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)
30. 5. 2000 EN Official Journal of the European Communities C 150 E/43 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 manu- facture, presentation and sale of tobacco products (recast version) (2000/C 150 E/03) COM(1999) 594 final - 1999/0244(COD) (Submitted by the Commission on 7 January 2000) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of Committee, the Economic and Social Having regard to the opinion of the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty, Whereas: (1) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and adminis- trative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use (1) was amended substantially by Directive 92/41/EEC (2). Since further amendments are to be made to those Directives, as well as to Council Directive 90/239/EEC of 17 May 1990 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the maximum tar yield of cigarettes (3), all those Directives should be recast in the interests of clarity. Such manufacture, presentation and (2) There are substantial differences between the Member States’ laws, regulations and administrative provisions on tobacco the manufacture, presentation, products. sale transcend the borders of the Member States and the differences in question are likely to give rise to barriers tobacco to the movement between Member States of thereby competition, as products, impeding the functioning of the internal market. and sale of as well distort (3) Those barriers should be eliminated and, to this end, the rules relating to the manufacture, presentation and sale of tobacco products should be approximated, whilst leaving Member States the possibility of introducing, under certain conditions, such requirements as they consider necessary in order to guarantee the protection of the health of indi- viduals. (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. (4) In accordance with Article 95(3) of the Commission is obliged, in its proposals under Article 95(1) concerning health, safety, environmental protection and consumer protection, to take as a base a high level of protection. the Treaty, (5) Directive 90/239/EEC established maximum limits for the tar yield of cigarettes marketed in the Member States with effect from 31 December 1992. The carcinogenic nature of tar makes it necessary further to reduce the levels of tar in cigarettes. (6) Directive 89/622/EEC established a general warning to be carried on the unit packaging of all tobacco products, together with additional warnings exclusively for cigarettes and, from 1992, extended the requirement for additional warnings to other tobacco products. (7) Directive 89/622/EEC prohibited the sale in the Member States of certain types of tobacco for oral use. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden a derogation from the provisions of that Directive in this regard. (8) Cigarettes have been shown to produce amounts of carbon monoxide which are hazardous to human health and capable of contributing to heart disease and other ailments. Differences carbon monoxide are liable to constitute barriers to trade and to impede the smooth operation of the Internal Market. concerning rules in (9) There are differences between the laws, regulations and administrative provisions of the Member States on the limitation of the maximum nicotine yield of cigarettes. Such differences are liable to constitute barriers to trade and to impede the smooth operation of the internal market. Member States and scientific authorities have raised specific problems of public health in a field which has already been the subject of prior harmonisation measures, which the Commission has examined. (10) Those obstacles should accordingly be eliminated and to that end the release for free circulation, marketing and free to movement of cigarettes common rules and carbon monoxide levels. concerning maximum nicotine should be made subject C 150 E/44 EN Official Journal of the European Communities 30. 5. 2000 tobacco manufacturers (11) The size of the internal market in tobacco products and the increasing tendency of to concentrate production for the whole of the Community in only a small number of production plants within the Member States, calls for legislative action to achieve the smooth operation of tobacco products to be carried out at Community rather than national level. the internal market of (18) A number of the Member States have neither existing legislation nor voluntary agreements in place on the ingredients and additives used in the manufacture of tobacco products. Several Member States in which such receive no legislation or voluntary agreements exist information from tobacco manufacturers on the quantities of such ingredients and additives present in particular tobacco products on a brand name by brand name basis. (12) In applying this Directive provision should be made for establishing time-limits which allow, on the one hand, completion to a maximum degree of efficiency of the conversion already begun by Directive process of 90/239/EEC, and, on the other, consumers and manu- facturers to adapt to products with a lower tar, nicotine and carbon monoxide yield. the relevant authorities (19) This lack of information together