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Wool fat tin (adeps lanae), at the Centre touristique de la Laine et de la Mode in Verviers, Belgium

Lanolin (from Latin lāna 'wool', and oleum 'oil'), also called wool fat, wool yolk, wool wax, sheep grease, sheep yolk, or wool grease, is a wax secreted by the sebaceous glands of wool-bearing animals.[1] Lanolin used by humans comes from domestic sheep breeds that are raised specifically for their wool. Historically, many pharmacopoeias have referred to lanolin as wool fat (adeps lanae); however, as lanolin lacks glycerides (glycerol esters), it is not a true fat.[2][3] Lanolin primarily consists of sterol esters instead.[4] Lanolin's waterproofing property aids sheep in shedding water from their coats. Certain breeds of sheep produce large amounts of lanolin.

Lanolin in nature protects wool and skin from climate and the environment; it is also involved in skin (integumental) hygiene.[2] Lanolin and its derivatives are used in the protection, treatment, and beautification of human skin.[2]

Composition

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A typical high-purity grade of lanolin is composed predominantly of long chain waxy esters (approximately 97% by weight) with the remainder being lanolin alcohols, lanolin acids and lanolin hydrocarbons.[2]

An estimated 8,000 to 20,000 different types of lanolin esters are present in lanolin, resulting from combinations between the different lanolin acids and alcohols; about 200 acids and 100 alcohols had been identified by 1986.[2][3]

In addition to being useful itself, lanolin's complex composition of long-chain esters, hydroxyesters, diesters, lanolin alcohols, and lanolin acids makes it a starting point for the production of a whole spectrum of lanolin derivatives with wide-ranging chemical and physical properties. The main derivatisation routes include hydrolysis, fractional solvent crystallisation, esterification, hydrogenation, alkoxylation and quaternisation.[2][3][5][6] Lanolin derivatives obtained from these processes are used widely in both cosmetics and skin treatment products.

Hydrolysis of lanolin yields lanolin alcohols and lanolin acids. Lanolin alcohols are a rich source of cholesterol, an important skin lipid, and are powerful water-in-oil emulsifiers; they have been used extensively in skincare products for over 100 years.[2] Approximately 40% of the acids derived from lanolin are alpha-hydroxy acids (AHAs).[2][3] The use of AHAs in skin care products has attracted much attention.[citation needed] Details of the AHAs isolated from lanolin can be seen in the table below.

Type of lanolic acid Carbon chain length Number identified
Alpha-hydroxy normal C
13–C
24 		12
Alpha-hydroxy iso C
13–C
23 		6
Alpha-hydroxy anteiso C
12–C
24 		7

Production

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Crude lanolin constitutes about 5–25% of the weight of freshly shorn wool. Wool from one Merino sheep produces about 250–300 ml of recoverable wool grease. Lanolin is extracted by washing the wool in hot water with a special wool-scouring detergent to remove dirt, wool grease (crude lanolin), suint (sweat salts), and anything else stuck to the wool. The wool grease is continuously removed during this washing process by centrifuge separators, which concentrate it into a waxlike substance which melts at approximately 38 °C (100 °F).[7]

Applications

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Lanolin ointment

Lanolin and its many derivatives are used extensively both for personal care (e.g. cosmetics, facial cosmetics, lip products) and healthcare (topical liniments). Lanolin is also used in lubricants, rust-preventive coatings, shoe polish, and other commercial products.[8]

Lanolin is a relatively common allergen, causing what is often misunderstood as a wool allergy. However, allergy to a lanolin-containing product is difficult to pinpoint, and often different forms of lanolin may not cause an allergic reaction in the same person. Patch testing can be done if a lanolin allergy is suspected.[8]

It is frequently used in protective baby skin treatment. It is also used for sore nipples from breastfeeding,[9] but health authorities recommend alternative methods first, including nipple cleaning,[10] improving baby positioning, and ultimately expressing milk by hand. Lanolin is reported to have soothing properties, but the lack of research leads to the previous recommendations being primary.[11]

Lanolin is used commercially in many industrial products ranging from rust-proof coatings to lubricants. Some sailors use lanolin to create slippery surfaces on their propellers and stern gear to which barnacles cannot adhere. Commercial products (e.g. Lanocote) containing up to 85% lanolin[12] are used to prevent corrosion in marine fasteners, especially when two different metals are in contact with each other in the presence of saltwater. The water-repellent properties make it valuable in many applications as a lubricant grease where corrosion would otherwise be a problem.

