Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products

• Published date: 28 March 2012
• Official Gazette Publication: Official Journal of the European Communities, L 194, 18 July 2001

2001L0037 — EN — 28.03.2012 — 002.001

---

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B DIRECTIVE 2001/37/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products (OJ L 194, 18.7.2001, p.26)

Amended by:

		Official Journal
		No	page	date
►M1	REGULATION (EC) No 596/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009	L 188	14	18.7.2009
►M2	COMMISSION DIRECTIVE 2012/9/EU Text with EEA relevance of 7 March 2012	L 69	15	8.3.2012

---

▼B

DIRECTIVE 2001/37/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 5 June 2001

on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 95 and 133 thereof,

Having regard to the proposal from the Commission ( 1 ),

Having regard to the opinion of the Economic and Social Committee ( 2 ),

Having regard to the opinion of the Committee of the Regions ( 3 ),

Acting in accordance with the procedure laid down in Article 251 of the Treaty ( 4 ), in the light of the joint text approved by the Conciliation Committee on 5 April 2001,

Whereas:

(1) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative 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 ( 5 ) was amended substantially by Directive 92/41/EEC ( 6 ). Since further amendments are to be made to that Directive, 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 ( 7 ), those Directives should be recast in the interests of clarity.

(2) There are still substantial differences between the Member States' laws, regulations and administrative provisions on the manufacture, presentation, and sale of tobacco products which impede the functioning of the internal market.

(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, while 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 individuals.

(4) In accordance with Article 95(3) of the Treaty, a high level of protection in terms of health, safety, environmental protection and consumer protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts; in view of the particularly harmful effects of tobacco, health protection should be given priority in this context.

(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 to reduce further 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) Several Member States have indicated that, if measures establishing maximum carbon monoxide yields for cigarettes are not adopted at Community level, they will adopt such measures at national level. Differences in rules concerning carbon monoxide are likely to constitute barriers to trade and to impede the smooth operation of the internal market. In addition, 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.

(8) A revision of the regulatory framework needs to evaluate evidence-based claims for tobacco products designed and/or marketed to ‘reduce risk’, or for which harm reduction is claimed by the manufacturers.

(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 manufacture of cigarettes should be made subject to common rules not only concerning tar but also concerning maximum nicotine and carbon monoxide levels.

(11) This Directive will also have consequences for tobacco products which are exported from the European Community. The export regime is part of the common commercial policy. Health requirements are, pursuant to Article 152(1) of the Treaty and the case law of the Court of Justice of the European Communities, to form a constituent part of the Community's other policies. Rules should be adopted in order to ensure that the internal market provisions are not undermined.

(12) The provisions of this Directive are without prejudice to Community legislation governing the use and labelling of genetically modified organisms.

(13) Internationally applicable standards for tobacco products are one of the subjects of the negotiations for the drafting of a World Health Organisation Framework Convention on Tobacco Control.

(14) For measuring the tar, nicotine and carbon monoxide yields of cigarettes, reference should be made to ISO standards 4387, 10315 and 8454, which are the only internationally recognised standards, it being understood that subsequent research and technological progress to be promoted should make it possible to develop and use more precise and reliable measurement methods for cigarette yields and to develop measurement methods for the other tobacco products.

(15) There are no internationally agreed standards or tests for quantifying and assessing the yields of constituents in cigarette smoke other than tar, nicotine and carbon monoxide. A procedure for development of such standards, in consultation with the International Standards Organisation, is therefore necessary.

(16) In Directive 90/239/EEC, in view of particular socioeconomic problems, Greece was granted a derogation from the time limits for the implementation of maximum tar yields. That derogation should be maintained for the period stipulated.

(17) The application of tar, nicotine and carbon monoxide ceilings to exported cigarettes should be subject to transitional arrangements in order to allow more time to change product specifications and to allow for the establishment of internationally agreed standards.

(18) Transitional periods should also be provided for in relation to other provisions of this Directive in order to allow the necessary modifications in production to take place and for disposal of stocks, particularly for products other than cigarettes. Use of irremovable labels should be allowed to facilitate the introduction of the labelling requirements of this Directive.

(19) 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 unacceptable and are liable to constitute a barrier to trade and to impede the operation of the internal market in tobacco products, and should therefore be eliminated. It is necessary to that end that the existing legislation be strengthened and clarified, while ensuring a high level of health protection.

(20) Provision should be made for batches of tobacco products to be marked so that those products are traceable for the purposes of monitoring compliance with this Directive.

(21) The direct and indirect socioeconomic costs of active and passive tobacco use should be regularly evaluated and made available to the public in the context of the appropriate Community programmes.

(22) The situation varies in the different Member States regarding the ingredients and additives used in the manufacture of tobacco products. A number of Member States have neither existing legislation nor voluntary agreements in place on those substances. Several Member States in which such legislation or voluntary agreements exist receive no 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. An approximation of the measures applicable in this field should be introduced, resulting in greater transparency.

(23) The lack of information together with the lack of toxicological data prevents the relevant authorities 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

...