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Report of a virtual assessment of Spain's food safety controls for fish and seafood - 2021

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Abbreviations and special terms used in the report

AC
Autonomous Community
ACCA
Autonomous Community Competent Authority
AESAN
Agencia Española de Seguridad Alimentaria y Nutrición (Spanish Food Safety and Nutrition Agency)
ALCON
Aplicación Informática para la Gestión de Alertas Alimentarias y Control Oficial (Computer Application for the Management of Food Alerts and Official Control)
BAP
Best Aquaculture Practices
BRC
British Retail Consortium
BTSF
Better Training for Safer Foods
CA
Competent Authority
CETA
Canada-European Union Comprehensive Economic and Trade Agreement
CEXGAN
Comercio Exterior Ganadero
CFIA
Canadian Food Inspection Agency
CNA
Centro Nacional Alimentación (National Food Center)
DG SANTE
Directorate General for Health and Food Safety
EFSA
European Food Safety Authority
ENAC
Entidad Nacional de Acreditación (National Accreditation Entity)
EU
European Union
EURL
European Union Reference Laboratory
FBO
Food Business Operator
IFS
International Featured Standards
ILAC
International Laboratory Accreditation Cooperation
GHP
Good Hygiene Practice
HACCP
Hazard Analysis Critical Control Points
INFOSAN
World Health Organization International Food Safety Authorities Network
INTECMAR
Instituto Tecnolóxico Para o Control do Medio Mariño de Galicia (Technological Institute for the Control of the Marine Environment of Galicia)
ISO
International Standards Organization
JACUMAR
Junta Nacional Asesora de Cultivos Marinos (National Advisory Board of Marine Cultures)
MANCP
Multi-annual National Control Plan
MAPA
Ministerio de Agricultura, Pesca y Alimentación (Ministry of Agriculture, Fisheries and Food)
MC
Spain's Ministerio de Consumo (Ministry of Consumer Affairs)
MPZ
Molluscan Production Zone
MRL
Maximum Residue Limit
MS
Spain's Ministerio de Sanidad (Ministry of Health)
NC
Non-compliance
NRL
National Reference Laboratory
OCL
Official Control Laboratory
PNCOCA
Plan Nacional de Control Oficial de la Cadena Alimentaria (National Plan for Official Control of the Food Chain)
RASFF
Rapid Alert System for Food and Feed
RGSEAA
Registo General Sanitario de Empresas Alimentarias y Alimentos (General Health Registration of Food and Food Establishments)
REGA
Registro General de Explotaciones Ganaderas (General Registration of Livestock Farms)
RELSA
Red de Laboratorios de Seguridad Alimentaria (Network of Food Safety Laboratories)
SAE
Sistema de Autocontrol Especifico Para los Exportación (Specific Self-Control System for Exports)
SANDACH
Subproductos de origen animal No Destinados al Consumo Humano (By-products of Animal Origin Not Destined for Human Consumption)
SCIRI
Sistema Coordinado de Intercambio Rápido de Información (The Coordinated System for Rapid Information Exchange)
SFCR
Safe Food for Canadians Regulations
SITRAN
Sistema Integral de Trazabilidad Animal (Comprehensive Animal Traceability System)
TRACES
Trade Control and Export System

Executive summary

This report describes the observations and recommendations generated as a result of an assessment of Spain's food safety control system for fish and seafood. The Canadian Food Inspection Agency (CFIA) conducted the assessment from March 22 to April 6, 2021. Due to COVID-19 travel restrictions, the assessment was conducted virtually.

The main goals of the assessment were to verify how the Spanish competent authority's (CA) food safety controls:

The assessment included virtual meetings with national, regional and local CAs, fish and seafood industry, and a national laboratory. The assessment included virtual meetings with national, regional and local CAs, fish and seafood industry, and a national laboratory. Lack of on-site visits limited the ability of the assessment team to observe how Spain's system of food safety controls is implemented. The findings in this report are based on information collected through interviews and document reviews.

As a member of the European Union (EU), Spain must carry out and enforce the EU regulatory requirements for the harvest, treatment, production, packing, import and export of fish and seafood – for example, the requirements for:

Member States also benefit from the EU's existing guidance materials, laboratory network, and systems for scientific advice and communication.

Spain has developed a series of national and regional legal instruments and processes that enable them to apply the EU requirements at a practical level. This has resulted in a comprehensive national food safety control system. The system is being implemented as written by well-trained, able and dedicated individuals.

FBOs or their suppliers or both meet the food safety requirements established by the EU and Spain. They may also hold third-party certifications to meet the needs of their customers. These can include the:

This report identifies several recommendations to improve the existing system and its programs.

The observations and recommendations contained in this report are based on information gathered by the assessment team. The information was gathered through the Canadian Assessment Standards tool, personal interviews, and on-site observation. They represent the collective understanding of the members of the assessment team.

1. Introduction

The CFIA has a broad mandate that includes food safety, animal health, plant protection and international market access. CFIA's main priority is protecting the health and safety of Canadians. CFIA periodically conducts audits and assessments of the food control systems of Canada's foreign trading partners. This is to verify that these countries have controls in place for the safe production of the foods they export to Canada. These activities:

The results of this assessment will inform CFIA's import controls. In general, assessments of other country's food safety systems conducted by the CFIA:

The CFIA conducted a virtual assessment of Spain's food safety control system for fish and seafood from March 22 to April 6, 2021. It included virtual interviews and document reviews with:

A virtual opening meeting was held on March 22, 2021. Representatives from both national CAs, Spanish ACCAs, and the Embassy to Canada in Madrid were present. During this meeting, the CFIA assessment team explained the goals and technical aspects of the assessment. The Spanish CAs then presented an overview of the Spanish regulatory foundation, roles and responsibilities, and the Multi-annual National Control Plan (MANCP).

Virtual meetings were held with:

Spanish national and regional representatives participated in all of the meetings.

A virtual closing meeting was held on April 6, 2021. It was attended by the national CAs, ACCAs, and representatives from both the Embassy of Spain in Washington and the Embassy of Canada in Madrid. The CFIA's goal for the meeting was to:

2. Audit objective, scope and methods

The main objective of the assessment was to verify Spanish food safety controls. How are the controls applied by the CAs to the production and export of fish and seafood, and how these controls achieve:

The scope of the assessment was limited to:

The assessment didn't include evaluations of:

Also, the assessment didn't include any virtual site visits of capture/landing or aquaculture sites, virtual tours of FBOs, or laboratories.

The assessment considered information about Spain's system of food safety controls using information collected by different methods. This included a desk review of information provided by MAPA. They provided relevant fish and seafood:

A virtual assessment was then conducted to:

Information was collected during the virtual assessment. Presentations and virtual interviews with, and follow-up responses from, the following entities as outlined in Table 1:

The number and variety of FBOs visited gave a representative sample of the fish and seafood Spanish exporters that export to Canada. FBOs with a diversity in size, complexity and geographical locations were represented. This allowed the CFIA assessment team to draw an unbiased conclusion about how the national system is implemented.

Table 1: Summary of organizations the assessment team met with
Virtual meetings No. CA or location
National CAs 3 MAPA, MS and MC (AESAN)
Regional CAs (ACCAs) 2 Galicia and the Basque Country
Local CAs 3 A Coruña, Gipuzkoa, Pontevedra
Laboratories 1 The National Food Center (Centro Nacional Alimentación; CNA)
FBOs 3 Galicia and the Basque Country

3. Legal basis for the audit

This assessment was carried out in agreement with the Spanish CAs and under the Safe Food for Canadians Act and Regulations and Food and Drugs Act and Regulations.

4. Background

With a total land area of 506,030 km2 and a coastline of almost 8,000 km, Spain's territory is largely located on the Iberian Peninsula. It also includes:

Spain has the largest fishing industry among the EU Member States. Its fishing fleet has 8,884 vessels that fish in international, EU and national Spanish waters. They make up one quarter of the European fishing fleet.

The majority of Spain's fisheries activities occur in the coastal regions. Spain enjoys entry points into both the Atlantic Ocean and the Mediterranean Sea. Both waters offer good conditions for marine and freshwater aquaculture. The autonomous area of Galicia produces 90% of Spain's shellfish. Spain's fishing industry has preserved age-old historical marine traditions, such as the role of fishermen's guilds ("cofradías") and their federations.

Spain is the largest producer of fish in the EU by volume and value. They export roughly 1.98 million tonnes of fish and seafood per year. Most of this goes to other EU countries (70%). The rest is exported to third-countries. 249 fish and seafood FBOs are registered by Spanish CAs.

Spain is also the largest consumer market in the EU for fresh fisheries and aquaculture products. They import roughly 2.2 million tons of fish and seafood per year. Fish and seafood products make up 23.5% of Spain's total food related imports (second by volume after fruit imports). While most imports come from third-country sources (58%), a significant amount come from other EU Member States (42%). Canada supplied 656 of the 47,05  consignments of fish and seafood products imported by Spain in 2020.

The country is divided up into 17 autonomous areas and 2 autonomous cities (Melilla and Ceuta). These will all be called Autonomous Communities (AC) for the purposes of this report. In turn, the ACs are divided into provinces and municipalities. All organizational levels have critical responsibilities in ensuring fish and seafood safety.

5. Observations

The following sections summarize the information collected during the assessment.

5.1 Regulatory foundation

The legal framework for fish and seafood food safety in Spain is established by EU and national legislative instruments, including:

  1. EU regulations and directives
  2. Spanish national (state) instruments
    • a. Spanish Constitution
    • b. Spanish Royal Decrees
    • c. Spanish Laws
  3. Spanish regional instruments
    • a. Spanish regional ministerial orders

The EU legislative instruments give the legal foundation for the minimum food safety measures that must be implemented in all Member States. Spain's national legal instruments give the authority to enforce the EU laws. Finally, regional legal instruments convey the powers to carry out and enforce the requirements at the practical level. For instance, through the delivery of the MANCP.

The Spanish MANCP is known as the National Plan for the Official Control of the Food Chain (Plan Nacional de Control Oficial de la Cadena Alimentaria; PNCOCA) in Spain. A comprehensive list of Spain's national and regional food safety legal instruments can be found in the PNCOCA (2016-2020) (Spanish only – PDF (80 mb). This includes instruments that were in force during the time the 2016-2020 PNCOCOA was implemented. But some may have since been replaced.

Some of the key instruments that govern the safety of Spanish fish and seafood products are summarized in Table 2.

Table 2: Key legal instruments that govern the safety of fish and seafood products in Spain
Organization level Legal instrument Description or highlight
EU regulations and directives Regulation (EC) No. 178/2002 General food law and food safety procedures.
Regulation (EU) 2017/625

Principle regulation for the official control of food safety systems.

Articles 109 to 111:

Establish the need for the PNCOCA and its contents.

Regulation (EC) No. 852/2004 Requires FBOs to carry out a self-control system based on Hazard Analysis Critical Control Points (HACCP).
Regulation (EC) No. 853/2004 Specific hygiene rules for food.
Regulation (EC) No. 854/2004 Organization of official controls on food of animal origin.
Spanish national instruments Spanish Constitution (Spanish only)

Article 148:

Gives regional ACCAs powers to create and carry out their own legal instruments.

Royal Decree 19/2014 (Spanish only)

Food safety controls at the food establishment and production level.

Article 16:

Food alert networks, risk management, consumer defense and legal actions.

Royal Decree 66/2015 (Spanish only)

Article 10:

Roles, responsibilities and powers of inspectors in their duty to apply the measures outlined in Law 12/2013.

Royal Decree 1945/1983 (Spanish only)

Articles 13, 15 and 19:

Gives ACCAs the authority to take added measures to protect public health.

Describes the actions that can be taken during an inspection.

Spanish Law 17/2011 (Spanish only) Food safety and nutrition law for food and feed.
Spanish regional instruments Ministerial Order APA/524/2019 (Spanish only)

Bivalve mollusc and other marine invertebrate's production area list for the Spanish coast.

