EC publishes preliminary opinion on electronic cigarettes

SCHEER preliminary opinion on electronic cigarettes

Electronic cigarettes and any e-liquid containing nicotine are subject to the discipline set out by the Tobacco Products Directive 2014/40/EU (TPD). It is worth pointing out that any e-liquid which does not contain nicotine will be subject instead to the rules set out by the General Product Safety Directive 2001/95/EC (GPSD) and corresponding national implementing acts.

In accordance with the Commission reporting obligations set out by the TPD, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided a preliminary opinion on electronic cigarettes. The European Commission will be able to evaluate whether any legislative change is required, based on the latest scientific information available on electronic cigarettes provided by the preliminary opinion.

Main findings of the opinion

Strong overall weight of evidence for risks in long term systemic effects on the cardiovascular system are highlighted in the conclusions of the SCHEER opinion; the same weight of evidence exist regarding risks of poisoning and injuries due to burns and explosion, although the incidence of such events has been reported to be low.

There is moderate overall weight of evidence for risks of local and irritative damage to the respiratory tract for both users of electronic cigarettes and second-hand exposed persons.

At the same time, there is weak to moderate evidence regarding risks of carcinogenicity of the respiratory tract in both users and passively exposed people. Such risk would be due to the long-term, cumulative exposure to nitrosamines, acetaldehyde and formaldehyde.

E-cigarettes as a gateway to smoking?

The SCHEER points out that there is strong evidence suggesting that e-cigarettes could be responsible forthe beginning of young people’s smoking habit. Such risk appears to be caused by the addictive nature of nicotine containing e-liquids and the presence of flavoring, which may render an e-liquid more appealing and inviting young people with a wider availability of tastes to choose from.

Moreover, the Scientific Committee also specifies that there currently is only weak evidence substantiating the effectiveness of smoking cessation programs using electronic cigarettes. Such findings are in contrast with previous situations in which e-cigarettes have been treated as medical devices, due to their link with smoking cessation claims.

Public consultation open until October 26, 2020

A public consultation has been open in order to enable the scientific community and all the relevant stakeholders to provide their feedback on the preliminary report. All interested parties are requested to submit their comments until October 26, 2020.

Alessandro Polimeno

Regulatory Affairs Expert Consultant

R&D Department


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