Official controls on food hygiene: a complete guide

This guide aggregates the site's atomic pages. For the step-by-step account of an inspection, with the written report and sampling, see the reference page official controls: what to expect; here the angle is broad and obligation-oriented.

The legal basis for official controls

The first step is to identify the correct source, because this is where general-purpose content goes wrong most often. Regulation (EC) No 852/2004 sets the substantive hygiene obligations; the heading of its Article 6 mentions "official controls", but paragraph 1 merely requires the FBO to cooperate with the competent authorities "in accordance with other applicable Community legislation" Article 6(1) of Regulation (EC) No 852/2004. That "other legislation" is today Regulation (EU) 2017/625, which comprehensively governs the designation of authorities, the methods, the frequency and the outcomes of controls along the whole agri-food chain Article 1 of Regulation (EU) 2017/625.

The decisive point is the repeal. Until 13 December 2019, controls were governed by two regulations — Regulation (EC) No 882/2004 on controls in general and Regulation (EC) No 854/2004 on controls specific to products of animal origin. Both were repealed by Regulation (EU) 2017/625 with effect from 14 December 2019 Article 146 of Regulation (EU) 2017/625; references to the repealed acts are now to be read as references to the new regulation, according to the correlation table in Annex V Article 146(2) of Regulation (EU) 2017/625. Citing Regulation (EC) No 882/2004 Regulation (EC) No 882/2004 (repealed) or Regulation (EC) No 854/2004 Regulation (EC) No 854/2004 (repealed) as sources in force is therefore an error: they can be cited only for historical context. In our view the confusion is insidious, because many guides, forms and training materials still in circulation present 882/2004 as though it were in force.

Who carries out the controls

Each Member State designates the competent authorities responsible for organising official controls Article 4 of Regulation (EU) 2017/625. In Italy general competence over food hygiene lies with the veterinary services and the food hygiene and nutrition services of the local health authorities, coordinated by the Ministry of Health and the Regions; the NAS Carabinieri act as judicial police. The detailed division of responsibilities, with institutional references, is on the competent authorities in Italy page. Control staff must be free from conflicts of interest and suitably qualified Article 5 of Regulation (EU) 2017/625. Because the allocation of competence differs from State to State, operators outside Italy should refer to the authority designated in their own national system.

How an inspection works and what is checked

Official controls are carried out using appropriate methods — including inspection, sampling, analysis and documentary checks — are planned on a risk basis and, as a rule, take place without prior notice Article 9(4) of Regulation (EU) 2017/625. In a typical food business the inspection focuses on five clusters, corresponding to the firm's core obligations.

• Registration or approval. The inspector first checks that the establishment has been notified to the authority for registration Article 6(2) of Regulation (EC) No 852/2004, or that it is approved where approval is required: the distinction is explained in registration vs approval.
• HACCP procedures. It is verified that the FBO has put in place, implements and maintains permanent procedures based on the HACCP principles Article 5(1) of Regulation (EC) No 852/2004, and demonstrates their implementation with the required records Article 5(4) of Regulation (EC) No 852/2004; for building the system see the complete HACCP guide.
• Structural and general hygiene requirements. The inspection of premises is measured against the Annex II requirements: the state of premises and equipment Annex II, Chapter I of Regulation (EC) No 852/2004, potable water, sanitary facilities, staff hygiene, pest control.
• Temperatures and the cold chain. Storage temperatures of perishable foods and the continuity of the cold chain are checked, with instrument readings and monitoring records Annex II, Chapter IX of Regulation (EC) No 852/2004.
• Traceability. The operator must be able to identify suppliers and customers under the "one step back, one step forward" principle Article 18 of Regulation (EC) No 178/2002: the inspection asks for documentary evidence (see traceability).

At the end, the staff draw up a written report and hand the operator a copy of the report setting out the outcomes and any non-compliance Article 13 of Regulation (EU) 2017/625. The step-by-step account of the phases — access, documentary review, sampling, counter-analysis — is on the official controls: what to expect page.

The outcomes of a control

If no non-compliance emerges, the control closes with a favourable outcome. If instead the authority finds non-compliance, it takes the measures needed to establish its cause and extent and to bring the breach to an end Article 138 of Regulation (EU) 2017/625. The range is graduated and proportionate to the seriousness: requirements with a deadline for compliance, formal notices, imposition of treatments, restrictions or bans on placing on the market, suspension or closure of the activity, up to withdrawal of registration or approval in the most serious cases. The administrative level (measures to restore compliance) must be distinguished from the punitive level (financial or criminal penalties).

Regulation (EU) 2017/625 does not set financial penalties: their determination is left to the Member States, which must lay down effective, proportionate and dissuasive penalties Article 139 of Regulation (EU) 2017/625. In Italy the penalty framework for food hygiene is set by Legislative Decree No 193/2007 Article 6 of Italian Legislative Decree No 193/2007: amounts, offences and enforcing authorities are on the penalties (Legislative Decree 193/2007) page. For an indicative estimate you can use the penalty calculator. This guide does not quote amounts: they are national figures that may change and must be read on the up-to-date source.

Rights and appeals

The operator is not a passive party. There is a duty to allow access and to assist control staff Article 15 of Regulation (EU) 2017/625: obstructing the inspection is itself a breach. In return the operator enjoys procedural safeguards: the right to a counter-analysis of samples taken Article 35 of Regulation (EU) 2017/625, receipt of the control report Article 13 of Regulation (EU) 2017/625 and, at national level, the right to submit observations and to challenge the acts before administrative or judicial bodies. Handling the non-compliance recorded in the report, the deadlines and the avenues of appeal are covered on the non-compliance and appeals page. Knowing these rights is part of the preparation: it allows the operator to cooperate without simply enduring, and to manage the stages after the report correctly.

How to prepare for a control

Because controls are normally unannounced Article 9(4) of Regulation (EU) 2017/625, compliance must be maintained at all times, not arranged for the occasion. In practice it is worth continuously checking that: registration (or approval) is in order Article 6(2) of Regulation (EC) No 852/2004; the HACCP plan is up to date and consistent with actual operations Article 5(1) of Regulation (EC) No 852/2004; temperature, cleaning and traceability records are completed and available; the premises meet Annex II. For an overview of the start-up obligations the complete guide to opening a food business is useful; to work out which obligations apply to your case, use the check your obligations tool. Preparation is not something to do "before the inspection": it is the ordinary running of the business, which the control simply photographs.