Assessment report: Switzerland's dairy product food safety system

On this page

• Abbreviations
• Introduction
• Objective and scope
• Methodology
• Element 1: Regulatory basis
  • Competent authorities (CA)
  • Regulatory framework
    • Powers
    • Authorization
    • Primary production (milk)
    • Food production
    • Traceability
    • Complaints and recalls
    • Exports
• Element 2: Training program and human resources
• Element 3: Inspection and control program
  • Monitoring chemical residues
  • Monitoring microbial contamination
  • Licences
  • Establishment controls
  • Labelling, identification, traceability and packaging
  • Exports
• Element 4: Program evaluation or audit
• Element 5: Investigation of food-borne illnesses and outbreaks
• Element 6: Compliance and enforcement program
• Element 7: Industry and community relations
• Element 8: Program resources
• Element 9: International communications and harmonization
• Element 10: Laboratory support
  • Microbiology
  • Chemistry
• Conclusion
• Recommendations

Abbreviations

ADNS

Animal Disease Notification System

CA

Competent Authority

CFIA

Canadian Food Inspection Agency

CVED

Common Veterinary Entry Document

DCAI

Federal Food Control Diploma

DDCAI

Federal Diploma in Food Control Management

EAER

Federal Department of Economic Affairs, Education and Research

EAER Org

Federal Department of Economic Affairs, Education and Research Organization

EC

Examination commission

EU

European Union

FA

Foodstuffs Act

FDHA

Federal Department of Home Affairs

FDHA Organization

Federal Department of Home Affairs Organization

FFCU

Federal Food Chain Unit

FOAG

Federal Office for Agriculture

FSVO

Federal Food Safety and Veterinary Office

HACCP

Hazard Analysis and Critical Control Points

HFAA

Health and Food Audits and Analysis of the European Commission

ISO

International Organization for Standardization

IVI

Institute of Virology and Immunology

MANCP

Multiannual National Control Plan

NFUP

National Foreign Substance Testing Program

OAbCV

Ordinance on the Slaughter of Animals and Meat Inspection

OCL

Ordinance on Milk Control

ODAIOUs

Ordinance on Foodstuffs and Utility Articles

OELDAI

Ordinance on the Implementation of Foodstuffs Legislation

OFDF

Federal Office of Customs and Border Security

OHyPL

FDHA Ordinance on Hygiene in Milk Production

OITE-PT

Ordinance on the Import, Transit and Export of Animals and Animal Products from and to Third Countries

OPPr

Ordinance on Primary Production

OSALA

Ordinance on Animal Feed

PAE

Platform for Agricultural Exports

PAFF Committee

Standing Committee on Plants, Animals, Food and Feed

PDO

Protected Designation of Origin (AOC)

PNSE

National Foreign Substance Testing Program

POE

Port of Entry Violation

RASFF

Rapid Alert System for Food and Feed

SAAV

Food Safety and Veterinary Affairs Office (canton of Fribourg)

SAS

Swiss Accreditation Service

TRACES

Trade Control and Expert System

WTO

World Trade Organization

Introduction

The CFIA has a broad mandate that includes food safety, animal and plant health and access to international markets. The CFIA's priority is to protect the health and safety of Canadians. To this end, it regularly conducts assessments of Canada's trading partners' food control systems to ensure that these countries have implemented control measures to guarantee the safety of food exported to Canada.

These assessments help the CFIA:

• proactively identify shortcomings
• make recommendations to strengthen a country's food safety control system
• strengthen relationships to improve food safety
• direct surveillance resources to the highest-risk sectors
• prevent food safety risks before products enter Canada
• increase consumer confidence in imported foods
• contribute to market access

Objective and scope

Assessment objective and scope

The CFIA's foreign system audit program is designed to verify the safety of imported food. Countries and commodities are selected according to two criteria. The first is to take action when non-compliance is observed. The second is to conduct routine verifications. These are based on the risk of the commodity and the volume of imports.

The CFIA uses a system assessment tool to evaluate foreign systems. The tool includes the following ten elements:

• Element 1: Regulatory basis
• Element 2: Training program and human resources
• Element 3: Milk and milk products inspection and control program
• Element 4: Program evaluation or audit
• Element 5: Investigation of food-borne illnesses and outbreaks
• Element 6: Compliance and enforcement program
• Element 7: Industry and community relations
• Element 8: Program resources
• Element 9: International communications and harmonization
• Element 10: Laboratory support

Methodology

The CFIA team completed its evaluation in four steps:

Step 1 – Review of the Swiss dairy product safety system

The main portion of the assessment was rounded out by a documentary review. The review is based on Platform for Agricultural Exports (PAE) responses to the CFIA questionnaire. The CFIA team reviewed the regulations and ordinances, manuals and procedures, reports and other reference documents.

Step 2 – Identification of audit scope

The purpose of the audit was to assess the official inspection system in place for dairy products to ensure that Canada's import requirements are met. The audit focused on the surveillance of cheese production by federal authorities and cantons.

Step 3 – On-site visit

The opening meeting took place virtually on November 8, 2023. The following topics were covered:

• regulatory framework
• stakeholder roles and responsibilities
• training
• food recalls
• establishment licensing
• milk controls

The on-site visit took place from November 23 to 30, 2023. Visits included observation of cheese production, maturation and preparation (cutting, slicing, grating and packaging). Company inspections carried out by the cantonal authorities were also assessed. The establishments visited were chosen in collaboration with the PAE. The processing establishments visited were selected based on import volume, risk, and history of non-compliance observed in Canada. The on-site visit included a visit to a cantonal office and five establishments.