7-Dehydrocholesterol from lanolin is used as a raw material for producing vitamin D3 by irradiation with ultraviolet light.[13]

Baseball players often use it to soften and break in their baseball gloves—shaving cream with lanolin is popularly used for this.

Anhydrous liquid lanolin, combined with parabens, has been used in trials as artificial tears to treat dry eye.[14][15] Anhydrous lanolin is also used as a lubricant for brass musical instrument tuning slides.

Lanolin can also be applied to woollen garments to make them water- and dirt-repellent, such as for cloth diaper covers.

Lanolin is used in lip balm products such as Carmex. It can irritate the lips of some people.

Lanolin is sometimes used by people on continuous positive airway pressure therapy to reduce irritation with masks, particularly nasal pillow masks that often create sore spots in the nostrils.

Lanolin is a popular additive to moustache wax, particularly 'extra-firm' varieties.

Lanolin is used as a primary lubricating component in aerosol-based brass lubricants when reloading ammunition. It is mixed warm 1:12 with ethanol, usually about 99% pure, which acts as a carrier which evaporates quickly after application, leaving a thin film of lanolin which protects against brass seizing in resizing dies.

Lanolin is used as a lubricant for leather and fur, and in polishes and protective coatings for shoes and leather goods.[16]

Lanolin, when mixed with ingredients such as neatsfoot oil, beeswax and glycerol, is used in various leather treatments, for example in some saddle soaps and in leather care products.

Standards and legislation

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In addition to general purity requirements, in the US lanolin must meet official requirements for permissible levels of pesticide residues. The Fifth Supplement of the United States Pharmacopoeia XXII published in 1992 was the first to specify limits for 34 named pesticides. A total limit of 40 ppm (i.e. 40 mg/kg) total pesticides was stipulated for lanolin of general use, with no more than 10 ppm of any individual pesticide.[2]

A second monograph also introduced into the US Pharmacopoeia XXII in 1992 was entitled 'Modified Lanolin'. Lanolin conforming to this monograph is intended for use in more exacting applications, for example on open wounds. In this monograph, the limit of total pesticides was reduced to 3 ppm total pesticides, with none present at over 1 ppm.

In 2000, the European Pharmacopoeia introduced pesticide residue limits into its lanolin monograph. This requirement, which is generally regarded as the new quality standard, extends the list of pesticides to 40, and imposes even lower concentration limits.

Some very high-purity grades of lanolin surpass monograph requirements. New products obtained using complex purification techniques produce lanolin esters in their natural state, removing oxidative and environmental impurities resulting in white, odourless, hypoallergenic lanolin. These ultra-high-purity grades of lanolin are ideally suited to the treatment of dermatological disorders such as eczema and on open wounds.[17]

Lanolin attracted attention owing to a misunderstanding concerning its sensitising potential.[18] A study carried out at New York University Hospital in the early 1950s had shown that about 1% of patients with dermatological disorders were allergic to the lanolin used at the time. By one estimate, not differentiating between the general healthy population and patients with dermatological disorders exaggerated the sensitising potential of lanolin by 5,000–6,000 times.[18][19]

The European Cosmetics Directive, introduced in July 1976, contained a stipulation that cosmetics which contained lanolin should be labelled to that effect. This ruling was challenged immediately, and in the early 1980s, it was overturned and removed from the directive. Despite only being in force for a short period of time, this ruling did harm both to the lanolin industry and to the reputation of lanolin in general.[18] The Cosmetics Directive ruling only applied to cosmetics, not to the many hundreds of lanolin's different uses in dermatological products for the treatment of compromised skin conditions.

