EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/7697/2008 CP Final COUNTRY PROFILE OF SPAIN ON FOOD AND FEED SAFETY, ANIMAL HEALTH, ANIMAL WELFARE AND PLANT HEALTH

2 TABLE OF CONTENTS EXECUTIVE SUMMARY...3 INTRODUCTION COMPETENT AUTHORITIES AND OVERALL DISTRIBUTION OF RESPONSIBILITIES COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS Control system for animal health Control system for food of animal origin Control system for imports of animals and food of animal origin Control system for feedingstuffs and animal nutrition Control system for TSEs and Animal By-Products (ABP) Control system for veterinary medicines and residues Control system for foodstuffs and food hygiene Control system for imports of food of plant origin Control system for pesticides Control system for animal welfare Control system for plant health FOLLOW-UP OF FVO INSPECTIONS Animal health Food of animal origin Imports of animals and food of animal origin Feedingstuffs and animal nutrition TSEs/ABP Veterinary medicines and residues Foodstuffs and food hygiene Imports of food of plant origin Pesticides Animal welfare Plant Health Overview of more recent inspections ANNEX 1 - ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS ANNEX 2 - RESOURCES

3 EXECUTIVE SUMMARY Overview In Spain, overall responsibility at national level for the organisation and operation of control systems is shared between two main ministries, the Ministry of Health and Consumer Affairs (MISACO) and the Ministry of the Environment, Rural and Marine Affairs (MARM). MISACO has principal responsibility for food safety. It is directly responsible for implementing import controls on all food. Most of the Ministry s other food safety responsibilities have been delegated to the Spanish Food Safety and Nutrition Agency (AESAN), established in MARM has principal responsibility through its Directorate General for Agricultural and Livestock Resources for animal health, animal welfare, animal feeding stuffs, and primary production of food of animal origin, and plant health and the marketing and use of pesticides. This directorate general is also directly responsible for implementing import controls on live animals, plants, animal feedingstuffs, and products of animal origin not destined for human consumption. MARM is also responsible, through its Directorate General for Fishery Resources and Aquaculture, for shellfish and fish production prior to processing. Except for import controls, the operational implementation of official controls in Spain is the responsibility of the 17 autonomous communities and the two autonomous cities of Ceuta and Melilla. In general, these are operated through the Ministries of Agriculture and Health of the autonomous communities. Some of the larger cities are autonomous for the purposes of food of animal origin and food hygiene controls. The central authorities in Spain retain overall responsibility for co-ordinating implementation of controls. A number of bodies have been set up to support this co-ordination and to promote a consistent application of EU law across the whole territory of Spain. The political co-ordination forum for agriculture is the Sectoral Council for Agriculture and Rural Development, composed of the national Minister of the Environment, Rural and Marine Affairs, and the Ministers of Agriculture of the 17 autonomous communities. The Director General for Agricultural and Livestock Resources of MARM and his counterparts from the autonomous communities participate in seven co-ordination committees, each with a specific legal basis. MARM also chairs a co-ordination committee for plant health, and a co-ordination committee for aquaculture and live bivalve molluscs. The highest political co-ordination forum for health, including food safety, is the Interterritorial Health Council composed of the national Minister of Health, and the Ministers of Health of the 17 autonomous communities. The Institutional Committee of AESAN is the main body for co-ordination with autonomous communities. Annex 2 of the country profile gives details of the staff resources employed in official controls in Spain. Overall, some 900 staff are employed at central level in Spain, and 8,600 at regional and local level. Around 2,900 private sector employees are also 3

4 contracted to do certain official tasks related to livestock controls. Some 350 staff are employed for official controls by autonomous municipalities. Multiannual National Control Plan The implementation of the multiannual national control plan is overseen by an Interministerial Committee, made up largely of officials from MARM and MISACO. The plan was forwarded to the Commission in July The FVO has presented its initial assessment of the plan to the Spanish authorities. Audit Systems A national audit system as required by Regulation (EC) No 882/2004 is not yet fully in place. Timeframes for the implementation of audit throughout Spain are not yet available for any sector. AESAN and MARM have each set up working groups for the implementation of Regulation 882/2004, including audit, and have provided details of the audit programme for the period to the Commission. A draft Royal Decree is under discussion to implement audits, and to give central authorities an oversight role for audits within the autonomous communities. Inspections in Spain by the Food and Veterinary Office Since 1999, the FVO has carried out 88 inspections and 3 general review missions in Spain. A general audit, including 12 specific audits, is being carried out in The following table gives an overview of the main sectors that have been or will be covered by these inspections and missions: SECTOR Total Animal Health Food of Animal Origin * 22* Imports of animals and food of animal origin * 9* Feedingstuffs and animal nutrition TSEs/ABP Veterinary medicines and residues Foodstuffs and food hygiene Imports of food of plant origin Pesticides

5 SECTOR Total Animal Welfare Plant Health General Review Total per year * One combined mission in 2008: food animal origin/imports Progress on FVO recommendations At the time of the last general review mission in February 2008, final reports had been issued and action plans received from the Spanish authorities setting out their responses to recommendations made in 78 of the 88 completed inspections. These action plans have been assessed to determine whether sufficient progress is being made by the Spanish authorities to deal with the weaknesses in control systems identified in FVO inspections. Of the 579 recommendations made in these reports, 487 had been closed prior to the last general review mission. Of the remainder, in 19 cases appropriate remedial action by the authorities was still required and in 73 cases evidence was sought to verify that promised action had been taken. Progress on these recommendations was reviewed during the last general review mission. The following table summarises the results of this review: Pre-GRM 2008 Post-GRM 2008 Inspections finalised and assessed Total Recommendations Closed / No longer relevant Outstanding/Action still required 19 8 Action in progress/verification The main issues that have been identified in successive FVO inspections and still need to be fully addressed include: Horizontal issues Co-ordination of the control activities of regional and local authorities by central authorities has improved in recent years but is not fully effective. For import controls, the central authorities are directly responsible for implementation, and can therefore ensure that FVO recommendations are addressed. But for all other control sectors, which account for the bulk of recommendations, the individual autonomous communities are the responsible bodies, and the central authorities are unable to demonstrate that the necessary action is being taken. 5

