Benzoyl Peroxide

Benzoyl Peroxide has undergone the Food and Drug Administration’s (FDA) drug active review process and it was determined to be a safe and effective anti-acne ingredient. Benzoyl Peroxide is on the FDA’s list of direct food substances affirmed as 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.). 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) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.

Link to FDA Code of Federal Regulations for Benzoyl Peroxide

• Benzoyl Peroxide 
• Hydroxylated Lecithin 
• Flour 

FDA requirements when Benzyol Peroxide is used an ingredient in OTC acne products.

In products marketed in Europe, Benzoyl Peroxide may be used in artificial nail systems at a maximum concentration of 0.7% (after mixing) for professional use only, with conditions to be printed on the label (see Annex III).

The European Scientific Committe on Consumer Products has reviewed the safety of Benzoyl Peroxide and concluded that it is safe for use for the indicated proposes with the restrictions and conditions of use. The indicated purpose is as a technical aid in artificial nail systems.

In Canada, Benzoyl Peroxide is permitted at concentrations equal to or less than 10% for use only as a catalystA substance that facilitates a chemical reaction, but which itself is not chemically changed by the reaction. in products to be applied to the fingernails or in hair dyes.