Updated every 2 years.

EU regulations and directives

The EU regulations give the overarching legal authority for food safety in Spain. They are a common national requirement for fish and seafood products at all stages of production, processing and distribution.

For instance, Regulation (EC) No. 178/2002 establishes:

The principle regulation for the official control of Spain's fish and seafood food safety system is Regulation (EU) 2017/625 (March 15, 2017). This regulation is the foundation for food safety requirements such as:

The main EU regulations for hygiene and the official controls for fish and seafood products at the time of the 2016-2020 PNCOCA were Regulation (EC) Nos.:

In particular, Regulation (EC) No. 852/2004 requires that FBOs have a HACCP based self-control system in place.

For a list of key EU legal instruments involved in this virtual assessment, see Annex 2 – Table 1.

Spanish national (state) instruments

Spain's national instruments give the authority to enforce the EU laws. They also give the authority for the ACs to make their own laws for the implementation of EU law at the practical level.

The Spanish Constitution is the highest legal basis for the national and regional laws. It gives rise to Royal Decrees (Legislative Royal Decrees and Royal Decrees) and Laws.

Some of the main food safety points in the Spanish Constitution include:

Royal Decree 1945/1983 Articles 13, 15 and 19 gives ACCAs the power to:

Spanish Law 17/2011 is the main national food safety and nutrition law that applies to food and feed. It establishes:

For a list of key Spanish national legal instruments involved in fish and seafood food safety, see Annex 2 – Table 2.

Regional level

The regional legal instruments are based on Spanish national level legal instruments. Each of the 19 ACCAs can develop, apply and carry out their own regional food safety laws. This is done to ensure the implementation and enforcement of the legal requirements established by the EU and by Spain. The local city level also has some regulatory autonomy (for example, mayoral decisions).

Regional level legal instruments may differ slightly from region to region. Their targets and results should be the same. Regional control plans are reviewed nationally by AESAN to check that they don't conflict with EU or Spanish legal instruments. In the case of conflict, national legal instruments are the default. The ACCAs are responsible for auditing their own regional control plans.

Some examples of Spanish regional legal instruments involved in fish and seafood food safety are listed in Annex 2 – Table 3.

Conclusion

Spain's legal framework consists of EU-level requirements and a series of national and regional legal instruments that give the authority to enforce them. These instruments outline the basic food safety requirements and responsibilities of FBOs. They also give powers to inspectors. Powers include; to take and analyze samples, take compliance and enforcement actions, and to implement a national system of official controls (PNCOCA).

5.2 Roles and responsibilities

Spain's legal architecture empowers 3 main levels of governments to regulate food safety, including:

  1. EU level
  2. National (state) level
  3. Regional level

Some of their key roles and responsibilities are described here.

5.2.1 EU

As described above, the EU establishes the basic legal framework which must be implemented in the Member States. The EU's European Commission:

These roles will be discussed in the following sections.

5.2.2 National (state) roles and responsibilities

In general, the national level CAs are:

The 3 main national ministries responsible for the food safety of fish and seafood products in Spain are:

At the most basic level, MAPA is responsible for primary production. MS and MC have shared responsibilities for food safety after primary production. Of particular importance, MC (through AESAN) provides an overarching coordinating function as the organization responsible for the PNCOCA.

Besides MAPA, MS and MC, many other organizations have roles in the food safety of fish and seafood products. Some of them are outlined in this report.

5.2.2.1 Ministry of Agriculture, Fisheries and Food (MAPA)

Royal Decree 2/2020 (January 12, 2020) restructured Spain's ministerial departments and created MAPA (among others). As introduced above, MAPA handles all aspects related to primary production, including:

This includes the coordination and reporting on the aspects of the national official control system that relate to these activities. MAPA also establishes the national legal foundation for the regional food safety official controls on primary production.

MAPA's General Sub-directorate for Sanitary Agreements and Border Control manages all food that crosses the Spanish border. They are responsible for:

MAPA's General Secretariat of Fisheries is responsible for the control of bivalve mollusc production, including:

JACUMAR

Created by the Spanish Law of Marine Cultures 23/1984, JACUMAR is Spain's main aquaculture control body. JACUMAR:

5.2.2.2 Ministry of Health (MS)

In January 2020 (Royal Decree 2/2020), the Ministry of Health, Consumer Affairs and Social Welfare was replaced by the MS and MC. MS is responsible (through the Member States' General Sub-Directorate for Foreign Health) for the verification of food safety controls:

5.2.2.3 Ministry of Consumer Affairs (MC)

The MC's key areas of responsibility and the organizations responsible for them include:

AESAN

As part of the restructuring in 2020, AESAN became part of the newly created MC. As required by Regulation (EU) 2017/625 Article 109, a single body must be assigned to manage the MANCP (in Spain's case, the PNCOCA). In Spain, AESAN is tasked with this responsibility. In fulfilling this requirement, AESAN coordinates the development, implementation and reporting of the PNCOCA with the ACCAs, MAPA and MS. AESAN is the contact point with the European Commission. This is for the purposes of reporting and ensuring consistency of delivery of the official controls across the ACs.

With respect to food safety, AESAN controls:

5.2.3 Regional roles and responsibilities

In general, the ACs are responsible for the implementation of the official controls established in the national control plan (PNCOCA). The ACs have the authority to organize their own institutions of self-government (that is, the ACCAs) to enable them to carry out the plans. In most cases, the structure of the ACCA's mirrors that of the national-level ministries. For instance, the ACs tend to have regional:

Other CA organizations exist in some ACs. For example, the Ministry of the Sea in Galicia.

The ACCAs are responsible for the safety of fish and seafood products produced in their borders, including:

Also, the ACCAs are responsible for the implementation of the PNCOCA in their regions.

Galician CA roles and responsibilities

During the assessment, information was collected from the Galician provinces of Pontevedra and A Coruña. The information highlighted the roles and responsibilities of the following Galician authorities:

INTECMAR

The Technological Institute for the Control of the Marine Environment of Galicia (Instituto Tecnolóxico Para o Control do Medio Mariño de Galicia; INTECMAR (Spanish only)) contributes to the protection and improvement of the aquaculture marine environments of Galicia's coastal waters.

INTECMAR manages issues about marine biotoxins, microbiological and chemical contaminants. They also share sampling vessels with the Spanish Institute of Oceanography. INTECMAR collaborates with the Department of the Sea and fisherman's guilds for bivalve mollusc sampling.

Basque Country CA roles and responsibilities

Information collected from the Basque Country province of Gipuzkoa highlighted the following roles and responsibilities of the following authorities:

5.2.4 Coordination of roles and responsibilities

As described above, the responsibilities for fish and seafood safety are shared across multiple ministries and levels of government. Coordination between national and regional (AC) levels is key to the integrity and consistent implementation of the system of controls. Within Spain, this is achieved at the highest level through the work of various coordination bodies including:

Also, as the national lead for the PNCOCA, AESAN chairs the Institutional Committee. The Committee approves the PNCOCA and serves to further coordinate the implementation of the system. The Committee includes Directors General of the various national, regional (AC) and sectorial institutions involved in the system of controls.

Consistency in the implementation of the national system of controls is further enhanced through:

Other aspects of national coordination are described further in the PNCOCA.

Conclusion

The national, regional and local organizations responsible for fish and seafood safety have well-defined roles and responsibilities. Spain has implemented mechanisms to ensure multiple levels of coordination: region to region, region to national level, and nationally between the ministries responsible for fish and seafood safety.

5.3 Program resources

As described earlier, several organizations at the national, regional and local levels work together. They design and carry out the system of food safety controls. This ensures that EU requirements are met through the delivery of the PNCOCA, which is the national Spanish control plan for all food. The PNCOCA includes programs about public health, quality, animal welfare, food fraud and the delivery of the program itself.

In 2019, about 14,176 staff worked to support the entire Spanish system of official controls. Of those who had public health responsibilities, 646 staff worked at the national level and 6,642 at the regional (AC) level.

Staff involved in food safety at the national level:

Total ACCA staff involved in food safety at the regional level:

Note: This represented a decrease of 138 staff compared to 2018.

For the regional authorities visited, the Basque Country Ministry of Health employs:

The Galician regional Department of Health ("Xunta de Galicia", "Consellería de Sanidade") has 240 staff, including:

Their general organizational structure consists of central services, zone leaders and inspectors in the areas.

It is difficult to figure the budget allocated specifically to fish and seafood safety. This is because of the shared responsibilities of various Spanish departments and their organizational scheme. Within MAPA, about €68,414,000 was assigned to the General Secretariat of Fisheries in 2019. AESAN received funds totaling €10.5 M to directly or indirectly support:

Added funding was given to the Ministry for Ecological Transition and Demographic Challenge (responsible for the control of marine affairs, water quality and coastal surveillance), the Ministry of Defense (responsible for marine patrol and intervention), and the 17 ACs (to support their inspection tasks and the regional laboratories).

5.3.1 Training

EU-level training

National and regional staff involved in the delivery of the official controls attend the European Commission developed Better Training for Safer Foods (BTSF) program. It was developed following Regulation (EU) 2017/625 (Article 130). The BTSF program offers a standardized and consistent approach to the verification of compliance with:

BTSF is also a mechanism to ensure that Member States are up to date with any changes to EU requirements. Staff who have finished the BTSF program should share the information received during the training with their immediate department. In 2019, the MS delivered 23 BTSF workshops attended by 197 participants.

National training

Article 5 of Regulation (EU) 2017/625 requires CAs to develop and carry out training programs. The programs ensure that staff are trained and qualified to efficiently and effectively do the official controls and other official activities. The training topics required for those who conduct official controls and duties are outlined in Regulation (EU) 2017/625 (Annex II, Chapters I and II). Similarly, Spanish Law 17/2011 (Chapter IV, Article 28) requires a certain level of training for public administrations. Public administrations should guarantee that all staff in charge of carrying out official controls receive adequate on-going training. This enables staff to carry out their jobs in an able and consistent manner.

In Spain, AESAN decides the national level training needs. The needs are based on their evaluation of the information provided by the regional CAs through the annual reporting process. The training activities are then integrated into the PNCOCA plan for the following year. MAPA and the MS work with the ACs to develop plans to ensure the delivery of the training needs identified. The ACs also set up and carry out their own training programs based on areas of interest, knowledge requirements of staff and identified needs.The planned training is presented in the PNCOCA and the training delivered is documented in the PNCOCA's annual reports. In 2019, there were 49 national training courses delivered and attended by more than 1,000 participants.

Veterinarians with a degree from 1 of the 12 Spanish veterinary schools, or an equivalent foreign degree, can apply to be an inspector. Before the applicants can be appointed as an inspector, they must also pass a comprehensive examination on:

This is following the Regulation (EU) 2017/625 (Articles 44 and 49). It requires the official inspection of products of animal origin to be carried out by official veterinarians.

Auxiliary inspectors must be accompanied by official veterinarian in carrying out tasks related to the OCs as per Regulation (EU) 2017/625, Articles 17 (a)(b).

The assessment team was informed that of the 867 staff who work in public laboratories, 47.4% are university graduates and 15.7% have some level of university education.

Auditors who conduct internal audits (supervision of inspectors, see section 5.5.6.2 'Supervision of inspectors') are subject to a graduated training program. Besides completing the basic training required to be an inspector, auditors must do a certain number of hours of audit training and meet minimum requirements for experience. For example:

Auditors sign commitment letters on confidentiality and impartiality. To avoid conflicts of interest, auditors should not audit systems which they inspect or otherwise oversee.

Regional training

Both ACs assessed by CFIA have implemented programs for continuous training. The Basque Country Department of Public Health develops their annual training plan based on gaps identified by their Knowledge Management Program. The Basque Country ACCA also has a mentoring program to transfer competencies to new staff.

The Galician Department of Health conducts training in a 5-year cycle that aligns with the PNCOCA. For the 2016-2020 cycle, about 1,470 inspection staff participated in training on HACCP, microbiology, labelling, thermal processing, exports, and other areas. These were delivered by 2 public agencies in Galicia: Axencia de Coñecemento en Saúde (ACIS) and Escola Galega de Administracion Publica (EGAP).

