The short answer
FDA does not issue, approve or require a “HACCP certificate”. What FDA requires is a written food safety system that fits your product:
| Your product | What FDA requires | Rule | HACCP certificate? |
|---|---|---|---|
| Fish and seafood | A written Seafood HACCP plan when the hazard analysis shows hazards that need control | 21 CFR Part 123 | Not required by FDA |
| Juice | A written Juice HACCP plan, including a pathogen reduction step | 21 CFR Part 120 | Not required by FDA |
| Most other foods | A written food safety plan with preventive controls, prepared by a PCQI | 21 CFR Part 117 | Not required by FDA |
So why does everyone ask for a HACCP certificate? Because buyers, distributors and retailers often want proof from an independent auditor. That is a commercial requirement, not an FDA one — but it can still decide whether you win the order.
1. Seafood: HACCP is the law
Processors of fish and fishery products — in the US and abroad — must carry out a hazard analysis and, where hazards are reasonably likely, have and follow a written HACCP plan. FDA's own guidance is clear on three points:
- FDA does not approve HACCP plans. Plans are not sent to FDA or pre-approved, and FDA keeps no list of foreign firms with “acceptable” plans.
- Training applies to foreign processors too. The hazard analysis and plan must be done by a HACCP-trained person, who does not have to be your employee.
- US importers must verify you. Under 21 CFR 123.12 the importer must take steps to verify that seafood was processed under HACCP — for example by keeping your HACCP plan and records, or a certificate from a third party. FDA has no standard certificate form, and a foreign processor cannot do the importer's verification for them.
Example
A shrimp processor in Vietnam or India shipping frozen shrimp to a US distributor needs: FDA food facility registration with a U.S. Agent, a Seafood HACCP plan run by a trained person, Prior Notice for each shipment, and English labels. The distributor will usually ask for the HACCP plan or an audit certificate to meet its own importer verification duty.
2. Juice: HACCP plus a pathogen reduction step
Juice processors follow 21 CFR Part 120. The plan must include controls that reduce the most resistant pathogen of concern — this is why juice HACCP is stricter than general food safety. As with seafood, FDA does not certify the plan; it checks it during inspection.
3. Most other foods: a food safety plan, not “HACCP”
Since FSMA, most facilities that must register with FDA follow the Preventive Controls for Human Food rule (21 CFR Part 117). It is built on HACCP principles but goes further: the written food safety plan covers process controls, allergen controls, sanitation controls and supply-chain controls, and it must be prepared or overseen by a Preventive Controls Qualified Individual (PCQI).
Facilities that follow seafood or juice HACCP rules are exempt from these preventive controls requirements (21 CFR 117.5) — you follow one system, not both.
4. When a HACCP certificate does help
- Buyer requirements: many US importers and retailers ask for a third-party HACCP or GFSI-scheme certificate before they buy.
- Supplier verification: a good audit report helps your US importer meet its FSVP or seafood importer verification duties — see GFSI certificates and FSVP.
- Inspections: a working HACCP system makes an FDA foreign inspection far easier.
HACCP training: what counts
For seafood, FDA worked with the Seafood HACCP Alliance on a standardized curriculum. FDA does not approve or recognize other courses; trainers are expected to compare their course to the Alliance curriculum. A person can also qualify through job experience. For other foods, the equivalent role is the PCQI.
Checklist for exporters
- Know which rule applies to your product: seafood HACCP, juice HACCP, or preventive controls
- Written plan in place, developed by a trained person (HACCP-trained or PCQI)
- Records kept and available in English for your US importer
- FDA food facility registration active, with a U.S. Agent
- Third-party certificate only if your buyer asks for it
Registration, U.S. Agent, labels and FSVP — handled for you.
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
Frequently asked questions
Does FDA issue HACCP certificates?
No. FDA does not approve, certify or keep a list of HACCP plans. HACCP plans are not submitted to FDA. A HACCP certificate comes from a private certification body, usually because a buyer asks for one.
Is HACCP mandatory for exporting food to the US?
A HACCP plan is mandatory for fish and fishery products (21 CFR Part 123) and for juice (21 CFR Part 120) when the hazard analysis shows hazards that need control. Most other food facilities that register with FDA need a written food safety plan under the Preventive Controls rule (21 CFR Part 117) instead.
Who can write a seafood HACCP plan?
The hazard analysis and HACCP plan must be developed by a person trained in HACCP — through a course at least equivalent to the standardized curriculum FDA developed with the Seafood HACCP Alliance, or through job experience. The trained person does not have to be an employee of the processor, and the rule applies equally to foreign processors.
Is a HACCP certificate the same as FDA registration?
No. FDA food facility registration is a separate legal requirement for facilities that make, pack or hold food for the US. A HACCP certificate does not replace registration, Prior Notice or FSVP.
Sources
- FDA — Questions and Answers on HACCP Regulation for Fish and Fishery Products (guidance)
- eCFR — 21 CFR Part 120, Juice HACCP
- FDA — Questions and Answers on Juice HACCP Regulation (guidance)
- FDA — Seafood HACCP and the FDA Food Safety Modernization Act (guidance)
- eCFR — 21 CFR Part 117 (CGMP and Preventive Controls for Human Food)
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.