COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251(2) of the EC Treaty concerning the common Position of the Council on the adoption of a European Parliament and Council Directive 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)

(Text with EEA relevance)

1. Background

- Date of transmission of the proposal to the EP and the Council (COM(1999)594 final - 1999/0244 COD): 07.01.2000

- Date of the opinion of the Economic and Social Committee: 29.03.2000

- Date of the opinion of the Committee for the Regions: 12.04.2000

- Date of the opinion of the European Parliament, on first reading: 14.06.2000

- Date of transmission of the amended proposal: 28.06.2000

- Date of adoption of the common position: 31.07.2000

2. Purpose of Commission proposal

The proposal is a "recasting" exercise, intended to regroup and update the provisions of three Internal Market directives (Council Directive 89/622/EEC [1], as amended by Council Directive 92/41/EEC [2], and Council Directive 90/239/EEC [3]) on tar content of cigarettes, labelling of tobacco products, and oral tobacco. The new proposal is also based on Article 95 of the Treaty as an Internal Market harmonising measure.

[1] OJ L 359, 8.12.1989 p. 1.

[2] OJ L 158, 11.6.1992 p 30.

[3] OJ L 137, 30.5.1990 p. 36.

It proposes to:

- reduce the tar content from the existing 12mg per cigarette to 10mg. There is a proposal to grant Greece a derogation until December 2006 to allow for the fact that Greek tobacco farmers grow tobacco varieties high in tar levels, and that a similar derogation exists in the 1990 directive already.

- set a nicotine ceiling of 1mg per cigarette. Some Member States already have a national ceiling, but this is now clearly difficult to apply when internal border controls have been abolished.

- set a carbon monoxide ceiling of 10mg per cigarette. The CO level is closely associated with the burning of tobacco, and can be varied according to the filter, paper and ventilation used, as well as the mix of tobacco used.

- apply these ceilings to all products manufactured in the Community in order to ensure that products manufactured in the EU not destined for the internal market and which re-enter will respect the product specifications. Also, this will avoid control problems arising from simultaneous production in the EU of two or more lines of product, intended for external or domestic consumption.

- allow Member States to continue to ask for additional tests for tobacco products, as they presently can do, but to impose a requirement that the testing laboratories should be approved, and that the results of the tests should be communicated to the Commission, so that in time a judgement can be made as to whether these tests should be required at the Community level.

- set bigger warnings on tobacco packets. The Commission proposes 25% front and back, and 10% on the side of cigarette packets for the yield indication. The content of the warnings is also revised.

- oblige manufacturers and importers to declare additives, together with toxicological data.

- ban misleading descriptions such as « light, low-tar » unless specifically authorised by the Member States.

- produce regular Commission reports on the implementation of the directive, accompanied if necessary by proposals.

3. Comments on the Common Position

3.1. The Common Position is less ambitious than the provisions sought by the European Parliament, and reflected in the Commission's amended proposal, particularly as regards labelling size. However, it represents a significant improvement in the level of harmonisation of Internal Market rules compared to the present position, while taking a high level of public health protection into account. It may also be mentioned that the Common Position is stronger in certain respects than the European Parliament text, for example as regards products manufactured in the Union (Article 3) where the Common Position provides for no transitional period for products not intended for internal consumption. In addition, the Commission considered it desirable to agree to the Common Position in view of the opposition of several Member States to a more ambitious approach. It should be noted in this regard that one Member State did not support the Common Position, and that three Member States abstained.

3.2. Parliament's amendment on the first reading:

- Integrated in the Amended Proposal and incorporated in the Common Position:

- Amendments: 2, 4, 7, 8, 14, 27, 28+115+87 (partly), 30 (partly), 33, 35, 38, 43, 113, 119 (partly) and 120.

- Integrated in the Amended Proposal but not incorporated in the Common Position:

- Amendments: 75, 3, 5, 6, 11, 12, 13, 15, 16, 18, 19, 98, 107, 22, 108, 24, 25, 26, 29, 116, 39 and 44.

- Issues where the Commission's Amended Proposal differs from the Council's Common Position:

- Labelling: As regards the size of the warning label, the Amended Proposal foresees 30% for the maximum yields on the side of the packet, 30% for the general warning message and 40% for the additional warning. The Council has considered in its Common Position that 10% of the surface should be allocated for the side maximum yield indication, and 25% for each of the general and additional warning messages. Furthermore, the Council has not accepted to only print on the packets the maximum authorised yields, rather than the actual yield of the cigarettes, as in the Amended Proposal. It is clear that larger sized warnings could have an even more significant impact on consumers. However, the Commission considered that accepting the Common Position would nevertheless lead to an improvement in Internal Market harmonisation while ensuring a high level of public health protection through greater visibility of warnings.

