Canadian audit of Italys food safety controls for milk and dairy products

On this page

• Abbreviations and special terms used in the report
• Executive summary
• 1. Introduction
  • 1.1 Audit objective, scope, and methodology
  • 1.2 Legal basis for the audit and audit standards
• 2. Competent authority and oversight
  • 2.1. Regulatory framework
  • 2.2. Oversight framework
  • 2.3. Training framework
  • 2.4. Export controls
  • 2.5. Import controls
  • 2.6. Enforcement framework
• 3. Controls at the farm, raw milk collection and transportation
• 4. Processing controls
• 5. Preventive control plans
• 6. Microbiological controls
• 7. Chemical residue controls
• 8. Closing meeting
• 9. Conclusions
• 10. Recommendations

Abbreviations and special terms used in the report

ASL

Azienda Sanitaria Locale (Local Health Unit)

BCP

Border Control Posts

CA

Competent Authority

CCA

Central Competent Authority

CFIA

Canadian Food Inspection Agency

DGISAN

Direzione Generale per l'Igiene e la Sicurezza degli Alimenti e la Nutrizione (Directorate-General for hygiene, food safety and nutrition)

DGOCTS

Directorate-General for collegial bodies for health protection

E. coli

Escherichia coli

EFSA

European Food Safety Authority

EU

European Union

GMP

Good Manufacturing Practices

HACCP

Hazard Analysis and Critical Control Point

IZS

Istituti Zooprofilattici Sperimentali (Experimental Zoo Prophylaxis Institute)

LHU

Local Health Unit

LVS

Local Veterinary Services

MH

Ministry of Health

MS

European Union Member States

NRMP

National Residue Monitoring Plan

PCNP

Piano Di Controllo Nazionale Pluriennale (Integrated National Control Plan - Multi-annual National Control Plan)

PRI

Integrated Regional Plan

RPHS

Regional Public Health Services

TRACES

Trade Control and Expert System

VMP

Veterinary medical products

Executive summary

This report describes the outcome of an audit of Italy's inspection system governing the production of milk and dairy products intended for export to Canada. The audit was carried out using a hybrid format. The open and closing meetings with Italy's central authorities and the dairy association (Assolatte) took place virtually on November 10, 2022, and December 20, 2022. The on-site portion of the audit took place from November 28 to December 7, 2022.

The Canadian Food Inspection Agency (CFIA) audit team was made up of 3 auditors. The team was accompanied by representatives from Italy's Ministry of Health (MH) and the dairy association (Assolatte). The audit scope included on-site visits to locations in the northern part of Italy:

• 7 processing establishments
• 1 distribution plant
• 1 dairy farm
• 1 regional office

The audit covered the following subjects:

• competent authority (CA) and oversight
• controls at the farm, raw milk collection and transportation processing controls
• preventive control plan and prerequisite program controls
• microbiological controls
• chemical residue controls

The audit report includes observations and recommendations for Italy's milk and dairy product inspection system.

1. Introduction

1.1 Audit objective, scope, and methodology

The CFIA conducted an audit of Italy's inspection system for the production of milk and dairy products intended for export to Canada. The audit was carried out using a hybrid format. The open and closing meetings with Italy's central authorities and the dairy association (Assolatte) was held virtually on November 10, 2022, and December 20, 2022. The on-site portion of the audit took place from November 28 to December 7, 2022.

The CFIA audit team of 3 auditors was accompanied on-site by 2 representatives from Italy's Central Competent Authority (CCA) and the dairy association. The audit covered the verification of the following subjects:

• competent authority and oversight
  • regulatory framework
  • oversight framework
  • training framework
  • export controls
  • import controls
  • enforcement framework
• controls at the farm
  • raw milk collection and transportation
• processing controls
• preventive control plan and prerequisite program controls
• microbiological controls
• chemical residues controls

The CFIA team reviewed administrative functions at the CCA headquarters and at the regional office.

The audit scope can be seen in Table 1:

1.2 Legal basis for the audit and audit standards

The CFIA audits under the specific provisions of Canadian laws and regulations, in particular:

• Safe Food for Canadians Act and Regulations
• Food and Drugs Act and Regulations
• Health of Animals Act and Regulations

The audit standards also included all applicable European Union (EU) regulations.