with the lack of toxico- logical data prevents in the Member States from assessing in any meaningful manner the toxicity of and hazards posed to the health of the consumer by tobacco products. This is inconsistent with the obligation placed on the Community to ensure a high level of protection for human health. (13) In Directive 90/239/EEC Greece was granted a derogation from the time-limits for the implementation of maximum tar yields. That derogation is still in force. and substances (14) Tobacco products have been shown to contain and emit known carcinogens many noxious hazardous to human health when burnt. The consumer has the right to be informed of the presence of these substances when purchasing or consuming the product and to have such information conveyed in a clear, legible and comprehensible manner. One of the most effective methods of presenting this information is through the medium of warning labels on tobacco product packaging. rights of (20) The Community and the Member States have an obli- gation to ensure that the commercial and intellectual are property tobacco manufacturers protected under national and international law. Provision should therefore be made for confidential treatment of product data in so far as this is compatible with the public interest. the (21) Technical and scientific progress in the field of tobacco products calls for regular re-evaluation of the provisions and application in the Member States of this Directive. Therefore, reports by the for Commission is provided for. a procedure regular (15) Experience of the application of the labelling provisions of Directive 89/622/EEC has shown that the requirements laid down therein are insufficient to meet their objective, particularly given the hazardous, including addictive, nature of tobacco products, and the complexity and amount of information to be supplied. (22) Council Directive 89/552/EEC (1), as last amended by Directive 97/36/EC of the European Parliament and of the Council (2), prohibits all forms of television advertising tobacco products. Directive for cigarettes and other 98/43/EC of the the European Parliament Council (3) regulates direct and indirect advertising of tobacco products, including sponsorship. and of (16) The presentation of warning labels and yields has continued to remain variable in the different Member States. As a consequence, consumers in one Member State may be better informed as to the risks of tobacco products than in another. Such differences are unac- ceptable and are liable to constitute a barrier to trade and to impede the operation of the internal market in tobacco products. It is necessary that the existing legis- lation be strengthened and clarified. A high level of health protection should be ensured. (23) The Council Resolution of 26 November 1996 on the reduction of smoking in the European Community (4) called upon the Commission to take particular account, in its policies in various fields in so far as they have relevance to tobacco or tobacco products, of the detri- mental effect of smoking on the health and quality of the Community. The same Council life of citizens of Resolution called upon the Commission to examine further the possible measures which might be taken by the Community and the Member States directed towards the reduction of smoking. (17) These obstacles should accordingly be eliminated and, to that end, the release for free circulation, marketing and free movement of tobacco products should be subject to clearer and strengthened rules on warnings and yields. (1) OJ L 298, 17. 10. 1989, p. 23. (2) OJ L 202, 30. 7. 1997, p. 60. (3) OJ L 213, 30. 7. 1998, p. 9. (4) OJ C 374, 11. 12. 1996, p. 4. 30. 5. 2000 EN Official Journal of the European Communities C 150 E/45 (24) The Commission Communication to the Council and the European Parliament on the present and proposed Community role in combating tobacco consumption (1) called for further review of maximum permitted tar and nicotine limits. The Communication advocated a review of existing warning label requirements and called for action on the definition of the description álow tarí considering that such descriptions may mislead consumers by under- stating the dangers to health of such products. The Communication noted the lack of any Community legis- lation to evaluate or regulate the toxicity and health consequences in tobacco products. There is Community legislation on additives and ingredients in a wide range of other products which may have health consequences for the consumer. arising from the use of additives into believing that (25) The use of terms such as álow tarí on cigarette packaging can mislead the consumer such products are inherently safer than other types of ciga- rettes. National rules on the definition of such cigarettes are not reflected in Community law, leading to potential internal market obstacles, and to a gap in measures to ensure a high level of public health protection in this context. Certain smokers ingest higher levels of tar than those indicated on ’low tar’ cigarette packets because of the nature of their smoking behaviour. (26) The European Parliament Report of 4 November 1997 on the Commission Communication calls for any substance added to tobacco