Tag Archives: food importers

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FDA Launches Webpage on Equivalence and Food Safety

By Food Safety Tech Staff
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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.

 

 

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FDA Issues Final Guidance for Foreign Supplier Verification Programs

By Food Safety Tech Staff
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The FDA has issued its final guidance for the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. FSVP, which is part of the FDA Food Safety Modernization Act, makes importers accountable for verifying that foreign suppliers are producing food in a manner that meets U.S. safety standards.

This guidance includes recommendations on the requirements to analyze the hazards in food; evaluate a potential foreign supplier’s performance and the risk posed by the food; and determine and conduct appropriate foreign supplier verification activities.

The guidance also addresses how importers can meet modified FSVP requirements in a variety of categories, such as requirements for importers of dietary supplements or very small importers.

In response to comments received to the 2018 draft guidance, changes were made to the final guidance, including providing additional clarification regarding to what food the FSVP regulation applies; what information must be included in the FSVP; and who must develop and perform FSVP activities.

“Food” covered under FSVP includes:

  • Articles used for food or drink for humans or other animals,
  • Chewing gum, and
  • Articles used for components of any such article.

Training materials, developed in collaboration with the Food Safety Preventive Controls Alliance (FSPCA), are available to help facilitate FSVP compliance by importers.

Download the final guidance here.