IJT - CIR - February 2024 - 9S

Becker et al.
9S
Table 3. FDA Regulations on the Method of Manufacture and Residual Solvents in " Modified Hop Extract, " as a Food Additive Used or
Intended for Use as a Flavoring Agent in the Brewing of Beer [21CFR172.560].
Method of Manufacture
(b)(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, whereby the additive
meets the following specifications:
A solution of the food additive solids is made up in approximately .012
n alkaline methyl alcohol (6 mL of 1 n sodium hydroxide diluted to
500 mL with methyl alcohol) to show an absorbance at 253 µmof .6
to .9/cm. (This absorbance is obtained by approximately .03 mg
solids/mL.) The ultraviolet absorption spectrum of this solution
exhibits the following characteristics: An absorption peak at 253
mµ; no absorption peak at 325 to 330 mµ; the absorbance at 268
mµ does not exceed the absorbance at 272 mµ.
(b)(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. The light petroleum spirits and
benzene solvents shall comply with the specifications in §172.250
except that the boiling point range for light petroleum spirits is
150°F to 300°F.
(b)(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.
(b)(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. The
light petroleum spirits and benzene solvents shall comply with the
specifications in §172.250 except that the boiling point range for
light petroleum spirits is 150°F to 300°F.
(b)(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.
(b)(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.
(b)(7) The additive is manufactured from hops as set forth in
paragraph (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.
Residues of solvents in the modified hop extract shall not exceed 1.0
ppm of benzene, 1.0 ppm of light petroleum spirits, and 250 ppm of
methyl alcohol.
Solvent/Impurities restrictions
The boron content of the food additive does not exceed 310 ppm
(.0310%), calculated as boron.
Residues of the solvents in the modified hop extract shall not exceed 5
ppm of methylene chloride, 25 ppm of hexane, and 100 ppm of
methyl alcohol.
Residues of solvents in the modified hop extract shall not exceed 1.0
ppm of benzene, 1.0 ppm of light petroleum spirits, 50 ppm of
methyl alcohol, 50 ppm of n-butyl alcohol, and 1 ppm of ethyl
acetate.
Residues of the solvents in the modified hop extract shall not exceed
125 ppm of hexane; 150 ppm of ethylene dichloride, methylene
chloride, or trichloroethylene; or 250 ppm of isopropyl alcohol or
methyl alcohol.
The additive shall meet the residue limitations as prescribed 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 ppm (.0300%), calculated as boron.
(continued)

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