Lanolin

What Is It?

Lanolin is an ointment-like material isolated from wool that is sheared from sheep. Lanolin can be separated into Lanolin Oil, a liquid phase, and Lanolin Wax a solid phase. Heating Lanolin with water (hydrolysis) produces a mixture of organic acids (Lanolin Acid) and a mixture of organic alcohols (Lanolin Alcohol). Acetylated Lanolin, Hydrogenated Lanolin, and Hydroxylated Lanolin result when acetate, hydrogen and hydroxyl groups are added to Lanolin, respectively. Acetylated Lanolin Alcohol results when acetate is added to Lanolin Alcohol. Lanolin and its related ingredients are widely used in the formulation of cosmetics and personal care products. These ingredients can be found in baby products, skin care, shaving, manicuring, hair care, suntan and sunscreen products, as well as eye, lip and facial makeup.

Why is it used in cosmetics and personal care products?

Lanolin and its related ingredients moisturize the skin, hair and nails. These ingredients act as a lubricants on the skin surface, which gives the skin a soft, smooth appearance. Lanolin helps to form emulsions and blends well with nearly all other substances used in cosmetics and personal care products. Lanolin also possesses adhesive characteristics.

Scientific Facts:

Lanolin is derived from the sheep sebaceous gland. The raw material isolated from sheep’s wool is also called Adeps lanae, wool wax, wool fat or wool grease. Lanolin aids sheep in shedding water from their coats.

Safety Information:

The Food and Drug Administration (FDA) permits Lanolin to be used in Over-the-Counter (OTC) drugs that protect the skin, and in OTC drugs that protect the anorectal area. Lanolin is also permitted to be used as an opthalmic emollient in OTC ophthalmic drug products. In food, FDA permits the use of Lanolin as an softener in chewing gum. Lanolin is also approved for use as an indirect food additive. For example, it may be used as a component of cellophane that comes in contact with food. The safety of Lanolin and lanolin-derived ingredients has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Lanolin, Lanolin Oil, Lanolin Wax, Lanolin Alcohol, Acetylated Lanolin, Acetylated Lanolin Alcohol, Hydrogenated Lanolin and Hydroxylated Lanolin were safe for use in cosmetics and personal care products. In 2003, the CIR Expert Panel considered available new data on Lanolin and the other Lanolin-derived ingredients and reaffirmed the above conclusion.

More safety Information:

CIR Safety Review: The CIR Expert Panel noted that Lanolin and related ingredients, as a group, are used extensively in cosmetics and personal care products, as well as in many other consumer products, and there has been ample opportunity for a large proportion of the population to be exposed to some of these materials. Tests with Acetylated Lanolin, its related cosmetic ingredients, and with numerous cosmetics and personal care products containing these materials attest to the safety of these ingredients used in cosmetics and personal care products. The acute toxicity of these materials is low and tests for skin sensitization are negative.

Extensive clinical experience indicates that there is a low incidence of sensitivity to these materials among exposed persons. This appears to be mainly due to the Lanolin Alcohols. There was no evidence of photosensitization. However, comedogenic effects, or the formation of pimples, from cosmetics and personal care products containing Lanolin and related materials have been reported.

FDA: Link to Code of Federal Regulations for the OTC uses of Lanolin

FDA: Link to Code of Federal Regulations for the food additive uses of Lanolin

When conforming to European Union animal by-products legislation, Lanolin and Lanolin-derived ingredients may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.

EU Cosmetic Regulation

More Scientific Information:

Lanolin is a complex esterified mixture of high molecular weight esters of fatty acids with aliphatic and alicyclic alcohols and sterols. Hydrolysis yields a mixture of compounds; purification yields individual components which may then be further modified by alkoxylation, esterification, or amidation to form materials not found in natural lanolin. Lanolin can also be separated into components by temperature-dependent physical or mechanical methods. This yields a variety of materials, possessing different properties, which can then be subjected to further chemical processes. Lanolin and its derivatives include hard solids, pastes, and mobile liquids. They may be water-soluble or water insoluble. They may be mixtures (e.g., Lanolin Wax) or fairly pure compounds (e.g., Lanosterol). Lanolin is also an important commercial source of certain sterols, especially cholesterol. As the characteristics of Lanolin derivatives are variable, these materials find uses in all types of cosmetics and personal care products designed for skin, nail and hair care.

Resources:

Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration

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