Final report of an onsite audit conducted in Spain to evaluate meat inspection systems governing the production of meat and meat products

The CCA representatives accompanied the CFIA auditors throughout the audit, with a focus on government controls and oversight.

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

• regulatory framework
• supervisory oversight
• import and export controls
• laboratory framework
• ante-mortem, humane handling and animal welfare controls
• post-mortem and slaughter
• processing controls
• export controls
• preventive control plans
• microbiological controls
• chemical residue controls

Administrative functions were reviewed with the Ministry of Health (MISAN), the Ministry of Agriculture, Fisheries and Food (MAPA), and the Spanish Agency for Food Safety and Nutrition (AESAN), during which the auditors evaluated whether inspection, verification, and enforcement were being implemented as intended.

The CFIA auditors verified the system and its implementation via

• document review of the documents, directives and regulations
• onsite observations
• Interviews of the competent authorities and operators

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

• Safe Food for Canadian Act and Regulations
• Health of Animal Act and Regulations

The audit standards also included all applicableEUregulations determined as equivalent as part of the Agreement between the European Community and the Government of Canada on sanitary measures to protect public and animal health in respect of trade in live animals and animal products, as amended from time to time.

Spain is an EU Member State and is required 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). The key relevant EU regulations are:

• Regulation (EC) No. 178/2002: general principles and requirements of food law (General Food Law Regulation)

• Regulation (EC) No. 2073/2005: microbiological criteria for foodstuffs. This regulation is deemed equivalent as it relates to process hygiene criteria. Compliance with Canadian microbiological food safety criteria is required.
• Regulation (EC) No. 852/2004: hygiene of foodstuffs
• Regulation (EC) No. 853/2004: specific hygiene rules for food of animal origin
• Regulation (EC) No. 854/2004: specific rules for the organization of official controls
• 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. 2017/625: official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products
• Regulation (EU) 2019/6 of the European Parliament and the Council: on veterinary medicinal products
• Regulation (EU) No. 2022/1644: supplementing Regulation (EU) 2017/625 of the European Parliament and the Council with specific requirements for the performance of official controls on the use of pharmacologically active substances authorized as veterinary medicinal products or as feed additives and of prohibited or unauthorized pharmacologically active substances and residues
• Regulation (EC) No. 999/2001: prevention, control and eradication of certain transmissible spongiform encephalopathies
• Regulation (EC) No. 37/2010: pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin
• Regulation (EC) No. 2015/1474: use of recycled hot water to remove microbiological surface contamination from carcasses

Under the Spanish Constitution, Article 148.1 and the Statutes of Autonomy and corresponding Royal Decrees transferring functions and services, 17 autonomous communities and 2 autonomous cities are exclusively responsible for implementing control systems in Spain. The main laws and royal decrees of importance in Spain are:

• Law 11/2001: the creation of the Spanish Agency for Food Safety
• Law 17/2011: on food safety and nutrition, and establishes the public administration responsible for carrying out official controls such as the Food Safety Laboratory Network (RELSA)
• Law 14/1986: General of Health regulates infractions and sanctions in sanitary matters
• Royal Decree 5/2015: Law of the Basic Statute of the Public Employee
• Law 19/2013: transparency, access to public information and good governance
• Royal Decree 1945/1983: regulates infractions, sanctions regarding consumer protection and Agri-food production, standards of inspections, and official sampling methods
• Royal Decree 3/2023: Establishing the technical and sanitary criteria for the quality, control, and supply of drinking water

Spain has 3 public administration levels, including Central, Regional and Local Administration. The MISAN, MAPA and the Ministry of Social Rights and Consumption and Agenda 2030 are the central competent authorities. Under the Ministry of Social Rights and Consumption, the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AESAN) is an autonomous body responsible for implementing, coordinating and developing strategies for food safety controls in food establishments. There are coordination bodies and working groups between the central and regional administration levels to facilitate coordination and maintain effective communication.

Each Member State is required to submit an annual report to the European Commission, providing information on the implementation of the multi-annual national control plans (MANCP). As stipulated in Regulation (EC) No. 2017/625, the MANCP are prepared by each Member State. These plans promote a consistent, comprehensive, and integrated approach to official controls of feed and food, animal health, and animal welfare legislation and should embrace all sectors and all stages of the feed and food chain, including import and introduction.