The closing meeting took place virtually on December 13, 2023. The CFIA team presented its preliminary observations to the competent Swiss authorities.

Step 4 – Report and recommendations

The report includes a summary of the Swiss system for each element, as well as recommendations.

Element 1: Regulatory basis

Competent authorities (CA)

The Federal Office for Food Safety and Veterinary Affairs (FSVO) is the federal authority responsible for food safety. Its mission is to promote human and animal health and well-being.

The main groups included in the FSVO organizational chart:

• international affairs
• scientific bases
• food and nutrition
• Institute of Virology and Immunology
• animal health and protection
• Plant Protection Product Approval Service

The main activities of the FSVO are defined in Article 12 of the Federal Department of Home Affairs Organization (FDHA Org) Ordinance – Federal Office for Food Safety and Veterinary Affairs . The FSVO acts as the Confederation's Competence Centre for food safety.

The scope of the FSVO's responsibilities includes the following:

• regulating the production, import and export of food
• protecting consumers against deception
• raising public awareness on nutrition
• ensuring that animals are free from transmissible epizootic diseases
• ensuring animal welfare
• supporting free markets
• regulating plant protection products
• preparing and developing food safety laws and regulations
• administering the Institute of Virology and Immunology (IVI) and the Plant Protection Product Certification Service
• co-managing the Federal Food Chain Unit (FFCU)

Article 7 of the Federal Department of Economic Affairs, Education and Research Organization Ordinance – Federal Office for Agriculture – defines the role of the Federal Office for Agriculture (FOAG). The FOAG is the Confederation's Competence Centre for the agricultural sector and is responsible for:

• creating and ensuring suitable conditions for exporting
• agricultural and agri-food research
• maintaining the registry of products with protected designation of origin (AOP)

The Federal Food Chain Unit (FCCU) is jointly managed by the directors of the FOAG and the FSVO. The FFCU monitors and aligns the enforcement activities at the federal and cantonal level. The Unit is ISO 9001:2015 certified and is evaluated annually. Its mandate is to:

• prepare a risk-based monitoring plan
• perform, evaluate and report on monitoring
• develop and communicate standardized solutions
• help develop action plans based on surveillance results
• monitor the effectiveness of the measures taken

The cantonal authorities are responsible for carrying out food inspection and surveillance activities. These activities are described in Overview of Official Controls – 2021 . The cantons ensure compliance with federal legislation. In addition, they verify that companies have implemented self-monitoring. The controls can be divided into 2 categories:

• analytical testing of samples (product control)
• company inspections (process control).

The Cantonal chemist manages the planning of inspection activities and supervises the cantonal laboratory. The Cantonal veterinarian is generally responsible for managing animal health matters. Their role includes the surveillance of primary production such as milk production. For the canton of Fribourg, the Cantonal chemist and veterinarian jointly manage the Service de la sécurité alimentaire et des affaires vétérinaires (SAAV) (Food Safety and Veterinary Affairs Department)

The Multiannual national control plan (MANCP) describes the strategic and operational objectives. The Plan also defines the organization and structure of the official food control systems. Appendix B – Official Controls of the 2020–2023 MANCP defines the controls to be carried out in the cantons and includes:

• monitoring of milk hygiene procedures in primary production
• monitoring of food processing and distribution procedures
• product monitoring
• national testing program

 Switzerland publishes an annual summary of food controls.

Regulatory framework

 Swiss regulations include a set of ordinances for the surveillance of food production.

Powers

Under Art. 29 – Obligation to assist and to provide information of the Foodstuffs Act, any person carrying out the following activities must cooperate with the enforcement authorities:

• manufacturing
• handling
• storage
• transporting
• placing on the market
• importing
• exporting

This includes providing product samples or any information required for inspection.

Authorization

Companies that handle food of animal origin must hold an operating licence issued by the canton. This is a requirement under Article 11 – Licensing and reporting requirements for businesses of the Foodstuffs Act. The licensing conditions are defined in Article 2 – Duty to licence of the Ordinance on Foodstuffs and Utility Articles (ODAlOUs).

Licences are granted if the requirements are met. Article 21 – Licensing requirements of the Ordinance on Foodstuffs and Utility Articles (ODAIOUs) outlines these requirements. The requirements for a preventive control plan (PCP) are defined in Article 79 of the HACCP System and Principles .

Primary production (milk)

The Federal Department of Home Affairs (FDHA) issues the technical regulations relating to milk production. The Ordonnance sur le contrôle du lait (OCL) governs food safety for milk production and covers the following:

• animal health
• milk requirements
• production
• hygiene, including:
  • milking
  • processing
  • storage
  • cleaning and disinfection of premises, facilities and utensils
  • production

The 1999 Agreement between the European Community and the Swiss Confederation on trade in agricultural products strengthens free-trade relations between Switzerland and the European Union (EU). Annex 11 coordinate health and zootechnical measures. The agreement facilitates the movement and traceability of animals and food of animal origin, including milk.

Food production

Article 14 of the Ordinance on the Implementation of Foodstuffs Legislation (OELDAl) regulates self-monitoring. Under this article, an assessment of the obligations and procedures associated with the self-monitoring requirement under Chapter 4 of the Ordinance on Foodstuffs and Utility Articles is mandatory and covers:

• good manufacturing practices
• good hygiene practices
• procedures based on HACCP principles

Traceability

Article 5 of the Primary Production Ordinance (OPPr) covers traceability at the farm. The ordinance requires dairy farms to inform the CA about the recipients of their products. Article 28 – Traceability of the Foodstuffs Act requires production establishments to ensure food traceability. It requires that food be traceable during production, processing and distribution. Establishments must self-monitor in compliance with Article 75 of the Ordinance on Foodstuffs and Utility Articles. The article includes traceability requirements for the industry.

