Canadian audit of France's 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. On-farm controls, collection and transport of raw milk
• 4. Process controls
• 5. Preventive control plan and prerequisite programs
• 6. Microbiological controls
• 7. Chemical residue control
• 8. Closing meeting
• 9. Conclusions
• 10. Recommendations

Abbreviations and special terms used in the report

ANSES

Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail

PDO

Protected Designation of Origin

GHP

Good Hygienic Practices

BCP

Border Control Posts

BTSF

Better Training for Safer Food

CA

Competent Authority

CCA

Central Competent Authority

CETA

Comprehensive Economic and Trade Agreement

CFIA

Canadian Food Inspection Agency

CNIEL

Centre National Interprofessionnel de l'Économie Laitière

COFRAC

Comité français d'accréditation

CVO

Chief Veterinary Officer

DDETSPP

Direction Départementale (de la Cohésion Sociale) et de la Protection des Populations

DDPP

Direction Départementale de la Protection des populations

DG for Health

European Commission's Directorate-General for Health and Food Safety

DGAL

Direction Générale de l'Alimentation

DGCCRF

Direction générale de la Concurrence, de la Consommation et de la Répression des fraudes

DRAAF

Direction Régionale de l'Agriculture, de l'Alimentation et de la Forêt

EFSA

European Food Safety Authority

EU

European Union

GBPH

Guides de bonnes pratiques d'hygiène

GTV

Groupements Techniques Vétérinaires

GDS

Groupements de Défense Sanitaire

HACCP

Hazard Analysis Critical Control Point

MAA

Ministère de l'Agriculture et de l'Alimentation

MCP

Monitoring and Control Plans

OV

Official Veterinarian

PCP

Preventive Control Plan

PNCOPA

Plan national de contrôles officiels pluriannuel

POE Violation

Port of Entry Violation

SFCR

Safe Food for Canadians Regulations

SIRET

Système d'identification du répertoire des établissements

SIVEP

Service d'inspection vétérinaire et phytosanitaire aux frontières

SSOP

Sanitation Standard Operating Procedures

TRACES

Trade Control and Expert System

WOAH

World Organisation for Animal Health

Executive Summary

This report describes the outcome of an on-site audit conducted in France by the Canadian Food Inspection Agency (CFIA) in collaboration with the Direction générale de l'Alimentation (DGAL) from November 16 to 22, 2022. The audit was performed in a hybrid format. The opening and closing meetings with the French central authorities and the French agricultural office (FranceAgriMer) took place virtually on November 8 and December 12, 2022.

The purpose of the audit was to evaluate the official inspection system in place for producing milk and dairy products for human consumption and to ensure that Canada's import requirements are met. The audit focused mainly on cheese-producing establishments.

The CFIA audit team of 3 auditors was accompanied by representatives from the DGAL and FranceAgriMer. The audit scope included visits to a regional office of the competent authority, a departmental office, 6 production facilities, one distribution facility and a dairy farm.

The following areas were audited:

• The competent authority and oversight
• Food process controls
• Hazard Analysis and Critical Control Points (HACCP)
• Export controls
• Import controls
• Microbiological controls
• Chemical residue controls

The audit report includes findings and recommendations addressed to France to remedy the shortcomings identified during the on-site audit.

1. Introduction

1.1 Audit objective, scope and methodology

The Canadian Food Inspection Agency (CFIA) audited France's inspection system governing the production of milk and milk products for export to Canada. The opening and closing meetings with the French central authorities and the French agricultural office (FranceAgriMer) took place virtually on November 8 and December 12, 2022. The CFIA conducted the on-site audit in collaboration with the Direction Générale de l'Alimentation (DGAL) from November 16 to 24, 2022. The audit was performed in a hybrid format. The audit team consisted of 3 CFIA auditors, who were accompanied throughout the audit by 2 representatives from the CCA and the French agricultural office (FranceAgriMer).

The audit covered activities in the following areas:

• The competent authority and oversight
  • Regulatory framework
  • Oversight and supervision framework
  • Training framework
  • Export controls
  • Import controls
  • Enforcement framework
• On-farm controls, collection and transport of raw milk
• Processing controls
• Preventive control plan and prerequisite programs
• Microbiological controls
• Chemical residue control

Summary of audit scope and competent authority and sites visited included:

• Central competent authority
• Departmental office
• Dairy farm (cattle)
• Dairy processing and maturing establishments distribution establishments

A total of 11 sites were audited.