The 2019 EU audit has a recommendation to strengthen HACCP analysis and controls. In response, the Basque Country offered audit training to their public health technicians in 2020. The Galician Department of Health conducts HACCP training almost every year.

In 2019, a total of 447 regional training programs were delivered and attended by 8,000 participants.

FBOs

Generally speaking, the 3 FBOs met with during the assessment were knowledgeable on the EU requirements and HACCP principles. The assessment team was advised that all 3 FBOs had annual training plans. These weren't reviewed during the assessment.

Transparency, confidentiality and impartiality of civil servants

The general obligations for the impartiality and confidentiality of the CAs involved in the system of official controls are described in Regulation (EU) 2017/625 Articles 5 and 8, respectively.

Legislative Royal Decree 5/2015 (Articles 52, 53 and 54) sets the code of conduct for public administration employees in the state, AC and local levels. It requires public employees to carry out their duties in observance of the Constitution and other legal provisions.

Several other legal instruments strengthen the requirements for public employees, including:

Conclusion

The CAs involved in the delivery of the system of official controls appear to have resources to support the country's food safety program for fish and seafood.

The European Commission sets the minimum training requirements for inspectors. They are further developed by Spain. Training programs for the CAs who carry out the official controls at the national, regional and local levels are established in the PNCOCA. This includes training on EU, national and technical requirements.

The 3 FBOs observed were generally knowledgeable on EU requirements and HACCP principles.

Legal requirements for confidentiality, impartiality and transparency must be upheld by those involved in the design and delivery of the system of official controls.

5.4 Industry, community and international relations

AESAN

As described earlier, AESAN is Spain's contact point with the European Commission and Member States. AESAN is also the focal point within Spain for all official control systems.

AESAN is the national contact point for the national alert network; the Coordinated System for Rapid Information Exchange (Sistema Coordinado de Intercambio Rápido de Información; SCIRI (Spanish only)). They are also the contact point for the EU's RASFF and the World Health Organization's International Food Safety Authorities Network (INFOSAN).

AESAN's website has information about food safety alerts, their laboratory network and the PNCOCA. Notably the PNCOCA's annual report, residue limits and information on industry procedures. Using social media, AESAN also actively notifies associations affected by food safety issues. For example, allergy associations.

ACCAs

ACCAs also offer information on food safety, such as alerts, via their websites. In the case of Galicia, their website also includes:

Also in Galicia, INTECMAR was created in 1992 to promote compliance with laws on quality of molluscs and marine organisms. INTECMAR conducts research and contributes to the protection of the marine environment. They respond to issues within their mandate, including marine biotoxins and microbiological and chemical contaminants. INTECMAR posts the status of MPZs on their website (Spanish only).

INTECMAR sends information to the relevant regional departments and aquaculture and shellfishing organizations. For example, fishermen's associations, producers' organizations and professional associations. Other information, including bioassay results for any given day, can be obtained using their Wireless Application Protocol technology.

Industry

The fisherman's guilds and their federations have a historical and traditional role in securing fishing rights. The current focus of the fisherman's guilds is mostly on fisheries management. The fishing wardens also conduct patrols of shellfish harvest zones to ensure harvesting isn't conducted in closed areas.

Conclusion

AESAN coordinates and shares annual reports on the PNCOCA with the EU. AESAN is also the main contact for both international (RASFF, INFOSAN) and national (SCIRI) alerts. ACCAs also offer information on food safety via their websites. Industry and consumers can access a variety of information on fish and seafood safety through the websites of the key organizations responsible.

5.5 The national food safety control program

Regulation (EC) No. 178/2002 requires Member States to keep a system of official controls and to conduct food safety surveillance activities. Regulation (EU) 2017/625 (Article 109) requires each Member State to implement a MANCP (PNCOCA in Spain) to ensure that European Commission regulations are implemented effectively. Regulation (EU) 2017/625 (Article 77) says that the MANCP (PNCOCA in Spain) should be coordinated by a single body (in Spain AESAN has this responsibility). Also, Regulation (EU) 2017/625 (Article 9) requires CAs to conduct official controls on all FBOs with a proper frequency based on risk.

5.5.1 The national control plan (PNCOCA)

The PNCOCA describes the system of official controls to be implemented by the national, regional and local authorities to ensure compliance with EU legislation. This includes: measures of public health, quality, animal welfare and the delivery of the plan itself. The plan is the basis of inspection and audit programs. It outlines the:

The PNCOCA is a 5-year plan which aligns with high-level and strategic goals. The official controls are categorized and prioritized based on risk. The general plans are publicly available (Spanish only). The Computer Application for the Management of Food Alerts and Official Control (Aplicación Informática para la Gestión de Alertas Alimentarias y Control Oficial; ALCON (Spanish only)) manages the coordination of official controls at the national level.

AESAN coordinates the development of the plan with the national and regional governments. The national and regional governments are in turn responsible for the implementation and reporting on their respective area(s) of responsibility in the PNCOCA. The ACCAs in turn develop detailed procedures to implement the official controls in their regions. A guide has been produced to aid the partners in implementing the plan in a consistent way. The ACCAs the assessment team met with have also developed procedures to support the implementation of their respective plans.

As per Regulation (EU) 2017/625 (Article 111), the PNCOCA is reviewed and updated annually to incorporate:

For instance, the 2016-2020 PNCOCA was updated to reflect the creation of the MC and MS in 2020. The 2021-2025 plan highlights their new responsibilities.

The results of each program are evaluated annually against performance criteria to decide how effective they are. Plans for the subsequent year(s) are adapted based on the results. Spain has also implemented a process to verify the effectiveness of the multi-year plan against the strategic goals in years 3 and 5 of the cycle.

AESAN submits annual reports on the delivery of the plan to the European Commission as required by Regulation (EU) 2017/625 (Article 113). Regulation (EU) 2019/723 (May 2, 2019) sets the standard format and content for the annual report.

Implementation of the PNCOCA

The PNCOCA provides the general requirements for the official control programs. For example, the general instructions to carry out proper official controls according to a risk-based schedule. It also outlines areas of focus in a series of themes and related programs. This includes measures to take in response to a NC, and indicators with which to check compliance. The ACs develop detailed implementation plans that align with the national plan. In doing so, ACs name the foods and hazards to sample in their respective regions based on:

In developing their detailed implementation plans, ACs prioritize the risks using a computer-based matrix that considers factors such as:

Highlights of the 2021-2025 PNCOCA

The 2021-2025 PNCOCA (Spanish only) was in place at the time of the assessment. In this version, the programs are more closely in line with Spain's high-level and strategic goals. These include reducing the risks to health associated with food and strengthening the program of official controls. The 2021-2025 PNCOCA also focuses on increasing industry compliance and the prevention of food fraud.

In the 2021-2025 PNCOCA, the programs of particular interest to fish and seafood include:

The 2021-2025 PNCOCA also elaborates the procedures for the verification of whether or not the controls are effective – as required by Regulation (EU) 2017/625 (Article 5).

Samples taken under the PNCOCA

All samples taken under the PNCOCA plans are referred to as official control (that is, official) samples. They are typically taken by the local ACCA inspectors. A guidance document for microbiological testing of food products is available to support Regulation (EC) 882/2004 Footnote 1. Procedures have also been developed at the regional level.

As a Member State of the EU, all foods in Spain must follow the microbiological criteria established in Commission Regulation (EC) No. 2073/2005. For fish and seafood products, the pathogens of primary concern include:

Added parameters could be relevant as a result of a risk assessment, history of issues, etc.

Commission Regulations (EC) No. 1881/2006 outlines the methods for sampling and analysis. It also outlines the acceptability criteria for lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs.

Conclusion

Spain has implemented a 5-year national control program (that is, the PNCOCA) to ensure that EU food safety requirements are met for all foods. From this framework, the ACs develop and deliver their own risk-prioritized official control plans.

The PNCOCA results are summarized in annual reports that are provided to the EU. Plans are routinely reviewed and adjusted as needed. Changes to the plan can come from: results obtained, any changes to the EU, national or regional legislation, and new emerging health risks scientific information.

5.5.2 General requirements

The foundational system requirements for those involved in the harvest, production, import and export of fish and seafood are dictated by the EU, MAPA and MS. These requirements are described below.

Registration of entities involved in primary production

Spain's General State Administration manages the Census of the Operative Fishing Fleet. The Census tracks the activities of all Spanish flagged fishing vessels. Vessels not registered with the Census of the Operative Fishing Fleet can't undertake fishing activities.

The Spanish Constitution (Article 148.1.11) gives the ACs authority over shellfish harvesting and aquaculture. The role of the national government is limited to coordinating and supporting the activities of the ACs. The list of MPZs is kept in the State Agency Official State Gazette: Ministerial Order APA/524/2019. The list of MPZs is updated every 2 years.

Although aquaculture harvesting areas are registered by the ACCAs, they are then authorised by MAPA – as required by Council Directive 2006/88/EC (Article 6). They appear in the General Registration of Livestock Farms (Registro General de Explotaciones Ganaderas; REGA) and are then listed in 2 registries managed by MAPA. The 2 MAPA registries are:

Entities listed in SITRAN are considered to be "authorized" by Spain, as per Council Directive 2006/88/EC (Article 4), and are eligible to trade within the EU.

Registration of FBOs

FBOs are required to be registered by the CA as per:

This includes dispatchers, purification centres, processing and packing FBOs, wholesale markets and auction halls. The FBOs are listed in Spain's national registry – the General Health Registration of Food and Food Establishments (Registo General Sanitario de Empresas Alimentarias y Alimentos; RGSEAA (Spanish only)). RGSEAA is managed by AESAN with technical support from the ACCAs. The registry has information about the FBO and the types of food and processes involved. The registry is publicly available.

To become registered, FBOs submit a request to their regional CA (that is, ACCA). The ACCA then inspects them to confirm that food safety requirements are in place. If the inspection is acceptable, the ACCA sends the application to AESAN. AESAN issues a certificate with a national Sanitary Registration Number.

FBOs are required to inform their ACCA of any changes to their operation. This includes adding and removing processes or products. Any such changes require the FBO's registration to be updated. The assessment team observed that this was being done consistently at the FBOs visited.

Approval of FBOs

FBOs that handle foods of animal origin must also be approved by the CA as per Regulation (EC) No. 853/2004 (Article 4 (2)). The RGSEAA is recognised by the EU as the list of Spanish FBOs that are authorized to market products within the EU and to third-countries. This is as per 2006/88/EC, Article 3 (f). The sanitary registration number must appear on the label of products produced by these FBOs.

HACCP

Regulation (EC) No. 852/2004 (Article 5) requires FBOs to carry out and support procedures based on HACCP, except in the case of primary production. In reality, this exception also applies to:

The above mentioned FBOs are required to carry out pre-requisites or Good Hygiene Practices (GHPs) or both. All FBOs met with during the assessment had implemented HACCP plans.

FBOs are ranked according to HACCP rating schemes that are established by the ACCAs. The FBO's rating influences the frequency of inspections and HACCP audits. In the least, audits of each FBO are conducted once every 5 years.

The assessment team observed 2 different approaches to determining HACCP ratings. While both ACCAs the assessment team worked with use a basic risk formula to decide overall risk (see Figure 1), the mechanics behind the formula differ.

Figure 1: Basic risk formula

Generic (inherent) risk + Specific risk = Total risk

On one hand, Galicia's scoring system assigns a total of 5 points to each the generic (inherent) risk and the specific risk. This results in a total score of 10 with a 4-level rating scheme. On the other hand, the approach used by the Basque Country involves a 5-level rating scheme with different minimum inspection and audit frequencies (see Figures 2a and 2b).