Complaints and recalls

Article 34 – Products in respect of which a complaint has been filed of the Foodstuffs Act gives enforcement authorities the power to file a complaint about a product. The authorities can then order measures concerning the use, destruction or confiscation of the product. Chapter 7 of the Foodstuffs Act provides for fines or prison sentences for non-compliance.

Article 27 – Guaranteeing health protection of the Foodstuffs Act sets out the procedures for withdrawing or recalling foodstuffs. The industry is primarily responsible for food recalls. These procedures are defined in Article 84 of the Ordinance on Foodstuffs and Utility Articles .

Exports

The import, transit and export of animals and animal products with third countries is governed (or regulated) by Article 51 of the Ordinance on import, transit and export trade in animals and animal products with third countries. Specific export requirements are defined under the Licensing of export establishments by cantonal authorities.

Element 2: Training program and human resources

Articles 52 and 53 of the Foodstuffs Act set out the professional requirements for personnel of enforcement bodies. These requirements include training and examination requirements. This area is covered in detail in Title 4 of the Ordinance on the Implementation of Foodstuffs Legislation (OELDAl).

Inspection staff follow a formal training program. There are three training levels:

1. Certificat de capacité cantonal d'assistant officiel (Cantonal certificate of competence for official assistants)
   • Official assistant
2. Diplôme fédéral en contrôle des denrées alimentaires (DCAl) (Federal food control diploma)
   • Official testing technician
   • Food controller
   • Food inspector
3. Diplôme fédéral en direction du contrôle des denrées alimentaires (DDCAl) (Federal diploma in food control management)
   • Deputy cantonal chemist
   • Cantonal chemist

The DCAI comprises 83 hours of training taken over three months. The curriculum includes self-study modules and training provided by the FSVO and the cantons. Training covers regulations, food safety and inspection processes. The FSVO issues a diploma upon successful completion of the exam. The FSVO keeps a training registry.

The CFIA team reviewed the training programs in place during its visit to the canton of Fribourg. The team noted that training is offered on an ongoing basis. The cantonal inspectors we met with demonstrated an adequate level of knowledge. They also demonstrated a consistent approach to inspections.

Element 3: Inspection and control program

The enforcement authorities of the 26 cantons are responsible for controlling dairy products. Standards and regulations are federal. Article 50 of the Foodstuffs Act requires each canton to develop a cantonal food safety regulation. Cantonal authorities are responsible for:

• issuing operating licences
• monitoring establishments
• monitoring products, including sampling
• managing the cantonal laboratory

Fromarte is an association of Swiss artisanal cheesemakers. Its mission is technical support and marketing. Fromarte offers tools to establishments, such as sector-specific templates for PCP, standards and written records. The FSVO has recognized these tools as being aligned with federal regulations. Three of the establishments visited on-site follow Fromarte standards. These standards are often cited when companies revise their PCPs. They serve as a benchmark for the industry and inspectors. Fromarte standards, therefore, strongly influence factory controls and monitoring by the cantons.

Swiss cheesemakers produce cheeses such as Gruyère, Emmental and Tête de moîne under protected designation of origin (AOP). The AOP designation guarantees that all companies follow the same production process. An AOP specification defines the processes involved and the equipment and materials permitted. A number of AOP requirements have an impact on food safety. The CFIA assessed some of these elements during its on site visits. Many seasonal mountain producers (Alp cheese producers) produce AOP artisanal cheeses.

AOP and Alp cheese producers have a significant impact on the industry as a whole. This leads to several establishments producing the same cheeses. In many cases, the cheeses are then moved to a specialized maturing facility. Once aged, the cheeses are purchased by an exporter, who takes care of cutting, packaging and marketing.

Monitoring chemical residues

The FSVO conducts an annual milk sampling program to detect foreign substances. The plan includes veterinary drugs, pesticide residues and contaminants. The FSVO uses a network of government and private laboratories for analysis. Laboratories and analysis methods are ISO/CEI 17025 certified. The authorities initiate an investigation at the operator's premises when an official sample is positive.

Switzerland complies with Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products under the bilateral agreement with the European Union. The Directive set out control measures for substances and identifies the groups of residues to be targeted in Annex I.

The EU requires Switzerland to submit an annual report to the group responsible for Health and Food Audits and Analysis. The annual report is entitled the National Foreign Substance Testing Program (NFUP). The substances reported in the NFUP are consistent with those listed in Annex I of Directive 96/23/EC.

The maximum residue limits applicable to be processed or mixed products are the same as for the raw product. The limits are incorporated by reference and follow the standards set by the EU.

Commission Delegated Regulation (EU) 2022/931 outlines the contaminants to be sampled. Annex 1 identifies the halogenated persistent organic pollutants, metals, mycotoxins and other contaminants that must be tested for in milk.

The FSVO sets the annual sampling rate based on production volume. The rate for 2022 was one sample per 15,000 tonnes of product. The target for 2022 was 225 samples. The target rate for 2023 was adjusted to one sample per 30,000 tonnes. This level aligns with the European standards defined in Annex 1 of the Commission implementing regulation (EU) 2022/1646.

