Publications

3 December 2013 – The future legislation of nicotine containing products (NCPs) including e-cigarettes is part of the ongoing discussion on the revision of Tobacco Products Directive (TPD). In light of the available regulatory options EPHA has identified and presented in a briefing document, EPHA recommends principles of future EU wide NCP legislation, public health requirements of NCPs, and policy options for regulating NCPs.

The future legislation of Nicotine containing products (NCPs) including e-cigarettes is part of ongoing discussion on the revision of Tobacco Products Directive (TPD).

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– EPHA Briefing on Regulatory options for Nicotine Containing Products (NCPs) in the EU

– Annexes to the EPHA Briefing on Regulatory options for Nicotine Containing Products (NCPs) in the EU

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In light of the available regulatory options for Nicotine Containing Products (NCPs), identified and presented in the EPHA Briefing, EPHA recommends the following principles of future EU wide NCP legislation, public health requirements of NCPs, and policy options for regulating NCPs

– Principles of future EU wide NCP legislation

• Public health needs to be the driving motivation of regulation of NCPs. All NCPs should demonstrate proven safety and quality
• NCPs must not become a gateway product, especially for young people and must not re-normalise smoking
• NCPs should be regulated at EU level, in order to reduce existing health inequalities, and to provide greater legal certainty, in line with the EPHA European Charter for Health Equity
• NCPs should be regulated in an appropriate manner in line with the precautionary principle.
• Future NCP regulation should take into consideration the future and fast development of this market.
• NCPs should facilitate access to social support networks through the provision of information. Tobacco cessation services (quit lines) are crucial to sustained and successful efforts to quit smoking. NCPs of high quality have significant potential to help smokers who are not otherwise ready or able to quit smoking.

– Public Health requirements of NCPs

Regulation of NCPs, including e-cigarettes, needs to protect public health by ensuring;

• product safety and quality,
• control of advertising and sponsorship,
• market surveillance and monitoring,
• accesibility of NCPs for existing smokers

– Policy options for regulating NCPs

• Appropriate safety assessment should be a cornerstone of any future EU legislation.
• The public health benefit of NCPs is that they may help smokers to quit smoking. In order to maintain the same standards for the same products, both the product safety aspects and the claimed effects of the given product should be taken into consideration by future regulation of NCPs.
• Strict marketing limits – similar to tobacco and medicine marketing rules – are essential so that NCPs do not promote smoking behaviour either in a direct or indirect way.
• Given the potential of products such as e-cigarettes not containing nicotine to indirectly promote smoking and undermine smoking cessation policy, the European Commission should be empowered to adopt delegated acts to regulate these products appropriately.
• Having no new regulation on NCPs, or maintaining long transitional periods – which is equivalent to maintaining the status quo – has the potential danger of market developments which do not provide a high level of public health protection to EU citizens, violating Article 168 of the Treaty on the Functioning of the European Union (TFEU) . Therefore, the transition period before the application of the new NCP legislation, as well as the binding deadline for the European Commission to submit a report about the application of the future NCP legislation should be as short as possible, and the European Commission should be empowered to adopt delegated acts in other to be able to reflect public health risks emerging from the rapid market development.
• Appropriate monitoring – including surveys and data collection – is necessary so that any future legislation should rely on the latest data and evidence. Particular attention should be given to the attitudes and preferences of children and young people in that regard.
• Future regulations should include elements which ensure appropriate funding and resources for more research for both social and biomedical aspects of NCPs.
• Flavourings have two dimensions: On the one hand, some flavours are necessary to make NCPs intended for oral use palatable. On the other hand, additional flavours can make NCPs more attractive for both smokers and non-smokers. NCPs should be allowed to contain the necessary flavours which are allowed in Nicotine Replacement Therapies (NRT) but should be subject to flavouring restrictions, as regards additional flavourings not necessary for the use.
• An appropriate simplified authorisation procedure for NCPs – merging the necessary elements of other legislations – would be useful ensuring that NCPs comply with the principles and guidelines of Good Manufacturing Practice (GMP), Manufacturers present all ingredients of the products, including emissions and a Risk Management Plan for monitoring and recording any adverse reactions, similarly, NCPs should be subject to appropriate labelling and packaging rules
• The future legal framework should ensure that accessibility to NCPs for existing smokers is not hindered while ensuring that they are unappealing and inaccessible to minors.

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