1.2 Legal basis for the audit and audit standards

The audit was conducted under the specific provisions of Canadian laws and regulations, in particular:

• Safe Food for Canadians Act (SFCA)
• Safe Food for Canadians Regulations (SFCR)
• Food and Drugs Act (FDA)
• Food and Drugs Regulations (FDR)
• Health of Animals Act (HAA)
• Health of Animals Regulations (HAR)

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

2. Competent authority and oversight

2.1 Regulatory framework

France is an EU member state. As such, milk and dairy products manufactured in that country are governed by EU regulations. The EU has developed an integrated "farm to fork" approach to food safety. In addition to EU regulations, French national legislation supplements this European legislation.

Key relevant EU regulations:

• Regulation (EC) No. 178/2002 : general principles/requirements of food law
• Regulation (EC) No. 852/2004 : hygiene of foodstuffs
• Regulation (EC) No. 853/2004 : hygiene rules for food of animal origin
• Regulation (EC) No. 183/2005 laying down requirements for feed hygiene
• Regulation (EU) No. 2017/625 : official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products
• Regulation (EC) No. 2073/2005 : microbiological criteria for foodstuffs
• Regulation (EC) No. 2074/2005 on implementing measures for certain products governed by Regulation (EC) No. 853/2004
• Regulation (EU) No. 931/2011 on the traceability requirements set by Regulation (EC) No. 178/2002
• Regulation (EU) 2022/1644 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with specific requirements for the performance of official controls on the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof

France's principal national regulations are as follows:

• Order of June 8, 2006, on the health safety approval of establishments that market products of animal origin or foodstuffs containing products of animal origin.
• Order of December 18, 2009, on health safety rules applicable to products of animal origin and foodstuffs containing them
• Order of December 21, 2009, on health and safety rules applicable to the retail, storage and transport of products of animal origin and foodstuffs containing them.
• Order of November 7, 2012, on health and safety rules applicable to traditional dairy products

2.2 Oversight framework

In France, 3 ministries jointly carry out official duties to ensure food safety and fair industrial and commercial practices for consumers. The Ministère de l'Agriculture et de la Souveraineté alimentaire (MAA), which through the DGAL is the central competent authority (CCA) that manages and controls the inspection system for milk and dairy products. The DGAL issues technical instructions (TI) such as DGAL/SDPRAT/2016-941, which outlines the national management approach. Jointly, the Ministère responsable de l'Économie, des Finances et de la Souveraineté industrielle et numérique handles fraud enforcement under a single health policing body. Lastly, the Ministère de la Santé et de la Prévention is responsible for drinking water quality and toxic infection investigations.

In accordance with Regulation (EU) No. 2017/625, France, as an EU member state, has set up the Plan-national-de-controles-officiels-pluriannuel-2021-2025 (PNCOPA) containing information on the organizational structure of its inspection system and how official controls are conducted throughout its food chain. An annual report containing the results of official controls and sampling is sent annually to the European Commission.

The Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES) and the European Food Safety Authority (EFSA) provide the DGAL with their expertise on food-related risks. FranceAgriMer is a public administrative body whose mission is to educate, guide and support the stakeholders who act as intermediaries between the production sectors and the French government. FranceAgriMer supports foreign audit missions in support of the MAA's departments and provides technical, logistical and financial assistance to the agri-food sectors to facilitate access to international markets and the negotiations of the Agreement on Sanitary and Phytosanitary Measures (SPS), which represent priority issues for these sectors.

The DGAL controls the dairy product inspection system at the national, regional and departmental levels. France has 96 departments in mainland France and 5 overseas departments. The veterinary services responsible for dairy products are located within inter-ministerial directorates (DDI). In the most populous departments, the term "Direction Départementale de la Protection des Populations" (DDPP) is used, and in the most sparsely populated departments, "Direction Départementale de l'Emploi, du Travail, des Solidarités et de la Protection des Populations" (DDETSPP). Technical instruction DGAL/SDSSA/2022-349, supplemented by sector-specific information sheets, sets out the conditions and procedures to be followed by DDPPs when approving establishments under Regulation (EC) No. 853/2004. This instruction specifies the specific hygiene rules applicable to foodstuffs of animal origin and is supplemented by the Ministerial order of June 8, 2006, on health safety approval.

