Generally recognised as safe GRAS

The U.S. Food and Dmg Administration (FDA) has affirmed the status of beeswax as Generally Recognised as Safe (GRAS) (5) in Tide 21 of the Code of Federal Regulations, Section 184.1973 (21 CFR 184.1973). The major use of beeswax is in the cosmetic industry, with smaller amounts used in pharmaceuticals and candle production. 

Absence of carcinogenity, genotoxicity, developmental and reproductive toxicity and of chronic toxicity effects at low exposure levels are indispensable prerequisites for food additive approvals. All substances approved in the European Union or the USA or deemed generally recognised as safe (GRAS) in the USA fulfil this requirement. 

The use of antioxidants in food products is governed by regulatory laws of the individual country or by internal standards. Even though many natural and synthetic compounds have antioxidant properties, only a few of them have been accepted as generally recognised as safe (GRAS) substances for use in food products by international bodies such as the Joint FAOAVHO Expert Committee on Food Additives (JECFA) and the European Community s Scientific Committee for Food (SCF). 

The effective but volatile 2,6-di-ferf.butyl-4-methyIphenol (11) was replaced for most applications by various mononuclear (12), binuclear (13), trinuclear (14) and tet-ranuclear phenols (15, 16). Recently, synthetic DL-a-tocopherol (17) was introduced for effective melt stabilization of PO. This antioxidant may be listed among the stabilizers generally recognised as safe (GRAS). 

Some food and colour additives may have (generally recognised as safe) (GRAS) status, which also gives some assurance that they could be used in pharmaceutical products with minimal additional safety testing. This is especially the case if the excipient is not likely to be absorbed systemically from the formulation. 

Derived semisynthetically from 3, 5,7-Tri-hydroxy-4 -methoxyflavanone. Intensely sweet, 612 times more sweet than sucrose. Permitted in EU at low cones. (=10 ppm) for certain applications, e.g. low-alcohol beer. Generally recognised as safe (GRAS) in the USA. 

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