Final report of virtual audit of Denmark's meat inspection system governing the production of bovine and swine meat and meat products – March 15 to 24, 2021

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. Ante-mortem, humane handling and animal welfare controls
  • 3.1 Traceability and animal identification
  • 3.2 Ante-mortem inspection
  • 3.3 Humane handling and animal welfare
• 4. Slaughter and post-mortem
• 5. Processing controls
  • 5.1 Antimicrobial controls
  • 5.2 Chilling/freezing controls
  • 5.3 Water retention controls
  • 5.4 Allergen controls
  • 5.5 Processing controls
• 6. Preventive control plans
• 7. Microbiological controls
• 8. Chemical residue controls
• 9. Closing meeting
• 10. Conclusions
• 11. Recommendations

Abbreviations and special terms used in the report

BIP

Border Inspection Post

CA

Competent Authority

CCA

Central Competent Authority

CCP

Critical Control Point

CFIA

Canadian Food Inspection Agency

DVFA

Denmark Veterinary and Food Authority

EC

European Commission

EFSA

European Food Safety Authority

EU

European Union

FBO

Food Business Operator

HACCP

Hazard Analysis Critical Control Points

ISO

International Organisation of Standards

MRL

Maximum Residue Limit

MS

Member States

NRMP

National Residue Monitoring Plan

OA

Official Auxiliaries

OV

Official Veterinarian

RTE

Ready-to-Eat

SRM

Specified Risk Materials

TRACES

Trade Control and Expert System

Executive summary

This report describes the outcome of virtual audit of the meat inspection system governing the production of bovine and swine meat and meat products in Denmark intended for export to Canada. The Canadian Food Inspection Agency (CFIA) conducted the audit virtually from March 15 to 24, 2021 due to COVID-19 travel restrictions. As a consequence, findings of this audit were based on document review and interviews of representatives from the Danish Veterinary and Food Administration (DVFA) and Food Business Operator (FBO). Lack of onsite visit to the establishments selected for this audit resulted in limited review of the competent authority and FBO controls at each establishment.

The main objective of the audit was to verify if Denmark continues to implement a meat inspection system equivalent to that of Canada, producing safe, unadulterated, and properly labelled meat products for export to Canada.

The audit scope included virtual visits to the Central Competent Authority (CCA) headquarters and slaughter and processing establishments located in different regions of Denmark. These included 2 slaughter houses (1 each for bovine and swine) and 1 meat canning/processing establishment.

The audit covered activities within the following subject areas:

• competent authority and oversight
• ante-mortem, humane handling and animal welfare controls
• slaughter and post-mortem
• processing controls
• preventive control plans
• microbiological controls
• chemical residues controls

Following the review of action plan provided by competent authority, the CFIA determined that Denmark continues to implement the bovine and swine meat inspection systems determined equivalent to those of Canada.

1. Introduction

• 1.1 Audit objective, scope, and methodology
• 1.2 Legal basis for the audit and audit standards

1.1 Audit objective, scope, and methodology

The audit covered verification of activities within the following subject areas:

• competent authority and oversight
  • regulatory framework
  • oversight framework
  • training framework
  • export controls
  • import controls
  • enforcement framework
• ante-mortem, humane handling and animal welfare controls
  • premises registration, animal identification and traceability
  • animal movement controls
  • ante-mortem inspection
  • humane handling and animal welfare
• post-mortem and slaughter
• processing controls
  • chilling/freezing controls
  • water retention
  • Allergen Control Program
  • commercially sterilized canned meat products
• preventive control plans
• microbiological controls
• chemical residues controls

The CFIA auditors virtually reviewed the administrative functions of central competent authority. The auditors evaluated regulatory framework, oversight framework, enforcement framework, training framework, export controls and import controls. Lack of onsite visit to the establishments selected for this audit resulted in limited review of the competent authority and FBO controls at each establishment.

The CFIA currently recognizes Denmark's meat inspection system for bovine and swine. Therefore, the bovine and swine meat and meat products were selected for this virtual audit.

