PART 189—SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD Authority: 21 U.S.C. 321, 342, 348, 371, 381. Source: 42 FR 14659, Mar. 15, 1977, unless otherwise noted. Editorial Note: Nomenclature changes to part 189 appear at 61 FR 14482, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001; 70 FR 40880, July 15, 2005; and 70 FR 67651, Nov. 8, 2005. Subpart A—General Provisions § 189.1 Substances prohibited from use in human food. (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. [42 FR 14659, Mar. 15, 1977, as amended at 54 FR 24899, June 12, 1989] Subpart B—Prohibited Cattle Materials § 189.5 Prohibited cattle materials. (a) Definitions. (1) Prohibited cattle materials (i) Tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, gelatin, hides and hide-derived products, and milk and milk products, and (ii) Cattle materials inspected and passed from a country designated under paragraph (e) of this section. (2) Inspected and passed (3) Mechanically separated (MS) (Beef) (4) Nonambulatory disabled cattle (5) Specified risk material (6) Tallow http://www.aocs.org http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (7) Tallow derivative (8) Gelatin (b) Requirements. (2) The small intestine is not considered prohibited cattle material if the distal ileum is removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small intestine, as measured from the caeco-colic junction and progressing proximally towards the jejunum, or by a procedure that the establishment can demonstrate is equally effective in ensuring complete removal of the distal ileum. (c) Records. (2) Records must be retained for 2 years after the date they were created. (3) Records must be retained at the manufacturing or processing establishment or at a reasonably accessible location. (4) The maintenance of electronic records is acceptable. Electronic records are considered to be reasonably accessible if they are accessible from an onsite location. (5) Records required by this section and existing records relevant to compliance with this section must be available to FDA for inspection and copying. (6) When filing entry with U.S. Customs and Border Protection, the importer of record of a human food manufactured from, processed with, or otherwise containing, cattle material must affirm that the food was manufactured from, processed with, or otherwise contains, cattle material and must affirm that the food was manufactured in accordance with this section. If a human food is manufactured from, processed with, or otherwise contains, cattle material, then the importer of record must, if requested, provide within 5 days records sufficient to demonstrate that the food is not manufactured from, processed with, or does not otherwise contain, prohibited cattle material. (7) Records established or maintained to satisfy the requirements of this subpart that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart but that are also required under other applicable statutory provisions or regulations remain subject to part 11 of this chapter. (d) Adulteration. (2) Human food manufactured from, processed with, or otherwise containing, prohibited cattle materials is unfit for human food and deemed adulterated under section 402(a)(3) of the act. (3) Food additive status. (e) Process for designating countries. [70 FR 53068, Sept. 7, 2005, as amended at 71 FR 59668, Oct. 11, 2006; 73 FR 20793, Apr. 17, 2008; 81 FR 5596, Feb. 3, 2016; 81 FR 14731, Mar. 18, 2016] Subpart C—Substances Generally Prohibited From Direct Addition or Use as Human Food Source: 42 FR 14659, Mar. 15, 1977, unless otherwise noted. Redesignated at 69 FR 42273, July 14, 2004. § 189.110 Calamus and its derivatives. (a) Calamus is the dried rhizome of Acorus calamus (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 Federal Register (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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, also from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. [42 FR 14659, Mar. 15, 1977, as amended at 47 FR 11855, Mar. 19, 1982; 54 FR 24899, June 12, 1989; 78 FR 14667, Mar. 7, 2013] § 189.113 Cinnamyl anthranilate. (a) The food additive cinnamyl anthranilate (C 16 15 2 (b) Food containing any added cinnamyl anthranilate is deemed to be adulterated in violation of the act based upon an order published in the Federal Register [50 FR 42932, Oct. 23, 1985] § 189.120 Cobaltous salts and its derivatives. (a) Cobaltous salts are the chemicals, CoC 4 6 4 2 4 (b) Food containing any added cobaltous salts is deemed to be adulterated in violation of the act based upon an order published in the Federal Register § 189.130 Coumarin. (a) Coumarin is the chemical 1,2-benzopyrone, C 9 6 2 (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 Federal Register (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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] § 189.135 Cyclamate and its derivatives. (a) Calcium, sodium, magnesium and potassium salts of cyclohexane sulfamic acid, (C 6 12 3 2 6 12 3 6 12 3 2 6 12 3 (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 Federal Register (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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] § 189.140 Diethylpyrocarbonate (DEPC). (a) Diethylpyrocarbonate is the chemical pyrocarbonic acid diethyl ester, C 6 10 5 (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 Federal Register § 189.145 Dulcin. (a) Dulcin is the chemical 4-ethoxyphenylurea, C 9 12 2 2 (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 Federal Register (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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] § 189.155 Monochloroacetic acid. (a) Monochloroacetic acid is the chemical chloroacetic acid, C 2 3 2 (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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] § 189.165 Nordihydroguaiaretic acid (NDGA). (a) Nordihydroguaiaretic acid is the chemical 4,4′-(2,3-dimethyltetramethylene) dipyrocatechol, C 18 22 4 (b) Food containing any added NDGA is deemed to be adulterated in violation of the act based upon an order published in the Federal Register (c) The analytical method used for detecting NDGA in food is in section 20.008(b) of the “Official Methods of Analysis of the AOAC INTERNATIONAL,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989] § 189.175 P-4000. (a) P-4000 is the chemical 5-nitro-2-n-propoxyaniline, C 9 12 2 3 (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 Federal Register (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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989] § 189.180 Safrole. (a) Safrole is the chemical 4-allyl-1,2-methylenedioxy-benzene, C 10 10 2 (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 Federal Register (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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. [42 FR 14659, Mar. 15, 1977, as amended at 42 FR 56729, Oct. 28, 1977; 47 FR 11855, Mar. 19, 1982; 54 FR 24900, June 12, 1989; 78 FR 14667, Mar. 7, 2013; 81 FR 49897, July 29, 2016] § 189.190 Thiourea. (a) Thiourea is the chemical thiocarbamide, CH 4 2 (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), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989] § 189.191 Chlorofluorocarbon propellants. The use of chlorofluorocarbons in human food as propellants in self-pressurized containers is prohibited as provided by § 2.125 of this chapter. [43 FR 11317, Mar. 17, 1978] Subpart D—Substances Prohibited From Indirect Addition to Human Food Through Food-Contact Surfaces Source: 42 FR 14659, Mar. 15, 1977, unless otherwise noted. Redesignated at 69 FR 42273, July 14, 2004. § 189.220 Flectol H. (a) Flectol H is the chemical 1,2-dihydro-2,2,4-trimethylquinoline, polymerized, C 12 15 (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 Federal Register [42 FR 14659, Mar. 15, 1977, as amended at 58 FR 17099, Apr. 1, 1993] § 189.240 Lead solders. (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 Federal Register [60 FR 33109, June 27, 1995] § 189.250 Mercaptoimidazoline and 2-mercaptoimidazoline. (a) Mercaptoimidazoline and 2-mercaptoimidazoline both have the molecular formula C 3 6 2 (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 Federal Register § 189.280 4,4′-Methylenebis (2-chloroanaline). (a) 4,4′-Methylenebis (2-chloroanaline) has the molecular formula, C 13 12 2 2 (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 Federal Register § 189.300 Hydrogenated 4,4′-isopropylidene-diphenolphosphite ester resins. (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 Federal Register [54 FR 7188, Feb. 17, 1989] § 189.301 Tin-coated lead foil capsules for wine bottles. (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. [61 FR 4820, Feb. 8, 1996]