2. Competent authority and oversight

2.1 Regulatory framework

Italy is a Member State (MS) of the EU. They follow European Parliament Regulations and the Council Directives for dairy products. The EU has developed an integrated approach for food safety named "farm to fork". Italian national texts complement the EU regulations. The key relevant EU regulations are listed in Table 2.

The main laws and decrees related to food safety in Italy are outlined in Table 3.

2.2 Oversight framework

Italy has 3 levels (central, regional and local) of controls for the development and implementation of their dairy inspection system. The MH is the central level with 12 general secretariats and directorates. It handles the coordination and harmonization of the measures for animal health, food and feed safety, and animal welfare. The MH receives support from 3 main directorates:

• Directorate-General for animal health and veterinary medicinal products
• Directorate-General for food hygiene, food safety and nutrition
• Directorate-General for advisory bodies for health care

The Ministry of Agriculture, Foodstuff and Forestry Policies handles the controls on quality (recipes), some aspects of traceability, and labels of food and feed.

As per Regulation (EU) No. 2017/625, MS are required to draft a Multi-annual National Control Plan. The Italian plan is called 'Piano Di Controllo Nazionale Pluriennale' (PCNP). The PCNP 2020-2022 describes Italy's strategy to guarantee efficient results of controls, and the preservation of the respect of food and feed law. This plan contains general information on the structure and organisation of the inspection systems. Italy sends an annual report to the European Commission containing the inspection results gathered by the Regional Public Health Services (RPHS).

The MH shares the responsibility and the coordination of the inspection controls with the Italy regions via the agreements reached at the State-Region Conference. The regional government veterinary services are divided into 19 regions and 2 provinces in Italy. The RPHS are responsible for the planning of the official controls and registration of establishments. Each region drafts their inspection plan and coordinate their activities depending upon the uniqueness of the type of production in their territory. The RPHS have the autonomy to plan and enforce all official controls measures. The veterinary services of the ASL, and approximately 5334 official veterinarians of the local veterinary services oversee the official activities. They also carry out enforcement measures at the farms and dairy processing establishments.

The planning and the guidelines of the official controls are described in the Integrated Regional Plan (PRI) 2020-2022. The ASL, and their local veterinary services (LVS), has 3 areas:

• Area A, animal health controls
• Area B, controls of food of animal origin establishments
• Area C, hygiene of animal husbandry and of farm production
  • responsible for the organization and management of public health services

The risk category calculation set the minimum number of inspections in the establishment for the year. Risk categories are based on the:

• volume of production
• target markets
• product characteristics
• process category
• compliance history of the last 3 years

The regions calculate the risk categories which are classified as low, medium or high risk. The region can recalculate the risk category and the inspection if there is a non-compliant inspection outcome.

The RPHS are responsible for performing in-depth inspections. During an audit of the establishment, it verifies that the third countries import requirements are in place. The regional offices plan their inspection frequencies for the establishments in their region. The plan is based on a risk assessment evaluation. Since each region has different production types, they set their own inspection frequency and audit plan to comply with Regulation (CE) No. 2017/625.

The ASL evaluates the auto-control procedure using a checklist. They verify the establishment as described in Decree No. 292 of 2007. The dairy processing establishments audited were in the low, medium and high-risk categories. They were visited at the frequency established by the regional authorities. Every region has computerized databases for the registration and monitoring of official control activities.

2.3 Training framework

The training framework in Italy is part of the PCNP. The EU Commission, MH National Health Institute, the Food Law Enforcement Department, the Ministry of Agriculture of Port Authority or regional level provides the training. The Better Training for Safer Food is an EU training program which covers the EU legislation on food, feeds, animal health, animal welfare, and plant health. The program provides education to professionals carrying out official activities. The program provides updated information on EU legislation and aims to harmonize and improve efficiency of checks.

