Ozokerite, Ceresin and Montan Wax are mineral waxes, derived from coal and shale. Paraffin and Microcrystalline Wax are derived from petroleum. Emulsifying Wax, Synthetic Wax and Synthetic Beeswax are manufactured waxes. In cosmetics and personal care products, these waxes are used in many types of products including lipsticks, baby products, eye and facial makeup, as well as nail care, skin care, suntan, sunscreen, fragrance, and noncoloring hair preparations.
The safety of Ozokerite and the other fossil and synthetic waxes has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Ozokerite, Ceresin, Montan Wax, Paraffin, Microcrystalline Wax, Emulsifying Wax, Synthetic Wax and Synthetic Beeswax were safe for use in cosmetics and personal care products. In 2003, the CIR Expert Panel considered available new data on Ozokerite and the other waxes and reaffirmed the above conclusion.CIR Safety Review: The CIR Expert Panel concluded that Ozokerite, Ceresin, Montan Wax, Paraffin, Microcrystalline Wax, Emulsifying Wax, Syntethic Wax and Synthetic Beeswax have, at most, a potential for mild skin irritation and mild or no eye irritation. The CIR Expert Panel concluded that these waxes do not result in dermal sensitization. When formulations containing these ingredients were tested, they produced no skin irritation and the formulations were not phototoxic.
FDA: Link to Code of Federal Regulations for Paraffin use in OTC ophthalmic drugs
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
FDA: Link to Code of Federal Regulations for Ceresin, Montan Wax and Paraffin use as an indirect food additive
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Ozokerite and the other waxes 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...