How are the criteria for eligibility for classification as GRAS through scientific procedures different from the criteria for FDA’s approval of a food additive?

The difference between the criteria for eligibility for classification as GRAS through scientific
procedures (21 CFR 170.30(b) and 21 CFR 570.30(b)) and FDA’s approval of a food additive
(21 CFR 171.1 and 21 CFR 571.1) relates to who has access to the data and information and
who has reviewed those data and information. For a substance to be GRAS under the
conditions of its intended use, the data and information relied on to establish the safety of the
use of the substance must be generally available (e.g., through publication in the scientific
literature) and there must be a basis for a person to conclude that the substance is generally
recognized, among qualified experts, to be safe under the conditions of its intended use. In
contrast, for FDA’s approval of a food additive privately held data and information about the
substance under the conditions of its intended use are sent by the sponsor to FDA and FDA
reviews those data and information to determine whether they demonstrate that the substance
is safe under the conditions of its intended use.