p-Hydroxyanisole

The safety of p-Hydroxyanisole 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 reviewed the scientific data and concluded that p-Hydroxyanisole was unsafe for use as a cosmetic ingredient. In 2003, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on p-Hydroxyanisole and reaffirmed the above conclusion.

CIR Safety Review: Undiluted p-Hydroxyanisole was a severe skin and ocular irritant and a skin sensitizer. p-Hydroxyanisole was nonmutagenic in bacteria. Solutions of p-Hydroxyanisole produced embryotoxicity, but not teratogenicity.

The function of p-Hydroxyanisole in cosmetics is that of an antioxidant it is not intended for use as a skin lightener or skin-depigmenting agent. Because of the depigmenting action of p-Hydroxyanisole observed in laboratory studies at reported concentrations approaching those used in cosmetics, the CIR Expert Panel concluded that p-Hydroxyanisole was unsafe for use as a cosmetic ingredient. In the European Union, p-Hydroxyanisole may be used in professional use artificial nail systems at a maximum concentration of 0.02% after mixing (see Annex III).

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

In Canada, p-Hydroxyanisole is also permitted for use artificial nail systems at a maximum concentration of 0.02% after mixing.

Link to the Health Canada website: 
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri…