In September 16th, 2016, the  “Final Rules” provided in the “Food Safety Modernization Act ” ( FSMA ) issued by the Food and Drug Administration (the US agency for food and medicines) became mandatory.

This means that to market processed foods in the US market, all companies registered with the FDA will have to adapt to new US legislation, either when exporting in USA, or when the distributor is already on American soil: these “Final Rules” equally apply to both to the domestic market and outside the United States of America.

The ” Final Rule” most relevant to manufacturers is inherent to the ” Preventive Controls for Human Food “. This requires that the company has to adopt a system made of preventive control procedures, which in turn are based on risk analysis: this system, better known as HARPC (Hazard Analysis and Risk-Based Preventive Controls), complements the HACCP Plan already in use in the company and introduces new ones such as radiological hazards and intentional hazards.

In summary, the HARPC is a HACCP, but with higher control regarding prevention and mitigation of risks.

If an improper planning and implementation of HARPC is detected, the FDA may suspend the company’s registration and forbid the marketing of its products.

The HARPC and the new obligations introduced by the FDA for the US market

Since September 2016, the FDA includes among its duties prevention of the damage that may be caused by quality food quality, both locally produced and imported.

Specifically, these new laws require preventive controls across the food chain and allows the FDA new enforcement powers, aimed at obtaining higher rates of compliance with food safety standards.

A product that does not comply with the standard’s criteria  can be withdrawed from the market and its trading can be forbidden too.

The HARPC applies to all products processed with the exception of fruit juices, alcoholic beverages, fresh fish and live animals, meat, chicken and eggs, since they are controlled by the USDA (US Department of Agriculture).

The ” Final Rules” , as a result, have introduced a new figure responsible for the whole implementation of the internal control system, called Preventive Controls Qualified Individual , or better, PCQI.

To export to the US, therefore, all companies registered with the FDA will have to implement their own Self-Control Manual, which also needs to be translated into English and expanded with preventive controls introduced from FSMA, and ensure the presence of a PCQI for its management.

The benefits of adopting the HARPC within the company are:

  • Compliance with US regulations;
  • High decrease of the chances of receiving sanctions or measures;
  • More controls on the production of its products;
  • Consulting services from qualified staff (PCQI).


ESHQ Consulting Srl offers specialized professional advice, in order to provide services tailored to the company’s need and ensure proper implementation of the controls carried out in food companies exporting to the United States.

By ensuring maximum effectiveness and quality of services offered, ESHQ Consulting Srl offers:

  • A counselling and control service, performed by a qualified PCQI
  • Implementation and English translation of the self-control manual
  • Introduction of new control system in the company, compliant to the HARPC system;
  • Development and translation of labels, which is required to ensure compliance of the products on the US market.

For more details visit “the catalogue section”