U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) reviewed the safety of undecylenic acid and its calcium and zinc salts and approved these ingredients for use in over-The-counter (OTC) antifungal drug products.
Expert Panel for Cosmetic Ingredient Safety
The Expert Panel for Cosmetic Ingredient Safety has deferred evaluation of these ingredients because the safety has been assessed by FDA. This deferral of review is according to the provisions of the Expert Panel procedures.
In the U.S., OTC antifungal products may contain undecylenic acid, calcium undecylenate or zinc undecylenate, individually or in any ratio that provides a total undecylenate concentration of 10 to 25%.
Link to FDA Code of Federal Regulations for undecylenic acid
Undecylenic acid and its salts may be used as preservatives in cosmetics and personal care products marketed in Europe according to the Cosmetics Directive of the European Union (see Annex VI).
Link to the EU Cosmetic Regulation: