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Are your FDA-regulated food products made with ingredients sourced from outside the U.S.? If so, and if they are further processed, your food product may have resulted in a new or different product that differs substantially from its original state before processing. In FDA’s and CBP’s (U.S. Customs and Border Patrol) view this is considered “substantial transformation and requires new labeling elements in accordance with the FSVP (Foreign Supplier Verification Program) and the Food Safety Modernization Act (FSMA). Changes to a food product that causes it to be considered substantially transformed can be form, appearance, nature, or character, perhaps via processing or manufacturing from the country’s origin. These changes can add to a product’s value so that, upon export, it exceeds the value of its pre-existing components, (i.e. – when it is exported from its country of origin). The end result of “substantial transformation” is usually a new article of commerce– one with a different name–that differs substantially from the pre-existing components.

An example is sugar from country A, flour from country B, dairy products from country C, and nuts from country D, all of which are taken to country E where they undergo manufacturing (substantial transformation) that results in cookies. These ingredients were “substantially transformed” into that new product in country E because a new finished product resulted from processing.

What about fresh vegetables, grown in various countries exported to another country to be mixed together and frozen? In this case, the vegetables were NOT substantially transformed into a new product of the country where mixing and freezing occurred. In this case, the mixture must be labeled with the origin of each ingredient.

Repackaging, dilution with water, and similar minor processes usually does NOT cause a substantial transformation. However, assembly or disassembly may result in a substantial transformation, depending on the nature of the products involved and the complexity of the operations.

Confused? EAS Consulting Group’s team of food consulting experts can help you to determine whether your products meet the “substantial transformation” definition. We can assess processing and labeling, assist with verification and robustness of FSVP programs and assist when products are detained at the U.S. border. EAS can also act as your U.S. Agent and Qualified Individual under FSVP.

We look forward to working with you! Contact us for assistance with understanding and complying with FDA and USDA regulations, as well as their import requirements.

Posted in Foods.