Propyl Gallate is a fine white to light brown powder with a slightly bitter taste. In cosmetics and personal care products, Propyl Gallate is used in many product categories, including lipsticks, bath products, skin cleansing products, moisturizers, skin care products, makeup products, self-tanning products, and sunscreen and suntan products.
The safety of Propyl Gallate has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Propyl Gallate was safe in the practices of use in cosmetics and personal care products at concentrations less than or equal to 0.1%.CIR Safety Review: The CIR Expert Panel noted that little systemic toxicity was associated with oral or dermal exposure to Propyl Gallate. Rather than resulting in adverse effects, laboratory studies using oral exposure to Propyl Gallate showed preventive effects, including a reduction in cancer, birth defects and cavities of the teeth. These positive effects were consistent with the ability of Propyl Gallate to scavenge free radicals.
Propyl Gallate has been shown to be a dermal sensitizer. Sensitization occurred at concentrations of Propyl Gallate of 1% and greater.
The CIR Expert Panel noted that in actual practice, cosmetics and personal care products were reported to contain Propyl Gallate at concentrations up to 0.1%. Clinical experience by members of the CIR Expert Panel has not included observations of sensitization reactions from Propyl Gallate in cosmetics and personal care products. Because of the potential for sensitization, the CIR Expert Panel set a concentration limitation of 0.1% for Propyl Gallate use in cosmetic and personal care products.
FDA: Link to Code of Federal Regulations for Propyl Gallate
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Propyl Gallate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-1.4 mg/kg body weight for Propyl Gallate. http://www.inchem.org/documents/jecfa/jeceval/jec_2042.htm