Modern analytical methods have revealed lanolin possesses a number of important chemical and physical similarities to human stratum corneum lipids; the lipids which help regulate the rate of water loss across the epidermis and govern the hydration state of the skin.[2][20][21]

Cryogenic scanning electron microscopy has shown that lanolin, like human stratum corneum lipids, consists of a mass of liquid crystalline material. Cross-polarised light microscopy has shown the multilamellar vesicles formed by lanolin are identical to those formed by human stratum corneum lipids. The incorporation of bound water into the stratum corneum involves the formation of multilamellar vesicles.[2][21]

Skin bioengineering studies have shown the duration of the emollient (skin smoothing) action produced by lanolin is very significant, and lasts for many hours. Lanolin applied to the skin at 2 mg/cm2 has been shown to reduce roughness by about 35% after one hour and 50% after two hours, with the overall effect lasting for considerably more than eight hours.[2] Lanolin is also known to form semiocclusive (breathable) films on the skin.[3] When applied daily at around 4 mg/cm2 for five consecutive days, the positive moisturizing effects of lanolin were detectable until 72 hours after final application.[2] Lanolin may achieve some of its moisturizing effects by forming a secondary moisture reservoir within the skin.[20][21]

The barrier repair properties of lanolin have been reported to be superior to those produced by both petrolatum and glycerol.[2] In a small clinical study conducted on volunteer subjects with very dry (xerotic) hands, lanolin was shown to be superior to petrolatum in reducing the signs and symptoms of dryness and scaling, cracks and abrasions, and pain and itch. In another study, a high-purity grade of lanolin was found to be significantly superior to petrolatum in assisting the healing of superficial wounds.

References

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Lanolin

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Lanolin, also known as or wool grease, is a natural, yellow to amber-colored, viscous secreted by the sebaceous glands of sheep to waterproof and protect their fibers. It is obtained by extracting and refining the grease from sheared during processing, resulting in a purified product free from impurities like pesticides when produced to pharmaceutical standards. Chemically, lanolin is a complex mixture comprising approximately 87% high molecular weight esters, along with 7-10% lanolin alcohols (sterols and diols), minor amounts of lanolin acids (primarily straight-chain and branched fatty acids), and hydrocarbons and other . This composition gives lanolin its characteristic emollient properties, including high water-binding capacity (up to 200% of its weight), occlusive barrier formation on the skin, and compatibility with both and oils, making it superior to many or oils for hydration. Physically, it appears as a tenacious, , unctuous mass that is insoluble in but soluble in , , and , with a around 38-44°C. Lanolin's primary applications are in and pharmaceuticals, where it serves as a key ingredient in moisturizers, ointments, lip balms, and barrier creams due to its ability to soften , promote , and prevent moisture loss. It is particularly valued in products for dry or irritated , such as those for chapped lips or postpartum nipple care, as it mimics the structure of and supports natural barrier repair without clogging pores. Beyond personal care, lanolin finds industrial uses as a preventive, conditioner, and component in polishes and textiles, leveraging its lubricating and protective qualities. While for topical use by regulatory bodies like the FDA, lanolin can cause in sensitized individuals, particularly those with or sensitivities, though purified forms minimize such risks. Its as a byproduct of the wool industry further enhances its appeal in modern formulations, though vegan alternatives are increasingly sought in response to animal-derived concerns.

Chemical Composition and Properties

Composition

Lanolin, also known as wool wax or wool grease, is a complex mixture of esters, diesters, and other derived from the reaction of wool wax alcohols (primarily sterols and triterpenoid alcohols) with fatty acids present in sheep sebum. This natural secretion from sheep sebaceous glands forms a protective coating on fibers, consisting mainly of high-molecular-weight esters that impart water-repellent properties. The primary components of lanolin include wax esters (approximately 48%), sterol esters (33%), free sterols (6%), free fatty acids (3.5%), lactones (6%), and hydrocarbons (1-2%). The wax esters are formed from long-chain fatty acids and aliphatic or steroidal alcohols, while sterol esters predominantly involve cholesteryl and other sterol derivatives. Free lanolin alcohols, which encompass unesterified sterols and triterpenoid alcohols, constitute about 3-5% of the mixture, contributing to its emollient characteristics. Among the sterols, cholesterol is the most abundant, comprising about 34-37% of the total sterol content when considering both free and esterified forms; lanosterol (19-25%) and agnosterol (4-7%) are also significant, with the remainder including dihydrolanosterol and other minor triterpenes. Fatty acid esters, such as cholesteryl esters, form a significant portion of the sterol esters, linking saturated and branched-chain acids (e.g., lanoceric and lanopalmitic acids) to sterols. The major constituents, particularly the wax esters, can be represented by the general structural formula \ceR−COO−R′\ce{R-COO-R'}, where \ceR\ce{R} denotes a long-chain (typically C16_{16} to C36_{36}, often branched) and \ceR′\ce{R'} a wool alcohol such as or . This linkage provides lanolin's semisolid consistency and , mimicking lipids. The composition of lanolin exhibits variability influenced by sheep , age, diet, and environmental factors such as and farming practices, which can alter the proportions of branched-chain s and s. For instance, wool from different breeds may show elevated levels of in lambs compared to ewes, affecting the overall profile.

Physical and Chemical Properties

Lanolin appears as a to amber-colored, unctuous, waxy solid at , with a faint, characteristic often described as mildly sheep-like in its refined form. It has a ranging from 0.932 to 0.945 g/cm³ and a between 38°C and 44°C, allowing it to soften and become a clear or pale liquid when heated. Lanolin is insoluble in but can absorb up to 200% of its weight in , enabling it to form stable water-in-oil emulsions due to its amphiphilic structure of long-chain esters. The material is tasteless or has a neutral to slightly fatty taste, making it suitable for topical applications. Chemically, lanolin exhibits hydrophobic characteristics from its non-polar components, yet its emulsifying ability arises from the amphiphilic nature of its and esters, which possess both hydrophilic and lipophilic moieties. It demonstrates good stability under normal conditions of heat and light, remaining non-reactive with most substances but incompatible with strong oxidizers. Lanolin reacts with bases through of its linkages to form soaps, as indicated by its of 90-105 mg KOH/g. In emulsions, it maintains pH neutrality, typically ranging from 6 to 8, supporting formulation stability. Characterization of lanolin often involves analytical methods such as gas chromatography to separate and identify its fatty acid and alcohol components, providing insights into its complex mixture. The iodine value, measuring the degree of unsaturation in its fatty chains, ranges from 18 to 36, determined by standard titration methods on samples of 780-820 mg. Crude wool grease, the initial extract from sheep wool scouring, differs from refined lanolin anhydrous in its higher impurity content, including dirt, salts, and pesticides, resulting in a darker color, stronger odor, and less consistent properties. Refining processes remove these contaminants and excess water (to <0.25%), yielding anhydrous lanolin with improved purity, milder odor, and enhanced emulsifying performance for pharmaceutical and cosmetic use.

