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).

Cosmetic Ingredient Review (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
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

Information about FDA requirements when Benzyol Peroxide is used an ingredient in OTC acne products.
http://www.fda.gov/cder/otcmonographs/Acne/benzoyl_peroxide_...

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).
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...

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.
http://ec.europa.eu/food/fs/sc/sccp/out167_en.pdf

In Canada, Benzoyl Peroxide is permitted at concentrations equal to or less than 10% for use only as a catalyst in products to be applied to the fingernails or in hair dyes.
Please check the Health Canada website at:
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/hotlist-liste_e... for updates and additional information about this list.