Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council on the Approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products, 'recast version'"

(2000/C 140/08)

On 15 February 2000 the Council decided to consult the Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Employment, Social Affairs and Citizenship, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 14 March 2000. The rapporteur was Mr Fuchs.

At its 371st plenary session (meeting of 29 March 2000) the Economic and Social Committee adopted the following opinion by 85 votes to 33, with 8 abstentions.

1. Introduction

1.1. The Economic and Social Committee notes that, in the context of the completion of the single market, the purpose of the current proposal for a directive is to recast, update and complete the three existing single market directives dealing with (i) the tar yield of cigarettes(1), (ii) oral tobacco(2) and (iii) the labelling of tobacco products.(3) This directive aims to harmonise the laws, regulations and administrative provisions of the Member States concerning the tar yields of cigarettes, the warnings regarding health to appear on packets of tobacco products, carbon monoxide and nicotine yields and the ingredients of tobacco products.

1.2. This proposal is based on Article 95 of the Treaty, taking as a basis a high level of public health protection. Account is also taken of public health issues raised by the Member States and scientific authorities, which have been brought to the attention of the Commission (Article 95 paragraph 8).

1.3. The ESC notes that the proposed measures are in line with the recommendations of the Commission's advisory committee for cancer prevention(4) and of the WHO World Health Assembly(5). They also take account of the opinion by the Commission's consumer committee on socially responsible community tobacco policy of 14 June 1998.(6).

1.4. This proposal seeks to continue the reduction in tar levels of cigarettes and requires that the tar yield of cigarettes put into free circulation, marketed or manufactured in the Member States must not exceed 10 mg per cigarette as from 31 December 2003 (or three years from date of adoption).

1.5. The proposal requires that the nicotine yield of cigarettes put into free circulation, marketed or manufactured in the Member States must not exceed 1 mg per cigarette from 31 December 2003 (or three years from date of adoption).

1.6. A ceiling of not more than 10 mg per cigarette is also to be established for carbon monoxide yield from 31 December 2003 (or three years from date of adoption).

1.7. The measurement systems proposed for the above-mentioned ceilings are to be those set down by the International Standards Organisation (ISO).

1.8. In addition to measuring the yields in cigarettes of tar, nicotine and carbon monoxide, the Commission proposes that Member States may require tobacco manufacturers or importers to carry out any other such tests as may be laid down by the appropriate national authorities in order to assess the yield of other substances produced by their tobacco products on a brand-by-brand basis.

1.9. Cigarette labelling is to include an indication of the yields not only of tar and nicotine but also of carbon monoxide. Improvements are also to be made in this context to the presentation, impact, visibility, comprehension and content of health warnings for consumers of tobacco products.

1.10. In respect of oral and other smokeless tobacco, the Commission recommends replacing the existing warning with a more general one.

1.11. This proposal also envisages that all manufacturers and importers of tobacco products must submit to their Member States a list of non-tobacco ingredients and constituents, including additives and quantities thereof, used in the manufacture of their tobacco products by brand. This list is to be accompanied by a statement setting out the reasons for the inclusion of such ingredients and constituents in their products. For the purposes of enabling an evaluation of the health impact of such non-tobacco components, it is furthermore proposed that Member States obtain toxicological data on these non-tobacco ingredients and constituents in burnt and unburned form and require manufacturers and importers to demonstrate that the said ingredients are safe for the health of the consumer when used as intended in their tobacco products.

1.12. The Commission proposal envisages prohibiting product descriptions such as "low tar", "light", "ultra light", "mild" and so on, since these terms can give rise to misapprehensions on the part of consumers who may mistakenly believe that some such products are less dangerous to health than others. Derogations whereby such terms are expressly authorised by Member States are to be permitted provided the Member States inform the Commission of the conditions for such authorisation.

1.13. Moreover, it is proposed that the Commission report every two years to the Council, the European Parliament, and to the Economic and Social Committee on the application of this proposed text, and if necessary make further proposals to adapt it to developments in the field of tobacco products.