6 Thirteen of the open recommendations relate to laboratories used by the autonomous communities for official controls Ten recommendations (2 for pesticides, and 8 for animal welfare) relate to the need for each autonomous community to have documented procedures (Article 8 of Regulation (EC) No 882/2004) Three recommendations (on animal health, pesticides and animal welfare) relate to training (Article 6 of Regulation (EC) No 882/2004). It remains to be demonstrated whether each autonomous community has systems in place to: identify training needs; manage delivery of training; and evaluate its effectiveness. In their response to the draft country profile, the Spanish authorities stated that they had started to improve training related to pesticides, through the collaboration of autonomous communities and MARM in the preparation of courses. Three recommendations (2 on TSE and 1 on animal welfare), relate to the need for competent authorities of the autonomous communities to have systems in place to verify the effectiveness of controls (Article 8.3 of Regulation (EC) No 882/2004) In three areas, Royal Decrees are being drafted to give legal effect throughout Spain to EU Regulations (reclassification of live bivalve mollusc production areas, traceability of ABP, and co-ordination of pesticide controls) Sector specific issues Two coastal autonomous communities perform no analyses of live bivalve molluscs for at least 5 of the 7 groups of biotoxins for which analysis is prescribed in Regulation (EC) No 853/2004 Although the new Animal Welfare Law adopted in 2007 now provides a legal basis for uniform sanctions throughout Spain, it still has to be applied in practice The co-ordination of controls on the marketing and distribution of veterinary medicines throughout Spain is in the initial stages. Validation of methods and laboratory accreditation remain to be addressed for residue controls For pesticide residues, the EU average level of analytical screening is reached in only 3 autonomous communities. In their response to the draft country profile, the Spanish authorities stated that 12 autonomous communities had accredited laboratories Weaknesses in controls on sheep and goat group identification undermine confidence in the system of traceability Recent FVO inspections that have not reached final assessment stage For 10 of the 88 FVO inspections in Spain, the process had not reached final assessment stage at the time of the general review mission in February The following tables show the stage now reached for each of these inspections. 6

7 2006 Inspections Ref No. Mission Date Sector Subject of Inspection Current Status Date 8174/ /03/2006 Animal Health Intra-community trade in live animals Action assessed plan 11/04/ Inspections Ref No. Mission Date Sector Subject of Inspection Current Status Date 7448/ /04/2007 Food of animal origin Food of animal origin, in particular meat, milk and their products Action assessed plan 1/09/ / /05/2007 TSEs/ABP Animal by-products (ABP) and gelatines Action assessed plan 17/04/ / /06/2007 Animal Health Bovine brucellosis eradication programme Action assessed plan 9/04/ / /10/2007 TSEs/ABP Protection measures against TSEs in sheep and goats Action assessed plan 21/07/ Inspections Ref No. Mission Date Sector Subject of Inspection Current Status Date 7929/ /01/2008 Food of animal origin Food of animal origin (meat and milk) and imports to EU (Ceuta) Final report 05/02/ / /02/2008 Food of animal origin Fishery products Draft report 1/07/ / /03/2008 Veterinary medicines residues and Residues in live animals and animal products, including controls on veterinary medicinal products Draft report 3/06/ / /04/2008 Foodstuffs and food hygiene Food additives and food contact materials Draft report 30/6/ / /04/2008 Animal health Intra-Community Trade in bovine semen and embryos Draft report 23/07/2008 7

8 The main issues identified in these more recent inspections relate to: Implementation of hygiene legislation in food of animal origin: In the Spanish action plan, many autonomous communities provided no response, or an inadequate response to the report's recommendations. This led to an FVO request in early February 2008 for additional information, which was sent by the Spanish authorities in June 2008 Implementation of bovine brucellosis controls by some autonomous communities in dairy and red meat establishments: The Spanish action plan provides a satisfactory response to all recommendations, but follow up is necessary to verify promised actions Implementation of controls on intra-community trade in live animals. The assessment of the Spanish action plan indicates that while the national control plan and the corresponding procedural manual address most recommendations, it remains to be demonstrated whether each of the 17 autonomous communities has confirmed that it implements controls in accordance with these documents Animal by-products: Steps have been taken to ensure better compliance through the production of a national control plan, and guidelines for official controls. However, the control system was not yet fully effective, as most of these measures had not yet entered into force. The assessment of the Spanish action plan indicates that 7 of the 16 recommendations are not satisfactorily addressed. Further follow up is necessary to verify autonomous community actions Future FVO inspections The following inspections are planned for Spain for the remainder of They are all part of the general audit to Spain in 2008 under Regulation (EC) No 882/2004. Ref Sector Summary 7766/2008 SA Animal welfare Animal welfare 7907/2008 SA Plant Health Erwinia amylovora (Burr) and its protected zones, and controls for Rhynchophorus ferrugineus and Gibberella circinata 7723/2008 SA Feedingstuffs and animal nutrition Feed and compliance with requirements for feed hygiene 7787/2008 SA Animal Health Disease contingency plans 7752/2008 SA Imports of animals and food of animal origin 7856/2008 SA Foodstuffs and food hygiene Import / Transit controls and border inspection posts Food hygiene, traceability and labelling 7792/2008 SA Animal Health Disease eradication control programme, SA = Specific Audit, as part of the general audit TB and Brucellosis 7816/2008 SA Food of animal origin Food of animal origin, in particular meat and milk, and infant formulae, follow-on formulae and baby foods 8

9 INTRODUCTION This country profile has been drawn up by the Food and Veterinary Office (FVO), a directorate of the Directorate-General for Health and Consumers of the European Commission. The aim is to present in summary form, the latest information available to the FVO on how control systems for food and feed safety, animal health, animal welfare and plant health are organised in Spain. The information in the country profile has been compiled from: recent written submissions and background documentation from the Spanish authorities detailing how control systems are organised; the results of missions to Spain carried out in recent years by inspection teams from the Food and Veterinary Office and, in particular, a general review mission (GRM) in Spain in February 2008, to evaluate the full range of control systems for food and feed safety, animal health, animal welfare and plant health. The country profile is presented in three parts: Part 1 describes the overall organisation of the Spanish authorities and the respective responsibilities of Ministries and Government agencies in relation to the different components of the control system. A chart is used to help the reader better understand the inter-relationships between the responsibilities of the different bodies. Part 2 gives a more detailed description of the main responsibilities for each of the eleven separate systems that form the complete range of control systems in Spain covering the whole chain of plant, animal and food production. As in Part 1, organisation charts are used to help the reader. Part 3 contains an overview of the missions carried out by the FVO to Spain since 1999 and, for each control system gives an assessment of progress on specific recommendations reviewed in the general review mission of February The country profile will be updated at regular intervals based on the results of future missions and other relevant information received by the Commission from the Spanish authorities. Acronyms are used extensively throughout this report for the sake of brevity. A list of acronyms, abbreviations and special terms is given in an Annex I to the report as a guide for the reader. 9