1.2 Legal basis for the audit and audit standards

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

• Safe Food for Canadians Regulations (SFCR)
• Health of Animals Regulations (HAR)

The audit standards also included all applicable European Union (EU) regulations determined as equivalent as part of the agreement between the European Community and the Government of Canada on sanitary measures. These measures protect public and animal health in respect of trade in live animals and animal products as amended from time to time as part of bilateral negotiations.

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

2.1 Regulatory framework

Denmark is an EU Member State and it is essential for Denmark to implement European Parliament and the Council adopted regulations. Regulation (EC) No. 178/2002 lays down the general principles and requirements of Food Law (general food law regulation). Other key relevant EU regulations are:

• Regulation (EU) No. 37/2010: pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin
• Regulation (EU) No. 101/2013: use of lactic acid to reduce microbiological surface contamination on bovine carcasses
• 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. 854/2004: rules for organization of official controls
• Regulation (EC) No. 882/2004: official controls to ensure verification of compliance with feed and Food Law, animal health and animal welfare rules
• Regulation (EC) No. 999/2001: prevention, control and eradication of certain transmissible spongiform encephalopathies
• Regulation (EC) No. 1069/2009: animal by-products and derived products not intended for human consumption
• Regulation (EC) No. 1099/2009: protection of animals at the time of killing
• Regulation (EU) No.2015/1375: official controls for Trichinella spriralis in meat
• Regulation (EC) No. 2015/1474: use of recycled hot water to remove microbiological surface contamination from carcasses
• Regulation (EU) No. 2016/429: transmissible animal diseases and amending and repealing certain acts in the area of animal health ('Animal Health Law')
• 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, amending Regulations (EC) No. 999/2001, (EC) No. 396/2005, (EC) No. 1069/2009, (EC) No. 1107/2009, (EU) No. 1151/2012, (EU) No. 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No. 1/2005 and (EC) No. 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC.
• Regulation (EU) No. 2017/625 repeals by article 146 the Regulations (EC) 854/2004 and No. 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/ EC and Council Decision 92/438/EEC (Official Controls Regulations)
• Regulation (EC) No. 2073/2005: microbiological criteria for foodstuffs
• Directive 96/22/EC: prohibition on the use in stock farming of certain substances having a hormonal or thyrostatic action and of beta-agonist
• Directive 96/23/EC: measures to monitor certain substances and residues thereof in live animals and animal products
• Directive 98/83/EC: quality of water intended for human consumption
• Directive 2001/82/EC: code relating to veterinary medicinal products

In addition to the EU regulations, Denmark also enforces its own inspection laws, policies and procedures in registered establishments to ensure that meat products destined for exports are safe, wholesome and produced under equivalent inspection system. The key relevant Danish national regulations are:

• Order No. 1287 of 14 December 2004 on penalties for violation of the food hygiene Regulation
• Order No. 456 of 24 April 2019 on penalties for violation of certain regulations on food hygiene
• Order No. 1352 of 10 December 2019 on approval and registration of food businesses etc.
• Order No. 727 of 29/05/2020 on On export of food and food contact material applies to all establishments exporting food and food contact material to countries outside the EU (third countries).
• Danish Executive Order No. 1351 of 10 December 2019 on official control in intra Union trade and import into the Union of live animals and products of animal origin and hay and straw
• Danish Executive Order No. 1359 of 15 September 2020 on intra Union trade and import into the Union on food, feed and animal by-products and related products and food contact materials subject to import restrictions, safeguard measures and temporary increase of official control etc.
• Order No. 1407 of 30 November 2018 provides the legal framework on registration of herds in the Central Husbandry Register (CHR) database
• Order No. 679 of 18 May 2020 governs identification, registration and movements of cattle, pigs, sheep or goats
• Order No. 135 of 14 February 2014 governs slaughtering/killing of animals
• Danish Act on Protection of Animals No. 50 of 11 January 2017 governs animal welfare

2.2 Oversight framework

In Denmark, the Danish Veterinary and Food Administration (DVFA) is the competent authority under the Ministry of Environment and Food. The DVFA is divided into 4 departments:

