OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the 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) AMENDING THE PROPOSAL OF THE COMMISSION pursuant to Article 250(2) of the EC Treaty

1999/0244 (COD)

OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the 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)

(Text with EEA relevance)

1. Background

The Commission sent the above proposal for a directive based on Article 95 of the Treaty to the European Parliament and Council on 7 January 2000 (COM(1999) 594 final - 1999/0244 COD).

The Economic and Social Committee gave its opinion on 29 March 2000.

The Committee of the Regions gave its opinion on 12 April 2000.

The European Parliament gave its opinion under the co-decision procedure at the first reading in plenary session on 14 June 2000.

Following the opinion of the European Parliament and pursuant to Article 250(2) of the EC Treaty the Commission adopted an amended proposal (COM(2000) 428 final) on 28 June 2000.

The Council adopted its common position by qualified majority on 31 July 2000. The Commission accepted the common position.

On 13 December 2000 at its second reading the European Parliament adopted 32 amendments to the Council's common position.

This opinion sets out the Commission's position on the European Parliament's amendments in accordance with Article 251(2), third subparagraph, point (c) of the EC Treaty.

2. Aim 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. Several Member States have proposed to adopt measures limiting carbon monoxide.

- 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. A transitional period is proposed.

- 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 30% on the front and 40% on the back, as well as 30% 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. Commission's opinion on the amendments proposed by the Parliament

3.1. Summary of the Commission's position

Commission's position: On 13.12.2000, the European Parliament adopted a total of 32 amendments, of which the Commission can accept 22.

The Commission can accept, in full or in part, amendments number 1, 2, 4, 5, 7, 10, 12, 13, 15, 17, 21, 22, 23, 24, 26, 29, 30, 31, 34, 48, 50 and 51. The Commission cannot agree to amendments 6, 16, 25, 28, 33, 40, 45, 46, 47 and 49.

The amendments that cannot be accepted by the Commission concern mainly a reference to GMO tobacco, health warnings on vending machines, detailed rules on how manufacturers have to declare tobacco additives, the requirement to propose a common additive list by a fixed date, and while this list is being prepared, a ban on additives that increase addiction.

In adopting its position on the amendments proposed by the Parliament, the Commission has taken due account of the judgement of the Court of Justice of the European Communities of 5 October 2000 in case C-376/98, Germany v Parliament and Council. This judgement annulled Directive 98/43/EC on tobacco advertising and clarified the requirements for the adoption of directives under the legal basis provided by Article 95 of the EC Treaty.

3.2. Parliament's amendments on second reading

Amendments relating to the legal basis of the proposed directive - Amendments 1, 2, 4 and 15

Amendment 1, in the light of the judgement of the Court in Case C-376/98 (see 3.1 above), seeks to add Article 133 as a subsidiary legal basis to cover exports of tobacco products manufactured in the EU. This amendment is acceptable to the Commission only in combination with amendments 4 and 51 as these amendments introduce a specific reference to "export" in the text of the proposal and justify the adoption of an additional legal base.

Amendment 2, in accordance with the judgement of the Court, clarifies that the provisions relating to maximum CO yields for cigarettes aim to remedy a real risk for the functioning of the Internal Market. This amendment can be accepted as the proposed recital is intended to better justify the adoption of harmonised rules on carbon monoxide and explains the intention of the Member States to legislate if rules are not adopted at Community level.

Amendment 4, taking account of the judgement of the Court, makes a specific reference to tobacco products exported from the EU. This amendment can be accepted in combination with amendment 1. However, the reference to the "case law of the Court of Justice of the European Communities" seems unnecessary.

Amendment 15 adds the words "taking as a basis a high level of health protection" to the last sentence of Article 1 and in this way re-introduces the initial Commission proposal. This amendment cannot be contested as it quotes the requirements for a high level of health protection mentioned in Article 95(3) of the EC Treaty.

Amendments seeking to modify the definitions - Amendments 16 and 17

Amendment 16 seeks to modify the common position to take account of other Community legislation on genetically modified organisms. The addition of this text does not appear to be justified. The need to mention genetically modified organisms is unclear, as there are no references to them in the Articles of the proposal. The Commission could, however, accept it as a recital as proposed in amendment 50.

