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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: 21CFR180]





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 180FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
 

Subpart B--Specific Requirements for Certain Food Additives

Sec. 180.22 Acrylonitrile copolymers.

Acrylonitrile copolymers may be safely used on an interim basis as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions:

(a) Limitations for acrylonitrile monomer extraction for finished food-contact articles, determined by a method of analysis titled "Gas-Solid Chromatographic Procedure for Determining Acrylonitrile Monomer in Acrylonitrile-Containing Polymers and Food Simulating Solvents," which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 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.

(1) In the case of single-use articles having a volume to surface ratio of 10 milliliters or more per square inch of food contact surface--0.003 milligram/square inch when extracted to equilibrium at 120 deg. F with food-simulating solvents appropriate to the intended conditions of use.

(2) In the case of single-use articles having a volume to surface ratio of less than 10 milliliters per square inch of food contact surface--0.3 part per million calculated on the basis of the volume of the container when extracted to equilibrium at 120 deg. F with food-simulating solvents appropriate to the intended conditions of use.

(3) In the case of repeated-use articles--0.003 milligram/square inch when extracted at a time equivalent to initial batch usage utilizing food-simulating solvents and temperatures appropriate to the intended conditions of use.

The food-simulating solvents shall include, where applicable, distilled water, 8 percent or 50 percent ethanol, 3 percent acetic acid, and either n -heptane or an appropriate oil or fat.

(b) Where necessary, current regulations permitting the use of acrylonitrile copolymers shall be revised to specify limitations on acrylonitrile/mercaptan complexes utilized in the production of acrylonitrile copolymers. Such copolymers, if they contain reversible acrylonitrile/mercaptan complexes and are used in other than repeated-use conditions, shall be tested to determine the identity of the complex and the level of the complex present in the food-contact article. Such testing shall include determination of the rate of decomposition of the complex at temperatures of 100 deg. F, 160 deg. F, and 212 deg. F using 3 percent acetic acid as the hydrolic agent. Acrylonitrile monomer levels, acrylonitrile/mercaptan complex levels, acrylonitrile oligomer levels, descriptions of the analytical methods used to determine the complex and the acrylonitrile migration, and validation studies of these analytical methods shall be submitted by June 9, 1977, to the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, unless an extension is granted by the Food and Drug Administration for good cause shown. Analytical methods for the determination of acrylonitrile complexes with n -dodecyl-mercaptan, n-octyl mercaptan, and 2-mercaptoethanol, titled "Determination of [beta]-Dodecyl-mercaptopropionitrile in NR-16R Aqueous Extracts" and "Measurement of [beta]-(2-Hdroxyethylmercapto) Propionitrile in Heptane Food-Simulating Solvent," are incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 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.

(c) The following data shall be provided for finished food-contact articles intended for repeated use:

(1) Qualitative and quantitative migration values at a time equivalent to initial batch usage, utilizing solvents and temperatures appropriate to the intended conditions of use.

(2) Qualitative and quantitative migration values at the time of equilibrium extractions, utilizing solvents and temperatures appropriate to the intended conditions of use.

(3) Data on the volume and/or weight of food handled during the initial batch time period(s), during the equilibrium test period, and over the estimated life of the food-contact surface.

(d) Where acrylonitrile copolymers represent only a minor component of a polymer system, calculations based on 100 percent migration of the acrylonitrile component may be submitted in lieu of the requirements of paragraphs (a), (b), and (c) of this section in support of the continued safe use of acrylonitrile copolymers.

