EU 852/2004
This glossary term is part of the SG Systems Global regulatory & operations guide library.
Updated January 2026 • Regulation (EC) No 852/2004 (Food Hygiene), HACCP-based procedures, prerequisite programs (PRPs), sanitation & cleaning verification, allergen and cross-contamination control, temperature management, supplier and intake discipline, training & competence, traceability & recall readiness, audit-ready records • EU & UK Food Manufacturing (food processing, bakery, ingredients/dry mixes, produce packing, co-packers, cold stores, distribution)
EU 852/2004 is the European Union’s foundational food hygiene regulation. Operationally, it is the rule set that turns “we run a clean food plant” into “we operate under a structured hygiene system that is based on HACCP principles and proven through defensible records.” It is the baseline hygiene law for most EU food businesses, and it is the reason regulators and major customers expect to see real, working controls—cleaning programs with verification, contamination prevention, temperature discipline, competent staff, and evidence that you can respond fast when something goes wrong.
This regulation matters because it formalizes hygiene as a system, not a vibe. 852/2004 expects food businesses to implement hygiene prerequisite programs and HACCP-based procedures that actually control hazards in real time. It also makes “paper compliance” fragile: you’re expected to align what you say you do with what happens on the floor. If your HACCP plan exists but monitoring is inconsistent, if sanitation is logged but not verified, or if allergen controls are “common sense,” the regulation is already doing its job—highlighting that your controls can’t survive routine operational pressure.
Tell it like it is: most 852/2004 failures don’t happen because teams don’t care about hygiene. They happen because controls collapse under speed—rushed changeovers, weak line clearance, incomplete cleaning verification, temperature excursions without documented disposition, unlabeled rework, poor segregation, and records assembled after the fact. 852/2004 punishes the “we’ll reconstruct it later” model because hygiene risk is judged by what you controlled at the time of work, not what you can explain afterward.
“Hygiene compliance isn’t proven by policies. It’s proven by how reliably your controls hold on your busiest day.”
- HACCP
- Food Safety Plan (FSP)
- Preventive Controls Program
- Cross-Contamination Control
- Allergen Cross-Contact
- Allergen Changeover Verification
- Packaging Line Clearance Verification
- Temperature-Controlled Storage
- Temperature Excursion
- Quarantine (Quality Hold Status)
- Traceability (End-to-End Lot Genealogy)
- Mock Recall Drill
- Recall Readiness
- Record Retention
- What people mean when they cite EU 852/2004
- Scope map: what 852/2004 actually controls
- HACCP-based procedures: control model, not paperwork
- Prerequisite programs (PRPs): the hygiene foundation that fails quietly
- Cleaning and sanitation: verification vs theatre
- Cross-contamination prevention: zoning, tools, and workflow reality
- Allergen controls: where hygiene becomes consumer safety
- Temperature control: evidence, alarms, and disposition decisions
- Supplier and intake discipline: bad inputs create bad hygiene outcomes
- Training and competence: prove behavior, not attendance
- Records and retrieval: “prove it now” is the standard
- Traceability and incident response: the fastest route to trust
- Copy/paste hygiene readiness scorecard
- Selection pitfalls: how 852/2004 compliance gets faked
- How this maps to V5 by SG Systems Global
- Where this matters by industry
- Extended FAQ
1) What people mean when they cite EU 852/2004
When teams say “we need to comply with 852,” they usually mean one of three operational realities:
- HACCP expectation: the site must run HACCP-based procedures that actually control hazards.
- Hygiene discipline: sanitation, segregation, and temperature controls must hold under pressure.
- Evidence speed: during inspections or incidents, records must be retrievable quickly and consistently.
Tell it like it is: 852/2004 is where “we have a plan” becomes “show me it worked yesterday.”
2) Scope map: what 852/2004 actually controls
EU 852/2004 is a control map for hygiene fundamentals. It expects hazards to be identified and controlled through PRPs and HACCP-based procedures, and it expects the evidence chain to be consistent with real practice.
| Control area | Operational meaning | What typically breaks |
|---|---|---|
| HACCP-based controls | Hazards mapped to process steps with monitoring and corrective action | Plans exist; execution drifts |
| Sanitation | Cleaning standards defined and verified | Checkbox cleaning |
| Segregation | Cross-contamination pathways blocked by workflow design | Boundary drift under pressure |
| Temperature control | Monitoring plus documented disposition on excursions | Excursions with no decisions |
| Training | Competence tied to roles and behaviors | Attendance without effectiveness |
| Traceability | Fast, accurate lot genealogy to support incident response | Slow retrieval and inconsistent lot IDs |
The practical takeaway: hygiene compliance is an execution property. If you’re relying on end-of-shift paperwork, the system is fragile.
