EU Potential Changes to TPD

In April 2026, the European Commission published its evaluation of the Tobacco Products Directive and Tobacco Advertising Directive (TPD) and Tobacco Advertising Directive (TAD). The evaluation concluded that, while the existing framework has made a positive contribution to the protection of public health, it is increasingly challenged by the emergence and growing use of novel tobacco and nicotine products. The European Union is therefore reassessing whether its framework for evaluating these products remains fit for market. Based on European Parliament reports on tackling cardiovascular diseases and cancer, one possibility receiving attention is a move from the EU’s largely notification-based approach toward more stringent pre-market assessment requirements. Under the current notification scheme, manufacturers provide certain information on their product before it can be placed on the market, and the manufacturer remains responsible for safety and compliance with the requirements set out in the legislation. A pre-market authorisation system on the other hand, not dissimilar – but perhaps less onerous – to the FDA’s PMTA process in the US, would require a regulatory agency to assess the scientific evidence provided by the manufacturer and issue a formal approval before their tobacco or nicotine products could reach the European market. Clearly, such a change to the regulatory framework would have huge implications on the industry and on regulators, but also on innovation, product choice and cost to the consumer. So all such potential changes to the TPD need careful planning, ultimately to ensure that consumers do not return to smoking combustible cigarettes. Another significant revision to the current TPD would be to include the full spectrum of product types, including e-cigarettes (possibly even those without nicotine), heated tobacco products, nicotine pouches and other novel delivery systems (including to future-proof for new product types not yet in production). We will know more about the upcoming changes to the framework when TPD3 is released in 2027.

Bibra's toxicologists have been working on the front-line of the e-cigarette sector since its inception, providing our clients with critical safety evaluations to ensure regulatory compliance (including for TPD and PMTA purposes). We have also been involved in the assessment of nicotine for EU REACH and EU CLP purposes, and in the safety assessment and preparation of regulatory data packages of a range of products including heated tobacco, nicotine inhalers, snus, nicotine pouches, and gums/lozenges. We are regularly commissioned to carry out hazard screenings of product ingredients (primarily to identify substances potentially of high concern to human health), as well produce toxicity profiles summarising the critical hazard data of ingredients, and carry out health risk assessments of nicotine-containing products. If you need assistance in this sector, please don’t hesitate to get in touch with us.