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Regulation (EC) No 852/2004 on the hygiene of foodstuffs

Updated 2026-07-12 · Consolidated text as of 2021-03-24 · Reviewed by: Redazione ce85204 — revisione editoriale assistita da AI (2026-07-12)

Regulation (EC) No 852/2004, adopted on 29 April 2004 and applicable since 1 January 2006, lays down general food hygiene rules for all food business operators. It comprises 5 chapters (18 articles) and 2 annexes, amended by Regulations 1019/2008, 219/2009 and 2021/382; the consolidated text is dated 24 March 2021.

At a glance

Commentary

Background and adoption

The Regulation was adopted by the European Parliament and the Council on 29 April 2004 as the horizontal instrument of the Hygiene Package: a single set of general hygiene rules applying to every foodstuff and every stage of production, processing and distribution, built on the principle that primary responsibility for food safety rests with the food business operator, as already stated in the General Food Law Article 17(1) of Regulation (EC) No 178/2002. From its date of application it repealed Directive 93/43/EEC on the hygiene of foodstuffs Article 17(1) of Regulation (EC) No 852/2004, replacing the earlier patchwork of vertical hygiene directives.

The act was published in Official Journal L 139 of 30 April 2004 and republished in full, by way of corrigendum, in Official Journal L 226 of 25 June 2004 Corrigendum, OJ L 226, 25.6.2004; the corrected version is the one to be referred to. The Regulation entered into force on the twentieth day following its publication but applies from 1 January 2006, in step with the other acts of the Hygiene Package Article 18 of Regulation (EC) No 852/2004.

Structure: five chapters and two annexes

ChapterArticlesSubject matter
I — General provisions1-3Scope, definitions, general obligation
II — Food business operators' obligations4-6General and specific hygiene requirements, HACCP-based procedures, official controls, registration and approval
III — Guides to good practice7-9Development, dissemination and use of guides, national guides and Community guides
IV — Imports and exports10-11Imported and exported food
V — Final provisions12-18Implementing measures, committee procedure, repeal, entry into force

Two annexes complete the act: Annex I sets out the requirements for primary production and associated operations Annex I of Regulation (EC) No 852/2004, while Annex II lays down the general hygiene requirements — twelve chapters plus two chapters added in 2021 — for all food business operators other than primary producers Annex II of Regulation (EC) No 852/2004.

The three amendments and the corrigendum

The consolidated text in force (CELEX 02004R0852-20210324) incorporates three amending acts:

In addition, the corrigendum published in Official Journal L 226 of 25 June 2004 Corrigendum, OJ L 226, 25.6.2004 republished the entire act, correcting the first publication. The full updated text is available on the consolidated text page.

Relationship with other instruments

The Regulation operates within the framework of the General Food Law: the definitions of "food", "food business" and "food business operator" are those of Regulation (EC) No 178/2002 Article 3 of Regulation (EC) No 178/2002, expressly referred to by Article 2 Article 2(2) of Regulation (EC) No 852/2004. Food of animal origin is additionally subject to the specific rules of Regulation (EC) No 853/2004 Article 1 of Regulation (EC) No 853/2004, and the microbiological criteria for foodstuffs are laid down in Regulation (EC) No 2073/2005 Article 3 of Regulation (EC) No 2073/2005.

Official controls on compliance with the Regulation are now governed by Regulation (EU) 2017/625 Article 1 of Regulation (EU) 2017/625, which repealed Regulations (EC) No 854/2004 and No 882/2004: references to those two acts, still common in secondary sources, must be read as references to the 2017 Regulation.

National implementation and penalties

As a regulation, the act is binding in its entirety and directly applicable in all Member States, with no transposition required Article 18 of Regulation (EC) No 852/2004. Penalties, however, remain national: in Italy the applicable penalty regime is set out in Legislative Decree No 193/2007 Article 6 of Italian Legislative Decree No 193/2007. The countries section collects implementation details, competent authorities and penalties for each Member State.

Frequently asked questions

What does Regulation 852/2004 cover?

Regulation (EC) No 852/2004 lays down general rules on the hygiene of foodstuffs for food business operators, at all stages of production, processing and distribution Article 1(1) of Regulation (EC) No 852/2004. It is the horizontal instrument of the EU Hygiene Package: it applies to every food, while Regulation (EC) No 853/2004 adds specific rules for food of animal origin.

When did Regulation 852/2004 become applicable?

The Regulation was adopted on 29 April 2004 and applies from 1 January 2006 Article 18 of Regulation (EC) No 852/2004. From that date it repealed Directive 93/43/EEC on the hygiene of foodstuffs Article 17(1) of Regulation (EC) No 852/2004.

Who does it apply to, and who is exempt?

It applies to all food business operators, including primary production. It does not apply to primary production for private domestic use, to the domestic preparation, handling or storage of food for private domestic consumption, or to the direct supply of small quantities of primary products by the producer to the final consumer or to local retail establishments, which is governed by national law Article 1(2) of Regulation (EC) No 852/2004. See the dedicated page on Article 1.

What are the main obligations for a food business?

Three pillars: complying with the general and specific hygiene requirements of Annexes I and II Article 4 of Regulation (EC) No 852/2004; putting in place, implementing and maintaining permanent procedures based on the HACCP principles (for stages after primary production) Article 5(1) of Regulation (EC) No 852/2004; and notifying each establishment to the competent authority for registration or, where required, obtaining approval Article 6(2) of Regulation (EC) No 852/2004.

Does Regulation 852/2004 provide for any certificate?

No. The Regulation establishes no certificate: it imposes obligations, namely registration of the establishment Article 6(2) of Regulation (EC) No 852/2004, self-monitoring based on the HACCP principles Article 5(1) of Regulation (EC) No 852/2004 and training of food handlers Annex II, Chapter XII of Regulation (EC) No 852/2004. Training certificates, where they exist, are governed by national or regional law in the Member States.

How many times has Regulation 852/2004 been amended?

Three times: by Regulation (EC) No 1019/2008 (clean water for fishery products, Annex II Chapter VII), by Regulation (EC) No 219/2009 (committee procedure, Articles 13 and 14) and by Regulation (EU) 2021/382 (allergen management in primary production, food redistribution, food safety culture), applicable from 24 March 2021 Article 1 of Regulation (EU) 2021/382. A corrigendum republishing the whole act appeared in OJ L 226 of 25 June 2004 Corrigendum, OJ L 226, 25.6.2004.

Where can I read the official up-to-date text?

The version consolidated as of 24 March 2021 (CELEX 02004R0852-20210324) is published on EUR-Lex and reproduced in full, navigable by article and paragraph, on the consolidated text page of this site. Only the text published in the Official Journal of the European Union is authentic.

What is the difference between Annex I and Annex II?

Annex I applies to food business operators carrying out primary production and associated operations (transport, storage and handling of primary products at the place of production) Annex I of Regulation (EC) No 852/2004; Annex II lays down the general hygiene requirements — premises, transport, equipment, personal hygiene, training — for all other food business operators Annex II of Regulation (EC) No 852/2004.

Sources

Drafting and review

Redazione ce85204. Draft generated with AI from primary sources; AI-assisted editorial review (see methodology).