2. General comments

2.1. The ESC welcomes the fact that the European Parliament and the Council are recasting measures for the harmonisation and approximation of the laws, regulations or administrative provisions of the Member States regarding the manufacture, presentation and sale of tobacco products.

2.2. The Committee agrees that the Commission proposals for the harmonisation and approximation of Member States' existing laws, regulations and administrative provisions make practical improvements to the provisions concerned. Trade barriers are to be removed. The ESC advocates a more extensive harmonisation and approximation of legal provisions as an additional necessary step towards completion of the single market. The ESC stresses that the harmonisation and approximation proposed by the Commission should if possible reflect the disparate nature of the market in tobacco products. The manufacturers of smoking, cigar, snuff and chewing tobacco are often small and medium-sized enterprises offering a very broad product range. These companies are mainly located in the less-favoured regions of the Community.

2.3. The ESC would stress that the Commission initiative can be seen as a further step towards improving public health in the European Union. The Committee has on many occasions welcomed the increasingly important role of public health at Community level(7).

2.4. The Committee sees the Commission's action as an additional step towards preventing smoking-induced health problems. In this context, the Committee would point out that lasting success is possible only by pursuing a comprehensive, trans-national strategy to avert tobacco-related damage to health. The ESC would therefore propose that the Commission submit a wide-ranging work plan for monitoring tobacco consumption including a range of measures targeting high-risk groups such as women, children, young people and people from poor economic and social backgrounds. This plan should contain in particular the following additional elements:

- development of appropriate preventive measures to stop tobacco consumption among children and young people;

- development of schemes to help young people and adults who do smoke beat the habit;

- ongoing health education in schools and the development of information campaigns for all age groups;

- ban on the sale of tobacco products to people under 18 (to be laid down at national level);

- ban on the sale of packs containing fewer than twenty cigarettes ("child packs");

- ban on smoking in public places;

- ban on the sale of cigarettes from vending machines unless (technical and/or physical) measures have been taken to prevent the purchase of cigarettes from vending machines by juveniles;

- increased and harmonised taxation of tobacco products, and, at the same time, systematic action to combat the smuggling of tobacco products.

Moreover, the ESC would reiterate its call of 9 July 1997(8) to ban direct and indirect tobacco advertising and hopes to see that call translated into practice quickly in all Member States.

The Committee calls on the Member States to use a considerable percentage of their tax take from tobacco sales to step up anti-smoking campaigns and to spend more on medical research and on treating the diseases afflicting smokers and the unwitting victims of the harmful effects of tobacco. Some of this tax revenue could go to the sickness funds.

2.5. The ESC refers to its many earlier opinions in which it noted that tobacco products are harmful to human health and lead to cardiovascular diseases, cancer and other illnesses. The World Health Organisation(9)(10) believes that some 500000 EU citizens die prematurely each year as a result of tobacco consumption. Given the Community's aim of securing a high level of health protection, and with a view to consumer protection, it is essential to provide consumers with adequate information on the ingredients of tobacco products and their effects. It is therefore essential to identify tobacco ingredients properly. This is the only way to ensure that consumers can make decisions backed by scientific fact.

2.6. The ESC believes that a reliable measurement system for the ingredients concerned is essential for comprehensive and accurate consumer information. The measurement systems laid down by the International Standards Organisation (ISO) for tar, nicotine and carbon monoxide yield do not adequately meet these criteria.(11)(12) The ISO test is machine-based. A large number of studies have shown that, quite simply, people do not smoke like machines. There is considerable variation in the average volume of smoke, the number and length of draws and depth of inhalation. Thus, a consumer's exposure to tobacco ingredients varies tremendously and may in fact be many times higher or lower than shown in the machine test. Machine-generated data can thus result in wrong information being passed to consumers. The development of reliable measurement systems is therefore vital to the regulation of tobacco substances and should be actively promoted by the Commission.

2.7. Cigarette smoke is made up of some 3500-4000 substances, many of which are known irritants. Over 40 of these substances have carcinogenic effects and others can be classified as toxic. Nicotine is the substance in cigarettes that causes dependency. The Commission is now proposing that tar, carbon monoxide and nicotine yield be stated on cigarette packets and that ceilings be fixed for these substances. The ESC considers the matter to be complex, and argues that each substance should be dealt with separately.

