By Vanee Komolprasert; Petra Turowski
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Additional resources for Food additives and packaging
Section 201(s) of the FD&C Act defines a food additive as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.
As the name indicates, there are two elements to a GRAS conclusion: first, that a use of a substance is safe, and second, that there is general recognition of that fact among qualified experts. The safety standard employed is the same as that used for evaluating the safety of food additives, often summarized as reasonable certainty of no harm. 21 CFR Sec. 3(i) (2). The general recognition requirement relies on publicly available information, ideally published facts in peer reviewed scientific or medical publications or reference books.
18938, April 17, 1997. 2010 FDA reopens 1997 proposed rule for comments 75 Fed. Reg. 81536, December 28, 2010. org/gras. eu. The European Union adopted in 2008 a package of regulations which further upgrades and further harmonises the rules for food additives and flavourings to be used in and on food and introduces harmonised EU legislation on food enzymes for the first time. In addition, a simplified common approval procedure for food additives, flavourings and enzymes, was created which is based on the scientific opinions from the European Food Safety Authority (EFSA).