The U.S. FDA’s 21 CFR 178.2650 regulation on organotin stabilizers in vinyl chloride plastics was recently updated, confirming that approved organotin compounds may be used at levels not exceeding 3 parts per hundred of resin as stabilizers in PVC homopolymers and copolymers.

The regulation governs which methyltin, butyltin, and octyltin compounds are permitted for food-contact applications, with specific migration limits and use conditions. Manufacturers serving the food and medical packaging sectors must ensure their stabilizer suppliers meet these stringent requirements.

Unistars Commitment: Our XY-728 methyl tin stabilizer has been tested per ASTM D3421-75 — all 16 phthalate items are below MDL (not detected). Cd, Pb, Hg, Cr(VI), PBBs, and PBDEs also pass ROHS. Processors can confidently use Unistars products for food-contact and medical-grade PVC.

Source: eCFR Title 21, Section 178.2650, updated October 2026