IJT - CIR - February 2024 - 15S

Becker et al.
15S
Council (Council), ofmaximum reported use concentration by
product category.
The Humulus lupulus (hops)-derived ingredients were
reported to the 2017 VCRP and surveyed by the Council in
2015 and 2016 under the former INCI names, and that is how
they are reported here.62,63
According to VCRP data received in 2017, Humulus
Lupulus (Hops) Extract was reported to be used in 375 formulations,
including 317 leave-on formulations and 54 rinseoff
formulations (Table 12).62
The results of the concentration of use survey conducted
by the Council in 2015 (and updated in 2016) indicate that
Humulus Lupulus (Hops) Extract is used at up to .2% in hair
conditioners.63,64 The highest reported maximum concentration
of use with dermal contact was reported to be .13%
in eye lotion and in the category of other skin care
preparations.
Humulus Lupulus (Hops) Cone Oil is not in use according
to the VCRP and the industry survey results.
Humulus Lupulus (Hops) Extract is reported to be used
in formulations that are used around the eyes at up to .13%
and in formulations that come in contact with mucus
membranes at up to .084% (e.g., bath soaps and detergents,
bubble baths).
Humulus Lupulus (Hops) Extract is used in cosmetic
sprays and could possibly be inhaled; for example, this
ingredient is reported to be used at up to .0002% in hair
sprays. In practice, 95% to 99% of the droplets/particles
released from cosmetic sprays have aerodynamic equivalent
diameters >10 µm, with propellant sprays yielding a greater
fraction of droplets/particles <10 µm compared with pump
sprays.65,66 Therefore, most droplets/particles incidentally
inhaled from cosmetic sprays would be deposited in the
nasopharyngeal and thoracic regions of the respiratory tract
and would not be respirable (i.e., they would not enter the
lungs) to any appreciable amount.67,68 There is a reported
use in face powders at up to .00055%. Conservative estimates
of inhalation exposures to respirable particles during
the use of loose-powder cosmetic products are 400-fold to
1000-fold less than protective regulatory and guidance
limits for inert airborne respirable particles in the
workplace.69-71
Neither of the Humulus lupulus (hops)-derived ingredients
named in the report (under the new or revised names) are
restricted from use in any way under the rules governing
cosmetic products in the European Union.72
Non-Cosmetic
Humulus lupulus (hops) strobiles are predominantly used to
make beer.2,3 They were originally added to beer for their
antimicrobial properties. Brewers then began using strobiles
(and their extracts) to add bitterness, flavor, and aroma.24
FDA determined that essential oils, oleoresins (solventfree),
and natural extractives (including distillates) of
Humulus lupulus L. (hops) are GRAS for human consumption.
[21CFR182.20] Modified Humulus lupulus (hops) 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 ofbeer,
and (b) the food additive is manufactured by one of the
prescribed processes (Table 3). [21CFR172.560]
Most parts of the Humulus lupulus (hops) plant (shoots,
leaves, flowers, seeds, rhizomes, and essential oils) are
edible.5,6 The shoots are consumed as a delicacy and resemble
asparagus.
In Europe, Humulus lupulus (hops) is administered as an
herbal supplement in the form of powders, liquid extracts
(ethanol extract drug ratio/dry extract ratio [DER] 1:1; sweet
wine extract DER 1:10), tinctures (ethanol extract DER 1:5),
and dry extracts (50% methanol extract DER 4 to 5:1) of the
inflorescence of the plant.49,73 It is also administered as a tea.
Humulus lupulus (hops) strobiles are used in European,
Indian-Ayurvedic, and Native American traditional medicines
for the relief of insomnia, excitability, and specifically for
restlessness associated with nervous tension, headache and/or
indigestion.
It has been shown that Humulus lupulus (hops) byproducts,
after harvesting of the strobiles, can be used to absorb lead
from contaminated waters.74
Toxicokinetic Studies
Obtaining data on the toxicokinetics of Humulus lupulus
(hops)-derived ingredients would not be practical because
these ingredients are complex mixtures. Exposure to the
components ofthese ingredients in cosmetics is expected to be
lower than that from dietary exposure because these ingredients
are incorporated into cosmetic products only at very
low concentrations.
Toxicological Studies
Acute Toxicological Studies
Acute toxicity data on Humulus lupulus (hops)-derived ingredients
were not found in the published literature and no
unpublished data were submitted.
Short-Term Toxicity Studies
Oral. Wistar rats (n = 7/group) were fed a low-fat diet, a highfat
diet, or high-fat diet supplemented with 1% xanthohumolrich
Humulus lupulus (hops) extract for 41 days.75 There were
no mortalities or other adverse effects observed in any ofthese
groups. The addition of the extract reduced the effects of the
high-fat diet on weight gain from days 21 to 41 of the study.
The weights of livers of rats fed the supplemented high-fat
diets were similar to the controls, as were the plasma glucose
levels, at the end of the test period.

IJT - CIR - February 2024

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