Cantons may increase the number of samples depending on their specific circumstances. The 2023 Residue Control Plan (FSVO internal document) includes five categories relating to dairy products:

• Group A – Cow's milk
• Group B – Residues in milk
• Pesticides in milk
• Other types of milk
• Contaminants in milk

Monitoring microbial contamination

Food operators are responsible for sampling as part of their self-monitoring procedures. Sampling is part of the process of validating HACCP plans. These samples are analyzed in ISO/IEC 17025-accredited laboratories. The company director decides on the sampling frequency as part of the self-monitoring process. This requirement is stipulated in Article 68 of Ordinance RS 817.024.1. The Guide des bonnes pratiques dans la transformation laitière artisanale (Best Practice Guide for Artisanal Dairy Processing) is used for cheese production. The work instructions cover:

• testing frequency
• target analytes
• where tests are to be performed

RS 916.351.021.1 define the hygiene requirements for milk production and raw milk analysis. The Suisselab AG laboratory tests on behalf of the FSVO and the industry. On-farm milk analysis results are published in the Contrôle officiel de la qualité du lait 2022 (Official Milk Quality Control 2022).

The Swiss Confederation publishes a multiannual national control plan (MANCP) for Switzerland and the Principality of Liechtenstein. The plan covers the official control system along the entire food production system. It provides an overview of:

• official controls
• details on the structure
• competent authority roles and responsibilities

The Federal Food Chain Unit (FFCU) coordinates the development of the MANCP in accordance with Ordinance RS 817 032. The Federal Office for Agriculture (FOAG), the FSVO and the cantons provide input into the MANCP, which is generally valid for 4 years. The federal offices and the FFUC prepare a report on the MANCP each year.

The cantonal offices are responsible for implementing the MANCP. They carry out sampling and microbiological analysis of dairy products. The FSVO coordinates the enforcement of measures taken by the cantons and also monitor their activities. Product sampling and analysis procedures are detailed in Ordinance RS 817 042.

The federal government does not set targets for the inspection of finished products, and there are no federal sampling plans for microbial contamination of cheeses. Cantonal authorities may, however, test finished products as part of their official controls. Each cantonal office can implement sampling programs in the form of campaigns. These campaigns target certain food commodities. They are based on risk, compliance history, manufacturing process or federal guidelines. These campaigns may include finished products such as cheese. The campaigns in place in the canton of Fribourg follow the following format:

• Internal – The Cantonal chemist develops these programs. For the canton of Fribourg, there were four campaigns for dairy products in 2023: cream, soft raw milk cheese, dairy products and appellations d'origine contrôlée (AOC)
• Multi-Canton – A group of cantons sets up these programs. For example, some programs are set up by the six cantons of French-speaking Switzerland (Geneva, Vaud, Valais, Friborg, Neuchâtel and Jura).
• National – The Association des Chimistes cantonaux (Association of Cantonal Chemists) establishes these programs throughout the country. The campaigns are set up during the quarterly meetings of the Association des Chimistes cantonaux.

The FSVO releases its recommendations and positions on specific issues through its newsletters, which also serve to interpret federal and cantonal regulations.

For example, Newsletter 2021/2.1 explains the microbiological guideline values for the control of good practices. It includes the following standards:

• Water
  • Aerobic mesophilic bacteria 300 CFU/ml (Colony Forming Units)
  • E. coli nd/100 ml
  • Enterococci nd/100 ml
• Ice
  • E. coli nd/100 ml
  • Enterococci nd/100 ml
  • Pseudomonas aeruginosa nd/100 ml
• Raw food, prepared for consumption
  • E. coli 100 UFC/g
  • Coagulase-positive staphylococci 100 CFU/g

Licences

Any establishment that manufactures, processes, treats, stores or delivers food of animal origin is subject to licensing requirements by the cantonal authorities. This requirement is defined in the Ordinance on Foodstuffs and Utility Articles (ODAIOUs). All establishments that process dairy products must be licensed. Every establishment visited by the CFIA had a licence posted online.

The Ordinance on Foodstuffs and Utility Articles defines the legal basis for the control of licensed establishments in Information Letter 2018/1 Guide for the inspection of establishments subject to usual licensing. Licensed establishments are subject to an initial full inspection and every five years thereafter. Adding new activities to the licence triggers an inspection of all operations.

Article 7 of the Ordinance on the Implementation of Foodstuffs Legislation (OELDAl) sets out the licensing process. The cantonal authority grants the licence and the licence number. The licence is granted when the legislation requirements for the authorized activities are met. The operating licence does not expire but may be suspended or withdrawn if justified.

Establishment controls

Operators are responsible for food safety as part of their self-monitoring activities. This includes developing and implementing an HACCP plan. Operators must demonstrate the effectiveness of their HACCP plan during inspections by cantonal authorities. This includes good manufacturing practices, process control and sampling plans.

The Federal Department of Home Affairs (FDHA) sets out the requirements for hygiene in dairy production, including:

• animal health
• milking
• milk requirements
• milk processing and storage
• cleaning and disinfection of premises
• facilities and equipment

Every 4 years, a cantonal inspector conducts raw milk inspections on dairy farms. The inspector checks that the producer meets the requirements set out in the Ordonnance réglant l'hygiène dans la production laitière (OHyPL) (Ordinance on Hygiene in Milk Production). Articles 10 to 16 and Annex 2 of the Ordonnance sur le plan de contrôle national pluriannuel de la chaîne agroalimentaire et des objets usuels (OPCNP) (Ordinance on the Multiannual National Control Plan for the Food Chain and Utility Articles) define the specific provisions for primary production.