10 1. COMPETENT AUTHORITIES AND OVERALL DISTRIBUTION OF RESPONSIBILITIES This part of the country profile outlines the: overall structure, organisation and responsibilities of the various ministries involved in control systems structure, organisation and responsibilities of the autonomous communities with responsibilities in the same fields organisation of the various co-ordinating committees and other co-ordination instruments that have been developed to ensure a harmonised and consistent approach to control systems in the 17 autonomous communities and two autonomous cities general organisation of laboratories involved in carrying out tests and analyses on food safety, animal health and plant health preparations in Spain for the implementation of the new feed and food controls Regulation. Overview At national level, the overall responsibility for the organisation and operation of control systems is shared mainly between two ministries, the Ministry of the Environment, Rural and Marine Affairs (MARM) and the Ministry of Health and Consumer Affairs (MISACO). The Ministry of the Environment, Rural and Marine Affairs has principal responsibility for animal health, animal welfare, animal feedingstuffs, some aspects of food of animal origin, and plant health. The responsibility of the Ministry of Health and Consumer Affairs relates to food safety. Three other Ministries have some limited responsibilities for controls within the Spanish system the Ministry of the Interior (animal welfare during transport, feedingstuffs, veterinary medicines and foodstuffs, and the administrative and legal pursuit of infringements or offences related to food safety), the Ministry of Public Administration (Border Inspection Posts) and the Ministry of Science and Innovation (which is represented on some co-ordination committees on aspects related to research). The involvement of the Ministry of Public Administration (MAP), is because all the administrative structures of the Peripheral State Administration (Delegations and Subdelegations of the Government in the autonomous communities) related to food safety, are organically assigned to it. However, in the execution of tasks within their spheres of competence, MAP staff are assigned to MARM or MISACO, and follow their instructions. Under the Spanish Constitution (Article 148.1) and the Statutes of Autonomy and corresponding Royal Decrees transferring functions and services, the 17 autonomous communities, and the two autonomous cities of Ceuta and Melilla, have exclusive responsibility for the operation of control systems in Spain. Therefore, with the exception of external trade and the authorisation of veterinary medicines and other related products, the responsibilities of the Ministries consist of preparing framework legislation, co-ordinating the activities of the autonomous communities, often through national co-ordination committees, and representing Spain at EU level and in international fora. 10

11 Ministry of the Environment, Rural and Marine Affairs Within the Ministry, three Directorates General have competences relating to food safety, animal health, animal welfare and plant health: Directorate General for Agricultural and Livestock Resources (DGRAG); Directorate General for Fishery Resources and Aquaculture (DGRPA); Directorate General for Industry and Food Markets (DGIMA). The Directorate General for Agricultural and Livestock Resources (DGRAG) has responsibility for animal and plant health, feedingstuffs, and animal welfare. In relation to food safety, DGRAG is responsible for labelling and the traceability of certain animal products. It is also responsible for controls on animal products at the stage of primary production, and on plant health. It has direct control responsibility for import controls on feedingstuffs, live animals and products of animal origin not intended for human consumption, and for import controls related to plant health. DGRAG is also the competent authority for zoonoses surveillance and controls, zoonotic agents and antimicrobial resistance in primary production, which includes both live animals (except for rabies suspects), and animal feed. In matters related to national control programmes for primary food production, feed, animal welfare, and external trade of live animals and plants, DGRAG is the competent authority responsible for co-ordinating FVO missions. The responsibility for implementation and development of controls rests with the autonomous communities. Therefore the main task of the Directorate General is coordinating the activities of the ACs, either directly through counterparts in the autonomous communities, or through a number of co-ordination committees. DGRAG is organised into nine sub-directorates general, the five relevant to this country profile being: Sub-directorate General for Means of Production (SGMP) is responsible for the means of agricultural production. It is responsible for authorising and maintaining the register of zoosanitary products, for agricultural machinery, and for pesticides and pesticide residues controls in plants at the level of primary production. Sub-directorate General for Health of Primary Production (SGSPP) is responsible for animal health, plant health (including forestry), as well as official controls of primary production. It manages the veterinary health alert networks. Sub-directorate General for Health Agreements and Border Controls (SGASCF) is responsible for import controls related to plant health, animal health, feedingstuffs, seeds and products of animal origin not for human consumption. It is also responsible for co-ordination at borders, in ports, and in airports, and operates as a point of contact for the Food and Veterinary Office of the European Commission. Sub-directorate General for Conservation of Resources and for Animal Feed (SGCRAA) is responsible for animal feed, for raw materials and for other products intended for feedingstuffs. It also manages the feedingstuffs alert network. Sub-directorate General for Farms and Traceability Systems (SGEST) is responsible for animal welfare, animal identification, the register of livestock holdings and the animal movement databases. SGOBPG is also responsible for traceability and labelling of certain unprocessed products of animal origin, including beef, and for links between livestock and the environment. 11

