Safe

(i) Safe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use. It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance. Safety may be determined by scientific procedures or by general recognition of safety. In determining safety, the following factors shall be considered: (1) The probable consumption of the substance and of any substance formed in or on food because of its use. (2) The cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet. (3) Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food and food ingredients, are generally recognized as appropriate.

Source

21 CFR § 170.3

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Scoping language

For the purposes of this subchapter

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