Tobacco and related products: manufacture, presentation and sale

The European Parliament adopted by 514 votes to 66, with 58 abstentions, a legislative resolution on the 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 and related products.

The issue had been referred back to the committee responsible during the session of 8 October.

Parliament adopted its position in first reading following the ordinary legislative procedure. The amendments adopted in plenary are the result of a compromise between Parliament and Council. The main amendments are the following:

Objectives of the Directive: the general objective should be to meet obligations under the WHO Framework Convention for Tobacco Control and to facilitate the functioning of the internal market in tobacco and related products, taking as a base a high level of health protection, especially for young people.

Maximum yields of tar, nicotine and carbon monoxide and other substances: the accuracy of the tar, nicotine and carbon monoxide indications shall be verified in accordance with ISO standard 8243. Tests verifying the validity of the result supplied by the tobacco companies shall be done on a regular basis by independent testing laboratories that are not owned or controlled directly or indirectly by the tobacco industry.

Priority list of additives and enhanced reporting obligations:  in addition to the reporting obligations laid down regarding the reporting of ingredients and emissions, enhanced reporting obligations shall apply to certain additives contained in cigarettes and roll-your-own tobacco that are included in a priority list.

The Commission shall adopt implementing acts laying down and subsequently updating such a priority list of additives. A first list of additives shall be adopted containing at least 15 additives within 2 years of entry into force of the Directive.

Manufacturers and importers of cigarettes and roll-your-own tobacco containing an additive that is included in the priority list must carry out comprehensive studies, which shall examine for each additive whether it contributes to the toxicity or addictiveness of the products concerned, or results in a characterising flavor, facilitates inhalation or nicotine uptake or leads to the formation of substances that have CMR properties.

Ingredients: the amended text prohibits the placing on the market of tobacco products containing a characterising flavour (a clearly noticeable smell or taste other than one of tobacco, resulting from an additive or a combination of additives, including, but not limited to, fruit, spice, herbs, alcohol, candy, menthol or vanilla). Also prohibited are additives such as vitamins, caffeine or taurine, additives having colouring properties for emissions, additives that facilitate inhalation or nicotine uptake, and additives that have CMR properties in unburnt form.

The use of additives necessary for the manufacture of tobacco products, for example sugar, is allowed.

These provisions shall not apply to tobacco for oral use.

Labelling and packaging: the health warnings on a unit packet and any outside packaging are irremovably printed, indelible and fully visible. They shall remain intact when opening the unit packet other than packets with a flip-top lid. All unit packets of tobacco products, which are placed on the market, must carry a tamper proof security feature, composed of visible and invisible elements.

Members want the combined health warnings to cover 65 % of both, the external front and back surface of the unit packet and any outside packaging. The warnings must contain a corresponding colour photograph specified in the picture library in Annex II.

The labelling shall not include any element or feature that: (i) promotes a tobacco product or encourages its consumption; (ii) suggests that a particular tobacco product has properties or has other health or lifestyle benefits; (iii) resembles a food or a cosmetic product; (iv) suggests that a certain tobacco product has improved biodegradability or other environmental advantages.

Packets of less than 20 are forbidden.

Cross-border distance sales of tobacco products: the amended text states that Member States may prohibit cross-border distance sales of tobacco products to consumers. Member States shall cooperate to prevent such sales. Retail outlets engaging in cross-border distance sales of tobacco products may not supply such products to consumers in Member States where such sales have been prohibited.

Electronic cigarettes: in accordance with Parliament’s wishes, E-cigarettes should be regulated, either as medicinal products for stopping smoking or tobacco products. In the second case, the nicotine concentration must be no more than 20mg/ml. E-cigarettes should carry health warnings and should not be sold to children.

They would be subject to the same advertising restrictions as tobacco products.

Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. 

The Commission shall submit a report on the potential risks to public health associated with the use of refillable electronic cigarettes within 2 years after entry into force of the Directive and where appropriate thereafter.