21 U.S.C. 321, 342, 348, 371.
42 FR 14659, Mar. 15, 1977, unless otherwise noted.
Nomenclature changes to part 189 appear at 61 FR 14482, Apr. 2, 1996.
(a) The food ingredients listed in this section have been prohibited from use in human food by the Food and Drug Administration because of a determination that they present a potential risk to the public health or have not been shown by adequate scientific data to be safe for use in human food. Use of any of these substances in violation of this section causes the food involved to be adulterated in violation of the act.
(b) This section includes only a partial list of substances prohibited from use in human food, for easy reference purposes, and is not a complete list of substances that may not lawfully be used in human food. No substance may be used in human food unless it meets all applicable requirements of the act.
(c) The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to establish, amend, or repeal a regulation under this section on the basis of new scientific evaluation or information. Any such petition shall include an adequate scientific basis to support the petition, pursuant to part 10 of this chapter, and will be published for comment if it contains reasonable grounds.
(a) Calamus is the dried rhizome of
(b) Food containing any added calamus, oil of calamus, or extract of calamus is deemed to be adulterated in violation of the act based upon an order published in the
(c) The analytical method used for detecting oil of calamus (β-asarone) is in the “Journal of the Association of Official Analytical Chemists,” Volume 56, (Number 5), pages 1281 to 1283, September 1973, which is incorporated by reference. Copies are available from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, also from the Division of Food and Color Additives, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(a) The food additive cinnamyl anthranilate (C
(b) Food containing any added cinnamyl anthranilate is deemed to be adulterated in violation of the act based upon an order published in the
(a) Cobaltous salts are the chemicals, CoC
(b) Food containing any added cobaltous salts is deemed to be adulterated in violation of the act based upon an order published in the
(a) Coumarin is the chemical 1,2-benzopyrone, C
(b) Food containing any added coumarin as such or as a constituent of tonka beans or tonka extract is deemed to be adulterated under the act, based upon an order published in the
(c) The analytical methods used for detecting coumarin in food are in sections 19.016-19.024 of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(a) Calcium, sodium, magnesium and potassium salts of cyclohexane sulfamic acid, (C
(b) Food containing any added or detectable level of cyclamate is deemed to be adulterated in violation of the act based upon an order published in the
(c) The analytical methods used for detecting cyclamate in food are in sections 20.162-20.172 of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(a) Diethylpyrocarbonate is the chemical pyrocarbonic acid diethyl ester, C
(b) Food containing any added or detectable level of DEPC is deemed to be adulterated in violation of the act based upon an order published in the
(a) Dulcin is the chemical 4-ethoxyphenylurea, C
(b) Food containing any added or detectable level of dulcin is deemed to be adulterated in violation of the act, based upon an order published in the
(c) The analytical methods used for detecting dulcin in food are in sections 20.173-20.176 of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(a) Monochloroacetic acid is the chemical chloroacetic acid, C
(b) Food containing any added or detectable level of monochloroacetic acid is deemed to be adulterated in violation of the act based upon trade correspondence dated December 29, 1941 (TC-377).
(c) The analytical methods used for detecting monochloroacetic acid in food are in sections 20.067-20.072 of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(a) Nordihydroguaiaretic acid is the chemical 4,4′-(2,3-dimethyltetrame-thylene) dipyrocatechol, C
(b) Food containing any added NDGA is deemed to be adulterated in violation of the act based upon an order published in the
(c) The analytical method used for detecting NDGA in food is in section 20.008(b) of the “Official Methods of Analysis of the Association of Official Analytical Chemists International,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(a) P-4000 is the chemical 5-nitro-2-n-propoxyaniline, C
(b) Food containing any added or detectable level of P-4000 is deemed to be adulterated in violation of the act based upon an order published in the
(c) The analytical methods used for detecting P-4000 in food are in sections 20.177-20.181 of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(a) Safrole is the chemical 4-allyl-1,2-methylenedioxy-benzene, C
(b) Food containing any added safrole, oil of sassafras, isosafrole, or dihydrosafrole, as such, or food containing any safrole, oil of sassafras, isosafrole, or dihydrosafrole, e.g., sassafras bark, which is intended solely or primarily as a vehicle for imparting such substances to another food, e.g., sassafras tea, is deemed to be adulterated in violation of the act based upon an order published in the
(c) The analytical method used for detecting safrole, isosafrole and dihydrosafrole is in the “Journal of the Association of Official Analytical Chemists,” Volume 54 (Number 4), pages 900 to 902, July 1971, which is incorporated by reference. Copies are available from the Division of Food and Color Additives, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(a) Thiourea is the chemical thiocarbamide, CH
(b) Food containing any added or detectable level of thiourea is deemed to be adulterated under the act.
(c) The analytical methods used for detecting thiourea are in sections 20.115-20.126 of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980),
The use of chlorofluorocarbons in human food as propellants in self-pressurized containers is prohibited as provided by § 2.125 of this chapter.
(a) Flectol H is the chemical 1,2-dihydro-2,2,4-trimethylquinoline, polymerized, C
(b) Food containing any added or detectable level of this substance is deemed to be adulterated in violation of the act based upon an order published in the
(a) Lead solders are alloys of metals that include lead and are used in the construction of metal food cans.
(b) Food packaged in any container that makes use of lead in can solder is deemed to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act, based upon an order published in the
(a) Mercaptoimidazoline and 2-mercaptoimidazoline both have the molecular formula C
(b) Food containing any added or delectable levels of these substances is deemed to be adulterated in violation of the act based upon an order published in the
(a) 4,4′-Methylenebis (2-chloroanaline) has the molecular formula, C
(b) Food containing any added or detectable level of this substance is deemed to be adulterated in violation of the act based upon an order published in the
(a) Hydrogenated 4,4′-isopropylidene-diphenolphosphite ester resins are the condensation product of 1 mole of triphenyl phosphite and 1.5 moles of hydrogenated 4,4′-isopropylidene-diphenol such that the finished resins have a molecular weight in the range of 2,400 to 3,000. They are synthetic chemicals not found in natural products and have been used as antioxidants and as stabilizers in vinyl chloride polymer resins when such polymer resins are used in the manufacture of rigid vinyl chloride polymer bottles.
(b) Food containing any added or detectable levels of these substances is deemed to be adulterated and in violation of the Federal Food, Drug, and Cosmetic Act, based upon an order published in the
(a) Tin-coated lead foil is composed of a lead foil coated on one or both sides with a thin layer of tin. Tin-coated lead foil has been used as a capsule (i.e., as a covering applied over the cork and neck areas) on wine bottles to prevent insect infestation, as a barrier to oxygen, and for decorative purposes. Information received by the Food and Drug Administration establishes that the use of such a capsule on wine bottles may reasonably be expected to result in lead becoming a component of the wine.
(b) The capping of any bottles of wine after February 8, 1996, with a tin-coated lead foil capsule renders the wine adulterated and in violation of section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act because lead from the capsule, which is an unsafe food additive within the meaning of section 409 of the act, may reasonably be expected to become a component of the wine.