Part 186—indirect Food Sub- Stances Affirmed as Gen- Erally Recognized as Safe

(a) The indirect human food ingredients listed in this part have been reviewed by the Food and Drug Administration and determined to be generally recognized as safe (GRAS) for the purposes and under the conditions prescribed, providing they comply with the purity specifications listed in this part or, in the absence of purity specifications, are of a purity suitable for their intended use in accordance with § 170.30(h)(1) of this chapter. Certain ingredients in this part may also be used in food-contact surfaces in accordance with parts 174, 175, 176, 177, 178 or § 179.45 of this chapter. Ingredients affirmed as GRAS for direct use in part 184 of this chapter are also GRAS as indirect human food ingredients in accordance with § 184.1(a) of this chapter. (b) The regulations in this part do not authorize direct addition of any food ingredient to a food. They authorize only the use of these ingredients as indirect ingredients of food, through migration from their immediate wrapper, container, or other food-contact surface. Any ingredient affirmed as GRAS in this part shall be used in accordance with current good manufacturing practice. For the purpose of this part, current good manufacturing practice includes the requirements that an indirect human food ingredient be of a purity suitable for its intended use, and that it be used at a level no higher than reasonably required to achieve its intended technical effect in the foodcontact article. (1) If the ingredient is affirmed as GRAS with no limitations on its conditions of use other than current good manufacturing practice, it shall be regarded as GRAS if its conditions of use are consistent with the requirements of paragraphs (b), (c), and (d) of this section. When the Food and Drug Administration (FDA) determines that it is appropriate, the agency will describe one or more current good manufacturing practice conditions of use in the regulation that affirms the GRAS status of the indirect ingredient. For example, when the safety of an ingredient has been evaluated on the basis of limited conditions of use, the agency will describe in the regulation that affirms the GRAS status of the indirect ingredient, one or more of these limited conditions of use, which may include the category of food-contact surface(s), technical effect(s) or functional use(s) of the indirect ingredient, and the level(s) of use. If the ingredient is used under conditions that are significantly different from those described in the regulation, such use of a substance may not be GRAS. In such a case, a manufacturer may not rely on the regulation as authorizing that use but shall independently establish that the use is GRAS or shall use the ingredient in accordance with a food additive regulation. Persons seeking FDA approval of an independent determination that a