Tobacco is unlike any other legal product. It is grown by farmers; processed, packaged, distributed and marketed by the tobacco industry; sold by retailers; taxed by governments; trafficked by smugglers; and smoked by millions of people worldwide. It is unique, in that it kills large numbers of its consumers when used exactly as intended by the manufacturers.

Roughly 50% of regular smokers die early: on average each loses about 14 years of normal life. Recent calculations suggest that every cigarette smoked by a regular smoker shortens his or her life by six minutes. Overall, tobacco-related disease kills 500,000 EU citizens each year – an entirely avoidable waste of life.

Yet the death toll persists, despite the fact that all those involved in the business (including most customers) know the risks that they are running. Why? The smoker smokes, because he or she is addicted to the nicotine in the tobacco. Most have picked up the habit as children or teenagers. This is the age group that the industry has to target in order to maintain sales as older smokers die off. Once addicted, a life-time of smoking (and a captive market for the tobacco industry) is virtually guaranteed. Unfortunately, to get their nicotine ‘kick’, smokers expose themselves to a cocktail of toxins contained in the tobacco and in various ingredients added during the manufacturing process.

The industry has no hesitation in marketing its products, whatever the cost in human misery and unnecessary premature death. Until recently the industry managed to escape virtually any control, due largely to historical accident. Tobacco had been marketed and used for hundreds of years before the direct causal relationship between smoking, disease and premature death came to be clearly understood in the mid 1900’s. If tobacco were to be introduced as a new product today - knowing what we know today - no government would possibly allow it to be marketed.

So, today, various jurisdictions around the world are adopting an increasingly rigorous approach to the regulation of tobacco products and the tobacco industry. In doing so, they recognise that they have a prime responsibility to protect the health of their individual citizens and that of the community as a whole.

This Directive is a step in the same direction. Representatives of all fifteen Member States welcomed the Directive, when it was announced by Commissioner David Byrne at the EU Health Council meeting on 18^th Nov 1999. Now the Council has to examine the content of the Directive in detail. So do the European Parliament, ECOSOC and the Committee of the Regions.

Voluntary health organisations throughout Europe have tracked the development of the Directive during the past few months. A Consultation was held in London, at the end of Jan 2000, to agree a detailed response to the text of the Directive, as adopted by the Commission in mid-November. This briefing paper is based on the outline agreement reached at that time.

Many of the networks most active in tobacco control were represented at the London Consultation, including the European Cancer Leagues (ECL), the European Heart Network (EHN), the European Network on Smoking Prevention (ENSP), the European Respiratory Society (ERS), the Federation of European Cancer Societies (FECS), the International Network of Women against Tobacco (INWAT), the International Non Governmental Association against Tobacco (INGCAT), the International Union against Tuberculosis and Lung Disease (IUATLD) and the International Union against Cancer (UICC).

No single measure will reduce the harm that tobacco does to society. It is necessary to develop, implement and maintain a broad range of measures designed, on the one hand, to make the industry increasingly accountable for the damage caused by its products and, on the other, to remove the risk to individuals by persuading them not to smoke.

An overall tobacco control strategy will therefore include measures to:

• restrain advertising
• provide effective health warnings
• de-glamorise the image of smoking
• regulate the content of the product to minimise harm (whilst recognising that there is no such thing as a safe cigarette)
• protect minors by controlling their access to tobacco products
• raise selling prices through higher taxes
• block smuggling to prevent cheap products flooding the market
• phase out subsidies for tobacco farming
• hold the industry accountable for the harm caused to individual smokers
• promote healthy lifestyle campaigns, to persuade young people not to start smoking
• provide advice, support and treatment programmes to help people quit smoking

There is one thing that a tobacco control strategy cannot do, namely to cure those suffering from many forms of tobacco-related disease. Once a diagnosis of lung cancer has been made, for instance, it is too late for effective intervention. For the individual smoker, given such a diagnosis, life is quickly coming to an end. Tobacco is the ultimate proof of that age-old homily: ‘prevention is better than cure’. For most of those suffering from tobacco-related disease, there is no cure. Only prevention will do.

The present Directive seeks to strengthen and extend some of the ‘preventative’ measures already taken by the EU, in the face of the tobacco epidemic experienced by all Member States. It is a recasting of three previous Directives (89/622/EEC, 90/239/EEC and 92/451 EEC) which deal with the tar content of cigarettes, oral tobacco and the labelling of tobacco products. It updates various provisions, taking into account the experience of implementing the existing Directives and recent developments in science and technology. It is framed as a further step towards completion of the Internal Market, respecting the Treaty requirement to ensure a high level of human health protection.