The results of milk controls are compiled and published annually in Food Safety Statistics and Reports. The DBMilch.ch database contains individual milk analysis results and reports. The Technical Directive on official controls in primary production in livestock facilities (including the Control Manual) sets out the provisions for on-farm milk controls. These provisions cover:

• hygienic milk production
• veterinary medicines
• animal health

Cantonal authorities are responsible for inspecting establishments in accordance with federal regulations. During the on-site visit, the CFIA:

• reviewed previous inspection reports for the establishments visited.
• interviewed the cantonal inspectors on their inspection process.
• discussed hazards and controls in the establishments with the cantonal inspectors.

The CFIA observed the implementation of the following regulations and ordinances:

The following provisions of the FDHA Ordonnance sur l'hygiène dans les activités liées aux denrées alimentaires (OHyg) (Ordinance on hygiene relating to foodstuffs-related activities):

• Implementation of microbiological criteria that milk processing plants must meet (Annex 1).
• Results-oriented sampling plans are permitted (Article 67).
• Microbiological criteria are used to validate and verify processes based on HACCP principles. They also cover hygiene control measures.
• Hygiene standards for food-related activities according to the 7 HACCP principles set out in the Codex Alimentarius.

The following provisions of the Ordinance on Foodstuffs and Utility Articles (ODAIOUs):

• Implementation of process controls during the manufacturing process.
• Operator responsibility for developing and implementing
  • process control programs
  • performance requirements

The risk assessment model is used to determine the inspection frequency for dairy processing plants. The model uses factors to determine the level of risk and inspection frequency. For the 3 cantons visited, the date of the next inspection was indicated on the plant profile in Limsophy. The required inspection frequency varied from 1 to 3 years, depending on the facility.

A written program was in place for each of the establishments visited. Four of the establishments visited follow the Fromarte standards guide. The fifth had its own PCP, and generally adheres to certification standards imposed by domestic and foreign customers. The CFIA team observed processing steps such as acidification, coagulation, curdling, molding, salting and ripening. Prerequisite programs document each production step. Operators monitor and control production steps using procedures and records. The establishments visited have a risk analysis specific to each cheese variety. The on-site operators demonstrated a good knowledge of hazards and controls.

The CFIA checked the following during the on-site visit:

• monitoring of the cleaning and sanitizing process
• application of good manufacturing processes
• environmental and product hazard monitoring

Operators regularly test for pathogens in the salted water used for mechanical rubbing and which comes into contact with many products. It was noted that the cantonal authorities do not conduct routine sampling at the plant. The operator is responsible for sampling food contact surfaces, the environment and the product.

The CFIA identified 2 methods for detecting antibiotic residues in milk:

• rapid tests
• acidification monitoring

The acidification monitoring method involves measuring changes in the pH of the cheese or in the whey output. Inadequate acidification indicates the potential presence of inhibiting substances.

For each establishment, the operators presented their business during the opening meeting. The CFIA team assessed the implementation of selected parts of the company's HACCP plans. The assessment included a review of written procedures and records. The establishments visited applied the general hygiene measures. They all had a program based on HACCP principles. The audit team had access to the facility plans of several processors. The plans reviewed on-site included manufacturing diagrams and described the product routing circuit. The plans clearly described the various stages in the manufacturing process, demonstrating that procedures specific to the type of dairy products exported to Canada are in place.

Information Letter 2020/7: Application du critère de sécurité des denrées alimentaires relatif à Listeria monocytogenes dans les denrées alimentaires prêtes à la consommation (PDF) sets out the FSVO's expectations regarding Listeria management by operators.

During site visits, the CFIA observed shortcomings concerning:

• assessing hazards associated with personnel movement
• identifying areas of the facility
• maintaining certain processing equipment
• recording of prerequisite programs
• implementing good sanitary and hygienic practices

These shortcomings were discussed with the cantonal authorities at the end of each visit. They were then brought up at the closing meeting.

Labelling, identification, traceability and packaging

FDHA Ordinance RS 817.02 and RS 817.024.1 regulate the packaging of milk and dairy products. The Ordinance on Primary Production 916.020 (in French, German, and Italian only) defines traceability requirements for primary products such as milk. Federal act RS 817 and Ordinance RS 817.02 cover traceability requirements for foods such as cheese.

Companies set up documented traceability programs to trace the product throughout the production chain. The programs in place ensure the traceability of brine, brine water and ingredients. It is common for cheeses to be sourced from another licensed facility for maturing, cutting or packaging. Their origin is documented so they can be identified throughout the processing chain. In such cases, the cheese wheels are often marked with the licensing number of the establishment of origin. During the audit, the CFIA assessed the traceability procedures and practices of specific operators. Recall plans are in place. They enable a non-compliant product to be recalled and withdrawn from the market.

The CFIA verified the measures one operator took for an instance of microbiological non-compliance. The operator provided a satisfactory account of the results of their investigation, as well as the action plan put in place.

Exports

The Member States of the European Union and Switzerland signed the Agreement on trade in agricultural products RS 0.916.026.81 in 1999. The agreement harmonizes animal health regulations. The veterinary agreement covers:

• the control and reporting of certain animal diseases
• trade in live animals, animal products and products of animal origin
• importation of animals and animal products from third countries.
• zootechnics
• safety of food of animal origin
• animal welfare

A computer network links Switzerland to the veterinary authorities of the European Union and EU member states. The Trade Control and Expert System (TRACES) and the Animal Disease Notification System (ADNS) act as communication channels.

