SERVICE EXPORT USA

The new regulatory package Food Safety Modernization Act (FSMA) obliges all food sector operators who produce, handle, hold or store products destined for the US market to adopt a food safety management system in line with what is defined by the FDA guidelines.


Food Defense supports food companies in adapting to legal requirements for the USA according to 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 in being able to export. Once registered, the FDA will provide the company with a specific number by which it is identified. Registration must be renewed every 2 years specifying any changes that have occurred at company level.

We offer support service in FDA registration and its renewal for food companies intending to export to the USA.


Furthermore, in order to export food products, it is 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 the FDA. Our team offers the US Agent service to represent food companies in the USA.


Food Safety Plan


The Food Safety Modernization Act requires the drafting of a Food Safety Plan in accordance with the Preventive Control for Human Food, based on the HARCP approach, for the management of food safety.

The Food Safety Plan is a plan in which the activities that guarantee the safety of food during production, processing, packaging and conservation are described.

For every company that exports food to the USA subject to FDA jurisdiction, it is mandatory to implement the Food Safety Plan, which must be led by a person whose skills are recognized by the FDA, the Preventive Control Qualified Individual.

Food Defense offers consultancy, support and implementation of Food Safety Plans based on Preventive Controls in order to guarantee compliance with US regulations thanks to its recognized expertise and the use of innovative IT systems.


Food Defense Plan


By Food Defense we mean 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 an 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 guided by a person whose skills are recognized by the FDA, the Food Defense Qualified Individual.

Food Defense provides consultancy, 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 institution such as, among others, the requirements for the implementation of HACCP Seafood plans for companies in the fishing sector that intend to export their food products to the USA. Such HACCP plans must be implemented following the conduct of a risk analysis according to the requirements of the HACCP Seafood Alliance.

We offer consultancy services in the implementation of HACCP Seafood plans according to current American legislation.

Gap Analysis FSMA Requirement


From the moment the food company is registered on the FDA portal, it can undergo an official inspection by FDA inspectors in order to verify their alignment with legal requirements. Following prescriptions from the FDA, the company may be subject to administrative sanctions up to the blocking of the goods at customs and the failure to enter American territory, with both economic and image damage.

We offer Audit services related to Food Safety and Food Defense in preparation for FDA inspections to verify the alignment of food companies with the requirements of the Food Safety Modernization Act.

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