Health sector NGO’s welcome proposals to introduce tougher controls on the content and packaging of tobacco products. However, we believe that certain aspects of the Directive could be modified or strengthened in order to maximise its potential benefits in terms of public health protection. These are described in the next section.

We also believe that there is no need to delay the implementation of several provisions within the Directive until Dec 2003. The Directive deserves to be progressed quickly through the EU decision-making process. Given the political agreement within the Council, and looking forward to sympathetic support in the Parliament, a ‘fast track’ approach seems well within the realms of possibility. The Directive could therefore easily take effect in Dec 2002.

But at the heart of our concerns there is a problem, namely the continuous development in our understanding of how tobacco can be manipulated in the manufacturing process, the impact that this has on individual smoking behaviour and consequent changes in morbidity and mortality trends amongst different groups of smokers. The potential for tobacco control evolves as our knowledge of science and technology advances, and as measurement standards and techniques catch up.

The tobacco industry will doubtless argue that this provides a good reason to do nothing. We argue, on the contrary, that it is a good reason for doing as much as we can now, given our present state of knowledge, to reduce the harm caused by tobacco; but, at the same time, to adopt a flexible approach that will allow for further advances in our understanding of the problem to be brought into use as quickly as possible. By this we mean a process of continuous review and recommendation, leading if necessary to appropriate modifications in the application of the Directive.

So we strongly urge the establishment of an effective Regulatory Committee, charged with responsibility to monitor the implementation of the Directive. We suggest a broad-ranging terms of reference (see our proposal concerning Art 10, below), which we regard as absolutely essential to the future success of the EU’s ongoing commitment to reduce the tobacco epidemic throughout Europe.

Here we identify the various Articles in the Directive, comment on the Commission’s proposals and add our own recommendations.

Commission proposal:

Clarifies the meanings of various words in the Directive, including a definition of the word ‘ingredient’.

Comment:

The proposed definition is too narrow. It allows for non-tobacco additives, but does not specify materials used in the manufacturing process (residues of which may remain in the final product). Nor does it specify the materials surrounding the final product, as lit and smoked.

Recommendation:

The definition of ‘ingredient’ should be widened, to cover every component of the product that is smoked other than natural tobacco (but identifying whether the tobacco has been genetically modified), including all additives and flavourings, contents such as paper, ink and filters, and materials used in the manufacturing process (such as adhesives etc.), present in the finished product – in burnt or unburned form.

Commission proposal:

Maximum yields of Tar 10 mg, Nicotine 1 mg, Carbon Monoxide 10 mg;

with effect from 31 Dec 2003

Comment:

For the past few years, tar yields have been regulated in the EU on the assumption that lower tar levels reduce the damage caused to smokers; or, put more simply, that ‘lower tar = harm reduction’. Research evidence now suggests that this may not be so. Indeed, possibly the reverse is the case.¹ Most ‘low yield’ cigarettes achieve their lower ratings because of filter characteristics, namely ventilation holes in the tipping paper at the mouth end. Most smokers unconsciously block these filter holes with their lips and fingers. They are therefore exposed to higher tar and nicotine yields than those measured by machines – which are the yields printed on the side of the pack.²

It has become clear, following the release of tobacco industry documents in litigation in the United States, that the industry has manipulated ingredients and additives in the manufacturing process, altering the flavour of low tar products to make them more palatable (and therefore more desirable) for the smoker:

‘Irrespective of the ethics involved, we should develop alternative designs (that do not invite obvious criticism) which will allow the smoker to obtain significant enhanced deliveries should he so wish’. (BAT Co., 1984)³

This makes the cigarette easier to smoke. The smoker inhales more deeply, drawing dangerous toxins further into the lungs.⁴ This may be the cause of an apparent increase in the incidence of adenocarcinoma of the lung, especially amongst young women who are more likely than men to smoke ‘low tar’ cigarettes.⁵

At present, the EU does not regulate for maximum yields of nicotine or carbon monoxide; although several individual Member States do so. The proposal for a harmonised approach throughout the EU is welcome.

Given the continuous change in our knowledge of tobacco ingredients, the proposed Regulatory Committee (see below) should maintain a constant review of emerging scientific and technical evidence, and be charged with recommending any further changes to maximum yields that appear to offer clear benefits in terms of health protection.

The implementation date does not need to be delayed to Dec 2003. The Article refers to cigarettes ‘marketed or manufactured in the Member States’. It is not clear whether this covers export markets. However, the same harm reduction concerns should apply to smokers everywhere, not just in the EU. The Article should be worded explicitly to include cigarettes intended for export, as well as the EU market.

