High-Purity Lactose and Lactose Syrup (99% or More Lactose by Weight)

Pharmaceutical and infant-formula manufacturers rely on high-purity lactose — containing 99% or more lactose expressed as anhydrous lactose on a dry-matter basis — as a critical excipient and nutritional ingredient, distinguishing it from lower-purity food-grade lactose under heading 170219. Classified under a single 10-digit line (1702110000), this product is subject to FDA oversight given its food and pharmaceutical applications. Germany and the Netherlands are the leading suppliers to the US, with New Zealand, Israel, and France also among top sources — reflecting the concentration of pharmaceutical-grade dairy processing in Western Europe and Oceania. Importers should consult a licensed customs broker regarding FDA admissibility requirements and any applicable dairy TRQ provisions.