Updated July 2026 FSMA 204 DEADLINE: 20 JULY 2028

HACCP Explained: The 7 Principles, 12 Steps, and How Global Food Safety Rules Fit Together

The single framework behind US, EU, and Japanese food safety law — and the practical guide to building a plan that satisfies all three. Includes the extended FSMA 204 Traceability Rule deadline and a cross-market comparison.

The Bottom Line

HACCP (Hazard Analysis and Critical Control Points) is the internationally recognised, preventive food-safety framework built on seven principles and implemented through twelve steps, codified by the Codex Alimentarius. It is mandatory in most major markets: the US requires HACCP for meat, poultry, seafood, and juice and a HACCP-based Preventive Controls plan for most other facilities; the EU requires HACCP-based procedures under Regulation (EC) 852/2004; and Japan has required HACCP-based hygiene control for nearly all food businesses since June 2021. The nearest major US deadline is FSMA 204 (Food Traceability Rule), extended in 2025 to July 20, 2028. Certification against a GFSI standard (FSSC 22000, BRCGS, SQF) sits on top of the legal baseline for businesses selling to major retailers or exporting.

What HACCP Is — and Why It Exists

HACCP is a systematic method for making food safe by building controls into the process rather than inspecting the finished product. It asks three questions at every step: what could go wrong (the hazard), where can we control it (the critical control point), and how do we prove we did (monitoring and records).

The framework was born in the 1960s from a collaboration between Pillsbury, NASA, and the US Army Laboratories, who needed to be certain that food for astronauts would not cause illness in space — where end-product testing that destroyed the sample was useless. The answer was to design safety in and document control at every step. The approach was later adopted by the Codex Alimentarius Commission (the joint FAO/WHO food standards body), whose General Principles of Food Hygiene made HACCP the global reference.

Because every major regulator anchored its rules to the same Codex principles, HACCP became the common language of food trade: a plan built correctly in one country speaks the same grammar as the rules in another.

Source: Codex Alimentarius — FAO/WHO →

The Seven Principles

These seven principles are the heart of HACCP and appear in near-identical form in US, EU, Japanese, and Codex frameworks.

1

Conduct a Hazard Analysis

Identify biological, chemical, and physical hazards at every process step and assess which are significant enough to require control.

2

Determine the Critical Control Points

Find the steps essential to controlling each significant hazard — the points where loss of control means an unacceptable risk with no later catch.

3

Establish Critical Limits

Set measurable, validated boundaries for each CCP — a minimum core cooking temperature, a maximum chill time, a metal-detector sensitivity.

4

Establish Monitoring

Define what is measured, how, how often, and by whom, so a deviation is caught in real time before unsafe product moves on.

5

Establish Corrective Actions

Predefine what happens when a limit is breached: bring the CCP back into control and decide the fate of the affected product.

6

Establish Verification

Confirm the system actually works — validate critical limits, calibrate instruments, review records, and reanalyse periodically.

7

Establish Documentation and Records

Keep the plan and its monitoring, corrective-action, and verification records as the evidence that control was maintained.

The Twelve Steps: Principles in Practice

Codex frames implementation as twelve steps. The first five prepare the ground; steps six to twelve are the seven principles. Skipping the preparatory five is the most common reason HACCP plans fail.

StepActionMaps To
1Assemble the HACCP teamPreparatory
2Describe the productPreparatory
3Identify the intended usePreparatory
4Construct the flow diagramPreparatory
5Confirm the flow diagram on sitePreparatory
6Conduct a hazard analysisPrinciple 1
7Determine the CCPsPrinciple 2
8Establish critical limitsPrinciple 3
9Establish monitoringPrinciple 4
10Establish corrective actionsPrinciple 5
11Establish verificationPrinciple 6
12Establish documentation and recordsPrinciple 7

CCPs, Prerequisite Programmes, and oPRPs

The single most misunderstood part of HACCP is the boundary between a critical control point and the hygiene foundations around it.

Prerequisite Programmes (PRPs)

The Foundation

Cleaning and sanitation, pest control, staff hygiene, maintenance, water quality, supplier control. These manage the general environment and must be working before HACCP can be validated. Strong PRPs reduce the number of CCPs you need.

Critical Control Points (CCPs)

The Controlled Steps

Specific, monitored steps that control identified significant hazards — cooking, chilling, pasteurisation, metal detection. Each has a validated critical limit, real-time monitoring, and defined corrective actions.

Between the two sit operational prerequisite programmes (oPRPs), used in ISO 22000 and FSSC 22000: measures that control a significant hazard but are not managed at a classic CCP with a measurable critical limit — for example, an allergen-changeover cleaning procedure.

