Issue No 1, April 2000

The EU Directive on Tobacco Product Regulation

• Commission proposal
• Response from the health lobby

Briefing papers

Industry quotes

On 16^th Nov 1999, the Commission agreed a proposal to recast three existing Directives which deal with the tar content of cigarettes, oral tobacco and the labelling of tobacco products. The new proposal updates the provisions that currently regulate tobacco product design and manufacture. It also strengthens requirements for package labelling and health warnings. These suggested improvements are based on recent developments in scientific understanding, and on the lessons learnt from implementing the existing Directives.

The principal features of the Commission’s proposal are:

1 Product modification

The maximum permitted tar yield is to be reduced from 12 mg to 10 mg. Maximum yields for nicotine (1 mg) and carbon monoxide (10 mg) are introduced at EU level for the first time. Measurements are to be undertaken on standard smoking machines, according to present ISO specifications.

2 Health warnings

Health warnings are to be bigger and bolder than previously. Now covering 25% of the main surfaces (i.e., front and back) of the pack, warnings are to be printed in black and white – to stand out clearly from the pack design. Tar, nicotine and carbon monoxide yields are to be printed on one side of the pack.

3 Ingredients disclosure

All ingredients and additives used in tobacco products are to be disclosed to Member States’ governments. The tobacco industry has to provide reasons for their use and evidence that they are safe in burnt and unburned form.

4 Product descriptions

Terms such as ‘light/ultra/mild’, that give the impression of harm reduction, are to be banned unless approved by individual Member States.

5 Implementation and report process

The Directive should come into force by 31 December 2001. Products already manufactured at that time may continue to be marketed for a transitional period of two years. The European Commission is to prepare a report on the application of the Directive by 31 December 2005, and every two years thereafter.

For hundreds of years, tobacco products have escaped virtually any regulation. This is an accident of history: tobacco use was already well entrenched in many societies throughout the world before the direct link between tobacco consumption, ill-health and premature death was first clearly recognised in the mid 1900’s. Now, tobacco stands unique as one of very few (perhaps the only) legally available product that kills many of its consumers: 500,000 people each year in the EU alone. Half of all regular smokers die as a result of tobacco-related disease. On average, each loses about 14 years of normal life.

It is the responsibility of governments, and of inter-governmental bodies, to protect the health of their citizens. In the case of the EU, this responsibility was clearly established by the Maastricht Treaty and confirmed again in the Amsterdam Treaty: ‘A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities’ (Art 152). This requirement is repeated in other articles of the Treaty, including the article concerned with the completion of the Internal Market (Art 95), which ‘will take as a base a high level of protection’.

So it is good to see the Commission responding to these concerns and introducing legislation that begins to tackle one of the major anomalies of our time: unrestricted marketing of a product that kills when used exactly as intended by the manufacturers. This move can scarcely come as a surprise to the tobacco industry. Evidence recently unearthed from industry archives shows that the industry has long understood the deadly nature of its products. It should now take the opportunity to prove that it has the real interests of its consumers at heart and negotiate to ensure that effective regulation is introduced, implemented and respected.

Will the Commission’s present proposals achieve effective regulation? The answer has to be ‘yes’ and ‘no’. The Directive charts a way forward, covering many of the necessary principles. However, its application is likely to be hampered by uncertainties resulting from recent scientific awareness that 'low tar' may not necessarily mean harm reduction and that machine-measured yields do not necessarily reflect the actual experience of individual smokers.

Smokers subconsciously adjust their smoking style to achieve their preferred nicotine ‘kick’. They do this by blocking or unblocking air vents in the filter and by inhaling smoke more or less deeply into their lungs. The proposal to lower tar yields from 12 mg to 10 mg makes little sense, given that present testing methods are flawed in this way. The 2 mg reduction can be achieved by adjusting the filter design. The apparent benefit falsely reassures smokers that they are smoking a ‘healthier’ cigarette.

The conclusion has to be that new testing standards and technologies are required, in order to ensure that tobacco content regulation ‘moves with the times’. This has two implications for the proper application of the Directive. First, there must be an effective, built-in review mechanism – by way of a Regulatory Committee – to ensure that developments in science and technology are monitored and their implications brought into play as quickly as possible. Second, an independent and adequately resourced agency should be established, to provide a European ‘centre of excellence’ for tobacco content regulation.

In addition to these two new ideas, some aspects of the Directive could be strengthened. The proposal to increase the warning signs on the labels to 25% of the front and back of the pack is welcome; but 30% would be better. This size is recommended largely because it mirrors new legislation recently introduced in Poland. Poland is one of the ‘first wave’ countries now in negotiation to join the EU, and its achievement should not be put at risk by comparison with lesser standards adopted in the existing EU Member States.

The Commission’s proposal to ban the use of words that imply harm reduction - like ‘light, mild and ultra’ – is very welcome. However, this needs to be extended to other aspects of product design, including the use of colours and graphic imagery. It also relates to another article in the Directive, which requires that maximum yields of tar, nicotine and carbon monoxide should be printed on the packs. This can only be driven by the belief that ‘lower yields equals less harmful’: an assumption that is now in doubt. Yet specifying amounts suggests that lower means better, giving smokers a false reassurance that the removal of ‘light’ etc is intended to avoid. The packs should indicate the presence of toxic substances, but not in any stated quantity.

UICC/ECL has produced two detailed briefing papers on the Directive. The first, an analysis and commentary on the Directive as a whole, is available in English, French, German and Spanish. The second, on the legal base proposed for the Directive, is available in English and German. Please contact us for copies.

‘Philip Morris agrees to US regulation’ according to a recent article (1st March 2000) in the International Herald Tribune, which quotes the company’s senior vice president, Steven Parrish, as saying: ‘I could see at some point in the future an appropriate way to regulate cigarettes’.

The report described recent revelations that the tobacco industry knew much more about the dangers and addictive nature of smoking than previously acknowledged.

INFO/DISINFO? is published by the International Union Against Cancer and he Association of European Cancer Leagues on behalf of the Campaign for a smoke-free Europe.

With the support of:

European Heart Network

European Respiratory Society

European Network for Smoking Prevention

Federation of European Cancer Societies

International Network of Women Against Tobacco