12 The Directorate General for Fishery Resources and Aquaculture (DGRPA), through its Sub-directorate General for the Conservation of Coastal Resources and Aquaculture (SGCRLA), is responsible for co-ordination of controls on fish (before the first point of processing) and on live bivalve molluscs. It co-ordinates the activities of the autonomous communities through the National Advisory Body for Marine Aquaculture (JACUMAR). The Directorate General for Fishing Affairs (DGOP) is responsible for fleet matters. The Directorate General for Industry and Food Markets participates in controls through its Agri-Food Laboratory (LAA), which is the national reference laboratory for certain feedstuffs, and veterinary medicines, for plant protection products, and for pesticide residues in plants and in food of plant origin. The Santander Agri-Food Laboratory (LAS), which is the NRL for milk and milk products, is also affiliated to this directorate general. Table 1 of Annex 2 shows the number of staff in MARM in the relevant areas. Ministry of Health and Consumer Affairs Within the Ministry, the Directorate General for Public and External Health (DGSPSE), through the Sub-directorate General of External Health (SGSE), is directly responsible for the operation of import controls on food of animal and plant origin. It is also responsible for certain aspects of zoonoses controls, and for veterinary public health legislation. Most of the Ministry s other responsibilities in the area of food safety (including residues of veterinary medicines, and pesticide residues) and nutrition have been assigned to the Spanish Food Safety and Nutrition Agency (AESAN). The Agency was established in 2002 to promote food safety as a fundamental aspect of public health and to provide guarantees and objective information to consumers and the agri-food industry. In December 2006, its objectives were extended to cover the planning, co-ordination and management of nutrition strategy and activities, through Law 44/2006. AESAN's management structure includes: The President whose main functions are to act as an intermediary between AESAN and the Ministry and to exercise high-level co-ordination of the AESAN bodies. The Board of Management AESAN s governing body, chaired by the President. The Executive Director is the legal representative of AESAN and manages AESAN staff, services and activities. Day-to-day activities of AESAN are organised through the following management bodies: Sub-directorate General for Co-ordination of Food Alerts and Official Control Programmes (SGCAAPCO) co-ordinates the annual official control programmes and control procedures of the ACs, manages alert networks, advises ACs on food safety policy, carries out training needs analyses and designs training programmes. It also co-ordinates national zoonosis programmes (excluding those in the primary production and animal feed areas) and is responsible for co-ordinating FVO missions in its areas of responsibility. Sub-directorate General for Food Risk Management (SGGRA) makes proposals for legislation, manages the general food safety register, co-ordinates national zoonoses 12

13 surveillance programmes, produces veterinary public health legislation, co-ordinates crisis management in relation to official controls by ACs, and consults with stakeholders. Sub-directorate General for Scientific Co-ordination (SGCC) monitors resources related to food safety, conducts studies, provides technical support to guarantee the use of best scientific knowledge, and assesses risks. The National Food Centre (CNA) and the Community Reference laboratory for Marine Biotoxins (CRL-MB) are both national reference laboratories and are attached to AESAN. The Advisory Committee of AESAN is the organ for public participation related to food safety. The Scientific Committee is the AESAN risk assessment body. It provides AESAN with scientific reports on food safety, establishes research programmes and co-ordinates the work of expert groups conducting risk assessment. The Food Risks Communication Office (OCRA) disseminates Scientific Committee reports and promotes information measures for consumers and users. The Spanish Agency for Medicines and Health Products (AEMPS) is responsible for the authorisation and registration of veterinary medicinal products (VMPs) and for controls on manufacturing them. AEMPS is an autonomous body affiliated to the Directorate General for Pharmaceuticals and Health Products (DGFPS) of MISACO. Table 2 in Annex 2 shows the number of staff in MISACO and associated bodies. Ministry of the Interior (MIR) The following Ministry of the Interior bodies perform controls in some ACs and sectors on the basis of agreements concluded with the relevant AC services: SEPRONA Civil Guard Environmental Protection Service may perform controls on pesticide marketing, labelling and use, on marketing of veterinary medicines and other zoosanitary products, and on the control of prohibited substances such as betaagonists in live animals. The Civil Guard Traffic Association may perform controls on animal welfare during transport, on veterinary medicines and other animal health products, and on foodstuffs. However, certain autonomous communities may perform these activities through their own bodies, such as the Mossos d Esquadra and the Ertzaina in Cataluña and Pais Vasco respectively. Civil Guard activities are based on Law 2/1986, on Security Bodies. Examples of collaboration between SEPRONA and MARM (for the detection of illegal animal products in passenger baggage from third countries), and between SEPRONA and the ACs of Murcia, Galicia and Cataluña, have been provided to the Commission. 13

14 Ministry of Science and Innovation (MCI) The Ministry of Science and Innovation participates in some co-ordination committees, such as the National Committee on Animal By-Products (CNSOA), in relation to research. Import Controls The Ministry of Health and Consumer Affairs and the Ministry of the Environment, Rural and Marine Affairs have direct responsibility for controls on imports of food, animals and plants into Spain. MISACO operates 40 border inspection posts (BIPs) at 21 ports and 19 airports to control imports of food. For aflatoxin controls, the number of designated points of entry has been reduced from 49 to 15. MISACO oversees all its import control operations through 19 Directors. MARM is responsible for controls on live animals, animal products not for human consumption, and feedingstuffs in the 40 BIPs. MARM also manages three points of entry for animal feedingstuffs which were notified to the Commission in At the BIPs, MISACO has a total of 352 staff, and MARM has a total of 84 staff. There are 39 points of entry for import controls related to plant health, 28 in ports and 11 in airports. MARM oversees all of its import control operations through nine regional coordinators, who organise and co-ordinate the inspection services and harmonise the criteria for inspection. In all, MARM has 87 staff performing plant health import control duties. Staff and equipment in all BIPs are provided and paid for by the Ministry of Public Administration (MAP). However, in relation to their inspection activities, staff in the BIPs and at the points of entry report to MARM or to MISACO, depending on their functional dependence. Autonomous Community and local authorities in Spain Except for matters explicitly reserved for the State, (Article 148 of the Spanish Constitution), such as import controls, the 17 autonomous communities (ACs) and the two autonomous cities of Ceuta and Melilla are responsible for the implementation of official controls on food safety, animal health, animal welfare and plant health. In general, these are operated through the Consejerias (autonomous community Ministries) of Agriculture (CAG-AC), Health (CS-AC), Environment (CMA-AC), or, in the case of Galicia, Fisheries (CP-AC). In the public health field, three ACs (Asturias, Castilla y León and Cataluña), besides having a DGSP, have a specific food safety agency (ASA-AC). The Catalan food safety agency has competences from primary production to the final consumer. Each autonomous community determines the organisation and structure of its own services. Therefore, the AC structures do not necessarily mirror those of the national ministries. 14

