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  1. International & Interagency Coordination

International Cooperation on Food Safety


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.

FDA-Mexico Food Safety Partnership

October 5, 2020

FDA held a ceremony commemorating the signing of a Statement of Intent (SOI) that enhances the Food Safety Partnership between the United States and Mexico. The SOI broadens and strengthens the scope of the existing Produce Safety Partnership SOI, signed in 2014. Now referred to as the Food Safety Partnership, this partnership is expanded from produce to include all human food regulated by the FDA.

Read the full update

Progress report on the previous Produce Safety Partnership with Mexico


Systems Recognition

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

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.

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:

Additional Information on Equivalence

Formal requests for equivalence recognition can be addressed to:

Director
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:


Food and Feed Import Practices of Foreign Governments to Improve Food Safety

Under contract to the U.S. FDA, Eastern Research Group, Inc. (ERG), in collaboration with independent subject matter experts, undertook this study of imported food and feed practices of foreign governments. FDA's objective was to better understand the practices used by other mature food safety systems that have similar public health goals to that of the U.S. and to perform a qualitative analysis of those import practices identified. The contractors reviewed publicly available literature and interviewed country officials involved in the importation of food and feed using a validated semi-structured interview protocol. The study was conducted from January to November 2011.

The countries selected for the study included: Australia, Canada, Chile, Ireland, Israel, Japan, Mexico, New Zealand (NZ), the Netherlands, and South Africa. Interviews were conducted with each country's officials (with the exception of Japan) – either in-person or via digital video conference – and focused on a variety of topics ranging from government authorities and private sector involvement in the safety of imported food and feed to meeting World Trade Organization (WTO) obligations.

Food and Feed Import Practices of Foreign Governments to Improve Food Safety (PDF - 4.4MB)


Codex Alimentarius Commission

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.

International Committees

Resources

 



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