Final opinion on additives used in tobacco products (Opinion 1) : tobacco additives I

The main purpose of this scientific Opinion is to assist the Commission in identifying the additives that should be put on the priority list as foreseen by Article 6 of the Tobacco Products Directive 2014/40/EU (TPD). The SCENIHR was asked to identify those additives, amongst the most commonly used additives by weight or number, that have one or more of the following attributes: a. Contributes to the toxicity or addictiveness of the products and/or increases the toxicity or addictiveness of any of the products concerned to a significant or measurable degree; b. Results in a characterising flavour; c. Facilitates inhalation or nicotine uptake; d. Leads to the formation of substances that have CMR (carcinogenic, mutagenic, repro-toxic) properties and/or increases the CMR properties in any of the products concerned (cigarettes/Roll-your-own) to a measurable or significant degree. To compile the list of priority substances, the SCENIHR considered inter alia several lists of additives from the European Union Member States and used the list from the Netherlands (containing 1260 compounds) as a typical example. The selection from that list was carried out following these steps: 1) Additives were ranked according to the frequency of detection in different brands as well as the highest amount used in cigarettes, which were considered the first two criteria for selection; this reduced the number of chemicals to be evaluated to approximately100 compounds. 2) An initial scan was carried out, considering the categories above (see also Article 6(2 a-d) in the TPD) and focussing on those present in tobacco and papers, and resulted in a preliminary selection of 56 additives for which a literature search for data on general characteristics of the compounds, toxicity data (including CMR properties), information about characterising flavour (potentially contributing to attractiveness), inhalation facilitation or increase in nicotine uptake (potentially contributing to addictiveness) as well as for data on pyrolysis products and their toxicity.