Calcium Stearate

The Food and Drug Administration (FDA) includes Magnesium and Zinc Stearate on its list of substances considered 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 direct addition to food. Salts of fatty acids (Aluminum, Calcium, Potassium and Sodium Stearate) are also permitted for direct addition to food. The FDA has also approved suitable grades of fatty acids and their aluminum, ammonium, calcium, magnesium, potassium, sodium, and zinc salts as indirect food additives. The safety of the Stearate salts has been assessed 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 scientific data and concluded that Lithium Stearate, Aluminum Distearate, Aluminum Stearate, Aluminum Tristearate, Ammonium Stearate, Calcium Stearate, Magnesium Stearate, Potassium Stearate, Sodium Stearate and Zinc Stearate were safe for use in cosmetics and personal care products. In 2001, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on the Stearate compounds and reaffirmed the above conclusion.

CIR Safety Review: The CIR Expert Panel reviewed acute oral studies indicating that the Stearate salts were practically nontoxic, and had a low potential for acute dermal toxicity. Skin irritation studies demonstrated that Stearates were only minimal to slight irritants at high concentrations. Pharmaceutical vehicles containing 5.5% Magnesium Stearate were neither teratogenic nor mutagenic. Seven out of 20 human volunteers exhibited minimal to mild skin erythema when tested with an aqueous solution of 1.5% Ammonium Stearate.

Similar results were obtained with Sodium Stearate at 0.5%. In a 21-day patch test with 10 subjects, an aqueous formulation containing 0.1-0.25% Sodium Stearate caused minimal skin irritation. No sensitization was reported in 100 subjects tested with the same formulation. The CIR Expert Panel concluded that on the basis of the available information presented in the report that the Stearate salts were safe as cosmetic ingredients.

Link to FDA Code of Federal Regulations for the Stearate salts

• Magnesium Stearate 
• Zinc Stearate 
• Salts of Fatty Acids 

Lithium Stearate, Ammonium Stearate, Potassium Stearate and Sodium Stearate 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. Aluminum, Calcium, Magnesium, and Zinc Stearates may be used as coloring agents in all cosmetics and personal care products (see Annex IV). If the stearic acid use to make these ingredients is derived from animal sources, it must comply with European Union animal by-products regulations.

EU Cosmetic Regulation