§348. Food additives — Inbound Citations

Implementing Regulations (Code of Federal Regulations)

Statutory authority for 17 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 60.1 — Scope.

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• 21 C.F.R. § 60.10 — FDA assistance on eligibility.

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• 21 C.F.R. § 60.2 — Purpose.

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• 21 C.F.R. § 60.20 — FDA action on regulatory review period determinations.

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• 21 C.F.R. § 60.22 — Regulatory review period determinations.

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• 21 C.F.R. § 60.24 — Revision of regulatory review period determinations.

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• 21 C.F.R. § 60.26 — Final action on regulatory review period determinations.

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• 21 C.F.R. § 60.28 — Time frame for determining regulatory review periods.

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• 21 C.F.R. § 60.3 — Definitions.

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• 21 C.F.R. § 60.30 — Filing, format, and content of petitions.

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• 21 C.F.R. § 60.32 — Applicant response to petition.

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• 21 C.F.R. § 60.34 — FDA action on petitions.

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• 21 C.F.R. § 60.36 — Standard of due diligence.

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• 21 C.F.R. § 60.40 — Request for hearing.

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• 21 C.F.R. § 60.42 — Notice of hearing.

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• 21 C.F.R. § 60.44 — Hearing procedures.

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• 21 C.F.R. § 60.46 — Administrative decision.

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Code of Federal Regulations Citations

Cited by 5 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 1.276(b)(5)(i)(A) — What definitions apply to this subpart?

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  (A) Food contact substances as defined in section 409(h)(6) of the act (21 U.S.C. 348(h)(6)); or

• 21 C.F.R. § 106.40(b)(1) — Controls to prevent adulteration caused by ingredients, containers, and closures.

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  (1) A food additive that is the subject of a regulation issued under section 409(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(c)) and is used consistent with the conditions of use of that regulation;

• 21 C.F.R. § 182.99 — Adjuvants for pesticide chemicals.

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  Adjuvants, identified and used in accordance with 40 CFR 180.910 and 40 CFR 180.920, which are added to pesticide use dilutions by a grower or applicator prior to application to the raw agricultural commodity, are exempt from the requirement of tolerances under section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348).

• 21 C.F.R. § 25.20(i) — Actions requiring preparation of an environmental assessment.

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  (i) Approval of food additive petitions and color additive petitions, approval of requests for exemptions for investigational use of food additives, the granting of requests for exemption from regulation as a food additive under § 170.39 of this chapter, and allowing notifications submitted under 21 U.S.C. 348(h) to become effective, unless categorically excluded in § 25.32(b), (c), (i), (j), (k), (l), (o), (q), or (r).

• 21 C.F.R. § 25.32(i) — Foods, food additives, and color additives.

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  (i) Approval of a food additive petition, establishment or amendment of a regulation for a food substance as GRAS under the conditions of its intended use for humans or animals under parts 182, 184, 186, 582, or 584 of this chapter, the granting of a request for exemption from regulation as a food additive under § 170.39 of this chapter, or allowing a notification submitted under 21 U.S.C. 348(h) to become effective, when the substance is present in finished food-packaging material at not greater than 5 percent-by-weight and is expected to remain with finished food-packaging material through use by consumers or when the substance is a component of a coating of a finished food-packaging material.

Citations to 21 U.S.C. § 348 as a whole

• 7 U.S.C. § 136(mm)(1)(B)

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  (B) in the intended use is exempt from, or otherwise not subject to, a tolerance under section 346a of title 21 or a food additive regulation under section 348 of title 21.

• 7 U.S.C. § 3157(e)(1)(B)

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  (B) tolerances for residues of minor use chemicals in or on raw agricultural commodities under sections 346a and 348 of title 21.

• 21 U.S.C. § 321(u)

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  (u) The term “safe” as used in paragraph (s) of this section and in sections 348, 360b, 360ccc, and 379e of this title, has reference to the health of man or animal.

• 21 U.S.C. § 331(j)

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  (j) The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial proceeding under this chapter, any information acquired under authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c, 360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc–1, 360ccc–2, 374, 379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b) of this title concerning any method or process which as a trade secret is entitled to protection; or the violating of section 346a(i)(2) of this title or any regulation issued under that section..¹This paragraph does not authorize the withholding of information from either House of Congress or from, to the extent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint committee of Congress or any subcommittee of such joint committee.

• 21 U.S.C. § 331(ll)(3)(A)

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  (A) a regulation issued under section 348 of this title prescribing conditions of safe use in food;

• 21 U.S.C. § 342(a)(1)

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  (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.¹ (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 346a(a) of this title; or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of this title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of this title; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title.

• 21 U.S.C. § 343(w)(7)(A)(ii)

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  (ii) a determination by the Secretary that the ingredient does not cause an allergic response that poses a risk to human health under a premarket approval or notification program under section 348 of this title.

