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United States • Title 21 CFR • Part 180

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

Part 180 outlines interim regulations for food additives, allowing their use on a temporary basis pending further study when new information raises safety or functionality questions, provided there's reasonable certainty of no harm. It details conditions for these interim regulations, including study commitments, progress reporting, and compliance with Good Laboratory Practice (GLP) and Institutional Review Board (IRB) requirements. The part also specifies limitations for certain substances like acrylonitrile copolymers and mannitol.

What this part covers

  • Interim food additive regulations may be issued when new information raises substantial questions about safety or functionality, but continued use is reasonably certain to be safe for a limited period.
  • Interim regulations are not promulgated if new information is conclusive regarding harm or if there's a reasonable likelihood of harm to public health.
  • The Commissioner can propose interim regulations on their own initiative or via petition.
  • Conditions for interim use include compliance with Commissioner-defined limitations, commitment to undertake adequate studies within 60 days, regular progress reports, and adherence to GLP and IRB/informed consent requirements for relevant studies.
  • Upon study completion, the Commissioner reviews data, terminates the interim regulation, and either issues a final regulation or requires elimination of the substance.
  • Emergency action levels may be issued for substances not yet approved as food additives.
  • Specific sections detail interim allowances and conditions for substances like acrylonitrile copolymers (with extraction limits and testing requirements) and mannitol (with usage limits and labeling requirements for laxative effects).
  • Acrylonitrile copolymers have specific requirements regarding monomer extraction, testing of complexes, and submission of data, with provisions for existing uses prior to June 14, 1976.

Sections in Part 180

§ 180.1

General.

(a) Substances having a history of use in food for human consumption or in food contact surfaces may at any time have their safety or functionality brought into question by new information that in itself is not conclusive. An interim food additive regulation for the use of any such substance may be promulgated in this subpart when new information raises a substantial question about the safety or functionality of the substance but there is a reasonable certainty that the substance is not harmful and that no harm to the public health will result from the continued use of the substance for a limited period of time while the question raised is being resolved by further study. (b) No interim food additive regulation may be promulgated if the new information is conclusive with respect to the question raised or if there is a reasonable likelihood that the substance is harmful or that continued use of the substance will result in harm to the public health. (c) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may propose an interim food additive regulation. A final order promulgating an interim food additive…

§ 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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: (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 °F with food-simulating solvents appropriate to the intended…

§ 180.25

Mannitol.

6521452652(a) Mannitol is the chemical 1,2,3,4,5,6,-hexanehexol (CHO) 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. Zygosaccharomyces rouxii.(2) The fermentation of sugars or sugar alcohols such as glucose, sucrose, fructose, or sorbitol using the yeast Lactobacillus intermediusfermentum(3) A pure culture fermentation of sugars such as fructose, glucose, or maltose using the nonpathogenic, nontoxicogenic bacterium (). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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: (c) The ingredient is used as an…

§ 180.30

Brominated vegetable oil.

The food additive brominated vegetable oil may be safely used in accordance with the following prescribed conditions: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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: (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…

§ 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: 752552352(a) Saccharin is the chemical, 1,2-benzisothiazolin-3-one - 1,1 - dioxide (CHNOS). The named salts of saccharin are produced by the additional neutralization of saccharin with the proper base to yield the desired salt. http://www.usp.orghttp://www.archives.gov/federal-register/cfr/ibr-locations.html.(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…

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