The MH Secretariat General and the regions are responsible for the coordination and planning of the training program. They focus on food safety, food hazard analysis, official certification, and animal health. The local and the regional authorities are responsible for the hiring process and directly pay the official staff to avoid any conflict of interest. New hires are given online, classroom and job-shadowing training. The regions, the ASLs and the Provincial Veterinary Chambers are responsible for providing continuing education which supports professional competence of the official staff. The official personnel received training according to the internal regional schedule and the number of credits were assigned by the MH.

2.4 Export controls

Italy's competent authorities are responsible for ensuring that the CFIA regulatory requirements are met. It is implemented by inspection staff in establishments authorized to export to Canada.

Regulation (EU) No. 2017/625, outlines the rules for the traceability of food and food ingredients along the food production chain. Approved and registered ASL establishments must comply with the sanitary requirements and health agreements of the importing country. Establishment approval includes the following steps:

• application
• document review of the operator controls
• initial on-site assessment

After a conditional approval period, the establishment is included in the InfoTech system called SINTHESIS. It is then available in an updated list on the MH website (in Italian only). Canada does not require Italy to have a specific list of establishments eligible to export dairy products to Canada.

Italy's competent authorities have the responsibility for ensuring that the CFIA regulatory requirements are consistently implemented by inspection staff in establishments authorized to export to Canada.

In Italy, the food export controls are under the exclusive responsibility of the MH CCA. At the MH level, the Directorate-General for hygiene, food safety and nutrition (DGISAN) handles:

• the export procedures
• registration of eligible establishments
• implementation of EU regulations

The MH, regional services and ASL are the official competent authorities responsible for ensuring export sanitary and traceability controls.

Dairy products can be exported from the processing establishment, a processing/packaging establishment, or a distributor. If dairy products move between eligible establishments, a pre-export certificate may be necessary depending on the third country's requirements. The certificate must follow the product for export from the EU to the third country. Canada does not require a certificate for cheese products imported into Canada. The CCA has delegated the responsibilities for export certification to the regions and ASLs. Each regional official veterinarian is responsible for issuing its certificates.

The certificate contains the following information about the product:

• producing establishment number
• date of processing
• type of product
• lot number and traceability requirements
• animal health requirements (zone)
• specific requirements of the importing country

The CFIA team observed the following deficiencies on the export certificates:

• some health certificates, and certificates of origin, issued by Italy for the export of dairy products to Canada refer to repealed EU regulations
• the official veterinarian is responsible for updating the health certificates which causes a lack of consistency in updating health statements
• formatting of certificates does not always meet the standards of the EU, World Organisation for Animal Health, and Codex Alimentarius

2.5 Import controls

Any food product imported into the EU must meet the requirements of European food law or be deemed equivalent as it complies with Regulation (EC) No. 852/2004. Once these conditions have been confirmed and an imported food has been accepted in the EU, it can move freely within EU MS without further monitoring. The Regulation (EU) No. 2017/625 outlines official controls and other official activities to ensure compliance with food law and feed law and rules relating to animal health and welfare, plant health and plant protection products.

One of the health certificate models from Regulation (EU) No. 2022/2235 must accompany imports of:

• milk
• dairy products
• colostrum
• colostrum-based products

into:

• Italy
• any other EU MS including countries that have adopted EU veterinary legislation
  • for example, Switzerland, Norway, Iceland and Liechtenstein

The certificate model depends on the category of risk associated with the type of dairy product.

The EU Trade Control and Expert System (TRACES) is a digital platform for the certification and management of goods. TRACES is used to support the issuance of official certificates issued to the EU.

The imports of dairy products, and other foods of animal origin, into Italy are controlled by the:

• MH
• Directorate-General for Animal Health and Veterinary Medicines Office
• Veterinary Offices for Intracommunity Trade

This control is done using terrestrial border control posts (BCP) and local units of air and sea health offices. Milk and dairy products imported from outside the EU borders are subjected to systematic checks before being allowed into EU territory. These products must originate from EU approved establishments and be accompanied with sanitary health certificates. Data is usually entered in TRACES (which contains all the information regarding the movement of the consignment) making the product traceable to, or from, its destination.

