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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR189]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
 
PART 189SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
 

Subpart C--Substances Generally Prohibited From Direct Addition or Use as Human Food

Sec. 189.110 Calamus and its derivatives.

(a) Calamus is the dried rhizome of Acorus calamus L. It has been used as a flavoring compound, especially as the oil or extract.

(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 of May 9, 1968 (33 FR 6967).

(c) The analytical method used for detecting oil of calamus ([beta]-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]

Sec. 189.113 Cinnamyl anthranilate.

(a) The food additive cinnamyl anthranilate (C16H15NO2, 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.

(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 of October 23, 1985.

[50 FR 42932, Oct. 23, 1985]

Sec. 189.120 Cobaltous salts and its derivatives.

(a) Cobaltous salts are the chemicals, CoC4H6O4, CoCl2, and CoSO4.They have been used in fermented malt beverages as a foam stabilizer and to prevent "gushing."

(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 of August 12, 1966 (31 FR 8788).

Sec. 189.130 Coumarin.

(a) Coumarin is the chemical 1,2-benzopyrone, C9H6O2. 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.

(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 of March 5, 1954 (19 FR 1239).

(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]

Sec. 189.135 Cyclamate and its derivatives.

(a) Calcium, sodium, magnesium and potassium salts of cyclohexane sulfamic acid, (C6H12NO3S)2Ca, (C6H12NO3S)Na, (C6H12NO3S)2Mg, and (C6H12NO3S)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.

(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 of October 21, 1969 (34 FR 17063).

(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]

Sec. 189.140 Diethylpyrocarbonate (DEPC).

(a) Diethylpyrocarbonate is the chemical pyrocarbonic acid diethyl ester, C6H10O5. 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.

(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 of August 2, 1972 (37 FR 15426).

Sec. 189.145 Dulcin.

(a) Dulcin is the chemical 4-ethoxyphenylurea, C9H12N2O2. 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.

(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 of January 19, 1950 (15 FR 321).

(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]

Sec. 189.155 Monochloroacetic acid.

(a) Monochloroacetic acid is the chemical chloroacetic acid, C2H3C1O2. 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).

(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]

Sec. 189.165 Nordihydroguaiaretic acid (NDGA).

(a) Nordihydroguaiaretic acid is the chemical 4,4'-(2,3-dimethyltetramethylene) dipyrocatechol, C18H22O4. It occurs naturally in the resinous exudates of certain plants. The commercial product, which is synthesized, has been used as an antioxidant in foods.

(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 of April 11, 1968 (33 FR 5619).

(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]

Sec. 189.175 P-4000.

(a) P-4000 is the chemical 5-nitro-2-n-propoxyaniline, C9H12N2O3. 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.

(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 of January 19, 1950 (15 FR 321).

(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]

Sec. 189.180 Safrole.

(a) Safrole is the chemical 4-allyl-1,2-methylenedioxy-benzene, C10H10O2. 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.

(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 of December 3, 1960 (25 FR 12412).

(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]

Sec. 189.190 Thiourea.

(a) Thiourea is the chemical thiocarbamide, CH4N2S. 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.

(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]

Sec. 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]

Authority: 21 U.S.C. 321, 342, 348, 371, 381.
Source: 42 FR 14659, Mar. 15, 1977, unless otherwise noted.

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