Chemical Requirements

What food-simulating solvents should be used in a migration study?

Mar 2001

Question: What food-simulating solvents should be used in a migration study?

Answer: Although analyses of actual foods is permissible under FDA's Guidance for Industry ? Preparation of Premarket Notifications for Food-Contact Substances: Chemistry Recommendations, such media often pose practical problems with the testing. For aqueous acidic, and low alcohol (less than 15 percent) foods, 10 percent ethanol is the appropriate solvent to use. For high alcohol foods, 50 percent ethanol. And, to simulate fatty foods, FDA suggests using food oil or synthetic fat (Miglyol 812 or HB307), or, alternatively, 95 percent ethanol for polyolefins, and 50 percent ethanol for rigid polyvinyl chloride, polystyrene, polyesters, and polycarbonate.

Back to FAQs