On June 5, the FDA published a new webpage dedicated to equivalence—the process of determining whether a foreign regulatory counterpart’s food safety controls achieve at least the same level of public health protection as measures required by U.S. law—for food safety.
As the FDA explains, equivalence is a right and an obligation for all members of the World Trade Organization (WTO). All members must accept the sanitary or phytosanitary measures of the other members as equivalent, even if these measures differ from their own or from those used by other members trading in the same product, if the exporting member objectively demonstrates to the importing member that its measures achieve the importing member’s appropriate level of sanitary or phytosanitary protection.
This means that a foreign regulatory authority is not required to develop and implement the same exact procedures and food safety controls that FDA requires, but rather that it must objectively demonstrate how its food safety controls meet at least the same level of public health protection achieved by U.S. measures. Likewise, for food exported from the United States, foods produced in compliance with U.S. regulations may be permitted entry into foreign markets based on a positive equivalence determination.
The webpage explains how equivalence is determined, the current equivalence determinations, and how regulatory authorities can submit a formal request for equivalence for FDA-regulated food products.