15 Ten autonomous communities are further subdivided into provinces, totalling 50 in all. The number of territorial service units usually, but not always, corresponds to the number of provinces. The number of provincial/territorial service units may differ between the Consejerias of Agriculture and of Health, as shown in Table 5 of Annex 2. This table also shows the numbers of local sub-provincial units. For activities managed by the CS-AC, operational implementation is by 74 territorial service units, as shown in Table 5 of Annex 2. The territorial health services, whose geographical areas for controls usually match provincial boundaries, are organised into smaller local health areas or district services, which include one or more municipalities. They are responsible for implementing official controls on foodstuffs, and have some autonomy to allocate available resources. Although information is available for some ACs in Table 5 of Annex 2, the total number of local health areas requires clarification. Table 4 of Annex 2 shows the numbers of staff in each AC Ministry of Health by areas of responsibility. There are approximately 230 graduate staff employed at central level in the 17 autonomous communities and 4,516 graduate staff (usually veterinarians or pharmacists) in the local services. In addition, 348 staff are employed in 20 municipalities which are autonomous for certain purposes. (In some towns with large populations, certain food safety control activities are carried out by local competent authorities.) Within the competencies of the Consejerias of Agriculture the veterinary services are generally structured as follows: At autonomous community level, the 17 Central Veterinary Services (SCV), and at provincial level, the 55 Territorial Veterinary Services (STV) are respectively responsible. At local level, the 481 local veterinary units (LVUs), also known as comarcal veterinary services, are responsible, as shown in Table 5 of Annex 2. The organisational structure described above is not found in all parts of Spain in the fields of animal health, animal welfare and animal feed. Sometimes, the preparation and implementation of programmes takes place through the STV and its staff. Elsewhere, implementation takes place by the LVUs, whose staff may perform tasks in various control fields. In País Vasco, the three provinces are autonomous within the AC for animal health purposes. In general, each AC Consejeria of Agriculture prepares its own control programme on the basis of the national programme. Instructions are usually prepared by the central services of each AC for uniform implementation by all its provincial and local services. Some business entities or associations which have their own veterinary services. This is the case for the Agrupaciones de Defensa Sanitaria (ADS), regulated by Royal Decree 1880/1996, some livestock co-operatives, and some businesses providing veterinary services. These bodies, set up on a voluntary basis, contract veterinary staff for animal health (including BSE) purposes. Certain activities or control tasks are also delegated to TRAGSEGA, a public state owned company, which is involved inter alia in animal health and food safety. In certain cases, on the basis of contracted responsibilities, these entities implement certain tasks related to official animal health programmes. Each AC decides for itself to contract responsibilities to these entities and the extent of their involvement in official animal health programmes. 15

16 Table 3 of Annex 2 shows the breakdown of staff employed in animal health and animal identification controls in each CAG-AC. Overall, approximately 3,000 staff are employed in the AC Ministries of Agriculture, 2,300 of whom are veterinarians. In addition, some 2,850 veterinarians are employed on a delegated contractual basis. Almost 600 staff are employed in AC laboratories. In Table 3, the heading "Local Services" includes staff from both the territorial/provincial service units, and the local veterinary units. Many of these are part-time. National co-ordination of the activities of autonomous communities The central authorities in Spain retain overall responsibility for co-ordination. To meet this responsibility, and to facilitate communication between different administrations, a number of co-ordination bodies have been set up to assist in ensuring compliance with EU law and to promote a harmonised and consistent application of EU law across the whole territory of Spain. The highest political co-ordination forum for agriculture is the Sectoral Council for Agriculture and Rural Development (CSADR), composed of the national Minister of MARM, as Chairman, and the Consejero (AC Minister) of Agriculture from each autonomous community. At an operational level, there are seven active co-ordination committees in which DGRAG of MARM, through its Director General, and Directors of the 17 ACs participate to co-ordinate activities in different sectors (veterinary medicine residues, animal health, animal identification, ABP, feedingstuffs, animal welfare and traceability). Each committee has a specific legal basis. New legislation, to be adopted to comply with European Union legislation on pesticides, currently under revision, is expected to provide a formal legal basis for a co-ordination committee for pesticides marketing and use. Those co-ordination committees which have a legal basis can approve their own internal rules of procedure. For all situations not provided for in these rules, the rules established in chapter II of Title II of Law 30/1992 on the Legal Rules of Public Administrations and of the Common Administrative Procedure apply. The Director of DGRAG also participates in a co-ordination committee for plant health with counterparts from the autonomous communities. The Secretary General of Marine Fisheries is the chairman of JACUMAR, the co-ordination committee for aquaculture and live bivalve molluscs. In some cases, national control programmes, following approval at co-ordination committee level, need to be ratified in the relevant Interterritorial Council. AESAN acts as co-ordinator for pesticide residues controls in food of plant origin on the market, and is the contact point with the Commission for reports on results of residues controls. DGRAG co-ordinates controls on marketing and use of plant protection products, and is the point of contact with the Commission for this issue. The highest political co-ordination forum for health is the Inter-territorial Health Council (CISNS). The Institutional Committee of AESAN (AESAN-CI), chaired by its President, is the highest level AESAN body for co-ordinating with ACs and with other state ministries. The Committee comprises one representative each from MISACO, MARM, and the Ministry of Science and Innovation, one from each of the autonomous communities, one 16