to be non-toxic and proven not to have any harmful effects on health in burnt or unburned form. The Report supports initiatives aimed at making the health warnings more prominent and clearly legible, printed in black on white. that effects on health of (27) In its Recommendation arising out of the Helsinki Consensus Conference on Tobacco, the High Level Cancer Experts Committee recommended (2) the Community should take action to regulate the toxicity and harmful ingredients, in cigarettes and considered that a including additives, should be introduced for cigarettes as nicotine limit soon as possible. The Committee recommended that the labelling provisions for cigarettes should be strengthened and made more prominent and that accurate information about smoking and its health consequences be given to the consumer. the (28) This Directive should be without prejudice to the obli- gations of the Member States concerning the time-limits (1) COM(96) 609 final. (2) Final Annex to COM(96) 609. for transposition and for application of the Directives set out in Annex III. HAVE ADOPTED THIS DIRECTIVE: Article 1 Object The objective of this Directive is the approximation of the laws, regulations and administrative provisions of the Member States concerning the tar yields of cigarettes and the warnings regarding health to appear on packets of tobacco products, together with the approximation of the laws, regulations and administrative provisions of the Member States concerning carbon monoxide and nicotine yields and the ingredients of taking as a base a high level of health tobacco products, protection. Article 2 Definitions For the purposes of this Directive: 1. Tobacco productsí: means products for smoking, sniffing, sucking or chewing, are, even partly, made of tobacco; the purposes of inasmuch as they 2. Tarí: means the raw anhydrous nicotine-free condensate of smoke; 3. Nicotineí: means nicotinic alkaloids; 4. Tobacco for oral useí: 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 - particularly those these forms presented in sachet portions or porous sachets - or in a form resembling a food product; 5. Ingredientí: means any substance except for natural tobacco leaf or its plant parts used as an additive in the manufacture or preparation of a tobacco product and still present in the finished product, even if in altered form. Article 3 Cigarettes: tar, nicotine and carbon monoxide levels 1. The tar yield of cigarettes released for free circulation, marketed or manufactured in the Member States shall not be greater than 10 mg per cigarette as of 31 December 2003; 2. The nicotine yield of cigarettes released for free circu- lation, marketed or manufactured in the Member States shall not be greater than 1. 0 mg per cigarette as of 31 December 2003; C 150 E/46 EN Official Journal of the European Communities 30. 5. 2000 The carbon monoxide yield of cigarettes released for free 3. circulation, marketed or manufactured in the Member States shall not be greater than 10 mg per cigarette as of 31 December 2003. This percentage shall be raised to 12 % for countries with two official languages and 15 % for countries with three official languages. Article 4 Derogation Each unit packet of 2. for smokeless and oral tobacco products, shall carry one of the following general warnings: tobacco products, except For Greece, as a temporary derogation, the limit value of tar yields and date of implementation shall be 10 mg of tar as of 31 December 2006. This derogation may not be used to justify controls at the Community’s internal frontiers. - Smoking killsí. - Smoking can killí. Article 5 Measurement methods 1. The tar, nicotine and carbon monoxide yields referred to in Article 3, which must be indicated on cigarette packets, shall be measured on the basis of ISO methods 4387 for tar, 10315 for nicotine, and 8454 for carbon monoxide. The accuracy of the indications on the packets shall be verified in accordance with ISO standard 8243. 2. Member States may require that the tests referred to in paragraph 1 be carried out by a testing laboratory approved for the purpose by the relevant Member State authorities. 3. Member States may also 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 yields of other substances produced by their tobacco products on a brand name by brand name basis. They may also require that such tests be carried out in approved testing laboratories as laid down in paragraph 2. 4. the The results of all such tests carried out under provisions of paragraph 3 shall be disclosed to the relevant national authorities annually. Each unit packet of smokeless tobacco products, warning taken exclusively from Annex I. tobacco products, except shall carry for oral and an additional Oral tobacco products, where they are permitted to be placed on the market pursuant to the provisions of Article 9, and smokeless tobacco products shall carry the warning in Annex II. This warning shall be placed on the most visible surface of the unit packet, and on any outside packaging used in the retail sale of the product. Member States shall have the right to determine the positioning of the warning on this surface in order to accommodate language requirements. 