Pantothenic Acid

The Food and Drug Administration (FDA) includes Panthenol (also called D-Pantothenyl AlcoholAlcohols are a large class of important cosmetic ingredients but only ethanol needs to be denatured to prevent it from being redirected from cosmetic applications to alcoholic beverages.) on its list of nutrients (in this case a vitamin) and/or dietary supplements Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.). 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 Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR 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 CIR Expert Panel considered available new data on Panthenol and reaffirmed the above conclusion.

CIR Safety Review: The CIR 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 CIR Expert Panel did not considere Panthenol or Pantothenic Acid to be photoirritants 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

• Pantothenyl Alcohol 
• 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 UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

EU Cosmetic Regulation