Figure 2a: Rating schemes in place in Galicia and the associated inspection and audit frequency (at the time of the assessment)
Risk level Inspection frequency Audit frequency
Minimum Every 5 years Every 5 years
Low Every 3 years Every 5 years
Medium Every year Every 5 years
High Every 6 months Every 2 years
Figure 2b: Rating schemes in place in the Basque Country and the associated inspection and audit frequency (at the time of the assessment)
Risk level Inspection frequency Audit frequency
A (Very low) Every 5 years Every 5 years
B (Low) Every 2 and 5 years Every 3 years
C (Medium) Every 18 months Every 26 months
D (High) Every 9 months Every 18 months
E (Very high) Every 5 months Every year

The fact that different rating schemes are in place may create difficulties in identifying problems, trends and solutions on a national level. The assessment team was informed that AESAN formed a working group to establish a common rating system across all regions. The 'Guidance Document for the classification of food establishments based on risk in the framework of PNCOCA 2021-2025' was created to help the adoption of the common rating system across the regions. It was approved by Spain's Institutional Commission on December 16, 2020.

The new national scheme has 4 levels and is a blended approach of those observed during the assessment where:

The scores of all the factors are tallied to decide the overall rating: from 1 (high) to 4 (very low). From here, the minimum frequency of official controls will be decided. A common approach to classifying FBOs will better enable Spain to find trends in industry non-compliance (NC) at a national level. This will inform the PNCOCA which guides the deployment of resources and efforts where they are most needed. It will also lend consistency and structure to the requirement for CAs to routinely carry out official controls with a frequency that is suited to the risk. This is as per Regulation (EU) 2017/625 (Article 9).

Added FBO requirements

FBOs are required by Regulation (EU) 2017/625 to carry out appropriate sampling and analysis plans. They also carry out corrective action procedures as part of their overall systems of controls. In doing so, they need to meet the limits established in Commission Regulation (EC) No. 2073/2005 and Commission Regulations (EC) No. 1881/2006. This is outlined in section 5.5.1 'The national control plan (PNCOCA)'.

FBOs are also obliged to inform their CA of any issues that could impact public health, such as NC results from samples taken and process deviations.

Conclusion

Fish and seafood FBOs are required to be both registered and authorized. They are listed in a national registry, which is publicly available. The national registry is a critical tool in the delivery of the overall system of controls.

FBOs are ranked according to HACCP rating schemes that are established by the ACCAs. The FBO's rating influences the frequency of inspections and HACCP audits. The assessment team observed 2 different HACCP rating schemes being used. Each resulted in different inspection and HACCP audit frequencies. Spain is in the process of developing and implementing a common rating approach. This will bring consistency and structure to the process of conducting official controls with a frequency that is suited to the risk.

FBOs have added responsibilities with respect to the implementation of their system of controls. This includes sampling and testing, and informing local CAs of any issues that could impact public health.

5.5.3 Import controls

Any food product imported into the EU must meet, or be decided to be equivalent to, the requirements of European food law. This is as per Regulation (EC) No. 852/2004 (Article 1). Once these conditions have been confirmed and an imported food has been accepted into the EU, the food can move freely within the Member States without added oversight.

To decide acceptability, import consignments of fishery products are subject to a series of checks by the veterinary staff at the Border Control Posts including:

If all of the above checks are satisfactory, consignments are released for free circulation within the EU. If not, they are rejected and may be removed from the EU. They can be destroyed, reprocessed to make it safe for human consumption, or used for another purpose.

Conclusion

Any food product imported into the EU must meet, or be determined to be equivalent to, the requirements of European food law. Once confirmed and the imported food has been accepted into the EU, the food can move freely within the Member States without added oversight.

Spain has implemented a program to decide whether import consignments meet EU requirements. Consignments that don't meet EU requirements are rejected.

5.5.4 Export controls

All exporters of foods of animal origin are required to be registered with AESAN (the RGSEAA national registry) before they are eligible to export.

Before an export certificate can be requested, the exporter must first request to be registered in the Spanish online export information system (Comercio Exterior Ganadero; CEXGAN (Spanish only)). CEXGAN is administered by MAPA. It manages the export certification process for products of animal origin. The website has a public side where people can access export:

The list of establishments that are eligible to export is publically available in CEXGAN. Private access to CEXGAN is granted to Spanish inspectors for the online management of export certificates. Access to CEXGAN can also be established for CAs from importing countries to allow them to receive pre-notification of certificates.

All exports must be accompanied by an export certificate. Spanish Royal Decree 993/2014 establishes the procedures and requirements for official veterinary certificates for exports. The 2 types of export certificates are: generic and specific.

EU countries, and third-countries which recognize EU requirements as being equivalent, only need a generic export certificate. These generic certificates confirm that EU requirements have been met. This is the case with Canada (as a result of the Canada-European Union Comprehensive Economic and Trade Agreement; CETA).

On the other hand, export agreements with some third-countries, such as China and the UAE, contain added export requirements. These are managed by the Specific Self-Control System for Exports (Sistema de Autocontrol Especifico Para los Exportacion; SAE). In this case, FBOs must carry out processes to ensure that the added third-country requirements are confirmed. These self-control processes must be audited by an independent certifying body authorized by MAPA (Spanish only) and accredited by ENAC. MAPA also supervises how the inspectors apply the controls.

In effect, the registered exporter makes a request for an export certificate in CEXGAN. They verify the importing country requirements and provide the supporting information to show that the requirements are met. Inspectors verify the registration, authorization, traceability, and conducts physical controls if needed. The need to conduct physical controls is informed by factors such as:

These considerations are described in more detail in the 2021-2025 PNCOCA (Spanish only), along with the process of inspector oversight.

If all the requirements are met, the certificate containing a unique serial number, security paper, signatures, stamps and seals is issued electronically by the inspectors. The assessment team observed that both generic and specific export certificates were consistently being issued according to the protocols in place. The assessment team was advised that there has been an increase in the number of certificates being issued in 2021 because of BREXIT.

Ensuring Canadian import requirements are met

Products imported into Canada from Spain (and any country) must meet all the applicable food safety and consumer protection requirements outlined in the Safe Food for Canadians Regulations (SFCR). Canadian importers are responsible to verify that the products they import meet these requirements.

Although Spanish FBOs are only legally required to verify EU and Spanish requirements, the companies assessed had implemented processes to verify that Canadian requirements are met.

Precautionary measures

Royal Decree 993/2014 (Article 18) outlines the precautionary measures related to export certificates and the circumstances under which they may be imposed. Examples of these circumstances include:

Examples of precautionary measures from Royal Decree 993/2014 (Article 18) include:

134 such measures have been recorded since 2015, 37 of which were still open at the time of the assessment.

Conclusion

Spain requires all exports of foods of animal origin to be accompanied by an export certificate. To be eligible to request an export certificate, an FBO must first be registered in the online export certificate management system (CEXGAN).

There are 2 types of export certificates: generic and specific. Generic certificates confirm that EU requirements have been met. Specific export certificates verify that any additional export requirements from export agreements have been met. As a result of CETA, Canada only needs a generic export certificate.

Processes are in place to verify that the high-level requirements of the importing country are met. Legal authorities support the implementation of precautionary measures that can block export certificates from being issued where the requirements aren't being met.

5.5.5 Shellfish and aquaculture controls

Although Spain isn't authorized to ship live and raw shellfish to Canada, they can export processed shellfish products. Regulation (EC) No. 853/2004 sets the European Commission requirements for the harvesting and processing of molluscan shellfish and carnivorous gastropods, including:

Commission Regulation (EC) No. 2073/2005 sets out the microbiological acceptability criteria for raw molluscan shellfish. Chapter 5 of Regulation (EC) No. 853/2004 outlines the levels of marine biotoxins permitted in molluscan shellfish. The allowable limits for both bacterial pathogens and marine biotoxins set by the EU are comparable to Canada's.

As per Regulation (EC) No. 854/2004 (replaced by Regulation (EC) 2017/625), Spain classifies shellfish harvest areas into 3 health ratings ('A', 'B' and 'C'). The ratings are assigned according to the microbiological and biotoxin levels found in the raw shellfish. Shellfish from harvest area 'A' can be placed directly on the market – if they meet the required microbiological and biotoxin requirements. Product from 'B' areas must be treated at a purification center before being sold. And product from 'C' areas must undergo long term relaying before being sold.

Shellfish harvesters may only harvest from production areas with fixed locations and boundaries that the CA has classified under EU requirements. Processing FBOs, depuration centers, relay stations, and dispatch centers may only receive product if accompanied by a registration certificate that identifies the harvest location and licensed gatherer.

The risk of shellfish facilities buying product from closed areas and unlicensed fishers is mitigated by:

In Galicia, the Ministry of the Sea has an enforcement section that conducts patrols to prevent poaching in closed harvesting areas. Entities responsible for patrols in other ACs weren't described during the assessment.

The assessment team observed that Spain does not have a consistent national procedure to let industry know when shellfish harvest areas are open or closed. While some ACs have implemented an automatic notification system, others rely on the facilities to manually check information posted on CA websites. For instance, INTECMAR posts various reports on the status of MPZs in Galicia. While each system seems to work within the AC implemented in, there may be potential for confusion. For example, in the event a harvester is working in more than 1 AC, or if a shellfish facility is purchasing product from harvesters in more than 1 area.

Each AC is responsible to design and carry out their own shellfish and aquaculture control programs. This ensures that the overarching EU requirements are met. Harvest areas are only classified by microbiological and biotoxin levels. But the results of monitoring samples must meet the minimum frequency and acceptability criteria established by the EU. Monitoring samples are conducted for pathogens, biotoxins, phytoplankton, heavy metals and other chemical contaminants. Phytoplankton levels are an indicator of the possible presence of marine biotoxins.

The sampling and testing frequency is decided by each AC based on the risk at each individual harvest area. The sampling frequency for microbial parameters and biotoxins changes depending on the current risk conditions at each harvest site. But as per Regulation (EU) No. 2019/627 (Article 61), biotoxin samples must be collected weekly while harvest activity is ongoing. They can be increased when levels are observed to be rising and approaching an unacceptable level.

Oversight of MPZs is further enhanced through a monitoring program delivered under the PNCOCA. The product samples are taken from at least 5% of the licensed shellfish harvest areas annually. MAPA's 2019 annual report indicates that the 5% oversight level was met and exceeded. If these plans are implemented as written, they should satisfy Canadian requirements.

Controls for the reception of shellfish inputs should be described and implemented by FBOs in their HACCP programs. 1 FBO that processes raw molluscan shellfish into various canned products outlined the controls they carry out, including that:

Aquaculture controls

Each AC also sets their own control plans for aquatic animal health at aquaculture farms. The individual control plans must meet EU and national standards. Vaccines, antibiotics and antifungals are administered only under veterinary prescription. They must meet the withdrawal times and MRLs set by the EU. Manufacturers of fish feed used in licensed aquaculture facilities must also be licensed as per Regulation (EC) No. 178/2002. Each lot of feed produced is traceable:

In Galicia, primary production of farmed fish is overseen by the Ministry of the Sea. They were the only ACCA the assessment team interviewed about this topic during the assessment. Marine biologists from the Ministry of the Sea make weekly visits to fish farms to check for aquatic animal diseases. Any medication is prescribed by a veterinarian, with dosage and withdrawal times specified. 1 FBO interviewed by the assessment team confirmed the strict controls on veterinary drug usage, withdrawal times, and MRL testing. They also confirmed all veterinarians are externally contracted and not direct employees of the aquaculture farm.

Under the Spanish Constitution, aquaculture is a responsibility of the ACs. The Spanish Law of Marine Cultures 23/1984 created the JACUMAR. As described earlier, JACUMAR coordinates with the ACCAs to:

JACUMAR offers a series of guidance papers to the ACCAs and industry to support the safe production of aquaculture fishery products.

Conclusion

In combination with licensing and traceability requirements, Spain has controls which should satisfy Canadian requirements if implemented as written. This includes robust chemical and microbiological sampling programs that support a clearly-defined harvest area monitoring and classification system.

