Petition route, food additive

The GRAS Notification has become the route of choice for the introduction of new ingredients because it is scientifically rigorous, far more efficient, and equally or more transparent than the Food Additive Petition route. Still, the current process to assess the safety of ingredients new to infant formulas is complex and presents a number of limitations. The committee reviewed the current process and raised a number of issues that need to be addressed. Some are addressed here, some are addressed elsewhere in this report, and some need further study. 

Countries that use a positive Hst, eg, Japan, Switzerland, the former Soviet Union, and the United States, Hst ak substances akowable in flavor and foods any material not Hsted is not akowable. Any material included on a positive Hst is considered safe for its intended use. This system works wek only if there is a specific procedure to akow for the addition of new materials. In the United States there is the Food Additive Petition and the GRAS route. No new material can be used in flavor or foods unless it undergoes one of these two procedures. This assures that any new technology can be added and used after it is reviewed for safety. 

The use of food additive petitions and GRAS procedures to evaluate the safety of a proposed new excipient would apply to the oral route of administration for the excipient and would not generally apply to other routes of administration. Some routes of administration (e.g., inhalation) result in unique toxicological requirements, and data would have to be developed for the specific route of administration. While toxicological data from systemic studies are important for excipients used for nonoral applications, separate data would be needed for the specific route of administration. Nevertheless, the amount of safety data, specifications, and intake information required for a food additive review is extensive, and therefore could provide a firm basis of safety for a new excipient. 

Infant formulas are regulated as food. If a manufacturer wishes to add a new ingredient to an infant formula, it must follow one of three routes it may determine a substance is GRAS without formally notifying FDA, it may file a GRAS Notification with FDA, or it may file a Food Additive Petition (see Box 4-1 for the definition of a food additive) with FDA. The GRAS Notification and the Food Additive Petition processes are described below. 

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