Answer: The estimated dietary intake (EDI) is calculated by multiplying the substance?s dietary concentration (usually obtained from migration studies) by the average daily intake of food, which is assumed by FDA to be 3,000 grams (including all liquids ingested). These calculations invariably represent a conservative estimate of the dietary intake of the additive because they are based on the assumption that the additive will always migrate at the maximum levels found in the extraction studies, and that all food-contact materials of a given type will be made using the subject substance.
One notable difference between petitions and FCNs is the new burden on submitters to calculate the cumulative estimated dietary intake (CEDI) from existing clearances of the substance, rather than just the EDI from the use that is the subject of the notification. FDA is already compiling its own estimates of CEDIs, beginning with the most widely used substances, and intends to make this information publicly available, probably through the FDA Web site. In the meantime, the required CEDI data can be obtained from FDA on a case-by-case basis.
Back to FAQs