- Article 3: The Amended Proposal had foreseen, in its Article 3(4), a three-year transitional period to apply maximum tar, nicotine and carbon monoxide levels to cigarettes other than those released for free circulation or marketed in the Member States. However, the Common Position seeks to apply those levels to all cigarettes manufactured in the Member States, as of 1 January 2004, without a transitional period. The Commission had considered that a case has been made by industry for a transitional period, a point not shared by Council. Nevertheless, the Commission agreed to the Council's approach as it ensures a higher level of harmonisation of the Internal Market and reduces the possibility of circumvention of the Directive's provisions.

3.3. New provisions introduced by the Council's Common Position and Commission's position:

- Preamble: the Council has modified the preamble in order to ensure better correspondence with the text of the Directive, merging certain recitals and deleting others, without significantly altering the contents.

- Article 5 (labelling): This Article has been modified to improve its structure. The Council has also inserted an additional provision (i.e. paragraph 7), taken from Directive 89/622/EEC, which foresees the possibility of mentioning the Authority responsible for the warning message. Nevertheless, this mention must be placed outside the frame of the warning, so as not to diminish its impact.

- Article 13: Paragraph 2 has been modified so that products which do not comply with the provisions of the Directive may continue to be marketed for one year after the date mentioned in paragraph 1 of Article 13. The time period has been halved, but it is now applicable after the deadline for transposition, as opposed to the date of entry into force of the Directive. This provides better legal certainty while allowing economic operators sufficient time to market existing stocks of non-complying products.

- Annex I (additional warnings): The Council has inserted two additional warnings (nos. 10 and 11).

The Commission could accept these new provisions in consideration of the fact that the changes to the preamble and to Article 5 improve the presentation and draftsmanship of these provisions. The mention of the author/source of the warnings is currently a feature of existing Directives. The requirement to mention the author/source outside the space for warnings ensures that the message's impact will not be diluted. The additional warnings in Annex I are considered to take account of specific elements, such as pointing smokers in certain directions for advice on cessation. In this respect, it is regrettable that pharmacies were not mentioned in the text of warning no. 11 in Annex I, as this is where nicotine replacement therapies are marketed in Member States, without requiring a prescription in many cases.

3.4. Problems encountered for the adoption of the Common Position:

The delegations of three Member States contested Article 95 of the EC Treaty as a legal basis and the application of Article 3 of the proposed Directive to products manufactured in the Community and not destined for internal consumption.

The Commission disagreed with this approach as the three Directives being recast are all based on Article 95 of the Treaty. In addition, the application of Article 3 to all products manufactured in the Community is required to ensure that the provisions of the Directive are not circumvented by means of products smuggled or through parallel imports/reimports.

4. Conclusions and general remarks

- The Common Position largely takes over the main elements of the Commission's original proposal, but fails to take full account of the amendments introduced by the European Parliament, and accepted by the Commission in its amended proposal. However, it can be concluded that the Commission supports the Common Position because it represents an improvement in the harmonisation of Internal Market rules, leading to the elimination of actual and potential obstacles, while ensuring a high level of public health protection.

5. Commission declarations

- The Commission issued a declaration concerning Article 11 of the amended proposal for a directive on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products (creation of a Tobacco Group within the Advisory Committee for Cancer Prevention), which is annexed to the present communication. This declaration was made as a result of a request made for clarification of the methods to be used by the Commission in drawing up the report provided for in Article 11 of the Directive.

ANNEX

Commission Declaration to the minutes of the Council in relation to Article 11 of the amended proposal for a European Parliament and Council Directive 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)

« The Commission recognises the complex issues covered in this proposed Directive, particularly the need to ensure that in drawing-up the reports provided for in Article 11 and any accompanying proposals, full scientific, technical and other data is taken into account. To this end, for the first report and the subsequent reports provided for in Article 11, it intends to create a multidisciplinary Tobacco Group of its Advisory Committee for Cancer Prevention.

This Group will call upon a range of recognised scientific expertise, independent from the tobacco industry, inter alia within Member State administrations, non-governmental organisations and the World health Organisation. It will, where appropriate, consult with tobacco industry representatives.

The Commission intends to hold the first meeting of this Tobacco Group before the end of the year 2000.

The issue of drawing-up a common approach to ingredients, covered in Article 7 of the proposal, will receive priority in preparing the first Commission report. »