There are no specific procedures in place for dairy products exported to Canada. Article 3 of the Foodstuffs Act requires that exported food comply with Swiss regulations. Only licensed establishments are authorized to export.

Element 4: Program evaluation or audit

Article 13 – Audits by Competent Authorities of the Ordinance on the Implementation of Foodstuffs Legislation (OELDAl) governs program audits. The OELDAI requires the bodies responsible for implementing the legislation to conduct internal or external audits. They must then take appropriate action to address the audit findings. Audits must be conducted transparently and be subject to independent scrutiny.

The Federal Food Chain Unit (FFCU) is responsible for assessing the inspection system. The Switzerland multiannual national control plan (MANCP) outlines the monitoring tasks carried out by the FFCU:

• Monitoring implementation within the cantons. This surveillance includes pre-announced visits by administrations.
• accompanying cantonal inspectors on site
• verifying the implementation of controls on federally imported products of animal origin
• auditing food safety programs

The results and findings of these activities are compiled in a comprehensive report.

As part of its mandate, the Swiss Accreditation Service (SAS) audits accredited organizations. The SAS verifies that conformity assessment bodies (CABs) such as the FFCU comply with the relevant international standards. One of the ways it does this is by accrediting inspection bodies to ISO/IEC 17 020. The template used to assess inspection bodies, ISO/IEC 17020:2012 Conformity assessment – Requirements for the operation of various types of bodies performing inspection, is available online. The SAS accredits laboratories under ISO 17 025.

Finally, the legal provisions of Article 61 OELDAl, Article 43 OAbCV, Article 8 OPPr and Article 71 OSALA guarantee the independence of inspection bodies.

The Switzerland multiannual national control plan (MANCP) provides details on the review of official sampling and monitoring plans for chemical residues and microbial contamination. Each official sampling and monitoring plan is subject to regular review. A triggering event may also lead to a review of the plan.

The FSVO is preparing the 2021 annual report of the National Foreign Substance Testing Program (NFUP). The report compares Swiss results with those of other foreign substance monitoring programs conducted in the EU. The results of the 2021 report show that, for all samples, 7 of 2,479 were non-compliant (0.28%).

A note will be added to the report where measures to improve the safety of the agri-food chain are required. This information will be recorded in Appendix 6 of the MANCP Annual Report – Safety improvement measures along the agri-food chain.

Element 5: Investigation of food-borne illnesses and outbreaks

Section two of the Ordinance on the Implementation of Foodstuffs Legislation (OELDAl), Investigating food poisoning outbreaks, defines food poisoning outbreaks. An outbreak occurs when:

• at least two cases of an illness or infection are most likely due to the consumption of the same food
• the number of cases attributable to the consumption of a food increases more than expected

Recall procedures are defined in Article 84 – Withdrawals and recalls of the Ordinance on Foodstuffs and Utility Articles (ODAlOUs). They cover the actions an operator must take if they observe or suspect that a food in their possession poses a hazard. In such cases, they must:

• notify cantonal authorities
• take the necessary steps to withdraw products from the market
• recall products sold to consumers
• keep samples of the food in question
• cooperate with enforcement authorities

Article 54 – Public warnings of the Foodstuffs Act requires the authorities to inform the population when they discover that dangerous foods have been distributed. Federal authorities release the information when the population of several cantons is at risk.

The authorities inform the public of warnings and recalls via press releases, mailing lists and Twitter. Detailed information is published on the Food Warnings and Recalls website. A site review showed that recalls have been issued for dairy products, mainly cheese.

The companies involved prepare recall information. The Guide to Product Recall Information explains what information is required.

The Public Warning, Recall and Withdrawal guide explains the difference between a withdrawal, a recall and a public warning. Responsibility for any action taken on a product is divided between the holders of the goods, the cantonal authorities and the FSVO.

Cantonal inspectors document follow-up actions in Limsophy. The FSVO publishes an annual report on public warnings and recalls on the Food Safety Statistics and Reports website.

At the international level, the FSVO is a member of INFOSAN. The FSVO shares food information with the EU via the European RASFF rapid alert system.

Element 6: Compliance and enforcement program

The cantons are responsible for implementing enforcement measures. They are also responsible for issuing licences.

Articles 3–14 of the Ordinance on Foodstuffs and Utility Articles (ODAIOUs) define the conditions that establishments must meet. The authorities issue an objection if they find the requirements have not been met. Articles 34–37 of the Federal Act on Foodstuffs and Utility Articles (Foodstuffs Act) describe the procedures and criteria for measures to be applied in the event of non-compliance.

Article 34 – Products in respect of which a complaint has been filed of the Foodstuffs Act defines in detail the possible actions to take when a product is non-compliant. When the enforcement authorities file a complaint against a product, they order the measures required to bring it back into conformity. The authorities decide what action to take with the contested product. The authorities may allow the product to be used subject to conditions. They may also:

• order the destruction of the product
• confiscate the product
• order the product to be made safe
• reject the product (imports)
• carry out additional verification

Article 35 of the Foodstuffs Act defines the rules surrounding Complaints not related to products. Article 35 applies when the issue concerns manufacturing, equipment, storage, transportation. They may require the responsible person at the business to:

• investigate the causes of the defects
• take suitable measures to rectify the defects
• inform the enforcement authorities of the measures taken

Under Articles 36 and 37 of the Foodstuffs Act, authorities may:

• temporarily or permanently prohibit:
  • a manufacturing process
  • use of facilities
  • use of equipment
  • use of agricultural vehicles and land
• order the immediate closure of a business
• detain or seize contested products
• report infringements to the criminal prosecution authorities

The FHDA Ordinance on Hygiene in Milk Production (OHyPL) governs the criteria for contesting or suspending the delivery of raw milk. The Directive technique concernant la suspension et la levée de la suspension de la livraison du lait dans le cadre du contrôle du lait(Technical Directive on the suspension and lifting of the suspension of milk deliveries under milk control procedures) aims to ensure ad hoc monitoring according to standardized procedures. Cantonal authorities enforce the suspension of delivery of non-compliant milk.