All guidelines underpinning the DGAL's actions are based on a risk assessment approach. Establishments with health safety certification are monitored according to a risk classification of 1 to 4, which means an inspection frequency every 2 years, 1.5 years, once a year and twice a year. The DDPP and DDETSPP food safety departments are staffed by veterinarians, engineers and technicians specially trained in food inspection. The inspector appointed to carry out the document review uses tools such as the general and sector-specific handbook on milk and dairy products, guides for good health safety practices (GBPH) and specific technical instructions. These tools set out the areas to be assessed by official staff based on regulatory requirements and the level of compliance of the operator's health and safety management plan.

Under Regulation (EC) No. 852/2004, dairy establishments must be approved by the competent authority. As part of the certification process, the dairy establishment must first obtain a unique 14-digit SIRET (Système d'identification du répertoire des établissements) identification number. Inspection reports audited by the CFIA contained SIRET approval numbers specific to the establishment.

Establishment certification applications are sent to the department. Site visits are mandatory to complete the health and safety certification process and allow operations to begin. All data relating to the establishment certification process and its completion are recorded in the Ministère de l'Agriculture et de l'Alimentation's RESYTAL authentication portal.

For the production of lists of certified establishments, technical instruction DGAL/SDSSA/2022-349 refers to the list of establishments certified at the community level and the list of establishments certified at the national level. This TI provides for a daily update of establishments on the DGAL website. However, since Canada adopted the Trade Control and Expert System (TRACES), the CFIA uses the TRACES list of establishments by country when verifying imports of dairy products from France. The CFIA has noted that the various DGAL and TRACES lists are not updated in any coordinated fashion. In some cases, there was as much as a 5-day difference between the 2 publication dates.

However, the CFIA observed that despite several minor non-conformities, this did not affect the establishment's immediate risk classification, nor did it alter the frequency of visits by the authorities.

2.3 Training framework

Competent authorities must have a sufficient number of suitably qualified and experienced staff to carry out official controls and other official activities efficiently and effectively. The PNCOPA 2021–2025 provides information on staff resources, professional skills, training requirements and networks of expertise.

In the area of dairy product inspection, the DGAL has set up a network of resource persons comprising a national coordinator specialized in dairy products who is in constant contact with regional experts. This network of 9 people provides technical expertise in the form of mentoring and coaching, technical support and monitoring of inspection assignments. This group plays a key role in interpreting regulations and developing handbooks and internal instructions. We met with the national coordinator and members of his network who were in charge of some of the establishments we visited.

To ensure official control of the milk and dairy products inspection system and support the work of inspectors, the DGAL has implemented several tools, including an inspection grid, a general and sectoral handbook on milk and dairy products, a report-writing guide and technical instructions (TIs) developed by the DGAL. The audit team noted that some TIs, such as the one specific to the export of dairy products to Canada, still referred to repealed EU regulations. The CA pointed out that instructions are not systematically revised when EU regulations are updated and that corrections are only made if an update to the TI is necessary.

2.4 Export controls

The DGAL is responsible for ensuring that CFIA regulatory requirements are uniformly implemented by inspection staff in establishments authorized to export to Canada. The DGAL has developed Technical Instruction DGAL/SDASEI/2019-170 concerning the terms and conditions for exporting dairy products to Canada. The DGAL is kept informed of import requirements for dairy products from Canada through the Département Agricole at the French Embassy in Washington, which also participates in negotiations concerning market access conditions in the North American zone.

Technical Instruction DGAL/SDASEI/2019-170 summarizes the health and safety certification system for dairy products exported to Canada, as well as the special conditions for exporting certain unpasteurized milk cheeses ripened to less than 60 days. This instruction supplements the guidelines in Technical Instruction DGAL/SDASEI/2018-419, which outlines the export health certification procedures from the time the operator's application is received through to the issuance or non-issuance by the DDPP of the health certificate required for export. When the CFIA audit team reviewed these technical instructions, it found that some repealed EU regulations were still cited as references.