3) HACCP-based procedures: control model, not paperwork
HACCP is a logic: identify hazards, define controls, monitor them, and take corrective action when controls fail. Under 852/2004, that logic must be real in daily work. Monitoring must happen because the workflow requires it, not because someone remembers.
Tell it like it is: a HACCP plan that can’t survive your busiest day isn’t a control system—it’s a document.
4) Prerequisite programs (PRPs): the hygiene foundation that fails quietly
PRPs are the baseline hygiene supports: cleaning, pest control, maintenance, calibration, supplier controls, allergen segregation, and facility design discipline. PRPs fail quietly because the consequences aren’t immediate—until the day they are.
Tell it like it is: most major food incidents are not “one bad day.” They are months of PRP drift that nobody made visible.
5) Cleaning and sanitation: verification vs theatre
Cleaning without verification is theatre. 852/2004 expects sanitation to be designed, executed, and verified in a way that controls risk—not simply documented. Verification can include inspections, swabs, ATP, trend reviews, and exception capture.
Tell it like it is: if sanitation records look perfect every time, you may be recording compliance instead of measuring outcomes.
6) Cross-contamination prevention: zoning, tools, and workflow reality
Cross-contamination prevention is a workflow discipline: movement patterns, tool control, raw/RTE separation, rework boundaries, and changeover procedures must be engineered so the wrong action is hard to take.
Tell it like it is: if segregation relies on “people being careful,” it will fail under schedule pressure.
7) Allergen controls: where hygiene becomes consumer safety
Allergen control is one of the highest consequence hygiene areas because failures can harm consumers quickly. Controls must survive real production: segregated storage, controlled staging, verified line clearance, and label integrity that prevents mislabel events.
Tell it like it is: allergen programs collapse when rework and changeovers are treated as “routine.” Those are the exact moments risk spikes.
8) Temperature control: evidence, alarms, and disposition decisions
Temperature monitoring is easy. Temperature governance is hard. 852/2004 expects the site to respond when temperatures deviate—quarantine impacted product, evaluate risk, and document disposition decisions. Excursions without disposition are compliance failures waiting to be discovered.
Tell it like it is: a temperature log is not proof of control. Your response is the proof.
9) Supplier and intake discipline: bad inputs create bad hygiene outcomes
Hygiene failures often begin upstream. Poor incoming controls, weak supplier qualification, and inadequate intake checks introduce risk that downstream sanitation cannot reliably “fix.” Strong sites treat receiving as a control point with holds and acceptance criteria that are enforced.
Tell it like it is: if your receiving dock is permissive, your whole food safety plan becomes reactive.
10) Training and competence: prove behavior, not attendance
Training is only valuable when it changes behavior. 852/2004 expects hygiene competence in real work: correct handoffs, correct tools, correct changeovers, correct responses to alarms, and correct documentation at time of action.
Tell it like it is: certificates don’t prevent incidents. Competent execution does.
11) Records and retrieval: “prove it now” is the standard
During inspections or incidents, the site must be able to produce evidence quickly: sanitation verification, monitoring records, corrective actions, and traceability outputs. If evidence exists but is slow to retrieve, it looks like lack of control.
Tell it like it is: retrieval speed is a compliance control because authorities make decisions on the evidence available during the window.
12) Traceability and incident response: the fastest route to trust
Even though 852/2004 is “hygiene,” incident response depends on traceability. When an issue is suspected, you must find affected lots, stop shipment, quarantine inventory, and respond quickly. Slow traceability expands incident scope and increases enforcement risk.
Tell it like it is: fast genealogy keeps problems small. Slow genealogy turns small problems into big ones.
13) Copy/paste hygiene readiness scorecard
Use this as a practical self-assessment. If you can’t answer these cleanly, your 852/2004 posture is fragile.
EU 852/2004 Readiness Scorecard
- HACCP execution: Are monitoring and corrective actions embedded in daily work?
- Sanitation verification: Do you verify outcomes and capture exceptions?
- Segregation discipline: Are cross-contamination boundaries enforced by workflow?
