Bisabolol

Conclusion

In a 1999 safety assessment of bisabolol, the Cosmetic Ingredient Review (CIR) Expert Panel (Panel) concluded that this ingredient was safe as used in cosmetic products. ¹ The Panel reviewed studies newly available since that assessment, ^{2 –12} along with updated frequency and concentration of use information. ^13,14 The Panel reaffirmed the original conclusion that bisabolol is safe as a cosmetic ingredient in the practices of use and concentration as given in Table 1.

Table 1.

Current and Historical Frequency and Concentration of Use of Bisabolol According to Duration and Exposure.

	No. of uses		Max concentration of use (%)
	201513	19971	201414	19951
Totalsa	999	184	0.00002-1	0.001-1
Duration of use
Leave on	774	142	0.00002-1	0.001-1
Rinse off	215	41	0.00002-0.5	0.01-0.02
Diluted for (bath) use	10	1	NR	0.25
Exposure type
Eye area	90	11	0.01-0.5	<0.1
Incidental ingestion	31	2	0.15-1	0.001-0.2
Incidental inhalation spray	Spray: 10 Possible: 209b; 185c	Spray: 3 Possible: 37b; 33c	Spray: 0.001-0.2 Possible: 0.000-0.1b	Spray: 0.01 Possible: 0.01-0.02b; 0.01-1c
Incidental inhalation powder	Powder: 9 Possible: 185c; 5d	Possible: 33c; 3d	Powder: 0.1-0.2 Possible: 0.01-1d	Possible: 0.01-1c
Dermal contact	912	176	0.00002-1	0.01-1
Deodorant (underarm)	34b	4b	Not spray: 0.1; aerosol: 0.11-0.3; pump spray: 0.2	1b
Hair—noncoloring	35	1	0.00002-0.5	NR
Hair coloring	5	1	0.1	NR
Nail	3	2	0.01-0.09	0.05
Mucous membrane	86	6	0.0001-1	0.001-0.25
Baby products	9	3	NR	NR

Abbreviation: NR, no reported use.

^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.

^bIncludes products that can be sprayed, but it is not known whether the reported uses are sprays.

^cNot specified whether this product is a spray or a powder or neither, but it is possible it may be a spray or a powder, so this information is captured for both categories of incidental inhalation.

^dIncludes products that can be powders, but it is not known whether the reported uses are powders.

Discussion

Information supplied to the US Food and Drug Administration (FDA) by industry as part of the Voluntary Cosmetic Ingredient Reporting Program indicates that use of bisabolol has increased since the time of the original review but that there is no increase in the concentration of use. Voluntary Cosmetic Ingredient Reporting Program data provided by FDA in 1997 indicated 184 uses, which is fewer than the 999 uses reported in 2015. The results of the 2015 industry survey indicated that bisabolol is used at up to 1% in leave-on formulations.

The Panel noted in the 1999 review ¹ that bisabolol is well absorbed following dermal application and can be a penetration enhancer. Because these ingredients are used in baby products, the Panel reiterated their caution to formulators of the possibility of increased absorption of other ingredients, especially those ingredients for which safety was based on their lack of dermal absorption. The Panel also noted a study that reported a possible lightening of the skin after induction of pigmentation by ultraviolet light (0.5% bisabolol topical daily for 8 weeks); however, they determined that this study did not warrant a change in the conclusion of the original (1999) report.

The Panel determined to not reopen this safety assessment and confirmed that bisabolol is safe as a cosmetic ingredient in the current practices of use and concentration (Table 1).