Peanut Glycerides

United States

FDA

The U.S. Food and Drug Administration (FDA) includes Peanut Oil on its list of 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.) indirect food additives (21CFR182.70). It is allowed for use in cotton and cotton fabrics used in dry food packaging. The polyglycerol esters of Peanut Oil are also approved as multipurpose direct food additives (21CFR172.854). 

The FDA Food Allergen Labeling and Consumer Protection Act requires all food containing Peanuts be clearly labeled so individuals with Peanut allergies are aware of its presence. Similarly, the Fair Packaging and Labeling Act, requires ingredients used in finished cosmetics products be declared. Ingredients must be listed in descending order of predominance (meaning the ingredient used most in the product will appear first) in a prominent and conspicuous place on the label where it should be easy for the consumer to read and understand (21CFR701.3). Thus, consumers will always be alerted to the presence of Peanuts or Peanut Oil in a cosmetic product.  

CIR

The safety of Peanut-derived ingredients has been reviewed on several occasions by 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. (CIR) Expert Panel. The CIR Expert Panel evaluated the available scientific data and literature in 2001 and concluded that Arachis Hypogaea (Peanut) Oil, Hydrogenated Peanut Oil, Peanut Acid, and Peanut Glycerides are safe for use in cosmetic formulations. The available data was, however, considered insufficient to determine the safety of Arachis Hypogaea (Peanut) Flour as an ingredient in cosmetics and personal care products. In 2017, Peanut Oil, Hydrogenated Peanut Oil, and Peanut Acid were included in a group of 244 plant-derived fatty acidA natural organic compound that consists of a carboxyl group (oxygen, carbon and hydrogen) attached to a chain of carbon atoms with their associated hydrogen atoms. The chain of carbon atoms may be connected with single bonds, making a ‘saturated’ fat; or it may contain some double bonds, making an ‘unsaturated’ fat. The number of carbon and hydrogen atoms in the chain is what determines the qualities of that particular fatty acid. Animal and vegetable fats are made up of various combinations of fatty acids (in sets of three) connected to a glycerol molecule, making them triglycerides. oils reviewed by the CIR. The Expert Panel concluded that all 244 ingredients were safe in the present practices of use and concentration in cosmetics.

European Union (EU)

Several EU Member States raised concerns about safety problems in relation to the use of Peanut Oil, its extracts, and its derivatives in cosmetic products. Specifically, there was a concern that allergic food reactions (i.e. sensitization) to peanuts could also be induced through skin exposure to Peanut Oil used in cosmetic products. The EU’s Scientific Committee on Consumer Safety (SCCS) acknowledged those concerns in its revised opinion in 2014, and concluded there is insufficient data to define a safe level of skin exposure in the non-sensitized population. In light of the documented safe levels of oral intake of Peanut proteins in sensitized individuals and the industry’s capability to refine Peanut Oil to proteinA naturally occurring complex organic substance present in relatively high amounts in meats, fish, eggs, cheese, legumes. Made of carbon, hydrogen, oxygen, and nitrogen, and sometimes sulfur and phosphorus. levels of 0.5 parts-per-million (ppm) or below, however, the SCCS noted that value can be accepted as the maximum allowable concentration in (refined) Peanut Oil, its extracts, and its derivatives used in cosmetic products. Therefore, in December 2017, the European Commission amended Annex III of the EU Cosmetics Regulation to restrict the maximum level of Peanut proteins in Peanut Oil, its extracts, and derivatives used in cosmetics to 0.5 ppm. The new restriction is effective for marketing purposes as of September 25, 2018.

CIR Safety Review: The 2001 CIR Expert Panel evaluation concluded that the results of toxicity, mutagenicity, carcinogenicity, reproductive/developmental, and sensitization studies support the safety of Arachis Hypogaea (Peanut) Oil, Hydrogenated Peanut Oil, Peanut Acid, and Peanut Glycerides in cosmetic formulations. While dermal irritation was observed in animal studies using technical grade Peanut Oil, the Panel relied on results in clinical (human) studies showing no irritation. Peanut Oil was not considered an ocular irritant. The Panel noted that when applied to the skin, Arachis Hypogaea (Peanut) Oil may enhance the absorption of other compounds. 

Peanuts are the food most likely to produce allergic and anaphylactic reactions. The major allergen is a protein that does not partition into Peanut Oil, Hydrogenated Peanut Oil, Peanut Acid, and Peanut Glycerides. Aflatoxins can be produced in stored agricultural crops such as peanuts, but do not partition into the oils, acids, or glycerides.

The CIR Expert Panel cautioned manufacturers to control levels of aflatoxins and protein. Formulators were cautioned that the oils, acids, or glycerides may enhance penetration and can affect the use of other ingredients whose safety assessment was based on their lack of absorption. The available studies on Peanut Oil supported the conclusion that Arachis Hypogaea (Peanut) Oil, Hydrogenated Peanut Oil, Peanut Acid, and Peanut Glycerides were safe for use in cosmetic formulations.