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

Regulatory Toxicology and Pharmacology : RTP
Liam SimmsRolf Lutz

Abstract

This paper 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. The Directive requires manufacturers and importers of cigarettes and 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 publication gives an overview on comprehensive smoke chemistry, in vitro toxicity, and human clinical studies commissioned by the members of the Priority Additives Tobacco Consortium t...Continue Reading

Citations

Sep 10, 2021·Nicotine & Tobacco Research : Official Journal of the Society for Research on Nicotine and Tobacco·Andrea VansickelLeanne Campbell

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