17 each from Ceuta and Melilla and four local authority representatives. The Committee maintains communication with the CISNS and other Inter-territorial Councils, such as CSADR. The Committee is supported by two technical working groups, the Technical Consensus Group, responsible for technical co-ordination of food safety and public health, and the Appointed Subcommittee, which handles inter-territorial and inter-sectoral preparation of the Committee s tasks. Among the eight co-ordination committees listed above for DGRAG, AESAN chairs the Committee for Residues in Live Animals and Animal Products (CNCICR) and participates in five other co-ordination committees. (SGSPP of DGRAG holds the position of secretary of CNCICR). Procedural rules governing the activities of these co-ordination committees are being adapted on an ongoing basis, taking into account the obligation on Spain to provide the Commission with sufficient evidence to demonstrate compliance with EU law in each of the 17 ACs. For example, the rules of procedure for CN-SANDACH (the ABP coordinating committee) include provisions for simple majority and absolute majority decisions. New rules of procedure for AESAN-CI were submitted for consideration by the committee in November The committees are increasingly involved in adopting manuals of procedure, instructions, or checklists, although they are not legally binding unless adopted by all ACs. These committees also serve as forums to obtain information on documented control procedures in each AC. For example in July 2006 and October 2006, SGAISV (now SGSPP) and the ACs, unanimously adopted in the co-ordination committee (CFN), manuals of procedures on potato disease controls and on internal market controls. Co-ordinating committees may also review progress by ACs in meeting EU requirements in areas such as laboratory accreditation. If an AC breaches an agreement, there are two legal courses of action (in addition to the possibility of political compromise through the Conferencias Sectoriales) to make the agreement binding: The signature of a Convention between the State and the autonomous communities (Article 6 of Law 30/1992, on the Legal Arrangements for the Public Administrations and the Common Administrative Procedure), failure to comply with which will result in legal action. The transformation of the agreement into a basic law (usually a Royal Decree, adopted by the Council of Ministers), failure to comply with which would also result in legal action being taken. Until now, these instruments have seldom been used. The instrument of high level inspection (Alta Inspección) gives powers to the General State Administration (AGE), for situations where there are non-compliances in the way ACs implement controls under constitutionally delegated powers, to adopt measures to ensure that ACs will comply. Action must be taken by the AC, rather than by the AGE, to ensure compliance. In practice, this instrument has not yet been used. 17

18 Legal Basis for Inspections and Penalty Procedures The procedure for competent authority inspections and penalty procedures are governed by the following national legislation: Procedure for inspections: Articles 13 to 19 of Royal Decree 1945/1983 regulating offences and penalties in matters of consumer protection and agri-food production, Articles 77 to 81 of Law 8/2003 on animal health, Articles 48 to 52 of Law 43/2002 on plant health, and Articles 98 and 99 of Law 29/2006 on guarantees and the rational use of medicines and health products. Penalty procedure: Articles 134 to 138 of Law 30/1992 and Royal Decree 1398/1993, of 4 August, adopting regulations on procedures for exercising powers to impose sanctions. Infringements and penalties: Articles 82 to 95 of Law 8/2003 (animal health and animal feed); Articles 2 to 12 of Royal Decree 1945/1983 (health and marketing infringements); Organic Law 12/1995, of 12 December, on repression of contraband (illegal imports or exports); Articles 53 to 65 of Law 43/2002; Articles 32 to 37 of Law 14/1986, the General Health Act (public health and food safety); Articles 100 to 104 of Law 29/2006, the Medicines Act. Laboratories There are 12 National Reference Laboratories (NRLs) for food safety, animal health, animal nutrition and plant health, as described in the following table. The full names of these laboratories may be found in Annex 1. Sector Name of NRL Notes Animal health Milk quality Animal nutrition Central veterinary laboratories in Madrid and Granada (LCVM and LCVGR) CISA-INIA, and CSIC Agri-Food Laboratory in Santander (LAS) CNA Agri-Food Laboratory (LAA) and LCVM Attached to MARM 61 staff in these 2 NRLs Attached to the Ministry of Science and Innovation Attached to MARM Attached to AESAN Attached to MARM Veterinary medicines residues National Food Centre (CNA) Attached to AESAN and contaminants LAA and LCVGR Attached to MARM Pesticide residues LAA Attached to MARM Food hygiene CNA LAA Attached to AESAN Attached to MARM 18

19 Marine biotoxins Plant health Community Reference Laboratory in Vigo (CRL-MB) CSIC-MADRID, PH-MADRID, IVIA-Moncada, and Valencia (2) Attached to AESAN See Annex 1: Table of NRLs The routine control laboratories are designated by the ACs and operate under their control. They perform the majority of analyses related to official controls implemented within their territories. The NRLs perform ring testing with the AC laboratories in some sectors. Laboratory functions are set out in specific rules for each sector. For animal health, their functions, as set out in Article 29 of Law 8/2003 on Animal Health, are to co-ordinate the activities of all officially approved laboratories both public and private, in order to standardise the methods of analysis in all laboratories. In addition, NRLs also have a defined function in confirming the results of laboratory analyses in suspect or positive cases recorded by AC official laboratories and in harmonising methods of analysis of official AC laboratories in national animal health and disease eradication control programmes. Analysis for animal health, feed, and certain residues of VMPs is performed by the routine control laboratories of the CAG-AC. Similarly, the routine control laboratories of the CAG-AC perform analyses of pesticides, and of pesticide residues in the agricultural area. Almost 600 staff are employed in agricultural service laboratories under the control of the ACs. From a food safety perspective, the analysis of foodstuffs is generally performed by routine laboratories which are dependent on the CS-ACs. These laboratories perform analyses for VMP residues, pesticides residues, or contaminants, as well as microbiological analysis in relation to food hygiene. ENAC is the National Body for Accreditation. The Spanish authorities have provided the FVO with lists of laboratories in various sectors and their progress towards accreditation. Progress towards accreditation for VMPs, food hygiene, feedingstuffs, and pesticide residue controls is described in greater detail in Part 3 of the Country Profile. The Spanish authorities provided assurances that ENAC has sufficient resources to ensure that applications for accreditation by all laboratories performing analysis for official controls of food, feed or animal health will be fully assessed by the date prescribed in Regulation (EC) No 2076/2005. Multiannual National Control Plan The Spanish authorities provided a copy of the Spanish multiannual national control plan to the FVO in July Both AESAN and MARM are engaged in parallel activities related to the plan, as described below. AESAN stated that a new version of the plan was being prepared and discussed, subject to the approval by the government of a new Royal Decree to give the plan an adequate legal basis. A new text of this Royal Decree was distributed for comments from the ACs in the AESAN-CI on 29 January The most significant changes to the plan will be made in areas such as risk categorisation and prioritisation of risk (which will become more harmonised), structure and organisation of competent authorities, staff training, and 19