Amendment 17 seeks to include paper, filter, inks and adhesives in the definition of "ingredient". This amendment is acceptable, as these elements also form part of the "ingredients" used to manufacture certain products.

Amendments relating to maximum tar, nicotine and carbon monoxide yields for cigarettes exported outside the European Union - Amendment 51

Amendment 51 proposes a transition period for exports in the context of the application of Article 3, so that its provisions would not need to apply to exports until January 2007. This amendment can be accepted, because this transitional period does not put into doubt the principle that exports should be eventually covered in the scope of the directive. The delayed implementation would resolve concerns that manufacturers need more time to adjust brand formulae and change marketing strategies. Also, it would allow the proposed World Health Organisation Tobacco Framework Convention enough time to develop international standardisation. A suitable recital text could be proposed in the context of the conciliation procedure, such as:

"The application of tar, nicotine and carbon monoxide ceilings to exported cigarettes may be subject to transitional arrangements in order to allow more time to change product formulae where necessary, and to develop new marketing strategies towards less harmful products."

Amendments relating to measurement methods - Amendments 5, 12 and 21

Amendment 5 calls for a procedure for the development of standards to test yields of constituents of smoke other than tar, nicotine and carbon monoxide. These standards do not exist yet and should be developed in consultation with ISO. This amendment is acceptable to the Commission, as it is complementary to recitals 10 and 11 of the common position and Article 11 thereof.

Amendment 12 requests the Commission to submit appropriate proposals on standards and measurement methodologies for tobacco products other than cigarettes. It is acceptable, as it largely reflects the existing text of Recital 21 and Article 11.3.

Amendment 21 seeks to have notification to the national authorities of results of tests each time there is a change in the composition of a tobacco product, instead of every year. This amendment can be accepted, as a notification in case of projected changes is an improvement on an annual notification. This was a change accepted in the Commission's amended proposal and appears justified. However, it could be improved during the conciliation procedure to avoid that Member States are informed unnecessarily of minor changes in the ingredients. A suitable text could be:

Article 4(4) first subparagraph of common position: "The results of tests carried out in accordance with paragraph 3 shall be reported at least annually to the competent national authorities, which shall also be informed of changes in the composition of the ingredients".

Amendments concerning labelling requirements - Amendments 6, 22, 23, 24, 25, 26, 28 and 34

Amendment 6 adds a recital explaining the inclusion of provisions relating to tobacco vending machines. The Commission cannot accept this amendment as it considers that the issue of warning messages on vending machines falls outside the scope of the present proposal. The Commission is however prepared to make a declaration stating its intention to examine possible options relying on other legal bases, i.e. Article 153 of the EC Treaty dealing with consumer protection (see also amendment 28).

Amendment 22 proposes to increase from 2 to 3 the number of general warning messages (including warnings on passive smoking, annual death toll, cancer and heart disease). This amendment can be accepted in part, if these additional texts are added to the list of additional warnings rather than changing the general warning proposed by the Commission in its proposal ("Smoking kills / Smoking can kill").

Another alternative as a proposal for conciliation would be to add a third warning to the two above-mentioned general warnings in the common position, which would read "Don't harm others with your smoke". As in Article 5(2)(b), a reference would be required to rotation of texts to guarantee their regular appearance.

Amendment 23 allows Member States to require that in the space provided for the additional warning there be colour photographs or other illustrations depicting the health consequences of smoking. This amendment cannot be accepted, as the issue of using colour photos as warnings has not been evaluated as part of the present proposal. However, this element could be analysed under the report provided for in Article 11 in line with the aim of amendment 31. In addition, under Article 12(2) Member States may go further than the rules of the Directive for public health reasons, subject to Treaty rules.

As regards Article 5(8), it would be desirable if, during the conciliation procedure, a material error in the common position were rectified (wrong ISO code) by inserting the text of amendment 27, which was not voted in Plenary.