The health certificates currently issued for the export of dairy products to Canada are as follows:

DGAL-issued certificates:

• Health certificate for the export of selected raw milk cheeses to Canada – Model CA PLA NOV 08 – Official negotiated certificate
• Health certificates for the export of milk and dairy products to Canada – Model CA PLI SEP 14 – Official non-negotiated certificate

Certificate issued by FranceAgriMer:

• AGREX export certificate

Certificate applications must be submitted before the shipment is dispatched, at least 48 hours before export. However, certain exceptions are possible if justified. Export certification for dairy products is not mandatory. The exporter is responsible for applying for a certificate. A waiver is required for unofficial certificates.

Expadon 2 is an online system for managing health safety certifications for establishments exporting to third countries, as well as health certificate templates. Exporters use this system to apply for the export of dairy products, and the system is also used to manage the licensing of establishments wishing to export. The system enables exporters to enter information concerning the batch being shipped and attach relevant documents. Expadon 2 does not yet allow the use of electronic signatures. The certifying officer must print the certificate for final review, stamping and signature. The certifying officers interviewed by the CFIA confirmed that a verification of the establishment's eligibility for export is always performed by checking the list of EC-approved establishments and the specific list of the importing country, where applicable. The issue of using imported dairy ingredients was also raised, and it was confirmed that pre-certification could be requested to support final certification. Health certificates are always signed by an official veterinarian. The exporter collects the signed certificates either from the DDPP or by mail.

Pre-export inspections are not mandatory. The decision to inspect a shipment is based on risk, the exporter's history and the third country's import conditions. However, operators must provide the establishment's approval or registration number, the name of a contact person and the time and date of visibility of the goods. The physical inspection rate for a DDPP handling around 33% of all French export activity is around 1%; certificates are not issued once goods have left France. However, this cannot always be confirmed, as systematic inspection of goods is not mandatory.

Canada does not currently have an establishment eligibility list, but dairy products exported to Canada must come from EC-approved establishments in accordance with Regulation (EC) No. 853/2004, Section IX raw milk, colostrum, dairy products and colostrum-based products. When controlling imports to Canada, CFIA inspectors refer to the list of establishments in TRACES to ensure that dairy products come from an EC-approved establishment, while DDPP officers use the list on the DGAL website.

Cheese producers exporting with model CA PLA NOV 08 are subject to an official control (targeted inspection and sampling for analysis) carried out at least every 3 months. Pathogens targeted for sampling include Listeria monocytogenes, Salmonella, Escherichia coli and Staphylococcus aureus. Technical Instruction DGAL/SDASEI/2019-170 is quite explicit on this subject. The CFIA auditors interviewed the dairy inspectors and official veterinarians involved in the certification process for exporting dairy products to Canada, and they were well aware of Canada's requirements.

A training and supervision program is set up for the first certification procedures. A specialist inspector is also available if required. However, the CFIA showed certificates issued by France with the following shortcomings:

• The CA's official "dry" stamp is not always in the right place or visible on the certificate. This causes problems for Canada Border Services Agency officers when verifying documents and delays in the goods release process. The problem also arises for the wet seal of DGAL certifying officers. 
• Lack of certificate number and link between certificate and appendix regarding product description.
• Model certificate CA PLA NOV 08 negotiated for the export of raw milk cheeses less than 60 days old was issued with formatting changes on page 2.
• One certificate had the exporter's stamp in the box intended for the CA's official stamp.
• A certificate was issued with incomplete microbiological analysis results.
• The destination of the products was not always indicated on the certificate.
• Some certificates had certificate numbers starting with the 3-letter ISO code for France, while others had a 2-letter ISO code.

Some certifying officers audited by the CFIA pointed out that the official "dry" stamp is not easy to use, especially when the stamp is affixed using a mechanical press and several certificate pages have to be stamped.

2.5 Import controls

Any food product imported into the EU must meet the requirements of European food regulations or be deemed equivalent as per Regulation (EC) No. 852/2004. Once these conditions have been confirmed and an imported foodstuff has been accepted into the EU, it can circulate freely within the member states without further monitoring. Regulation (EU) No. 2017/625 covers official controls and activities performed to ensure compliance with food and feed law, as well as rules on animal health and welfare, plant health and plant protection products.

