[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.560]
[Page 64-66]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 172 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
Subpart F Flavoring Agents and Related Substances
Sec. 172.560 Modified hop extract.
The food additive modified hop extract may be safely used in beer in
accordance with the following prescribed conditions:
(a) The food additive is used or intended for use as a flavoring
agent in the brewing of beer.
(b) The food additive is manufactured by one of the following
processes:
(1) The additive is manufactured from a hexane extract of hops by
simultaneous isomerization and selective reduction in an alkaline
aqueous medium with sodium borohydride,
[[Page 65]]
whereby the additive meets the following specifications:
(i) A solution of the food additive solids is made up in
approximately 0.012 n alkaline methyl alcohol (6 milliliters of 1 n
sodium hydroxide diluted to 500 milliliters with methyl alcohol) to show
an absorbance at 253 millimicrons of 0.6 to 0.9 per centimeter. (This
absorbance is obtained by approximately 0.03 milligram solids
permilliliter.) The ultraviolet absorption spectrum of this solution
exhibits the following characteristics: An absorption peak at 253
millimicrons; no absorption peak at 325 to 330 millimicrons; the
absorbance at 268 millimicrons does not exceed the absorbance at 272
millimicrons.
(ii) The boron content of the food additive does not exceed 310
parts per million (0.0310 percent), calculated as boron.
(2) The additive is manufactured from hops by a sequence of
extractions and fractionations, using benzene, light petroleum spirits,
and methyl alcohol as solvents, followed by isomerization by potassium
carbonate treatment. Residues of solvents in the modified hop extract
shall not exceed 1.0 part per million of benzene, 1.0 part per million
of light petroleum spirits, and 250 parts per million of methyl alcohol.
The light petroleum spirits and benzene solvents shall comply with the
specifications in Sec. 172.250 except that the boiling point range for
light petroleum spirits is 150 [deg]F-300 [deg]F.
(3) The additive is manufactured from hops by a sequence of
extractions and fractionations, using methylene chloride, hexane, and
methyl alcohol as solvents, followed by isomerization by sodium
hydroxide treatment. Residues of the solvents in the modified hop
extract shall not exceed 5 parts per million of methylene chloride, 25
parts per million of hexane, and 100 parts per million of methyl
alcohol.
(4) The additive is manufactured from hops by a sequence of
extractions and fractionations, using benzene, light petroleum spirits,
methyl alcohol, n-butyl alcohol, and ethyl acetate as solvents, followed
by isomerization by potassium carbonate treatment. Residues of solvents
in the modified hop extract shall not exceed 1.0 part per million of
benzene, 1.0 part per million of light petroleum spirits, 50 parts per
million of methyl alcohol, 50 parts per million of n-butyl alcohol, and
1 part per million of ethyl acetate. The light petroleum spirits and
benzene solvents shall comply with the specifications in Sec. 172.250
except that the boiling point range for light petroleum spirits is 150
[deg]F to 300 [deg]F.
(5) The additive is manufactured from hops by an initial extraction
and fractionation using one or more of the following solvents: Ethylene
dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene
chloride, trichloroethylene, and water; followed by isomerization by
calcium chloride or magnesium chloride treatment in ethylene dichloride,
methylene chloride, or trichloroethylene and a further sequence of
extractions and fractionations using one or more of the solvents set
forth in this paragraph. Residues of the solvents in the modified hop
extract shall not exceed 125 parts per million of hexane; 150 parts per
million of ethylene dichloride, methylene chloride, or
trichloroethylene; or 250 parts per million of isopropyl alcohol or
methyl alcohol.
(6) The additive is manufactured from hops by an initial extraction
and fractionation using one or more of the solvents listed in paragraph
(b)(5) of this section followed by: Hydrogenation using palladium as a
catalyst in methyl alcohol, ethyl alcohol, or isopropyl alcohol
acidified with hydrochloric or sulfuric acid; oxidation with peracetic
acid; isomerization by calcium chloride or magnesium chloride treatment
in ethylene dichloride, methylene chloride, or trichloroethylene
(alternatively, the hydrogenation and isomerization steps may be
performed in reverse order); and a further sequence of extractions and
fractionations using one or more of the solvents listed in paragraph
(b)(5) of this section. The additive shall meet the residue limitations
as prescribed in paragraph (b)(5) of this section.
(7) The additive is manufactured from hops as set forth in paragraph
[[Page 66]]
(b)(6) of this section followed by reduction with sodium borohydride in
aqueous alkaline methyl alcohol, and a sequence of extractions and
fractionations using one or more of the solvents listed in paragraph
(b)(5) of this section. The additive shall meet the residue limitations
as prescribed in paragraph (b)(5) of this section, and a boron content
level not in excess of 300 parts per million (0.0300 percent),
calculated as boron.
(8) The additive is manufactured from hops as a nonisomerizable
nonvolatile hop resin by an initial extraction and fractionation using
one or more of the solvents listed in paragraph (b)(5) of this section
followed by a sequence of aqueous extractions and removal of nonaqueous
solvents to less than 0.5 percent. The additive is added to the wort
before or during cooking in the manufacture of beer.
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