Final Report on the Safety Assessment of Lard Glyceride, Hydrogenated Lard Glyceride, Lard Glycerides, Hydrogenated Lard Glycerides, Lard, and Hydrogenated Lard

Lard obtained from the rendering of fatty porcine tissue is used in cosmetic products, as are several of its derivatives. These derivatives include Lard Glycerides (mono-, di-, and triglycerides derived from Lard), Lard Glyceride (the monoglycerides only), Hydrogenated Lard Glycerides, Hydrogenated Lard Glyceride, and Hydrogenated Lard. The latter three are produced by controlled hydrogenation of the described precursor. These ingredients function as skin-conditioning agents and, with the exception of Lard, as viscosity-increasing agents in several cosmetic products. No information was available regarding the fate during processing of impurities such as pesticides or heavy metals that may be found in animal tissue. Lard itself is established by the Food and Drug Administration (FDA) as a GRAS (generally recognized as safe) substance. Animal studies report adverse effects expected with the feeding of high fat diets, but other animal toxicity data were not available. Lard was not mutagenic in transgenic mice. Cell proliferation assays showed more proliferation in mice fed Lard compared to those fed plant-source fats, but another study showed no difference. Cocarcinogenic effects were observed when high-fat diets containing Lard were fed, with known carcinogens, to mice, rats, and hamsters. Consistent with the FDA GRAS determination, it was concluded that these ingredients may be used safely in cosmetic formulations. However, it was considered important to limit the presence of heavy metals and/or polychlorinated biphenyl (PCB) or other pesticide contamination. Accordingly, limits were established as follows: lead, not more than 0.1 ppm; arsenic (as As), ≤ 3 ppm; mercury (as Hg), ≤ 1 ppm; and total PCB/pesticide contamination, not more than 40 ppm, with not more than 10 ppm for any specific residue.