The Spanish MANCP, known as the National Plan for Official Control of the Food Chain (PNCOCA), outlines the official control systems throughout the food chain in Spain, from primary production to end consumers. The central level AESAN issues the PNCOCA. The MAPA is responsible for certification for exports and controls over primary production associated with agriculture, live animals, feed, fish, plant health and food quality. The MAPA manages non-compliance and communication with third countries.

The provinces have Autonomous Communities (AA.CC) with independent legal status. There are 17 autonomous communities and 2 autonomous cities at the regional level. These organizations are responsible for planning and implementing official controls on food safety, animal health, animal welfare, plant health, and food quality. The regional-level administration includes the regional Ministry of Public Health and the regional Ministry of Agriculture, which have the same mandate as their central-level counterparts.

The provinces and districts constitute the Local Administration. The districts also have full legal status, and their governance and administration correspond to those of the respective City Councils, which are governed by the Mayor and Councillors. The provinces manage local health districts, which are responsible for overseeing the activities of the slaughter and processing establishments.

Spain's official control program is divided into 4 sections, which are subdivided into different control programs. For example, section 1 includes Program No. 1 food establishments inspection, Program No. 2 audits of self-control systems (HACCP), and Program No. 3 slaughterhouses (animal welfare, antemortem, and postmortem). Each program describes inspection tasks for the official veterinarian and inspection staff.

The frequency of official visits and tasks depends on the risk categorization assigned to each food establishment. The frequency and priority of inspection tasks depend on the availability of resources, the type and depth of the inspection task, and the scope, which includes the type and category of product, as well as the laboratory's testing capacity.

The EU Commission, AESAN, and the Autonomous Communities provide training to inspection staff. The EU Commission offers training to participants via the Better Training for Safer Food (BTSF) program. AESAN prepares a training plan in PNCOCA and organizes workshops and training events every year.

Additionally, the Autonomous Communities have yearly training plans. The initial training program is designed for new veterinarians and inspectors, aiming to equip them with the necessary skills and knowledge for their roles. However, once this foundational training is completed, there is no formal, continuous training program in place to support ongoing professional development. While regional and national training opportunities are available periodically, these are not structured as part of a continuous learning framework.

For instance, in the case of animal Welfare Training, the CCA provides specific training to ensure veterinarians and inspectors are well-versed in key aspects of animal care and ethics. However, like the general training programs, there is no system for ongoing updates or periodic training on animal welfare topics. This lack of continuous learning applies to both general and specialized training.

The Regulation (EC) No. 178/2002 controls the export of meat and meat products. The food and feed exported or re-exported from the EU for placing on the market of a third country must comply with the relevant requirements of food law unless otherwise requested by the authorities of the importing country or established by the rules, regulations, standards, codes of practice and other legal and administrative procedures as may be in force in the importing country.

According to Regulation (EC) No. 852/2004, the traceability of food and food ingredients throughout the food chain is an essential element in ensuring food safety. Registered establishments must meet the specific sanitary requirements and health agreements of importing countries or blocks of countries.

The AESAN functions include proposing risk management measures, developing new regulations, providing technical support, and managing the National Registry of Food and Food Business Operators (RGSEAA). The RGSEAA is the registry that contains information on all registered operators and is available for consultation on the secure webpage of AESAN. Auto control System for export (SAE) is an independent certification body, separate from AESAN and MAPA. It verifies the operator's traceability controls throughout the entire supply chain from the farm, through the Official Veterinary (OV), to the slaughterhouse, and onward to any intermediary establishments, up to the final producer. SAE certification confirms that the animal health requirements and traceability standards are fully met.

Food exporters must meet all EU food regulations and the specific requirements of the importing country. To be eligible to export, the establishment must apply, pass an onsite audit, and meet the third country's import requirements before it becomes eligible to export.