• the Finance and Meat Inspection Department
• the Veterinary Department
• the Food Safety Department
• the Export and Innovation Department

The Meat Inspection Department is responsible for ante- and post-mortem inspection of animals in all Danish slaughterhouses, inspection of the slaughter process and processing of carcasses and accompanying offal. This department also verifies whether the establishments comply with veterinary legislation (animal welfare and animal health), food legislation (hygiene and food safety) and export requirements

As per article 18 of Regulation (EC) No. 2017/625, an Official Veterinarian (OV) is present onsite and performs ante- and post-mortem inspection and other inspection activities such as assessing food safety compliance and issuing certificates at animal slaughter establishments. The OV assigns the performance of an action to an Official Auxiliary (OA) who can perform post-mortem inspection and other inspection activities (daily/weekly inspections, sampling) under OV supervision. The competent authority must ensure that sufficient numbers of OA/OV are present at slaughterhouse/establishment.

Under the authority of Regulation (EC) No. 2017/625, the Head of Meat Inspection verifies the activities of Deputy Heads of Meat Inspection and generates quarterly reports. The Deputy Head of Meat Inspection verifies the performance of OV and OA. The OV verifies the performance of OA at slaughter line, and supervises OAs performing inspection at slaughter establishments. The OVs with specialized training of ante-mortem inspection also perform quality checks of OVs performing ante-mortem tasks.

During virtual audit, the CFIA noted that Denmark has the CCA with overall responsibilities in relation to food and feed safety, and animal health and welfare. However, the OV was not present full time during production at the medium and smaller slaughterhouses including those slaughterhouses exporting their products to third countries.

2.3 Training framework

As stipulated in article 5 of the Regulation (EU) No. 2017/625, the competent authorities must have access to a sufficient number of qualified staff to perform official controls and activities efficiently and effectively. The European Commission organises workshops within the program "Better Training for Safer Food". It is a training program covering legislation in the area of food, feeds, animal health, animal welfare and plant health. It serves for education of professionals from the EU Member States involved in the performance of official control activities. The aim of the program is to provide updated information on EU legislation and to ease the harmonisation and better efficiency of official control checks across EU Member States.

The DVFA is responsible for defining the training requirements and responsibilities and organisation of continuous training for staff performing the official control at slaughter and meat processing establishments. The OVs maintain up-to-date knowledge through regular continuing education activities and reading of professional literature. The Deputy Head of Meat Inspection discuss and communicate regularly with OVs as well as OAs to decide training and development requirements.

The CFIA noted that DVFA organised various training courses for veterinarians and Official Auxiliaries responsible for performing Official Veterinary control at slaughter and processing establishments in Denmark. However, the DVFA did not record initial training of OVs/OAs at audited bovine and swine slaughter establishments.

2.4 Export controls

The Regulations (EC) No. 178/2002 and No. 2017/625 articles 86 to 88 governs the controls for export of meat and meat products. The DVFA has the legal authority and responsibility to register and de-register establishments eligible to export to third countries. The establishments apply to the DVFA and demonstrate the capacity to implement the third countries export requirements to obtain the registration approval and number. The DVFA maintains an updated list of eligible establishments on its website. The DVFA perform an annual verification of the implementation of the third countries export requirements. The information for export of animals and animal products are publicly available at the DVFA website.

The FBOs in Denmark interested to export meat to Canada must meet the Canadian requirements. The OV verifies the compliance with Canadian requirements and completes the export verification and certification. For each shipment, an Official Veterinarian is responsible for checking the condition of trailer, the condition of product to be exported and associated documents. An OV signs the certificate after verifying and confirming that the products meet the importing country requirements.

The CFIA noted that the inspection services did not perform on-site verification of export certification for each shipment at swine and bovine slaughter establishments. In 2020, out of 1200 export certificates, the services verified only 12 consignments (1% of the total of the export consignments). The DVFA considers 1% sample control for export shipments as adequate for issuance of certificates. This is in line with the other requirements of Hazard Analysis Critical Control Points (HACCP) based control regime on establishment own-check procedures.