Production and Processing

Extraction Methods

Lanolin, also known as wool wax or wool grease, is primarily sourced from the sebaceous secretions on sheep fleeces, recovered as a during the scouring stage of processing. This process begins after shearing, where raw is cleaned to remove impurities, and the wool grease naturally emulsifies in the wash . The global production relies heavily on this industrial scouring, with major contributions from countries like , , and the , where is prominent. Traditional extraction methods center on aqueous scouring, where raw is washed in hot water (typically 50–60°C) containing detergents or to emulsify and solubilize the grease, suint (potassium salts from sweat), dirt, and other contaminants. The resulting scouring liquor, laden with emulsified wool grease, undergoes acidification to break the , followed by high-speed or to separate the crude grease from the . This mechanical separation yields a semi-solid material that constitutes the initial raw lanolin precursor. Solvent-based variants of traditional methods involve direct extraction from the fleece or scouring waste using organic solvents such as , , or , which dissolve the grease before evaporation recovers the crude product; however, these have largely been phased out in favor of less toxic alternatives due to environmental and health concerns./F0373343.pdf) Modern alternatives emphasize sustainability and efficiency, with (scCO₂) extraction emerging as a key eco-friendly technique. In this process, CO₂ is pressurized and heated to supercritical conditions (above 31°C and 7.38 MPa), often with cosolvents like to enhance , allowing selective recovery of wool grease from scoured waste or raw fleece without residues or thermal degradation. Studies have demonstrated yields comparable to traditional methods while producing a cleaner, odorless product suitable for direct refinement. Mechanical pressing of , though less common, involves compressing fleeces to express grease prior to scouring, particularly for high-grease breeds, and is sometimes integrated with for enhanced recovery in small-scale operations. Yield rates for wool grease typically range from 10% to 25% of the greasy weight, varying by sheep breed (e.g., higher in sheep at 15–20%) and processing efficiency. Key factors affecting yield include the initial cleanliness of the fleece—dirtier reduces recoverable grease due to dilution with contaminants—the scouring temperature and type, which influence emulsification, and the breed-specific grease content, with fine- breeds generally yielding more than coarse types. Post-extraction, the crude wool grease undergoes to remove impurities, as detailed in subsequent purification processes.

Refining and Purification

The refining of lanolin begins post-extraction from wool grease, involving a series of chemical treatments to isolate and purify its components, primarily esters of high molecular weight sterols and fatty acids. is typically performed using an alcoholic alkali solution, such as , to hydrolyze the esters into lanolin acids and alcohols; this step separates the water-soluble soaps of lanolin acids from the unsaponifiable alcohols. Following , acidification with a like protonates the soaps to liberate free fatty acids, which are then recovered alongside the alcohols through solvent extraction using non-polar solvents such as or to dissolve the lipophilic fractions while leaving impurities in the aqueous phase. These sequential steps ensure the breakdown and separation of crude lanolin's complex mixture into usable components. Bleaching follows extraction to remove color impurities and achieve a pale, uniform product suitable for commercial applications. Oxidative bleaching is commonly employed with (typically 4-15% concentration) at elevated temperatures around 85°C for 4 hours, often in the presence of stabilizers like to control the reaction and prevent degradation of the wax structure. Alternatively, adsorptive methods using treat the refined wax to bind and eliminate residual pigments and odor-causing compounds, resulting in a colorless and odorless final product after . These processes are carefully sequenced to minimize oxidation of sensitive components while enhancing purity. Refined lanolin is standardized into several product types based on water content and purity specifications for end-use applications. Lanolin anhydrous consists of nearly pure (less than 0.25% ), appearing as a to amber viscous paste with emollient properties ideal for formulations. Hydrous lanolin incorporates 25-30% , forming a softer, more spreadable ointment base that improves hydration in topical products. USP-grade lanolin meets standards for pharmaceutical use, requiring minimal impurities, a maximum of 1.0 mg KOH/g, and iodine values (18-36 g I₂/100g) to ensure safety and efficacy. Quality control in lanolin refining emphasizes the removal of contaminants to meet regulatory and sensory requirements. Pesticide residues, often introduced during sheep farming, are targeted through advanced techniques like supercritical CO₂ extraction, which selectively removes organochlorine and organophosphorus compounds with efficiencies up to 90% without altering the wax's core composition. Impurities such as dirt, salts, and oxidative byproducts are further eliminated via chromatographic methods, including gel permeation chromatography (GPC) for size-based separation of pesticides from lanolin matrices, ensuring residue levels below 0.1 ppm. Refinement processes also focus on achieving colorlessness (Lovibond color <5Y) and odorlessness by iterative bleaching and deodorization, verified through sensory panels and instrumental analysis like gas chromatography-mass spectrometry. On an industrial scale, lanolin predominantly employs batch processes in tank reactors for and extraction, allowing precise control over reaction conditions like (70-90°C) and pH, though continuous flow systems are emerging for extraction and bleaching to improve throughput in large facilities processing thousands of tons annually. Batch operations facilitate customization for varying wool grease qualities but incur higher labor costs, while continuous methods reduce downtime and enhance efficiency for high-volume production. varies by scale and method; for instance, batch for removal can require 50-100 kWh per ton, with overall processes consuming approximately 200-300 kWh/ton when including heating and recovery, though optimizations like heat integration can lower this by 20-30%.