The BCPs are responsible for health checks on imports. In accordance with EU regulations, dairy products are subject to:

• documentary checks
• 100% health checks for products of animal origin
• identity, physical and laboratory tests

The BCPs issue the common health entry document, that is the DSCE-P, via TRACES. The DSCE-P indicates that the dispatched batches have been inspected as well as the admissibility decision.

The CFIA team discussed the conditions regarding the possible use of raw milk from other MS, or third countries, or both, with the certifying veterinarians. In accordance with Regulations (EC) No. 852/2004 and 853/2004, milk can circulate freely within the EU area. However, a supporting document (pre-certification) could be requested from a MS, or a third country, if the particulars of the health certificate go beyond national or EU regulations. Or if they cannot be verified at the time of signing.

The officials perform random sampling for milk and dairy products from non-EU countries. The sampling frequency depends on risk, type of products and compliance history of the exporting country. The Instituti Zooprofilattici Sperimentali (IZS) laboratories provide analytical services to the BCP's.

2.6 Enforcement framework

In Italy, the MH is responsible for enforcement actions and coordination of enforcement activities among the:

• Food Law Enforcement Department
• RPHS
• related local health unit (LHU) areas
• LVS in the registered establishments

The Food Law Enforcement Department is a special unit of the Italian Corps of Carabinieri under the Ministry of Defence. This unit is authorized to perform criminal investigations and controls on illegal adulteration of foodstuffs, fighting food fraud, and illegal trafficking of medicines on its own or upon request from MH offices. They are responsible for hygiene inspections, verification of control systems, sampling and analysis of products, and examination of authorization documents.

The ASL and their LVS in the registered establishments verified compliance to the regulatory requirements. Adequate enforcement actions were taken in response to the non-compliances. The official personnel have legal powers to enter an establishment to take samples, do on-site visits and review documents. The ASL take actions, like the identification and retention and recall of unsafe dairy product(s). Escalation actions, like penalties and suspension of exportation activities, are in place when there are repetitive severe non-compliant observations.

The Rapid Alert System for Food and Feed (RASFF) enables competent authorities to rapidly exchange and disseminate information on serious direct or indirect risks to human health in relation to food or feed. Italy's RASFF contact point is the DGISAN Office 8. The regional LHU and the operators receive and issue appropriate information about dairy products when serious health risks are present.

The CFIA team verified the implementation of effective communications between stakeholders and the actions following a port of entry violation of microbiological and chemical residues detected in imported dairy products. The operator and local officials received the information in a timely fashion which triggered a hazard analysis, trace back of non-compliant dairy products and corrective/preventive actions by the operator.

3. Controls at the farm, raw milk collection and transportation

Canada officially recognized Italy as being free of Foot-and-mouth disease. Foot-and-mouth disease is listed in the World Organisation for Animal Health's Terrestrial Animal Health Code. The Directorate-General for Animal Health and Veterinary Medicines of the MH is the Italian CAA for animal health and designing national plans that are coordinated and implemented by the regional authorities. Regulation (EU) No. 2021/620 recognizes some regions/provinces of Italy as having a disease-free status from infection of:

• Brucella melitensis and Brucella abortus
  • in bovine, ovine and caprine populations
• Mycobacterium complex
  • in bovine herds

The national surveillance (control, or eradication, or both) programs currently cover epidemiological surveillance of bovine brucellosis and tuberculosis.

Raw milk must come from animal(s) from a zone free of brucellosis and tuberculosis as described in Directive 64/332/EEC and Regulation (EC) No. 853/2004. If not, the raw milk must undergo a heat treatment and be negative for phosphatase test.

A network of 10 public laboratories (IZS) sets all the National Reference Centers for Animal diseases. This network provides the diagnostic services to the official veterinary services who are responsible for the implementation of animal disease control programs.

In Italy, all the farms are registered in the computerized central database (National Data Base). The National Data Base includes all the information concerning the number and type of animals, holdings and their health status. The ASL Area A performs a visit at the farm once at least every 5 years. This visit includes milk and blood samples, animal identification updated by the farmer, and verification of the treatment register. The ASL official veterinarian performs testing to evaluate the animal health status when an animal is sold and transported or when an animal has nervous signs that can be indicative of BSE.

The ASL Area C is responsible for the official verification of the farmers' compliance with:

• hygiene requirements
• animal welfare
• veterinary medical products (VMPs) controls
• The NRMP

The frequency of the official controls at the farm is determined by farm risk categorization and is included in the PRI. The ASL official veterinarian of Area C performs official visits and records the results on a checklist. The checklist includes the verification of biosecurity measures.

The CFIA team visited 1 large scale bovine dairy farm under the responsibility of a freelance veterinarian. The freelance veterinarian visits the herd weekly to treat sick animals. The veterinarian develops a health management plan that includes:

• mastitis
• a vaccination and treatment plan
• the follow-up on the overall microbiological quality of milk
• the monitoring of the somatic cell levels affected by the udder health status of dairy animals

The freelance veterinarian issues the prescription of the VMPs using the application of the VETINFO national control system. The prescription is sent electronically to the local pharmacist responsible for delivering the VMPs to the farmer. Only veterinarians can prescribe VMPs and only pharmacists are authorized to sell prescription antibiotics to farmers. The VMPs are strictly controlled in locked areas. All bovines are identified and segregated when treated with VMPs. They must follow a strict VMP withdrawal period when treated.

Around 75% of the milk in Italy is produced in the northern Italian districts of Lombardia, Emilia-Romagna, Veneto and Piemonte. The milk collection and the transportation from the farm are done by private third-party companies or trucks owned by the processing establishment. The milk collection at the farm depends on the volume of milk produced and the herd size. During milk collection at the farm, meter tenders (or special weighing machines) establish the quantity of collected milk by the milk transportation company. The temperature of the milk tank at the farm is verified by the transportation employee. Immediately after milking, milk must be held in a clean place designed and equipped to avoid contamination. It must be cooled immediately to 8°C or less in the case of daily collection, or 6°C or less if collection is not daily as per Regulation (EC) No. 853/2004.

The dairy farmer conducts regular microbiological sampling to rule out the presence of Escherichia coli (E. coli) O157, Salmonella spp., Listeria monocytogenes and Campylobacter. The raw milk quality criteria for plate count and somatic cell count are verified to ensure compliance to the levels prescribed in Regulation (EC) No. 853/2004. When raw milk criteria are exceeded, the ASL verify the compliance of total plate count and somatic cell count results for a 3-month period.

Payment for milk is done according to quality. Milk samples routinely taken for official analysis include the:

• milk quality parameters
  • somatic cells, protein and fat levels
• absence of antibiotics

As seen at the dairy farm, milk samples are sent to the IZS. The transporter kept records of the milk provenance for traceability purposes in case of residue detection.

The bovine dairy farm audited had adequate milking equipment. The premises where milk is stored, handled or cooled is constructed and located to limit the risk of contamination of milk.

4. Processing controls

Regulation (EC) No. 853/2005 Annex III, section IX describes the requirements for the:

• hygiene
• control of the temperature of milk
• heat treatment at the holding

Raw milk is unloaded at listed collection centres, or directly at cheese processing establishments, after it is collected and transported. When the raw milk arrives at the processing establishment, a sample from every milk tanker is tested before the milk is unloaded. The milk is held and tested in an in-house laboratory for the presence of antibiotics and aflatoxins by rapid tests. The milk reception and testing are controlled and recorded under a critical control point.

If the milk tests positive for antibiotics, the truck is not unloaded. The positive milk is sent back to the farm or to a place where the milk is discarded in a manure pit. A traceability exercise is triggered and the farm that sent milk with the presence of antibiotics is identified. The cost of the discarded positive milk is paid by the dairy farm of origin.

Lethality treatments for milk refer to the thermal treatment done to achieve a reduction of the viable pathogens. The raw milk can be pasteurized depending on the type of cheese produced. The CFIA visited 1 processing establishment that pasteurizes using continuous flow pasteurizers on milk prior to the cheese processing. Pasteurization heat treatment was controlled with a critical control point at 72°C for 15 seconds. The validation of the pasteurization process is performed by measuring the level of alkaline phosphatase.