3. The general warning referred to in the first subparagraph of paragraph 2 shall be printed on the most visible surface of the unit packet, and on any outside packaging used in the retail sale of the product. Member States shall have the right to determine the positioning of the warning on this surface in order to accommodate language requirements. The warning referred to in the second subparagraph of paragraph 2 shall be printed on the other most visible the unit packet, and on any outside packaging surface of used in the retail sale of the product. Member States shall have the right to determine the positioning of the warning on these language requirements. to accommodate in order surfaces The Member States shall take such steps as are necessary the trade secrecy of all data and information 5. to protect submitted pursuant to the requirements of this Article. The text of warnings and yield indications required under 4. this Article, shall be: 6. The Member States shall supply all data and information submitted pursuant to this Article to the Commission not later than 31 May of each year. Article 6 Labelling - printed in black Helvetica bold type on a white back- ground. In order to accommodate language requirements, the 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; 1. The tar, nicotine and carbon monoxide yields of cigarettes 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. - in lower case type except for the first letter of the message; - centred in the area in which the text is required to be printed, parallel to the top edge of the packet; 30. 5. 2000 EN Official Journal of the European Communities C 150 E/47 - surrounded by a black border not less than 3mm in width and not more than 4mm in width which does not in any way interfere with the text of the warning or information given; The Member States shall supply all toxicological data and to the 3. information submitted pursuant Commission no later than 31 May of each year. to this Article - in the official language or languages of the Member State where the product is placed on the market. Article 8 Product descriptions 5. The printing of the texts required by this Article on the underside or on the tax stamps of unit packets shall be prohibited. The texts required pursuant to this Article shall be irremovably fixed, indelible and shall not in any way be hidden, obscured or interrupted by other written or pictorial matter, nor by the opening of the packet. The use of the terms álow tarí, álightí, áultra lightí, ámildí or 1. any other similar terms which have the aim or the direct or indirect effect of conveying the impression that a particular tobacco product is less harmful than others shall be prohibited, unless such terms have been expressly authorised by the Member States where the products in question have been marketed or manufactured. The general warning required pursuant 6. to the first subparagraph of paragraph 2 and the warning for smokeless and oral tobacco products referred to in the third subparagraph of paragraph 2 shall cover not less than 25 % of the external area of the corresponding surface of the unit packet of tobacco on which it is printed. This percentage shall be increased to languages and 30 % for 27 % for countries with two official countries with three official languages. The second additional warning referred to in the 7. subparagraph of paragraph 2 shall cover not less than 25 % of the external area of the corresponding surface of the unit is printed. This percentage shall be packet on which it increased to 27 % for countries with two official languages and 30 % for countries with three official languages. These additional warnings shall be rotated in such a way as to guarantee the successive appearance of each warning on an equal quantity of unit packets. A tolerance of 5 % shall be permitted. Article 7 Further product information 1. Not later than 31 December 2003, Member States shall require all manufacturers and importers of tobacco products to submit to them a list of all ingredients, and quantities thereof, used in the manufacture of their tobacco products by brand name. This list shall be accompanied by a statement setting out the and inclusion of constituents in their tobacco products. such ingredients reasons the for Member States shall also require manufacturers and importers to provide all data on these non-tobacco ingredients in burnt the said and unburned form, and to demonstrate that ingredients are safe for the health of the consumer when used as intended in their tobacco products. This information, together with that referred to in the first subparagraph shall be submitted for the first time on 1 January 2004 and on an annual basis thereafter. 