Applications and Uses

Cosmetics and Personal Care

Lanolin serves as a key emollient and occlusive agent in and , forming a protective barrier on the to reduce while softening and smoothing the surface. Its emollient properties derive from its ability to blend well with other cosmetic ingredients, enhancing texture and stability in formulations such as lip balms, creams, and lotions. In these products, lanolin is typically used at concentrations ranging from 5% to 37% in leave-on applications, with regulatory allowances up to 50% in certain over-the-counter skin ointments. In specific personal care items, lanolin is widely incorporated into nipple creams for mothers to soothe cracked and sore by replenishing natural and repairing the barrier without needing removal before . It also features in barrier creams designed for dry or irritated , providing long-lasting hydration and protection against environmental stressors. Historically, lanolin has been a staple in cold creams since the early , where it was added to traditional formulations of , water, and emulsifiers to improve emolliency and feel. One of lanolin's formulation advantages lies in its molecular similarity to human sebum, allowing it to integrate seamlessly with the skin's matrix and penetrate beyond superficial layers to deliver deeper hydration. This compatibility also enables lanolin to act as a carrier, enhancing the absorption and efficacy of other active ingredients, such as vitamins, in cosmetic blends by improving stability and skin penetration. In the market, lanolin appears in natural cosmetic brands like Lansinoh for targeted hydration products and is valued in formulations emphasizing ethical sourcing from sheep's . However, as an animal-derived ingredient, lanolin is not suitable for vegan consumers, prompting the development of plant-based alternatives such as or esters that mimic its occlusive and emollient effects.

Pharmaceuticals and Industrial Uses

In pharmaceuticals, lanolin serves as a key excipient due to its emollient and occlusive properties, acting as a base for ointments, suppositories, and topical drug formulations. It is commonly incorporated into antibiotic creams and other dermatological preparations to enhance drug penetration and provide a protective barrier on the skin, with concentrations typically ranging from 12% to 50% as permitted by U.S. federal regulations for over-the-counter skin ointments. Lanolin anhydrous, refined to meet United States Pharmacopeia (USP) standards, ensures high purity for these applications, with specifications including low levels of free fatty acids (around 0.56% as oleic acid), moisture (0.25%), and ash (0.1%), making it suitable for pharmaceutical-grade products. Its emulsifying properties, derived from its lipid composition, allow it to stabilize formulations containing active pharmaceutical ingredients, facilitating controlled release in topical therapies. Beyond human medicine, lanolin is utilized in veterinary products for animal , where it moisturizes and soothes dry or irritated skin in species like dogs, cats, and . It is a common ingredient in topical ointments and shampoos for pets, often combined with antiseptics to treat conditions such as or chafing, and is approved for use in veterinary medicines including homeopathic and preparations. In industrial applications, lanolin functions as a versatile and protective agent, particularly in rust preventives for metal parts, where its non-toxic and biodegradable nature provides long-lasting inhibition without environmental harm. It is also employed in treatments to soften and waterproof hides, in printing inks as a binder for improved flow and adhesion, and as a in processing to reduce during and finishing. Emerging research in the 2020s has explored lanolin's potential in for , particularly through lanolin-based nanoparticles that encapsulate active compounds for enhanced . Studies have demonstrated solid nanoparticles formulated with lanolin as carriers for UV filters and agents, showing improved stability and controlled release profiles suitable for advanced therapeutic systems. As of 2023, global lanolin production is estimated at around 50,000 tons annually, with the pharmaceutical sector accounting for approximately 20-30% of demand, driven by its role in topical and veterinary formulations.

