Regulation on the Hygiene of Foodstuffs
The EU's general food-hygiene regulation (Regulation (EC) No 852/2004 of 29 April 2004) — the counterpart of the US preventive-controls rule. It obliges every food business operator to ensure hygiene across all stages of production, processing, and distribution, and requires operators other than primary producers to implement permanent procedures based on the HACCP principles (Article 5). Annex I covers primary production; Annex II sets the general hygiene requirements for everyone else.
What this does not cover
stated in the document's own scope- Covers food business operators generally; specific hygiene rules for products of animal origin are in Regulation (EC) 853/2004, not here.
- Primary producers follow Annex I and are not subject to the Article 5 HACCP obligation, though national guides steer their practice.
- Sets hygiene obligations on operators; official controls by authorities are governed by the separate EU official-controls regulation.
- An EU instrument: the US preventive-controls and produce-safety regimes are distinct rules under FSMA, not applications of 852/2004.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Regulation (EC) No 852/2004 is the general food-hygiene law of the EU — the framework that makes every food business operator responsible for the safety of the food under its control, from primary production to retail. Its central instrument is Article 5: operators other than primary producers must establish, implement, and maintain permanent procedures based on the HACCP principles — hazard analysis, critical control points, critical limits, monitoring, corrective action, verification, and documentation. Annex I carries the hygiene rules for primary production and associated operations; Annex II sets the general hygiene requirements for all other operators, covering premises, transport, equipment, food waste, water supply, personal hygiene, wrapping, heat treatment, and training. Establishments must be registered with — and where required by other EU law, approved by — their competent authority.
Scope & applicability
All food business operators in the EU at every stage of the food chain after (and including, via Annex I) primary production. Sector-specific rules for products of animal origin sit in the companion Regulation (EC) 853/2004.
Legal basis & how it acquires force
A regulation of the European Parliament and of the Council of 29 April 2004, adopted as part of the EU "hygiene package" and applicable from 1 January 2006. As a regulation it is directly applicable in every Member State; enforcement runs through national competent authorities under the EU official-controls framework. It has been amended over time, including Commission Regulation (EU) 2021/382, which added allergen-management and food-safety-culture provisions to Annex II.
Document structure
| Part | Covers |
|---|---|
| General obligations and hygiene requirements | Operator responsibility for food safety and the general obligation to meet the relevant annex requirements |
| Article 5 — HACCP-based procedures | Permanent procedures based on the seven HACCP principles for operators beyond primary production |
| Registration, approval and national guides | Establishment registration/approval and the development of national and Community guides to good practice |
| Annex I — primary production | Hygiene provisions and record-keeping for primary producers and associated operations |
| Annex II — general hygiene requirements | Premises, rooms, transport, equipment, food waste, water, personal hygiene, foodstuffs, wrapping, heat treatment, and training — plus allergen management and food safety culture added in 2021 |
Key requirements
- Food business operators ensure hygiene at all stages under their control
- Permanent procedures based on the HACCP principles for operators beyond primary production (Article 5)
- Compliance with the general hygiene requirements of Annex II (premises, equipment, personnel, training, water, waste)
- Primary producers comply with Annex I and associated record-keeping
- Registration (or approval where required) of food establishments with the competent authority
Implementation tips
- Use the Codex general principles as the interpretive frame — Article 5 is written to Codex HACCP, so a Codex-conformant plan maps directly onto the EU obligation
Revision notes
Adopted 29 April 2004 as part of the EU hygiene package, applicable from 1 January 2006. Amended since, including Commission Regulation (EU) 2021/382 on allergen management and food safety culture in Annex II.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
The regulation is written to the Codex Alimentarius general principles of food hygiene: Article 5's HACCP obligation mirrors the Codex seven principles, so Codex-conformant systems satisfy it structurally. It is the EU counterpart of the US preventive-controls regime in 21 CFR Part 117, and the management-system standard ISO 22000 wraps the same HACCP core in a certifiable framework. Sector rules for products of animal origin sit in the companion Regulation (EC) 853/2004.
Reg. (EC) 852/2004: frequently asked questions
Quick answers to common questions about Reg. (EC) 852/2004.
Who must comply with Regulation 852/2004?
Every food business operator in the EU, at all stages of production, processing, and distribution — from farms (under Annex I) through manufacturers, distributors, caterers, and retailers (under Annex II and Article 5). Responsibility for food safety rests squarely on the operator.
Does Regulation 852/2004 require HACCP?
Yes, for operators other than primary producers: Article 5 requires permanent procedures based on the HACCP principles. Flexibility is built in — the procedures must be proportionate to the business, and guides to good practice can support compliance in small operations.
What did Regulation (EU) 2021/382 change?
It amended Annex II to add requirements on allergen management — avoiding cross-contamination of foods with allergens — and to embed a food safety culture: management commitment, training, and hygiene awareness across the workforce.
How does 852/2004 relate to the US FSMA rules?
They are counterpart regimes. 852/2004 obliges EU operators to run HACCP-based procedures under Annex II hygiene conditions; the US reaches similar outcomes through 21 CFR 117's hazard analysis and risk-based preventive controls and, on farms, the Part 112 produce-safety standards. The frameworks differ in structure and terminology, so exporters comply with each on its own terms.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.