“Food additives (direct, secondary, indirect) are essentially chemically derived, do not have a history of use in foods, and there is no general agreement among the scientific community with regard to their safety for the use that is proposed. Direct food additives are added to food for a technical purpose and have a lasting effect in the food (e.g., the antioxidants BHA/BHT). Secondary direct additives are added for a momentary technical effect and have no lasting effect in the food (e.g., antimicrobial agents, ozone, acidified sodium chlorite). Indirect food additives have the potential to become part of a food through processing or packaging but are not intended to be added to food for an intended technical effect (e.g., coatings and adhesives.)
“A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use.” As FDA discussed in a proposed rule to establish a voluntary notification program for GRAS substances (62 Fed. Reg. 18938; April 17, 1997), the data and information relied on to establish the safety of the use of a GRAS substance must be generally available (e.g., through publication in the scientific literature) and there must be a basis to conclude that there is consensus among qualified experts about the safety of the substance for its intended use. Thus, the difference between use of a food additive and use of a GRAS substance relates to the widespread awareness of the data and information about the substance, i.e., who has access to the data and information and who has reviewed those data and information.
1. For a food additive, privately held data and information about the use of the substance are sent by the sponsor to FDA and FDA evaluates those data and information to determine whether they establish that the substance is safe under the conditions of its intended use (21 CFR 171.1).
2. For a GRAS substance, generally available data and information about the use of the substance are known and accepted widely by qualified experts, and there is a basis to conclude that there is consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use. (proposed .170.36 (c)(4)(i)(C)).12