2.5 Import controls

As required in the Regulation (EC) No. 2017/625, the competent authority performs official controls at the point of entry regularly on animals and goods entering the EU. All EU Member States have border inspection posts (BIPs) for the entry of live animals, animal products and other veterinary goods imported from third countries. All live animals and animal products as defined in the Commission decision 2007/275/EC must undergo specific veterinary import controls at an approved and designated BIP prior to entry or transit through the territory of EU Member States. Additionally, Denmark also implements Danish Executive Orders No. 1351, No. 1359 and No. 727 that governs intra Union trade, import of foods into union and veterinary checks on conditions of live animals and animal products.

There are 12 BIPs in Denmark. The DVFA, in consultations with the Ministry of Environment and Food, implements veterinary import/transit controls. Animals, animal products and by-products imported from third countries enter into Denmark only via a BIP of the Denmark or of another EU Member State. The competent authority is responsible for implementation of veterinary import and transit controls and completes microbiological and chemical residue sampling as per national monitoring plan and conducting documentary, identify and physical checks.

2.6 Enforcement framework

As per article 138 of the Regulation (EU) No. 2017/625, Denmark is responsible for imposing immediate interventions in case of non-compliance.

In response to the non-compliance, the DVFA initiates enforcement actions such as warning, suspension of certification and further administrative enforcement measures as needed. The CFIA auditors observed that the competent authority implemented enforcement measures at each establishment as per Denmark's policy and guidelines as stipulated in EU and Denmark regulations and orders.

3. Ante-mortem, humane handling and animal welfare controls

• 3.1 Traceability and animal identification
• 3.2 Ante-mortem inspection
• 3.3 Humane handling and animal welfare

3.1 Traceability and animal identification

As per Regulations (EC) No. 2017/625, No. 2075/2005 and No. 853/2004 Annex II Section III, the FBO must, as appropriate, request, receive, check and act upon food chain information in respect of all animals sent or intended to be sent to the slaughterhouse. The EU Member State is responsible for the day to day enforcement through their national legislation and control activities. Additionally, article 18 of the Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 governs the traceability principles and requirements of Food Law.

Nationally, the Order No. 1407 of 30 November 2018 provides the legal framework on registration of herds in the Central Husbandry Register database, while the Order No. 679 of 18 May 2020 governs identification, registration and movements of cattle, pigs, sheep or goats. As audited, the operators implemented traceability and identification of the live animals and their movements requirements at the establishments in accordance with the regulatory requirements.

3.2 Ante-mortem inspection

Denmark fulfils ante-mortem inspection requirements as described in the Regulations (EC) No. 2017/625 and No. 2019/627. The FBO is responsible for monitoring of animals at arrival, and checking the veterinary health certificate, farmer's declaration (animal information document), and way bill. After confirmation of identification, the operator provides all documents to the OV responsible for completing the ante-mortem inspection at the establishment. The OV completes the ante-mortem inspection of each animal (bovine and swine) within 24 hours of arrival at the slaughterhouse and less than 24 hours before slaughter. Ante-mortem inspection includes animal identification, animal welfare issues and clinical health of animals. After completion of ante-mortem inspection, OV either approves or rejects the individual animal or lot for slaughter. The OV inspects all dead animals arriving during day and over night. The OAs under the supervision of OV may complete the ante-mortem inspection of animals.

During virtual audit, the CFIA auditors verified records for the completion of ante-mortem inspection by the OVs at the bovine and swine slaughter establishments.

3.3 Humane handling and animal welfare

The Denmark Order No. 135 of 14 February 2014 supplements the Regulation (EC) No 1099/2009 on the protection of animals at the time of killing. The Regulation (EC) No. 1099/2009 on the protection of animals at the time of slaughter (arrival, moving, and handling of animals) partly regulates the transport of animals related to operations at slaughterhouses. The OV inspects animals for any signs of compromised welfare and verifies animal welfare at slaughter via ante-mortem inspection and stunning and monitors bleeding checks at pre-determined frequencies as per regulations.