The United States: FSMA and Traditional HACCP

US food safety splits between traditional mandatory HACCP and the broader FSMA framework.

Mandatory HACCP Sectors

  • Meat and poultry — USDA FSIS HACCP, mandatory since the late 1990s
  • Seafood — FDA Seafood HACCP (21 CFR Part 123)
  • Juice — FDA Juice HACCP (21 CFR Part 120)

FSMA Preventive Controls (PCHF)

For most other FDA-regulated facilities, the Preventive Controls for Human Food rule requires a written food safety plan built on hazard analysis and risk-based preventive controls — a HACCP-derived framework that adds supply-chain controls, a recall plan, and a Preventive Controls Qualified Individual (PCQI) to oversee it.

FSMA 204: The Traceability Rule

Deadline: July 20, 2028. In 2025 the FDA extended the FSMA 204 compliance date by 30 months from January 20, 2026. Businesses handling foods on the Food Traceability List must keep and share Key Data Elements (KDEs) at Critical Tracking Events (CTEs) — harvesting, packing, shipping, receiving, transforming. No specific technology is mandated, but interoperable digital records are the practical route.
Source: FSMA Food Traceability Rule — FDA →

The European Union: Regulation (EC) 852/2004

The EU requires all food business operators — processors, restaurants, caterers, retailers — except primary producers to put in place, implement, and maintain permanent procedures based on the HACCP principles.

  • Flexibility for small businesses: simplified, generic HACCP-based guides are permitted where proportionate to the risk
  • Traceability: the General Food Law (Regulation 178/2002) requires 'one step back, one step forward' traceability for all food and feed operators
  • Official controls: Regulation (EU) 2017/625 governs how member-state authorities verify compliance

The EU model influenced Japan's system and shares the Codex backbone with the US, which is why an EU-compliant HACCP plan transfers readily to other markets.

Japan: Mandatory HACCP Since 2021

Japan amended its Food Sanitation Act in 2018, and from June 1, 2021 (after a one-year transition) HACCP-based hygiene control became mandatory for essentially all food business operators. Japan uses a two-tier structure:

TierWhoApproach
HACCP-based sanitation management (Standard A)Larger manufacturers and processorsFull Codex seven principles
HACCP-considerate sanitation management (Standard B)Small businesses, restaurants, certain retailersSimplified approach following industry-association handbooks

There is no separate national HACCP certificate in Japan; compliance is confirmed through routine inspections by local public-health centres. This guide is written by a Japanese Gyoseishoshi (administrative-law professional) who prepares food-business licensing and hygiene documentation.

US vs EU vs Japan: How the Rules Compare

AspectUnited StatesEuropean UnionJapan
Core instrumentFSMA (PCHF) + sector HACCPRegulation (EC) 852/2004Food Sanitation Act
Mandatory sinceMeat/poultry 1990s; PCHF 2016+2006June 2021
ScopeMost food facilitiesAll operators except primary productionNearly all food businesses
Small-business flexibilityQualified facility exemptionsSimplified generic guidesStandard B handbooks
TraceabilityFSMA 204 (from 20 Jul 2028)One step back / forward (178/2002)Voluntary guidelines
National certificateNo — plan requiredNo — procedures requiredNo — inspection-based
Codex basis

HACCP vs ISO 22000 vs FSSC 22000: What Buyers Ask For

Legal compliance requires a working HACCP plan. Selling to major retailers or exporting usually requires third-party certification on top.

1

HACCP

The core hazard-control method — the seven principles applied to your process. The legal baseline in most markets.

2

ISO 22000

A food safety management system that embeds HACCP inside an ISO management structure: leadership, planning, communication, continual improvement.

3

FSSC 22000

ISO 22000 plus sector prerequisite requirements (ISO/TS 22002) and FSSC additions — GFSI-recognised, the passport for global retail supply chains.

Other GFSI-benchmarked schemes buyers may specify include BRCGS, SQF, and IFS — all built on HACCP. Choose the one your customers and target markets recognise.

