Wool Grease (Non-Crude) & Fatty Substances Derived from Wool Grease, Including Lanolin

Pharmaceutical-grade lanolin must conform to recognized pharmacopeial standards such as USP or BP, which set limits on free fatty acids, water content, and pesticide residues. Cosmetic-grade lanolin has less stringent specifications. Importers should obtain a certificate of analysis confirming the applicable grade, as FDA may scrutinize pharmaceutical-grade lanolin imports under drug or cosmetic admissibility rules.

Crude wool grease (also called degras or raw lanolin) is the unrefined product recovered directly from scouring raw wool and is classified in a separate heading. Once the grease has been refined, bleached, or otherwise processed beyond its crude state — yielding lanolin, lanolin alcohols, or lanolin fatty acids — it falls under this heading. The degree of processing is the key classification criterion, so technical data sheets and processing records are important supporting documents.