Processing steps like acidification, coagulation, separating curds and whey, salting, shaping, and ripening are controlled by pre-requisites. The processing steps are monitored and controlled to ensure that the risks are minimized or eliminated. The establishments are responsible for validation and implementation of controls. The official authorities are responsible for the verification of controls.

Some audited establishments receive cheeses for ripening from other approved external processors under the Protected Designation of Origin logo. Examples of these cheeses are Parmesan, Grana Padano and Taleggio. These cheeses are included in the establishment's preventive control plan. The Protected Designation of Origin guarantees that all stages of product development are carried out:

• in a specific geographical area corresponding to the product's "terroir" of origin
• according to recognized know-how and specific specifications

The Italian hard cheeses are aged for a period of 12 to 72 months. The cheeses are brushed with a solution containing either only water or with a brine that has mesophilic cultures to inoculate the surface of the cheese wheels. The mesophilic cultures are specific to the Protected Designation of Origin specification. The cheese wheels are brushed and then turned manually or mechanically. The maturing, cutting, and packaging activities follow national and European legislation, which requires the:

• development and maintenance of the integrity of dairy products
• the traceability system at all levels of the food chain

The operators carry out traceability exercises. They have an effective recall plan that makes it possible to recall and withdraw a product that does not meet regulatory requirements. The label for cheese products exported to Canada is determined in collaboration with the Canadian importers. Operators demonstrated a good knowledge of Canada's import requirements for milk and dairy products.

5. Preventive control plans

The implementation of HACCP programs and principles are mandatory requirement for all establishments according to Regulations (EC) No. 852/2004. Commission notice 2022/C 355/01 gives flexibility in applying good hygiene practices, HACCP and prerequisite programs using a risk-based approach. The operators maintain and implement procedures based on the HACCP principles.

The operator implements different elements of their HACCP and prerequisite programs at the processing and storage establishments. The operators implement HACCP plans for each category of products. The CA verifies the implementation of HACCP and prerequisite programs. For example, the ripening and aging of hard cheese were under prerequisites in the operator's environmental conditions (that is, hygrometry and temperature) monitoring controls.

The establishments developed and implemented a prerequisite allergen control program for the identification and control of the food allergens as per Regulation (EC) No. 1169/2011. The presence of allergens other than milk, such as egg (lysozyme), are declared on the dairy product label.

The CFIA team noticed systemic deficiencies related to the elements of HACCP and prerequisite programs at the audited dairy processing establishments. Deviations in certain elements, such as the sanitation and maintenance of the building, food processing equipment and implementation of good manufacturing practices (GMP), may contribute to a drop in sanitary conditions. For example, some equipment, such as racks and conveyors, had surfaces that were damaged or rusted. Inadequate manufacturing and crowded production areas that may contribute to the deterioration of sanitary conditions were observed.

The operators provided most of the corrective actions before the end of the on-site audit.

6. Microbiological controls

The European Food Safety Authority (EFSA) monitors and analyzes information and data on:

• biological hazards
• chemical contaminants
• food consumption
• emerging risks

The MS must follow the recommended number of microbiological sampling and send results to the EFSA for publication.

The MH is responsible for implementing Italy's official national microbiological monitoring plan from the PCNP. The MH communicates the sampling plan to the Director of the RPHS for implementation at the local level. The official sampling is distributed according to the type and category of product, volume of production, and history of non-compliance. The authorities submit samples to the network of the public laboratories at national and regional level after the official veterinarian completes sampling. The laboratories analyze the samples and publish the results on the secured electronic portal.

The official microbiological sampling plan for the monitoring of Listeria monocytogenes includes only the sampling of the dairy products. It does not include the sampling of the environmental food contact surfaces. The local and regional officials give the responsibility of the sampling of the food contact surfaces to the operator. During the on-site visit, official authorities verify:

• the effectiveness of industry sanitation processes
• GMP's in preventing contamination of the cheese processing environment with Listeria spp. and Listeria monocytogenes

Microbiological criteria for raw milk are monitored by self-checks at the farm, collection centre and processing establishment as described in Regulation (EC) No. 853/2004. Criteria such as the total plate and somatic cell counts are the reflection of the global udder health controls. They are an indicator of the incidence of clinical mastitis and subclinical mastitis at the farm level. When raw milk criteria are exceeded, the ASL is notified. The ASL monitors the compliance results at the farm for a 3-month period, as required by Regulation (EU) 2019/627. If the dairy farmer doesn't correct the situation after 3 months, the delivery of raw milk at the processing holding is suspended. The raw milk must be subjected to a heat treatment validated by phosphatase activity testing. Also, the dairy farmer conducts regular microbiological sampling to rule out the presence of E. coli O157, Salmonella spp., Listeria monocytogenes and Campylobacter.