(e) On or before September 13, 1976, any interested person shall satisfy the Commissioner of Food and Drugs that toxicological feeding studies adequate and appropriate to establish safe conditions for the use of acrylonitrile copolymers have been, or soon will be, undertaken. Toxicity studies of acrylonitrile monomer shall include: (1) Lifetime feeding studies with a mammalian species, preferably with animals exposed in utero to the chemical, (2) studies of multigeneration reproduction with oral administration of the test material, (3) assessment of teratogenic and mutagenic potentials, (4) subchronic oral administration in a nonrodent mammal, (5) tests to determine any synergistic toxic effects between acrylonitrile monomer and cyanide ion, and (6) a literature search on the effects of chronic ingestion of hydrogen cyanide. Data on levels of acrylamide extractable from acrylonitrile copolymers shall also be submitted. Protocols of testing should be submitted for review to the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

(f) Acrylonitrile copolymers may be used in contact with food only if authorized in parts 174 through 179 or 181.32 of this chapter, except that other uses of acrylonitrile copolymers in use prior to June 14, 1976, may continue under the following conditions:

(1) On or before August 13, 1976, each use of acrylonitrile copolymers in a manner not authorized by 181.32 of this chapter or parts 174 through 179 of this chapter shall be the subject of a notice to the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Such notice shall be accompanied by a statement of the basis, including any articles and correspondence, on which the user in good faith believed the use to be prior-sanctioned. The Commissioner of Food and Drugs shall, by notice in the Federal Register, identify any use of acrylonitrile copolymers not in accordance with this paragraph. Those uses are thereafter unapproved food additives and consequently unlawful.

(2) Any use of acrylonitrile copolymers subject to paragraph (f)(1) of this section shall be the subject of a petition submitted on or before December 13, 1976, in accordance with 171.1 of this chapter, unless an extension of time is granted by the Food and Drug Administration for good cause shown. Any application for extension shall be by petition submitted in accordance with the requirements of part 10 of this chapter. If a petition is denied, in whole or in part, those uses subject to the denial are thereafter unapproved food additives and consequently unlawful.

(3) Any use of acrylonitrile copolymers subject to paragraph (f)(1) of this section shall meet the acrylonitrile monomer extraction limitation set forth in paragraph (a) of this section and shall be subject to the requirements of paragraph (b) of this section.

(g) In addition to the requirements of this section, the use of acrylonitrile copolymers shall comply with all applicable requirements in other regulations in this part.

[42 FR 14636, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 1989; 61 FR 14246, Apr. 1, 1996]

Sec. 180.25 Mannitol.

(a) Mannitol is the chemical 1,2,3,4,5,6,-hexanehexol (C6H14O6) a hexahydric alcohol, differing from sorbitol principally by having a different optical rotation. Mannitol is produced by one of the following processes:

(1) The electrolytic reduction or transition metal catalytic hydrogenation of sugar solutions containing glucose or fructose.

(2) The fermentation of sugars or sugar alcohols such as glucose, sucrose, fructose, or sorbitol using the yeast Zygosaccharomyces rouxii.

(3) A pure culture fermentation of sugars such as fructose, glucose, or maltose using the nonpathogenic, nontoxicogenic bacterium Lactobacillus intermedius (fermentum ).

(b) The ingredient meets the specifications of the "Food Chemicals Codex," 3d Ed. (1981), pp. 188-190, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, 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.

(c) The ingredient is used as an anticaking agent and free-flow agent as defined in 170.3(o)(1) of this chapter, formulation aid as defined in 170.3(o) (14) of this chapter, firming agent as defined in 170.3(o)(10) of this chapter, flavoring agent and adjuvant as defined in 170.3(o)(12) of this chapter, lubricant and release agent as defined in 170.3(o)(18) of this chapter, nutritive sweetener as defined in 170.3(o)(21) of this chapter, processing aid as defined in 170.3(o)(24) of this chapter, stabilizer and thickener as defined in 170.3(o)(28) of this chapter, surface-finishing agent as defined in 170.3(o)(30) of this chapter, and texturizer as defined in 170.3(o)(32) of this chapter.

(d) The ingredient is used in food at levels not to exceed 98 percent in pressed mints and 5 percent in all other hard candy and cough drops as defined in 170.3(n)(25) of this chapter, 31 percent in chewing gum as defined in 170.3(n)(6) of this chapter, 40 percent in soft candy as defined in 170.3(n)(38) of this chapter, 8 percent in confections and frostings as defined in 170.3(n)(9) of this chapter, 15 percent in nonstandardized jams and jellies, commercial, as defined in 170.3(n)(28) of this chapter, and at levels less than 2.5 percent in all other foods.