2.7.1. Tar and carbon monoxide are harmful to health(13). Yield labelling should therefore be welcomed on principle, provided it can be formulated correctly. Many experts regard the term "tar" as misleading because it is a collective name for the thousands of chemical substances which form the residue of tobacco smoke(14). Tar is composed of very different substances which are harmful in varying degrees, and the constituents of tar differ widely between products. The medium-term aim must therefore be to set ceilings for, and require the gradual reduction of specific toxic or carcinogenic substances in relation to nicotine concentrations (tar:nicotine ratio). Reducing toxic or carcinogenic substances in relation to nicotine should also include reducing carbon monoxide yield in proportion to nicotine yield.

2.7.2. Regulation of nicotine yield should be undertaken only with great caution, and the ESC thinks it is something that requires further research. It may seem appropriate to reduce the nicotine yield of tobacco products in order to protect children and young people, since this could be expected to prevent experimental users, including these groups, from developing nicotine dependence so quickly. On the other hand, it is likely that dependent smokers, who maintain nicotine levels in their bodies at a certain level, would be inclined to smoke more in order to build up the desired nicotine concentrations. The possibility cannot be ruled out that smokers' risk of lung cancer may not be reduced by laying down fixed levels of nicotine and tar. Since not enough research has been done in this area(15)(16)(17), no measures should be taken to limit nicotine yield further until work has been done to evaluate relevant investigations.

2.7.3. Over 600 additives may legally be added to tobacco products in the European Union. The intended use and effects of existing and new additives must be declared and justified on public health grounds.

2.7.4. The ESC points to the need for some protection of the legitimate interests particularly of smaller manufacturers and importers who must not have their livelihood jeopardised by excessive requirements.

3. Specific comments

3.1. Article 1

The ESC supports the objectives of the directive and hopes that it will lead to a high level of health protection in the Member States.

3.2. Article 3

3.2.1. The ESC feels that is confusing to talk about tar and carbon monoxide yield in cigarettes. Unlike nicotine, tar and carbon monoxide are produced by burning or carbonisation of the cigarette, and are present in the condensate (tar) and the gaseous (carbon monoxide) part of the cigarette smoke. It would therefore be better to describe the yield of these substances per cigarette as "nicotine in tobacco", "tar in smoke condensate" and "carbon monoxide in smoke". In the case of carbon monoxide, it can also be assumed that the quantity produced per cigarette will depend on the oxygen input, i.e. the intensity of smoking.

3.2.2. The ESC points out that it is questionable in toxicological terms to further cut the 1 mg per cigarette nicotine yield in tobacco. This may make sense for occasional smokers, whose smoking habits are not determined by the amount of nicotine absorbed. However, the smoking behaviour of nicotine-dependent smokers is determined by the amount of nicotine absorbed: if they need a lot of nicotine, they inhale more frequently and more deeply, and also smoke more cigarettes than those who need less nicotine. The impact of regulating nicotine yield has not, as yet, been sufficiently clarified. The ESC considers that an appropriate research project is needed to clear up this issue.

3.2.3. The ESC would very much welcome worldwide recognition of European standards in this regard in order to avoid the distortion of competition and the resultant threat to jobs. The ESC advises the Commission to do everything it can to achieve this objective as a matter of urgency. For the time being, the ESC calls on the Commission to set up a fund for compensation of the job losses and for retraining the workers affected.

3.3. Article 5

3.3.1. It is certainly right to require that the values proposed in the directive be measured, but the ESC wonders whether the proposed ISO system reflects the current state of technology. The ESC assumes that if other measurement systems prove satisfactory, these will also be made mandatory.

3.3.2. The ESC feels that consumers have the right to expect that tobacco products are checked, tested and approved in accordance with commonly approved standards. The ESC urges the Commission to develop for the long term a Community framework for national systems, based on internationally accepted standards. This will guarantee that the most suitable methods of analysis are applied in a consistent and uniform way within the EU in order to produce comparable results.