CEXGAN is Spain's official certification system and online management tool designed to streamline the export process of animals and animal-derived products. It provides exporters with easy access to vital information, including export requirements, health certificates, lists of approved establishments, and applicable regulations. Using CEXGAN, the operator can handle the entire export health certification process digitally, including maintaining traceability records of their products. The platform enables operators to submit applications for export health certificates and upload all necessary documentation. The operator submits a certification application through CEXGAN, along with the necessary supporting documents, to the local Official Veterinary for export authorization at the establishment. The local OV will then issue the sanitary attestation. At the Border Control Post (BCP), veterinary services conduct document verification and perform physical and identity inspections, including 3% random physical checks and 100% document reviews of consignments.

The BCP authorities are responsible for verifying documentation, conducting risk-based physical and identity inspections, and reviewing documents to verify the eligibility of the product for export.

As stipulated in Regulation (EC) No. 178/2002, the Commission is responsible for requesting that third countries intending to export food to the EU provide accurate and up-to-date information on the general organization and management of their sanitary control systems.

For the importation of food of animal origin in Spain, the Directorate General for Health of Agri-Food Production and Animal Welfare (DGSPAYBA) under the MAPA coordinates the incoming meat products via the border inspection posts (BIP) at the entry points located at the ports and airports. Animal and animal-origin products exported outside the EU borders are subjected to systematic checks before being allowed into EU territory. Animal products must come from EU-approved establishments. The BIP officials verify the accompanying sanitary health certificates and visually check the products.

The officials perform random sampling of meat products from non-EU countries. The sampling frequency depends on risk, type of products, volume of production, and the exporting country's history of non-compliance. The Ministry of Health, Consumption and Social Welfare officials collect samples at the BIP.

The latest list of BIPs (including Spain's BIPs) is set out in Commission decision 2009/821/EC and is available on the European Commission's website. The Spanish authorities must be notified prior to the arrival of the products at the BIP. Data are usually entered in the Trade Control and Expert System (TRACES), which contains all the information regarding the movement of the consignment, making it traceable to or from the destination.

The Royal Decree 1945/1983, Law 33/2011, and Law 14/1986 regulate infractions and sanctions in sanitary matters, consumer protection, and agri-food production. These include standards for inspections, rules for recording minutes, the obligation of operators to collaborate with the inspection, and the adoption of additional measures in case of risk to public health, infractions, and sanctions. The Organic Law 10/1995, on the Penal Code, predicts imprisonment for crimes against public health. The national procedure is available to guide the competent authorities regarding non-compliance with food safety and animal welfare regulations. This law includes all the measures described in Regulation (EC) No 2017/625.

In Spain, the Regulation (EU) No. 2017/625 lays down the requirements to designate the National Reference Laboratories (NRLs) for official feed and food control. Under the MISAN, the Division of Agricultural Production Health Laboratories is responsible for the Laboratorio Central de Veterinaria (LCV) and the Laboratorio Central de Sanidad Animal (LCSA), which carry out intense work in animal health and hygiene matters. The LCSA perform the detection of veterinary drug residues.

Under AESAN, the National Food Center (CNA) provide technical scientific support and analytical control, acting as the National reference laboratory (NRL) in the cases established in the corresponding provisions, and the development of research projects, both national and in the European Union. The NRLs support officials that test food samples for the local authorities to monitor official controls. The official laboratories also test the samples for official controls of food and feed. In addition, EASAN also designate NRLs for animal health and live animals.

The NRLs operate as per articles 100 and 101 of the Regulation (EU) No. 2017/625 and coordinate the networks of official food safety and animal health laboratories across Spain. The Network of food safety Laboratories (RELSA) in Spain shares and promotes the accreditation of testing private and public laboratories designated by the CCA, AESAN and SGSE, which are responsible for accreditation, auditing and monitoring of official and private laboratories used for testing of animal health and food safety by the International Standardization Organization (ISO/IEC)17025 standard as per agreement between NRLs and AESAN. Under shared responsibilities between central and regional competent authorities, Spain has 74 public health and 93 animal health laboratories.

The National Accreditation Entity (ENAC) is responsible for granting accreditation for laboratory tests to laboratories designated for official controls. The CA will withdraw the laboratory designation if the laboratory doesn't adopt corrective actions in view of the audit results.