Amendment 24 seeks to increase the size of the general health warning to 30% of the pack and the size of the additional warning to 40%, as it was foreseen in the Commission's amended proposal. The Commission can accept this amendment, as the increase in the size of warnings will improve their visibility and permit greater amounts of information to be conveyed to smokers, especially if the European Parliament warning texts are longer that those of the common position.

Amendment 25 proposes to reduce the sizes foreseen (in the amended proposal and the common position) for unit packets of products other than cigarettes: for boxes exceeding 50 cm2, the warnings should cover 15 cm2 (instead of 100 cm2 and 25 cm2, respectively). This amendment cannot be accepted, as it seeks to increase two fold the exception provided for in Article 5(4) of the common position. The Commission considers that there is no justification for this significant change, which introduces an aspect of discrimination in the treatment of cigar boxes.

Amendment 26 seeks to have the text of the warning irremovably printed as well as to allow the use of irremovable stickers in the case of tobacco products other than cigarettes. The Commission can accept this amendment, as it is a useful addition and clarifies that the use of stickers would be admissible, particularly for non-cigarette products where production amounts are small and there are difficulties to cope with heavier labelling requirements.

Amendment 28 aims at displaying in a legible manner on tobacco vending machines the general and the additional warnings, on the grounds that these machines are attractive to young people intending to start smoking because of 24h availability and lack of supervision. The Commission considers that vending machines are not the subject of this proposal and cannot therefore accept this amendment. However, the Commission is prepared to make a declaration indicating its willingness to examine this issue under another legal basis (for example, consumer protection), as indicated for amendment 6.

Amendment 34 provides for a longer and more detailed list of additional health warnings. This amendment can be partly accepted, as several of these proposed warnings on the list of additional warnings are valid, and could usefully be incorporated in the list.

Amendments relating to ingredients and additives in tobacco products - Amendments 49, 13, 47, 45 and 29

Amendment 49 intends to ban the use of ingredients having the effect of increasing the addictive properties of tobacco products, as they may undermine the limits on nicotine levels laid down in the proposal. The Commission is not in a position to accept this amendment. Banning "addiction enhancing" substances is premature in view of the need for examination of data on additives because their actual use has to be established first. Furthermore, there is no evidence of any national legislation banning or regulating such substances in these terms, or of other obstacles to free movement. Finally, scientific evidence on the effects of such substances is unclear.

A compromise could be examined either - by referring in a recital to the procedures of Article 95 of the Treaty and to Article 12.2 of the directive for Member States wishing to adopt stricter national measures than those laid down in the directive - or, by including examination of changes to Article 6 (additives declaration) in the context of Articles 9 and 10 (adaptations to the directive and regulatory committee).

Amendment 13 clarifies in a recital the need for the Commission to draw up a common list of ingredients. This amendment can be accepted as its modified wording, compared to that in first reading, allows sufficient flexibility for the Commission to maintain its right of initiative concerning future legislation.

Amendment 47 seeks to establish a prohibition of the use of ingredients having the effect of increasing the addictive properties of tobacco products. This amendment cannot be accepted for the same reasons as amendment 49, as provisions on particular ingredients at this stage would be premature. However, the same compromise possibilities exist as indicated for amendment 49 above.

Amendment 45 proposes detailed rules on future approach to additives declarations by manufacturers and importers. This amendment cannot be accepted as it stands, as the Commission considers the common position text to be more adequate for the objectives sought by the proposal. This amendment introduces a discrimination in treatment between cigarettes and other tobacco products, as regards additives. A compromise could be based on an adapted version of the latter paragraph of the amendment.

Amendment 29 requires Member States to publish the list of ingredients for each product, indicating tar, nicotine and carbon monoxide yields, on the grounds of consumers right to product information. This amendment can be accepted as it extends the information requirement to tar, nicotine and carbon monoxide yields, as well as "ingredients", while leaving the reference to trade secrecy intact.

