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Parliamentary question - P-6535/2009(ASW)Parliamentary question
P-6535/2009(ASW)
European Parliament

Answer given by Ms Vassiliou on behalf of the Commission

19.2.2010

Written question

The Commission shares the concerns of the Honourable Member about the products called ‘electronic cigarettes’.

In order to find a common understanding on how to treat these products, the Commission regularly shares knowledge with Member States, in particular in the Regulatory Committee under the Tobacco Products Directive[1]. This discussion has shown that there are several emerging nicotine and tobacco products that — like the ‘electronic cigarette’ — might undermine the smoking cessation policies and often fall in the borderline between tobacco and other legislation, such as legislation on medicinal products[2], medical devices[3], food and product safety[4].

As regards the applicable legislation, it must be noted that the qualification of a given product falls under the responsibility of the Member States where the product is placed on the market. This analysis must be done on a case-by-case basis, taking account of all the characteristics of the product. The Commission has published an ‘orientation note on electronic cigarettes’[5] which might constitute a useful basis for the Member States to decide which legislation applies to such electronic cigarettes.

As further developed in the abovementioned orientation note, in certain cases the electronic cigarette may fall under the definition of a medicinal product laid down in Directive 2001/83/EC, either if the product is presented as a remedy against nicotine addiction or if it is qualified as restoring, correcting or modifying physiological functions. In particular, assuming that the nicotine can be regarded as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC, if the delivery system and the nicotine form a single integral product which is intended exclusively for use in the given combination and which is not reusable, this single product will be governed by Directive 2001/83/EC and therefore will require a marketing authorisation which is based on studies on its safety, quality and efficacy. The relevant essential requirements of Annex I of Directive 93/42/EEC on medical devices will apply as far as the safety and performance-related features of the delivery system are concerned.

If a medical purpose can be established, the delivery system alone (i.e. without nicotine) may be seen as a medical device intended to administer a medicinal product. In such case this delivery system alone will be governed by Directive 93/42/EEC, without prejudice to the provisions of Directive 2001/83/EC with regard to the nicotine.

Last but not least, Directive 2001/95/EC[6] on general product safety applies in so far as there are no specific provisions with the same objective in other EC law. This directive provides for restrictive or preventive measures to be taken if the product is found to be dangerous to the health and safety of consumers.

The Commission will continue studying the regulatory challenges together with the Member States to ensure that all new tobacco and nicotine products are properly and coherently regulated at EU level. In particular, the Commission will address the ‘electronic cigarettes’ in assessing the impacts of a possible revision of the Tobacco Products Directive.

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