Spain has not implemented a consistent national procedure to let industry know when shellfish harvest areas are open or closed. Added controls for shellfish inputs were observed to be conducted by 1 processing FBO.

5.5.6 Oversight of the system of official controls

The system of official controls is subject to multiple levels of oversight and evaluation. Including the:

These are anchored in requirements such as Regulation (EU) 2017/625:

The PNCOCA outlines the oversight of Spain's system of official controls, including:

An overview of some of these measures is presented in the following sections.

The European Commission audits Spain as part of their Health and Food Audits and Analysis program. This offers an opportunity to identify added improvements to the official control system while ensuring that EU requirements are being met.

In discussions with the national CAs and ACCAs, CFIA noted on several occasions that the criteria for reporting delivery rates differed between ACs. These included: rates of inspection, audit and supervisory oversight, and compliance rates and NC type. Several national CA officials acknowledged that accurate national statistics are difficult to report on. This is due to the differences in reporting strategies. Spain indicated that efforts are underway to streamline and integrate the reporting processes.

5.5.6.1 Oversight of FBOs

The ACCAs are responsible for the direct oversight of FBOs. The PNCOCA divides the oversight of FBOs into 2 programs:

As mentioned in section 5.5.2 'General requirements', FBOs are ranked according to HACCP rating schemes established by the ACCAs. The FBO's rating influences the frequency of inspections and HACCP audits as shown in Figures 2a and 2b. In the least, audits of each FBO are conducted once every 5 years. Facility inspections are conducted according to the schedule decided by the ACCAs (see Figures 2a and 2b).

Each of the ACCAs the assessment team met with had an electronic system to store inspection and audit results. The electronic systems help in setting the risk ranking based on history, product and process information, and compliance. For at least 1 ACCA, the electronic system generates the inspection and audit tasks to be done with the proper frequency for the facilities risk ranking. All information received during the assessment indicated that each electronic system worked well on its own, but that the systems weren't able to interconnect.

Facility inspections

Program 1 of the PNCOCA establishes specific requirements and procedures for the inspection of FBOs (for all sectors and processing phases) including:

Inspections are unannounced in order for the inspectors to get an exact picture of the operating conditions at the FBO.

The ACCA officials interviewed indicated that the inspection frequency can range:

1 of the 3 FBOs the assessment team spoke with confirmed the inspection schedule was met. The third FBO could not make that confirmation. But, no documentation was provided to support those statements.

Facility representatives informed the assessment team that the same inspector can inspect and audit the same FBO for many years. 1 ACCA indicated that they had made changes to their procedures in 2020 to promote the rotation of inspectors. The other ACCA confirmed that there is no policy or procedure to promote the rotation of inspectors. In the case of the later ACCA, it was noted that the same inspector had inspected the same FBO for 15 years. This practice could create the potential for conflict of interest. An inspector who has not visited an FBO recently might see things that an inspector who visits routinely might not see.

HACCP audits

Program 2 of the PNCOCA establishes specific requirements and procedures for risk-based audits of hazard control plans in FBOs. They aim to ensure that plans implemented by the FBOs:

HACCP audits are often, but not always, conducted by the same inspectors who inspect the FBO. They are typically scheduled in advance to ensure that the quality assurance staff and the required documentation will be available. Both ACCAs, and the FBOs the assessment team met with, confirmed that facilities are notified a week in advance of audits. Depending on the risk and history, an audit may cover all aspects of the HACCP plan or, be more focused. The scope is decided by the inspector responsible.

The FBOs the assessment team met with were generally aware of the requirements of their AC. They were able to confirm their HACCP rating, inspection frequency, audit frequency and NC response times. 1 FBO stated their HACCP rating required an audit every 26 months, but almost 4 years had passed between their last 2 audits (May 2017 to March 2021). The assessment team was advised that the ACCA is aware of this issue and is taking steps to help ensure that targets can be met in the future (see section 5.5.2 'General requirements – HACCP').

1 FBO's HACCP plan allowed sealed cans of low acid canned food to be held at room temperature for up to 6 hours before they are thermally processed. This schedule is outside the norms for best practice. Issues about the delay in time between sealing and processing had also been made during a HACCP audit conducted by the ACCA in 2019. In that case, the auditor observed that the company's written procedure indicated a holding period of 3 or 4 hours depending on the product. These times had not been validated. Also, the procedure didn't indicate a maximum limit. The auditor pointed out that the scheduled time exceeded the norm of no more than 2 hours.

Corrective actions implemented by the FBO included a plan to validate a period of 3 or 4 hours depending on the product. Information provided to the assessment team didn't confirm whether:

Delivery of planned FBO oversight activities and determination of industry compliance

For facility inspections, NCs are classified into 3 types:

For HACCP audits, Spain's 'Guidance document for the classification of food establishments based on risk in the framework of PNCOCA 2021-2025' classifies NCs according to their severity:

Under Article 14 of Regulation (EC) No. 178/2002, inspectors have the authority to take preventative measures when they think that there may be a risk to human health. These preventative measures temporarily prevent the products from reaching the marketplace while the NC is investigated fully. The established time limits by which corrective actions must be implemented varied between the ACs, but are always related to the seriousness of the NC. Regulation (EU) 2017/625 (Article 138) sets out the measures that can be taken for a NC.

AESAN provided information about the inspections scheduled for 2020 showing an:

But, it is difficult to get reliable statistics on overall national compliance and delivery rates. This is due to the differences in how each ACCA reports on their:

Also, inspections of retail FBOs and other food businesses were included in those statistics. This means the 25% NC rate can't be linked exclusively to food processor FBOs.

Given the global public health challenges in 2020, it is understandable that CAs may have had difficulty meeting all the program delivery requirements. Nevertheless, a lack of consistent information gathering and submission criteria at the AC level make it more difficult to produce national compliance data. Spain advised that they are developing a set of harmonized risk criteria and HACCP ratings to improve consistency and transparency in the system. This should better enable Spain to find trends in industry NC at a national level.

5.5.6.2 Supervision of inspectors

Besides inspection and audit activities, the ACCAs conduct internal quality control ("supervision audits") to ensure that their inspectors are effectively implementing the inspection and audit program. There is no EU or national level regulation that makes this mandatory. Although, Regulation (EC) 2017/625 (Article 5) states that the CA shall ensure that inspectors are qualified to deliver the work that is prescribed to them. This requirement effectively prevents inspectors from being able to decline taking part in supervision activities.

Each ACCA sets the schedule and priorities for their supervision program. AESAN offers guidelines that can be implemented in each AC. The ACCAs from Galicia and the Basque Country stated that they set their annual priorities and supervision schedule by reviewing:

Both ACCAs conduct documentation reviews and on-site observations to evaluate staff performance. They conduct "supervision audits" of each of their inspectors on an annual basis. Although Galicia noted that inspectors from offices with more than 15 inspectors are subject to this supervision process every 2 years.

In making detailed plans for the implementation of the annual priorities set by the ACCA, auditors further prioritize their supervision activities. They consider:

Internal audit teams consist of:

Being part of the supervision team is voluntary, but audit team members can't audit FBOs they inspect or supervise.

5.5.6.3 Inspections of fishing vessels

Regulation (EC) No. 854/2004 (Annex III, Chapter 1) establishes the authority for EU Member States to inspect fishing vessels at regular intervals. It was replaced by Regulation (EC) 2017/625 (Article 18). This is to make sure that they are meeting the requirements for:

Since HACCP isn't required for entities involved in primary production, Good Manufacturing Practices and GHPs are considered to be appropriate.

Inspections of fishing vessels are required every 4 years. Spanish inspectors travel to the third-country port to deliver the inspections for:

In the case of vessels docked in another EU Member State, Spain can ask that other Member State to deliver the inspection on their behalf. In 2020, paper reviews were conducted due to the COVID-19 pandemic and travel restrictions.

The PNCOCA has requirements for monitoring primary production hygiene in extractive fisheries, including fishing vessels. The goal of oversight inspection for 5% of fishing vessels, to verify GHPs and record keeping, was met in 2020. The decision on which vessels are prioritized is based on risk criteria including:

Conclusion

Spain's system of official controls is subject to a comprehensive oversight framework. This includes the inspections of fishing vessels, the oversight of the controls implemented by FBOs, and the verification of the overall effectiveness of the controls. Some challenges were noted in meeting planned HACCP audit frequencies and in generating reliable statistics on the overall delivery of the program as well as industry NC.

5.6 Traceability

Regulation (EC) No. 178/2002 (Article 18) establishes the basic requirement for a traceability system to be in place for all stages of production, processing and distribution. In the least, FBOs must be able to trace forward and backward by 1 level.

FBOs are required to verify the effectiveness of their traceability programs by conducting mock recalls. The assessment team confirmed that this is an annual requirement, and that the FBOs the assessment team spoke to met this requirement.

The FBOs the assessment team spoke to were consistently able to prove:

1 FBO was further able to trace the fish they received back to the feed source used to raise them.

ACCAs verify traceability requirements during audits and when issuing export certificates. If there is an issue that could impact public health, a traceability report is generated. An example of a traceability report was given for 1 lot of cockles for export that was positive for biotoxins. A traceback found that the primary product had been harvested from an open harvest area. The FBO ceased processing pending more information. The harvest area was then closed but follow-up samples taken from it were normal. Other product on-site at the FBOs was also found to be positive and was destroyed. No other product was identified, therefore no recall was required and the case was closed.

MAPA's online system By-products of Animal Origin Not Destined for Human Consumption (Subproductos de Origen Animal No Destinados al Consumo Humano; SANDACH (Spanish only)) manages the requirements for animal by-products not intended for human consumption. For example, the registration of FBOs and the movement of by-products. This ensures the traceability of products like feed for aquaculture use.

The EU's online system TRACES further supports the traceability of:

Conclusion

EU regulations require FBOs to be able to trace back and trace forward at least one level. FBOs need to verify the effectiveness of their traceability programs annually by conducting mock recalls. The traceability processes in place at the FBOs visited were effective in meeting this requirement.

5.7 Compliance and enforcement

The EU establishes common requirements for all Member States with relation to food safety, animal health and traceability. The Spanish national government develops laws to enforce EU regulations and delegates the enforcement of those laws to the ACCAs. The ACCAs develop legislation to implement the EU and national laws on a practical basis.

Regulation (EC) No. 178/2002 ensures that Member States keep a system of official controls and other activities as appropriate to the circumstances, including:

Spanish Royal Decree 1945/1983 regulates infractions and sanctions in matters of consumer defense and agri-food production. It also establishes the authority of inspectors to:

Spanish Law 14/1986 further regulates infractions and NCs where public health may be affected. The ACCA gives sanctions and takes enforcement actions – except in the case of products that have been exported (MAPA would lead these cases).

When a NC is detected during an inspection or audit, on site ACCA inspectors can decide the right enforcement response. NCs observed during inspections are classified and managed as follows:

Type 1 NC (issues that can affect human health)

These are addressed through pre-cautionary measures, including the suspension of an FBO's production license until corrective actions are implemented and assessed. If the suspension goes longer than 6 months, the ACCA can revoke the production license and initiate disciplinary proceedings. Spain's 'Measures Adopted by the Competent Authorities in the Detection of Non-Compliance' aids the ACs in assessing NC in a consistent manner.

Type 2 NC (issues that don't have a direct impact on human health)

In this case, a time period is established to correct the issue. The issue is followed up at the next inspection.

For NCs observed during HACCP audits, enforcement actions are assigned and managed appropriately:

For any case where inspectors authorize enforcement actions, those actions are then reviewed by inspection supervisors. Inspectors have options on how to proceed when an inspection or HACCP audit identifies a NC that may affect public safety, including:

EU Members States have the authority and responsibility to remove unsafe food products from the marketplace. This authority is given by Regulation (EC) No. 178/2002 (Article  14) and Regulation (EC) 2017/625 (Article 138). The withdrawal of products deemed to have a human health risk is always mandatory. There is no option for an FBO to refuse the decision.