Recommendation:

The maximum tar yield should remain at 12 mg. Maximum yields of 1 mg for nicotine and 10 mg for carbon monoxide should be welcomed.

The implementation date should be brought forward by one year, i.e., to 31 Dec 2002.

The wording needs to be strengthened, to ensure that cigarettes manufactured for export are clearly included within the provisions of the Article.

Proposal:

Greece is allowed a derogation until 31^st Dec 2006, before it has to introduce the proposed lower tar yield of 10 mg.

Comment:

The present Directive (90/239/EEC) limits the tar yields of cigarettes marketed in the Member States to 12 mg as from 31^st Dec 1997. There is an exception for Greece (known as a ‘derogation’), which delays the requirement to move from 18 mg to 15 mg to Dec 2000, and from 15 mg to 12 mg to Dec 2006.

The proposal in the new Directive therefore means that Greece would have to complete the move to 10 mg by the date at which it is now required to achieve 12 mg.

However, our earlier recommendation - to retain the maximum tar yield at 12 mg throughout the EU - means that the present derogation for Greece would not need to be altered in this way.

Recommendation:

No change in the existing Derogation is required, if the overall tar yield is retained at 12 mg.

Proposal:

The measurement of tar, nicotine and carbon monoxide yields should continue to be based on existing ISO methods. Tests should take place annually. Trade secrecy should be respected.

Comment:

At present, cigarette yields in the EU are measured according to International Standards Organisation (ISO) testing methods. The ISO method is almost identical to the Federal Trade Commission (FTC) standard, which is the measurement standard used in the United States. Both standards were developed by the tobacco industry. Yields are assessed according to results given by a smoking machine which draws a puff of 35^cm3 volume over two seconds every sixty seconds until the cigarette has burned down to a fixed butt length. Both the tobacco industry and the FTC now accept that this test does not accurately reflect the smoking rate or manner of a real smoker:

‘We now know that the way a person smokes affects the amount of tar and nicotine they get. The present system does not reflect this.’ (FTC Press Release, Sept 1997)

‘The smoker profile data reported earlier indicated that Marlboro Lights cigarettes were not smoked like regular Marlboros. There were differences in the size and frequency of the puffs, with larger volumes taken on Marlboro Lights by both regular Marlboro smokers and Marlboro Lights smokers.’ (Philip Morris, 1975)⁶

‘I did, however, point out that measurement of tar yields, or indeed any smoke yields, under laboratory conditions bore no direct relationship to any individual’s exposure to any substance.’ (Philip Morris executive 1978)⁷

Unfortunately, whilst we know that the ISO system is flawed, there are no practical alternatives available at present.⁸ It is logical, therefore, to refer to existing tests and standards in the Directive only insomuch as these offer a point of reference to the one methodology that is currently available worldwide. The Directive cannot be based on something which does not yet exist. However, the Directive as a whole has to offer a solution to this problem. A Regulatory Committee should be established (see below), tasked to identify new standards and testing technologies and to recommend their implementation within a given time frame. Moreover, the EU should not continue to depend on FTC/ISO systems, but should devise its own independent testing regime for the future. One possibility would be to ask the Brussels-based European Standards Centre (CEN) to develop a new EU regulatory standard.

The tobacco industry invests heavily in product development. Individual brands are continuously adapted to changes in scientific understanding, production processes or market conditions. The test results required in this article should be provided more frequently than once a year, in order to keep up with the rate of change between competing brands.

The Article includes a commitment to trade secrecy. However, there is no obligation to respect ‘trade secrecy’ when public health is at risk. This principle has been recognised in other countries, such as the province of British Columbia in Canada, which obtained such disclosure and made it publicly available in 1998.⁹

Recommendation:

Add an additional recital, along the following lines: ‘Whereas steps should be taken to identify and fund an independent testing laboratory within the EU, to develop and implement appropriate European standards and testing methodologies’.

Delete the requirement for annual reporting and substitute ‘six monthly’.

Delete Art 5.5 concerning trade secrecy

Proposal:

Tar, nicotine and carbon monoxide yields should be printed on one side of the packet. Unit packs should carry one of two general warnings: ‘Smoking kills’ and ‘Smoking can kill’, and another warning drawn from an approved list of alternatives.

Comment:

Yields should not be publicised, because this seems to imply harm reduction. It also contradicts the intended purpose of Article 8 (on product descriptions).

