Report from the Commission to the European Parliament and the Council on the potential risks to public health associated with the use of refillable electronic cigarettes

Article 20(10) of Directive 2014/40/EU (‘Tobacco Products Directive’ or ‘TPD’) requires the European Commission to submit a report to the European Parliament and the Council on the potential risks to public health associated with the use of refillable electronic cigarettes (‘e-cigarettes’). At the time of the adoption of the TPD, there were concerns about the risks of refillable e-cigarettes to users and consumers, due to their particular characteristics, which allow users to come into direct contact with refill liquids (‘e-liquids’) containing nicotine and other ingredients which may have adverse health effects.

It should be noted that this report identifies the particular risks that may be associated with refillable e-cigarettes and their refill containers, as requested by the co-legislators. The report does not aim to make comparisons between refillable and other types of e-cigarettes, and does not consider the potential public health impact of e-cigarettes in general (such as initiation, cessation, dual use and long-term health effects).

E-cigarettes are relatively new products on the EU market and evidence concerning their potential risks and benefits is only starting to emerge. At this stage, the Commission and Member States are monitoring scientific evidence, user profiles and market developments regarding all types of e-cigarettes. This evidence will also inform the report on the application of the Tobacco Products Directive to be submitted from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions pursuant to Article 28 of the TPD.

This report was prepared with input from the PRECISE study prepared by an external contractor. This study analysed the available scientific literature on health risks of refillable e-cigarettes, data from EU poison centres in eight Member States, and performed chemical analysis on e-cigarette samples. The contractor also conducted a survey amongst the e-cigarette industry to determine what they believed to be the main risks associated with refillable e-cigarettes.

The Commission has carefully considered the risks of refillable e-cigarettes identified by Member States and has discussed this report with the Expert Group on Tobacco Policy and the Subgroup on Electronic cigarettes. Information based on discussions with international regulators has also been included in this report.

ESO: Background information: 10 key changes for tobacco products sold in the EU http://www.europeansources.info/record/cpmmission-summarises-changes-for-tobacco-products-sold-in-the-european-union-as-transposition-is-concluded/

EurActiv, 07.02.17: E-cigarettes are not ‘cool’, EU’s top health official says http://www.euractiv.com/section/health-consumers/news/e-cigarettes-are-not-cool-eus-top-health-official-says/

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