Article 1 Aim
The aim of this Directive is to approximate the laws, regulations and administrative provisions of the Member States concerning the maximum tar, nicotine and carbon monoxide yields of cigarettes and the warnings regarding health and other information to appear on unit packets of tobacco products, together with certain measures concerning the ingredients and the descriptions of tobacco products, taking as a basis a high level of health protection.
Article 2 Definitions
For the purposes of this Directive: 1. ‘tobacco products’ means products for the purposes of smoking, sniffing, sucking or chewing, inasmuch as they are, even partly, made of tobacco, whether genetically modified or not; 2. ‘tar’ means the raw anhydrous nicotine-free condensate of smoke; 3. ‘nicotine’ means nicotinic alkaloids; 4. ‘tobacco for oral use’ means all products for oral use, except those intended to be smoked or chewed, made wholly or partly of tobacco, in powder or in particulate form or in any combination of those forms, particularly those presented in sachet portions or porous sachets, or in a form resembling a food product; 5. ‘ingredient’ means any substance or any constituent except for tobacco leaf and other natural or unprocessed tobacco plant parts used in the manufacture or preparation of a tobacco product and still present in the finished product, even if in altered form, including paper, filter, inks and adhesives.
Article 3 Cigarettes: maximum tar, nicotine and carbon monoxide yields
1. From 1 January 2004, the yield of cigarettes released for free circulation, marketed or manufactured in the Member States shall not be greater than: — 10 mg per cigarette for tar, — 1 mg per cigarette for nicotine, — 10 mg per cigarette for carbon monoxide. 2. By way of derogation from the date referred to in paragraph 1, as regards cigarettes manufactured within, but exported from, the European Community, Member States may apply the yield limits laid down in this Article as from 1 January 2005 but shall in any event do so by 1 January 2007 at the latest. 3. For Greece, as a temporary derogation, the date of application of the maximum tar yield of cigarettes manufactured and marketed within its territory, as referred to in paragraph 1, shall be 1 January 2007.
Article 4 Measurement methods
1. The tar, nicotine and carbon monoxide yields of cigarettes shall be measured on the basis of ISO standards 4387 for tar, 10315 for nicotine, and 8454 for carbon monoxide. The accuracy of the tar and nicotine indications on packets shall be verified in accordance with ISO standard 8243. 2. The tests referred to in paragraph 1 shall be carried out or verified by testing laboratories which are approved and monitored by the competent authorities of the Member States. Member States shall send the Commission a list of approved laboratories, specifying the criteria used for approval and the methods of monitoring applied, by 30 September 2002, and whenever any change is made. 3. Member States may also require tobacco manufacturers or importers to carry out any other tests as may be laid down by the competent national authorities in order to assess the yield of other substances produced by their tobacco products on a brand-name-by-brand-name basis and type-by-type-basis and in order to assess the effects of those other substances on health, taking into account, inter alia , their addictiveness. Member States may also require that such tests be carried out or verified in approved testing laboratories as laid down in paragraph 2. 4. The results of tests carried out in accordance with paragraph 3 shall be submitted to the relevant national authorities on an annual basis. Member States may provide for less frequent disclosure of test results in cases where the product specifications have not varied. Member States shall be informed of changes in such product specifications Member States shall ensure the dissemination, by any appropriate means, of information submitted in accordance with this Article with a view to informing consumers and in so doing shall take account, where appropriate, of any information which constitutes a trade secret. 5. Each year Member States shall communicate all data and information submitted pursuant to this Article to the Commission, which shall take account thereof when drawing up the report referred to in Article 11.
