as being justified on grounds of the protection of health and life of humans, and it does not offend against the principle of proportionality. 

There is one further matter that I should deal with before turning to the Plaintiffs' alternative claim based on the two Council Directives. Both the Plaintiffs and the State referred to what the text books call the "rule of reason" and what Mr. Fitzsimons preferred to call a "mandatory requirements rule". It is a rule which permits exceptions to be made to the prohibition contained in Article 30. I mention it only because it was referred to-in the course. of the argument. In my opinion it has no relevance in a case where-one of the exceptions provided for in Article 36 has been established. In such a case the party is relying on an express exception contained in Article 36 and does not have to have recourse to exceptions equitable in nature which are to be found in the jurisprudence of the Court of Justice under the relevant rule. That is the position here, and accordingly it is not necessary to consider submissions based on the rule. 

I now turn to the two Directives, the first of which is Council Directive of the 13th November 1989 (89/622/EEC), referred to in argument as the "labelling" Directive. Its objective, as stated in Article 1 of the Directive is "the harmonization of the laws, regulations and administrative provisions of the Member States concerning the warnings regarding health to appear on the unit packet of tobacco products and the indication of the tar and the nicotine yield to appear on cigarette packets, taking as a base a high level of health protection by reducing the harm done to health by tobacco addiction." 

In my opinion there is nothing in the Directive which could effect the validity of Section 6. It is concerned solely with introducing common rules concerning labelling. It does not prevent Member States from laying down their own requirements concerning the import, sale and consumption of tobacco products. Article 8 (2) provides as follows:- 

"The provisions of this Directive do not affect the right of the Member States to lay down, in. compliance with the Treaty, requirements concerning the import, sale and consumption of tobacco products which they deem necessary in order to protect public health, provided such requirements do not imply any changes to labelling as laid down in this Directive."

The Plaintiffs submitted that this provision permits in regard to imports, the State to make regulations in tobacco products but not to impose a ban. In my opinion that is not the correct construction of the Article. What the Directive is stated not to affect is "the right of Member States to lay down, in compliance with the Treaty, requirements concerning the import, sale and consumption of tobacco products". A ban is such a requirement. It is a requirement that the products be not imported. And it is not excluded by the proviso with which the sub-article concludes. A ban could not imply any changes to labelling as laid down in the Directive; it does not impose any form of labelling since it prohibits totally the import of the product. 

Even if my view as to the construction of Article 8 (2) should not be correct, in my opinion there is still no doubt that the Directive could not effect the ban. The only prohibition in the Directive is that contained Article 8 (1) which is as follows:- So Member States may not, for reasons of labelling, prohibit or restrict the sale of products which comply with this Directive." 

That clearly does not affect Section 6 as the import and sale of smokeless tobacco is not being prohibited for reasons of labelling, but for reasons of public health. In the absence of any other prohibition, and there 'is none, there is nothing to prevent the State. from relying on the exception in Article 36 of the Treaty, as it has done. The to me to be unnecessary as declaration in Article 8 (2) seems it must follow from the fact that it is only for reasons of labelling that Member States may not prohibit o r restrict the sale of products which comply with the Directive, that there is no restriction on Member States prohibiting or restraining the import or sale of such products for other reasons. So imposing a ban for reasons of public health is not prohibited. lam satisfied accordingly, that the Directive does not in any way affect the validity of Section 6. 

The second Directive relied on by the Plaintiffs was Council Directive of the 28th of March 1983 (83/189/EEC) as amended by Council Directive of the 22nd March 1988 (88/182/EEC), jointly referred to as the "notification" Directive.

The Directive requires that draft technical regulations be communicated to the Commission. The Plaintiffs contend that Section 6 is such a regulation; that it ought accordingly to have been communicated to the Commission when in draft; and that failure to communicate it makes Section 6 unenforceable. In reply to this contention the State submitted-that the products to which the 1983 Directive applied did not include oral smokeless tobacco as the definition of "product" in that Directive excluded agricultural products and products for human consumption; and that while oral smokeless tobacco came within the amended definition in the--1"8-Di-rective --as that Directive fixed the is January 1989 as the date by which compliance was required, it was not in force when the 1988 Act was passed in July 1988. It was also submitted that Section 6 is not a technical regulation, technical. specification, or technical standard, and for that reason also-the Directive did not apply to the section.

It seems to me that this latter submission is well founded. The obligation under Article 8 of the Directive, which is the Article with which the Plaintiffs contend the State ought to have complied, is that "Member States shall immediately communicate to the Commission any draft technical regulation, except where such technical regulation merely transposes the full text of an international or European standard in which case information regarding the relevant standard shall suffice........Technical regulation is defined as including "technical specifications" and technical specification is defined as being:- 

"A specification contained in a document which lays down the characteristics required of a product such as levels of quality, performance, safety or dimensions, including the requirements applicable to the products as regards terminology, symbols, testing and test methods, packaging, marking or labelling." 

In my opinion Section 6 is not a specification. It does not lay down the characteristics required of oral smokeless tobacco - it simply defines "smokeless tobacco" for the purposes of the section. There is nothing in the definition to suggest that in order to come within the definition the product or substance, made wholly or partly of tobacco, had to be . of a certain level of quality, or comply with certain dimensions or have any particular characteristics. It is clearly a definition only and not a specification. For this reason Section 6 is not in my opinion a technical regulation and so there was no obligation on the State to communicate it to the Commission under the Directive. Apart from this, there was a further obstacle to the Plaintiffs' submission succeeding. No authority was cited to me in support of the contention that a failure to comply with the Directive would make Section 6 unenforceable. It seems to me that it does not necessarily follow that it would, and in the absence of authority I would not have been prepared to hold that it did. For this reason also I reject the Plaintiffs' submission based on the "notification" Directive. It follows that the Plaintiffs' claim fails in toto and must be dismissed.

 Doc No. 0633J(ANK)