C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 130—FOOD STANDARDS: GENERAL › Subpart B—Food Additives in Standardized Foods

21 C.F.R. § 130.20

Food additives proposed for use in foods for which definitions and standards of identity are established

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(a) Where a petition is received for the issuance or amendment of a regulation establishing a definition and standard of identity for a food under section 401 of the act, which proposes the inclusion of a food additive in such definition and standard of identity, the provisions of the regulations in part 171 of this chapter shall apply with respect to the information that must be submitted with respect to the food additive. Since section 409(b)(5) of the act requires that the Commissioner publish notice of a petition for the establishment of a food additive regulation within 30 days after filing, notice of a petition relating to a definition and standard of identity shall also be published within that time limitation if it includes a request, so designated, for the establishment of a regulation pertaining to a food additive.

(b) If a petition for a definition and standard of identity contains a proposal for a food additive regulation, and the petitioner fails to designate it as such, the Commissioner, upon determining that the petition includes a proposal for a food additive regulation, shall so notify the petitioner and shall thereafter proceed in accordance with the regulations in part 171 of this chapter.

Notes of Decisions
Cited in 1 case, 1974–1974 · leading case: Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974).
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Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974). “The regimen used varied from an injunction every 6 hours to one injection every 2 or 3 days, for a total of one to 16 injections over a period of 2 to 25 days. However, there was no correlation between the number of injections and days of treatments (21 C.”
— 21 C.F.R. § 130.20(a)(5)(ii)(a) — 1 case
Cooper Labs., Inc. v. Comm'r, Fed. Food & Drug Admin., 501 F.2d 772 (D.C. Cir. 1974). “The regimen used varied from an injunction every 6 hours to one injection every 2 or 3 days, for a total of one to 16 injections over a period of 2 to 25 days. However, there was no correlation between the number of injections and days of treatments (21 C.”
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