Article 5 Labelling
1. The tar, nicotine and carbon monoxide yields of cigarettes measured in accordance with Article 4 shall be printed on one side of the cigarette packet in the official language or languages of the Member State where the product is placed on the market, so that at least 10 % of the corresponding surface is covered. That percentage shall be raised to 12 % for Member States with two official languages and to 15 % for Member States with three official languages. 2. Each unit packet of tobacco products, except for tobacco for oral use and other smokeless tobacco products must carry the following warnings: (a) general warnings: 1. ‘Smoking kills/Smoking can kill,’ or 2. ‘Smoking seriously harms you and others around you.’ The general warnings indicated above shall be rotated in such a way as to guarantee their regular appearance. The warning shall be printed on the most visible surface of the unit packet, and on any outside packaging, with the exception of additional transparent wrappers, used in the retail sale of the product; and (a) general warnings: 1. ‘Smoking kills/Smoking can kill,’ or 2. ‘Smoking seriously harms you and others around you.’ The general warnings indicated above shall be rotated in such a way as to guarantee their regular appearance. The warning shall be printed on the most visible surface of the unit packet, and on any outside packaging, with the exception of additional transparent wrappers, used in the retail sale of the product; and (b) an additional warning taken from the list set out in Annex I. The additional warnings referred to above shall be rotated in such a way as to guarantee their regular appearance. That warning shall be printed on the other most visible surface of the unit packet, and on any outside packaging, with the exception of additional transparent wrappers, used in the retail sale of the product. (b) an additional warning taken from the list set out in Annex I. The additional warnings referred to above shall be rotated in such a way as to guarantee their regular appearance. That warning shall be printed on the other most visible surface of the unit packet, and on any outside packaging, with the exception of additional transparent wrappers, used in the retail sale of the product. Member States may determine the positioning of the warnings on those surfaces in order to accommodate language requirements. 3. The rules for the use of colour photographs or other illustrations to depict and explain the health consequences of smoking shall be adopted by the Commission with a view to ensuring that internal market provisions are not undermined. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(3). Where Member States require additional warnings in the form of colour photographs or other illustrations, these shall be in accordance with the abovementioned rules. 4. Tobacco products for oral use, where their marketing is permitted under Article 8, and smokeless tobacco products shall carry the following warning: ‘This tobacco product can damage your health and is addictive.’ This warning shall be printed on the most visible surface of the unit packet and on any outside packaging, with the exception of additional transparent wrappers, used in the retail sale of the product. Member States may determine the positioning of the warning on that surface in order to accommodate language requirements. 5. The general warning required pursuant to paragraph 2(a) and the warning for smokeless and oral tobacco products referred to in paragraph 4 shall cover not less than 30 % of the external area of the corresponding surface of the unit packet of tobacco on which it is printed. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages. The additional warning required pursuant to paragraph 2(b) shall cover not less than 40 % of the external area of the corresponding surface of the unit packet of tobacco on which it is printed. That proportion shall be increased to 45 % for Member States with two official languages and 50 % for Member States with three official languages. However, in the case of unit packets intended for products other than cigarettes, the most visible surface of which exceeds 75 cm 2 , the warnings referred to in paragraph 2 shall cover an area of at least 22,5 cm 2 on each surface. That area shall be increased to 24 cm 2 for Member States with two official languages and 26,25 cm 2 for Member States with three official languages. 6. The text of warnings and yield indications required under this Article shall be: (a) printed in black Helvetica bold type on a white background. In order to accommodate language requirements, Member States shall have the right to determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required; (b) in lower-case type, except for the first letter of the message and where required by grammar usage; (c) centred in the area in which the text is required to be printed, parallel to the top edge of the packet; (d) for products other than those referred to in paragraph 4, surrounded by a black border not less than 3 mm and not more than 4 mm in width which in no way interferes with the text of the warning or information given; (e) in the official language or languages of the Member State where the product is placed on the market. 7. The printing of the texts required by this Article on the tax stamps of unit packets shall be prohibited. The texts shall be irremovably printed, indelible and shall in no way be hidden, obscured or interrupted by other written or pictorial matter or by the opening of the packet. In the case of tobacco products other than cigarettes, the texts may be affixed by means of stickers, provided that such stickers are irremovable. 8. Member States may stipulate that the warnings referred to in paragraphs 2 and 4 are to be accompanied by a reference, outside the box for warnings, to the issuing authority. 9. To ensure product identification and traceability, the tobacco product shall be marked in any appropriate manner, by batch numbering or equivalent, on the unit packet enabling the place and time of manufacture to be determined. The technical measures to apply this provision shall be adopted in accordance with the procedure laid down in Article 10(2).
Article 6 Further product information
1. Member States shall require manufacturers and importers of tobacco products to submit to them a list of all ingredients, and quantities thereof, used in the manufacture of those tobacco products by brand name and type. This list shall be accompanied by a statement setting out the reasons for the inclusion of such ingredients in those tobacco products. It shall indicate their function and category. The list shall also be accompanied by the toxicological data available to the manufacturer or importer regarding these ingredients in burnt or unburnt form as appropriate, referring in particular to their effects on health and taking into account, inter alia , any addictive effects. The list shall be established in descending order of the weight of each ingredient included in the product. The information referred to in the first subparagraph shall be provided on a yearly basis and for the first time by 31 December 2002 at the latest. 2. Member States shall ensure the dissemination of the information provided in accordance with this article by any appropriate means, with a view to informing consumers. Due account shall nevertheless be taken of protection of any information on specific product formulae which constitutes a trade secret. 3. Member States shall ensure that the list of ingredients for each product, indicating tar, nicotine and carbon monoxide yields, is made public. 4. Each year Member States shall communicate all data and information submitted pursuant to this Article to the Commission, which shall take account thereof when drawing up the report referred to in Article 11.