20 annual reports. The AESAN-CI has adopted rules to manage the Commission initiative on "better training for safer food". Audit Systems The AESAN audit procedures provide that audits of official controls by ACs are carried out in line with audit guidelines, to be prepared by a technical group, operating in close collaboration with AESAN and its co-ordination forums. This autonomous group will have an oversight role in relation to audits performed by the ACs. The draft Royal Decree referred to above provides for this power of oversight. Although some ACs have started to implement audit in the public health area, an implementation timeframe is not yet available, either at AC or at central level. AESAN provided audit training to 75 staff from both AESAN and the ACs in 2007, and plan to provide audit training to 125 more staff in MARM has created a body to co-ordinate work on the MANCP with the ACs, and has formed working groups on official controls and on audit. The working groups have prepared: documented procedures for the audit system; guidance on delegated control tasks as defined in Regulation (EC) No 882/2004; a manual for the preparation of documented procedures; a document on the annual report on controls; and a training programme for MARM and the ACs. The audit programme for the period , includes a list of the control programmes, and the autonomous communities being audited, and distinguishes between general audits and specific audits. National Implementing Legislation The legal units of each competent service in Spain plan to review national legislation, including implementing legislation, to ensure that Spanish legislation gives full effect to EU Regulations such as Regulation (EC) No 882/2004. The Technical Secretaries General of both ministries plan to maintain an overview of this process. 20

21 21 Risk assessment, scientific advice SGSPP AESAN & DGG SGCRAA SGCRAA DGRAG AESAN CESMUV AESAN AESAN CCR CEPF Routine Laboratories CAG-AC, CS-AC CAG-AC, CS-AC DGSPSE (MISACO) CAG-AC CAG-AC CAG-AC CS-AC CS-AC DGSPSE (MISACO) CAG-AC &CS- AC CAG-AC &CS- AC CAG-AC NRLs LCV+ 4 CNA & LCR-BM & LAS LCV+ CNA LAA+ 2 LAA+ 2 LCV CNA+ 2 CNA CNA &LAA CNA & LAA LAA LAA 6 NRLs Implementation CAG-AC & SEPRONA CAG-AC, CS-AC, CP- AC Municipalities DGRAG & DGSPSE CAG-AC DGRAG CAG-AC &CS-AC CAG-AC &CS-AC CAG-AC &CS-AC CS-AC, Municipalities DGSPSE CAG-AC, CS-AC, Municipalities CAG-AC, CS-AC & SEPRONA CAG-AC &CS-AC CAG-AC Guardia Civil (SEPRONA & Agrupación de Tráfico CAG-AC Co-ordination Forum CNSASV & CNIGRE CI-AESAN, JACUMAR MCTPOA DGRAG & DGSPSE CNCAA MARM-DGRAG CNPIC-TSE & CNSOA CNCICR CI-AESAN DGSPSE CI-AESAN GTF CEBPAP CEBPAP CFN Policy, co-ordination, EU and International Relations MARM & DGRAG AESAN & MARM DGRAG & DGSPSE MARM-DGRAG MARM-DGRAG MARM -DGRAG & AESAN AESAN &DGRAG AEMPS AESAN, MARM MISACO- DGSPSE, MARM DGSPSE & AESAN MARM-DGRAG MARM-DGRAG- SGEST MARM-DGRAG- SGEST MARM-DGRAG- SGSPP Animal health Food of animal origin Imports of animals and food of animal origin Feedingstuffs Feedingstuffs - imports TSEs\ABP Veterinary residues Veterinary medicines authorisation, marketing and use Food hygiene Imports of food of plant origin Pesticides - residues Pesticides - authorisation, marketing and use Animal welfare - slaughter/farms Animal welfare - transport Plant health The following chart gives an overview of the distribution of responsibilities in relation to control systems and operational levels. More detailed descriptions of the allocation of responsibilities between authorities in relation to each control system are given in the following chapters. Distribution of responsibilities in relation to control systems

22 2. COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS 2.1. Control system for animal health MAPA (DGRAG) Eradications Plans to Commission SGSPP SGEST RAS -Rapid Reaction -Database Dev Control of NRLs NRLs CNSASV CNIGRE CEIEA Ring Testing Co. ordination National Eradication Programmes & Contingency Plans Co-ordination National ID controls RCL Designated by AC 17 ACs CAG-AC Co-ordination Electronic Identification AC Routine Labs (RCL) Co. Ordination Laboratory Accreditation ENAC Agreements with some ACs ~50 Territorial Veterinary Units Management of Comarcal activities Unique delegated competences for each AC SEPRONA ~400 Comarcales ADS Contract staff Movement Controls Controls on: -Animal ID -Animal health -Blood Sampling -Vaccination MARM DGRAG SGSPP SGEST RAS CNSASV NRL Ministry of the Environment, Rural and Marine Affairs Directorate General for Agricultural and Livestock Resources Sub-directorate General for Health of Primary Production Sub-directorate General for Farms and Traceability Systems Rapid Reaction Database Animal health Co-ordinating Committee National Reference Laboratory 22

23 CNIGRE CEIEA Co-ordination Committee for Identification and Registration of Livestock Spanish Committee for Electronic Identification of Animals AC Autonomous Community CAG-AC Ministry of Agriculture and Livestock of the AC ENAC National Body for Accreditation SEPRONA Civil Guard Environmental Protection Service Competent Authorities: National level Within the Directorate General for Agricultural and Livestock Resources of the Ministry of the Environment, Rural and Marine Affairs, SGSPP and SGEST are responsible for animal health and for animal identification respectively. SGSPP transposes EU legislation into national law, and is responsible for co-ordination of animal health activities, including the control of disease outbreaks, contingency plans and national eradication programmes. SGSPP is also responsible for management of all animal health laboratories attached to MARM. It represents Spain in European institutions. SGSPP forwards eradication programme results to the Commission. SGSPP manages co-ordination of animal health through the National Committee for a Veterinary Alert System CNSASV, set up under Law 8/2003 on Animal Health. Chaired by the Director General of DGRAG, it comprises one representative from each AC, and representatives of the NRL. For zoonoses issues, MISACO is represented. CNSASV has set up a number of working groups, which may advise it on issues to be addressed at CNSASV level. CNSASV rules of procedure are based on Article 28 of Law 8/2003, on animal health, and its system for adoption of agreements is based on Chapter II of Title II of Law 30/1992 on Public Administrations and the Common Administrative Procedure. The Health Rapid Reaction Network (SIR) was created in 2001 under article 6 of RD 1440/2001 to deal with disease outbreaks. It is attached to DGRAG of MARM and has powers to assist any AC in the event of a disease outbreak. SIR directly intervenes in disease controls in emergency situations, where action is required by the General State Administration (AGE). It co-ordinates with AC competent authorities, and provides training and expertise in disease control. Its staff are drawn from DGRAG. For AC zoonotic disease controls, such as for salmonella, co-ordination is by SGSPP (through CNSASV for primary production) and by the AESAN Institutional Committee (from the first point of processing). SGEST manages co-ordination of animal identification through the Co-ordination Committee for Identification and Registration of Livestock (CNIGRE), set up under RD 479/2004. It comprises the Sub-director General of SGEST (the Chairman), representatives of all other Sub-directorates of DGRAG, and a representative of each AC. Working groups may also be set up under the framework of CNIGRE, which is required to meet at least every quarter. Six meetings of CNIGRE and six working group meetings related to animal identification took place in A Committee for the Electronic Identification of Animals (CEIEA), set up in 2002, met once in SGSPP is responsible for co-ordination related to controls on semen and embryos. The co-ordination body for semen and embryo controls is CNSASV. 23

