Pursuant to its obligations under the World Trade Organization (WTO), the FDA works with foreign governments and international standard-setting bodies to harmonize food safety laws, regulations and standards based on science. The FDA also establishes arrangements with regulatory partners to harmonize food safety standards and eliminate duplication or overlap in food safety controls. The FDA maintains two mechanisms in furtherance of these efforts: 1) Systems Recognition – whereby the FDA recognizes that a foreign food safety system achieves food safety outcomes comparable to those of the FDA; and 2) Equivalence – whereby the FDA recognizes that a foreign food safety system achieves the same level of public health protection as the U.S. despite having different food safety controls.
The FDA-SENASICA-Cofepris Food Safety Partnership (FSP) was established in September 2020, through a new Statement of Intent (SOI) between the US Food and Drug Administration (FDA) and Mexico’s National Service of Agro-Alimentary Health, Safety and Quality (SENASICA) and the Federal Commission for Protection against Sanitary Risk (Cofepris).
Systems recognition, previously referred to as comparability, involves reviewing a foreign country’s food safety regulatory system to determine if it provides a similar set of protections to that of the FDA. Outcomes of these reviews may be used by the FDA to make risk-based decisions regarding foreign inspections, import examination, and responses to food safety incidents.
Once systems recognition assessments are completed, the arrangement leads the way to a new level of regulatory cooperation between FDA and our regulatory partners in other countries, allowing us to avoid duplication of effort while leveraging the high quality work done by regulatory authorities in each country.
Equivalence is the process of determining whether a country’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 country is not required to develop and implement the same exact procedures and food safety controls that FDA requires, but rather the country must objectively demonstrate how its food safety controls 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 imported food products are permitted into the U.S. market, even if they do not comply with U.S. requirements, so long as FDA has made a determination of equivalence, which means that the imported products are produced in accordance with food safety controls that achieve at least the same level of public health protection as U.S. law and regulatory requirements. An equivalence determination is made by FDA at the request of a foreign regulatory authority and entails an in-depth scientific and regulatory analysis of the other country’s system of food safety controls and how they are implemented for a product. For example, FDA has received requests for equivalence for molluscan shellfish and Grade A milk and milk products.
Likewise, for U.S. food exports, foods produced in compliance with U.S. regulations may be permitted entry into foreign markets on the basis of equivalence when a foreign competent authority has determined U.S. food safety controls for the product to be equivalent to its own domestic requirements.
International Trade Agreement Obligations
Equivalence is an obligation for countries that are members of the World Trade Organization (WTO). Article 4 of the WTO Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) states:
Members shall accept the sanitary or phytosanitary measures of 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. For this purpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures.
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 URAA states that U.S. agencies may find foreign SPS measures equivalent if they “provide at least the same level of sanitary or phytosanitary protection as the comparable [SPS] measure established under the authority of Federal law.”
Questions & Answers
A. If a foreign country wishes to pursue equivalence for food product(s) it intends to export to the United States, FDA first examines information provided by the country’s regulatory authority to determine whether its legal standards related to foods and implementation are enough for an equivalence evaluation. In evaluating equivalence, FDA conducts an assessment to determine whether the food safety measures included in the exporting country’s regulatory system are “equivalent,” i.e., whether they, despite being different, provide at least the same level of public health protection as relevant U.S. food safety requirements.
The process generally involves two main components:
1) a technical evaluation of the food safety control system; and
2) administrative procedures to propose and finalize an equivalence determination, if appropriate.
The technical evaluation 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 conduct a comprehensive review of the information provided, hold technical consultations with their foreign counterparts, and conduct on-site evaluations, audits and inspections necessary to assess the implementation and enforcement of the relevant food safety controls. If the FDA technical experts believe 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 finding of equivalence. The agency then will initiate administrative procedures to propose and finalize the determination, as appropriate. Foreign governments may follow a similar process when evaluating U.S. food safety controls for equivalence.
A. No, a finding of equivalence is not required to export products to the United States that comply with all applicable U.S. requirements. Foreign countries and producers can always ensure that products produced for export to the United States meet the same regulatory requirements as product produced in the United States instead of seeking an equivalence determination.
Specifically, in the case of imported shellfish and Grade “A” milk and milk products, FDA can, and has signed a Memorandum of Understanding with certain exporting countries specifying that these products for export comply with U.S. legal and regulatory requirements. For imported shellfish, this means that the products comply with the requirements of the National Shellfish Sanitation Program (NSSP). For Grade “A” milk and milk product imports, the exported products must satisfy the requirements of the National Conference of Interstate Milk Shippers’ Pasteurized Milk Ordinance (PMO).
Current Equivalence Determinations
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. Please refer to:
- 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
- Annex I of COMMISSION IMPLEMENTING REGULATION (EU) 2019/626 of 5 March 2019 concerning lists of third countries or regions thereof authorized for the entry into the European Union of certain animals and goods intended for human consumption, amending Implementing Regulation (EU) 2016/759 as regards these lists.
- 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
- Information for U.S. Exporters
Additional Information on Equivalence
Formal requests for equivalence recognition can be addressed to:
International Affairs Staff
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
5001 Campus Drive, Mail Stop 550
College Park, MD 20740
For more information on the international and U.S. legal framework for equivalence:
- WTO SPS Agreement
- Uruguay Round Agreements Act
- Information on the Codex Alimentarius guidelines on equivalence
The Codex Alimentarius Commission (CAC), created in 1963, is an intergovernmental body with over 170 members within the framework of the Joint Food Standards Programme established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). The Commission’s purpose is to protect the health of consumers and to ensure fair practices in the food trade. It also promotes coordination of all food standards work undertaken by international governmental and non-governmental organizations.
The Codex Alimentarius, a result of the Commission's work, is a collection of internationally adopted food standards, guidelines, codes of practice and other recommendations and is the major international mechanism for encouraging fair international trade in food while promoting the health and economic interest of consumers.
- U.S. Office for Codex Alimentarius (USDA/FSIS)
- Codex Alimentarius Commission
- FDA's Participation in Codex
- The Joint FAO/WHO Expert Committee on Food Additives (JECFA)
- The Joint FAO/WHO Meeting on Pesticide Residues (JMPR)
- The Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA)
- World Health Organization (WHO)
- Food and Agriculture Organization of the United Nations
- Pan American Health Organization (PAHO)
- World Organization for Animal Health (OIE)
- International Plant Protection Convention
- Organization for Economic Cooperation and Development (OECD)
- International Programme on Chemical Safety (IPCS)