DIN/TR 10133:2021 Edition

The title of this guide "Toxicological evaluation of additives for tobacco products" raises the question of a clear definition of the term additive in relation to tobacco products. In the English-speaking environment, two terms, often interchangeable or without a clear definition in relation to additives in tobacco products, are used side by side: "additives" and "ingredients". Both terms result from a different approach. Substances added to a cigarette become the contents of the cigarette after it has been added. The European Tobacco Products Directive, which is relevant for the regulation of tobacco products in Germany and the rest of the EU, defines the term "ingredient", but also uses the term "additive" in the context of "ingredient", but without a definition. The definition of "ingredient" in the Directive makes it clear that tobacco and unprocessed tobacco ingredients are not considered as "ingredients", but all substances and constituents which have been added to the tobacco product during the manufacturing process, irrespective of whether they are present in the final tobacco product in unchanged or modified form. In accordance with the Tobacco Products Directive, additives are defined in this guide as materials and substances used in the manufacturing process. The use of additives in cigarettes or other tobacco products is regulated differently in EU countries and the rest of the world. In many EU countries, such as Denmark, Greece or Portugal, there are no specific legal regulations regarding the addition of additives to cigarettes or other tobacco products. In Germany, the prohibition principle applies subject to permission. The approval of substances is regulated in particular in the Tobacco Ordinance (TVO) by a positive and a negative list. The use is determined there according to their intended use and location, the product category and the quantity used in the final product. In general, at the time these guidelines went to press, there was a discussion in the EU about the general permissibility of tobacco additives, which had been initiated by the revision of the Tobacco Products Directive. A far-reaching ban on tobacco additives exists in Canada and is to be introduced in Brazil. It should be noted that Canada traditionally has a strong market presence of so-called Virginia cigarettes. These cigarette types are largely manufactured without tobacco additives. In the USA and Australia, too, the use of tobacco additives has been restricted to such an extent that the final tobacco products may not have any dominant ("characterizing", USA) or confectionarily sweet ("like", Australia) taste properties beyond the typical tobacco smoke aroma, such as "strawberry". Menthol cigarettes are exempt from this ban in the USA and Australia. Toxicological studies did not play a role in the more restrictive tobacco additive regulations in Canada, USA and Australia. In addition to toxicological considerations, a possible dependency-increasing potential of additives is also being discussed. This aspect is not dealt with further in this guideline for two reasons. While there are decades of experience in the toxicological evaluation of additives and a large number of methods have been established, no suitable methods are yet available for the measurement and evaluation of a possible increase in dependence caused by a tobacco additive. Furthermore, there is a lack of clear scientific definitions of terms in this area. A European commission of experts came to the conclusion that, on the basis of the available data, no tobacco additive with a potential for dependence can be identified. For most tobacco additives in their unburnt form, sufficient toxicological data are available, as a large number of the substances used are food additives. In the case of tobacco additives, however, the different route of ingestion (inhaled in the case of smoking products) and the ingestion dose of the additives must be taken into account. Although toxicological data on additives in burnt form are available for a large number of additives, they have often been collected using a wide variety of methods. Accordingly, their informative value can vary greatly. The procedure for obtaining suitable data for the toxicological evaluation of additives for cigarettes represents the core point of this guideline. In principle, transferability to other tobacco products or modifications of the cigarette should be possible.