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FDA Proposes Regulation on Registering Food Facilities

May 20, 2015

The U.S. Food and Drug Administration (FDA) has proposed a rule aiming to amend and update the regulation on registration of food facilities. The amendments aims to provide improvements to the food facility registration system that would implement certain provisions of the FDA Food Safety Modernization Act (FSMA).

The amendments include a change in the definition of a retail food establishment to one that sells food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers

Additional provisions are:

  • Registrations for domestic facilities must contain the email address of the contact person of the facility, and registrations for foreign facilities must contain the email address of the U.S. agent for the facility
  • Food facilities that are required to register with FDA must renew their registrations every two years, between October 1 and December 31 of each even-numbered year
  • All food facility registrations must contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act
  • Additional requirements to improve food facility registration system:
  • All food facility registrations would be required to be submitted to FDA electronically (although this requirement would not take effect before January 4, 2016)
  • Registrations would be required to contain the type of activity conducted at the facility for each food product category
  • The proposed rule would provide for measures to verify certain information submitted in registrations

The proposed rule is open for public consultation until June 8, 2015.

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