Article 6 of Regulation (EC) No 852/2004 — Official controls, registration and approval

Rationale and origin

Article 6 closes Chapter II of the Regulation, on the obligations of food business operators, and supplies the knowledge base on which official controls rest: an authority cannot plan risk-based controls over businesses it does not know exist. Registration answers that need — a public inventory of food establishments fed by the operators' own notifications Article 6(2) of Regulation (EC) No 852/2004, on which competent authorities schedule controls with a frequency proportionate to risk under Regulation (EU) 2017/625 Article 9 of Regulation (EU) 2017/625.

The provision is deliberately two-tiered. For the generality of food businesses the applicable regime is registration, which is declaratory in structure: the operator notifies, the authority records, and the activity may start without any prior assessment. For higher-risk establishments — above all those handling products of animal origin under Regulation (EC) No 853/2004 — the regime is approval, which is authorisational: the establishment may not operate until the authority has approved it following at least one on-site visit Article 6(3) of Regulation (EC) No 852/2004. Point (c) of paragraph 3, in the consolidated version, reflects the alignment with the regulatory procedure with scrutiny made by Regulation (EC) No 219/2009 Regulation (EC) No 219/2009.

Personal scope

The duty falls on every food business operator as defined in Article 3(3) of Regulation (EC) No 178/2002 Article 3(3) of Regulation (EC) No 178/2002, for each establishment under its control. "Establishment" means any unit of a food business — see Article 2 Article 2(1) of Regulation (EC) No 852/2004 — so an operator running a workshop, two shops and a warehouse notifies each of the four units. The obligation spans all stages of production, processing and distribution Article 6(2) of Regulation (EC) No 852/2004, including primary production governed by Annex I: a farm is an establishment to be registered. Outside the duty lie only the activities excluded from the Regulation's scope by Article 1, such as domestic preparation for private consumption and the direct supply of small quantities of primary products, which national law regulates Article 1(2) of Regulation (EC) No 852/2004. Movable and temporary premises are establishments too Annex II, Chapter III of Regulation (EC) No 852/2004, and national authorities now uniformly treat home-based and online-only food businesses the same way.

Material scope

Paragraph 1 lays down a general duty to cooperate with the competent authorities "in accordance with other applicable Community legislation" or, failing that, with national law Article 6(1) of Regulation (EC) No 852/2004. The cross-reference is dynamic: when the Regulation was adopted it pointed to Regulations (EC) No 882/2004 and No 854/2004 on official controls, both repealed with effect from 14 December 2019 by Regulation (EU) 2017/625 Article 146 of Regulation (EU) 2017/625, which now occupies that space and obliges operators to give control staff access to premises, equipment and documentation Article 15 of Regulation (EU) 2017/625.

Paragraph 2 contains the core obligation: notifying each establishment to the appropriate competent authority, in the manner that the authority requires, with a view to its registration Article 6(2) of Regulation (EC) No 852/2004. Three points follow from the text. First, the initiative lies with the operator and the form is set by the authority (in Italy, the SCIA notification). Second, registration involves no prior verification and no finding of compliance: food safety remains a matter for the operator's own HACCP-based procedures under Article 5 Article 5(1) of Regulation (EC) No 852/2004 and for subsequent official controls. Third, registration is not a time-limited title: the continuing duty is to keep the authority's information current by notifying any significant change in activities and any closure Article 6(2) of Regulation (EC) No 852/2004.

Paragraph 3 governs approval: operators must ensure that establishments are approved by the competent authority, following at least one on-site visit, but only where approval is required under the national law of the Member State, under Regulation (EC) No 853/2004 or by a Commission decision Article 6(3) of Regulation (EC) No 852/2004. A Member State that imposes national approval regimes must inform the Commission and the other Member States Article 6(3) of Regulation (EC) No 852/2004. Approved establishments receive an approval number, and competent authorities keep lists of the operators subject to controls within the framework of Regulation (EU) 2017/625 Article 10 of Regulation (EU) 2017/625.

Coordination with other rules

By far the most important approval trigger is Article 4 of Regulation (EC) No 853/2004: establishments handling products of animal origin for which Annex III of that Regulation lays down requirements may not operate unless approved, with exceptions for primary production, transport operations, storage of products not requiring temperature-controlled conditions and, in principle, retail Article 4 of Regulation (EC) No 853/2004. A retail butcher or fishmonger therefore normally stays within registration; a plant producing for supply to other establishments needs approval. For the two regimes in the system of the Regulation, see the Regulation 852/2004 hub.

As for controls, the article's heading ("official controls, registration and approval") should not mislead: the discipline of official controls is not here. It sits in Regulation (EU) 2017/625, which governs the designation of competent authorities Article 4 of Regulation (EU) 2017/625, the risk-based planning of controls Article 9 of Regulation (EU) 2017/625 and enforcement measures in the event of non-compliance Article 138 of Regulation (EU) 2017/625.

Application in practice and points of interpretation

The main practical issue is terminological, and it feeds a widespread commercial misunderstanding: registration under Article 6 is often marketed as a certificate to buy and renew. The text does not support that reading. Paragraph 2 sets up a notification from the operator to a public authority Article 6(2) of Regulation (EC) No 852/2004; no document is issued by a certification body, nothing expires, and no renewal is due. Voluntary schemes (ISO 22000, FSSC 22000, BRCGS, IFS) are private standards that Article 6 never requires: the point is developed in the page there is no certificate under Regulation 852/2004 and in the obligations pillar.

A second issue is what counts as a "significant change in activities" that must be notified Article 6(2) of Regulation (EC) No 852/2004. The Regulation does not define it and Member State practice diverges: adding new production lines, extending premises or changing the operator generally requires notification, while ordinary staff turnover does not. Where national practice diverges, the territorial competent authority's position governs (see the country pages).

A third issue, common in secondary sources, is the citation of repealed law: many pages still present Regulation (EC) No 882/2004 as the legal basis of official controls. That has been wrong since 14 December 2019 Article 146 of Regulation (EU) 2017/625: references to the repealed acts are to be read as references to Regulation (EU) 2017/625.

Penalties

The Regulation sets no penalties of its own; Member States must lay them down under Article 17(2) of Regulation (EC) No 178/2002 Article 17(2) of Regulation (EC) No 178/2002. In Italy, starting a food business without the notification required for registration carries an administrative fine of EUR 1,500 to 9,000, and operating an establishment subject to approval without approval is punished more severely under the same provision Article 6 of Italian Legislative Decree No 193/2007. The country-by-country picture is in the country pages.

As at the date of this page's last update, no ruling of the Court of Justice of the European Union deals specifically with the interpretation of Article 6 of Regulation (EC) No 852/2004. Litigation arises mainly before national courts, in challenges to penalties for failure to notify or for operating establishments without the approval required under Regulation (EC) No 853/2004 Article 4 of Regulation (EC) No 853/2004.

Registration is directly binding, but the manner of notification is left to each national authority Article 6(2) of Regulation (EC) No 852/2004, and procedures differ markedly across Member States. In Italy the notification takes the form of the SCIA (certified notice of commencement of activity), filed with the municipal one-stop desk (SUAP), which forwards it to the competent local health authority; failure to notify is penalised under Legislative Decree No 193/2007 Article 6 of Italian Legislative Decree No 193/2007. Member States that impose national approval requirements beyond Regulation (EC) No 853/2004 must inform the Commission and the other Member States Article 6(3) of Regulation (EC) No 852/2004. Authorities and forms for each country are in the country pages.