3.3.3. The Committee broadly welcomes the provision whereby Member States may also request that tobacco manufacturers and importers carry out any other such tests as may be required by the appropriate national authorities in order to assess the yields of other substances produced by their tobacco products on a brand-by-brand basis.

3.4. Article 6

3.4.1. The ESC supports and welcomes the improvement in the presentation, impact, visibility, comprehension and content of health warnings for consumers of tobacco products.

3.4.2. The Committee would advocate that the general warnings must be readily discernible. 25 % of the external area of the corresponding surface of the packet of tobacco would appear an appropriate figure, taking due account of the size of the packet so as to avoid any measures not commensurate with the objective sought.

3.4.3. The ESC proposes that the Member States should be allowed to require details of a tobacco withdrawal programme to be printed on all packets of tobacco products.

3.5. Article 7

The ESC welcomes the Commission's proposal to list all non-tobacco ingredients for each tobacco product and in particular the requirement that producers and importers state the reasons for including such ingredients and constituents. The transparency this ensures will promote a high level of health protection within the Community. At the same time the ESC would like to know where, how and according to what criteria these lists will be interpreted.

The absence of a Community framework for national systems and the tests is likely to lead to widely varying national laws and artificial barriers to the internal market of the same type as those which this directive seeks to avoid.

The ESC considers that harmonisation as regards ingredients can be achieved by drawing up a list of permitted substances, taking as an example one of the existing positive lists in Belgium, Germany, Austria or France, or a combination of these.

3.6. Article 8

3.6.1. The ESC fundamentally welcomes the Commission's proposed ban on misleading descriptions such as "low tar", "light" or "mild", since the claimed advantages are demonstrably non-existent, and it makes little sense for nicotine-dependent smokers to distinguish between cigarettes with low, light, ultra-light, etc. tar yield. Member States must be prevented from introducing special arrangements.

3.6.2. The ESC suggests that from a preventive point of view it would make sense for occasional smokers to be allowed to choose a "light", and therefore less harmful, cigarette. But such labelling can be allowed only if measuring methods exist to demonstrate a very high correlation with such descriptions.

3.7. Article 10

The ESC supports the proposed two-year review and report, and asks the Commission to check whether the relevant scientific committee could be given the task of regularly reviewing the existing directive and adapting it in the light of experience.

3.8. The ESC considers that the transitional provisions should be aligned on those pertaining to the implementation of existing directives in order to take account of the limited possibilities of technical adjustment open to SMEs and the slow turnover in certain products.

Brussels, 29 March 2000.

The President

of the Economic and Social Committee

Beatrice Rangoni Machiavelli

(1) Directive 90/239/EEC, OJ L 137, 30.5.1990, p. 36.

(2) Directive 92/41/EEC, OJ L 158, 11.6.1992, p. 30.

(3) Directive 89/622/EEC, OJ L 359, 8.12.1989, p. 1.

(4) COM(96) 609 final - annex.

(5) WHO, Tobacco or Health, A global status report, Geneva, 1997, p. 49.

(6) Opinion by the Consumer Committee on Socially Responsible Community Tobacco Policy, 14 June 1998

(7) ESC Opinion on the development of public health policy, OJ C 407, 28.12.1998.

(8) OJ C 296, 29.9.1997, p. 32.

(9) WHO, Tobacco or Health, a global status report, Geneva, 1997.

(10) Peto et al., Mortality from smoking in developed countries 1950-2000, Oxford, Oxford University Press, 1994.

(11) WHO Conference on the Regulation of Tobacco Products, conclusions, Helsinki, 18 October 1999.

(12) Slade, J. & Henningfield, J.E., Tobacco products regulation: context and issues, Food and Drug Law Journal, 53 (suppl.), 43-77, 1998.

(13) US Department of Health and Human Services: Reducing the health consequences of smoking, 1989.

(14) Gray, N. et al. Tar concentration in cigarettes and carcinogen content. Lancet, 352, 787-8, 1998.

(15) Bates C. et al. The future of tobacco product regulation and labelling in Europe: Implications for the forthcoming European directive. Tobacco Control, 8, 225-235, 1999.

