Food packaging regulation in the United States

Abstract
The U.S. Food, Drug and Cosmetic Act mandates pre‐market clearance of food additives. Food contact materials are considered to be ‘indirect’ food additives and are thus subject to regulation. The regulatory structure governing the use of these materials in the U.S. will be discussed. The elements of FDA's pre‐market safety assessment of new indirect food additives will be presented with emphasis on the estimation of probable human exposure. Finally, some new regulatory initiatives which will likely impact on food contact materials will be discussed.

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