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172.560 Modified hop extract.

Home > Regulations > Food additives permitted for direct addition to food for human consumption > 172.560 Modified hop extract.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.560]

[Page 65-66]
 
                        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 
CONSUMPTION--Table of Contents
 
            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, 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

[[Page 66]]

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 
(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.





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 172, Section 560


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