Basic principles of safety evaluation

The safety evaluation of flavoring substances provides a unique challenge to regulators due to their large number and their generally low level of use. In addition, many flavoring substances occur in natural products (i.e., extracts, oleoresins, and essential oils) and have a long history of safe use. 

Assessing the safety of flavoring substances, in principle, is similar to that of other food additives and includes the consideration of four basic elements  

Regardless, it is important to carry out the safety evaluation for all flavoring substances. In many cases, it is possible to use pharmacokinetic or metabolic data on the substance in addition to toxicity data or other information on structurally-related compounds. 

Unlike many substances which are added to foods to achieve a desired effect, flavoring substances are added in amounts that are self-limiting and governed by the potency of the substance used to provide the necessary organoleptic characteristics of the food product. As a result, flavoring substances generally are used in low concentrations and add only small amounts to human intake. 

Knowledge of chemical structure, pharmacokinetics, and metabolic pathways provides a method to assess the safety of flavoring substances that lack a full safety testing profile using data from structurally related substances which have been adequately tested for toxicity. 

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