Color Lakes and Preparations Based on Color Lakes

Color additives used in food, drugs, and cosmetics in the US must be either listed and certified by FDA (for synthetic dyes and their lakes) or listed as exempt from certification (for certain natural colorants). Aluminum lakes of FD&C dyes require batch certification by FDA. Importers must ensure the lake is produced from a certified batch of the parent dye and that the lake itself meets FDA specifications for the intended use category. Admissibility is subject to FDA review at entry.

The substrate — alumina, barium sulfate, calcium carbonate, or others — affects oil dispersibility, heat stability, and regulatory acceptability. Alumina-based lakes are preferred for pharmaceutical and food applications due to their regulatory acceptance and compatibility with tablet coating systems. The substrate does not change the classification of the lake within this heading, but it is a critical specification variable that buyers must confirm against their application's regulatory requirements.