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FDA Proposes New Registration Requirements and Exemptions

The U.S. Food and Drug Administration (FDA) issued a proposed rule that would expand on the definition of a retail food establishment and add new requirements to the food facility registration system.

Retail Food Establishments Definition

Retail food establishments are exempt from FDA’s food facility registration requirements. A retail food establishment is defined as an establishment with the primary function of selling food products directly to consumers. According to FDA, “an establishment’s primary function is to sell 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.”

In the proposed rule, FDA seeks to clarify that these sale values include sales from platforms such as farmers’ markets, roadside stands, and Community Supported Agriculture programs. This clarification would increase the number of facilities that are exempt from FDA registration requirements. These facilities would also be exempt from the upcoming Food Safety Modernization Act (FSMA) preventive control requirements.

New Food Facility Registration Requirements

FDA’s proposed rule would require food facility registrations to be submitted electronically (this would take effect on January 4, 2016 or later) and would require registrants to include the type of activity conducted at the facility for each food product category. The proposed rule would also “provide for measures to verify certain information submitted in registrations.”

In addition to the new requirements, the proposed rule would update current regulations to cover already-existing provisions that became effective upon the enactment of FSMA. These include biennial registration renewal and the requirement for registrations to contain the e-mail address of the facility contact person and, if the facility is foreign, it’s U.S. Agent. The proposed rule would also add the FSMA requirement that registering with FDA grants FDA the permission to inspect the facility.

Registrar Corp can help food facilities determine whether or not they are required to register with the U.S. FDA. For those that are required to register, Registrar Corp can properly register them with FDA, as well as assist them to comply with other FDA regulations for food and beverage companies. The firm also offers mock FDA inspections to help food facilities prepare in advance of an FDA facility inspection. For questions or assistance, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at http://www.registrarcorp.com/LiveHelp.

This blog was originally published as a press release.





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