§170.30. Eligibility for classification as generally recognized as safe (GRAS). — Inbound Citations
21 C.F.R. § 170.30
Statutory Authority
Cited by 11 regulations in release Current.
Citations to 21 C.F.R. § 170.30 as a whole
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(3) Data and information about a substance submitted as part of the procedures for establishing that the substance is generally recognized as safe for use that results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in §§ 170.30 and 570.30.
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The definitions and interpretations of terms in § 170.3 apply to such terms when used in this subpart. The following definitions also apply:
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(k) General recognition of safety shall be in accordance with § 170.30.
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(3) The Commissioner will evaluate all comments received. If he concludes that there is convincing evidence that the substance is GRAS under the conditions of its intended use as described in § 170.30, he will publish a notice in the Federal Register listing the GRAS conditions of use of the substance in part 184 or part 186 of this chapter, as appropriate.
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(j) Group 1 mixtures means any product whose only pesticidal active ingredient(s) is: a common food/food constituent or non-toxic household item; or is a substance that is generally recognized as safe (GRAS) by the Food and Drug Administration (21 CFR 170.30, 182, 184, and 186) in accordance with good manufacturing practices, as defined by 21 CFR part 182; or is exempt from FIFRA under 40 CFR 152.25.
Citations to §170.30(a)
Citations to §170.30(b)
Citations to §170.30(c)
Citations to §170.30(h)(1)
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(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. 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. 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 purity specifications in this part do not apply when the ingredient is used in indirect applications. 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.
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(b) The ingredient must be of a purity suitable for its intended use in accordance with § 170.30(h)(1) of this chapter.
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(a) The indirect 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, 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.