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.

A real drag as european parliament threatens to take electronic cigarettes off the shelves : european conservatives and reformists group

Electronic cigarettes which are being increasingly used as a smoking ‘quit aid’ risk being taken off the market by a short sighted vote in the European Parliament that will classify them as a medicinal product, Conservative MEP Martin Callanan has warned.

Today’s vote in the parliament’s environment and public health committee was intended to primarily look at ways of making tobacco smoking less attractive to young people, through mandatory warnings, minimum pack sizes, and rules on flavourings. However, the revision of the ‘Tobacco Products Directive’ would classify most electronic cigarettes as a medicinal product, despite the fact that in the UK alone 25 percent of all quit attempts were made using e cigarettes, making them the most popular quit aid.

1.3 million people in the UK alone now use electronic cigarettes (compared to nine million tobacco smokers). Before the vote in the parliament today, users of e cigarettes (known as vapers) protested, arguing that through e cigarettes they were able to kick the tobacco habit.

Today’s vote classifying them as medical devices will mean they must undergo a costly and protracted authorisation processes. As many of the producers of e cigarettes are small start up businesses, such a process could push many out of business and reduce choice for e cigarette users.

Mr Callanan, who was the European Conservatives and Reformists Group lead member on the directive, proposed an amendment that would see e cigarettes authorised in a similar way to other nicotine products. Speaking after today’s vote, he said

«It is preposterous to classify e cigarettes as medical devices.

«Thousands of people have given up smoking thanks to e cigarettes. For the EU to over regulate them is completely counter productive and hypocritical.

«Electronic cigarette production has become lucrative for many small businesses and many jobs now depend on e cigarette production. By making the authorisation procedure for e cigarettes so difficult, many of these small businesses will pack up shop.

«This vote is not the end of this process and we will be working with vapers to make other MEPs see sense and support e cigarette producers and users.

«The world has gone mad when tobacco is less regulated than products designed to end tobacco use.»