2. The Member States shall take such steps as are necessary to protect the trade secrecy of all such data and information submitted pursuant to the requirements set out in paragraph 1. The Member States which authorise the use of such terms 2. shall notify the Commission thereof, together with the conditions applied to such authorisation. The Commission shall present this information in the report referred to in Article 10. Article 9 Oral tobacco The Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to the provisions of Article 151 of the Act of Accession of Austria, Finland and Sweden. Article 10 Report submit the Council and the Economic than 31 December 2005, and every two years Not later to the European the Commission shall thereafter, Parliament, and Social Committee a report on the application of this Directive and, if necessary, make further proposals to adapt to devel- opments in the field of to the extent necessary for the establishment and operation of the internal market, and taking account of any new development based on scientific facts. tobacco products, it Article 11 Import, sale and consumption of tobacco products 1. Member States may not, for considerations of limitation of the tar, nicotine or carbon monoxide yields of cigarettes, labelling, or other requirements of this Directive prohibit or restrict the import, sale and consumption of tobacco products which comply with this Directive. 2. This Directive shall not otherwise affect the right of the Member States to adopt, in accordance with the Treaty, more stringent rules concerning the import, sale and consumption of tobacco products they deem necessary in order to protect public health. C 150 E/48 EN Official Journal of the European Communities 30. 5. 2000 Article 12 Implementation Article 13 Repeal for 1. Without prejudice to the provisions of Article 13, as shall time-limits regards bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2001 at the latest. They shall forthwith inform the Commission thereof. transposition, Member States When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Products existing at the date of entry into force of this Directive which do not comply with this Directive may continue to be marketed for two years thereafter. 3. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. Directives 89/622/EEC, 90/239/EEC and 92/41/EEC are repealed, without prejudice to the obligations of the Member States transposition and time-limits concerning the application set out in Annex III. for References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV. Article 14 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. Article 15 Addressees This Directive is addressed to the Member States. ANNEX I Tobacco products other than smokeless and oral tobacco Additional health warnings which must be included on the national lists pursuant to the second subparagraph of Article 6(2) 1. Smokers die younger 2. Smoking causes heart disease and strokes 3. Smoking causes cancer Additional warnings from amongst which the Member States may choose 1. Smoking when pregnant harms your baby 2. Protect children: don’t make them breathe your smoke 3. Your doctor can help you stop smoking 4. Smoking is addictive 5. Stopping smoking reduces the risk of serious disease 30. 5. 2000 EN Official Journal of the European Communities C 150 E/49 ANNEX II Oral and smokeless tobacco products Smokeless (or oral, as appropriate) tobacco can damage your health ANNEX III Time-limits for transposition and for application of repealed Directives (referred to in Article 13) Directive Time-limits for transposition Time-limits for application 89/622/EEC (OJ L 359, 8. 12. 1989, p. 1) 1 July 1990 90/239/EEC (OJ L 137, 30. 5. 1990, p. 36) 18 November 1991 92/41/EEC (OJ L 158, 11. 6. 1992, p. 30) 1 July 1992 31 December 1991 31 December 1992 31 December 1993 31 December 1992 (1) 31 December 1997 (2) 31 December 1992 (3) 31 December 1998 (4) 31 December 2000 (5) 31 December 2006 (6) 1 July 1992 1 January 1994 1 December 1994 (1) For all the Member States except Greece. (2) Ibid. (3) Derogation applying to Greece only. (4) Ibid. (5) Ibid. (6) Ibid. C 150 E/50 EN Official Journal of the European Communities 30. 5. 2000 ANNEX IV CORRELATION TABLE This Directive Directive 89/622/EEC as amended by Directive 92/41/EEC Directive 90/239/EEC Other Acts Article 1 Article 1 Article 1 Partly new Article 2 point 1, 2 and 3 Article 2(1), (2) and (3) Article 2(1) Article 2(4) Article 2(2) Article 2(3) Article 3 and 4 Article 3(1) and (2) Article 2, point 4 Article 2, point 5 Article 3(1) Article 3(2) Article 3(3) Article 4 Article 5(1) Article 5(2) to (6) Article 6(1) Article 3(3) Article 6(2) first subparagraph Article 6(2) second subparagraph Article 6(2) third subparagraph Article 4(1) Article 4 (2a)(a) Article 4(1) and (2a)(c) Article 6(3) Article 4(1) and (2a)(a) Article 6(4) Article 4(4) Article 6(5) Articles 4(4) and 4(5) Article 6(6) Article 4(4) New Partly New New New Partly New Partly New New Partly New Partly New Partly New Partly New Partly New New (except for final indent) Partly New Partly New 30. 5. 2000 EN Official Journal of the European Communities C 150 E/51 This Directive Directive 89/622/EEC as amended by Directive 92/41/EEC Directive 90/239/EEC Other Acts Article 4(4) Article 4(2) second indent Article 6(7) first subparagraph Article 6(7) second subparagraph Article 7 Article 8 Article 9 Article 8(a) Article 10 Article 11(1) Article 8(1) Article 7(1) Article 11(2) Article 8(2) Article 7(2) Partly New New New Partly New New Partly New Act of Accession for Sweden Article 12(1) Article 9(1) Article 8(1) Partly New Article 12(2) Article 9(2) Article 8(2) Article 12(3) Article 9(1) Article 8(3) Article 13 Article 14 Article 15 Article 10 Article 9 Annex I Annex 1 Annex II Annex 2 New Partly New Partly New