Conclusion

Spain's authority to take enforcement action comes from EU and national level requirements. Enforcement actions are taken according to the nature of the NC. The enforcement actions range from a recall, suspension or cancellation of FBO's licenses, to sanctions.

5.8 Outbreak investigation and alerts

As highlighted earlier, Spain has several processes in place to ensure the rapid notification of direct and indirect risks to health posed by food. Information flows across, up, and down all the levels of government as needed.

At the highest level, Spain is a member of INFOSAN. As a Member State of the EU, Spain is also a member of the RASFF. This is required by Regulation (EC) No. 178/2002 (Article 50).

At the national level, Spain's rapid alert system consists of the national network of alerts (SCIRI (Spanish only)). As per Law 17/2011 on Food Safety and Nutrition (Article 25), SCIRI's membership consists of:

AESAN is the national contact point for INFOSAN, SCIRI and RASFF. AESAN's ALCON (Spanish only) computer program manages the coordination of official controls at the national level. This includes notifications for both SCIRI and RASFF.

Within the SCIRI architecture, notifications are generally classified into 4 categories:

Alerts can be issued by the various national and regional members of the network, including MS, MAPA, and the MC (AESAN). In doing so, they aim to trigger a response that is appropriate to the issue like blocking an import or export, and conducting an investigation. Procedures and guides are available on the AESAN website to promote consistent implementation of the alert management system. AESAN also publishes annual reports of the network which include issues.

Risk assessments are typically conducted at the inspection level using the AC risk matrix/computer program. Unless the level of risk isn't clear or if an implicated food has been distributed to more than 1 AC. In this case, the ACCA assesses the situation and decides if added actions are required, like an alert to other ACs or countries.

AESAN also has a scientific committee which can offer advice. As the point of contact with the EU, if needed, they could seek input from EFSA for issues that might impact the EU more broadly.

An example of a 2019 histamine outbreak was shared with the assessment team. It showed how information quickly moved up the chain, through the local public health department, to trigger an investigation at the restaurant and at the manufacturer. The investigation concluded that temperature abuse at the restaurant caused the formation of histamine, resulting in illnesses. The restaurant was closed until corrective measures were implemented, and a disciplinary procedure was lodged against the restaurant. In this case, a recall wasn't warranted since the issue didn't implicate other product in distribution. The assessment team was advised that if other cans had been confirmed to contain histamines:

Conclusion

Spain has processes in place to ensure the rapid notification of direct and indirect risk to health posed by food. These processes include the international level (RASFF and INFOSAN) and the national level (SCIRI).

The alert process triggers responses including investigations, precautionary measures and disciplinary actions. The consistent implementation of the system of alerts is supported by a series of guides and protocols which are available on the AESAN website.

5.9 Laboratory controls

Organization

In the EU, food safety is supported by a network of laboratories, including:

Food Safety and Nutrition Law 17/2011 (Article 35) identifies the Spanish Network of Food Safety Laboratories (Red de Laboratorios de Seguridad Red de Laboratorios de Seguridad Alimentaria; RELSA (Spanish only)). It includes 8 EURLs, 14 NRLs, 74 public health OCLs and 93 animal health OCLs.

The EU laboratory networks are organized by theme. For example: food safety, marine biotoxins, feed, heavy metals in fish products, veterinary medicine residues, and viruses. There are 26 laboratory networks in the EU. Each network generally consists of a EURL, NRLs, and appointed OCLs. They work in a coordinated way as required by Regulation (EU) 2017/625 (Title III). Spain has 21 NRLs total: 20 NRLs under the CNA and 1 NRL under the Universitario de Vigo Laboratory.

EURLs:

Spain provides some EURL services. For example, the EURL for marine biotoxins in fish products located at the Citexvi Campus Universitario de Vigo.

NRLs are the contact point with the corresponding network EURL and with the OCLs. Regulation (EU) 2017/625 (Article 101) requires that NRLs:

NRLs are appointed by the Member State according to the requirements of Regulation (EU) 2017/625 (Article 100). AESAN's General Sub-directorate for the Promotion of Food Safety is responsible for 21 NRLs including:

OCLs conduct analyses of the samples that are taken under the national plan of official controls. They must use the official methods and performance criteria that are published in the EU Regulations. For example, Commission Regulation (EC) No. 2073/2005 on the microbiological criteria of food (ISO standards), and Commission Regulation (EU) No. 15/2011 for the detection of marine biotoxins in live bivalve molluscs.

The EU requires all network laboratories be accredited to ISO 17025. In Spain, accreditation is granted by the national accreditation body (Entidad Nacional de Acreditación; ENAC). ENAC is a member of the International Laboratory Accreditation Cooperation (ILAC).

RELSA

Laboratories in the network share a common database which is accessed through the RELSA computer program. It was created by AESAN to optimize resources and to ensure all of the CAs in the system of official controls have access to the information they need. It has a:

National Food Centre (CNA)

AESAN's CNA is the NRL for 20 of the 26 EU laboratory networks. Areas of focus include:

The CNA is also the administrator of the RELSA computer program.

Designation of OCLs

OCLs must be appointed in writing according to principles established in Regulation (EU) 2017/625 (Article 37). A standard operating procedure that has the technical criteria was developed by AESAN. It was developed in collaboration with all CAs, NRLs, and OCLs to guide the designation process. The most recent version of the Standard Operating Procedure for the designation of laboratories was approved on September 18, 2020. RELSA (Spanish only) isn't legally binding, but serves as a general agreement between all CAs and the laboratories.

OCLs must be designated for both the analyte and matrix, be accredited accordingly, and can be public or private. Public and private OCLs are both subject to the same oversight and controls, including audits by ENAC. The system of oversight is also managed in the RELSA computer program. For instance, the computer program pushes notifications when:

Conclusion

Spain has in place a comprehensive laboratory program that is designed to ensure coverage, as well as reliability and comparability, of results. It encompasses a national network of laboratories, which consists of EURLs, NRLs and OCLs. The RELSA computer program ensures that all users have access to the laboratory information they need to support their system of control functions.

6. Closing meeting

A virtual closing meeting was held on April 6, 2021. It was attended by:

The CFIA assessment team thanked MAPA for their efforts in coordinating and supporting the mission. The team also thanked all participants for their openness and transparency. The team presented an overview of their understanding of Spain's system of controls and their observations about its implementation. The team shared preliminary recommendations to further strengthen Spain's national food safety system. The team expressed support for Spain's ongoing efforts to:

An open discussion gave participants the opportunity to comment on the assessment team's observations and recommendations.

Representatives from MAPA, MS, MC (AESAN) acknowledged the team's observations and recommendations. They expressed their interest in future collaboration.

Overall, the virtual visit reinforced CFIA's understanding of Spain's system of controls and the good relations that CFIA has with Spain with respect to the safety of fish and seafood products exported to Canada.

7. Conclusions

Spain has in place a comprehensive food safety control system that encompasses all levels of production and trade in fish and seafood products. The system is fortified by EU, national and regional legislation. The system is implemented according to a national plan by able staff at the national, regional and local levels. It was generally observed to be implemented consistently in the 2 regions that were visited virtually.

As a result of this assessment, CFIA has established:

8. Recommendations

The following recommendations were made in response to the observations and findings documented during the assessment.

  1. Observation: The CFIA assessment team observed that the notification procedures used to inform industry when shellfish harvest areas are open or closed, differ between 2 ACs. While 1 AC has implemented an automatic notification system, the other had not. In this case, FBOs need to check information posted on the CA's website. They typically do this at the time of receipt.

    Recommendation: ACs that don't have a system to auto-notify FBOs and other stakeholders of the most current information on the status of MPZ could consider implementing one. If it is implemented, FBOs would no longer need to manually verify the MPZ status by looking at information posted on the AC's website in order to determine if they should accept or reject a product.

  2. Observation: 1 FBO's HACCP plan allowed for cans of low acid canned food to be held at room temperature for up to 6 hours before they are thermally processed.

    Recommendation: Exporters should generally ensure the effectiveness of their scheduled canning process. This includes the time that sealed cans of low acid canned foods are held at room temperature until the time they are thermally processed. Any deviations from best practices should be validated by a competent authority instead of relying on testing.

    Note: In Canada, the thermal processing requirements come from the Commercial sterilization of low-acid food in hermetically sealed containers: retort systems. With respect to the maximum lapse time:

    • a. "Generally, elapsed time should not exceed 1 hour unless
      • i. a longer time has been determined to be safe by an expert in thermal processing
      • ii. sealed product is held at temperatures that will not permit the growth of microorganisms that could impact on the safety of the process (that is, less than 4 °C or greater than 65 °C)
      • iii. the heat transfer characteristics of the product aren't affected
    • b. If the maximum lapse time is exceeded, treat this as a process deviation and hold the product for safety evaluation by an expert in thermal processing."

  3. Observation: The regions the assessment team met with have different approaches to counting how they deliver the written program in their region. This makes it challenging to report on the overall delivery of the program at the national level. Specifically, whether the inspection and audit targets established in the written program are being met.

    Recommendation: Develop and implement a strategy to enhance the ability of the CA to report on the delivery of the written program at the national level, particularly with respect to the inspection and audit targets established in the written program.

Annex 1: Summary of the Canadian Food Inspection Agency (CFIA) recommendations from the 2021 virtual assessment of Spain's food safety controls for fish and seafood

Recommendation 1

ACs that don't have a system to auto-notify FBOs and other stakeholders of the most current information on the status of MPZ could consider implementing one. If it is implemented, FBOs would no longer need to manually verify the MPZ status by looking at information posted on the AC's website in order to determine if they should accept or reject a product.

Spain's action plans / comments

November 29, 2021:

"After consulting the Autonomous Communities present at the audit, Galicia informed us that in their case, operators can consult the status of the production zones on the website of the Regional Department of the Sea and that the competent body for the control of production zones (INTECMAR) also notifies operators by e-mail of any changes in the situation of the zones."

April 29, 2022:

"The models for each Autonomous Community are described below:

País Vasco

The closures and openings of the mollusc extraction areas are communicated directly and immediately to Public Health, Directorate of Fisheries and Aquaculture and economic operator.

Galicia

Operators can consult the status of the production zones on the website of the Regional Department of the Sea and that the competent body for the control of production zones (INTECMAR) also notifies operators by e-mail of any changes in the situation of the zones. Public Health Services are also notified.

Asturias

When there is a precautionary closure, a resolution signed by the Director General is drafted and sent by e-mail to the growers and the nearby fishermen's associations, and of course also to the Ministry, the Government Delegation, the Guardia Civil and the Surveillance. It is not an automatic system, therefore.

There had been no plans to change the system, except perhaps to incorporate the closures and openings to the web page of the Directorate General of Maritime Fisheries of the Principality of Asturias.

In Asturias there is only one open area with farming, and very little shellfishing in the other open area. As there are very few cultivation companies, which communicate directly with the technicians of the DG Fisheries, no significant problems have arisen.

Cantabria

In Cantabria, when closures and/or openings occur due to marine biotoxins, there is an alarm system which consists of sending an e-mail to all the interested parties (shellfish sector, purification and/or dispatch centres, auctions, cooperatives, maritime service, town councils, etc.) with the resolution of closure and/or opening of the production area and the reason for it.

For temporary closures due to changes in the health status of mollusc production areas, a closure decision is published in the Official Gazette of Cantabria (BOC). Likewise, when the area is reopened due to compliance with the health and hygiene requirements, the corresponding opening resolution is published. In this case, the sector has to access the BOC page to see the resolution.

In the future, it is planned to use the communications and notifications system of the electronic headquarters of the Government of Cantabria for the communication of closures and openings of production areas due to changes in their health status. In this way, interested parties who are identified in the headquarters will be notified via the electronic notice board.