Article 7 Product descriptions
With effect from 30 September 2003, and without prejudice to Article 5(1), texts, names, trade marks and figurative or other signs suggesting that a particular tobacco product is less harmful than others shall not be used on the packaging of tobacco products.
Article 8 Tobacco for oral use
Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden.
Article 9 Adaptations
1. The adaptation to scientific and technical progress of the measurement methods laid down in Article 4 and the definitions relating thereto shall be decided by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(3). 2. The adaptation to scientific and technical progress of health warnings to be shown on unit packets of tobacco products as set out in Annex I and the frequency of rotation of the health warnings shall be decided by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(3). 3. The Commission shall, in accordance with the procedure laid down in Article 10(2), adapt to scientific and technical progress the marking for identification and tracing purposes of tobacco products.
Article 10 Committee procedure
1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 11 Report
No later than 31 December 2004, and every two years thereafter, the Commission shall submit to the European Parliament, the Council and the Economic and Social Committee a report on the application of this Directive. With a view to drafting the report referred to in the first paragraph, the Commission shall be assisted by scientific and technical experts in order to have all the necessary information available. On submission of the first report, the Commission shall indicate in particular the features which should be reviewed or developed in the light of developments in scientific and technical knowledge, including the development of internationally agreed rules and standards on products, and shall pay special heed to: — subsequent reduction of the maximum yields laid down in Article 3(1), — possible links between these yields, — improvements in health warnings, in terms of size, position and wording, — new scientific and technical information regarding labelling and the printing on cigarette packets of photographs or other illustrations to depict and explain the health consequences of smoking, — methodologies for more realistically assessing and regulating toxic exposure and harm, — evaluation of the addictive effects of those ingredients which encourage addiction, — evaluation of tobacco products which may have the potential to reduce harm, — development of standardised testing methods to measure the yields of constituents in cigarette smoke other than tar, nicotine and carbon monoxide, — toxicological data to be required from manufacturers on ingredients and the manner in which they should be tested in order to allow public health authorities to assess their use, — development of standards concerning products other than cigarettes, in particular rolling tobacco. The report shall also examine the links between the labelling requirements laid down in Article 5 and consumer behaviour. That report shall be accompanied by any proposals for amendments to this Directive which the Commission deems necessary to adapt it to developments in the field of tobacco products, to the extent necessary for the establishment and operation of the internal market, and to take into account any new development based on scientific facts and developments on internationally agreed product standards.
Article 12 Common list of ingredients
In the framework of the first report referred to in Article 11, at the latest by 31 December 2004, and with a view to the proper functioning of the internal market, the Commission is invited to submit, on the basis of the information provided under Article 6, a proposal providing for a common list of ingredients authorised for tobacco products, taking into account, inter alia , their addictiveness.
Article 13 Import, sale and consumption of tobacco products
1. Member States may not, for considerations relating to the limitation of the tar, nicotine or carbon monoxide yields of cigarettes, to health warnings and other indications or to other requirements of this Directive, prohibit or restrict the import, sale or consumption of tobacco products which comply with this Directive, with the exception of measures taken for the purposes of verifying the data provided under Article 4. 2. This Directive shall not affect the right of Member States to keep or introduce, in accordance with the Treaty, more stringent rules concerning the manufacture, import, sale and consumption of tobacco products which they deem necessary in order to protect public health, in-so-far as such rules do not prejudice the rules laid down in this Directive. 3. In particular, Member States may provide for the prohibition, pending the establishment of the common list of ingredients referred to in Article 12, of the use of ingredients which have the effect of increasing the addictive properties of tobacco products.
Article 14 Implementation
1. Without prejudice to the first paragraph of Article 15, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2002 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Products which do not comply with the provisions of this Directive may continue to be marketed for one year after the date referred to in paragraph 1. 3. By way of derogation from paragraph 2, products other than cigarettes which do not comply with the provisions of this Directive may continue to be marketed for two years after the date referred to in paragraph 1. 4. Member States shall communicate to the Commission the text of the provisions of domestic law which they adopt in the field governed by this Directive.
Article 15 Repeal
Directives 89/622/EEC and 90/239/EEC are hereby repealed, without prejudice to the obligations of Member States concerning the time limits for transposition and application of the Directives listed in Annex II. References to the Directives repealed shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
Article 16 Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities .
Article 17 Addressees
This Directive is addressed to the Member States.