A cantonal inspector followed up on non-compliance while we were visiting an establishment. He explained the process, the actions taken, and how the information is recorded in Limsophy.

Element 7: Industry and community relations

The ARAMIS information system is a directory of research, innovation and assessment projects funded or carried out by the Confederation. It coordinates the research activities of the federal administration.

Article 62 of the Foodstuffs Act – Information system of the Federal Food Safety and Veterinary Office requires the FSVO to operate an information system for the following purposes:

• ensure food safety and hygiene
• facilitate legally mandated federal and cantonal enforcement tasks
• prepare national and international reports

Internal documents are distributed via the Awisa system. The FSVO participates in the quarterly meetings of the Association of Cantonal Chemists and the Association of Cantonal Veterinarians.

The FSVO website includes the following information:

• warnings and recalls
• food safety
• nutrition
• publications
• research

Information useful to the industry, such as import and export details, legislation, enforcement documents, licensing and certification, is readily available on the Confederation's website.

Element 8: Program resources

Resources assigned to food safety can be found at two levels. At the federal level, the FSVO comprises a team of approximately 200 full-time equivalents (FTEs). The team is responsible for setting food safety standards and regulations. The FFCU has 8 FTEs, and the SAS has 2 FTEs. They support the surveillance and accreditation activities of the FSVO and cantonal authorities.

The cantonal authorities are responsible for implementing the food safety system. They monitor primary production and processing facilities. The cantons maintain and manage the infrastructure required for microbiological and chemical sample analysis. A total of 630 FTEs are employed by the cantonal food safety authorities. The responsibilities of the cantonal authorities also include monitoring:

• restaurants
• drinking water
• utility articles (packaging and body care products)
• personal service establishments (esthetics, tattooing, piercing)

The Service de la sécurité alimentaire et des affaires vétérinaires (SAAV) is the competent authority for the canton of Fribourg. The CFIA team reviewed its organizational structure during a visit to its Fribourg office. The team noted the number of employees assigned to each role:

• chemical laboratory – 8 employees
• microbiology laboratory – 16 employees
• food inspection – 10 employees
• inspection of milk products – 3 employees

The annual work plan is based on the requirements outlined in the FSVO ordinances.

The cantons determine the frequency of inspections of cheese production, ripening and preparation establishments. The inspection intervals are:

• a full inspection is carried out at the time of licensing
• inspection every 1–3 years, depending on risk
• full inspection every 5 years

The risk level and the date of the next inspection are recorded in LIMSOPHY.

Element 9: International communications and harmonization

Switzerland has an international presence. Organizations such as the World Health Organization and the World Trade Organization are headquartered in Geneva.

Switzerland participates in several Codex Alimentarius committees. It also works closely with European Union bodies such as the Rapid Alert System for Food and Feed (RASFF) and the EU Reference Laboratories (EURLs).

Food regulations include key provisions harmonized with international standards, such as:

• food hygiene
• food additives
• pesticide and veterinary drug residues
• contaminants
• labelling
• analysis and sampling
• inspection

Element 10: Laboratory support

Under the direction of the cantonal chemists, the cantonal authorities are responsible for enforcing Swiss food legislation. To fulfill these responsibilities, the cantonal chemist manages a laboratory and a team of inspectors. According to the directory of accredited laboratories, the network comprises 23 laboratories:

• 4 national laboratories
• 2 national and cantonal laboratories
• 17 cantonal laboratories, some of which are responsible for more than one canton

As required by Article 44 of Ordinance RS 817.042, laboratories are accredited to ISO/IEC 17 025 General requirements for the competence of testing and calibration laboratories Accordingly, they have documented quality management systems. Accreditation and assessment of conformity with ISO/IEC 17025 are carried out by the Swiss Accreditation Service (SAS). The SAS is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA).

Article 24 of the Ordonnance sur le système suisse d'accréditation et la désignation de laboratoires d'essais et d'organismes d'évaluation de la conformité, d'enregistrement et d'homologation (OAccD) (Ordinance on the Swiss Accreditation System and the Designation of Testing Laboratories and Conformity Assessment, Registration and Approval Bodies) governs the accreditation of organizations that conduct tests or conformity assessments.

Title 3 of the Ordinance on the Implementation of Foodstuffs Legislation (OELDAl) – Prélèvements d'échantillons et analyses, laboratoires et laboratoires de référence (Sampling and Analysis, Laboratories and Reference Laboratories) describes the requirements for food laboratories. It covers requirements for:

• official laboratories
• sampling methods
• analyses
• references laboratories

Annex 7 of the Ordinance on the Implementation of Foodstuffs Legislation (OELDAI) identifies the specific areas for which a reference laboratory must be designated. These organizations are responsible for specific areas, such as zoonoses, viruses, veterinary drug residues and pesticides. They are listed in the List of Reference Laboratories for Switzerland. Article 43 – National reference laboratories of the Foodstuffs Act gives the Confederation responsibility for managing the national reference laboratories. The laboratories are part of the European network of reference laboratories (EURL). They must also:

• meet the international standards for testing laboratories
• be accredited
• have sufficient staff, rooms, equipment and resources to fulfill their tasks
• provide suitable guarantees of their credibility, impartiality and independence

Annex 5 of the OELDAI outlines the methods for official sampling and laboratory testing, assays and diagnosis. The Annex also refers to the EU regulation describing authorized methods. Annex 1 of the FDHA Ordonnance sur l'hygiène dans les activités liées aux denrées alimentaires describes the microbiological reference methods.