The CFIA auditors verified the records of implementation of Animal Welfare Program and animal handling, stunning and bleeding procedures, and the monitoring of these procedures at the audited animal slaughter establishments. For non-ambulatory cattle and swine, the operator stunned and bled the animal on site without being moved. The competent authority followed on incidents of animal welfare non-compliance detected during transportation, handling and slaughter of animals and verified FBO's corrective actions.

4. Slaughter and post-mortem

In Denmark, national legislation Guide No. 9446 of 8 July 2020 on meat inspection and EU regulations govern slaughtering of animals. As per Regulation (EC) No.. 2019/624 article 9 and No. 2017/625 article 17, post-mortem inspections and auditing activities are essential to protect human health, animal health, and animal welfare. As per articles 7 of the Regulation (EC) No. 2019/624 and 18(2)(c) of the Regulation (EU) No. 2017/625, the OAs under the supervision of OVs complete post-mortem inspection. The post-mortem inspection consists of an examination of carcasses, carcass parts, organs, tissues and lymph nodes, by means of observation, palpation, sense of smell, and incisions. At medium and small slaughter establishments, the post-mortem was completed by OA without the physical presence of OV at the establishment.

At the bovine slaughter establishment, the operator implemented zero tolerance for fecal contamination using a CCP. However, the CFIA noticed that the operator did not include ingesta and milk contamination in the CCP or described it in the contamination monitoring procedure.

5 Processing controls

• 5.1 Antimicrobial controls
• 5.2 Chilling/freezing controls
• 5.3 Water retention controls
• 5.4 Allergen controls
• 5.5 Processing controls

5.1 Antimicrobial controls

As required in the Regulations (EC) No. 2015/1474 and No. 101/2013, the establishments can use steam and antimicrobial aids such as steam vacuum or lactic acid to reduce microbiological surface contamination on bovine and swine carcasses.

As audited, the operator used steam vacuum at the end of evisceration line at bovine slaughter establishment, but the operator did not use either lactic acid or steam or any other acceptable antimicrobial on the carcass at swine slaughter establishment.

5.2 Chilling/freezing controls

The Regulation (EC) No. 853/2004 lays down chilling requirements applicable to domestic ungulates and poultry. During cutting, boning, trimming, slicing, dicing, wrapping and packaging, the FBO ensures the maintenance of meat at not more than 3°C for offal, 7°C for ungulates meat by means of an ambient temperature of 12°C. The operator can have an alternative system having an equivalent effect. However, meat may be boned and cut prior to reaching the temperature mentioned above when the cutting room is on the same site as the slaughter premises. The operator must transfer the meat to the cutting room either directly from the slaughter premises or after a waiting period in a chilling or refrigerating room.

The audited establishment maintained chilling and freezing controls using a CCP. The competent authority verified the implementation of chilling controls at each audited establishment.

5.3 Water retention controls

Currently, there are no regulatory requirements related to Retained Water Control Program for bovine and swine meat and meat products in EU Member States. As audited, the operators did not implement the Retained Water Control Program as per Canadian requirements at the bovine and swine slaughter establishments. The FBOs are responsible for developing and implementing Retained Water Control Program for carcass, parts and offal as per the Canadian requirements as prescribed in the Canadian control programs: water retention in edible raw red meat products.

5.4 Allergen controls

Slaughter establishments and the producers and processors of meat products in Denmark must comply with the requirements of Regulation (EU) No. 1169/2011. There are 14 major allergens listed in annex II of this regulation. If the Food Business Operators use allergens onsite, they must implement Allergen Control Program. The list of allergens is similar to that of Canada, with the exception of pine nuts.

The CFIA auditors verified and observed that the audited establishments in Denmark developed and implemented the Allergen Control Program in accordance with the EU regulation. However, the canning establishment did not include all Canadian priority allergens in its written Allergen Control Program.