Health, Safety, and Regulations

Allergenicity and Safety

Lanolin can cause in approximately 1-2% of patients patch-tested for , with higher rates observed among individuals with pre-existing allergies due to shared allergenic components in wool grease. This reaction typically manifests as redness, itching, and upon topical application, particularly in sensitive areas like the skin around wounds or mucous membranes. Crude lanolin may also contain residues from sheep treatments, such as organochlorines and organophosphates, which can exacerbate irritation or pose additional risks if not removed during processing. Lanolin's toxicity profile is low, with an oral LD50 exceeding 10 g/kg in rats, indicating minimal acute risk from ingestion. It is not classified as carcinogenic by the International Agency for Research on Cancer (IARC), as it does not appear on their list of evaluated agents. The U.S. Food and Drug Administration (FDA) recognizes lanolin as generally recognized as safe (GRAS) for use as a direct food additive in small amounts, such as in chewing gum bases, under 21 CFR 172.615. Post-2020 studies have highlighted the development of refined lanolin variants, achieved through advanced purification techniques that reduce free lanolin alcohols and impurities responsible for , resulting in lower reactivity rates such as 0.4% in a 2021 clinical study. ing recommendations include using 30% lanolin alcohol in petrolatum or a combination of lanolin alcohol and Amerchol L101 applied to the back for 48 hours, with readings at 48 and 96 hours to confirm and guide avoidance. For safe handling, store lanolin in tightly closed containers in a cool, dry, well-ventilated area away from strong oxidants, heat sources, and moisture to prevent degradation or rancidity. In case of exposure, first aid measures include rinsing skin or eyes with plenty of water for at least 15 minutes if contact occurs, moving to for incidents, and inducing or administering water only if ingestion is suspected and the person is conscious—seek immediate medical attention for severe symptoms like persistent irritation or gastrointestinal distress.

Standards and Legislation

Lanolin quality is governed by pharmacopeial s that establish purity criteria for pharmaceutical and cosmetic applications. The (USP) and National Formulary (NF) for anhydrous lanolin specifies a maximum of 0.25%, ensuring stability and preventing microbial growth. Similarly, the European Pharmacopoeia (Ph. Eur.) for wool fat (lanolin) limits free lanolin alcohols to less than 3%, reducing potential irritancy while maintaining emollient properties. Legislation in major markets imposes restrictions on impurities and production methods to safeguard consumer safety. Under the European Union's Cosmetics Regulation (EC) No 1223/2009, lanolin is permitted without specific concentration limits, but all cosmetic ingredients, including lanolin, must comply with general impurity controls, such as limits on heavy metals and pesticide residues to prevent contamination. In the United States, the (FDA) has affirmed lanolin as (GRAS) for use as a masticatory substance in bases and as an indirect in contact materials, provided it meets purity standards under 21 CFR Parts 172, 175, and 176. Additionally, regulations prohibit the use of certain hazardous solvents like (TCE) and perchloroethylene (PCE) in extraction processes due to their toxicity, as mandated by the U.S. Environmental Protection Agency (EPA) under the Toxic Substances Control Act, influencing global lanolin refining to adopt safer alternatives. Global variations reflect regional production and trade priorities. In , a leading wool producer, lanolin adheres to standards set by the Australian Government and industry bodies like the Woolmark Company, emphasizing low residues from clean practices to meet export quality benchmarks. For organic certifications, imports of lanolin into markets like the under USDA National Organic Program (NOP) rules require documentation verifying levels below 40 ppm total, with no individual exceeding 10 ppm, and compliance with international equivalence agreements for certified organic sources. Compliance with these standards involves rigorous testing for contaminants. Residue analysis protocols, as outlined in USP and Ph. Eur. monographs, mandate detection limits for such as lead (≤10 ppm), (≤3 ppm), and mercury (≤1 ppm), alongside screening using gas chromatography-mass spectrometry to ensure levels remain below 40 ppm total for general-grade lanolin. These tests are essential for verifying adherence to both pharmacopeial purity and legislative impurity restrictions.

