Lanolin
Lanolin is the waxy secretion of sheep (Ovis aries) that coats wool. It is recovered from the wash water of wool scouring by centrifuging, then refined by washing, bleaching and deodorizing, and in pharmaceutical grades purified further to lower free alcohols and pesticide residues. Chemically it is a mixture of esters of sterols and fatty alcohols with fatty acids. Brands buy anhydrous lanolin USP or EP in pails or drums for ointments, lip products, creams and nipple balms.
Suppliers sell different products under the same name. Specify the one you need.
Refined lanolin with not more than a small percentage of water; the standard cosmetic and pharmaceutical grade.
Lanolin purified further to reduce free lanolin alcohols, detergent and pesticide residues, used in nipple care and sensitive-use products.
Lanolin blended with about a quarter to a third water, a softer ointment base.
Lanolin alcohols, lanolin oil, acetylated and hydrogenated lanolin, and PEG lanolins; each is a separate ingredient with its own INCI name and specification.
Compare each result with your own specification when the lot arrives.
Store lanolin in closed containers at room temperature, away from heat, light and air, because it slowly oxidizes and its odor and color increase. Melt gently and avoid repeated heating of the same container. Shelf life follows the supplier's specification, with a retest of acid value, peroxide value and color for older stock.
Odor, color and residue levels vary with wool origin and refining, so record pesticide results, color and acid value for each lot. Rotate FIFO and confirm the grade (anhydrous, hydrous, high-purity) on every delivery.
Facts from regulators and standards bodies, each linked to its source.
21 CFR 347.10 lists lanolin at 12.5 to 50 percent as a skin protectant active ingredient in the OTC skin protectant monograph.
Source: ecfr.gov (opens in a new tab)Health Canada's Natural Health Products Ingredients Database lists lanolin (proper names anhydrous lanolin and lanolin, CAS 8006-54-0) with Ovis aries wool as the source material and non-medicinal purposes of ointment base, plasticizer and emollient.
Source: webprod.hc-sc.gc.ca (opens in a new tab)FDA's Substances Added to Food inventory lists lanolin (CAS 8020-84-6) with the technical effect "masticatory substance" and cites 21 CFR 172.615 among other regulations.
Source: hfpappexternal.fda.gov (opens in a new tab)This is general information, not regulatory advice. Status differs by country and by how the ingredient is used, so check the rules for your product and market.
Manufacturers and distributors whose own websites say they sell it.
Distributor · Des Plaines, IL
Illinois supplier of bulk oils, butters, waxes and soap-making bases, owned by Columbus Vegetable Oils, selling to soap makers and small personal care brands.
Suppliers are in alphabetical order and none pays to appear. Each claim is checked against the supplier’s own website on the date shown. Ask for the specification sheet and a recent COA before you order, and confirm details with the supplier.
Common forms include anhydrous lanolin USP / EP, medical or high-purity grade, hydrous lanolin and lanolin derivatives. Ask each supplier for the specification sheet of the exact grade they quote.
Expect identity and melting range, acid and iodine values, water and loss on drying, pesticide residues, free lanolin alcohols and paraffins and heavy metals, each with its method, specification and result for that lot.
Store lanolin in closed containers at room temperature, away from heat, light and air, because it slowly oxidizes and its odor and color increase. Melt gently and avoid repeated heating of the same container. Shelf life follows the supplier's specification, with a retest of acid value, peroxide value and color for older stock.
21 CFR 347.10 lists lanolin at 12.5 to 50 percent as a skin protectant active ingredient in the OTC skin protectant monograph. Health Canada's Natural Health Products Ingredients Database lists lanolin (proper names anhydrous lanolin and lanolin, CAS 8006-54-0) with Ovis aries wool as the source material and non-medicinal purposes of ointment base, plasticizer and emollient. FDA's Substances Added to Food inventory lists lanolin (CAS 8020-84-6) with the technical effect "masticatory substance" and cites 21 CFR 172.615 among other regulations.
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