E-cigarettes are subjected to the Tobacco Products Directive 2014/40/EU. According to the directive, 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 notification should also contain toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled.

Currently the toxicological testing requirements are not clearly defined. Also, inhalation toxicology is one of the least developed areas of toxicology, being costly to do, and more difficult to carry out. Nonetheless, existence of any studies relating to the carcinogenicity, mutagenicity, toxicity for reproduction, and to any toxicological effects of the ingredients and thermal degradation products on the heart, blood vessels or respiratory tract should be provided, if relevant.

To this purpose, in silico methods can serve as a screening tool to identify the riskiest substances, to fill data gaps, and to take conclusions.

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