Article 4 of Regulation (EC) No 852/2004 — General and specific hygiene requirements

Rationale and origin

Article 4 gives concrete content to the general obligation of Article 3: it states which hygiene requirements apply, distinguishing them by stage of the food chain Article 4(1) of Regulation (EC) No 852/2004. The basic design is a two-way split: on one side primary production, governed by a lighter body of rules (Annex I, Part A); on the other all later stages — processing, preparation, storage, transport, service, retail — governed by the main and more detailed body of requirements (Annex II) Article 4(2) of Regulation (EC) No 852/2004. On this skeleton paragraph 3 grafts a second layer: the technical specific measures (microbiological criteria, temperatures, cold chain, sampling), whose detailed content is delegated to Commission acts.

Personal scope

The addressee is the food business operator at every stage. Paragraph 1 identifies the subset of primary producers and of those carrying out the associated operations listed in Annex I (transport, storage and handling of primary products at the place of production, transport of live animals, transport from the place of production to an establishment) Article 4(1) of Regulation (EC) No 852/2004. Paragraph 2 covers everyone else: any operator at a later stage Article 4(2) of Regulation (EC) No 852/2004. The dividing line is the same one that Article 5 uses to delimit the HACCP obligation Article 5(3) of Regulation (EC) No 852/2004: a deliberate consistency, because primary production and later stages have different hazards and different control tools.

Material scope: the architecture by annex

Annex II is organised into thematic chapters, referenced here because they are the operational content of paragraph 2: premises, transport, equipment, food waste, water supply, personal hygiene, foodstuffs and training. Temperature requirements for foodstuffs sit in Annex II, Chapter IX Annex II, Chapter IX, point 5 of Regulation (EC) No 852/2004.

The specific measures of paragraph 3

Paragraph 3 lists five measures that FBOs adopt "as appropriate" Article 4(3) of Regulation (EC) No 852/2004. "As appropriate" is not a discretionary choice: it means the measure applies where it is relevant to the type of food and process, according to the outcome of the hazard analysis.

• (a) Microbiological criteria. Food safety and process hygiene parameters that products must meet. The content is set by Regulation (EC) No 2073/2005 Article 3 of Regulation (EC) No 2073/2005, which FBOs must observe and verify when validating their self-checking procedures.
• (b) Procedures to meet the Regulation's targets. The procedures needed to achieve the safety objectives; they connect with the Article 5 self-checking Article 5(1) of Regulation (EC) No 852/2004.
• (c) Temperature control. A cross-cutting requirement for perishable food; under Annex II, Chapter IX, foods that support microbial growth must be kept at appropriate temperatures Annex II, Chapter IX, point 5 of Regulation (EC) No 852/2004.
• (d) Maintenance of the cold chain. Continuity of the controlled-temperature regime across all stages, from storage to transport to sale.
• (e) Sampling and analysis. Sampling and laboratory testing to verify compliance, in particular with the microbiological criteria; the sampling plan is part of system verification Article 4 of Regulation (EC) No 2073/2005.

Coordination with other rules

Paragraph 4 empowers the Commission to lay down the criteria, requirements, targets and sampling and analysis methods Article 4(4) of Regulation (EC) No 852/2004: the main act adopted under this delegation is Regulation (EC) No 2073/2005 on microbiological criteria Article 1 of Regulation (EC) No 2073/2005. Paragraph 5 introduces a methodological equivalence clause: where sampling or analysis methods are not specified, the FBO may use appropriate methods laid down in other Union or national legislation or, in their absence, methods offering results equivalent to the reference method, provided they are scientifically validated under internationally recognised protocols Article 4(5) of Regulation (EC) No 852/2004. Paragraph 6 refers to the guides to good practice of Articles 7, 8 and 9 as an aid to compliance Article 4(6) of Regulation (EC) No 852/2004. On the control side, compliance with the Article 4 requirements is verified within the official controls of Regulation (EU) 2017/625 Article 9 of Regulation (EU) 2017/625.

Application in practice and interpretive issues

General requirements as HACCP prerequisites. The Annex II requirements are, functionally, the prerequisite programmes (PRPs) on which self-checking rests: without suitable premises, potable water, personal hygiene and waste control, the Article 5 hazard analysis has no basis Article 5(1) of Regulation (EC) No 852/2004. In our view the relationship is hierarchical: Article 4 is the base, Article 5 the overlay.

"As appropriate" and proportionality. As throughout the Regulation, application of the paragraph 3 measures is scaled to the nature of the activity: a business handling only shelf-stable ambient food does not apply the cold-chain measures Article 4(3) of Regulation (EC) No 852/2004. The choice must, however, be justified in the hazard analysis and remains open to review by the control authority.

Sanctions

Article 4 lays down no penalties of its own: the power to penalise lies with the Member States, with effective, proportionate and dissuasive measures Article 17(2) of Regulation (EC) No 178/2002. In Italy breaches of the general and specific hygiene requirements are penalised by Legislative Decree No 193 of 6 November 2007 Article 6 of Italian Legislative Decree No 193/2007; the framework with amounts and competent authorities is on the Italian penalties page.

Directly relevant is Case C-443/13, Reindl (Court of Justice, Fourth Chamber, 13 November 2014, ECLI:EU:C:2014:2370): the Court held that a food business operator involved solely at the distribution stage is bound to comply with the microbiological criteria of Regulation (EC) No 2073/2005 Article 3 of Regulation (EC) No 2073/2005, criteria that Article 4(3)(a) of Regulation (EC) No 852/2004 invokes as a specific measure Article 4(3) of Regulation (EC) No 852/2004. The ruling confirms that the paragraph 3 measures are not mere programmatic targets but enforceable obligations against each operator.

Article 4 is directly applicable. Its technical content is completed by Union acts (chiefly Regulation (EC) No 2073/2005 on microbiological criteria Article 1 of Regulation (EC) No 2073/2005) and by national guides to good practice validated under Article 8 Article 8(1) of Regulation (EC) No 852/2004. For Italy the penalties are in Legislative Decree No 193/2007 Article 6 of Italian Legislative Decree No 193/2007; general picture on the Italy page and cross-country comparison on the country pages.