IJT - CIR - February 2024 - 85S

Burnett et al.
85S
formaldehyde, monomers, nitrosamines, ethylene oxide,
triethanolamine, 1,4-dioxane, or volatile organic
compounds.
Butyrospermum Parkii (Shea) Seedcake Extract. Accordingtoa
supplier, Butyrospermum Parkii (Shea) Seedcake Extract is
composed of 2.8% of the seedcake extract, 50.0% butylene
glycol, and 47.2% water.19 This supplier also reported that
alkaloids were less than the limit of sensitivity (.05 g/L in
Dragendorff reagent), heavy metal composition included
trace levels of nickel (.049 ppm) and lead (.478 ppm), and
the sum of the concentrations of aflatoxins B1, B2, G1, and
G2 was less than 1.0 µg/kg. The supplier also reported that
neither the 26 allergenic compounds regulated by the European
Union nor any pesticides were detected in this
ingredient.
Shea Oleine. The primary component of shea oleine is the
oleate triglyceride (Figure 3).
However, the sterol component of shea oleine is approximately
8% (w/w), of which approximately 97% is 4,4dimethyl
sterols (mostly as esters of cinnamic acid), 2% is 4demethylsterols
and .5% is 4-α-methylsterols.16
Use
Cosmetic
The safety of the cosmetic ingredients included in this assessment
is evaluated based on data received from the US
FDA and the cosmetics 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 VCRP database.
Use concentration data are submitted by Industry in
response to surveys, conducted by the Personal Care Products
Council (Council), of maximum reported use concentrations
by product category.
According to 2017 VCRP data, Butyrospermum Parkii
(Shea) Butter has the most reported uses of the ingredients
listed in this safety assessment in cosmetic products, with a
total of5447; more than three-fourths ofthe uses are in leaveon
formulations (Table 4).3,22 Butyrospermum Parkii (Shea)
Butter Extract has the second greatest number of overall uses
reported, with a total of 560; two-thirds of the uses are in
leave-on formulations. The results of the concentration of use
survey conducted in 2016 by the Council indicate Butyrospermum
Parkii (Shea) Butter has the highest reported
maximum concentration of use; it is used at up to 100% in
moisturizers.23 Butyrospermum Parkii (Shea) Oil has the
second highest maximum concentrations ofuse, and is used at
up to 11% in lipsticks.24 No uses were reported for Hydrogenated
Shea Oil or Hydrolyzed Shea Seedcake Extract.
In some cases, reports of uses were received from the
Figure 1. General description of the manufacturing of
Butyrospermum parkii (shea)-derived ingredients.
VCRP, but no concentration of use data were provided.
For example, Hydrogenated Shea Butter is reported to be
used in 23 formulations, but no use concentration data
Table 2. Mean Concentrations of Tocopherols in 102 Butyrospermum Parkii (Shea) Butter Samples by HPLC Analysis (μg/g).5
α-Tocopherol
112
β-Tocopherol
16
γ-Tocopherol
38
δ-Tocopherol
34
Table 3. Total Fatty Acid Composition of Butyrospermum parkii (Shea)-Derived Ingredients (%).2,6,46
Fatty Acids
Myristic (C14)
Palmitic (C16)
Stearic (C18)
Oleic (C18:1)
Linoleic (C18:2)
Linolenic (C18:3)
Arachidic (C20)
NR-Not reported.
Butyrospermum Parkii (Shea) Oil
NR
3.8-4.1
41.2-56.8
34.0-46.9
3.7-6.5
NR
1-2
Total tocopherol
208
Butyrospermum Parkii (Shea) Butter
.5
2.6-9
25.6-50.2
37.1-62.1
.6-10.8
.5 max
0-3.5
IJT - CIR - February 2024

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