Preparing For and Managing Health and Safety Inspections by Italian ASL or NAS — A Comprehensive Guide

Control anxiety is useless. Preparation is everything

It may be a routine inspection by the Local Health Authority or a surprise visit by the Carabinieri Health Protection Command. In both cases, the feeling of ‘being under scrutiny’ is common. The truth is that a properly prepared company has nothing to fear, because official inspections serve to protect public health and reward those who operate properly.

This guide will provide you with practical tools, operational advice, and a checklist to help you prepare for—and effectively manage—the next official inspection, as well as methodically address any post-inspection issues (inspection reports, requirements, product seizures, etc). The regulatory framework is based on EU regulations, namely, Regulation (EC) No 852/2004 on hygiene and HACCP; Regulation (EC) No 178/2002 on traceability; Regulation (EU) No 1169/2011 on allergens and labelling; and Regulation (EU) 2017/625 on official controls. Regarding penalties applied in Italy, the reference text is Legislative Decree No 193/2007. 

ASL vs NAS: what do they do?

• In Italy, the ASL is the competent territorial authority for official controls regarding food hygiene and safety, pursuant to Regulation (EU) 2017/625. ASL inspectors are responsible for controlling premises, equipment, production processes, compliance with the HACCP protocol, product traceability, proper allergen management, official records, and staff training. Inspectors may take samples and, in truly serious cases such as when a crime is reported, they may act with the same powers as the judicial police.
• Typically, the ASL conducts unannounced inspections by choosing from a list of businesses belonging to the same category. The ASL may also schedule an inspection following a report or if an initial inspection has uncovered any instances of nonconformity.

• As specialized units of the Carabinieri, the NAS operate in conjunction with the Ministry of Health: they conduct official inspections and investigations focusing on illegal activities and crimes (fraud, misleading labeling, non-compliant products). The NAS have judicial police powers, as they can order seizures and start criminal investigations).
• The NAS also mostly conduct unannounced inspections, which may lead to production being suspended and goods seized if serious cases of nonconformity are discovered (e.g., lack of hygiene and/or product traceability). NAS activities often receive significant media coverage, especially when the NAS shut down a restaurant or a food factory or seize significant amounts of non-compliant food products.

ASL vs. NAS: What do they monitor?

• HACCP Manual/Plan: must be updated with hazard analyses, Critical Control Points (CCPs) and their limits, monitoring activities, corrective actions, audits, and reviews. Inspectors ascertain that actual processes and documents are consistent and up to date after any changes; the inspectors will also check whether the required official records are properly maintained.
• Monitoring records: everything listed in the HACCP manual must be present in the workspace; for example, temperature records as well as stock inventory and the registration of blast chilling procedures, receipt of goods, sanitation, maintenance, pest control, management of nonconformity, and implementation of corrective actions, thermometer calibration, and staff training. All records must be present, in order, and truthful.
• Traceability (Section 18 of Regulation (EC) No 178/2002): systems and procedures must be in place to identify suppliers and B2B customers (excluding the final consumer); product lots must be traceable and identifiable; labels and accompanying documents must be retained to allow for product withdrawal or recall when necessary.
• Allergens (Regulation (EU) No 1169/2011): it is mandatory to prepare an updated list of the ingredients and allergens present in the menu and in individual products; allergens must be highlighted on labels and price lists; procedures must be in place to manage any cross-contamination; adequate information regarding non-prepackaged foods must be made available. Consumers must be clearly and unambiguously informed about which allergens are present in general and in individual products.
• Staff training: the inspected company must be able to demonstrate that its staff have received appropriate training for their role (Regulation (EC) 852/2004, Annex II, Chapter XII). If training courses are held internally, the required documents must include attendance records, course syllabi, the materials used for final exams, and the trainer’s qualifications. If training courses are held by external providers, it is required that the relevant certificates explicitly state that the courses are legally valid. The company must demonstrate that it has taken concrete steps to foster a culture of food safety per the regulations introduced in 2021, which promote the concept of ‘continuous training.’ According to these principles, for example, one course every two or three years’ is not enough; ongoing training is required, which can also take place in the workplace.
• SCIA (Segnalazione certificata d’inizio attività, Certified Notification of Commencement of Activity), registration and/or recognition of the production facility, specific authorizations where required, and technical data sheets for the facilities as appropriate (e.g., potability of water, disposal of harmful substances, waste and wastewater management, etc).
• Supplier documents: MOCA (Materiali e oggetti a contatto con gli alimenti, Food Contact Substances — FCS) declarations, declarations authorizing the consumption of raw meat and fish, organic certifications, Halal certification, Kosher certification, DOP/PDO (Protected Designation of Origin), IGP/PGI (Protected Geographical Indication), as well as other specifics of the products used and sold with these characteristics. Failure to provide these documents can lead to the seizure of goods, downgrading of the company, health-related complaints, and even accusations of food fraud.

The ‘hot spots’: what are inspectors really looking at?

