21 C.F.R. Subpart C—Solvents, Lubricants, Release Agents and Related Substances
Title 21 - Food and Drugs
A tolerance of 30 parts per million is established for acetone in spice oleoresins when present therein as a residue from the extraction of spice. 1,3-Butylene glycol (1,3-butanediol) may be safely used in food in accordance with the following prescribed conditions: (a) The substance meets the following specifications: (1) 1,3-Butylene glycol content: Not less than 99 percent. (2) Specific gravity at 20/20 °C: 1.004 to 1.006. (3) Distillation range: 200°–215 °C. (b) It is used in the minimum amount required to perform its intended effect. (c) It is used as a solvent for natural and synthetic flavoring substances except where standards of identity issued under section 401 of the act preclude such use. Ethyl acetate (CAS Reg. No. 141–78–6) may be safely used in food in accordance with the following conditions: (a) The additive meets the specifications of the Food Chemicals Codex,1 1 Copies may be obtained from: National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418 or 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.php. (b) The additive is used in accordance with current good manufacturing practice as a solvent in the decaffeination of coffee and tea. [47 FR 146, Jan. 5, 1982, as amended at 49 FR 28548, July 13, 1984] A tolerance of 30 parts per million is established for ethylene dichloride in spice oleoresins when present therein as a residue from the extraction of spice; Provided, however, That if residues of other chlorinated solvents are also present the total of all residues of such solvents shall not exceed 30 parts per million. Isopropyl alcohol may be present in the following foods under the conditions specified: (a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 50 parts per million. (b) In lemon oil as a residue in production of the oil, at a level not to exceed 6 parts per million. (c) In hops extract as a residue from the extraction of hops at a level not to exceed 2.0 percent by weight: Provided, That, (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract specifies the presence of the isopropyl alcohol and provides for the use of the hops extract only as prescribed by paragraph (c)(1) of this section. Methyl alcohol may be present in the following foods under the conditions specified: (a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 50 parts per million. (b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent by weight; Provided, That: (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract specifies the presence of methyl alcohol and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section. Methylene chloride may be present in food under the following conditions: (a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 30 parts per million; Provided, That, if residues of other chlorinated solvents are also present, the total of all residues of such solvents shall not exceed 30 parts per million. (b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent, Provided, That: (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract identifies the presence of the methylene chloride and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section. (c) In coffee as a residue from its use as a solvent in the extraction of caffeine from green coffee beans, at a level not to exceed 10 parts per million (0.001 percent) in decaffeinated roasted coffee and in decaffeinated soluble coffee extract (instant coffee). Hexane may be present in the following foods under the conditions specified: (a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 25 parts per million. (b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent by weight; Provided, That: (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract specifies the presence of the hexane and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section. The food additive hydrogenated sperm oil may be safely used in accordance with the following prescribed conditions: (a) The sperm oil is derived from rendering the fatty tissue of the sperm whale or is prepared by synthesis of fatty acids and fatty alcohols derived from the sperm whale. The sperm oil obtained by rendering is refined. The oil is hydrogenated. (b) It is used alone or as a component of a release agent or lubricant in bakery pans. (c) The amount used does not exceed that reasonably required to accomplish the intended lubricating effect. A solvent extraction process for recovery of citric acid from conventional Aspergillus niger fermentation liquor may be safely used to produce food-grade citric acid in accordance with the following conditions: (a) The solvent used in the process consists of a mixture of n-octyl alcohol meeting the requirements of §172.864 of this chapter, synthetic isoparaffinic petroleum hydrocarbons meeting the requirements of §172.882 of this chapter, and tridodecyl amine. (b) The component substances are used solely as a solvent mixture and in a manner that does not result in formation of products not present in conventionally produced citric acid. (c) The citric acid so produced meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 86–87, 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.php.), and the polynuclear aromatic hydrocarbon specifications of §173.165. (d) Residues of n-octyl alcohol and synthetic isoparaffinic petroleum hydrocarbons are removed in accordance with good manufacturing practice. Current good manufacturing practice results in residues not exceeding 16 parts per million (ppm) n-octyl alcohol and 0.47 ppm synthetic isoparaffinic petroleum hydrocarbons in citric acid. (e) Tridodecyl amine may be present as a residue in citric acid at a level not to exceed 100 parts per billion. [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10106, Mar. 19, 1984] Tolerances are established for residues of trichloroethylene resulting from its use as a solvent in the manufacture of foods as follows:
Title 21: Food and Drugs
PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
Subpart C—Solvents, Lubricants, Release Agents and Related Substances
§ 173.210 Acetone.
§ 173.220 1,3-Butylene glycol.
§ 173.228 Ethyl acetate.
§ 173.230 Ethylene dichloride.
§ 173.240 Isopropyl alcohol.
§ 173.250 Methyl alcohol residues.
§ 173.255 Methylene chloride.
§ 173.270 Hexane.
§ 173.275 Hydrogenated sperm oil.
§ 173.280 Solvent extraction process for citric acid.
§ 173.290 Trichloroethylene.
------------------------------------------------------------------------ ------------------------------------------------------------------------Decaffeinated ground coffee............... 25 parts per million.Decaffeinated soluble (instant) coffee 10 parts per million. extract.Spice oleoresins.......................... 30 parts per million (provided that if residues of other chlorinated solvents are also present, the total of all residues of such solvents in spice oleoresins shall not exceed 30 parts per million).------------------------------------------------------------------------
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