Amendments seeking to limit the ban on misleading product descriptors - Amendments 10 and 30

Amendment 10 seeks to exclude certain already registered trademarks from the provisions banning the use of descriptors, when they are in fact not used to communicate a specific level of smoke constituents. This amendment cannot be accepted. However, the following could be accepted as a compromise text:

-Amendment 10, recital 18(a) (new): "The use on packaging of tobacco products of terms such as "low-tar", "ultra-light", "light" and other similar elements might mislead the consumer by giving a false impression that such products are less harmful, since smoking behaviour also determines the level of inhaled substances. This matter is not reflected in the use of such product descriptors. The fact that national rules in this respect may differ represents a potential obstacle for the internal market."

Amendment 30 excludes certain already registered trademarks from the provisions banning the use of descriptors. It also provides for Member States to notify the Commission, which shall include the information in its report under Article 11, together with proposals for remedial action for internal market problems. This amendment cannot be accepted. However, the following could be accepted as a compromise text:

-Article 7(1)(a) (new): "Member States shall take all measures necessary to ensure that, without prejudice to Article 5, paragraph 1, texts, names, trade marks, pictures and figurative or other signs are not used on packaging of tobacco products to imply that a particular tobacco product is less harmful than others."

-Article 11(3): Add a new indent as follows: "- Implementation of the provisions of Article 7".

Amendments seeking to make changes to the reporting requirements - Amendments 31 and 46

Amendment 31 seeks to widen the scope of the first Commission report under Article 11 on the measures to be taken to complete and amend the directive: health warnings, labelling, assessment of toxic exposure and harm, products which have the potential to reduce harm, testing methods, toxicological data. It also mentions the internal market, new scientific developments and new international standards as elements for the adaptation of the Directive. This amendment can be accepted as it addresses in a more detailed manner the areas to be considered for future harmonisation, as well as the operation of the provisions of the present proposal.

Amendment 46 foresees that on 31 December 2006 at the latest, Parliament and Council will adopt a Directive establishing a common list of ingredients. This amendment is not acceptable to the Commission, as it is contrary to its power of legislative initiative under the EC Treaty. The reports foreseen in Article 11 may, however, be accompanied by proposals if necessary. Notwithstanding, it must be noted that a proposal for a common list of ingredients would only be achievable for the first report if information on ingredients is supplied in timely manner by Member States. The Commission could accept the following text:

"The Commission is invited, for the functioning of the internal market, to submit on the basis of the data provided under Article 6, if appropriate, a proposal providing for a common list of ingredients authorised for tobacco products, taking into account inter alia their addictiveness."

Amendments seeking to modify the deadlines for implementation - Amendment 33

Amendment 33 establishes a derogation for products other than cigarettes, so that these products, when they do not comply with the Directive, may continue to be marketed for three years after its entry into force. The Commission cannot accept this amendment, as it would allow a too lengthy circulation of non-conform products, unjustified except for economic reasons with no evaluation of public health impact.

Other amendments - Amendments 48, 50, 7 and 40

Amendment 48 calls for evaluation of evidence-based claims for tobacco products designed or marketed to "reduce risk" or for which the manufacturer claims harm reduction. The Commission accepts this amendment as the recital proposed refers to a provision in Article 11(3), covered by amendment 31, which is also acceptable.

Amendment 50 seeks to take account of other Community legislation on genetically modified organisms. This amendment is acceptable to the Commission in the form of a recital, as indicated in amendment 16.

Amendment 7 states that socio-economic direct and indirect costs of active and passive tobacco use should be regularly evaluated and made available to the public. This amendment is acceptable, as this has been Commission practice, for example in the case of documents COM(96) 609 and COM(99) 407. This issue could be dealt with under the relevant Community public health programmes, which could include a reference to this task, and a recital to that effect could be considered acceptable.

Amendment 40 seeks to point out that in the European Union, tobacco growing continues to receive approx. EUR 1 billion per year in assistance, and that this amount is out of all proportion to European Union spending on prevention of cancer and cardiovascular diseases. This amendment cannot be accepted, as the Common Agricultural Policy should not be dealt with in the context of this legislative text on the Internal Market.

3.3. Amended proposal

Having regard to Article 250 paragraph 2 of the EC Treaty, the Commission modifies its proposal as indicated above.