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.
Registrations are now required to contain the type of activity conducted at the facility for each food product category. This will be required when the final rule becomes effective on July 14, 2016. The final rule also amends the definition of a retail food establishment in a way that expands the number of establishments that are considered retail food establishments, and that are therefore not required to register with the FDA as food facilities. However, all food establishments, including retail food establishments, continue to have a responsibility to ensure their food is safe.
- Federal Register Notice to view full text of the Rule
- Docket Folder FDA-2002-N-0323 for commenting
- Regulatory Impact Analysis
- Food Facility Registration (includes Guidance and Registration Instructions)
- Webinar: Final Rule under FSMA to Update Food Facility Registration August 3, 2016
- Frequently Asked Questions on FSMA
- FSMA Training
- How to Contact FDA about FSMA (Technical Assistance Network)