Safety Aspects of Flavors and Fragrances

The flavor and fragrance industry has, for a long time, been conscientious about the safety of its products, From the very beginning it has participated in the development of safety evaluations and regulations for flavors and fragrances, both in the US and Europe. In this paper the developments of both flavors and fragrances will be summarized. The difference in approach in these two areas will be discussed, as well as possible future developments.

History-Flavors, US

The first significant regulatory developments in the US took place in the flavor area. Prior to 1958 there was really very little activity, although on paper, there was a black or white situation: only materials approved by the FDA were permitted, whereas other materials were “poisonous and deleterious,” regardless of their application or concentration.

In the Food Additives amendment of 1958, this situation was confirmed for food additives: their specific application and use levels are being decided by the FDA, However, a new class of materials was created, exempt from the regulations for food additives—the materials “Generally Recognized As Safe under the conditions of their intended use.” This class became known by its acronym GRAS. In 1958 and 1960, the FDA published relatively short lists of such GRAS materials, indicating what kinds of materials belong in this class. Only a few comments from the scientific community were received on these lists.

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