3.

Member States shall ensure that: nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2 ml; the nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml; the nicotine-containing liquid does not contain additives listed in Article 7(6); only ingredients of high purity are used in the manufacture of the nicotine-containing liquid. Substances other than the ingredients referred to in point (b) of the second subparagraph of paragraph 2 of this Article are only present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture; except for nicotine, only ingredients are used in the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form; electronic cigarettes deliver the nicotine doses at consistent levels under normal conditions of use; electronic cigarettes and refill containers are child- and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage.

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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.