United States · Certification
FSSC 22000 certification in the United States
Achieve FSSC 22000 certification in the US with Sterling: 8,100+ client engagements in 60+ countries, 20+ years.
- Accredited certification
- New York office team
- Effivity software included
- Academy training included
Who asks for FSSC 22000 in the US
Clients include
FSSC 22000 certification in the US at a glance
One US instrument bears on FSSC 22000. It does not name the standard. So why do buyers in the US keep asking for the certificate?
North American retailers and brand owners routinely ask food manufacturers for a GFSI-recognised certificate; FSSC 22000 is one of the schemes that qualifies. Managed by Foundation FSSC, it combines ISO 22000 with sector prerequisite programmes and the scheme's own additional requirements, and certificates are issued only by certification bodies licensed by the Foundation and accredited for the scheme. The regulatory floor sits underneath: FDA's preventive controls rule at 21 CFR Part 117 requires a written food safety plan prepared or overseen by a preventive controls qualified individual, and many manufacturers build one FSSC 22000 system that serves the FDA obligation and the customer's audit together. Food and beverage processors, packaging manufacturers and ingredient suppliers are the usual applicants. Sterling's New York office aligns the hazard analysis, prerequisite programmes and verification records with both, with Effivity and Sterling Academy included. Local questions follow.
Who needs FSSC 22000 in the US, and what happens without it
In the US the question rarely comes from a law. It comes from the buyer, the regulator or the partner that wants proof before it signs. These are the organisations that get asked.
- Food and beverage manufacturers supplying national retailers and brand ownersBuyers ask for a GFSI-recognised certificate.
- Human food facilities under FDA preventive controlsA written food safety plan is required; FSSC 22000 can be built to meet it alongside the customer audit.
- Packaging and ingredient manufacturersScheme categories cover packaging and ingredient supply.
Not sure which of these applies to you?Answer a short set of questions and your readiness report arrives by e-mail.
Take the FSSC 22000 readiness checkFSSC 22000 requirements in the US
Strip away the vocabulary and FSSC 22000 asks a company to prove six things about food safety to the level global buyers expect.
In the US these six sit alongside the local laws and regulations listed under drivers below; one system can evidence both. The detail is on the global hub: FSSC 22000 explained →
How to get FSSC 22000 certified in the US
One team from the New York office carries the work from scoping to certificate. Delivered from the New York office across the US, with remote delivery for teams in other time zones and on-site work as agreed.
- Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
- Gap assessment against FSSC 22000 and the US requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
- Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
- Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before the certification body arrives.
- Certification body stage 1 and stage 2, then surveillanceAn accredited body audits and decides. Sterling supports the audits and the three-year cycle.
- End to end, from one team
- Effivity ISO & GRC software
- Preferential Sterling Academy access, with complimentary awareness training for your people
- Internal auditor training for your audit team, as applicable to your standard
- Vulnerability assessment on ISMS engagements
The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.
How long does FSSC 22000 certification take in the US?
There is no standard duration: it depends on your scope and on how much of the system already runs. In the US these are the factors that set the timeline.
- Number of sites and product categories
- Existing HACCP or preventive controls plan
- Prerequisite programme gaps
- Certification body availability
Sterling agrees a dated plan with you on the discovery call, once the scope is known.
How much does FSSC 22000 certification cost in the US?
The cost has two parts: the consulting work to build and prove the system, and the certification body’s audit fees, which are quoted separately. In the US these factors move both.
- Number of sites and production lines
- Certification body audit fees quoted separately from consulting
- Prerequisite programme upgrades (hygiene, pest control, allergen management)
- Training of the food safety team
Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.
FSSC 22000 consultants and certification bodies in the US
Two different organisations are involved. A consultant helps you build the system and prove it works; an accredited certification body then audits or assesses it and decides. Keeping the two separate is what makes the result credible to buyers and regulators.
- Check that the body’s accreditation or approval covers FSSC 22000 and your sector, and that its certificates can be verified online.
- Ask the consultant how the local requirements in the US are mapped into the same system, so nothing runs twice.
- Ask for client references in your sector; Sterling’s client letters are available on request.
- Agree who owns the evidence and the tool after the engagement; with Sterling the system stays yours, in Effivity.
Laws and regulations that drive FSSC 22000 in the US (2)
| Instrument | How it treats the standard |
|---|---|
| Foundation FSSC — FSSC 22000 scheme | Scheme rule FSSC 22000 is a GFSI-recognised food safety management system. |
| FDA preventive controls for human food (21 CFR Part 117) | Expected in practice Written food safety plan; FSSC 22000 not cited. |
"Expected in practice" means the instrument asks for the outcomes FSSC 22000 covers without naming a standard, and FSSC 22000 is what buyers and regulators commonly accept as evidence of them.
Accreditation, audit language and remote audits in the US
FSSC 22000 certificates are issued only by certification bodies licensed by Foundation FSSC and accredited for the scheme. No body is named here unless verified. Edition and transition details: FSSC 22000 hub →
Audit language
Audits are conducted in English; agree the audit and document language with the certification body at application.
Remote and on-site
Remote audit elements are at the certification body's discretion under its accreditation rules; operational sites are normally visited on-site.
FSSC 22000 in the US: questions clients ask
Is FSSC 22000 required by the FDA?
No. The FDA requires a written food safety plan for human food facilities under its preventive controls rule, 21 CFR Part 117, and that rule does not cite FSSC 22000. The scheme is a voluntary route that buyers may request on top of your legal duties. Check your obligations with your counsel or the FDA.
Is FSSC 22000 GFSI-recognised?
Yes. According to Foundation FSSC, the scheme owner, FSSC 22000 is a GFSI-recognised food safety management system. If a buyer requires a GFSI-recognised certificate, this is one the buyer can accept. Confirm the current recognition status with Foundation FSSC before quoting it in a tender or on a label.
Can one system meet FSMA and FSSC 22000?
Largely, if you plan for both from the start. FSMA calls for a written food safety plan built on a hazard analysis, and the scheme has its own audit requirements. Align the hazard analysis and the preventive controls with the scheme's requirements so one set of records serves both, then ask the certification body to confirm the fit.
More on FSSC 22000 for US organisations
Other standards US businesses ask Sterling for
Organisations in the US often combine FSSC 22000 with one of these, under one management system where the scopes allow.
Start with a free discovery call from the New York office
A Sterling consultant goes through your entities, your regulators and your target date with you. No proposal until the scope is agreed.
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Plan your certification with the New York team.
Tell us your goals, locations and target date. We’ll help you define the scope, timeline and next steps.
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