To export milk, milk products, colostrum and colostrum-based products to France or any other EU member state, including countries that have adopted EU veterinary legislation (like Switzerland, Norway, Iceland and Liechtenstein), the consignment must be accompanied, depending on the risk category associated with the type of milk product, by one of the health certificate forms in Regulation (EU) No. 2022/2235. The EU's TRACES system is a digital certification and goods management platform used to support the issuance of official certificates to the EU.

Veterinary border control posts (BCP) are responsible for import health safety controls and are grouped under the DGAL's Service d'Inspection Vétérinaire et Phytosanitaire aux Frontières (SIVEP). France has 27 BCPs approved by the European Commission. Dairy products are subject to documentary checks (100% for products of animal origin), identity checks and physical examinations, as well as laboratory tests in accordance with EU regulations. Via the TRACES application, SIVEP issues the common health entry document (CHED-P), which attests that checks have been carried out on consignments and that a decision has been reached on their acceptance or rejection in the European Community.

The CFIA discussed with veterinary certifiers the requirements concerning the possible use of raw milk or dairy ingredients from other EU member states and/or third countries. Due to harmonized legislation, milk and dairy products can circulate freely within the EU. However, supporting documentation (pre-certification) may be requested from an EU member state or third country if any of the statements in the health certificate go beyond national or EU regulations, or if they cannot be verified when a certificate is signed.

2.6 Enforcement framework

As per Regulation (EU) No. 2017/625, France, as an EU member state, is responsible for imposing immediate interventions in case of non-compliance.

France's Code rural et de la pêche maritime (Rural and Maritime Fishing Code) regulates violations and sanctions in the areas of hygiene, consumer protection and agri-food production. Failure to comply may result in the issuance of a formal notice. EU-approved establishments are subject to minimum inspections, depending on their risk rating. In response to non-compliance, the DGAL takes enforcement measures such as warnings, product blocking or production stoppage, suspension of certification and, if necessary, other administrative enforcement measures. Non-compliance identified by a third country is treated as a product alert in the same way as a national alert, and investigation may lead to suspension of exports.

The CFIA carried out an on-site documentary audit that included inspection reports and the competent authority's implementation of enforcement measures in establishments in accordance with French policy, guidelines and national orders. The CFIA reviewed inspection reports submitted by the DDPP and discussed non-compliant items and the Notation system. The results of official controls are published on the "Alim'confiance" (in French only) website for one year.

3. On-farm controls, collection and transport of raw milk

Canada officially recognizes France as a country free of foot-and-mouth disease, a disease listed in the World Organization for Animal Health (WOAH) Terrestrial Animal Health Code. France is officially free of tuberculosis and brucellosis according to Regulation (EU) No. 2021/620.

Farms in France are overseen by the competent authority but are not approved in the same way as processing establishments. For dairy products to be produced, raw milk must come from farms registered in compliance with Regulations (EC) No. 852/2004 and No. 2019/627. DDPPs are responsible for monitoring herd health. Any problem detected on a farm that could affect milk quality and thus restrict its use for human consumption is communicated to operators. These measures are formalized by prefectural surveillance orders (APMS) or prefectural declaration of infection orders (APDI), which are made public.

The DGAL also assigns private vétérinaires sanitaires (sanitary veterinarians) to conduct event-driven or scheduled visits or oversight on all farms. Reports are forwarded to the DDPP for verification and action where necessary.

The audit team visited a medium-sized dairy cattle farm. During this visit, the team was shown that health visits are carried out regularly by an accredited veterinarian and that a data collection system was in place to provide a real-time status of the health and feed situation. The farm received health visits in December 2020 and 2021, and its risk indicators were categorized as low. The farm's herd was free of brucellosis and tuberculosis, and the cows were free-stall and in good body condition. Cows were segregated and identified by milking priority. The cows are milked twice a day in a traditional milking parlour. To meet the specific requirements for producing Protected Designation of Origin (PDO) cheeses, a farm must also comply with a set of specifications setting out breeding and production criteria.

Veterinary medicines stored in the dairy were kept in a locked cupboard. Records of veterinary drug use (veterinary prescriptions, use and withdrawal times) were adequately managed. Medicines are dispensed by a DDPP-certified pharmacy.

