scope:

Scope of testing

Toxicological testing should cover a wide range of various toxicological mechanisms of action of tobacco smoke. This means that a single test system will hardly suffice; more likely one will require several test systems, i.e. a test battery. How comprehensive a test battery has to be can only be estimated taking into consideration the fact that most tobacco additives will ultimately be used only in small amounts. In principle, toxicological concerns are fewer for low doses than for high doses of additives. This leads to the reasoning that for expected low exposures to the consumer product toxicological testing might be deemed unnecessary [90]. This principle of a "Level of Toxicological Concern" that determines the scope of required testing is customary in many other safety tests and is laid down in regulations. Regulations for the Chemical Industry in Europe (REACH) are designed on the basis of the annual production of a chemical. For the toxicological assessment of food additives, the consumers' level of exposure is the decisive parameter. In line with these principles it follows that the scope of required testing should be based on the planned doses of an additive [91].

Purpose

The purpose of the toxicological testing and assessment of tobacco additives is to ensure that they will not increase the risk potential of tobacco products.