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37.—(1) No person may produce or supply an electronic cigarette or refill container unless it complies with paragraphs (2) to (6).
(2) Each unit packet of the electronic cigarette or refill container must include a leaflet with information on—
(a)instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers;
(b)contra-indications;
(c)warnings for specific risk groups;
(d)possible adverse effects;
(e)addictiveness and toxicity;
(f)contact details of the producer; and
(g)if the producer is not based in a member State, a contact person within a member State.
(3) Each unit packet and any container pack must include—
(a)a list of all ingredients contained in the product set out in descending order by weight;
(b)an indication of the nicotine content of the product and the delivery per dose;
(c)the batch number; and
(d)a recommendation to keep the product out of reach of children.
(4) Each unit packet and any container pack must carry a health warning consisting of the text: “This product contains nicotine which is a highly addictive substance”.
(5) The health warning must—
(a)appear on both the front and back surfaces of the unit packet and any container pack;
(b)cover 30% of the area of each of those surfaces, calculated in relation to the area of the surface concerned when the pack is closed;
(c)be in black Helvetica bold type on a white background;
(d)be in a font size which ensures that the text occupies the greatest possible proportion of the surface area reserved for it; and
(e)appear at the centre of that area.
(6) The health warning must be parallel to the main text on the surface concerned.
(7) For the purposes of paragraph (2)(a), the instructions for use must—
(a)include appropriate instructions for refilling, including diagrams; and
(b)comply with paragraph (8).
(8) Instructions for use comply with this paragraph where—
(a)if the refill mechanism is as described in regulation 36(10)(a), the instructions for use indicate the width of the nozzle or the width of the opening of the tank (as appropriate) in a manner that enables consumers to identify the compatibility of refill containers and electronic cigarettes; or
(b)if the refill mechanism is as described in regulation 36(10)(b), the instructions for use specify the type or types of docking system with which the electronic cigarette or refill container is compatible.
(9) Paragraph (7) does not apply to instructions for use that relate to disposable electronic cigarettes.
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