HACCP and Food-Safety Milestones

1960s
Pillsbury, NASA, and the US Army develop HACCP for space-mission food Active
1997
Codex adopts HACCP guidelines; USDA FSIS mandates HACCP for meat and poultry Active
2006
EU Regulation (EC) 852/2004 applies — HACCP-based procedures required Active
2011
US Food Safety Modernization Act (FSMA) signed into law Active
1 Jun 2021
Japan makes HACCP-based hygiene control mandatory for nearly all food businesses Active
2025
FDA extends FSMA 204 compliance date by 30 months Active
20 Jul 2028
FSMA 204 Food Traceability Rule compliance date — KDEs at CTEs for Food Traceability List foods Future
Source: FSMA 204 Compliance Date — FDA →

Frequently Asked Questions

HACCP stands for Hazard Analysis and Critical Control Points. It is a systematic, preventive approach to food safety that identifies biological, chemical, and physical hazards throughout the production process and establishes controls to reduce them to acceptable levels. Rather than relying on end-product testing, HACCP builds safety into the process itself. It originated in the 1960s from a collaboration between Pillsbury, NASA, and the US Army to ensure safe food for space missions, and is now the internationally recognised foundation of food safety management, codified by the Codex Alimentarius Commission.
The seven principles are: (1) Conduct a hazard analysis; (2) Determine the critical control points (CCPs); (3) Establish critical limits for each CCP; (4) Establish monitoring procedures; (5) Establish corrective actions when a critical limit is not met; (6) Establish verification procedures to confirm the system works; and (7) Establish record-keeping and documentation procedures. These seven principles are universal — they appear in essentially identical form in US, EU, Japanese, and Codex frameworks, which is why HACCP is the common language of global food trade.
The Codex Alimentarius sets out twelve steps: the first five are preparatory, and the last seven are the principles themselves. Steps 1-5: (1) assemble the HACCP team; (2) describe the product; (3) identify the intended use; (4) construct a flow diagram; (5) confirm the flow diagram on site. Steps 6-12 correspond directly to the seven principles: (6) hazard analysis, (7) determine CCPs, (8) set critical limits, (9) establish monitoring, (10) establish corrective actions, (11) establish verification, and (12) establish documentation and record-keeping.
A critical control point is a step in the process at which a control can be applied and is essential to prevent, eliminate, or reduce a food safety hazard to an acceptable level. Classic examples are cooking (to kill pathogens), chilling (to prevent bacterial growth), metal detection (to remove physical hazards), and pasteurisation. CCPs are distinguished from prerequisite programmes and ordinary control points by the Codex decision tree — a CCP is a step where loss of control would result in an unacceptable safety risk with no later step to catch it.
Prerequisite programmes (PRPs) are the foundational hygiene conditions and practices — cleaning and sanitation, pest control, staff hygiene, maintenance, supplier control — that must be in place before HACCP can work. CCPs are the specific, monitored control steps identified by the hazard analysis for particular hazards. PRPs manage the general environment; CCPs manage identified significant hazards at defined process steps. A robust PRP foundation reduces the number of CCPs needed. In some schemes, operational prerequisite programmes (oPRPs) sit between the two, controlling significant hazards that are not managed at a classic CCP.
In most major markets, yes — for most food businesses. In the United States, HACCP is mandatory for meat and poultry (USDA FSIS), seafood, and juice, while the broader FSMA Preventive Controls rule applies a HACCP-based framework to most other FDA-regulated food facilities. In the European Union, Regulation (EC) 852/2004 requires all food business operators except primary producers to implement procedures based on HACCP principles. In Japan, HACCP-based hygiene management became mandatory for essentially all food businesses in June 2021. Codex HACCP is the shared basis for all of these.
The Food Safety Modernization Act (FSMA) modernised US food safety around prevention. Its Preventive Controls for Human Food rule (PCHF) requires a food safety plan built on hazard analysis and risk-based preventive controls — a HACCP-derived framework with additional elements such as supply-chain controls and a recall plan. Traditional HACCP still governs meat, poultry, seafood, and juice. The most significant near-term FSMA milestone is the Food Traceability Rule (FSMA 204), whose compliance date was extended to July 20, 2028 — requiring enhanced records for foods on the Food Traceability List.
FSMA 204, the Food Traceability Rule, requires businesses that manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to keep and share Key Data Elements (KDEs) at Critical Tracking Events (CTEs) such as harvesting, packing, shipping, receiving, and transforming. The goal is rapid tracing during outbreaks. In 2025 the FDA extended the compliance date by 30 months, from January 20, 2026 to July 20, 2028. The rule does not mandate any specific technology, but interoperable digital record-keeping is the practical path to compliance for complex supply chains.
Regulation (EC) 852/2004 on the hygiene of foodstuffs requires all food business operators — from processors to restaurants and caterers, but excluding primary production — to put in place, implement, and maintain permanent procedures based on the HACCP principles. The EU allows flexibility for small businesses, permitting simplified, generic HACCP-based guides where appropriate. The regulation sits alongside the General Food Law (Regulation 178/2002), which establishes traceability 'one step back, one step forward' for all food and feed operators across the Union.