Quality control of the raw milk collected is the responsibility of professionals (producer and inter-professional organizations), in particular through payment for milk according to its composition and quality. Milk must meet specific composition and hygiene criteria. The bonus or penalty principle is applied depending on the analysis results of the samples taken at each collection. Raw milk samples collected by collectors from producers are analyzed in one of the 13 laboratories accredited by the Centre national interprofessionnel de l'économie laitière (CNIEL), using analysis methods recognized by the DGAL. No raw milk transport vehicles were inspected during the audit.

The Accord interprofessionnel national relatif au paiement du lait de vache en fonction de sa composition et de sa qualité (National interprofessional agreement on payment for cow's milk based on composition and quality) specifies the criteria and conditions for sampling and analysis required to determine the price of milk Regulation (EU) No.1308/2013 defines the framework applicable to interprofessional organizations.

Section IX of Regulation (EC) No. 853/2004's Annex III outlines the specific requirements for raw milk, colostrum, dairy products and colostrum-based products. Regulation (EC) No. 853/2004 lays down the health requirements applicable to the production of raw milk and colostrum. Each tanker received by a processing plant is systematically checked for somatic cells and total germs. Other criteria, depending on the destination of the milk, may also be checked. If the milk is tested and found to contain antibiotics, it is destroyed. The leucocyte count and total bacteria count of the farm visited for 2021 and 2022 met the criteria applicable to raw milk in Regulation (EC) No. 853/2004. Dairy farmers are subject to strict regulations and a penalty system to encourage them to produce quality cow's milk.

If germ and somatic cell criteria exceed regulatory limits, the milk undergoes heat treatment, with reinforced self-controls, and the final products undergo microbiological checks. The Centre régional interprofessionnel de l'économie laitière sends the DDPP a monthly report on non-compliant milk. Collection may then be suspended. Technical Instruction DGAL/SDSSA/2022-845 sets out the management of milk payment according to quality and describes the specific role of the DDPP.

During a visit to the farm during milking, the CFIA noted many flies in the dairy establishment, despite sticky traps that had reached saturation. In addition, the milk tank's cover was not closed, and the lid was placed on the sink, giving open access to pests.

4. Process controls

Process controls implemented throughout the manufacturing process help ensure the production of safe food. Regulation (EC) No. 853/2004 defines the operator's responsibility to develop and implement process control programs and performance requirements. Regulation (EC) No. 2073/2005 stipulates that microbiological criteria can be used to validate and verify HACCP-based processes and other hygiene control measures.

The control of raw milk is a regulatory requirement that is included in the interprofessional agreement relating to the presence of antibiotic residues in cow's milk. Raw milk from every tanker received at a milk and dairy product processing plant is systematically subjected to a rapid test for antibiotics. In the establishments visited, the receipt of raw milk is identified as a Critical Control Point (CCP) and/or an operational prerequisite program. If raw milk tests positive for antibiotics, it is systematically rejected and destroyed by the collector. The establishments audited had procedures in place for receiving raw milk that were adapted to the type of dairy products manufactured and aligned with EU and French requirements.

Lethality treatment refers to the heat treatment administered to the milk to achieve a reduction in viable pathogenic organisms. Depending on the type of cheese produced, the raw milk may be pasteurized. The CFIA visited processing plants that use a continuous flow pasteurizer to heat-treat the milk before turning it into cheese. Heat treatment is controlled by a CCP, and the pasteurization process is validated by measuring alkaline phosphatase levels. However, in one of the plants audited, the location of the pasteurizer's indicator thermometer probe was not in the ideal position for measuring the temperature and time of the pasteurization process.

Processing stages such as acidification, coagulation, separation of curds and whey, salting, shaping and maturing are controlled by prerequisite programs which have been audited. Production stages are monitored and controlled by the operator to ensure that risks are minimized or eliminated. Establishments are responsible for validating and implementing controls, and official authorities for verifying them.

Some of the establishments audited receive cheeses for maturing from other approved external processors, including farmhouse producers under the PDO label such as Saint-Nectaire, Comté and Roquefort cheeses. These cheeses are included in the establishment's process control plan. The PDO label guarantees that all stages in the production are carried out in a specific geographical area corresponding to the product's terroir of origin and following recognized expertise and particular specifications.

