The Food and Drug Administration (FDA) includes synthetic fatty alcohols including cetyl Alcohols 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., stearyl alcohol and myristyl alcohol on its list of food additives permitted for direct addition to food as multipurpose food additives. Synthetic fatty alcohols are also permited as indirect food additives as adjuvants and production aids.
The safety of cetearyl alcohol, cetyl alcohol, isostearyl alcohol, myristyl alcohol and behenyl alcohol has been assessed by the Cxpert Panel for Cosmetic Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that these fatty alcohols were safe for use as cosmetic ingredients.
In 2005, the Expert Panel considered available new data on cetearyl alcohol and the other fatty alcohols and reaffirmed the above conclusion.
The Expert Panel noted that much is known about the biological activities of fatty acids and long-chain aliphatic alcohols and esters.
The toxicological data for the five long-chain aliphatic alcohols included in this report (cetearyl alcohol, cetyl alcohol, isostearyl alcohol, myristyl alcohol, behenyl alcohol) revealed no significant toxicity. For example, cetyl alcohol was not mutagenic. Formulations containing these fatty alcohols were not dermal irritants or sensitizers. Assuming that the five ingredients are of the same grade of purity, the similar chemical structure permits extrapolation of data for one of the alcohols to the remaining four alcohols. Thus, the Expert Panel considered it reasonable to assume that the fatty alcohols reviewed in this report have equivalent biological activity.
FDA: Link to Code of Federal Regulations for synthetic fatty alcohols including cetyl, stearyl and myristyl alcohols
If they are derived from plants, cetearyl, cetyl, isostearyl, myristyl and behenyl alcohols may be used in cosmetics and personal care products marketed in Europe according to the Under 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..
Ingredients of animal origin must comply with European Union animal by-products regulations.