5.5 Processing controls

Lethality treatments refer to the treatment delivered to a meat product to achieve a reduction in the viable pathogenic organisms. The Regulation (EC) No. 852/2004 Annex II, Chapter 11 on heat treatment describes the requirements that apply only to food placed on the market in hermetically sealed containers. These requirements relate to any heat treatment process used to process an unprocessed product, and prevent the product from becoming contaminated during the process. Additional requirements are control of temperature, pressure, sealing and microbes as per international standards.

The Regulation (EC) No. 852/2004 also outlines the operator's responsibility to develop and implement process control programs and performance requirements for canned products. The operator must complete the quality control check internally via validation of the horizontal autoclave and externally by third party twice a year. The incubation of final product requires 10 days at 37°C. The operator usually assigns CCP to control the container integrity and thermal processing. On a daily basis, the operator performs the destructive sampling of 4 cans per batch to verify the container integrity at in-house laboratory.

The CFIA virtually audited an establishment producing and exporting Canned Premium ham Chungjungone Luncheon meat, Chef Crown Luncheon pork and Mini Vienna sausage to Canada. The CFIA reviewed the controlling factors used for canned cured meat products in hermetically sealed containers being exported to Canada. The F₀-values for shelf stable cured meat products are according to Annex D to the Recommended International Code of Hygienic Practice for Low-acid and Acidified Low-acid Canned Foods, Codex Committee Meeting Report (ALINORM) 91/16, Appendix II (PDF).

The Regulation (EC) No 1333/2008 and the Danish Order 1247/2018 describe the maximum level of added nitrites in the canned products. The operator used the maximum permitted level of 150 mg/kg of sodium nitrite in canned meat products at the audited canning establishment.

The CFIA analyzed the summary of controlling factors currently used in Denmark in canned cured meat products in hermetically sealed containers being exported to Canada. The CFIA observed that certain canned products met some aspects of the ALINORM criteria but others did not for the reasons of lower levels of nitrite (120 ppm versus 150 ppm) or lower F₀ (<3 versus >3) or lower salt (<3% versus >3%) than the required levels. For example, the operator employed a F_o value of 1.5 and salt concentration of less than 3, but sodium nitrite of 120-150ppm for the Premium Ham and Chef's Crown Less Sodium products. In accordance with the ALINORM criteria, using any F_o value < 3 requires a nitrite level of 150 ppm regardless of the salt level. Additionally, the operator again used a salt level higher than 3% (3.2% and 3.3%) and F₀ of 3 but sodium nitrite less than 100 ppm for pork Luncheon Meats. In case of F₀ value 3 or higher, there is no need to add nitrites or to meet specific salt criteria.

Although operator referenced the ALINORM standards which may be acceptable to justify F₀ < 3, but did not meet the minimum level of nitrite requirements. Furthermore, the operator did not provide the validation for thermal process to achieve commercial sterility for some of the canned meat products.

6. Preventive control plans (PCP)

The application of HACCP program and principles is a mandatory requirement for all establishments according to the Regulations (EC) No. 178/2002, No 852/2004, No. 853/2004 and No. 854/2004. As required in the article 5 of Regulation (EC) No. 852/2004, it is essential for the operators (except primary producers) in each EU Member State to develop, implement and maintain effective HACCP system in their establishments.

Denmark implemented different elements of HACCP and pre-requisite programs in the bovine and swine slaughter and meat processing establishments. At the audited animal slaughtering and meat processing establishments, the Danish competent authority audited the implementation of HACCP system at a defined frequency, and monitored the functionality of the HACCP system and prerequisite programs (sanitation, pest control and others). However, the auditors noted various deficiencies related to elements of HACCP system in all of the audited establishments such as lack of written program to control carcass contamination other than fecal and verification frequency for CCP-1.

7. Microbiological controls

The Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs specifies the requirements for food safety and process hygiene microbiological sampling from meat and meat products. Additionally, under the regulation (EC) No. 882/2004, the competent authorities have to verify that feed and food should be safe and wholesome and that the criteria are met. The Regulation (EC) No. 2017/625 lays down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption.

The DVFA issues official sampling plan as part of Microbiological Monitoring Program to verify that the Food Business Operators comply with the microbiological criteria and food safety levels defined in the EU and national legislations.