The CFIA did not visit any laboratories that test official samples for microbiology and chemical residue controls. However, the CFIA reviewed Spain's documents for laboratory infrastructure and testing results and observed that only accredited laboratories analyzed the food safety control samples for chemical residues and microbiology.

The CFIA audited the in-house laboratory in a turkey slaughter establishment and assessed the management and technical requirements for quality control. Technical requirements included personnel, environmental conditions, test methods and methods for validation, handling of test items, quality of test methods and reporting of results. The in-house laboratory of the poultry slaughter establishment visited was certified under ENAC. The in-house laboratory was using VIDAS (SPT) to detect Salmonella (method ISO 6579-1) and VIDAS (CAM) to detect Campylobacter (Methods ISO 10272-2) in raw poultry meat as per requested by Regulation 2017/1495 amending Regulation (EC) 2073/2005.

As per Regulation (EC) No. 853/2004, food business operators must, as appropriate, request, receive, check, and act upon food chain information regarding all animals sent or intended to be sent to the slaughterhouse. The Member State is responsible for the day-to-day enforcement through its national legislation and control activities. The official veterinarian verifies the controls and accompanying documentation for the animals.

At the establishments visited during the audit, the animals were adequately identified upon arrival at the slaughterhouse. The ovine were individually identified using 2 ear tags and a transportation permit, while the poultry had an accompanying flock document with a unique farm identifier. The operators had a secure electronic system to maintain the food chain information during slaughter operations.

National legislation requires developing and maintaining a traceability system at every food chain level from farm to fork. Food business operators must develop a recall plan that equips them to recall and withdraw a product that does not meet regulatory requirements. As an EU member, Spain participates in the Rapid Alert System for Food and Feed (RASFF). A recall plan was implemented per requirements at the establishments visited, and a yearly mock recall was completed.

Ante-mortem inspection is completed according to Regulation (EC) No. 854/2004. This regulation lays down specific rules for organizing official controls on products of animal origin intended for human consumption.

When animals are received, the operator and officials verify the transport document, food chain document, and truck disinfection certificate. The transport document includes information about the farm of origin, the transporter, and the animal health attestation signed by the local MAPA testifying to the disease zoning. The food chain document contains information about veterinary drug usage, the associated withdrawal period and the attestation for freedom from chemical residues. The truck disinfection certificate attests to information about washing and disinfecting trucks before transporting the animals.

The food business operator completes the animal-receiving procedures and performs controls as required. The local official veterinarian conducts antemortem inspections for every truckload of live animals and accompanying documents. The officials perform antemortem examinations within 24 hours of the animal's arrival at the slaughterhouse and less than 24 hours before slaughter. The official veterinarian communicates with the operator when the animals cannot be slaughtered.

As verified during the audit, operators adequately segregated the suspect animals in a suspect pen. All the suspects or non-ambulatory animals were marked and not allowed for export.

The Regulation (EC) No. 1099/2009 on protecting animals at the time of killing (arrival, moving, and handling of animals) partly regulates the transport of animals related to slaughterhouse operations. According to Regulation (EC) No. 854/2004, Annex I, Section II, Chapter IV, the official veterinarian must verify that the operator immediately takes the necessary corrective measures and prevents the recurrence of any animal welfare concerns during slaughter or killing.

The Member States are responsible for enforcing animal welfare regulations through their national legislation and control activities, transposition of directives into national legislation, and implementing EU requirements. Adequate welfare procedures are followed during unloading and mobilization to ensure the safe handling of animals. This includes checking that animals are healthy, non-ambulatory animals are handled appropriately, and all identification and documentation are in place as needed.

The audited establishments have animal welfare managers who implement the animal welfare program. Carbon dioxide was used for stunning turkey, while a penetrating captive bolt or electric stunner was used for ovine and caprine. The official veterinarian performs daily inspections focused on animal transport, unloading, humane handling, ritual slaughter and stunning. One of the ovine establishments was certified by a third party for both Halal and Kosher, while another ovine and turkey establishment was certified for Halal only. The program was reviewed; however, auditors did not observe the ritual slaughter during the audit.