The operators in dairy products processing establishments shall ensure that foodstuffs comply with the relevant microbiological criteria set out in Annex I of Regulation (EC) No. 2073/2005. Process hygiene microbiological sampling for the absence of Salmonella and Staphylococcal enterotoxins and Coagulase positive staphylococci for cheese from raw milk are performed. Cheese and dairy products produced from pasteurized milk are tested for E. coli, Enterobacteriaceae and coagulase positive staphylococci.

Operators that manufacture ready-to-eat foods that may pose a Listeria monocytogenes risk to public health shall include their processing areas and equipment as part of their Listeria monocytogenes sampling plan. The Listeria monocytogenes sampling plan, and sample frequency, is established according to the food safety criteria for ready-to-eat food able to support the growth of Listeria monocytogenes found in Annex I of Regulation (EC) No. 2073/2005. Some operators use alternate sampling frequency based on the validation of their annual risk analysis for each type of cheeses include in their written HACCP procedures. This is permitted by Regulation (EC) No. 2073/2005.

The number of dairy product samples taken by the official ASL for Listeria monocytogenes in the processing establishment is risk-based. There is no prescribed frequency for each establishment. Furthermore, the official microbiological sampling plan for the monitoring of the Listeria monocytogenes includes only the sampling of the dairy products and not the sampling of the food contact surfaces. The MH gives the responsibility to the operator to monitor the presence of Listeria monocytogenes. The MH oversees the monitoring.

The CFIA team verified the implementation of the operator actions after a port of entry violation related to non-compliant microbiological results. Each operator presented their effective corrective and preventive actions plan followed by the verification by official authorities. It was noted that non-compliant microbiological results for cheeses can increase the risk category calculation and the inspection frequency at the exporting establishment.

7. Chemical residue controls

Italy implements a NRMP that is a surveillance program that monitors the presence of chemical residues in all foods of animal origin, including dairy products. The NRMP is created and coordinated by DGISAN Office 8. The NRMP is included in the PCNP. The MH shares the annual plan and results with European Commission and EFSA.

The MH's DGISAN consults the regions, provinces, National Reference Laboratories and IZS before issuing the NRMP every year. The NRMP includes the:

• species
• categories
• sampling locations
• substances for testing
• testing procedures

This is prescribed in the European Commission's legal provisions to ensure wholesomeness of the dairy products. The planned NRMP number of samples per substance evolves based on the detected non-compliance results of the previous year and alerts. NRMP plans are annually published on the MH website (in Italian only). Over 100% of the planned samples for 2020 and 2021 for milk were carried out.

Regulation (EU) No. 2017/625 states that the CA shall continue to perform the official controls necessary to detect the presence of the substances and groups of residues listed in Annex I to Directive 96/23/EC until December 14, 2022. The EU MS will implement the new Regulations (EU) No. 2022/1644 and 2022/1646 in 2023. The new regulations set the requirements for sampling frequency for each group of residues by commodities established on a risked-based control and surveillance plan included in the Multi-annual National Control Plan (that is the PCNP for Italy).

The NRMP in Italy is implemented by the RPHS and the LHU in the farms and the dairy processing establishments. The regional plan for residues is included in the PRI. The regional plan for residues:

• monitors any illegal use of substances
• monitors the misuse of authorized veterinary medicines
• minimizes the recurrence of chemical residues over the permitted maximum level

After receiving the NRMP from the MH, the RPHS develops a regional plan and coordinates with the LHU for the execution. The LHU and LVS perform sampling, issue sampling reports and send the samples to the laboratory. The regional offices coordinate the follow-up actions and investigations, after the detection of chemical residues in dairy products, with the LHU.

