WHAT’S NEW WITH ELECTRONIC CIGARETTES? FINAL OPINION FROM SCHEER

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) of the European Commission adopted on April 16, 2021 the Final Opinion on electronic cigarettes.

The Commission directed SCHEER to evaluate the most recent scientific and technical information on electronic cigarettes, with a focus only on health impacts in comparison to non-smoking.

THE MAIN AXES OF THE OPINION

The Opinion examined the role of electronic cigarettes, with a focus on possible effects, regarding 3 specific aspects:

  • Their use and possible health issues caused, in relation to their technical design and chemical composition, taking into consideration the applicable EU regulatory context;
  • Their function as means to the initiation of smoking (particularly in young generations);
  • Their contribution in the cessation of the traditional smoking.

FINAL RESULTS OF THE OPINION

Concerning the three axes, the SCHEER reached the following conclusions:

  • According to moderate and growing amount of human data, the use of electronic cigarettes can result in health issues, particularly related to the cardiovascular system. The SCHEER believes that the chemicals found in aerosol should be considered as the main responsible for the occurrence of health issues. There is also strong evidence linked to nicotine.  Same level of evidence with low incidence reveals a risk for poisoning and injuries caused by burns and explosion.

Regarding second-hand exposure, the main issue is the exhaled air and, in particular, the chemicals with strong evidence on nicotine. Nevertheless, there is limited evidence due to lack of research on children and adolescents;

  • Moderate data suggest that electronic cigarettes function as a trend for young people, which results in the initiation of smoking; curiosity being the most frequent reason.  Equally strong evidence suggests that nicotine included in the e-liquids is related to the development of addiction, whereas the flavors play a significant role in the attractiveness of the product and, consequently, initiation of smoking.
  • There is weak evidence that relates the use of electronic cigarettes to the cessation of traditional smoking, and weak to moderate evidence relating the use of electronic cigarettes to smoking reduction.

REGULATORY FRAMEWORK FOR ELECTRONIC CIGARETTES

Electronic cigarettes are regulated as products in the EU market under Article 20 of the Tobacco Products Directive (2014/40/EU). This Directive includes requirements concerning safety, quality, packaging, labelling, notification to the Competent Authority by the manufacturer and importer, monitoring and reporting of developments; whereas the Commission adopted further legislation for

the implementation of Article 20. The requested Opinion might help the European Commission to evaluate whether there is a need for legislative amendments.

Manufacturers should be aware that also additional legislation, such as EMC/LVD, GPSD, Rohs and Battery directive, apply to their products.


26/05/2021

Anna Karavasili

Regulatory Affairs Department


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