Guide
FSVP: what US importers of European food have to do
The Foreign Supplier Verification Program rule makes the US importer responsible for checking foreign suppliers. Here is who it applies to, what the program must contain and how FDA checks it.
In short
- The FSVP importer is the US owner or consignee of the food when it enters the US. If there is none, a US agent has to sign on to the role.
- You need a written program for each food and supplier: hazard analysis, supplier evaluation and approval, verification and corrective actions.
- Every entry must name the FSVP importer, with an email address and a DUNS number.
- FDA checks the program by reviewing your records. Importers without one can be put on Import Alert 99-41, and their shipments detained without examination.
What FSVP is
FSVP is one of the rules under the FDA Food Safety Modernization Act (FSMA). It sits in 21 CFR Part 1, Subpart L. It took effect in 2016, and all of its compliance dates have passed.
The idea is that food made abroad should give the same level of public health protection as food made in the US, and the rule puts the job of checking that on the US importer. Your program has to give adequate assurance that each foreign supplier makes the food in line with the US preventive controls or produce safety rules where they apply, that the food is not adulterated, and that it is not misbranded for major food allergens (§1.502).
Who the FSVP importer is
The rule defines the importer as the US owner or consignee of the food at the time of entry. In practice that is usually the US distributor, wholesaler or retailer buying from Europe.
If there is no US owner or consignee, for example when a European brand still owns the goods as they enter, the FSVP importer is the US agent or representative of the foreign owner. That person has to confirm the role in a signed statement of consent.
Two points that often get mixed up:
- Your customs broker is not automatically the FSVP importer. The broker files the entry, but the duty sits with the owner or consignee unless the broker has formally taken on the role.
- There is no FSVP certification. FDA does not approve or certify programs. Training courses certify people, not programs. The program is yours, and FDA reviews it when it inspects you.
What the program must include
A qualified individual has to develop the program and carry out its activities. The core elements are:
| Element | What it means | Rule |
|---|---|---|
| Qualified individual | Someone with the education, training or experience to do the work, who can read the records they review. | §1.503 |
| Hazard analysis | A written analysis for each food of the known or reasonably foreseeable biological, chemical and physical hazards. Chemical hazards explicitly include unapproved food or color additives and food allergens. | §1.504 |
| Evaluation and approval | Assess the hazards, the supplier's own controls and its compliance history. Approve suppliers on that basis, in writing. | §1.505 |
| Verification | Onsite audits, sampling and testing, or review of the supplier's food safety records, matched to the risk. Where the supplier controls a serious hazard, an annual onsite audit is the default. | §1.506 |
| Corrective actions | Act promptly when a supplier falls short, including stopping imports from them where needed. | §1.508 |
| Reevaluation | Review the evaluation at least every three years, or sooner when new information comes up. | §1.505 |
| Identification at entry | Your name, email address and DUNS number on each entry line. | §1.509 |
| Records | Keep them at least two years. Records kept offsite must be available within 24 hours of an FDA request, with an English translation on request. | §1.510 |
Exemptions and lighter rules
Very small importers
If you average under $1 million a year (adjusted for inflation, over three years) in human food sales plus the US market value of the human food you import, lighter rules apply. The main duty becomes getting written assurance from each supplier before you import and at least every two years after that, and acting if the supplier falls short. You still have to be identified at entry.
Modified rules
Food from certain small suppliers and dietary supplements have their own, modified requirements.
Outside the rule
Juice and seafood already covered by FDA's HACCP rules, food for research or personal use, alcoholic beverages, food imported only to be exported again, and some meat, poultry and egg products regulated by USDA. Low-acid canned foods are exempt for microbiological hazards only.
Countries with comparable systems
Lighter rules can apply to food from countries whose food safety system FDA formally recognizes. At the time of writing that is Australia, Canada and New Zealand. No EU country is on the list, so food from Europe follows the standard rule.
How FDA enforces it
FSVP inspections are mostly record reviews, at your office or done remotely. Investigators ask for your program and the documents behind it.
The most common finding is the most basic one: no program at all. An industry analysis of FDA's 2020 inspection data found that failing to develop an FSVP was the top observation for food that year.
Findings can lead to a Form 483 and then a warning letter. If problems are not fixed, FDA can add the importer to the Red List of Import Alert 99-41. Food that importer brings in can then be detained without physical examination until FDA accepts that the problems are solved.
Where European food needs attention
The FSVP rule names two hazards that matter for European candy and snacks in particular:
- Colour and food additives. The EU and the US approve different lists. A colour that is legal across Europe can be unapproved in the US, or allowed only under conditions. Food with an unapproved additive counts as adulterated under US law.
- Allergen labeling. The US has nine major food allergens and its own labeling rules. A label that is correct for the EU can still leave out what US rules require.
Other label rules, such as English text, Nutrition Facts and net quantity, sit outside FSVP. A shipment can still be detained over them. See what happens in an FDA detention.
Where Westbound fits
Check the additive and allergen points before you order
We screen the ingredients, colours and labels of European food against current FDA rules and give you a written, dated verdict for every product. It is not an FSVP, we don't act as your FSVP importer, and it doesn't make you compliant. It gives you a documented check on those points before the goods ship.
Get a quoteCommon questions
Is FSVP the same as FDA food facility registration?
No. The factory in Europe registers with FDA. FSVP is the importer's duty. Prior notice for each shipment is a third, separate requirement. You need all three.
What does the European supplier have to do?
Supply the information you need: details of their food safety controls, audit reports, test results and specifications. The duty to verify sits with the US importer.
Do I need a DUNS number?
Yes. Each entry has to identify the FSVP importer with a unique facility identifier, and FDA recognizes the DUNS number for this.
Can my European supplier be the FSVP importer?
Not directly. When there is no US owner or consignee at entry, a US agent or representative of the foreign owner takes the role and signs a statement of consent.
Sources
This guide explains the rules in general terms, as we read them on 26 September 2026. It is not legal advice. Rules change, so check the current text through the sources above or with a qualified adviser before you rely on it.
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