US Regulatory Approval of Membrane Technology

Publisher Summary This chapter provides general guidance and direction for the regulatory approval of membrane technology materials used by the food industry in the manufacture of food products. Regulatory approval of food contact materials is determined on a country by country basis. The focus of this regulatory guidance is exclusively for those products that fall under the authority of the US Food and Drug Administration (FDA). In those situations where manufactured product falls under the authority of the US Department of Agriculture (USDA), regulatory approval of food contact material is generally deferred to the FDA due to their expertise, although there are exceptions. For product produced through membrane technologies that are intended for animal feed uses, one must consider the regulatory status of both: any substances potentially migrating from the membrane technology and the resultant feed ingredient itself. Under the US Federal Food, Drug, and Cosmetic Act (FFDCA), food is considered “adulterated” if it is found unsafe or unfit for consumption. Food is considered adulterated if it contains a poisonous or deleterious substance that may render it injurious to health. Under the FFDCA, for a food contact substance to be legally used in US commerce, it must satisfy one of the legal and regulatory constructs: found to be “generally recognized as safe”, subject to a prior sanction approval, satisfy the requirements of the appropriate food additive regulation, and be the subject of an approved food contact notification (FCN).