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Manufacture, presentation and sale of tobacco products

This Directive concerns the manufacture. presentation and sale of tobacco products in the Member States of the EU, in particular the use of warnings on packets, the prohibition of descriptions such as 'mild' or 'light', the maximum tar, nicotine and carbon monoxide yields, and the prohibition of tobacco for oral use.

ACT

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 [See amending act(s)].

SUMMARY

This Directive aims to approximate the laws, regulations and administrative provisions of the Member States concerning:

  • the maximum tar, nicotine and carbon monoxide yields of cigarettes;
  • the warnings regarding health and other information to appear on unit packets of tobacco products;
  • certain measures concerning the ingredients and the descriptions of tobacco products.

Cigarettes: maximum yields

The Directive lays down maximum tar, nicotine and carbon monoxide yields for cigarettes released for free circulation, marketed or manufactured in the Member States. These maximum yields are lower than those laid down by Directive 90/239/EEC concerning maximum tar yields and are extended to two other substances (nicotine and carbon monoxide).

From 1 January 2004, the maximum yields for cigarettes released for free circulation, marketed or manufactured in the Member States will be as follows:

  • 10 mg per cigarette for tar;
  • 1 mg per cigarette for nicotine;
  • 10 mg per cigarette for carbon monoxide.

As regards measurement methods, tests are carried out on the basis of standards specified by approved laboratories designated by the Member States. The information must be submitted on an annual basis to the competent authorities in the Member States, which will forward it to the European Commission.

The Member States must also disseminate this information to consumers, taking account of any information which constitutes a trade secret.

Labelling

With regard to labelling, this Directive lays down the following provisions:

  • Maximum yields: the information on the maximum yields for cigarettes must cover at least 10 % of the surface of the packet (12 % for a Member State with two official languages and 15 % for a Member State with three official languages). The Directive also specifies where this information is to be placed on the packet.
  • Warnings: there are two types of compulsory warning for all products (except for tobacco for oral use and other smokeless tobacco products):
    1. a general warning ("smoking kills/can kill" or "smoking seriously harms you and others around you"), which must cover not less than 30 % of the external area of the corresponding surface of the packet (32 % and 35 % for Member States with two or three official languages respectively);
    2. an additional warning (an annex to the Directive sets out a choice of such warnings), which must cover not less than 40 % of the external area of the corresponding surface of the packet (45 % and 50 % for Member States with two or three official languages respectively).
      As in the case of maximum yields, the Directive specifies where the warnings are to be placed on the packet and the text to be used. The Directive also defines the rules relating to the use of colour photographs or other illustrations aimed at explaining the health consequences of smoking. These rules must not block the smooth operation of the internal market.
  • Tobacco products for oral use and smokeless tobacco products: there are separate provisions for these two categories of products, i.e. the following warning: "This tobacco product can damage your health and is addictive."
  • Product identification and traceability: the Directive provides for identification of the place and time of manufacture of the product by means of batch numbering or equivalent.

List of ingredients

Manufacturers and importers are required to submit to the Member States, on a yearly basis a list of all ingredients, and quantities thereof, used in the manufacture of tobacco products, together with toxicological data on their effects on health and any addictive effects. This list must be accompanied by a statement setting out the reasons for their inclusion. It must also be made public and be submitted to the Commission on a yearly basis.

Product descriptions

Since 30 September 2003, it is prohibited to describe a product as less harmful than another (by using names, figurative signs, etc.).

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, which stipulates that the placing on the market in Sweden of tobacco for oral use may continue.

Effects on trade

As harmonisation and approximation of the rules relating to the internal market will lead to greater clarity and increased security for market operators, the overall economic effects are considered to be positive.

Implementation

The Directive provides for transitional periods for the application of its specific provisions (on maximum yields etc.). It also provides for a second transitional period in respect of the presentation and sale of products. In actual fact, products which do not comply with the provisions of the Directive may continue to be marketed for one year after the deadline for implementation in the Member States. For products other than cigarettes, the transitional period is increased to two years.

Adaptations of the Directive to scientific and technical progress will be taken into account by the Commission, assisted by a committee. The Commission will also be assisted by a group of experts for the control of tobacco, set up within its Advisory Committee on Cancer Prevention, particularly in connection with the preparation of a report on the application of the Directive.

Evaluation

Every two years, the Commission has to submit to the European Parliament, the Council and the Economic and Social Committee a report on the application of the Directive.

REFERENCES

ActEntry into forceDeadline for transposition in the Member StatesOfficial Journal

Directive 2001/37/EC

18.7.2001

30.9.2002

OJ L 194, 18.7.2001

Amending act(s)Entry into forceDeadline for transposition in the Member StatesOfficial Journal

Regulation (EC) No 596/2009

7.8.2009

-

OJ L 188, 18.7.2009

The successive amendments and corrections to Directive 2001/37/EC have been incorporated into the basic text. This consolidated version is of documentary value only.

RELATED ACTS

Commission Decision 2003/641/EC of 5 September 2003 on the use of colour photographs or other illustrations as health warnings on tobacco packages [Official Journal L226, of10.09.2003].
This Decision establishes rules for the use, on cigarette packets, of colour photographs or other illustrations to depict the health consequences of smoking. It is a follow-up to Directive 2001/37/EC on tobacco products, which required an increase in the size of health warnings on packaging. However, the use of shock images in addition to warning messages is not mandatory.

Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products [Official Journal L 152 of 20.06.2003].
This Directive is designed to put a ban, at European Union level, on tobacco advertising in printed publications, in radio broadcasting and in information society services. It also bans the sponsorship of events which have a cross-border effect and seek to promote tobacco products.

Council Recommendation 2003/54/EC of 2 December 2002 on the prevention of smoking and on initiatives to improve tobacco control [Official Journal L 022 of 25.01.2003].
This Recommendation seeks to control the sale of tobacco to children and adolescents. It also aims to better inform the public of the health risks associated with tobacco in order to discourage smoking.

Last updated: 04.03.2011
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