The phrase ‘Smoking can kill’ implies that it may or may not kill. However, there is no ‘if or but’ about smoking: it does kill. The first of the two general warnings - ‘Smoking kills’ - is the only one that is valid, and is therefore the only one that should be authorised.

The space suggested for the general warning (25% of the most visible surface) is less than that already adopted in one of the accession countries (30%, in Poland). We should not run the risk of diminishing existing legislation in a neighbouring country likely to be amongst the first wave of new EU Member States.

Moreover, there is clear evidence from recent Canadian research that the size of the health warning message has a direct influence on the decision to stop smoking: the larger the message, the more effective it is.¹⁰

It is not clear whether the proposed black border (3-4 mm in width) is in addition to, or within, the proposed 25% proportion. This needs to be specified, otherwise the industry will take the opportunity to reduce the warning to the bare minimum required.

The type face to be used is specified (Helvetica), but not the colours – other than black and white. This gives scope for the industry to print warnings in two slightly contrasting shades of grey. Pantone numbers for deep black and bright white would remove any doubt or possible legal challenge.

The Article does not specify where the main warning should be placed on the ‘most visible surface’ of the pack. The smoker opens the pack at the top. This would be the most logical location for the warning.

There is no mention of a quitline, or access to smoking cessation advice – despite the fact that we know many smokers would dearly like to quit, and the most direct way of communicating with smokers is on the packaging of the products that they smoke. This is a missed opportunity and should be remedied.

Around the world, the industry has proved itself adept at avoiding or manipulating legislation (or voluntary agreements) designed to warn smokers of the dangers inherent in the product they are smoking. It is important to leave absolutely no ambiguity as to what is intended – the size, location, colour etc. These have to be specified quite clearly.

Recommendation:

Art 6.1 should be amended to the effect that smokers are exposed to tar, nicotine, carbon monoxide and other toxins – without specifying actual or maximum yields. The tobacco industry should be denied the right to quote maximum yields themselves.

The space allocated for this purpose should amount to 30% (35% for two and 40% for three languages) of both the front and the back - the ‘most visible surfaces’ - of the pack.

A new paragraph should be added, mandating a quitline or smoking cessation message (to include a telephone number or website address according to circumstances in the different Member States) to be printed on the opposite side of the packet. This should occupy exactly the same dimensions as the message concerning tar and nicotine etc.

Unit packs should carry just one general warning (Art 6.2), i.e., ‘Smoking kills’. The option of a second general warning (‘Smoking can kill’) should be deleted.

The effectiveness of the ‘additional warnings’ list should be reviewed annually by the Regulatory Committee. In the meantime, two further warnings should be added already to the additional ‘alternative list’, namely ‘Smoking causes emphysema’ and ‘Smoking causes impotence’.

The general warning should occupy the top part of the ‘most visible surface’ of the pack. The precise location of all the warnings (front, back and both sides of the pack) should be clearly identified, with the dimensions specified, on an illustration of a cigarette pack to be included as an extra annexe to the Directive.

The pantone numbers of permitted black and white colours should be specified.

The black border (3-4 mm wide) surrounding the various warning messages must be additional to the surface covered by the text, and not included as part of the mandated area (30%).

Proposal:

Tobacco manufacturers and importers should disclose all tobacco ingredients to Member States’ authorities, by brand name. This shall be done annually, starting not later than 31 Dec 2003. Trade secrecy shall be respected.

Comment:

The article requires lists of ‘all ingredients and quantities thereof’. It does not refer to actual yields, nor to what happens to any of the ingredients under combustion – i.e., the burned form, inhaled by the smoker. This should be rectified.

The article requires manufacturers to demonstrate that ‘ingredients are safe for the health of the consumer’ when used as intended. This is fine as far as it goes, but it does not include the possible effect of interaction between ingredients. Some of these may be ‘safe’ in themselves; but mixed together they may have the effect of enhancing nicotine delivery and sustaining or increasing addiction.

The comments concerning export markets (Art 3) and disclosure and trade secrecy (Art 5) apply here also.

Recommendation:

The requirement to disclose all tobacco ingredients should be amended to include tar, nicotine and carbon monoxide yields. The industry must prove that ingredients are safe and do not induce dependence, both separately and when mixed with one another.

The requirement as applied to manufacturers of tobacco products should clearly apply to products intended for export, as well as to those for the EU market.

Disclosure should be required six monthly. The commitment to trade secrecy (Art 7.2) should be deleted.

The implementation date should be brought forward by one year, i.e., to 31 Dec 2002. The date for the first submission required from the industry should become 01 Jan 2003.