- Allergen controls: Are changeovers verified and labels controlled under pressure?
- Temperature governance: Do excursions trigger holds and documented disposition?
- Supplier/intake control: Are bad inputs blocked by holds and acceptance criteria?
- Training effectiveness: Can you prove competence by role, not just training completion?
- Traceability speed: Can you produce genealogy and customer lists quickly?
- Record integrity: Are records complete, consistent, and resistant to quiet edits?
- Retrieval: Can you produce evidence during the inspection window without scrambling?
The goal isn’t “a good audit.” The goal is hygiene controls that remain stable when the plant is busy.
14) Selection pitfalls: how 852/2004 compliance gets faked
- Binder HACCP. Plans exist; monitoring is inconsistent.
- Cleaning theatre. Schedules are completed; outcomes aren’t verified.
- Allergen hope. Segregation exists until production is late.
- Excursion normalization. Temperature drift is treated as routine.
- Rework ambiguity. Rework is used without strong boundaries or evidence.
- Traceability by spreadsheet. Genealogy exists only after manual reconstruction.
- Slow retrieval. Evidence exists but can’t be produced during inspections.
Tell it like it is: these are system design failures. Fixing them requires workflow gates, not more reminders.
15) How this maps to V5 by SG Systems Global
V5 supports EU 852/2004 outcomes by making hygiene controls executable: enforced checks, real-time holds, scan-based genealogy, and fast retrieval. The advantage isn’t that software “knows hygiene.” The advantage is that software makes evidence a byproduct of work.
- Platform overview: V5 Solution Overview
- Execution control: Manufacturing Execution System (MES) for stepwise monitoring, line clearance, and batch records
- Inventory + movements: Warehouse Management System (WMS) for lot/location discipline, holds, and shipment genealogy
- Quality governance: Quality Management System (QMS) for deviations, CAPA, audits, and sanitation/incident investigations
- Integration layer: V5 Connect (API) to link sensors, temperature logs, labeling systems, and ERP data into one evidence chain
Tell it like it is: 852/2004 compliance collapses when temperature, sanitation, and traceability live in separate systems. V5 aligns them so inspections and incidents are answered with retrieval, not heroics.
16) Where this matters by industry
EU 852/2004 is universal in EU food manufacturing, but the failure modes differ by process. In Food Processing, hygiene drift typically shows up in sanitation verification, cross-contamination boundaries, and rapid disposition during temperature or process excursions. In Bakery and Ingredients & Dry Mixes, the common pain is changeovers, allergen control, and rework governance under speed.
For logistics-heavy operations like Produce Packing, the “hygiene system” is often judged by cold chain evidence, rapid holds, and traceability speed when events occur. Even in adjacent sectors like Consumer Products and Cosmetics, the same hygiene disciplines—sanitation verification, segregation, and evidence retrieval—drive trust during audits and customer challenges.
If you want the full market map, start here: Industry Solutions. The same evidence-first hygiene posture also strengthens readiness in regulated environments like Dietary Supplements and Pharmaceutical Manufacturing, where record integrity expectations are already high.
17) Extended FAQ
Q1. Is EU 852/2004 basically “HACCP law”?
It requires HACCP-based procedures and hygiene prerequisite programs. The practical standard is that controls must be operating and provable, not merely documented.
Q2. What’s the most common failure pattern?
PRP drift: cleaning and segregation are logged but not verified, and excursions don’t trigger holds and documented disposition decisions.
Q3. Why does traceability matter in a hygiene regulation?
Because when hygiene risk is suspected, you must identify affected lots and act quickly. Traceability speed determines how small the incident stays.
Q4. How do we stress-test 852 readiness?
Pick a shipped lot and produce the evidence chain quickly: sanitation verification, HACCP monitoring and corrective actions, temperature history and disposition, holds/releases, and customer genealogy. If it takes hours and spreadsheets, tighten workflow controls.
Q5. What changes outcomes fastest?
Verified sanitation, enforced holds on excursions, and scan-based genealogy with rapid retrieval. Those three controls eliminate most “busy shift” hygiene failures.
Related Reading
Build food hygiene as an execution system: anchor risk controls with HACCP and a clear Food Safety Plan, keep allergen risk honest with Allergen Cross-Contact + Line Clearance, and make incident response survivable with End-to-End Lot Genealogy + Recall Readiness. Support evidence across V5, MES, WMS, QMS, and V5 Connect.
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