E-cigarettes an evidence update A report commissioned by Public Health England

E-cigarettes: an evidence update no promotional element or feature or such that suggests the product is harmreducing (or other features described in Article 13 of the Directive)health warnings: One of the following must be shown:• ‘This product contains nicotine which is a highly addictive substance. It isnot recommended for use by non-smokers’ or• ‘This product contains nicotine which is a highly addictive substance’ Member States shall determine which health warning to use health warnings must comply with regulations concerning specific provisions onposition and sizecross-border advertising and promotion, sponsorship etc of products will beprohibited (unless trade information)cross-border sales of products may be prohibited or subject to a registrationschememanufacturers/importers of products to submit an annual submission on theirproducts to competent authorities in MS which should include: comprehensive data on sales volumes, by brand name and product type information on preferences of various consumer groups, including youngpeople, non-smokers and the main types of current users mode of sale of the products executive summaries of any market surveys carried out in respect of the above,including an English translation thereof productsMS shall monitor the market developments concerning products, including anyevidence that their use is a gateway to nicotine addiction and ultimately traditionaltobacco consumption among young people and non-smokers. This information to bemade publicly available on a website although the need to protect trade secretsshould be taken into accountMS should on request, make all information relevant to this Article available to theCommission and other Member States who will respect confidential informationMS shall require manufacturers, importers and distributors of products to establishand maintain a system for collecting information about all of the suspected adverseeffects on human healthcorrective action should be taken immediately if economic operators consider orhave reason to believe that products are not safe or of good quality or notconforming to the Directive, ensuring conformity or withdrawal or recall from themarket. In such cases, operators are required to inform immediately marketsurveillance authorities of the MS giving details of risk to human health and safety,corrective action taken and results of such corrective action. MS may requestadditional information from the economic operators on safety and quality aspects orany adverse effect of productsthe Commission will submit a report to the European Parliament and the Council onpotential risks to public health by 20 May 2016 and as appropriate thereafter22