Andalucía

According to the control programme established in this Autonomous Community, the Territorial Delegations of this Regional Ministry of Agriculture, Livestock, Fisheries and Sustainable Development have the following powers in the production areas located in their province:

These actions are carried out by means of a Resolution that is automatically published on the Regional Ministry's website, the legal status of which can be consulted at the following link by all interested parties and the general public:

Zonas de Producción de Moluscos Bivalvos y otros Invertebrados Marinos (Spanish only).

In addition, a system of communication by SMS was established to automatically inform shellfish gatherers, so that they know the legal situation of the production areas they intend to visit for shellfishing, prior to departure, with a form available to request the service in each of the Territorial Delegations and on the Regional Ministry's own website at the same link above.

With this double communication, the problem is solved, in case there was an error in the sending of SMS.

Islas Baleares

Closures are communicated by direct resolution to the interested parties (professionals and administrations involved). It is also published on the website (http://www.caib.es/sites/estatszonesdeproducciomolluscs (Spanish only)), but it is not automatic. For the time being, there are no plans to automate it.

Cataluña

They notify all operators of temporary closures by e-mail and we also publish on our website the updated status of the production areas when a closure or opening occurs. So far there have been no problems with email communications, in the event of a computer failure, we will look for an alternative communication solution.

Comunidad Valenciana

Production is concentrated in a few operators, which allows for immediate and effective action in the event of any eventuality and is carried out as reflected in our 'Surveillance programme for bivalve mollusc production areas in the waters of the Valencian Community 2020-2024'.

In the event of an incident with unfavourable results, the Subdirectorate General for Fisheries will send the resolution of the Director General for Agriculture, Livestock and Fisheries (temporary or definitive closure or reclassification of the area) and once favourable results are obtained that allow a return to normality, the corresponding opening resolution will be sent to all those involved:

To date, they consider this system to be sufficient and effective and have not yet considered the need for an automatic communication system.

It is important to bear in mind that Galicia accounts for 97.35% of the national production of live bivalve molluscs and, so the vast majority of operators have a system of immediate notification.

Table 1. Commercial size bivalve molluscs produced in Spain in 2020
ACCA Kg Production value Kg % Kg
Andalucía 744,857.19 686,808.25 0.36%
Cantabria 7,977.50 71,187.61 0.00%
Cataluña 3,489,077.50 4,457,366.05 1.69%
Comunidad Valenciana 1,060,365.00 2,466,997.00 0.51%
Galicia 201,268,035.44 113,843,948.78 97.35%
Baleares 119,220.00 332,672.00 0.06%
País Vasco 40,000.00 80,000.00 0.02%
Asturias 24,550.70 172,249.38 0.01%
Total 206,754,083.33 122,111,229.07 100.00%

In addition, the authorities with jurisdiction over the MPZ communicate any closures to the public health authorities."

Recommendation 2

Exporters should generally ensure the effectiveness of their scheduled canning process. This includes the time that sealed cans of low acid canned foods are held at room temperature until the time they are thermally processed. Any deviations from best practices should be validated by a competent authority instead of relying on testing.

Note: In Canada, the thermal processing requirements come from the Commercial sterilization of low-acid food in hermetically sealed containers: retort systems. With respect to the maximum lapse time:

Spain's action plans / comments

April 29, 2022:

"Programme 1. Inspection of Food Establishments of the PNCOCA 2021-2025 (P1 PNCOCA 2021-2025) states that:

"Economic operators must notify the competent authority, for the purposes of registration and, where appropriate, for approval, the start of the activities of their business and establishment, and the relevant modification in their facilities and processes. In these cases, the economic operators carrying out activities with food of non-animal origin:

Programme 1 also states the following:

"Once registered and operational, economic operators must notify the competent authority of any modification of the information in the initial registration or authorisation, as well as the definitive cessation of the economic activity of the enterprises at the time of its occurrence. In the first case, if a modification is made, as set out in article 5 of Royal Decree 191/2011 that affects any activity for which Annex III of Regulation (EC) No 853/2004 establishes requirements, the corresponding authorisation will be requested and the CA will proceed to review the establishment's risk assessment based on the new information."

In addition, Programme 1 provides for the following:

"b) Verification of the registration or approval status of the establishment after the start of the activity:

The competent authorities shall verify that all establishments or non-facility businesses whose activity is related to the production, processing and distribution of food downstream of primary production are duly registered and/or authorised in the RGSEAA or, in the case of food processing and distribution, in the case of food processing and distribution, are duly registered and/or authorised in the RGSEAA.

Production are duly registered and/or authorised in the RGSEAA or, in the case of retail trade, listed and/or registered at Autonomous Community level by the competent authorities of the Autonomous Communities.

The control will also refer to the fact that the existing authorisation, register or census, accurately reflects the data on ownership and of the activities carried out by the undertaking, as well as the details of the person responsible for the latter, if applicable, checking where applicable, verifying:

On the other hand, Programme 1. Inspection of Food Establishments establishes that:

"Economic operators must implement pre-requisite programmes, which include good hygienic practices (GHP) and good manufacturing practices (GMP), as described in Article 4 and Annexes I and II of Regulation (EC) No 852/2004 and the specific requirements for establishments dealing with food of animal origin in Annex III of Regulation (EC) No 852/2004 and the specific requirements for establishments dealing with food of animal origin in Annex III of Regulation (EC) No 853/2004."

In addition, economic operators must verify that the pre-requisite programmes in place are effective to ensure hygiene in their products and processes. This verification should include process hygiene criteria for certain micro-organisms and foodstuffs. Criteria for certain micro-organisms and food as laid down in Regulation 2073/2005.

Programme 1 states:

"The control of good hygiene practices shall include, inter alia (non-exhaustive list):

The process hygiene criteria set out in Annex I of Regulation (EC) 2073/2005 determine the acceptable performance of a production process by establishing indicative contamination values for certain micro-organisms, above which corrective measures are required to be implemented by the economic operator, in order to maintain optimal hygiene conditions in food production processes. These process hygiene criteria refer to micro-organisms such as Salmonella, aerobic colonies, E. coli, Enterobacteriaceae, coagulase-positive Staphylococci and Bacillus cereus for certain foodstuffs in different sectors.

The economic operator must carry out sampling and analysis of his foodstuffs during the manufacturing process (…)."

The official control actions will be aimed at verifying the compliance of the economic operator with this verification of the process hygiene criteria by means of documentary control of the established sampling plan and of the results provided by the economic operator, and also, if deemed necessary, by sampling in order to verify the degree of compliance with these criteria:

Control of good manufacturing practices, raw materials, ingredients and products will include the following aspects (non-exhaustive list):

Programme 1 also states that the competent authorities shall monitor the HACCP system of economic operators, targeting all food sectors and all stages of the chain except distributors and importers without warehousing.

For the control of HACCP, it has to be taken into account in the first place whether the company applies guidelines for good hygiene practice and for the application of HACCP principles or flexibility criteria in its self-monitoring system.

HACCP-based procedures are considered as a useful tool for food business operators to detect and control hazards that could occur in food and during food processing in their own establishment.

The official control will include a documentary review, a check of records relating to the selfchecks and the necessary in-plant checks, in order to obtain evidence that the system or the corresponding guide (in case of flexibility) is being followed.

Audits of self-control systems of the PNCOCA 2021-2025 (P2 PNCOCA 2021-2025), includes operational objectives, among which, in order to respond to the question posed, we point out the following:

On the other hand, the P2 PNCOCA 2021-2025, establishes that, during audits of economic operators, compliance with the following aspects must be verified:

Likewise, with regard to the control of prerequisites (Good Hygiene Practices and Good Manufacturing Practices for raw materials, ingredients and products), it is verified that the operator has documented and implemented prerequisite programmes and that they are correctly verified, including the following aspects:

Among the Good Manufacturing Practices for raw materials, ingredients and products (GMP), the selection of suppliers and specifications, work methodology, process, heat and preservation treatments, technical specifications and labelling of the final product, packaging and wrapping requirements are verified.

Response from the CA of Galicia

Inspection Services verifies the HACCP plans of FBOs, including the canning processes. Any resulting corrective actions are also verified. Examples of reference documents for low-acid heat treated canning processes are:

Recommendation 3

Develop and implement a strategy to enhance the ability of the CA to report on the delivery of the written program at the national level, particularly with respect to the inspection and audit targets established in the written program.

Spain's action plans / comments

April 29, 2022:

"The competent authorities of the Autonomous Communities report the results of the implementation of the control programmes in order to draw up the annual report on the results of the National Plan for the official control of the Food Chain as required by Regulation 2017/625 and Law 7/2011 on Food Safety and Nutrition. In order to improve the exchange of information and the collection of data derived from official control actions and other official activities, the AESAN is carrying out the following actions:

A new computer application TULSA is being developed, which will integrate the information on controls, inspections and analyses from the competent authorities of the Autonomous Regions, in accordance with the requirements of the European Commission and EFSA. Likewise, this application will allow the evaluation, processing and management of the data to carry out different analyses and draw up the annual report that must be published every year."

Annex 2: Key legislative instruments

Key legislative instruments presented to the CFIA assessment team.

Table 1: Key EU food safety legal instruments

Legal instrument Topic
Commission Regulation (EU) No. 15/2011 (January 10, 2011) Recognised testing methods for detecting marine biotoxins in live bivalve molluscs.
Commission Regulation (EU) No. 37/2010 (December 22, 2009) Pharmacologically active substances and their classification about MRLs in foodstuffs of animal origin
Regulation (EC) No. 178/2002 (January 28, 2002)

General food legislation and food safety procedures.

Establishes the:

  • principles and general requirements of food legislation
  • food safety procedures

Article 14: Food safety requirements

Article 17: Responsibilities

Article 19: Responsibilities for food: FBOs

Articles 50, 51 and 52: Legal foundation of European Food Safety Authority and RASFF.

  • Its basis is the fast exchange of information about human health risks related to food and feed, contributing to the safety of consumers.
Regulation (EU) No. 2019/627 (March 15, 2019)
(amending Commission Regulation (EC) No 2074/2005)

Laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption per Regulation (EU) 2017/625.

Article 59: Monitoring of classified production and relaying areas

Article 61: Sampling plans
Regulation (EU) 2019/723 (May 2, 2019) Laying down rules for the application of Regulation (EU) 2017/625 for the standard model form to be used in the annual reports submitted by Member States.
Regulation (EC) No. 852/2004 (April 29, 2004)

General rules for FBOs on the hygiene of foodstuffs

Establishes that FBOs are required to have a self-control system based on HACCP.
Regulation (EC) No. 853/2004 (April 29, 2004)

Specific hygiene rules for foodstuffs

Article 4: Registration and approval of establishments
Regulation (EC) No. 854/2004 (April 29, 2004)
(replaced by Regulation (EU) 2017/625 (March 15, 2017) on December 14, 2019)		 Laying down specific rules for the organization of official controls on products of animal origin intended for human consumption
Regulation (EC) 882/2004 (April 29, 2004)
(replaced by Regulation (EU) 2017/625 (March 15, 2017))

Official controls and other official activities performed to ensure the use of EU food and feed law, rules on animal health and welfare, plant health and plant protection products.

Establishes that the EU Member States provide an annual report.

Article 5: Delegation of specific tasks to a control body by the competent authorities.

Article 18: Specific rules on official controls and for action taken by the competent authorities in relation to the production of products of animal origin intended for human consumption

Article 18 (6): For the purpose of the official controls referred to in paragraph 1 performed in relation to live bivalve molluscs, the competent authorities shall classify production and relaying areas.

Article 51: Empowers the Commission to develop training for competent authority staff in EU countries and non-EU countries responsible for controls in:

  • food and feed law
  • animal health and welfare
  • plant health

Article 94: Activities as EU reference laboratory

Article 101: Activities as a national reference laboratory

Article 109: PNCOCA and a single body for the PNCOCA

Article 110: Content of the PNCOCA

Article 111: Preparation, update and review of the PNCOCA

Article 130: Training (allowance for creation of Better Training for Safer Foods program)

Article 138: Actions in the event of a non-compliance
Regulation (EU) No. 1169/2011 (October 25, 2011) Provision of food information to consumers.
Regulation (EU) No. 1331/2014 (December 15, 2014) Import controls on fishery products
Council Regulation (EC) No. 1224/2009 (November 20, 2009)

Establishes a community control system to ensure compliance with the rules of the common fisheries policy.

