Not all substances that are used in food contact materials in the U.S. are subjected to a safety review by FDA scientists prior to their use. This also applies to substances that are “generally recognized as safe” (GRAS), if their safety is determined by the manufacturer. Such manufacturer self-determined GRAS substances can legally be used in food contact materials and foos without FDA being aware of this use. Consequently, there is no way for the public to know what these substances are, and to access any data used for safety assessment. This practice has been questioned in the past by Tom Neltner and his colleagues from PEW Charitable Trust. Now the industry has addressed this criticism by making public some manufacturer self-determined GRAS substances. Manufacturers are invited to add their self-affirmed GRAS substances to this list. However, critics maintain that this effort is insufficient, and that attempts to more transparency need to address substance characterization, safety data, and use.

Article in Food Navigator USA “Who has self-affirmed GRAS? New database addresses transparency concerns.”

Neltner et al. 2011 „Navigating the U.S. Food Additive Regulatory Program” 

AIBMR self-affirmed GRAS database