Stearyl Palmitate

What Is It?

Stearyl Heptanoate, Stearyl Caprylate, Stearyl Palmitate, Stearyl Stearate, Stearyl Behenate and Stearyl Olivate are waxy solid cosmetic ingredients with similar structures.

These ingredients are esters of stearyl alcoholAlcohols are a large class of important cosmetic ingredients but only ethanol needs to be denatured to prevent it from being redirected from cosmetic applications to alcoholic beverages. and acids that differ only in the number of carbons in the chain. In cosmetics and personal care products, Stearyl Heptanoate, Stearyl Caprylate, Stearyl Palmitate, Stearyl Stearate, Stearyl Behenate and Stearyl Olivate may used in the formulation of bath products, eye makeup, lipsticks, rouges, and skin and hair care products.

Why Is It Used?

The following functions have been reported for Stearyl Heptanoate and the related ingredients:

BinderIngredients that hold together the ingredients of a compressed tablet or cake. – Stearyl Palmitate
Emulsion stabilizerIngredients that help to keep an emulsion from separating into its oil and liquid components. – Stearyl Palmitate
Hair conditioning agentIngredients that enhance the appearance and feel of hair, by increasing hair body, suppleness, or sheen, or by improving the texture of hair that has been damaged physically or by chemical treatment. – Stearyl Palmitate
HumectantIngredients that slow the loss of moisture from a product during use. – Stearyl Palmitate
Opacifying agentSubstances that reduce the clear or transparent appearance of cosmetic products. Some opacifying agents are used in skin make-up for hiding blemishes. – Stearyl Palmitate
Skin-conditioning agent – emollient – Stearyl Olivate
Skin-conditioning agent – miscellaneous – Stearyl Palmitate
Skin-conditioning agent – occlusive – Stearyl Heptanoate, Stearyl Caprylate, Stearyl Stearate, Stearyl Behenate
SurfactantAn ingredient that helps two substances that normally do not mix to become dissolved or dispersed in one another. Also called a surface active agent. – emulsifying agent – Stearyl Olivate
Viscosity increasing agent – nonaqueous – Stearyl Stearate

Scientific Facts

Stearyl Heptanoate, Stearyl Caprylate, Stearyl Palmitate, Stearyl Stearate, Stearyl Behenate and Stearyl Olivate are the esters of stearyl alcohol and heptanoic acid, caprylic acid, palmitic acid, stearic acid, behenic acid and olive acid (fatty acids from olive oil), respectively. These ingredients are not soluble in water.

Safety Information

The Food and Drug Administration (FDA) permits Stearyl Palmitate and Stearyl Stearate to be used as indirect food additives in the production of some food packaging materials.

The safety of Stearyl Heptanoate, Stearyl Caprylate, Stearyl Palmitate, Stearyl Stearate, Stearyl Behenate and Stearyl Olivate 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 these ingredients were safe for use as a cosmetic ingredient.

CIR Safety Review:

Based on the similarity of the structures of these six ingredients, the CIR Expert Panel determined that safety data on Stearyl Heptanoate and palmitic acid and stearic acid were sufficient to support the safety of Stearyl Heptanoate, Stearyl Caprylate, Stearyl Palmitate, Stearyl Stearate, Stearyl Behenate and Stearyl Olivate.

The CIR Expert Panel reviewed safety data on Stearyl Heptanoate indicating the potential for mild skin irritation. It was not a sensitizer. Undiluted Stearyl Heptanoate was an eye irritant, but a 1.5% solution produced no effects. Mutagenesis assays (bacteria and micronucleus test) were negative. Clinical data showed no evidence of irritation or sensitization or comedogenicityRefers to the chance that an ingredient or product will cause pores in the skin to clog. This may result in blackheads or whiteheads, officially called comedones.. Although sensitization studies were done at a low concentration compared with expected use concentrations, the data suggest that Stearyl Heptanoate would not be a sensitizer even at higher concentrations. Data on ocular irritation show only mild reactions to undiluted Stearyl Heptanoate, suggesting that expected use concentrations should not produce significant ocular irritation.

FDA: Link to Code of Federal Regulations for Stearyl Palmitate and Stearyl Stearate

If derived from plants, Stearyl Heptanoate, Stearyl Caprylate, Stearyl Palmitate, Stearyl Stearate, Stearyl Behenate and Stearyl Olivate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

ngredients of animal origin must comply with European Union animal by-products regulations.

Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm

Resources

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm

Substances 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.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/