(16) Henningfield J.E. et al. Reducing the addictiveness of cigarettes. A report of the American Medical Association. Tobacco Control, 7, 281-93, 1999.

(17) Shatenstein S. et al. Eliminating nicotine in cigarettes. Tobacco Control, 8, 106-9, 1999.

APPENDIX

to the Opinion of the Economic and Social Committee

During the debate, the following amendments, which received more than 25 % of the votes cast, were defeated.

Point 2.4, fourth bullet

Replace text with:

"ban on the sale of tobacco products to young people (the age limit to be laid down at national level in accordance with the subsidiarity principle)."

Reason

The original text contradicts itself by stipulating a minimum age, but then requiring that the Member States fix that age. By not stipulating any age, the amendment makes it clearer that the Member States are responsible for defining the term "younger" in accordance with their specific social and cultural situation.

Result of the vote

For: 43, against: 59, abstentions: 13.

Point 2.4, seventh bullet

Delete

"ban on the sale of cigarettes from vending machines."

Reason

A complete ban on the sale of cigarettes from vending machines is inappropriate and discriminates between vending machines and other sales outlets.

Result of the vote

For: 35, against: 75, abstentions: 13.

Point 2.4, eighth bullet

Amend the indent "increased and harmonised taxation of tobacco products, and, at the same time, systematic action to combat the smuggling of tobacco products" to read as follows:

"harmonised taxation of tobacco products, and at the same time, systematic action to combat the smuggling of tobacco products".

Reason

Any increase in the already high taxation of tobacco products in the EU will lead to distortion of the market as it will bring an increase in smuggling, with the end result that consumers will find products at even lower prices, which is the opposite of the desired effect. Some countries that had high taxation like Sweden and Canada have decreased their taxation exactly in order to combat smuggling.

Result of the vote

For: 59, against: 61, abstentions: 16.

Point 3.2.3

Add the following to the end of the paragraph:

"In the meantime, it is advisable to limit the establishment of content ceilings for products placed on the market in the EU and a transition period should be introduced for Greece, in respect of nicotine and carbon monoxide, as is the case for tar."

Reason

There is simply no reason to give only products manufactured outside the EU the possibility of meeting the demand for products with different characteristics.

Greece's current derogation for tar should be extended to cover nicotine and carbon monoxide, since there is a close correlation between the yields of these components.

Result of the vote

For: 29, against: 74, abstentions: 14.

Point 3.2.3

Add a new point after point 3.2.3 as follows:

"Article 4

The ESC feels that the upper limits for nicotine and carbon monoxide should be proportionate to the limit proposed for tar. Thus, the temporary derogation for Greece should refer not only to tar but also to nicotine and carbon monoxide."

Reason

There is a relationship between the yields of tar, nicotine and carbon monoxide in cigarettes. Therefore, if the limits of 1 mg of nicotine and 10 mg of carbon monoxide also apply to Greece from 31 December 2003, in effect this will indirectly impose a limit of 10 mg of tar on that country from the same date. The temporary derogation on tar alone granted under Article 4 thus has no practical relevance.

Result of the vote

For: 36, against: 58, abstentions: 14.

Point 3.2.4

Add the following new point 3.2.4:

"3.2.4. The ESC agrees that the ceiling for carbon monoxide yield in cigarettes should be proportionate to the proposed ceiling for tar (10 mg) and nicotine (1 mg). The ESC suggests, therefore, that the Commission take the necessary steps to ensure that the proposed ceiling on carbon monoxide yield is proportionate to the ceilings for tar and nicotine and that it is established on the basis of reliable scientific data."

Reason

The Commission's explanatory memorandum recommends the introduction of "... a ceiling for carbon monoxide yields proportionate to the ceilings already mentioned ..." for tar and nicotine. Given the inevitable differences in the results of experiments carried out under current methods for measuring carbon monoxide yields, great care needs to be taken when establishing an appropriate ceiling. The Commission therefore needs to ensure that the proposed ceiling for carbon monoxide yield has been established on the basis of reliable scientific data and that it is proportionate to the ceilings for nicotine and tar, as envisaged.