Proposal:

The use of terms such as ‘light/ultra/mild’ shall be prohibited, unless authorised by the Member States

Comment:

The use of these terms by the tobacco industry is intended to convey a sense of less harmful (maybe even safe or healthy) as compared to ‘normal’ cigarettes. This is clear from internal tobacco industry documents from 30 years ago:

‘Manufacturers are concentrating on the low TPM (tar) and nicotine segment in order to create brands ….. which aim, in one way or another, to reassure the consumer that these brands are relatively more ‘healthy’ that orthodox blended cigarettes.’ (BAT Co., 1971)¹¹

So the proposal to ban their use is welcome. However, there is no logic in suggesting that the ban should apply in some Member States and not others. The terms should not be permitted anywhere in the EU.

The expression ‘terms’ refers to words only. The tobacco industry uses graphic design and imagery, in addition to words, to convey the ‘benefits’ of one product as against another.

Recommendation:

The last phrase of Art 8.1 (after the word ‘prohibited’) and the whole of Art 8.2 should be deleted.

The first sentence of Art 8.1 needs to be expanded, to limit the industry’s scope for manipulation, by inserting a phrase such as:

… ‘mild’ or any other similar terms, graphics and product design features, which have the aim ….

Proposal:

The review process is delegated to the Commission, which is required to submit biennial reports to the Council and Parliament from 31 Dec 2005 onwards.

Comment:

This proposal is too weak, and the proposed time frame is far too lengthy, given the fast-changing nature of tobacco production and marketing, of the science and technology of testing standards and methods, and of the epidemiological evidence of trends in morbidity and mortality.

Recommendation:

A Regulatory Committee should be appointed specifically to track developments in the field of tobacco products, to make recommendations on testing standards and methodology based on new scientific developments, to monitor health trends resulting from tobacco consumption and to review the level of protection offered to consumers through the implementation of the Directive.

The first biennial report should be required within one year of the Directive coming into operation, i.e., by 31 Dec 2002.

Comment:

In its 1997 Report on ‘Fraud in the Transit System’, the European Parliament drew attention to the major loss of excise revenue experienced throughout the EU as a result of tobacco smuggling. However, smuggling is not only a tax dodge. Because cigarettes are price elastic (i.e., the cheaper they are, the more they are bought) black market products are particularly attractive to young people. This is the target audience of the tobacco industry, in its attempts to secure future long-term sales.

So the tobacco industry benefits from smuggling in two ways. It sells more cigarettes now (at absolutely no loss to its own revenues, for even smugglers have to pay the industry’s factory gate prices). And it sells more cigarettes later: it is happy to see cigarettes sold at any price (even in competition with its own duty paid products) because this serves to consolidate future sales:

‘Where any government is unwilling to act or their efforts are unsuccessful, we act, completely within the law, on the basis that our brands will be available alongside those of our competitors in the smuggled as well as the legitimate market.’¹²

The EU has an interest in the harmonisation of excise duties on tobacco; and in ensuring that those duties are collected, in order to avoid loss of revenue. In its commitment to a ‘high level of human health protection’, the EU also has a direct interest in minimising tobacco smuggling. It is a pity, therefore, that the opportunity is not taken in this Directive to tighten up regulations covering the transit system, by way of introducing checks to ensure that individual consignments can be traced from the factory to the point of sale.

Recommendation:

An extra paragraph should be added to Article 6 (Labelling), requiring the industry to place special markings on unit packs of tobacco products and also on the packaging (boxes and cartons etc.) of tobacco products distributed for wholesale or retail use, identifying the factory, date of manufacture, country of provenance and the intended final destination.

This could be done by printing the details clearly on the packs, or by means of a stamp, bar code or other form of security marking – provided that the method adopted had previously been agreed by, and was accessible to, the customs authorities in the relevant Member States.

However, we would also like to see identifying markings on tobacco products for reasons of public health protection. All other products on sale in the EU bear batch markings, which enable Member State authorities to recall unsafe products. Tobacco products should not be treated any differently. If a tobacco product exceeds legal tar, nicotine and/or carbon monoxide yields, or fails to comply with any other aspect of EU regulation, it should be withdrawn immediately. The use of identifying markings on tobacco products will allow this to be done effectively and rapidly.

International Union against Cancer
and the
Association of European Cancer Leagues
EU Liaison Office
33 rue de Pascale
B-1040 Brussels
Tel: (32) 2 230 20 27
Fax: (32) 2 231 18 58
E-mail: hayes@globalink.org