Answer: FDA's proposed rule indicates that FCNs will be accepted for unapproved uses of products that meet the definition of an FCS, regardless of whether the substance is of a type regulated under FDA's existing regulations for direct food additives (those materials added directly to food and intended to have a technical effect in the food, regulated under Part 172 of 21 C.F.R.), secondary direct food additives (additives intended to have a technical effect on food during food processing -- but not the final food -- regulated under Part 173 of 21 C.F.R.), or indirect food additives (additives intended to have a technical effect on a food-contact material, regulated under Parts 174-186 of 21 C.F.R.).
Thus, the FCN process can be utilized for secondary directs that have no technical effect in the food, such as defoamers used in food processing.
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