Frequently Asked Questions

To import into the US

F.A.Q.

Is it mandatory to retain an FSVP agent to export to the US?

Yes, it is a mandatory requirement if there is not a US owner or designated receiver when your products enter the US boarders. The same requirements also apply in case you intend to show your food products at American trade fairs or ship them through Amazon to a public storage facility in the US, and from there, enter the local markets with your local distribution network.

Is a foreign producer/exporter with a US subsidiary company/division registered in the US

Not necessarily.

However, if the aforesaid US subsidiary/division does not dispose of a qualified employee professionally familiar with the FSVP regulations, it does need to retain an FSVP Agent

Who is qualified to act as an di agente FSVP agent?

A qualified  FSVP Agent must be a US-resident professional specifically competent in the FSVP regulation, formally retained by the foreign exporter/FSVP importer to check and ensure that all the food product imported into America comply with the relevant US laws and can pass the FDA food safety controls.

Is the FSVP Agent obliged to designate a FSVP Qualified Individual?

Yes, it is.

Pursuant to the FSMA relevant dispositions, upon its designation, the FSVP Agent must designated a FSVP Qualified Individual for Prevention Controls (PCQI) as its assistant in drafting, monitoring, and keeping updated  the FSVP Manual for the importer, as required by the FDA.

Which activities must the FSVP Agent perform

The standard requirements to pass the foreign supplier verification programs (FSVP) are as follows:  

  • Providing risk analyses for all products to be imported into the US;
  • Evaluating and approving the foreign suppliers in consideration of their production processes, singles ingredients used in such processes, and types of  product to be imported into the US;  
  • Pinning down and implement the verification activities specifically relevant to each and any foreign suppliers;
  • Implementing correction procedures (when necessary);
  • Representing the importer in the identification procedure when the shipments enter the US and acting as the official record keeper of the importer before the FDA for all concerning documents and registers relevant to the FSVP regulations for two years or more;
  • Subsequent evaluations and approvals of the foreign suppliers every three year or more.
What the FSVP Agent is supposed to ensure with is activities?

The FSVP Agent must ensure that all the food products to be imported into the US satisfy the same food safety regulatory requirements which apply to the American producer and distributors. Also, the FSVP Agent needs to specifically verify that the products comply with the US regulations aimed to sanction sophistication and/or improper labeling with respect to allergens.

Which activities is the producer supposed to carry out to comply with the FSMA regulation?

The producer must draft a HARPC (Food Safety Plan) containing the following documents:

  • A Risk Analysis aimed to pin down the possible hazards requiring preventive control.
  • Certification attesting the preventive food safety controls performed at the producer facility.

The Food Safety Plan includes the preventive controls on the following areas of interest:

Production processes; hygiene and allergens controls; foreign supplier verification plan, along with a product recall plan from the American market; implementation of the aforesaid preventive controls and corrective/verification procedures.

What happens if my labeling set non does not comply with the US rules?

Two options are available to the firm: Either correctly relabeling the products to keep marketing it in America, or shipping it off the US, or destroyng it at its own expenses. Labeling incompliance constitutes one of the most common cause of block of sales imposed by the FDA and the consequent product recall by the firms.

What happens if a producer does not comply with the US laws and regulations?

A producer who is not compliant with the regulation PCHF of the FSMA and undergoes a FDA inspection, may incur the block of the product when the merchandise is still in the phase of importation and/or in the process of recall from the American market. A producer, to be sure to obtain custom clearance and marketing feasibility in the States for its human food products, needs to demonstrate that its firms can meet the requirements and dispositions set on the FSMA.

What happens if a producer does not comply with the FSMA regulations?

A producer who is not compliant with the regulation FSVP of the FSMA and undergoes a FDA inspection, may incur the block of the product when the merchandise is still in the phase of importation into the US, and/or in the phase of recall from the American market. A producer, to be sure to obtain custom clearance and marketing feasibility in the States for its human food products, needs to demonstrate that its firms meets can meet the requirements and dispositions set on the FSMA.

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