Validation of a recommended practice for assessing “characterizing flavor” to meet requirements of the EU Tobacco Product Directive (2014/40/EU)

Abstract

AbstractThis publication describes a sensory assessment recommended to fulfill the regulatory requirement for Article 6(2) of the EU Tobacco Products Directive 2014/40/EU, related to whether specific cigarettes have “characterizing flavor,” which is no longer allowed in the European Union (EU) when that “characterizing flavor” results from the use of an additive or combination of additives. It describes (a) background and protocol development, (b) a proposed protocol, (c) studies to evaluate the protocol, (d) the final recommended protocol, and (e) testing results for eight priority additives that the Scientific Committee on Health, Environmental, and Emerging Risks deemed likely to provide nontobacco characterizing flavor in tobacco products. The final protocol screens assessors for sensory acuity, trains them to understand products with/without characterizing flavor, screens out assessors unable to perform the task successfully, determines which cigarette products may have a characterizing flavor, and then what, if any, characterizing flavor is present. The methodology using smell tests as suggested by regulatory staff and other authors was able to identify the positive controls included in the test and a test product containing menthol as having “characterizing flavor.”Practical Application“Characterizing flavor” in cigarettes is a sensory phenomenon. Implementation of the recommended protocol for determining “characterizing flavor” in cigarettes, whether premade or “roll your own” is needed to make an objective determination for regulatory needs. This recommended protocol is reliable as determined by various studies and can meet the needs in a reliable manner by various groups.