IJT - CIR - February 2024 - 14S

14S
International Journal of Toxicology 43(Supplement 1)
Table 11. Constituents of Humulus lupulus (Hops) that Have IFRA Standards.118
Constituent
Citral
Citronellol
Farnesol
Furfural
Geranial
Geraniol
(2E)-Hexenal
Limonene
Linalool
Standard Limits
Limited to .04-5%, depending on use categorya due to sensitization
Limited to .8-21.4%, depending on use category due to sensitization
Limited to .08-5%, depending on use category due to sensitization
Skin contact - .001%; non-skin contact - .05% due to carcinogenicity
Limited to .04-5%, depending on use category due to sensitization
Limited to .03-8.6%, depending on use category due to sensitization
Limited to .01-02%, depending on use category due to sensitization
d-, l-and dl-Limonene and natural products containing substantial amounts of it, should only be used when the level of
peroxides is kept to the lowest practical level, for instance by adding antioxidants at the time of production. Such
products should have a peroxide value of less than 20 millimoles peroxides per liter due to sensitization
Neral (citral)
Limit peroxide level to 20 mmol/L due to sensitization
Linalool and natural products known to be rich in linalool, such as bois de rose, coriander or ho wood oil, should only be
used when the level of peroxides is kept to the lowest practical level. It is recommended to add antioxidants at the time
of production of the raw material. The addition of .1% BHT or alpha-tocopherol for example has shown great
efficiency. The maximum peroxide level for products in use should be 20 mmol/L
Limited to .04-5%, depending on use category due to sensitization
Phenylacetaldehyde Limited to .02-3%, depending on use category due to sensitization
IFRA - International Fragrance Association.
aUse categories are based on types of skin contact (e.g., skin, lips), length of contact (e.g., leave-on, rinse-off), or type of use (e.g., mouthwash).
triglyceride) reports a theoretical content of β-myrcene of 22
ppm based on the content ofthe starting materials.37 However,
it is noted that the method of manufacture does not favor
β-myrcene retention. The HPLC profile of this mixture shows
a peak at xanthohumol and no other prenylflavonoids.
Humulus Lupulus (Hops) Oil. Humulus Lupulus (Hops) Oil is
reported to contain geraniol (.2%), limonene (1%), and linalool
(.6%).57
Impurities
Humulus lupulus (hops). Multiple fungi and bacteria may be
found on Humulus lupulus (hops) plants.3 Analysis ofthe dust
in air samples collected during harvest showed that total
concentrations of microorganisms ranged between 2.08 and
129.58 × 103 cfu/m3; the concentrations of endotoxin ranged
between 26 and 6250 ng/m3.58 In samples of the settled dust
after harvest, the concentrations of total microorganisms
ranged from .25 × 106 to 2.87 × 108 cfu/g; the concentrations
of endotoxin ranged between 312.5 and 6250 μg/g (median
6250 μg/g).
FDA regulations restrict the amounts of residuals from
solvents in the manufacture of " modified hop extract " as a
food additive (Table 3). [21CFR172.560] These restrictions
include: boron, 310 ppm; benzene, 1.0 ppm; light petroleum
spirits, 1.0 ppm; methyl alcohol, 250 ppm; hexane,
125 ppm; ethylene dichloride, 150 ppm; methylene chloride,
250 ppm; trichloroethylene, 250 ppm; and isopropyl
alcohol, 250 ppm.
Analysis of dried food grade Humulus lupulus (hops)
strobiles (possible source material for Humulus Lupulus
(Hops) Extract) produced for beer production had the following
results: lead <1.0 ppm, arsenic <.5 ppm, cadmium <.03 ppm,
and total heavy metals <10 ppm.23 Heavy metals, pesticides,
herbicides, fungicides, nitrates, and radioactivity are reported
to be below tolerance levels. Another analyses of leaves
and strobiles of Humulus lupulus (hops) plants had the following
results: copper, 102.3 and 81.1 ppm; vanadium, .07
and .05 ppm; molybdenum, .07 and .12 ppm; iron, 49.3 and
54.2 ppm; tin, 1.4 and 1.2 ppm; lead, 3.1 and 2.3 ppm, and
nickel, 7.9 and 5.5 ppm, respectively.59
The levels of residual solvent present in commercial hop
extracts used for brewing beer are reported to be <100 ppm.60
Humulus Lupulus (Hops) Extract. Authors of an analysis of a
product mixture that contained Humulus Lupulus (Hops)
Extract (.6 to 1.2%) reported that heavy metals were certified
to be present at ≤5 ppm, microbes at <100 cfu/mL, yeasts and
molds at < 100 cfu/mL, and enterobacteria absent.61
Use
Cosmetic
The safety of the cosmetic ingredients included in this assessment
is evaluated based on data received from the US
FDA and the cosmetic industry on the expected use of these
ingredients in cosmetics. Use frequencies of individual ingredients
in cosmetics are collected from manufacturers and
reported by cosmetic product category in FDA's Voluntary
Cosmetic Registration Program (VCRP) database. Use concentration
data are submitted by the cosmetic industry in
response to surveys, conducted by the Personal Care Products

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