The European Parliament has proposed amendments to the EU Commission’s proposal for a Revised Tobacco Products Directive.  The proposed directive will, if passed, impose stricter requirements on the manufacture, presentation and sale of tobacco and related products.

The key measures proposed 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 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 but 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
  Tobacco products that contain additives not included in the approved additives list, as set out in the proposed directive, 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 packets of cigarettes containing less than 20 cigarettes.

  In an effort to strengthen the fight against illicit trade and falsified products, Member States will be required to ensure that all packaging (including 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 proposal on 14 April 2014.  

If approved, EU Member States will have 18 months from the date the directive enters into force to transpose its provisions into national law, with the exception of those relating to the regulation of ingredients which must be implemented within 3 years.  The ban on the use of menthol will be subject to a further 5-year exemption period.

The proposed directive 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.

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