Opinion on additives used in tobacco products (Opinion 2) : tobacco additives II

The Commission has established a priority list of 15 additives contained in cigarettes and roll-your-own tobacco subject to enhanced reporting obligations, based on a scientific Opinion (Tobacco Additives I) of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). The EU Tobacco Product Directive (TPD) prescribes that Member States shall require manufacturers and importers of tobacco products to carry out comprehensive studies on these additives. The European Commission requested the SCHEER to provide guidance on the type and criteria for comprehensive studies, and on the most suitable methodologies to be used on the first 15 tobacco additives and for additives on future updated lists. The SCHEER has provided such guidance together with a reporting template in Annex I. As tobacco additives have no benefits for health, but rather may promote use of and addiction to an extremely toxic product, a risk-benefit analysis is not the appropriate paradigm for assessing the additive. When comprehensive studies confirm that additives have any of the four properties listed in Article 6 of the TPD, regulatory action should be considered in line with Article 7 of the TPD. If uncertainties cannot be solved by comprehensive studies, the SCHEER recommends that the assessors consider the worst-case evaluation