• 21 U.S.C. § 343–3(a)

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  (a) No provision of section 321(n), 343(a), or 348 of this title shall be construed to require on the label or labeling of a food a separate radiation disclosure statement that is more prominent than the declaration of ingredients required by section 343(i)(2) of this title.

• 21 U.S.C. § 346a(i)(1)

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  (1) Data and information that are or have been submitted to the Administrator under this section or section 348 of this title in support of a tolerance or an exemption from a tolerance shall be entitled to confidential treatment for reasons of business confidentiality and to exclusive use and data compensation to the same extent provided by sections 3 and 10 of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a, 136h].

• 21 U.S.C. § 346a(j)(2)

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  (2) Regulations that established tolerances for substances that are pesticide chemical residues in or on processed food, or that otherwise stated the conditions under which such pesticide chemicals could be safely used, and that were issued under section 348 of this title on or before August 3, 1996, shall be deemed to be regulations issued under this section and shall be subject to modification or revocation under subsection (d) or (e), and shall be subject to review under subsection (q).

• 21 U.S.C. § 346a(j)(4)(A)

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  (A) Notwithstanding paragraph (2), any regulation applying to the use of the substance that was in effect on the day before October 30, 1998, and was on such day deemed in such paragraph to have been issued under this section, shall be considered to have been issued under section 348 of this title.

• 21 U.S.C. § 346a(j)(4)(B)

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  (B) Notwithstanding paragraph (3), any regulation applying to the use of the substance that was in effect on such day and was issued under this section (including any such regulation issued before August 3, 1996) is deemed to have been issued under section 348 of this title.

• 21 U.S.C. § 453(g)(2)(C)

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  (C) if it bears or contains any food additive which is unsafe within the meaning of section 348 of this title;

• 21 U.S.C. § 453(g)(7)

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  (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title;

• 21 U.S.C. § 601(m)(2)(C)

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  (C) if it bears or contains any food additive which is unsafe within the meaning of section 348 of this title,

• 21 U.S.C. § 601(m)(7)

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  (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title;

• 21 U.S.C. § 1033(a)(2)(C)

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  (C) if it bears or contains any food additive which is unsafe within the meaning of section 348 of this title;

• 21 U.S.C. § 1033(a)(7)

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  (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title; or

Citations to §348(b)

• 21 U.S.C. § 348(j)

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  (j) Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by regulation provide for exempting from the requirements of this section any food additive, and any food bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

Citations to §348(c)

• 21 U.S.C. § 348(j)

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  (j) Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by regulation provide for exempting from the requirements of this section any food additive, and any food bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

Citations to §348(d)

• 21 U.S.C. § 348(j)

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  (j) Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by regulation provide for exempting from the requirements of this section any food additive, and any food bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

Citations to §348(e)

• 21 U.S.C. § 348(j)

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  (j) Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by regulation provide for exempting from the requirements of this section any food additive, and any food bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

Citations to §348(f)

• 21 U.S.C. § 348(j)

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  (j) Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by regulation provide for exempting from the requirements of this section any food additive, and any food bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

Citations to §348(f)(2)

• 21 U.S.C. § 379e(d)(3)

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  (3) the Secretary’s order after public hearing (acting upon objections filed to an order made prior to hearing) shall be subject to the requirements of section 348(f)(2) of this title; and

Citations to §348(g)

• 21 U.S.C. § 348(j)

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  (j) Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by regulation provide for exempting from the requirements of this section any food additive, and any food bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

• 21 U.S.C. § 379e(d)(4)

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  (4) the scope of judicial review of such order shall be in accordance with the fourth sentence of paragraph (2), and with the provisions of paragraph (3), of section 348(g) of this title.

Citations to §348(h)

• 21 U.S.C. § 331(ll)(3)(D)

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  (D) a food contact substance notification that is effective under section 348(h) of this title; or

• 21 U.S.C. § 348(j)

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  (j) Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by regulation provide for exempting from the requirements of this section any food additive, and any food bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

Citations to §348(h)(6)

• 21 U.S.C. § 321(q)(1)(B)(ii)

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  (ii) The definition in such clause for the term “pesticide chemical” does not include the substance if the substance is a food contact substance as defined in section 348(h)(6) of this title, and any of the following circumstances exist: The substance is included for such use in an object that has a food contact surface but is not intended to have an ongoing effect on any portion of the object; the substance is included for such use in an object that has a food contact surface and is intended to have an ongoing effect on a portion of the object but not on the food contact surface; or the substance is included for such use in or is applied for such use on food packaging (without regard to whether the substance is intended to have an ongoing effect on any portion of the packaging). The food contact substance is not excluded under this subclause from such definition if any of the following circumstances exist: The substance is applied for such use on a semipermanent or permanent food contact surface (other than being applied on food packaging); or the substance is included for such use in an object that has a semipermanent or permanent food contact surface (other than being included in food packaging) and the substance is intended to have an ongoing effect on the food contact surface.

Citations to §348(i)

• 21 U.S.C. § 348(j)

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  (j) Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by regulation provide for exempting from the requirements of this section any food additive, and any food bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.