The 10 IZS laboratories in Italy are responsible for the official analysis of samples using International Organization for Standardization (ISO) 17025 accredited methods. All public and IZS laboratories are accredited under the ACCREDIA accreditation body. The IZS perform the analyses and record results in an electronic platform informatics system to inform the regional offices in the case of non-compliances. In case of non-compliant results, the LHU triggers an investigation at the regional level and at the farm of origin as described in Regulation (EU) No. 2019/2090. The dairy processing operator performs a traceability exercise to recall the affected dairy products.

The MH is responsible for:

• issuing market authorizations for veterinary medicine products
• licensing manufacturers
• importation
• compliance with GMP

The maximum residue limits in foodstuffs of animal origin for each substance, and their classification, are established at the EU level. This is done by the relevant species and products according to Regulation (EC) No. 37/2010. The policy for off-label VMP use is described in Directive 2001/82. The cascade rule is applied under the supervision of the private veterinarian of the dairy herd. The cascade rule is only applied in cases where there is no registered medicinal product for the species and usage in question.

Imported dairy products from Italy are subjected to routine monitoring for chemical residues and enforcement measures in the case of non-compliances. The CFIA team reviewed Italy's NRMP and results for 2021 and 2022. Italy's NRMP included the number of samples, species, targeted matrix, points of sampling, substances for testing, and test analytical methods as prescribed in the European Commission's legal provisions to ensure wholesomeness of the dairy products.

Canada routinely monitors imported dairy products for chemical residues and assesses the results. The assessed results must comply with Canadian maximum residue limits. The maximum residue limits for veterinary drug residues in milk and contaminants for food products are established by Health Canada.

8. Closing meeting

The closing meeting was held virtually with representatives from MH and Assolatte on December 20, 2022. At the meeting, a summary of the preliminary findings was presented by the CFIA lead auditor.

9. Conclusions

The preliminary audit report included recommendations for Italy to address the observations identified during the on-site audit. The CFIA reviewed the information requested and the action plan provided by the CA. The CFIA determined that Italy's milk and dairy product inspection system is functioning adequately and produces products that meet Canadian requirements.

10. Recommendations

The following recommendations have been made in response to the observations and findings documented during the audit.

Recommendation 1

The CFIA recommends that all establishment specific findings identified during the audit be corrected and the implementation be verified by the CA in a timely fashion.

MH action plan/comments

The MH has immediately shared to the Regional and Local services all establishment specific findings identified during the audit asking for the verification of the corrective action implemented by the operators.

Recommendation 2

Section 2.4: The CFIA recommends that export certificates issued for Canada to be updated with the most recent EU regulations and meet the international World Organisation for Animal Health and Codex standards.

MH action plan/comments

The MH released to the Regional and Local Services the revision of the export certificates model to be used when an agreed OMIC^Footnote 1 do not exist. The new model was created according to the international standards set up by OIE and Codex.

It contains the most recent EU regulations that in case of repealing must be updated by the official veterinarian issuing the certificate. Moreover, in the case of the export to Canada is mandatory, to implement the procedure in order to avoid the repeating of the Health Certificate id number. Basically, each certificate should be identified by an alphanumeric code based on the following structure ITA 00 00 00000 0000 where:

• ITA= National code
• 00= Regional ISTAT
• 00= Local ISTAT code
• 00000= progressive number
• 0000= year

The above-mentioned measures have been released with the DGISAN circular 0024494-13/06/2023-DGISAN-MDS-P here after attached.

Recommendation 3

Section 5: The CFIA recommends that the CA reviews the Preventive control plans (HACCP) and pre-requisite programs implemented in the establishments to prevent the deficiencies identified in this report.

MH action plan/comments

The MH has immediately shared to the Regional and Local services all establishment specific findings identified during the audit asking for the verification of the corrective action implemented by the operators. The Preventive control plans (HACCP) and pre-requisite programs implemented in the establishments to prevent the deficiencies identified in this report will be reviewed and verified during the routinely and planned inspection and audit activity performed by Central, Regional and Local competent authority.