Companies importing food products regulated by the FDA, already see changes to the entry process.
When food is offered for entry into the United States, the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system will require the filer to enter at least one additional code as part of the required data elements.
This will then prompt the ACE system to ask for the importer’s name, email address, and Unique Facility Identifier (UFI) recognized as acceptable by the FDA.
Therefore, being willing and able to provide your company’s DUNS Number, upon request, is essential.
Because the FDA started enforcing the FSVP rules, you are expected to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) for each food and supplier, unless exempt.
Importers are required to establish and follow written procedures to ensure that they import foods only from foreign suppliers they approved based on an evaluation of the risk posed by the imported food and the supplier’s performance, or from suppliers whose foods are subjected to adequate verification activities before being imported.
Identify known or reasonably foreseeable hazards in each food:
> Biological, chemical, and physical hazards
> Foreseeable hazards that may be present in a food because
■ hazard occurs naturally
■ hazard may be unintentionally introduced
■ hazard may be intentionally introduced for purposes of economic gain.
Evaluate identified hazards, including pathogens, to assess probability that hazard will occur in the absence of controls and the severity of the illness or injury, if the hazard were to occur.
Relevant factors to consider:
■ formulation, condition, function, and design of the establishment and equipment of a typical entity that manufactures/processes, grows, harvests, or raises this type of food
■ raw materials and other ingredients
■ transportation practices
■ harvesting, raising, manufacturing, processing, and packing procedures
■ packaging and labeling activities
■ storage and distribution
■ intended or reasonably foreseeable use
■ sanitation, including employee hygiene.
Reevaluate if new information or concerns relating to foreign supplier or at the end of any 3-year period.
Take actions: discontinue use of foreign supplier, change verification activities, based on reevaluation if results of verification activity do not provide adequate assurance that hazards requiring a control in the food were significantly minimized or prevented.
The hazard analysis must be conducted by a qualified individual or entity other than the foreign supplier.
Please note that in case there is no U.S. owner or consignee, the U.S. Agent or representative becomes the importer for the purpose of FSVP. However, an approval would be required.
Let’s suppose one of the Affirmation of Compliance codes “FSV” (entry subject to the FSVP regulation) or “FSX” (food exempt from FSVP), is not transmitted for an imported food product. Then, what?
Under these circumstances, the entry line will be rejected, which will result in detention of the shipment by the FDA then by the U.S. Customs.
Small and mid-sized importers may be less ready to comply with FSVP requirements than their large importer and food producer counterparts.
Working with documents in different languages, having to overcome language barriers, while under-resourced and unable to dedicate complete resources to fulfilling the requirements of FSVP, can be challenging.
ITB HOLDINGS LLC assists companies in the United States, Canada, Mexico, Brazil, Australia, India, China, Japan, South Korea, Russia, Portugal, Spain, Italy, France, Belgium, Netherlands, Switzerland, Germany, Sweden, United Kingdom, and Ireland, among many other countries.
We simply expect you to provide all relevant documentation, upon request. So, get in touch, 24/7.