Title 21 CFR reference

(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…

Acorus calamus(a) Calamus is the dried rhizome of L. It has been used as a flavoring compound, especially as the oil or extract. Federal Register04(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 of May 9, 1968 (33 FR 6967). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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: [42 FR 14659, Mar. 15, 1977, as amended at 47 FR…

16521552252(a) The food additive cinnamyl anthranilate (CHNO, CAS Reg. No. 87-29-6) is the ester of cinnamyl alcohol and anthranilic acid. Cinnamyl anthranilate is a synthetic chemical that has not been identified in natural products at levels detectable by available methodology. It has been used as a flavoring agent in food. Federal Register04(b) Food containing any added cinnamyl anthranilate is deemed to be adulterated in violation of the act based upon an order published in the of October 23, 1985. [50 FR 42932, Oct. 23, 1985]

452652452252452(a) Cobaltous salts are the chemicals, CoCHO, CoCl, and CoSO.They have been used in fermented malt beverages as a foam stabilizer and to prevent “gushing.” Federal Register04(b) Food containing any added cobaltous salts is deemed to be adulterated in violation of the act based upon an order published in the of August 12, 1966 (31 FR 8788).

952652252(a) Coumarin is the chemical 1,2-benzopyrone, CHO. It is found in tonka beans and extract of tonka beans, among other natural sources, and is also synthesized. It has been used as a flavoring compound. Federal Register04(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 of March 5, 1954 (19 FR 1239). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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: [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989]

6521252352252652125235265212523522526521252352(a) Calcium, sodium, magnesium and potassium salts of cyclohexane sulfamic acid, (CHNOS)Ca, (CHNOS)Na, (CHNOS)Mg, and (CHNOS)K. Cyclamates are synthetic chemicals having a sweet taste 30 to 40 times that of sucrose, are not found in natural products at levels detectable by the official methodology, and have been used as artificial sweeteners. Federal Register04(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 of October 21, 1969 (34 FR 17063). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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…

6521052552(a) Diethylpyrocarbonate is the chemical pyrocarbonic acid diethyl ester, CHO. It is a synthetic chemical not found in natural products at levels detectable by available methodology and has been used as a ferment inhibitor in alcoholic and nonalcoholic beverages. Federal Register04(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 of August 2, 1972 (37 FR 15426).

9521252252252(a) Dulcin is the chemical 4-ethoxyphenylurea, CHNO. It is a synthetic chemical having a sweet taste about 250 times that of sucrose, is not found in natural products at levels detectable by the official methodology, and has been proposed for use as an artificial sweetener. Federal Register04(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 of January 19, 1950 (15 FR 321). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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: [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989]

252352252(a) Monochloroacetic acid is the chemical chloroacetic acid, CHClO. It is a synthetic chemical not found in natural products, and has been proposed as a preservative in alcoholic and nonalcoholic beverages. Monochloroacetic acid is permitted in food package adhesives with an accepted migration level up to 10 parts per billion (ppb) under § 175.105 of this chapter. The official methods do not detect monochloroacetic acid at the 10 ppb level. (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). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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…

18522252452(a) Nordihydroguaiaretic acid is the chemical 4,4′-(2,3-dimethyltetramethylene) dipyrocatechol, CHO. It occurs naturally in the resinous exudates of certain plants. The commercial product, which is synthesized, has been used as an antioxidant in foods. Federal Register04(b) Food containing any added NDGA is deemed to be adulterated in violation of the act based upon an order published in the of April 11, 1968 (33 FR 5619). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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: [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989]

9521252252352(a) P-4000 is the chemical 5-nitro-2-n-propoxyaniline, CHNO. It is a synthetic chemical having a sweet taste about 4000 times that of sucrose, is not found in natural products at levels detectable by the official methodology, and has been proposed for use as an artificial sweetener. Federal Register04(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 of January 19, 1950 (15 FR 321). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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: [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12,…

10521052252(a) Safrole is the chemical 4-allyl-1,2-methylenedioxy-benzene, CHO. It is a natural constituent of the sassafras plant. Oil of sassafras is about 80 percent safrole. Isosafrole and dihydrosafrole are derivatives of safrole, and have been used as flavoring compounds. Federal Register04(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 of December 3, 1960 (25 FR 12412). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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…

452252(a) Thiourea is the chemical thiocarbamide, CHNS. It is a synthetic chemical, is not found in natural products at levels detectable by the official methodology, and has been proposed as an antimycotic for use in dipping citrus. (b) Food containing any added or detectable level of thiourea is deemed to be adulterated under the act. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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: [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989]

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]

12521552(a) Flectol H is the chemical 1,2-dihydro-2,2,4-trimethylquinoline, polymerized, CHN. It is a synthetic chemical not found in natural products, and has been used as a component of food packaging adhesives. Federal Register04(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 of April 7, 1967 (32 FR 5675). [42 FR 14659, Mar. 15, 1977, as amended at 58 FR 17099, Apr. 1, 1993]

(a) Lead solders are alloys of metals that include lead and are used in the construction of metal food cans. Federal Register04(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 of June 27, 1995. [60 FR 33109, June 27, 1995]

352652252(a) Mercaptoimidazoline and 2-mercaptoimidazoline both have the molecular formula CHNS. They are synthetic chemicals not found in natural products and have been used in the production of rubber articles that may come into contact with food. Federal Register04(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 of November 30, 1973 (38 FR 33072).

13521252252252(a) 4,4′-Methylenebis (2-chloroanaline) has the molecular formula, CHClN. It is a synthetic chemical not found in natural products and has been used as a polyurethane curing agent and as a component of food packaging adhesives and polyurethane resins. Federal Register04(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 of December 2, 1969 (34 FR 19073).

(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. Federal Register04(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 of September 9, 1987 (52 FR 33929). [54 FR 7188, Feb. 17, 1989]

(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]

Definitions.(a) The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) apply to such terms when used in this part. The following definitions also apply: Prohibited cattle materials(1) mean specified risk materials, small intestine of all cattle except as provided in paragraph (b)(2) of this section, material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS)(Beef). Prohibited cattle materials do not include the following: (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. Inspected and passed(2) means that the product has been inspected and passed for human consumption by the appropriate regulatory authority, and at the time it was inspected and passed, it was found to be not adulterated. Mechanically separated (MS) (Beef)(3) means a meat food product that is finely comminuted, resulting from the mechanical separation and…