The Food and Drug Administration (FDA) includes panthenol (also called D-pantothenyl alcohol) on its list of nutrients (in this case a vitamin) and/or dietary supplements Generally Recognized As Safe (GRAS). The calcium salt of pantothenic acid, calcium pantothenate, is on FDA’s list of direct food subbstances affirmed as GRAS. The safety of panthenol and pantothenic acid has been assessed by the Expert Panel on Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that panthenol and pantothenic acid were safe for use in cosmetics and personal care products. In 2004, the Expert Panel considered available new data on panthenol and reaffirmed the above conclusion.
The Expert Panel reviewed studies that found that products containing panthenol did not induce significant skin irritation or sensitization. Significant skin irritation was also not observed with 100% panthenol. Based on ultraviolet light absorption data, the Expert Panel did not consider panthenol or pantothenic acid to be photo irritants or photosensitizers. Mutagenicity and carcinogenicity data were not available for the safety assessment of panthenol and pantothenic acid. The low concentrations of use of these ingredients in cosmetics and personal care products and the requirement of vitamin B5 for normal metabolism, suggested that the dietary exposure levels of this ingredient would greatly exceed the amount that could be absorbed from cosmetic use. A salt of pantothenic acid, calcium pantothenate, did not cause developmental effects.
FDA: Link to Code of Federal Regulations for D-pantothenyl alcohol and calcium pantothenate
Panthenol and pantothenic acid may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.