GRAS and Prior-Sanctioned Additives

The definition of food additive, as described in Section 15.4.1, excludes substances 

Any material can be added to the GRAS list if there is data to support its safety. The FDA allows a food manufacturer to affirm to the Agency that a substance is GRAS, and supply the supporting data to get the substance reviewed. This can be done and the product put into production before the review process is complete. However, the manufacturer assumes all responsibility in the event the affirmation is not verified by the Agency. 

Substances that are excluded from the definition of food additive because they were used in accordance with a sanction or approval granted prior to September 6,1958. .. are referred to as prior-sanctioned materials. 

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