• Warehousing best practices and proper goods reception: obligation to keep the goods lifted from the floor, FIFO (First In, First Out), FEFO (First Expired, First Out), separation of raw from cooked products, separation of non-food materials from food products; Goods Reception Logs and Temperature Control Logs must be orderly compiled in accordance with the HACCP plan.
• Refrigerators, cold rooms, and freezers: temperatures must remain within the limits set by the HACCP plan (e.g., storage at refrigeration or freezing temperatures); temperature probes and alarms must function correctly; records must be systematic and timely (routine records, recording of non-conformities, and nonconformity management procedures); there must be no overloading; containers must be closed and appropriately labelled.
• Kitchens and food processing facilities: certain flows—e.g. dirty materials vs. clean materials—must be kept separate; surfaces must be intact; cleaning and disinfection must be carried out with registered products; the appropriate technical sheets of those products must be available; the company must also devise the correct procedures for blast chilling and rapid cooling, safe thawing management, and prevention of cross-contamination.
• Allergens and labelling: the 14 Major Allergens must be clearly marked both on menus and labels; allergenic raw materials must be stored separately from other products; staff must be trained in the relevant procedures.
• Expiration and management of open products: all products must be provided with internal-use labels showing the opening date and the Minimum Consumption Date or expiration date; FEFO rotation must be respected; expired products or products incorrectly identified as ‘non-compliant’ must not be present in the warehouse.
• Changing rooms, bathrooms, and staff areas: these must be separate, clean, and equipped with hand basins with hygienic faucets (activated by a photocell, pedal, or clinical lever), soap, and disposable towels (or jet air dryers). Smoking restrictions signs must be exposed. Staff must have appropriate clothing, including PPE (Personal Protective Equipment) and work clothes, as well as the necessary personal hygiene products. Each employee must be provided with a double-compartment locker.
• Pest control: the inspected company must have signed a valid contract with an external pest control company or established an internal pest control program; pest baits must be indicated on the layout plan; reports/logs must be prepared regarding pest control interventions, catch limits, and corrective actions taken if any limit is exceeded; the resolution of any nonconformity must be documented.
• Traceability and product withdrawals/recalls: to test traceability, the inspectors may select a food product and required that the relevant supplier is identified/contacted. Food manufacturers must also demonstrate knowledge of the recipients of manufactured products containing the selected ingredient (B2B).

Sanctions

• Failure to prepare mandatory procedures and documents (e.g., HACCP procedures/HACCP manual)
  Legislative Decree No 193/2007, Section 6, Paragraph 6 — Failure to prepare HACCP procedures
   Sanction: EUR 1,000 to EUR 6,000
• Failure to apply HACCP procedures
  Legislative Decree 193/2007, Section 6, Paragraph 8 — Failure to apply or incorrect application of established systems and/or procedures
  Sanction: EUR 1,000 to EUR 6,000 
• Failure to disclose allergens (restaurants/group catering/non-prepackaged products)
  Legislative Decree No 231/2017, Section 23, Paragraph 2 — Failure to disclose allergens, Section 44 of Regulation (EU) No 1169/2011 
  Sanction: EUR 3,000 to EUR 24,000
• Failure to disclose allergens (pre-packaged products: allergens not listed among the mandatory information)
  Legislative Decree No 231/2017, Section 5, Paragraph 1 — Failure to list allergens on labels
  Sanction: EUR 5,000 to EUR 40,000
• Incorrect consumer information (e.g., a product is sold as PDO but is not PDO)
  Legislative Decree No 231/2017, Section 3, Paragraph 1 — Violation of ‘fair information practices’ – misleading information 
  Sanction: EUR 3,000 to EUR 24,000
• Failure to train staff (HACCP/hygiene)
  Legislative Decree No 193/2007, Section 6, Paragraph 5 — Failure to comply with general hygiene requirements; see Annex II to Regulation (EC) No 852/2004; training is included among the staff hygiene requirements
  Sanction: from EUR 500 to EUR 3,000
• Expired foods not identified as non-compliant and potentially resalable (products displayed or sold beyond their expiration date)
  Legislative Decree No 231/2017, Section 12, Paragraph 3 (food sold or displayed beyond their expiration date
  Sanction: EUR 5,000 to EUR 40,000
• Poor hygiene in production environments
  Legislative Decree No 193/2007, Section 6, Paragraph 5 — General hygiene requirements — see Annex II to Regulation (EC) No 852/2004
  Sanction: from EUR 500 to EUR 3,000
• Poor maintenance (premises/equipment)
  Legislative Decree No 193/2007, Section 6, Paragraph 5 — General hygiene requirements — see Annex II to Regulation (EC) No 852/2004, includes maintenance of premises and equipment
  Sanction: EUR 500 to EUR 3,000

