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Hetoc Frep En.Pdf Mapping of best practices and development of testing methods and procedures for identification of characterising flavours in tobacco products Final Report RfS Chafea/2014/health/19 Contract nº 20146202 Directorate-General for Health and Food Safety HETOC Consortium Health Programme July 2016 Consumers, Health, 2015 Agriculture and Food Executive Agency EUROPEAN COMMISSION HETOC Consortium October 2015 EUROPEAN COMMISSION Directorate-General for Health and Food Safety Directorate B— Health systems, medical products and innovation Unit B2 — Health in all policies, global health, tobacco control E‐mail: [email protected] European Commission B-1049 Brussels 2016 EUROPEAN COMMISSION Mapping of best practices and development of testing methods and procedures for identification of characterising flavours in tobacco products RfS Chafea/2014/health/19 Contract nº 20146202 2016 Europe Direct is a service to help you find answers to your questions about the European Union. Freephone number (*): 00 800 6 7 8 9 10 11 (*) The information given is free, as are most calls (though some operators, phone boxes or hotels may charge you). LEGAL NOTICE This report was produced under the EU Health Programme (2008-2013) in the frame of a service contract with the Consumers, Health, Agriculture and Food Executive Agency (Chafea) acting on behalf of the European Commission. The content of this report represents the views of HETOC and is its sole responsibility; it can in no way be taken to reflect the views of the European Commission and/or Chafea or any other body of the European Union. The European Commission and/or Chafea do not guarantee the accuracy of the data included in this report, nor do they accept responsibility for any use made by third parties thereof. More information on the European Union is available on the Internet (http://europa.eu). Luxembourg: Publications Office of the European Union, 2016 ISBN 978-92-9200-681-5 Doi:10.2818/08983 © European Union, 2016 Reproduction is authorised provided the source is acknowledged. 2016 EUROPEAN COMMISSION HETOC (Health Effects Tobacco Composition) Consortium, July 2016 Consortium leader: National Institute of Public Health and the Environment (RIVM), Bilthoven, the Netherlands Consortium member: Wageningen University (WUR), Wageningen, the Netherlands Subcontractor: OP&P Product Research (OP&P), Utrecht, the Netherlands 5 2016 EUROPEAN COMMISSION Abstract The new EU Tobacco Product Directive 2014/40/EU (TPD) prohibits cigarettes and roll-your-own tobacco having a characterising flavour other than one of tobacco. Although some other jurisdictions have legislation on tobacco flavour, no methods are currently available to assess characterising flavours. The overall aim of this project was to deliver a test approach for the assessment of characterising odours in tobacco products, by a combination of sensory profiling, chemical-analytical measurements, other methods, or a combination of methods. The tobacco industry and the food industry in general conduct expert panel and consumer research to test the flavour and other sensory characteristics of a product for purposes of successful product development. In summary, the project consisted of carrying out four work packages (WP), in the time period August 2014-June 2015: WP1: Review the literature, with the aim to draft a review of the current methods and approaches that may be suitable for the objective determination of characterising flavours in tobacco products. WP2: Identify concept profiles, with the aim to draft three testing approaches, based on the output of WP1, for sensory analysis of tobacco products (including chemical-analytical measurements) applicable to tobacco product regulation. WP3: Optimise and peer-review the procedure, with the aim to test, refine and finalise the methodology that had been proposed based on the outcomes of WP1 and WP2. WP4: Assess the feasibility and impact, with the aim to check whether the overall aim, to deliver a method to decide whether a tobacco product imparts a characterising flavour other than tobacco, has been reached. Based on a review of the relevant literature, and discussions with experts from several fields, it was decided that the best approach for assessing characterising flavours would be a combination of sensory profiling and chemical analysis. More specifically, a combination was proposed of a trained expert panel that assesses odours by smelling tobacco samples, with headspace GC-MS. To test this approach, pilot experiments were performed with a semi-trained expert panel and headspace GC-MS to test the procedure. Based on the findings, a robust and feasible procedure was proposed for assessment by a sensory expert panel, complemented by chemical analysis, laid down in the main document and two SOPs. It was concluded that an expert panel is a good approach to assess characterising flavours. The pilot in general yielded valid, robust, reliable and reproducible results. Smelling is the preferred starting point, as it captures most of the products with characterising flavours. Products currently marketed on their packaging to contain characterising flavours (cherry, menthol, vanilla) can be distinguished from a reference space of ‘normal’ commercial cigarettes brands and natural tobacco leaves. Chemical analysis with Headspace GC-MS is a suitable method to identify flavour components and additives. The results can be used to build a flavour library. Comparing results of flavoured cigarettes with those of natural tobacco leaves gives an indication whether a component is added. In the report, detailed conclusions and recommendations are given to set up a reliable method. 6 2016 EUROPEAN COMMISSION Contents 1 Executive summary .................................................................................................... 13 2 Introduction ............................................................................................................... 16 3 Background ................................................................................................................ 17 3.1 References ..................................................................................................................... 18 4 Methodology ............................................................................................................. 19 4.1 WP1: Literature review .................................................................................................. 19 4.1.1 Task 1.1 Development of methodology to retrieve relevant information .................... 19 4.1.2 Task 1.2 Review of methods recorded to be used by the tobacco industry for sensory analysis 19 4.1.3 Task 1.3 Review of methods used for assessment of tobacco products by EU Member States and third countries ............................................................................................................. 20 4.1.4 Task 1.4 Review of methods for sensory analysis of any type of consumer or food products 20 4.1.5 Task 1.5 Review of alternative methods, not based on sensory analysis ..................... 20 4.1.6 Task 1.6 draft and review report ................................................................................... 20 4.2 WP2: Identification of the applicable methods ............................................................... 21 4.2.1 Task 2.1 Assessment of the usability/adaptability of sensory analysis ......................... 21 4.2.2 Task 2.2 Identification of applicable standards and/or best practices for determination of characterising flavours .............................................................................................................. 22 4.2.3 Task 2.3 Identification of applicable alternative methods for sensory analysis ........... 22 4.2.4 Task 2.4 Identification of three concept profiles for the testing approach .................. 23 4.2.5 Task 2.5 Seminar to discuss the three concept profiles ................................................ 24 4.3 WP3: Optimisation of the testing approach on the basis of pilot studies ........................ 24 4.3.1 Task 3.1 Selection and possibly adaptation of the profile for pilot testing ................... 24 4.3.2 Task 3.2 Selection of samples for pilot testing .............................................................. 27 4.3.3 Task 3.3 Pilot testing...................................................................................................... 27 4.3.4 Task 3.4 Optimising the study protocol ......................................................................... 27 4.4 WP4: Feasibility and impact assessment ......................................................................... 27 4.4.1 Task 4.1 Technical feasibility and quality of outcomes ................................................. 27 4.4.2 Task 4.2 quantification of costs and funding model ..................................................... 28 4.4.3 Task 4.3 describe possible modifications and alternative options ................................ 28 5 Findings ..................................................................................................................... 29 5.1 WP1: Literature review .................................................................................................. 29 5.2 WP2: Identification of the applicable methods ............................................................... 29 5.3 WP3: Optimisation of testing – sensory research ............................................................ 31
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