Refining, cutting and packaging processes comply with national and European regulations requiring the development and maintenance of dairy product integrity and traceability systems at all levels of the food chain. Because they are audited, operators carry out traceability exercises and have an effective recall plan in place, enabling them to recall and withdraw a product that does not meet regulatory requirements. Labelling compliance for products exported to Canada is the responsibility of importers. Operators demonstrated a good knowledge of Canadian import requirements.

5. Preventive control plan and prerequisite programs

Regulation (EC) No. 178/2002 relates to food law requiring operators in the food sector to implement procedures based on HACCP principles associated with Good Manufacturing Practices (GMP). HACCP requirements should take into account the 7 principles set out in the Codex Alimentarius.

The establishments visited apply the general hygiene provisions, and a program based on the principles of a Hazard Analysis Critical Control Point (HACCP) system is in place in accordance with the relevant EU regulations. The audit team had access to facility drawings outlining the flow of products, as well as to manufacturing diagrams for several processors. The various stages in the manufacturing process were clearly described. The presentations and the manufacturers' documentary review enabled us to verify that specific procedures were in place depending on the type of dairy products exported to Canada.

However, the CFIA identified systemic shortcomings related to implementing prerequisite programs such as building and equipment maintenance. For example, some surfaces in direct contact with the product had a build-up of organic matter, weathering or rust. Inadequate manufacturing and product handling practices were also observed, which could contribute to the deterioration of health safety conditions. In 2 of the establishments audited, several prerequisite program files and registers did not include the responsible employee's verification signature or written follow-up of corrective and preventive actions.

6. Microbiological controls

The European Food Safety Authority (EFSA) monitors and analyzes information and data on biological hazards, chemical contaminants, food consumption and emerging risks. Member states must monitor the recommended level of microbiological sampling and send the results to EFSA for publication. Member states must follow the recommended number of microbiological samples and send the results to EFSA for publication. After verification, the PNCOPA presents the results of microbiological sampling each year, as required.

The DGAL is responsible for planning the official control programs included in the MCP to monitor biological risks and contaminants related to food safety. The DGAL distributes the sampling plan to the departments. As noted during the audit, the number of samples taken by the competent authorities for the presence of Listeria monocytogenes in the processing plant is risk-based, with no prescribed frequency for each establishment. In addition, the official microbiological sampling plan for Listeria monocytogenes monitoring includes sampling only dairy products. It does not include sampling of environmental food contact surfaces to monitor the effectiveness of the industry's sanitation processes.

As noted during the audit, official authorities monitor the effectiveness of industry sanitation processes and GMPs to prevent contamination of the cheese processing environment by Listeria spp. and Listeria monocytogenes during the on-site visit. Once the official technician has taken the sample, the authorities submit it to the network of laboratories. The laboratories analyze the sample and publish the results on the secure electronic portal.

Regulation (EC) No. 2073/2005 laying down microbiological criteria for dairy products specifies the requirements for microbiological sampling of food safety and process hygiene by the operator. Member states must ensure that official risk-based controls are carried out regularly and with sufficient frequency to achieve the objectives of Regulation (EU) No. 2017/625. In one of the establishments audited, the operator's risk analysis did not include a description of germs other than Listeria monocytogenes and sampling for Listeria monocytogenes in finished products and contact surfaces.

During site visits, the CFIA found that finished products were not systematically sampled. Food operators determine sampling and testing frequencies as part of their HACCP and other hygiene control procedures. Manufacturers are responsible for demonstrating that they are in control of all stages of the dairy manufacturing process.

France has a certificate negotiated with Canada for raw milk cheeses aged less than 60 days. Analysis results are required for Listeria monocytogenes, Salmonella, Escherichia coli and Staphylococcus aureus. All operators visited by the audit team demonstrated a good knowledge of the Canadian import requirements stipulated in the Automated Import Reference System (AIRS).

7. Chemical residue control

Directive 96/23/EC repealed by Regulation (EU) No. 2017/625 requires EU member states to develop and implement a national residue monitoring plan each year. The DGAL is responsible, in collaboration with other ministries, for implementing monitoring and control plans (MCPs). The outcomes of these plans are forwarded to the ANSES and EFSA for food risk assessment purposes in France and the European community.

