INCI 41316 + FDA DMF Type II 044197: the two filings your EU/US launch needs
Two filings on the TONGNIAN EV material line are now in place: INCI 41316 naming for cosmetic formulation use, and FDA DMF Type II 044197 on file with the US Food and Drug Administration.
What each filing unlocks INCI naming is what lets a formula house list the ingredient on an EU or US cosmetic label; a DMF Type II file is what lets a US reviewer see exactly how the material is made without the supplier disclosing its process. Together they support an EU launch (Reg. 1223/2009, CPNP) and a US launch (MoCRA). Most exosome SKUs ship with neither filing — yours can.
Both filings cover the material line that feeds every TONGNIAN program family: skincare, topical, inhaled, oral and delivery formats. Every batch ships with COAs referencing the documented chain. Ask for the characterization baseline and the filing reference list with your inquiry — we send both with the quote.
Request the documentation pack.
Get the test panel that matches your batch
Tell us your target category and expected first batch size (a sample run, around 100 units, or 1,000 and up). We will send the matching test panel, characterization references, and a sample COA for your tier.