History and Sustainability

Historical Development

Lanolin, known anciently as wool grease or oesypum, has been utilized since antiquity for its protective and emollient properties. The ancient and Romans employed it in treatment to maintain fiber integrity and as a base for ointments to soothe wounds, burns, and sores. Greek physician Pedanius Dioscorides referenced oesypus in the 1st century AD for its medicinal applications in wound care. Similarly, Roman naturalist described wool grease mixed with honey and lead scales as a remedy for carbuncles and privates sores in his (Book 28). The modern term "lanolin" originated in 1885, coined by German pharmacologist Oscar Liebreich from the Latin words lana (wool) and (oil) to denote the purified wool-derived substance. This naming coincided with advancements in refining techniques during the late . Liebreich, along with , developed a centrifugal separation method to purify crude wool grease into a stable, form, patented in the United States in 1883 as an improvement in treating wool-oil. later commercialized refined lanolin products, such as Lanum, contributing to its pharmaceutical adoption. Industrial-scale lanolin production emerged amid the 19th-century wool boom in and , where sheep populations exploded to meet global textile demand— alone exported over 100 million pounds of annually by the 1890s. Wool scouring processes, essential for cleaning raw fleece, yielded substantial wool grease as a , enabling commercial extraction through water-based or early methods. This expansion transformed lanolin from a rudimentary into a viable emollient for and medicine. In the 20th century, lanolin saw key milestones, including its role in medical salves for treating chapped skin, immersion foot, and wounds among troops, often in petrolatum-lanolin bases for barrier protection. Post-war, environmental concerns over solvent residues in processing prompted a shift in the 1970s toward solvent-free extraction techniques, such as enhanced aqueous scouring and , to reduce from chemical effluents. These innovations aligned with broader regulatory pressures on industries while preserving lanolin's utility.

Environmental and Economic Aspects

Lanolin, derived as a from the wool scouring process following , helps minimize waste in the wool industry by the natural grease that would otherwise be discarded. However, the extraction and refining stages can contribute to environmental , particularly through the use of solvents in some production methods, which generate containing lanolin residues and that are challenging and costly to treat. To mitigate these impacts, sustainable sourcing practices have emerged, such as obtaining lanolin from organic produced by sheep raised under controlled, chemical-free farming conditions that prioritize and . The global lanolin market was valued at approximately USD 356 million as of October 2025, reflecting steady demand in , pharmaceuticals, and industrial applications. Major production occurs in sheep-rearing regions, with and accounting for significant shares due to their high-quality output, alongside , which accounts for approximately 12% of global supply as of 2024. Lanolin prices are subject to fluctuations tied to demand, as variations in production volumes— influenced by factors like feed costs and global trends—directly affect the availability and cost of raw grease feedstock. In the 2020s, the industry has seen a push toward certifications for lanolin-containing products, with brands like Lanolips achieving Leaping Bunny approval by ensuring no in their supply chains, though lanolin's animal-derived nature limits full vegan status. Efforts to recycle lanolin from shearing waste have intensified, involving efficient of grease post-scouring to capture more of this without additional animal harm. As of 2025, sustainability initiatives have intensified, with a focus on ethical sourcing, traceable supply chains, and ESG-compliant production to reduce environmental impacts. poses challenges to , exacerbating from ruminants—which constitute up to 75% of 's carbon footprint—and altering pasture conditions through droughts and , potentially reducing wool yields and lanolin supply. Plant-based alternatives, such as , , and synthetic emollients, are increasingly challenging lanolin's , driven by rising consumer preference for vegan and ethical options that avoid animal-derived ingredients and associated environmental concerns of farming.

References

  1. https://pubchem.ncbi.nlm.nih.gov/compound/Lanolin
  2. https://go.drugbank.com/drugs/DB11112
  3. https://www.cir-safety.org/sites/default/files/FAR_Lanolin_092024.pdf
  4. https://www.healthline.com/health/lanolin-oils
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