Assessment of priority tobacco additives per the requirements of the EU Tobacco Products Directive (2014/40/EU) part 1: Background, approach, and summary of findings

Publication date: Available online 21 February 2019Source: Regulatory Toxicology and PharmacologyAuthor(s): Simms Liam, Clarke Anna, Paschke Thilo, Manson Andrew, Murphy James, Stabbert Regina, Esposito Marco, Ghosh David, Roemer Ewald, Martinez Javier, Freiesleben Jarl, Kim Hyo-Keun, Lindegart Thomas, Scharfe Marc, Vincze Istvan, Vlachos Panagiotis, Wigotzki Diane, Pollner Gwen, Lutz RolfAbstractThis publication is part of a series of 3 publications and describes the non-clinical and clinical assessment performed to fulfill the regulatory requirement per Art. 6 (2) of the EU Tobacco Products Directive 2014/40/EU under which Member States shall require manufacturers and importers of cigarettes and roll-your-own tobacco containing an additive that is included in the priority list established by Commission Implementing Decision (EU) 2016/787 to carry out comprehensive studies (European Union, 2016). The Directive requires manufacturers and importers of cigarettes and RYO (roll your own) tobacco to examine for each additive whether it contributes to and increases the toxicity or addictiveness of tobacco products to a significant or measurable degree, if it leads to a characterizing flavor of the product, if it facilitates inhalation or nicotine uptake, and if it results in the formation of CMR (carcinogenic, mutagenic and reprotoxic) constituents and if these substances increase the CMR properties of the respective tobacco product to a significant or measurable degree. This publ...
Source: Regulatory Toxicology and Pharmacology - Category: Toxicology Source Type: research