Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles

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The Food and Drug Administration (FDA) is amending its food additive regulations to establish a process for determining when the likelihood or extent of migration to food of a substance used in a food-contact article is so trivial as not to require regulation of the substance as a food additive. Although still a ``food additive,'' a substance exempted from regulation under this process will not be required to be the subject of a food additive listing regulation. Under this process, information about the proposed use of the substance will undergo an abbreviated review by FDA, as opposed to the extensive review normally required for food additives. This final rule also lists the criteria that FDA will use in its review in deciding whether it is necessary to regulate the use of a substance as a food additive and identifies the types of data that it will need to make this determination.