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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: 21CFR173]





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 173SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
 

Subpart C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.210 Acetone.

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.

Sec. 173.220 1,3-Butylene glycol.

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 deg. C: 1.004 to 1.006.

(3) Distillation range: 200deg. -215 deg. 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.

Sec. 173.228 Ethyl acetate.

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, 7th ed. (2010), pp. 343-344, 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.

(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; 78 FR 71466, Nov. 29, 2013]

Sec. 173.230 Ethylene dichloride.

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.

Sec. 173.240 Isopropyl alcohol.

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.

Sec. 173.250 Methyl alcohol residues.

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.

Sec. 173.255 Methylene chloride.

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).

Sec. 173.270 Hexane.

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.

Sec. 173.275 Hydrogenated sperm oil.

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.

Sec. 173.280 Solvent extraction process for citric acid.

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 polynuclear aromatic hydrocarbon specifications of 173.165 and the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 226-227, 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.

(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; 78 FR 71466, Nov. 29, 2013]

Sec. 173.290 Trichloroethylene.

Tolerances are established for residues of trichloroethylene resulting from its use as a solvent in the manufacture of foods as follows:

Decaffeinated ground coffee25 parts per million.
Decaffeinated soluble (instant) coffee extract10 parts per million.
Spice oleoresins30 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).

Authority: 21 U.S.C. 321, 342, 348.
Source: 42 FR 14526, Mar. 15, 1977, unless otherwise noted.

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