Article 3 of Regulation (EC) No 852/2004 — General hygiene obligation of the FBO

Rationale and origin

Article 3 is the pivotal duty-side provision: it opens Chapter II of Regulation (EC) No 852/2004 and states the general obligation, that is, the rule that makes the hygiene requirements scattered across the following articles and annexes binding on the operator Article 3 of Regulation (EC) No 852/2004. The Regulation states as its premise, in Article 1, that primary responsibility for food safety rests with the food business operator Article 1(1) of Regulation (EC) No 852/2004; Article 3 turns that premise into a specific, enforceable duty. Systematically it is the bridge between general food law and the detailed hygiene rules: the FBO's primary responsibility is laid down in general terms by Article 17 of Regulation (EC) No 178/2002 Article 17(1) of Regulation (EC) No 178/2002, and Article 3 is its specific application to hygiene.

The wording is deliberately broad — "all stages of production, processing and distribution". The legislature adopts the farm-to-fork approach, so the whole food chain is covered, but it assigns to each operator only the part "under [its] control". This is not joint-and-several liability over the entire chain but segmented responsibility: a caterer answers for service, not for the growing of the raw material; a primary producer answers for primary production, for which Annex I applies rather than Annex II Article 4(1) of Regulation (EC) No 852/2004.

Personal scope

The addressee is the food business operator, a concept the Regulation borrows by reference from general food law Article 2(1) of Regulation (EC) No 852/2004. The notion is wide and independent of legal form, size and profit motive: it covers industry, craft operations, restaurants, bars and cafés, food trucks, retail, storage and transport. Article 3 does not scale the obligation to the size of the business: proportionality operates, if anywhere, on the technical content of the requirements and on the documentation of self-checking Article 5(2) of Regulation (EC) No 852/2004, not on the existence of the duty to ensure hygiene.

Material scope

Article 3 has no self-standing technical content: it is a referring provision. The "relevant hygiene requirements laid down in this Regulation" are, first, the general and specific requirements of Article 4 and of the annexes it invokes Article 4(2) of Regulation (EC) No 852/2004, and, second, the permanent HACCP-based procedures required by Article 5 Article 5(1) of Regulation (EC) No 852/2004. The word "relevant" is the interpretive key: only the requirements relevant to the stage carried out apply to a given operator. An ambient-temperature warehouse is not bound by cold-chain requirements if it handles no perishable food; a service-only activity does not apply the chapters of Annex II that concern industrial heat treatment. Selecting the relevant requirements is itself part of the obligation and must be justified in the hazard analysis.

Coordination with other rules

The essential link is with Article 17(1) of Regulation (EC) No 178/2002, which places on operators the duty to ensure, at all stages under their control, that food law requirements are met Article 17(1) of Regulation (EC) No 178/2002: Article 3 is its hygiene-specific expression. Downstream, Article 3 connects with Article 4 (structural and operational requirements) Article 4(2) of Regulation (EC) No 852/2004, with Article 5 (HACCP self-checking) Article 5(1) of Regulation (EC) No 852/2004 and with Article 6, which requires registration or approval of the establishment as the administrative precondition of the activity Article 6(2) of Regulation (EC) No 852/2004. Compliance with the hygiene requirements is then the subject of official controls governed by Regulation (EU) 2017/625 Article 9 of Regulation (EU) 2017/625, which repealed and replaced the earlier official-controls regulations.

Application in practice and interpretive issues

"Under their control" as the test of attribution. The phrase delimits liability: the operator answers for what it can govern. In our view the test is substantive rather than merely formal — whoever has material and organisational command of a stage is responsible for it, regardless of legal title over the goods. The Commission, in Notice 2022/C 355/01 (see Sources), places Article 3 among the general obligations that food safety management systems are meant to implement.

A "blanket" rule and the referring technique. Because Article 3 contains no precepts of its own, its breach always takes the form of a breach of the requirements it invokes (annexes, Articles 4 and 5). In practice the control authority cites the specific non-conformity (for example a chapter of Annex II), not Article 3 in the abstract.

Sanctions

Article 3 lays down no penalties of its own. Measures and penalties for infringements of food law are left to the Member States, which must make them effective, proportionate and dissuasive Article 17(2) of Regulation (EC) No 178/2002. In Italy the penalty framework for breaches of the hygiene requirements of Regulation (EC) No 852/2004 is set out in Legislative Decree No 193 of 6 November 2007 Article 6 of Italian Legislative Decree No 193/2007; the national picture, with amounts and competent authorities, is on the Italian penalties page. The comparison across Member States is on the country pages.

As at the date of this page there is no Court of Justice of the European Union ruling specifically devoted to Article 3 of Regulation (EC) No 852/2004, a general provision whose application normally runs through the technical requirements it invokes. On the operator's responsibility at the distribution stage, Case C-443/13, Reindl (Court of Justice, Fourth Chamber, 13 November 2014, ECLI:EU:C:2014:2370) is systematically relevant, concerning the FBO's obligations as regards the microbiological criteria of Regulation (EC) No 2073/2005 Article 3 of Regulation (EC) No 2073/2005.

Article 3 is directly applicable and needs no transposition. Member States act essentially on the penalty side Article 17(2) of Regulation (EC) No 178/2002 and through national guides to good practice. For Italy the penalties are in Legislative Decree No 193/2007 Article 6 of Italian Legislative Decree No 193/2007; the general picture is on the Italy page.