Result of the vote

For: 34, against: 70, abstentions: 8.

Point 3.2.5

Add the following new point 3.2.5:

"3.2.5. The ESC is concerned that the Commission proposal, which in its current form covers tobacco products exported from the EU, will hinder EU exports unnecessarily, harm the competitiveness of the Community and of the Member States, and adversely affect employment in the EU."

Reason

The Commission proposal, which in its current form covers tobacco products exported from the EU, is an unnecessary obstacle to EU exports, will harm the competitiveness of the Member States and the EU, and will adversely affect employment in the EU. In 1998, 16 % of the cigarettes manufactured in the EU were exported to third countries and the tobacco manufacturing industry employed around 50000 people. This provision could, therefore, jeopardise EU jobs and manufacturing.

Result of the vote

For: 44, against: 67, abstentions: 7.

Point 3.4.2

Replace "25 %" by "10 % of the external area, with the warning framed by a 1-mm-thick line, ..."

Complete the sentence: "... for cigarettes. For other tobacco products warnings can be attached to the container (e.g. cigar boxes, pipe tobacco tins), but should not exceed 15 cm2 in size."

Reason

The percentage proposed by the Commission seems excessive given that the objective is to improve legibility.

It is not possible to print warnings on containers of certain products and doing so would anyway be very uneconomical for manufacturers of products with limited circulation in Europe, given that each market would require special packaging.

Result of the vote

For: 34, against: 71, abstentions: 1.

Point 3.4.4

Insert a new point:

"3.4.4. To ensure fair treatment for all products, irrespective of the colour of the packaging, manufacturers should be allowed to use colours other than black and white, provided warnings are perfectly legible."

Reason

By proposing the use of black type on a white background, the Commission is effectively favouring products with this type of packaging. The amendment should make it possible for other background colours to be used.

Result of the vote

For: 33, against: 71, abstentions: 7.

Point 3.5.1

Insert a new point 3.5.1 as follows:

"3.5.1. As an alternative, the ESC advocates the development of a Community framework for testing and reporting non-tobacco ingredients. Testing methods should be based on developing and establishing uniform, internationally accepted standards, so as to obtain data and information confirming that use of these ingredients does not constitute a major health risk. This would ensure that the most appropriate and reliable testing methods were consistently and uniformly applied throughout the EU and would help to ensure efficient operation of the single market."

Reason

If the draft directive does not establish a Community framework for listing ingredients, 15 different national systems will probably be set up. This would create additional obstacles to the internal market and could constitute a considerable economic burden for operators, which is contrary to the proposal's intention.

Result of the vote

For: 39, against: 72, abstentions: 8.

Point 3.6.2

Replace the second sentence with:

"Standards must therefore be fixed, both for each description and for the maximum tar levels that it denotes."

Reason

As the opinion notes, indicating absolute levels is not informative for smokers, who should therefore be given more precise information that will be of more help to them when choosing a product.

Result of the vote

For: 42, against: 70, abstentions: 10.

Point 3.6.3

Insert a new point 3.6.3 worded as follows:

"The ESC suggests that descriptions such as 'light' or 'mild' ('soft') could be permitted if they clearly designate features connected with the aroma, taste or colour of tobacco products other than cigarettes."

Reason

The descriptions "light" and "mild" often refer to the aroma or the taste of cigars, cut tobacco and snuff.

Result of the vote

For: 35, against: 65, abstentions: 16.

There was a request, by over a quarter of votes cast, to keep the following passage in the section opinion, but it was deleted subsequent to an amendment adopted by the plenary session.

Point 2.4, third paragraph

"In the medium term, this list of measures should also include an end to Community subsidies for growing tobacco products. The aim is to eliminate inconsistencies in Community policy, which seeks to prevent tobacco consumption on the one hand, while promoting tobacco growing on the other. The Commission should buy up more areas where tobacco is grown in the Community and discontinue production there. Aid for tobacco production granted up to now should be converted into social aid."

Result of the vote

For: 73, against: 64, abstentions: 2.