The Tobacco and Related Products Regulations 2016

Product requirements U.K.

36.—(1) No person may produce or supply an electronic cigarette or refill container unless it complies with paragraphs (2) to (8), so far as relevant to the product concerned.

(2) Nicotine-containing liquid which is presented for retail sale must be in—

(a) a dedicated refill container in a volume not exceeding 10 millilitres; or

(b) a disposable electronic cigarette, a single use cartridge, or a tank, in a volume not exceeding 2 millilitres.

(3) The capacity of the tank of a refillable electronic cigarette must not exceed 2 millilitres.

(4) Nicotine-containing liquid which is presented for retail sale in an electronic cigarette or refill container must not contain nicotine in excess of 20 milligrams per millilitre.

(5) Nicotine-containing liquid in an electronic cigarette or refill container—

(a) must not contain any additive referred to in regulation 16 (no vitamins, colourings or prohibited additives in tobacco products);

(b) must be manufactured using only ingredients of high purity;

(c) must not contain substances other than the ingredients notified under regulation 31, unless present in trace levels, where such trace levels are technically unavoidable during manufacture; and

(d) must not include ingredients (except for nicotine) which pose a risk to human health in heated or unheated form.

(6) An electronic cigarette must be able to deliver a dose of nicotine at consistent levels under normal conditions of use.

(7) An electronic cigarette or refill container must be—

(a) child-resistant and tamper-evident; and

(b) protected against breakage and leakage.

(8) An electronic cigarette or refill container must have a mechanism for ensuring re-filling without leakage (unless it is a disposable electronic cigarette).

(9) For the purposes of paragraph (7), a product is tamper-evident if it has one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence that the product (or its packaging) has been opened.

(10) For the purposes of paragraph (8), a product has a mechanism for ensuring re-filling without leakage if the mechanism—

(a) entails—

(i) the use of a refill container possessing a securely attached nozzle at least 9 millimetres long which is narrower than, and slots comfortably into, the opening of the tank of the electronic cigarette, and

(ii) in the case of refill containers, a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically and subjected only to atmospheric pressure at a temperature between 15 and 25 degrees Celsius; or

(b) operates by means of a docking system which only releases refill liquids into the tank of an electronic cigarette when the electronic cigarette and refill container are connected.

[F1 (11) Regulations may amend the technical standards in paragraph (10) for the refill mechanism required by paragraph (8) as they apply in relation to GB related products.]

Textual Amendments

F1 Reg. 36(11) inserted (31.12.2020) by S.I. 2019/41, regs. 1, 6(22) (with reg. 9) (as amended by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(3)(27), 5); 2020 c. 1, Sch. 5 para. 1(1)