Misinformation circulating on the Internet about the petrolatum used in cosmetic and personal care products claims that there is a risk of contamination from polycyclic aromatic hydrocarbons (PAHs) – cancer-causing chemicals found in crude oil and its by-products. Such claims are simply not true. The petrolatum used in cosmetics and personal care products is a highly refined grade that must meet very strict safety standards, which includes limits on the content of PAHs. The purity of cosmetic grade petrolatum is also evident from its allowed uses in the U.S. as an OTC skin protectant, and in OTC ophthalmic and anorectal drugs.
FDA permits the use of petrolatum as a multipurpose additive for direct addition to food. Petrolatum is also an FDA-approved indirect food additive. For example, it may be used as a defoaming agent and it may be used in adhesives in contact with food.
The Expert Panel for Cosmetic Ingredient Safety has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is in accordance with Expert Panel Procedures.
In the EU, the full refining history for petrolatum must be documented showing the substance from which it is produced is not a carcinogen (i.e., the petrolatum must be properly refined). Petrolatum that does not meet these requirements, as listed in Annex II of the Cosmetics Directive of the European Union, must not be used in cosmetics and personal care products.
Petrolatum (mineral oil jelly) is used widely in cosmetics as a moisturizer as well as in OTC drugs as a skin protectant. Its safety has been reviewed by Health Canada for these purposes. Food, drug and cosmetic petrolatum products are required to be made from highly refined petrolatum at pharmaceutical or cosmetic grade.
In Canada, if an ingredient is susceptible to impurities, the manufacturer must make sure the ingredients and products are of good quality and safe when used as directed. Manufacturers should follow Good Manufacturing Practices (GMPs) and use acceptable quality materials (for example, pharmaceutical grade). Health Canada reports that there have been no reports of unacceptable impurities (such as polycyclic aromatic hydrocarbons) in petrolatum found in Canadian products.