In Europe, chemical substances are classified according to their toxicity levels. Those that are deemed potentially harmful are subject to rules on packaging and labelling. The purpose of this report is not to provide guidance on every regulation that may apply in all member states of the European Union, but to concentrate on an important piece of regulation that may apply to nicotine-containing products such as modern oral admixtures and heated tobacco/e-cigarette hybrids.

In the case of tobacco alternatives, the ingredient that is generally most affected by Classification, Labelling and Packaging (CLP) regulation is nicotine but it is necessary to understand if any other ingredient may be subject to regulatory obligations.

Each product mixture should be adequately and individually assessed by manufacturers, because it is possible that some flavours and/or ingredients may also be considered potentially harmful, and covered by CLP regulation.

Furthermore, aside from the existence of a particular substance in a mixture, both the overall quantity and the relative quantity are crucial.

It is the exclusive responsibility of the supplier to adequately classify their mixture before placing it on the market. A supplier is defined as: “any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture”.


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