At the bovine slaughter establishment, the operator implemented control measures and testing plan for E.coli O157:H7/NM in raw beef products precursor materials as per Canadian export requirement. The establishment used the N60 method for beef meat intended to be used in production of raw ground beef.

As described in the Regulation (EU) No. 2015/1375 specifics rules on official controls for Trichinella in meat, every carcass is sampled for Trichinella spiralis in the swine slaughter establishments. The carcasses are tested and held until results are negative.

At the audited slaughter establishments, the carcasses and meat products were tested according the operator's sampling plan as per the annex 1 of the regulation (EC) No. 2073/2005. The CFIA noted that the annual audit for the Canadian export requirements did not include the verification of sampling and testing of E. coli O:157/H7 at the bovine slaughter establishment.

8. Chemical residue controls

Denmark implements National Residue Monitoring Plan (NRMP) and report the results for the illegal use of substances, misuse of authorized veterinary medicines, and minimize residue recurrence in accordance with directive 96/23/EC and 96/22/EC. These directives provide measures to monitor certain substances and residues thereof in live animals and animal products. The Council directive 96/23/EC requires EU Member States to adopt and implement a NRMP for specific groups of residues.

Under the EU regulations, the DVFA forecasts NRMP every year and submit to EU Commission for approval followed by submission of the results to EFSA for publication. The number of samples and frequency depends on the total previous year national slaughter volume per species, compliance history and the slaughterhouse participation in the Quality Assurance Program. The NRMP include the species, categories, points of sampling, substances for testing, and test procedures as prescribed in the European Commission's legal provisions to ensure wholesomeness of the meat products. The officials collect and ship residue samples to the laboratories for analysis. In the case of non-compliant testing results, the competent authority performs investigation and takes necessary measures.

As audited, the DVFA established and implemented a chemical residue sampling plan for bovine and swine as per council directive 96/23/EC Annex IV. In regard to off-label policy, Denmark implemented the cascade rule as described in EU directive 2001/82/EC on the Community Code related to use of veterinary medicinal products.

Canada routinely monitors the imported meat products for chemical residues, and assess the testing results. The results must comply with Canadian maximum residue limits. The maximum residue limits for veterinary drug residues are established by Health Canada and described in the list of maximum residue limits (MRLs) for veterinary drugs in foods.

9. Closing meeting

The virtual closing meeting was held with representatives from DVFA on March 24, 2021. The CFIA presented a summary of the preliminary findings in the closing meeting.

10. Conclusions

Following the review of action plans provided by competent authority, the CFIA determined that Denmark continues to implement the bovine and swine meat inspection and meat processing systems determined equivalent to those of Canada.

11. Recommendations

The recommendations are linked to the specific conclusions made during this report.

CFIA recommendation 1

The CFIA recommends that all establishment specific findings be corrected and verified in a timely fashion.

DVFA action plans/comment 1

DVFA provides a response to CFIA recommendations for the operator's correctives actions and DVFA verification of the findings in the establishments audited.

CFIA recommendation 2

The CFIA recommends that all establishments must be under permanent supervision of OV during the production of meat and meat products intended for export to Canada.

DVFA action plans/comment 2

All slaughterhouses approved for export to Canada are listed at the Canadian website.

To be listed, the establishment must comply with Regulation (EC) No. 2017/625 and Canadas requirements. Regarding the ante- and post-mortem inspection all approved slaughterhouses fulfils the statement written in Safe Food for Canada Act Article 139 (1)(2) and 149 (1) which states that ante and post mortem inspection must be performed by a veterinarian inspector or inspector under the supervision of a veterinary inspector.

CFIA recommendation 3

The CFIA recommends that the adequate training records be maintained for initial training of Official Veterinarians and Official Auxiliaries.

DVFA action plans/comment 3

The DVFA have accommodated this recommendation, and all training of Official Veterinarians and auxiliaries will be documented thoroughly in the future. Training of new employees will be coordinated centrally in the Meat Inspection Department.

CFIA recommendation 4

The CFIA recommends that each shipment of meat and meat products for export to Canada be verified by the DVFA official.

