The European Union has reached agreement on the regulation of e cigarettes, the final outstanding feature in the new Tobacco Directive.

EU member states have agreed to include e cigarettes into the scope of the directive. Member States which regulate e cigarettes as pharma products will be able to continue doing so.

It was agreed that there would be a maximum permitted nicotine concentration level of 20 mg/ml. Use of refillable cartridges for e cigarettes will be allowed and the maximum size of the single use cartridges will be 2 ml.

Strict safeguards were introduced allowing the Commission to ban via delegated acts certain electronic cigarettes or refill containers which are banned on justified ground by at least three member states.

The EU initiated the review of the Tobacco Directive after having considered the pressing need to reduce smoking among youth, decrease the number of smoking related diseases, tackle the illegal trade, regulate marketing and advertising of tobacco products to discourage the public from smoking.

The purpose of the directive is to approximate the laws, regulations and administrative provisions of the Member States concerning the ingredients and emissions of tobacco products and related reporting obligations including the maximum yields for tar, nicotine and carbon monoxide for cigarettes certain aspects of the labelling and packaging of tobacco products including the health warnings to appear on unit packets of tobacco products and any outside packaging as well as traceability and security features to ensure compliance with this Directive the prohibition to place on the market tobacco for oral use and the notification obligation for novel tobacco products.

Some core elements of the agreement include

Prohibition of placing on the market of tobacco products with a characterizing flavours transitory period of four years for mentholated tobacco products, which will be banned of summer 2020 Combined health warnings which shall cover 65 % of the external area of both the front and back surface of the unit packet and any outside packaging.

Significantly in the context of the John Dalli controversy, tobacco for oral use (Snus) remains banned in the EU, except for Sweden.

Eu tobacco deal could include ban on refillable e-cigarettes

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Refillable electronic cigarettes could be banned in the European Union under an agreement to regulate the devices for the first time.

Despite intensive lobbying from the burgeoning e cigarette industry, an EU wide ban could be imposed if at least three member states prohibit refillable e cigarettes.

Under the deal struck between the 28 governments and the European Parliament, both sides agreed not to regulate e cigarettes which includes refillable and disposable as medicinal products, as initially proposed by the European Commission.

Instead, they will be treated as tobacco products if they contain less than 20mg of nicotine per ml of liquid and their