The golden rules for managing the visit

1. A competent representative — Welcome the inspectors
   Make sure a trained representative (preferably the business owner or his/her delegate) is present and welcomes the inspectors: the representative must be familiar with the HACCP plan and the location of all necessary documents. This is a crucial requirement for all official inspections.
2. Transparent collaboration
   Let the inspectors access the premises and the records/logs; inspectors can take samples and interview staff. Avoid any over-defensive attitude: the goal is to verify and rectify.
3. Demonstrate process control
   Do not just produce ‘a pile of sheets’: explain how the company monitors its Critical Control Points, which actions are taken if limits are exceeded, and how the effectiveness of corrective actions is monitored in accordance with Regulation (EC) No 852/2004.
4. Annotate, ask to clarify
   Take note of the inspectors’ observations; ask for regulatory references and clarification if something is unclear. Any objections from the inspectors must be clear and always in writing, never ambiguous or merely verbal; otherwise, they are ‘suggestions’ rather than objections.
5. Read the report before signing it
   The inspection report lists findings, requirements, and deadlines. You should read it carefully, include your own observations if appropriate. Make sure you can meet the deadlines set by the inspectors. For example, if the inspectors give you three days to solve a problem and you already know that is not going to be enough, do say that immediately and ask for more time. Be cautious: one thing is to request more time because you are sincerely committed to solving the problem as best you can; another thing is to kick the can just to delay resolution, which is never the best course of action. 

How to manage reports, prescriptions and seizures

• No issues: the inspection reveals neither instances of nonconformity nor other issues, and therefore, ends with satisfaction of all requirements.
• Prescriptions/Corrective Actions: due to administrative or management nonconformity, ASL or NAS inspectors may impose prescriptive orders with defined compliance deadlines. If all requirements are met and nonconformity issues are fixed within the allowed time, no sanctions will be imposed. It may also occur that the inspectors immediately impose a fine upon detecting a grave case of nonconformity. In this case, you will be required to both correct the nonconformity and pay the fine to resolve the case.
• Seizure of Goods/Suspension of Operations: for serious violations such as fraud, dangerous practices, and/or use of non-genuine products, the inspecting authority may order certain goods to be seized as a precaution and even your company’s operations to be halted on the spot. In this case, you should seek technical and legal assistance ASAP, as the situation becomes more complicated and may have serious legal consequences.

Inspections: from Threat to Opportunity

FAQ — Frequently Asked Questions

• Are ASL/NAS inspections always unannounced? What should I do if they arrive?
  Yes, ASL/NAS inspections are almost always unannounced. A trained representative must be present to welcome the inspectors, grant access to premises and documents, and act cooperatively, acknowledging the report. Any seizures or complaints require immediate technical/legal assistance.
• Which documents does an inspector look at first? 
  The first documents checked are the HACCP manual/plan, key records/logs (temperatures, sanitation, pest control, nonconformity), traceability tests, allergen information, training records, and the SCIA.
• Should temperatures be recorded daily?
  It depends on the HACCP plan: it remains mandatory to monitor and demonstrate that the cold chain has been maintained, but in some situations, recording nonconformity instances alone is permitted if monitoring is effective and documented.
• What is mandatory regarding allergens? 
  It is necessary to clearly inform customers about the presence and/or absence of the 14 Major Allergens in products and dishes, marking them conspicuously on all lists, menus, and labels. For restaurants, staff must also be trained to answer customer questions about allergens.
• Food handler training: are specific ‘certificates’ required?
  Regulation (EC) No 852/2004 requires adequate and documented training. The focus is on Food Safety Culture and the Food Business Operator (FBO)’s responsibility to design risk-based training. You should provide your employees with sufficient training, from basic training (hygiene and HACCP) to more advanced on-the-job training to demonstrate best hygiene practices.
• What are the most common sanctions imposed on food companies and restaurants?
  Among the most common sanctions are those due to the lack of HACCP certification or the inadequacy of such certification. Other common causes for sanctioning include poor hygiene standards, ineffective product traceability, failure to indicate allergens, and lack of mandatory registration.

A Practical Checklist

• ⬜ Updated HACCP (flow diagrams, Critical Control Points, limits, monitoring, verifications, reviews). 
• ⬜ Records: temperatures (with local strategy for frequency and cases of nonconformity), sanitizations, pest control, calibrations, maintenance, cases of nonconformity and corrective actions. 
• ⬜ Traceability: suppliers and recipients of product lots (‘back/forward’), product recall tests. 
• ⬜ Allergens: list of the 14 Major Allergens, highlighting of allergens on menus and labels, segregation of raw materials, staff training. 
• ⬜ Staff training: certificates must be updated. 
• ⬜ Premises/equipment: surface integrity; law-compliant hand sinks, personal protective equipment, changing rooms, and bathrooms. 
• ⬜ Warehouse/expiration dates: FIFO/FEFO, internal labels with dates, separation of raw and cooked products. 
• ⬜ Refrigerators/cells: compliant and demonstrable temperature checks, products stored in an orderly fashion, correct labelling of opened products. 
• ⬜ Documents: SCIA, all important authorizations, supplier documentation on sensitive products (e.g. consumption of a raw product), FCS declarations.