DVFA action plans/comment 4

The DVFA performs 1% sample control of the exported consignments.

This procedure is part of Denmark's export control system and complies with the EU requirements laid down in the Official Control Regulation (EU) No. 20 17/625, Chapter VII, Official certification, articles 86-91.

The physical inspections of consignments are carried out by the DVFA with the same cate as the control of other factors essential to the issuance of export certificates, such as the HACCP own-check procedures. Furthermore, the establishments are not notified before the 1% randomized export control is carried out.

The above legislated requirements are the foundation for Denmark's issuance of export certificates and the assurance for the importing country that the products fulfil the specific requirements from the importing country. The DVFA refers to the official letter of April 20, 2021 regarding export control.

CFIA recommendation 5

The CFIA recommends that:

• All establishments exporting meat and meat products to Canada have a written and validated Retained Water Control Program as per the Canadian requirements
• The DVFA annual verification of Canadian export requirements include the verification of E. coli O:157/H7 sampling and testing at bovine slaughter establishments

DVFA action plans/comment 5

The DVFA informed that the porcine and bovine slaughterhouses in Denmark do not use chilling systems, which makes water retention in the meat unavoidable.

At Danish slaughterhouses;

• no water is used in the slaughter process after evisceration
• no post-evisceration washing of carcasses is per-formed neither with hot water, cold water, nor an antimicrobial, including on-line reprocessing systems
• no water is used for chilling carcasses and edible by-products

So a water retention protocol should not be necessary at the Danish porcine and bovine slaughterhouses as long as the slaughterhouses do not use water in the slaughtering process which makes water absorption and retention unavoidable.

The DVFA agreed to verify the Canadian export requirements including verification of E. coli O:157/H7 sampling and testing at bovine slaughter establishments. This will be included in their annual control plan. Next verification of this item took place on September 15, 2021.

CFIA recommendation 6

The CFIA recommends that the pine nuts be included in the Allergen Control Program at all processing establishments eligible to export meat and meat products to Canada.

DVFA action plans/comment 6

As per DVFA's response, the written Allergen Control Program does only include the allergens that are handled in the factory as ingredients. The factory has the policy that no food is allowed in the production area preventing other allergens including pine nuts from entering the products. The rules for hygienic behaviour "hy- giejneregulativ" is added as evidence.

CFIA recommendation 7

The CFIA recommends that:

• validation for thermal process to achieve commercial sterility be completed for canned meat products for export to Canada
• the competent authority clarifies whether the somewhat higher salt level in canned products compensates for the lower than required nitrite levels
• the competent authority provides any documentation or studies results that verify compensatory action of higher sodium nitrite level for lower salt concentration level or F₀ value and vice-versa

DVFA action plans/comment 7

The DVFA provided the controlling factors regarding current canned cured meat products in hermetically sealed containers being exported to Canada.

Regarding the low acid cured products the shelf stability is assured by partial thermo-destruction of the bacterial spore contaminations and/or subsequent inhibition of the surviving spores. In preserving shelf-stable cured meat products in hermetically sealed containers the following factors are critical: Aqueous salt content, ingoing nitrite content, microbial contamination of meat and non-meat ingredients and the heat process. The site policy regarding F₀-values for shelf stable cured meat products is according to Annex D to the Recommended International Code of Hygienic Practice for Low-acid and Acidified Low-acid Canned Foods, ALINORM 91/16, Appendix II.

CFIA recommendation 8

The CFIA recommends that the competent authority implements and monitors the HACCP and pre-requisite programs effectively to correct and prevent deficiencies identified in this report.

DVFA action plans/comment 8

The Competent Authority audits the implementation of HACCP system, and monitors the functionality of the HACCP system and prerequisite programs on a risk-based frequency.

At least annually, the company's compliance with special export requirements to Canada is audited.

In regard to verification frequency for CCP 1 in HACCP plan, the can closing data are verified every day by a member of the quality assurance team. This information has been added to the HACCP plan. Denmark provided the copy of updated HACCP plan.