Bisabolol

The Food and Drug Administration (FDA) includes German chamomile (also called Hungarian chamomile or camomile) on its list of spices and other natural seasonings and flavorings considered as Generally Recognized as Safe (GRAS). The flowers of this plant on are on the list of GRAS essential oils, oleoresins and natural extractives.

The safety of Bisabolol has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated scientific data and concluded that Bisabolol was safe as used in cosmetics and personal care products.CIR Safety Review: Although Bisabolol was well-absorbed following dermal exposure, no effects were observed in a 28-day dermal toxicity study at doses higher than expected from use of this ingredient in cosmetics and personal care products. Bisabolol was negative in bacterial and mammalian genotoxicity tests, and it did not produce reproductive or developmental toxicity. The CIR Expert Panel noted that the results of oral and dermal toxicity, genotoxicity, reproductive/developmental toxicity, sensitization, and photosensitization studies showed little toxicity at levels in cosmetic formulations. Because Bisabolol may increase the skin penetration of other ingredients, the CIR Expert Panel cautioned formulators to be alert to this possibility.

Link to FDA Code of Federal Regulations for chamomile.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

Bisabolol may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...