Enzymes & Prepared Enzymes (NESOI)

Penicillin G amidase (3507902000) is singled out because it is a pharmaceutical-grade enzyme with a specific and narrow application: catalyzing the hydrolysis of penicillin G to produce 6-aminopenicillanic acid (6-APA), the core building block for semi-synthetic antibiotics. Its separation from the general enzyme NESOI line (3507907000) allows customs authorities to track this strategically important pharmaceutical input distinctly from commodity industrial enzymes.

Food-grade enzymes must come from an FDA-registered foreign facility, and Prior Notice must be filed before arrival. The importer should confirm that the enzyme has GRAS status or an applicable food additive regulation for its specific food-use application. Technical documentation — including the enzyme's activity specification, source organism, and intended use — should be retained to support both FDA admissibility review and correct HTS classification.