The sequential numbers are used to identify each carcass before entry into the evisceration room. The sequential numbers on the carcass were used to maintain a correlation between the carcass and viscera. The viscera trays were identified with a label or colour-coded in the establishments to achieve correlation. The operator monitored the correlation between the carcasses, viscera and heads while the official veterinarian verified the correlation.

As per the Regulation (EC) No. 854/2004, the post-mortem inspection of ovine and caprine carcasses and parts is adequately performed by officials by visual inspection of the carcasses' internal and external surfaces. Additionally, they used palpation, incision, and sense of smell to detect pathologies and defects on the head, tongue, kidneys, and red and grey offal.

There were 3 veterinary inspection stations: one each for the carcass, head and red offal, and grey offal. The veterinarian at the carcass stations was responsible for establishing the wholesomeness of the carcass and its parts for human consumption. The carcasses with local pathologies and defects were marked and railed out. After trimming local pathologies and defects, the official veterinarian re-inspected the carcass and allowed it to bear the health mark before entering the cooling room.

Before the final wash, a CCP was implemented to control the presence of feces, ingesta, and defects on the carcass. The operator monitored 100 % of the carcasses before the end of the evisceration room. As observed in one of the ovine slaughter establishments, the operator's monitoring and verification procedures were insufficient to identify and remove the fecal contamination and defects. This was evident from the fecal contamination and fleece on the carcasses in both the cooler and the cutting areas.

The Commission Decision of 29 June 2007 and the Regulation (EC) No. 999/2001 lay down rules for preventing, controlling and eradicating transmissible spongiform encephalopathies (TSEs) in animals. The World Organisation for Animal Health (WOAH) recognizes Spain as a country with a negligible BSE risk status.

The operator identified and verified the animal's origin and age using the individual ear tag at the time of animal receipt and recorded the information in the Information Technology system to maintain the identification throughout the slaughter process. All the ovine slaughtered during the audit were young animals less than 12 months of age. If by any chance an animal is above 12 months, the operators demonstrate having proper specific risk materials (SRM) written identification and segregation procedure to assure that the SRM material is identified as category 1 as required by Regulation (EC) No. 1069/2009.

However, one of the ovine slaughter establishments audited didn't implement sufficient controls at the evisceration step, resulting in contamination on the carcass after the CCP at the evisceration area.

All poultry shall undergo post-mortem inspection, which may include the assistance of slaughterhouse staff in accordance with Article 18(3) of Regulation (EU) No. 2017/625. At the poultry slaughter establishment audited, a trained employee of the food business operator performs pre-selection to separate the carcasses with conditions such as emaciation, extensive bruising, or cellulitis. The operator rejects these carcasses as inedible. These employees are under the direct supervision of the official veterinarian at the evisceration line.

As observed at the turkey slaughterhouse, the official veterinarian on the evisceration line performs a visual post-mortem inspection of the external surface of the carcass and viscera. Trained operator employees check the cavity and viscera of each bird and segregate the carcass/viscera with quality and pathological defects. As stipulated in Regulation No. 2017/625 and 2017/627, the official veterinarian inspects the carcass, the viscera and the body cavities of a representative sample of birds for 5 minutes every hour. The CFIA observed that the operator had completely removed the uropygial glands from poultry carcasses as described in Canadian SFCR article 145.

Regulation (EC) No. 2015/1474 stipulated that the establishment can use antimicrobial aids and steam application to reduce microbiological surface contamination on carcasses. Both ovine slaughter establishments were using a validated steam vacuum procedure during the audit.

As per Regulation No. 853/2004, slaughter poultry establishments cannot use antimicrobial chemical aids to reduce microbiological surface contamination on poultry carcasses. As audited, no antimicrobial aids were used in the water of the turkey slaughter establishment.

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 food business operator ensures the maintenance of meat at not more than 3°C for offal and 7°C for ungulate meat, or an equivalent effect. The establishments had a CCP for carcass chilling for caprine and ovine carcasses and parts.

At the turkey establishment visited, air and water chillers were used to cool the turkey carcasses. The cooling steps controlled via a control point were able to cool the carcass temperature to 4°C before cutting and less than 3°C for by-products (liver and giblets).

