FDA Achieves Key Milestone, Finalizes Framework That Will Resume Shellfish Trade with Europe for the First Time in 10 Years

September 23, 2020

Today, the U.S. Food and Drug Administration finalized a molluscan shellfish equivalence determination for two European Union (EU) Member States, Spain, and the Netherlands.

“Today’s announcement is a significant milestone that will resume trade in shellfish between the U.S. and the EU for the first time since 2010. These actions reflect key strategic international engagement and several years of careful review by the FDA on behalf of consumers at home and abroad,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation and International Affairs. “Today we’re helping unlock economic opportunity by creating a path forward to new market access for U.S. exporters.”

The equivalence determination finalizes the proposed determination that the FDA published in the Federal Register in 2018 and is a result of a multi-year, in-depth review of EU shellfish safety controls implemented in Spain and the Netherlands. Technical experts on both sides of the Atlantic have completed separate equivalence assessments and each side recommended a finding of equivalence after reviewing food safety control measures for molluscan shellfish and on-site audits to verify the other’s systems. The FDA will recognize other EU Member States in the future, as appropriate, in separate determinations.

“Today we’re making a wider selection of healthy and safe seafood options available to the American consumer from Europe,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. “Americans can be confident in the equivalence determination that Spain and the Netherlands have implemented safety controls that are equivalent to ours, thereby enabling us to allow Spain and the Netherlands to export raw molluscan shellfish to the U.S. The FDA is committed to keeping consumers safe and ensuring the safety of our food supply, and that includes seafood, whether it is imported or harvested domestically.”

In a separate action, the European Commission has also made a food safety equivalence determination that will permit raw and processed molluscan shellfish, including clams, mussels, oysters and scallops, to be imported from the United States, beginning with shellfish from Massachusetts and Washington.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Hot this week

Avery Dennison Medical Introduces Ipdated SilFoam Lite: Sustainability, MDR Certification & Performance Improvements

The newly enhanced SilFoam Lite delivers superior efficiency and reliability, bringing improved fluid handling capabilities and improved tack. These improvements make the product ideal for customers seeking quality, high-performance solutions in wound care notes Avery Dennison Medical.

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

New advancements in the AiBLE Spine Surgery ecosystem build upon the company's commitment to procedural innovation and execution

Axlab, Danish Medtech Pioneer, expands to US with Advanced Robotic Tissue Sectioning for Pathology Laboratories

Kris Rokke, National Sales Director for Axlab in the US. "My team and I are extremely excited and honored about this unique opportunity to also offer this advanced technology to labs across the US and thus contribute to the pathology labs of tomorrow."

Spartan Medical Broadens Single-Use Sterile Instrument Portfolio to Improve Outcomes, Increase Efficiency, and Generate Cost Savings

Spartan Medical products portfolio of single-use, sterile med tech includes micro and minor surgical convenience kits, kerrison rongeurs, spinal and general surgical retractors, dural repair kits, synthetic biologics, and a wide range of orthopedic pre-sterilized implants and devices.