Abstract
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1982, along with updated information regarding product types and concentrations of use, and confirmed that Squalane and Squalene are safe as cosmetic ingredients in the practices of use and concentration as described in this report.
Current and Historical Frequency and Concentration of Use of Squalane and Squalene According to Duration and Exposure.
aBecause each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types may not equal the sum of total uses.
bIt is possible these products are sprays, but it is not specified whether the reported uses are sprays.
cNot specified whether a spray or a powder, but it is possible the use can be as a spray or a powder; therefore, the information is captured in both categories.
dIt is possible these products are powders, but it is not specified whether the reported uses are powders.
NR, not reported.
The reported frequency of use has increased significantly for both ingredients since the initial re-review was considered. According to VCRP data, Squalane and Squalene were reported to be used in 595 and 29 formulations, respectively, in 2001. 2 In 2019, the VCRP indicates that Squalane is used in 2785 formulations, and Squalene is used in 527 formulations. 14 For Squalane, the current maximum concentration of use (96.8%) 14 is the same as that reported in 2001 (97%); 2 however, the maximum concentrations of use by exposure type (e.g., eye area and nails) have increased for some categories. The opposite is true for Squalene; the maximum concentration of use has decreased since the previous re-review. In 2001, Squalene was used at up to 10%; 2 data received in 2018 report that the maximum concentration of use is 1.2%. 15
Squalane and Squalene are natural components of human sebum. Although new studies indicated there could be sensitization potential, there is no significant clinical evidence of sensitization. The Panel stated the lack of case reports, in spite of the increased frequency of use, and the Panel’s clinical experience with these ingredients support the safety of these ingredients for use in cosmetics.
Footnotes
Author’s Note
Unpublished sources cited in this report are available from the Director, Cosmetic Ingredient Review, 1620 L Street, NW, Suite 1200, Washington, DC 20036, USA.
Author Contributions
The articles in this supplement were sponsored by the Cosmetic Ingredient Review.
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review. The Cosmetic Ingredient Review is financially supported by the Personal Care Products Council.