Regulation (EC) No. 543/2008 lays down detailed rules regarding the marketing standards for poultry meat. Article 16 of this regulation stipulates an obligation on operators to carry out regular checks on water absorption by chicken carcasses during chilling/freezing. The audited turkey slaughter establishment implemented a validated written water retention control program for carcasses, parts, and by-products such as giblets and liver.

The EU and national legislation do not establish water retention control program requirements for ovine and caprine meat and meat products. As audited, the air chilling method was used for ovine and caprine slaughter establishments. The operators in these 2 ovine establishments didn't implement any validated written water retention control program as required by the Canadian Control Programs: water retention in edible raw red meat products.

Regarding allergens, operators of slaughterhouses and producers of meat products in Spain must comply with the requirements of Regulation (EC) No. 1169/2011. A total of 14 major allergens are listed in Annex II to Regulation (EC) No. 1169/2011. The food business operator label shall declare the presence of any of these allergens. The allergens listed in Annex II of Regulation (EC) No. 1169/2011 are recognized across Europe as the most common ingredients or processing aids causing food allergies and intolerances. If the food business operator uses allergens onsite, an allergen control program must be implemented.

In one of the slaughter establishment audits that includes further processing steps, develop and implement an allergen control program to identify and control major food allergens as per the EU regulatory requirement. All Canadian priority food allergens were included in the operator's allergen program or in a specific procedure for exporting products to Canada.

The CFIA requests that the operators implement corrective actions that are verified by the competent authorities regarding the establishment's specific findings listed in Annex 1: CFIA findings at the establishments visited during the audit of Spain's Caprine, Ovine and Poultry Meat Inspection Systems.

The CFIA received the operator's corrective actions to CFIA findings at the establishments visited during the audit of the Spain's Ovine, Caprine and Poultry Meat Inspection System and the AESAN verification of the corrective actions implementation.

The CFIA requests that the operators implement corrective actions that are verified by the competent authorities regarding the establishment's specific findings listed in Annex 1: CFIA findings at the establishments visited during the audit of Spain's Caprine, Ovine and Poultry Meat Inspection Systems.

The autonomous regions are developing a training program that integrates regional and national opportunities. The official veterinary services of the Autonomous Communities provided training program records to the CFIA.

The CFIA requests that AESAN and the operators of ovine and caprine slaughterhouses implement effective dressing procedures to control the presence of contamination and defects equivalent to the Canadian fresh red meat examination program. The CFIA would like to confirm that all the establishments intending to export to Canada will meet the dressing procedure as per Canadian requirements.

These procedures are being implemented. AESAN provide the procedure for authorising establishments to export fresh poultry meat for human consumption, published on the MAPA website, which details the requirements imposed by Canada. Official veterinary services verify that all establishments wishing to export to Canada comply with this procedure.

The CFIA requests that red meat establishments, including ovine and caprine, export meat products to Canada and implement validated written water retention controls and procedures for the carcasses, parts, and meat by-products when their post-evisceration processing causes excess water retention, as specified in the Canadian Control Programs: water retention in edible raw red meat products.

The CFIA requests that poultry meat establishments producing chicken, turkey, duck and quail to be exported to Canada implement validated written water retention controls and procedures for the carcasses, parts, and meat by-products when their post-evisceration processing causes excess water retention as specified in the Canadian Poultry water retention control program.

The CFIA recommends that AESAN supervise the operators' red meat and poultry water retention programs to verify that their overall control measures are effective in accordance with the Canadian Control Programs: water retention in edible raw red meat products

Written and validated controls and procedures for water retention in carcasses, parts and meat by-products required of ovine/caprine establishments.

Written and validated controls and procedures for water retention in carcasses, parts and meat by-products requested to poultry meats establishments.

AESAN will supervise operators' water retention programs for red meat and poultry.

The CFIA recommends that AESAN and the competent authorities strengthen official oversight and enforcement activities, considering multiple audit observations regarding operators' preventive control plans.

All non-conformities detected in the audited companies were reported by MAPA to the local official veterinary services responsible for the establishments. These veterinary services, after evaluating, verifying and approving the effectiveness of the measures taken by the companies to correct the errors, have issued the reports mentioned above.