Equivalence is 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. 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, though different, meet at least the same level of public health protection achieved by U.S. measures.
Typically, imported shipments of FDA-regulated food products are reviewed by FDA to determine whether imported food products are “admissible” into the U.S. market. FDA may refuse entry to any imported foods that violate or appear to violate applicable food provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Most imported food products must comply with FDA requirements to be admitted entry into the United States. However, some foods are permitted into the U.S. market, even if they do not comply with U.S. requirements, as long as the FDA has made a determination of equivalence. This means that the imported food products are produced in accordance with safety controls that achieve at least the same level of public health protection as U.S. law and regulatory requirements.
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.
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. Sanitary or phytosanitary measures include the laws, rules, and procedures that governments use to help ensure that foods and beverages are safe to consume and to protect animals and plants from pests.
WTO obligations are codified in U.S. law through the Uruguay Round Agreements Act (URAA), Pub. L. No. 103-465, 108 Stat. 4809 (1994). The international and U.S. legal framework for equivalence is based on these foundational documents:
How the equivalence process works
An equivalence determination is considered by the FDA at the request of a foreign regulatory authority and entails an in-depth scientific and regulatory analysis of the requester’s system of food safety controls and how they are implemented for a specific product, or specific set of products.
In response to a request for an equivalence determination, the FDA will provide the competent authority with a general description of the process and a request for documentation, including, and not limited to laws, procedures for inspections, provisions for certification, analytical methods, and facility specifications of their food safety system. The FDA first examines information provided by the requester’s competent regulatory authority to determine whether its legal standards related to a food, or a specific set of products, and the implementation of those standards, address all relevant U.S. food safety system requirements. Next the FDA will assess whether the requester’s legal standards provide at least the same level of public health protection to that achieved by the U.S. system.
The process generally involves three main components:
- a technical assessment of the food safety control system;
- an onsite verification audit if appropriate; and
- administrative procedures to propose and finalize an equivalence determination, if appropriate.
Technical assessment includes FDA’s in-depth scientific assessment and regulatory analysis of the foreign food safety system as applied to the requested product(s). FDA experts, including subject matter experts for commodities and laboratories, conduct a comprehensive review of the information provided; hold technical consultations with their foreign counterparts, as needed; and may conduct onsite audits to verify the implementation and enforcement of the relevant food safety controls that were provided for the documentation review. If the FDA technical experts conclude that a set of foreign controls provides at least the same level of food safety protection as the corresponding U.S. controls, the experts will recommend a positive determination of equivalence. The agency then will initiate administrative procedures to propose and finalize the determination.
Regulatory authorities may submit formal requests for equivalence for FDA-regulated food products to FDA-CFSAN-International-Engagement@fda.hhs.gov.
Current Equivalence Determinations
The FDA has been engaged in equivalence discussions on grade A dairy with Canada, the European Union, and New Zealand; and on shellfish with New Zealand.
Spain and Netherlands Raw Bivalve Molluscan Shellfish
The FDA’s final equivalence determination finds that the EU’s system of food safety control measures for raw bivalve molluscan shellfish, as implemented by Spain and the Netherlands, along with the application of additional measures specifically adopted for export to the United States, are equivalent to comparable U.S. controls. Separately, the European Commission has determined that U.S. controls for bivalve molluscan shellfish are equivalent to comparable EU controls and initially will allow imported molluscan shellfish from listed establishments in Massachusetts and Washington.
- Constituent Update: FDA Finalizes First Food Safety Equivalence Determination - Resumption of Shellfish Trade with Spain and Netherlands
- Federal Register Notice: Equivalence Determination - Implementation by Spain and the Netherlands of the European Union System of Food Safety Control Measures for Raw Bivalve Molluscan Shellfish with Additional Controls
- Questions and Answers on Shellfish Traded Between the United States and Certain Member States of the European Union
- Administrative Arrangement Between the United States Food and Drug Administration and the Directorate-General for Health and Food Safety of the European Commission Regarding Trade in Bivalve Molluscan Shellfish with accompanying Note from FDA to the European Commission and Note from the European Commission to FDA
- Annex I of Commission Implementing Regulation (EU) 2019/626 of 5 March 2019 contains the lists of countries, including the US, eligible to export animals and goods intended for human consumption to the European Union.
- Information for U.S. Exporters