The DGAL uses a network of official and private laboratories. Its analytical methods comply with ISO/CEI 17 025 standards and are overseen by the French Accreditation Committee (COFRAC). Any non-conformity detected during MCP sampling leads to the batch being seized and investigated by the official authorities at the operator's premises and on the farm, if applicable. The CFIA audit team visited did not visit any laboratories.

Each year, the DGAL develops a technical instruction describing the operation of MCPs at the regional and departmental levels. This instruction sets out the procedures for scheduling and carrying out sampling, routing and analyzing samples, forwarding results, managing non-compliant results and reporting. The audit team reviewed Technical Instructions DGAL/SDSPA/2021-163 and DGAL/SDSPA/2022-14, which detailed the implementation of the control plan for chemical residues in milk for 2021 and 2022, respectively. These instructions are available in the RESYTAL document library.

Dairy products imported from France are subject to routine monitoring for chemical residues and to enforcement action in the event of non-compliance. The CFIA reviewed France's MCPs and the results for 2021 and 2022. The MCP includes the number of samples, species, target matrix, sampling points, substances to be tested and test analysis methods, as prescribed by the European Commission's regulations to ensure dairy product compliance.

The DGAL is responsible for following up on residue violations at ports of entry for French products exported to Canada. In the establishments audited, the sampling program is implemented in compliance with the relevant requirements.

Canada regularly monitors imported dairy products for chemical residues and evaluates the results of analyses. All dairy products for export to Canada must be free of veterinary drug residues. Maximum residue limits are established by Health Canada for veterinary drugs in milk, as well as for contaminants food products.

8. Closing meeting

A virtual closing meeting was held on December 13, 2022. During the meeting, the preliminary findings of the audit were presented and discussed with representatives of the DGAL and FranceAgriMer.

9. Conclusions

The preliminary audit report includes recommendations for France to address the shortcomings identified during the on-site audit.

Following a review of the requested information and action plan provided by the competent authority, the CFIA will determine whether France's milk and dairy products inspection system is functioning adequately and meets Canadian requirements.

10. Recommendations

The following recommendations have been made in response to the observations and findings documented during the assessment. An action plan outlining the actions that have been taken or will be taken to correct the shortcomings identified must be submitted to the CFIA within 60 working days of receipt of the report.

Summary of the Canadian Food Inspection Agency (CFIA) recommendations/findings from the Canadian Audit of France's mik and dairy program draft report – 2022

Recommendation 1:

The CFIA recommends that all audit findings be remedied and that implementation be verified in a timely manner by the CA.

DGAL action plan/comments:

• The DGAL has forwarded Annex 1 to local competent authorities (local CA) and to professionals.  
• The implementation of corrective actions by some of the audited operators has been re-checked by local CAs, while others are scheduled for the next inspection.
• The DGAL provided additional information in October 2023 and March 2024.

Response accepted by CFIA

Recommendation 2:

Section 2.4: The CFIA recommends that the competent authority ensure that export certification procedures are applied consistently across the country.

Furthermore, the CFIA recommends that certificates issued for dairy products exported to Canada be stamped with an official wet seal.

DGAL action plan/comments:

• The DGAL has issued a technical instruction for national distribution to all export certification services to standardize practices.  
• In addition, the DGAL has a national referral agent for exports of live animals and animal products whose role is to support local certification CAs where necessary and ensure that standardized certification procedures are applied.
• Where necessary, the DGAL will send awareness or cautionary messages to export certification services.
• The DGAL will include the CFIA's recommendation concerning the use of the official wet stamp in the next version of the technical instruction concerning exports to Canada.
• In the meantime, the DGAL has emailed all local CAs responsible for export certification asking them to implement this recommendation.

Response accepted by CFIA

Recommendation 3:

Section 3: CFIA recommends that all findings identified during the farm visit be corrected and verified by the CA.

DGAL action plan/comments

• The DGAL has provided responses and comments to the CFIA's on-farm audit observations.

Response accepted by CFIA

Recommendation 4:

Section 5: The CFIA recommends that the competent authority review the preventive control plans (HACCP) and prerequisite programs already in place at the establishments to address the shortcomings identified in this report.

DGAL Action plan/comments

• The DGAL has assured local CAs that all the recommendations made by the CFIA during this audit have been taken into account.
• The local CAs have included these recommendations in the areas of concern for departments to take into account and verify during the next scheduled inspections of each facility.

Response accepted by CFIA