2018 Food Facility Biennial Registration Renewal Required with new Updates
The Amendments to Registration of Food Facilities final rule updates FDA’s food facility registration requirements to better protect public health by requiring additional registration information that will improve the accuracy of the food facility registration database for facilities both in the United States and abroad. This final rule will support the FDA’s efforts to act quickly in response to food-related emergencies and will help the FDA to use its inspectional resources more efficiently.
Food facilities that manufacture/process, pack or hold food for consumption in the United States are required to register with the FDA, and this final rule adds new provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of FSMA. Those provisions include the requirement of an email address for registration, required renewal of registration every two years, and that all food facility registrations must contain an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.
In addition, the final rule adds certain new requirements that will improve the food facility registration system. All food facility registrations are required to be submitted to the FDA electronically, although this requirement does not take effect until January 4, 2020.
Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are registered with FDA to renew facility registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. If a registration is not renewed by December 31, 2018, the registration is considered expired and will be removed by the FDA from the system and will require a new registration.
All current Register-FDA customers will be renewed as part of our annual fee of $295.
If you would like to assign Register-FDA as your US Agent to renew your registration, please click here.
See for the number of registered facilities by activity, the following table.
|Facility Activity||No. Domestic Facilities||No. Foreign Facilities||Grand Total|
|Warehouse/Holding Facility (e.g. storage facilities, including storage tanks, grain elevators)||55296||45002||100298|
|Manufacturer / Processor||24767||64408||89175|
|Repacker / Packer||15316||34546||49862|
|Labeler / Relabeler||9517||25326||34843|
|Acidified / Low Acid Food Processor||2884||6279||9163|
|Animal Food Manufacturer / Processor||5117||3347||8464|
|Interstate Conveyance Caterer / Catering Point||1113||1259||2372|
|Salvage Operator (Reconditioner)||323||1605||1928|
|Molluscan Shellfish Establishment||541||1224||1765|
|Other Activity Conducted||1386||4169||5555|