Title V: Traceability
Regulation (EU) 1715/2019 (September 30, 2019) Laying down the rules for the operation of the information management system for official controls.
Regulation (EC) No. 1774/2002 (October 3, 2002) Laying down health rules concerning animal by-products not intended for human consumption.
Commission Regulations (EC) No. 1881/2006 (December 19, 2006)
(amended by Commission Regulation (EC) No. 629/2008 (July 2, 2008),
Commission Regulation (EU) No. 835/2011 (August 19, 2011), and
Commission Regulation (EU) No. 1259/2011 (December 2, 2011))

Set maximum levels for certain contaminants in foodstuffs.

Article 1 and Annex: General rules and maximum levels for certain contaminants in foodstuffs

Article 2: Dried, diluted, processed and compound foodstuffs

Commission Regulation (EC) No. 629/2008 amended the maximum levels of certain contaminants in food products.

Commission Regulation (EU) Nº 835/2011 amended the maximum levels of polycyclic aromatic hydrocarbons in foodstuffs.

Commission Regulation (EU) Nº 1259/2011 amended the maximum levels of dioxin maxima, dioxin-like PCBs, and non-dioxin-like PCBs in food products.

The EU food safety contaminants Catalogue has maximum levels for these contaminants:

  • mycotoxins (aflatoxins, ochratoxin A, fusarium-toxins, patulin, citrinin)
  • metals (cadmium, lead, mercury, inorganic tin, arsenic)
  • dioxins and Polychlorinated Biphenyls (PCBs)
  • Polycyclic Aromatic Hydrocarbons (PAH)
  • 3-MCPD
  • melamine
  • erucic acid
  • nitrates
Commission Regulation (EC) No. 2073/2005 (November 15, 2015) Microbiological criteria for foodstuffs establishes food safety criteria for zoonotic pathogens or their toxins including: Salmonella, Listeria monocytogenes, Staphylococcal enterotoxin, Escherichia coli, Enterobacter sakazakii and histamine
Commission Regulation (EC) No. 2074/2005 (December 5, 2005) Laying down implementing measures for certain products.
Commission Implementing Regulation (EU) 2019/2129 (November 25, 2019) Establishing rules for the uniform application of frequency rates for identity checks and physical checks on certain consignments of animals and goods entering the Union.
Commission Directive 93/26/EEC (June 4, 1993) Amending Council Directive 82/471/EEC concerning certain products used in animal nutrition
Directive 2000/60/EC (October 23, 2000) Establishing a framework for Community action in the field of water policy.

Table 2: Key Spanish national food safety legal instruments

Legal instrument Topic
Spanish Constitution (Article 43) Right to health protection by preventive measures put in place by public authorities.
Spanish Constitution (Article 137)

Organizes Spain territorially into municipalities, provinces and ACs.

Gives autonomy to manage their respective interests.
Spanish Constitution (Article 148.1.11a)

Gives executive powers to ACs for inland water fishing, shell-fishing and aquaculture.

The powers of the ACs are the development of legislation, and execution of the basic laws of the State on the management of the fishing sector.
Spanish Constitution (Article 149)

Giving Spain competency over areas including:

  • International relations.
  • Commercial legislation; procedural legislation, without prejudice to the necessary specialties that in this order derive from the particularities of the substantive law of the ACs.
  • Sea fishing, without prejudice to the powers attributed to the ACs in the management of the sector.
  • Matters not expressly attributed to the State by this Constitution may correspond to the ACs, by virtue of their respective Statutes. The jurisdiction over matters that have not been assumed by the Statutes of Autonomy will correspond to the State. State rules will prevail, in case of conflict, over those of the ACs in everything that isn't attributed to their exclusive competence. State law will be, in any case, supplementary to the law of the ACs.
Legislative Royal Decree 1/2007 (November 16, 2007) Consumer protection.
Legislative Royal Decree 5/2015 (October 30, 2015) Establishes the code of conduct for public administration employees.
Royal Decree 2/2020 (January 12, 2020)

Restructures the Spanish ministerial departments. Created MAPA, MC, and MS.

MAPA: The proposal and execution of the Spanish Government's policy on agricultural, livestock and fishing resources, agri-food industry, rural development and feeding.
Royal Decree 10/2020 (January 14, 2020) MC and Ministry of Health structure and organization.
Royal Decree 19/2014 (January 17, 2014)

Merges the National Consumer Institute and AESAN into a new autonomous body called the Spanish Agency for Consumer Affairs, Food Safety and Nutrition.

Article 16:

  • Coordinate the actions of public administrations in national territory to protect the health and interests of consumers and all the agents in the food chain. This relates to the official control of food products.
  • Coordinate the operation of existing alert networks in Spanish territory.
  • Propose risk management measures in food formulating and other measures. Proposals for new regulatory developments and promoting the simplification and unification of standards. This includes planning, coordinating and developing action strategies in relation to transmitted diseases food.
  • The management of the General Sanitary Registry of Food and Food Companies. Facilitate Administrations competent technical support and risk assessments for food safety.
  • Promote as many training, information and education actions as necessary for citizens, public administrations and the social agents involved.
  • Prepare proposals for the organization and laws on goods and services that facilitate and improve consumer protection. This includes mandatory information on projects of standards, authorizations or proposals that affect non-food consumer products or services.
  • The preparation of legal actions in defense of the general interests of consumers, as provided for in current legislation.
Royal Decree 28/2005 (January 28, 2005)

Government of Galicia:

  • Regulates the control of biotoxins in bivalve molluscs and other organisms from fishing, shellfish farming and aquaculture.

Article 6: Extraction prohibitions
Royal Decree 66/2015 (February 6, 2015)

Regulates the controls measures to improve the operation of the food chain.

Article 10

Roles, responsibilities and powers of inspectors in their duty to apply the measures outlined in Law 12/2013.
Royal Decree 136/2019 (October, 2019) Establishes the structure and organization of Galicia's regional Department of Health (Consellería de Sanidade)
Royal Decree 139/2020 (January 28, 2020)
(amended by Royal Decree 430/2020 (March 3, 2020))

Establishes the basic organizational structure of MAPA, MC and Ministry of Health – departments and governing bodies.

The MAPA is structured in the following governing bodies:

  • The General Secretariat of Agriculture and Food, with the rank of Under Secretariat, governs:
    • The General Directorate of Agricultural Productions and Markets
    • The General Directorate of Health of Agricultural Production
    • The General Directorate of Rural Development, Innovation and Agrifood Training
    • The General Directorate of the Food Industry
  • The General Secretariat for Fisheries, with the rank of Under Secretariat, governs:
    • The General Directorate of Sustainable Fishing
    • The General Directorate of Fisheries and Aquaculture Management
  • The Under Secretariat of Agriculture, Fisheries and Food governs:
    • The General Technical Secretariat
    • The General Directorate of Services and Inspection
Royal Decree 191/2011 (February 18, 2011) Sanitary registry of FBOs and food.
Royal Decree 401/2012 (February 17, 2012)

MAGRAMA organization (MAGRAMA split into MAPA and Ministry for the Ecological Transition and the Demographic Challenge in January 2020.)

Article 9: Develops the basic structure of the ministry.
Royal Decree 495/2020 (April 28, 2020) MC structure and organization.
Royal Decree 709/2002 (July 19, 2002)

Article 31: Sets up crisis and emergency committees.

Article 32: General procedures for action in crisis situations and food emergencies and general risk communication plan.
Royal Decree 722/2020 (July 31, 2020) Ministry of Health structure and organization.
Royal Decree 735/2020 (August 4, 2020) Ministry of Health structure and organization.
Royal Decree 993/2014 (November 28, 2014)

Establishes:

  • the procedure and requirements for official veterinary certification for export.
  • an audited system of specific self-controls for the export of products for human consumption to third-countries.
Royal Decree 1749/1998 (July 31, 1998) Article 13: Establishes the measures of control for veterinary drugs and other substances, and their residues, in live animals and foods of animal origin.
Royal Decree 1945/1983 (June 22, 1983)

Regulates infractions and sanctions in matters of consumer defense and agri-food production, without prejudice to other laws. (Under review.)

Article 13: Gives AC inspectors the authority toadopt added measures if there is a real or foreseeable risk to public health sample and take actions during an inspection.

Article 15: Gives AC inspectors the authority to sample in triplicate, including the possibility of contradictory analysis to the interested party.

Article 19: Establishes the competent authorities, offenses and penalties.
Law 2/2015 (April 29, 2015) Public service employment in Galicia.
Law 3/2001 (March 26, 2020)

State maritime fishing.

Title V: establishes the regime of infractions and sanctions.
Law 6/2015 (May 12, 2015) Denominations of origin and protected geographical indications of supra-autonomous territorial scope.
Law 7/2007 (April 12, 2007)
(Replaced by Legislative Royal Decree 5/2015 (October 30, 2015))		 Establishes the code of conduct for public administration employees.
Law 8/2003 (April 25, 2003)

Animal health.

Related to PNCOCA:

  • Chapter II and III detail the infractions and sanctions, and in Chapter IV
  • Execution measures and other measures
Law 8/2008 (August 21, 2008) Establishes how the Galician health authority carries out its functions.
Law 19/2013 (December 10, 2013) Governance, transparency and access to information for public officials.
Law 11/2001 (July 5, 2002) Establishes AESAN.
Law 12/2013 (August 2, 2013) Measures to improve how the food chain works.
Law 14/1986 (April 25, 1986)

General health.

Related to PNCOCA:

  • Chapter VI of Title II regulates Infractions and Sanctions in sanitary matters.
Law 17/2011 (July 5, 2011)

Food safety and nutrition.

Article 18: Establishes that the General State Administration will send the European Commission an annual report of the PNCOCA.

Related to PNCOCA:

  • Chapter IX: Sanctioning power

Related to AESAN:

  • Article 25: national alert network system (SCIRI) connected with the EU's RASFF
  • maintenance and updating of an information system on food safety and nutrition, in collaboration with the ACCAs
Law 28/2015 (July 30, 2015) Defense of food quality.
Law 29/2006 (July 26, 2006)

Guarantees and rational use of medicines and health products.

Related to PNCOCA:

  • Title VIII Sanctioning Regime (Chapter I Inspection and Precautionary Measures, Chapter II Infractions and Sanctions
Law 30/1992 (November 27, 1992)

Legal regime of public administrations and the common administrative procedure

Article 5: Minimum framework law of Sectorial Conferences which determines that they are convened by the head of the corresponding Ministry and that their agreements are signed by the same and by the Councillors of the ACs.
Law 32/2007 (November 8, 2007)

Care of animals – exploitation, transportation, experimentation and sacrifice.

Related to PNCOCA:

  • Title II Chapter I inspections. Title II infractions and penalties.
Law 33/2011 (October 4, 2011)

General public health.

Related to PNCOCA:

  • Title VI regulates infractions and sanctions.
Law 39/2015 (October 2, 2015) Common Administrative Procedure of Public Administrations.
Law 40/2015 (October 1, 2015)

Legal regime of the public sector.

Related to PNCOCA:

  • principles relating to the exercise of sanctioning powers
Law 50/1997 (November 27, 1997) Establishes the composition, organization and bodies of collaboration and support of the Government, its rules of operation and delegation of powers.
Law of Marine Cultures (1984) Article 27: Creation of the JACUMAR.

Table 3: Key Spanish regional food safety legal instruments

Legal instrument Topic
Ministerial Order APA/524/2019 (April 26, 2019)

Bivalve mollusc and other marine invertebrate's production area list for the Spanish coast.

  • Updated every 2 years.
Ministerial Order PRE/847/2016 (May 31, 2016) Establishes the animals and products included in the scope of Royal Decree 993/2014 (November 28, 2014).
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