Answer: The requirements for an FCN are substantially similar to those for a Food Additive Petition. Generally speaking, the notification should include information on:
- The composition, specifications, and method of manufacture for a substance;
- Its intended conditions of use;
- The quantity and identity of substances likely to become components of foods under the intended use conditions;
- An estimate of the concentration of the additive in the daily diet; and
- Toxicology data demonstrating the safety of this intake level.
One new requirement is that submitters must calculate the cumulative estimated dietary intake (CEDI) to potential migrants from all sources, not just the product in question, and provide supporting toxicology studies for exposures above 0.5 ppb in the diet.
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