9.

Member States shall require manufacturers, importers and distributers of electronic cigarettes and refill containers to establish and maintain a system for collecting information about all of the suspected adverse effects on human health of these products. Should any of these economic operators consider or have reason to believe that electronic cigarettes or refill containers, which are in their possession and are intended to be placed on the market or are placed on the market, are not safe or are not of good quality or are otherwise not in conformity with this Directive, that economic operator shall immediately take the corrective action necessary to bring the product concerned into conformity with this Directive, to withdraw or to recall it, as appropriate. In such cases the economic operator shall also be required to immediately inform the market surveillance authorities of the Member States in which the product is made available or is intended to be made available, giving details, in particular, of the risk to human health and safety and of any corrective action taken, and of the results of such corrective action. Member States may also request additional information from the economic operators, for example on the safety and quality aspects or any adverse effects of electronic cigarettes or refill containers.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.