Elaeis Guineensis (Palm) Derived Ingredients

United States

Expert Panel

The safety of palm oils and palm-derived fatty acid oils have been assessed by the Expert Panel for Cosmetic Ingredient Safety (formerly 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. Expert Panel) on several occasions. In 2000, the Expert Panel evaluated available scientific data and concluded that Elaeis guineensis (palm) oil, Elaeis guineensis (palm) kernel oil, hydrogenated palm oil and hydrogenated palm kernel oil are safe as used in cosmetics and personal care products.

In 2017, the Expert Panel assessed the safety of 244 plant-derived fatty acid oils, including additional Elaeis guineensis palm-derived ingredients, as used in cosmetics and personal care products, concluding that the following 15 ingredients are also safe as used at current concentrations:

* Ingredients not in current use. Were these ingredients to be used in the future, the expectation is that they would be used in product categories and concentrations comparable to others in this group.

FDA

The U.S. Food and Drug Administration (FDA) considers “cocoa butter substitute primarily from palm oil” Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.) for use as a direct food additive (21CFR184.1259; 21CFR172.861). Palm oil is also permitted to be added directly to food and is on the list of indirect food additives allowed to be used in paper and paperboard that comes into contact with food (21CFR176.210).

European Union (EU)

All of the palm oil ingredients reviewed by the Expert Panel are marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union and used as occlusive skin conditioning agents in cosmetics.

Although a large number of oils derived from the Elaeis guineensis palm were included in the Expert Panel’s safety assessments, they all are mixtures of triglycerides that contain fatty acids and fatty acid derivatives, the safety of which has been established in cosmetics and personal care products. Thus, the Expert Panel safety assessments discussed above focused on the basic chemistry, manufacturing and production methods, uses, and irritation and sensitization potential of these oils. Although nuts, fruits and vegetables themselves may cause allergic reactions in certain individuals, the refined oils derived from these plants generally pose no significant safety concern and their general biology is well characterized due to extensive use in food materials.

The Expert Panel expressed concern about potential pesticideSubstances that destroy or repel pests, or that prevent or mitigate the effects of pests. In the United States, pesticides for use in consumer products, including cosmetics, must be registered and approved by the EPA. residues, heavy metals and other plant species that may be present in botanical ingredients. They stressed that the cosmetics industry should continue to use current good manufacturing practices (cGMPs) to limit impurities.

In addition, because final product formulations may contain multiple botanicals, each possibly containing similar constituents of concern, formulators were advised to avoid reaching levels of plant constituents that may cause sensitization or other adverse health effects.

Link to more safety information on botanical ingredients.