The new regulatory package Food Safety Modernization Act (FSMA) requires all food business operators who produce, handle, hold or store products intended for the U.S. market to adopt a food safety management system in line with what is defined by FDA guidelines.
Food Defense supports food companies in complying with US regulatory requirements under the Food Safety Modernization Act, with activities such as:
· Registration of the organization on the FDA portal
· Food Safety Plan
· Food Defense Plan
· HACCP Seafood Plans
· Gap Analysis FSMA Requirement
· FCE registrations and SID forms
FDA Registration and US Agent Service
FDA registration is mandatory for all companies that want to export food products to the USA and represents the first step to be able to export. Once registered, FDA will provide the company with a specific number with which it is identified. Registration must be renewed every 2 years specifying any changes that have occurred at the company level.
We offer support services in FDA registration and its renewal for food companies that intend to export to the USA.
In order to export food products, it is also necessary to appoint your own US Agent, i.e. a reference entity that represents the company on US territory and that carries out an intermediary activity directly with FDA. Our team offers the US Agent service to represent food companies on US territory.
The Food Safety Modernization Act requires the development of a Food Safety Plan in accordance with the Preventive Control for Human Food Act, based on the HARCP approach, to manage food safety.
The Food Safety Plan is a plan that describes the activities that ensure the safety of food during production, processing, packaging and storage.
For every company that exports food to the USA subject to FDA jurisdiction, it is mandatory to implement a Food Safety Plan, which must be led by a person whose skills are recognized by FDA, the Preventive Control Qualified Individual.
Food Defense offers consulting, support and implementation of Food Safety Plans based on Preventive Controls in order to ensure compliance with US regulations thanks to its recognized expertise and the use of innovative IT systems.
Food Defense refers to the set of activities aimed at protecting food products from intentional acts of contamination, sabotage and tampering.
The Food Defense Plan (FDP) is a plan that is based on food defense principles, incorporates a vulnerability assessment, includes mitigation strategies, and outlines food defense monitoring, corrective actions, and verification procedures to be followed.
The adoption of a FDP has become a mandatory requirement for companies that produce and export to the USA subject to FDA jurisdiction following the establishment of the Food Safety Modernization Act; its implementation must be led by a person whose skills are recognized by FDA, the Food Defense Qualified Individual.
Food Defense provides consulting, support and implementation of Food Defense plans in order to ensure compliance with US regulations thanks to its recognized expertise and the use of innovative IT systems.
HACCP Seafood Plans
The Food Safety Modernization Act, in addition to establishing new food safety requirements according to the Preventive Control approach, incorporates FDA regulations prior to its establishment such as, among others, the requirements for the implementation of HACCP Seafood plans for companies in the seafood sector that intend to export their food products to the USA. These HACCP plans must be implemented by conducting a risk analysis according to the requirements of the HACCP Seafood Alliance.
We offer consulting services in the implementation of HACCP Seafood plans according to current American regulations.
Gap Analysis FSMA Requirement
From the moment the food company is registered on the FDA portal, the latter can undergo an official inspection by FDA inspectors in order to verify their alignment with the legal requirements. Following FDA requirements, the company can be subject to administrative sanctions up to the blocking of the goods in customs and the refusal to enter the American territory, with both economic and image damages.
We offer Food Safety and Food Defense Audit services in preparation for FDA inspections to verify the alignment of food companies with the requirements of the Food Safety Modernization Act.