The CFIA did not visit any laboratories during the on-site assessment. This assessment was based on a review of the documentation provided. The laboratory record-keeping process, internal laboratory management and methodologies were therefore not assessed. However, information was collected during a visit to the Fribourg cantonal office.

It was noted that the laboratories were generally close to sampling sites. For the canton of Fribourg, the laboratory is located in the same building as the SAAV inspection services. Inspectors bring samples directly to the laboratory to ensure traceability. Once a sample has been analyzed, the results are available directly to the cantonal inspector via the Limsophy software system. Results are reviewed and signed off by the Cantonal Chemist in the event of non-conformities. For example, a company will have one month to correct a non-conformity linked to an excessively high aerobic germ count. Failure to take action may result in a fine. The list of methods provided by SAAV refers to the activity and code. However, it does not provide details of the official method used. The list we were given did not include analyses of common hazards in dairy products.

Microbiology

Operators take samples as part of their self-monitoring process. These samples are tested in accredited private laboratories. In addition, the Suisselab laboratory works on behalf of the FSVO and the industry. It coordinates the collection of raw milk samples and carries out analyses. Each producer's milk is sampled twice a month. The samples are then analyzed in accordance with Ordinance RS 916 351 021.

RS 817 042 sets out the requirements for official laboratories. Laboratories take part in interlaboratory comparative or proficiency testing (PT). PTs are used to demonstrate analytical competence at the request of a national reference laboratory. The Swiss competent authority provided PT documents for the cantons of Fribourg and Bern for review. The documents described the PT supplier(s) and the target analyte(s). However, the documentation did not detail the specific methods used to analyze the PT samples

A review of the scopes of accreditation shows that laboratories have adopted different approaches to presenting the scope. A limited number of laboratories list specific methods. These include those identified in Appendix 1 of RS 817.024.1. Most cantonal laboratories are accredited on the basis of defined test types and measurement principles. This means that test methods are only listed in summary form within the various technologies. For example, the majority of accreditation scopes identify the "cultural detection method" as a measurement principle (test type). Or they list "test kits, own procedures or ISO." Since specific methods are not identified, it was not possible to verify a laboratory's ability to use the methods described in Annex 1 of RS 817.024.1. It was also impossible to validate them appropriately as equivalent methods. An exhaustive list of accredited methods for each cantonal laboratory was not provided. As a result, we could not fully assess and determine whether the canton's analytical skills meet its needs.

Chemistry

The National Surveillance Analysis Program for Foreign Substances (PNSE) 2024 – Sampling instructions provides general sampling instructions. It includes:

• equipment required
• establishment selection
• sampling
• sample storage and dispatch
• sampling report
  • evaluation of analysis results
  • guarantee of traceability

The document does not define timelines for completing the analysis and communicating the results. For milk, Article 6 of the Ordonnance sur le contrôle du lait defines the procedures for reporting results. Laboratories report milk control results to producers and enforcement authorities as soon as testing has been completed.

At the federal level, the FSVO generally draws up sampling plans. The National Foreign Substance Testing Program (NFUP) is carried out annually. It provides an overview of the presence of foreign substances in food of animal origin. Switzerland must have this program in place to export animals and food of animal origin to the EU.

To this end, the FSVO follows the guidelines issued in Regulations (eu) 2017/625 of the european parliament and of the council. The FFCU performs the following functions:

• Managing the National Foreign Substance Testing Program (NFUP). The program is based on the requirements of Delegated Regulation (EU) 2022/2292. The plan is developed based on production data, expert opinions and non-conformity history.
• point of contact with cantonal laboratory authorities and veterinary services
• results monitoring
• follow-up of corrective measures
• preparation of annual report to the European Commission
• publication of annual report

Conclusion

Switzerland has a comprehensive system for monitoring the safety of dairy products. The system includes a comprehensive regulatory framework and a structure to ensure its implementation.

Recommendations

Recommendation 1

The CFIA recommends that the findings specific to the establishments visited be corrected and verified. Related to Finding 3.4 in Appendix A (Appendix A is not published to protect food businesses confidentiality)

Response from the FSVO: The FSVO has provided details on how the observations noted in the establishments were addressed.

Recommendation 2

The CFIA recommends using rapid tests to detect antibiotics in milk at the time of delivery to processing plants. Related to findings 3.4.

Response from the FSVO: The FSVO tests milk on the farm through its National Foreign Substance Testing Program (PNSE). Artisanal cheesemakers monitor the presence of antibiotic residues by monitoring the acidification.

Recommendation 3

The CFIA recommends that Switzerland assess options for collecting results of microbiological contamination in finished products (cheese). This would make it possible to identify trends and monitor the effectiveness of the various controls of the food safety system at federal level. Related to Findings 3.1 and 3.2

Response from the FSVO: From 2002 to 2010, the FSVO conducted a coordinated national monitoring program for milk and dairy products. The results showed that establishments ensured food safety through self-monitoring. The results of the dairy product testing program are published in the Multi-Annual National Control Plan (MANCP).