Any use of such an ingredient not in full compliance with each such established limitation shall require a food additive regulation. (2) If the ingredient is affirmed as GRAS with specific limitation(s), it shall be used in food only within such limitation(s), including the category of food(s), the functional use(s) of the ingredient, and the level(s) of use. In such a case, a manufacturer may not rely on the regulation as authorizing that use but shall have a basis to conclude that that use is GRAS or shall use the ingredient in accordance with a food additive regulation. If the ingredient is used under conditions that are significantly different from those described in the regulation, that use of the ingredient may not be GRAS. 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 ingredient.įor 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 ingredient, one or more of these limited conditions of use, which may include the category of food(s), the technical effect(s) or functional use(s) of the ingredient, and the level(s) of use. (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 paragraph (b), (c), and (d) of this section. For the purpose of this part, current good manufacturing practice includes the requirements that a direct human food ingredient be of appropriate food grade that it be prepared and handled as a food ingredient and that the quantity of the ingredient added to food does not exceed the amount reasonably required to accomplish the intended physical, nutritional, or other technical effect in food. (b) Any ingredient affirmed as GRAS in this part shall be used in accordance with current good manufacturing practice. ![]() However, when used in indirect applications, the ingredient must be of a purity suitable for its intended use in accordance with § 170.30(h)(1) of this chapter. The purity specifications in this part do not apply when the ingredient is used in indirect applications. Ingredients affirmed as GRAS in this part are also GRAS as indirect human food ingredients, subject to any limitations prescribed in parts 174, 175, 176, 177, 178 or § 179.45 of this chapter or in part 186 of this chapter. ![]() The regulations in this part shall sufficiently describe each ingredient to identify the characteristics of the ingredient that has been affirmed as GRAS and to differentiate it from other possible versions of the ingredient that have not been affirmed as GRAS. (a) The direct human food ingredients listed in this part have been reviewed by the Food and Drug Administration and affirmed to be generally recognized as safe (GRAS) for the purposes and under the conditions prescribed. 184.1 Substances added directly to human food affirmed as generally recognized as safe (GRAS). SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)ĭIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
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