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 (Decomposition of a chemical compound into smaller constituents by reaction with water.) produces a mixture of organic acids (Lanolin Acid) and a mixture of organic alcohols (Lanolin Alcohols 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.). 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?
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 Ingredients that unite or bond surfaces together. characteristics.
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.
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 additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage.. 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 The 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 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.
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 Under 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..
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.
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
- Food Ingredients and Packaging
- Food Contact Substances
- Substances Generally Recognized As Safe (“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.)
- Search the Code of Federal Regulations
- EU Cosmetics Inventory