On 8 October last, the European Parliament adopted amendments to the EU Commission’s proposal for a Revised Tobacco Products Directive (RTPD). The RTPD seeks to amend the existing Tobacco Products Directive (2001/37/EC) by imposing stricter requirements on the manufacture, presentation and sale of tobacco and related products.
The key measures proposed by the RTPD include:
Regulation of nicotine-containing products
The manufacturers/importers of nicotine-containing products (including e-cigarettes) will be required to notify the competent authorities of member states of their intention to place such products on the market six months prior to doing so.
Nicotine-containing products that are presented as having properties for treating or preventing disease will have to be authorised as a medicinal product under Directive 2001/83/EC prior to being placed on the market.
Nicotine-containing products that are not presented as having curative or preventive properties will not require any such authorisation. However, the placing of such products on the market will be subject to a number of restrictions. For example the level of nicotine must not exceed a certain threshold; advertising, sponsorship and sales restrictions will apply; and tobacco trademarks, brand names and symbols will not be permitted on such products.
Regulation of ingredients
A list of approved additives will be annexed to the RTPD. Tobacco products that contain additives not included in the list will not be permitted to be placed on the market.
Additives which may impart a characterising flavour (e.g. fruit, chocolate or menthol flavour) when used or that increase the addictiveness or toxicity of tobacco products will not be approved for use.
Regulation of labelling & packaging
The combined health warning (picture and text) will have to cover 65% of both the front and back of packets of tobacco products and any outside packaging.
There will be a ban on unit packets of cigarettes that contain less than 20 cigarettes.
The RTPD also contains measures to strengthen the fight against illicit trade and falsified products. Member states will be required to ensure that all unit packets and any outside transport packaging of tobacco products are marked with a unique identifier which will allow the product to be traced through the whole supply chain.
Next Steps
The EU Parliament is scheduled to meet to further consider the RTPD on 14 April 2014.
The RTPD is likely to be subject to further amendment prior to final approval. Once approved, EU member states will have 18 months from the date the RTPD enters into force to transpose its provisions (save those relating to the regulation of ingredients) into national law. A 3-year period will apply in respect of provisions relating to the regulation of ingredients. The ban on the use of menthol will be subject to a further 5-year exemption period.
The RTPD allows for a transitional period: tobacco products and herbal products for smoking that are not in compliance with its provisions will be allowed on the market for 2 years from the date of entry into force, while nicotine-containing products will be allowed on the market for 3 years.
Separately, the Irish Minister for Health is planning to introduce legislation to provide for plain packaging of tobacco products.
Contributed by: Charleen O’Keeffe