(e) The label and labeling of food whose reasonably foreseeable consumption may result in a daily ingestion of 20 grams of mannitol shall bear the statement "Excess consumption may have a laxative effect".

(f) In accordance with 180.1, adequate and appropriate feeding studies have been undertaken for this substance. Continued uses of this ingredient are contingent upon timely and adequate progress reports of such tests, and no indication of increased risk to public health during the test period.

(g) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived.

[42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996; 69 FR 65542, Nov. 15, 2004]

Sec. 180.30 Brominated vegetable oil.

The food additive brominated vegetable oil may be safely used in accordance with the following prescribed conditions:

(a) The additive complies with specifications prescribed in the "Food Chemicals Codex," 3d Ed. (1981), pp. 40-41, which is incorporated by reference, except that free fatty acids (as oleic) shall not exceed 2.5 percent and iodine value shall not exceed 16. Copies of the material incorporated by reference may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, 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.

(b) The additive is used on an interim basis as a stabilizer for flavoring oils used in fruit-flavored beverages, for which any applicable standards of identity do not preclude such use, in an amount not to exceed 15 parts per million in the finished beverage, pending the outcome of additional toxicological studies on which periodic reports at 6-month intervals are to be furnished and final results submitted to the Food and Drug Administration promptly after completion of the studies.

[42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984]

Sec. 180.37 Saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin.

The food additives saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin may be safely used as sweetening agents in food in accordance with the following conditions, if the substitution for nutritive sweeteners is for a valid special dietary purpose and is in accord with current special dietary food regulations and policies or if the use or intended use is for an authorized technological purpose other than calorie reduction:

(a) Saccharin is the chemical, 1,2-benzisothiazolin-3-one - 1,1 - dioxide (C7H5NO3S). The named salts of saccharin are produced by the additional neutralization of saccharin with the proper base to yield the desired salt.

(b) The food additives meet the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 52-54, 153-154, 898-899, 961-962, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or 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/cfr/ibr-locations.html.

(c) Authority for such use shall expire when the Commissioner receives the final reports on the ongoing studies in Canada and publishes an order on the safety of saccharin and its salts based on those reports and other available data.

(d) The additives are used or intended for use as a sweetening agent only in special dietary foods, as follows:

(1) In beverages, fruit juice drinks, and bases or mixes when prepared for consumption in accordance with directions, in amounts not to exceed 12 milligrams of the additive, calculated as saccharin, per fluid ounce.

(2) As a sugar substitute for cooking or table use, in amounts not to exceed 20 milligrams of the additive, calculated as saccharin, for each expressed teaspoonful of sugar sweetening equivalency.

(3) In processed foods, in amounts not to exceed 30 milligrams of the additive, calculated as saccharin, per serving of designated size.

(e) The additives are used or intended for use only for the following technological purposes:

(1) To reduce bulk and enhance flavors in chewable vitamin tablets, chewable mineral tablets, or combinations thereof.

(2) To retain flavor and physical properties of chewing gum.

(3) To enhance flavor of flavor chips used in nonstandardized bakery products.

(f) To assure safe use of the additives, in addition to the other information required by the Act:

(1) The label of the additive and any intermediate mixes of the additive for manufacturing purposes shall bear:

(i) The name of the additive.

(ii) A statement of the concentration of the additive, expressed as saccharin, in any intermediate mix.

(iii) Adequate directions for use to provide a final food product that complies with the limitations prescribed in paragraphs (d) and (e) of this section.

(2) The label of any finished food product containing the additive shall bear:

(i) The name of the additive.

(ii) The amount of the additive, calculated as saccharin, as follows:

(a ) For beverages, in milligrams per fluid ounce;

(b ) For cooking or table use products, in milligrams per dispensing unit;

(c ) For processed foods, in terms of the weight or size of a serving which shall be that quantity of the food containing 30 milligrams or less of the additive.

(iii) When the additive is used for calorie reduction, such other labeling as is required by part 105 of this chapter.

[42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 72 FR 10357, Mar. 8, 2007; 78 FR 71467, Nov. 29, 2013]

Authority: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241.

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