Official controls: what to expect from a food hygiene inspection

What an official control is and its legal basis

An official control is defined as an activity performed by the competent authorities to verify that operators comply with food law and that animals and goods meet the applicable requirements Article 2 of Regulation (EU) 2017/625. It must not be confused with self-control: self-control is the verification the FBO carries out on itself through procedures based on the HACCP principles Article 5(1) of Regulation (EC) No 852/2004; the official control is the external, public verification the authority exercises over that self-control and over overall compliance.

The legal basis must be pinned down precisely, because this is where explanatory content most often goes wrong. Regulation (EC) No 852/2004 does not govern controls: the heading of its Article 6 mentions them, 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 criteria, methods and outcomes of controls along the whole agri-food chain Article 1 of Regulation (EU) 2017/625.

Regulation (EU) 2017/625 repealed Regulations 882/2004 and 854/2004

This is the decisive legal point. Until 13 December 2019 official controls on food were governed by two regulations: Regulation (EC) No 882/2004, on controls generally, and Regulation (EC) No 854/2004, on the specific controls concerning 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 Both were repealed by Regulation (EU) 2017/625, with effect from 14 December 2019 Article 146 of Regulation (EU) 2017/625. References to the repealed regulations in earlier acts are now to be construed as references to Regulation (EU) 2017/625 in accordance with the correlation table annexed to the new regulation Article 167 of Regulation (EU) 2017/625.

It follows that citing Regulation (EC) No 882/2004 Regulation (EC) No 882/2004 (repealed) or Regulation (EC) No 854/2004 Regulation (EC) No 854/2004 (repealed) as the regulation in force for official controls is a mistake: they may be referred to only historically, as the previous legal framework. In our view the error is as widespread as it is insidious, because many guides, forms and even training materials still in circulation present 882/2004 as if it were in force. Anyone preparing for an inspection should refer to Regulation (EU) 2017/625 and to the national implementing rules.

Who inspects: the competent authorities

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 and nutrition hygiene services (SIAN) of the local health authorities (ASL, in some Regions ATS), coordinated by the Ministry of Health and the Regions. Alongside them, acting as judicial police, are the Carabinieri NAS (anti-adulteration and health units). The detailed allocation of competences, with references, is set out in competent authorities in Italy. Control staff must be free from conflicts of interest and suitably qualified Article 5 of Regulation (EU) 2017/625.

What the inspection checks

Official controls are carried out using appropriate methods and techniques — including inspection, sampling, analysis, documentary checks and verification Article 14 of Regulation (EU) 2017/625. In a typical food business the inspection addresses five core areas.

Registration or approval. The inspector first verifies that the establishment has been notified to the authority with a view to 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. Operating without the required title is the most serious irregularity from an enforcement standpoint.

HACCP-based self-control procedures. The inspector verifies 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, proportionate to the nature and size of the business, and that it demonstrates their implementation with the required documentation Article 5(4) of Regulation (EC) No 852/2004. It is not merely the existence of the manual that is checked, but its consistency with operational reality: monitoring actually recorded, corrective actions traced, critical limits respected.

Structural and general hygiene requirements. The inspection of the premises is measured against the requirements of Annex II to Regulation (EC) No 852/2004: the condition of premises and equipment Annex II, Chapter I of Regulation (EC) No 852/2004, the availability of potable water, sanitary facilities and washbasins, staff hygiene, pest control and waste management.

Temperatures and the cold chain. The storage temperatures of perishable food and the continuity of the cold chain are checked, by instrument readings and against monitoring records Annex II, Chapter IX of Regulation (EC) No 852/2004.

Traceability. The operator must be able to identify suppliers and recipients (the "one step back, one step forward" principle) Article 18 of Regulation (EC) No 178/2002: the inspection requires documentary evidence of this. The concept is covered in the page on traceability.

How the inspection unfolds

Official controls are as a rule carried out without prior notice, save where advance notification is necessary and justified Article 9(4) of Regulation (EU) 2017/625: the absence of notice serves to capture the business in its ordinary state. The inspector identifies themselves, states the basis of the control and proceeds to visit the premises, examine documents and, where appropriate, take samples of food or surfaces. The operator is entitled, unless this would prejudice the purposes of the control or judicial proceedings, to a second expert opinion on the samples taken Article 35 of Regulation (EU) 2017/625.

At the end the staff draw up a written record: the official control is always documented and the operator is given a copy of the report, which sets out the outcomes and any non-compliance found Article 13 of Regulation (EU) 2017/625. The report is the act on which both remedial requirements and any enforcement proceedings are built: it should be read carefully and, where necessary, accompanied by observations.

Outcomes: from compliance to penalties

If no non-compliance is found, the control closes with a favourable outcome. If instead the authority establishes non-compliance, it takes the measures needed to ascertain its cause and extent and to bring the breach to an end Article 138 of Regulation (EU) 2017/625. The range is graduated: requirements with a deadline to comply, imposition of treatments, restrictions or prohibitions on placing on the market, suspension or closure of the business, up to withdrawal of registration or approval in the most serious cases. Measures are proportionate to the nature of the non-compliance and to the operator's record.

Regulation (EU) 2017/625 does not set the financial penalties: their determination is left to the Member States, which must provide for effective, proportionate and dissuasive penalties Article 139 of Regulation (EU) 2017/625. In Italy the penalty framework for food hygiene is laid down by Legislative Decree No 193/2007 Article 6 of Italian Legislative Decree No 193/2007, the detail of which — amounts, offences, enforcing authorities — is set out in penalties under Legislative Decree 193/2007.

The operator's rights and duties

The operator is not a passive party. It has a duty to grant access and provide assistance to the control staff Article 15 of Regulation (EU) 2017/625: obstructing the inspection is itself a breach. In return it enjoys procedural safeguards: the right to a second opinion on samples Article 35 of Regulation (EU) 2017/625, delivery 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 concerning it before administrative or judicial bodies. Knowing these rights is part of preparation: it allows the operator to cooperate without being at a disadvantage and to manage the stages following the report correctly. The set of obligations the inspection verifies is gathered in the obligations pillar.