Following a 2018 amendment to the Food Sanitation Act, HACCP-based hygiene control became mandatory for essentially all food business operators in Japan from June 1, 2021, after a one-year transition. Japan uses a two-tier system: 'HACCP-based sanitation management' (Standard A) modelled on the full Codex seven principles for larger operators, and 'HACCP-considerate sanitation management' (Standard B) — a simplified approach following industry-association handbooks for small businesses, restaurants, and certain retailers. There is no separate national certificate; compliance is verified through routine health-centre inspections.
For a small to medium food business, a realistic timeline is three to six months: a few weeks to assemble the team and document products and flow diagrams, several weeks for the hazard analysis and CCP determination, and further time to write procedures, train staff, and run the system before verification. Larger or higher-risk operations, or those pursuing GFSI-recognised certification such as FSSC 22000 or BRCGS, should plan for six to twelve months. The prerequisite programmes must be functioning before the HACCP plan is validated.
It depends on your market and customers. Regulators generally require you to implement and maintain HACCP-based procedures — not to hold a certificate. However, many buyers, retailers, and export markets require third-party certification against a GFSI-benchmarked standard such as FSSC 22000, BRCGS, SQF, or IFS, all of which incorporate HACCP. So a legally compliant business needs a working HACCP plan; a business selling to major retailers or exporting often needs certification on top. Certification is an audited, renewable demonstration that your HACCP system meets a recognised standard.
The FTL covers foods the FDA has identified as higher-risk for causing serious illness, including certain cheeses, shell eggs, nut butters, cucumbers, herbs, leafy greens, melons, peppers, sprouts, tropical tree fruits, tomatoes, certain fish and crustaceans, and ready-to-eat deli salads. Businesses handling these foods must maintain the enhanced FSMA 204 records. Foods that are changed through commercial processing so that a listed food is no longer recognisable, or that undergo a kill step, may qualify for exemptions — the specifics are set out in the rule.
HACCP is the core hazard-control methodology. ISO 22000 is a food safety management system standard that embeds HACCP within a broader management structure — leadership, planning, resources, communication, and continual improvement — modelled on the ISO management-system format. FSSC 22000 combines ISO 22000 with sector-specific prerequisite programme requirements (ISO/TS 22002 series) and additional FSSC requirements, and is recognised by the Global Food Safety Initiative (GFSI). In short: HACCP is the method, ISO 22000 wraps it in a management system, and FSSC 22000 makes that system GFSI-certifiable for global buyers.
Frequent failures include: treating HACCP as a paperwork exercise rather than a living system; identifying too many CCPs because prerequisite programmes are weak; setting critical limits that cannot actually be monitored in real time; neglecting to validate that critical limits genuinely control the hazard; failing to record corrective actions when limits are breached; and letting the plan go stale after process, supplier, or recipe changes. The remedy is disciplined verification and reanalysis: review the plan at least annually and whenever the process changes.
Follow the twelve steps in order. First, secure the prerequisite programmes — sanitation, pest control, hygiene, maintenance. Then assemble a multi-disciplinary team, describe each product and its intended use, and draw and verify an accurate process flow diagram on the factory floor. Conduct the hazard analysis for each step, determine CCPs using the decision tree, set measurable critical limits, and build monitoring, corrective action, verification, and record-keeping procedures around them. Train everyone, run the system, and validate it before relying on it. Reanalyse at least annually.

HACCP Build Checklist

#ItemStatus
1Prerequisite programmes documented and functioning (sanitation, pest, hygiene, maintenance, supplier)
2Multi-disciplinary HACCP team assembled
3Each product described (composition, packaging, shelf life, storage)
4Intended use and vulnerable consumers identified
5Flow diagram drawn and confirmed on the factory floor
6Hazard analysis completed for every step (biological, chemical, physical)
7CCPs determined using the Codex decision tree
8Validated critical limits set for each CCP
9Monitoring procedures defined (what, how, frequency, who)
10Corrective actions and product disposition predefined
11Verification and validation scheduled; instruments calibrated
12Record-keeping system in place; annual reanalysis scheduled
13Market-specific rules mapped (FSMA/PCHF, 852/2004, Food Sanitation Act)
14FSMA 204 exposure assessed if handling Food Traceability List foods (2028)
15Certification path chosen if buyers require GFSI (FSSC 22000 / BRCGS / SQF)
TS

Takayuki Sawai

Gyoseishoshi (Certified Administrative Scrivener) practising in Japan — the licensed profession that prepares food-business licensing and hygiene documentation. Compliance researcher covering HACCP, drone aviation law, and the EU AI Act. Over 20 years at Hiroshima Prefectural Government.

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