Article 8 of Regulation (EC) No 852/2004 — National guides to good practice

Rationale and origin

Article 8 is the operational hub of Chapter III. Where Article 7 fixes the voluntary nature of the guides, Article 8 designs the procedure for producing them and for quality-controlling national guides. The logic is co-regulation: the Commission and the Member States do not draft the guides, but they empower food business sectors to produce them while retaining a conformity assessment. This avoids hardening the guides into binding technical standards, preserving the flexibility intended by recital 15 and keeping a public check on the quality of the documents.

Personal scope

Three actors. The food business sectors — trade associations, federations, and possibly national standards institutes (paragraph 2 refers to Annex II to Directive 98/34/EC) — which develop and disseminate the guides Article 8(1) of Regulation (EC) No 852/2004 Article 8(2) of Regulation (EC) No 852/2004. The interested parties, which must be consulted: competent authorities and consumer groups are given as examples, but the wording ("parties whose interests may be substantially affected") is open. The Member States, responsible for the assessment and for forwarding compliant guides to the Commission Article 8(3) of Regulation (EC) No 852/2004 Article 8(4) of Regulation (EC) No 852/2004. The food business operators remain in the background: they are the end users, who will use the guides on a voluntary basis.

Material scope

Paragraph 1 sets three development conditions: consultation of interested parties (point (a)), regard to the Codex Alimentarius codes of practice (point (b)) and, for guides concerning primary production and associated operations, regard to the recommendations in Part B of Annex I (point (c)) Article 8(1) of Regulation (EC) No 852/2004 Annex I, Part B, point 1 of Regulation (EC) No 852/2004. Paragraph 3 sets the three criteria of the State assessment: procedural conformity with paragraph 1 (point (a)); practicability of the content for the intended sectors (point (b)); suitability to promote compliance with Articles 3, 4 and 5 (point (c)) Article 8(3) of Regulation (EC) No 852/2004. This is where a guide acquires its added value: once positively assessed, it is a document that the Member State recognises as workable for meeting the hygiene and food safety obligations. Paragraph 4 closes the circuit: compliant guides are forwarded to the Commission, which sets up and runs a registration system and makes it available to Member States Article 8(4) of Regulation (EC) No 852/2004. Paragraph 5 addresses transitional law: guides drawn up under Directive 93/43/EEC — the earlier regime — continue to apply if compatible with the Regulation's objectives Article 8(5) of Regulation (EC) No 852/2004.

Coordination with other provisions

Article 8 must be read with Article 7, which fixes its voluntary nature for operators, and with Article 9, which designs the parallel procedure for Community guides — where the State assessment is replaced by that of the Committee referred to in Article 14 Article 9(3) of Regulation (EC) No 852/2004. The suitability criterion in paragraph 3(c) anchors the guide to the substantive obligations: the good hygiene requirements of Article 4 Article 4(2) of Regulation (EC) No 852/2004 and the HACCP procedures of Article 5 Article 5(1) of Regulation (EC) No 852/2004. The prerequisite programmes and food safety procedures that a guide systematises are the substance the operator will pour into its own food safety management manual. Commission Notice 2022/C 355/01 (see Sources) presents sector guides as a preferred tool for the flexible application of HACCP in small businesses.

Application and interpretive issues

Assessment is not approval of the operator. Paragraph 3 requires the Member State to judge practicability and suitability, not to stamp automatic conformity. In our view a positively assessed guide does not "certify" the operator that adopts it: it provides a recognised reference, but the operator must still implement the procedures and tailor them to its own processes Article 5(2) of Regulation (EC) No 852/2004. A valid guide poorly applied offers no shelter.

Updating and the Codex. The reference to the Codex Alimentarius codes of practice (paragraph 1(b)) is dynamic: when the Codex revises its General Principles of Food Hygiene, national guides should follow. The State assessment is therefore, in our view, a recurring activity, not a one-off act.

Divergence between Member States. Because each Member State assesses independently, the breadth and level of detail of national guides vary considerably from one country to another. In Italy the good hygiene practice guides for individual sectors are numerous and detailed; elsewhere the instrument is used more sparingly. The rule is common; its implementation is not.

Penalties

Article 8 provides for no penalty. Consistent with the voluntary use of the guides, there is no offence for failing to use a national guide. Penalties attach to breaches of the obligations in Articles 4 and 5, left to the Member States; for Italy, see Legislative Decree No 193 of 6 November 2007 Article 6 of Italian Legislative Decree No 193/2007 and the country pages.

As at the date of this page, there is no case law of the Court of Justice of the European Union specifically addressing Article 8 of Regulation (EC) No 852/2004. The procedure for developing and assessing national guides has generated no supranational litigation: its procedural character and the voluntary use of the guides move any dispute onto the national implementation of the substantive obligations.

Article 8 calls for recurring State activity: assessment of sector guides against the paragraph 3 criteria and forwarding of compliant guides to the Commission for entry in the European register Article 8(4) of Regulation (EC) No 852/2004. In Italy the assessment of good hygiene practice guides involves the Ministry of Health, often after review by technical bodies; the overall picture is set out on the Italy page. The training profiles of food handlers, frequently addressed within the guides, follow regional rules.