24 Competent Authorities: Autonomous Community and local level The autonomous communities are responsible for implementation related to animal identification and animal health, usually through the Central Veterinary Services of the Directorate General for Livestock of the CAG-AC (DGG-AC). If the AC has more than one province, DGG-AC usually has a central office for livestock in each province or territorial veterinary service unit. Provinces are organised at local level where the responsibility for disease control rests with the veterinarians of the local offices and/or the local veterinary units (LVU). Sampling for eradication programmes is normally undertaken by temporarily contracted veterinarians, registered by the AC, or by veterinarians of business entities or associations authorised by the AC to implement programmes e.g. Agrupaciones de Defensa Sanitaria (ADS). Sometimes these tasks, including vaccination programmes, are carried out by local veterinary unit (LVU) veterinarians. In some ACs, the official services have selected an agency by tender to provide private veterinarians on a contract basis. Internal animal movements in some ACs must be certified by an official veterinarian. This certificate may, in some situations be issued by a veterinarian employed by the ADSs. In many ACs, the Police, through the Service for Nature Protection (SEPRONA), take an active role in movement controls. Infringements are communicated to the animal health departments of the CAG-ACs. CAG-AC are usually responsible for salmonella controls for primary production, and CS- AC from the point of first processing onwards. Animal health controls and Contingency Plans Eradication programmes are financed by AC budgets and through periodic transfers from the General State Administration (AGE) to the ACs. The national contact point with EFSA is SGSPP of MARM, for issues such as the national reports on salmonella. The Spanish authorities started an intensified national salmonella surveillance programme in July The Co-ordinated National Contingency Plan for Veterinary Health provides a synthesis of all disease contingency plans in the OIE list A. The plan is complemented by Practical Manuals of Operations for each list A disease. Holding registration, animal identification and movement controls SGEST is responsible for SIMOGAN, the national system since 1998 for bovine animal identification and movement control, and SIMOPORC, the national system since 2003 for pig identification and movement control, which are based on a national network integrating databases from each of the 17 ACs. Since the publication of the Animal Health Law 8/2003, all livestock farms must be registered in the AC where they are located. RD 479/2004 also establishes the General Register of Livestock Farms (REGA), which is managed by SGEST, and is now fully operational for all species in all ACs. This national register (REGA) includes basic data from all the AC registers. 24

25 Royal Decree 728/2007, establishing and regulating the general livestock movement database and the general animal identification database, was published in June On 1 February 2008, data was transferred from SIMOGAN (the bovine database) to REMO the new database to record movements of all livestock species, and to RIIA, the new database for individual identification of animals. In 2007 data was transferred from SIMOPORC (the pig database) to REMO. The Spanish authorities stated that SITRAN, the integrated system for animal traceability, which incorporates REGA, REMO and RIIA, is now operational in all ACs. Laboratories There are four NRLs for animal health in Spain: the MARM Central Veterinary Laboratory in Algete, Madrid (LCVM); the MARM Central Central Veterinary Laboratory in Santa Fe, Granada (LCVGR); the Animal Health Research Centre of the National Agricultural Research Institute of the Ministry of Science and Innovation (CISA-INIA); and the Marine Research Institute in Vigo (CSIC), for fish and bivalve molluscs. LCVM and LCVGR are preparing for accreditation. There are 54 routine control laboratories (RCLs) in the 17 ACs performing controls in Brucella melitensis. An overview of progress towards accreditation is not yet available for these laboratories. 25

26 2.2. Control system for food of animal origin MARM SEMRA (SGMR) ((DGRAG)) SGM (DGRPA) AESAN SGSPP SGEST SGSPP SGCRLA Managing Co-ordination For Primary Milk Managing Co-ordination on Traceabiliy & Labelling Transposition Hygiene Controls on Farms Managing Co-ordination on LBM & Aquaculture Food Safety Managing overall Co-ordination on food safety MSL MCTPOA CNSASV JACUMAR AESAN-CI Part icip ants MISACO MARM ACs Co-ordination Co-ordination: Preparation of National Co-ordinated Control Plan Coord Co-ord of LBM & Aquaculture Controls Co-ord Controls Processed Food 17 ACs CAG-AC CP-AC CS-AC ASA-AC Controls -Traceability & control on farms LBM and Fish Controls Controls -Slaughterhouses -Food Animal Origin MARM SEMRA SGMR DGRAG SGEST SGSPP SGM DGRPA SGCRLA AESAN MCL Ministry of the Environment, Rural and Marine Affairs Secretariat of State for Rural and Water Affairs Secretary General for Rural Affairs Directorate General for Agricultural and Livestock Resources Sub-directorate General for Farms and Traceability Systems Sub-directorate General for Health of Primary Production Secretary General for Marine Affairs Directorate General for Fishery Resources and Aquaculture Sub-directorate General for the Conservation of Coastal Resources and Aquaculture Spanish Food Safety and Nutrition Agency Co-ordination Board for Raw Milk Quality 26

27 MCTPOA Co-ordination Board for Traceability of Products of Animal Origin CNSASV National Committee for a Veterinary Alert System JACUMAR National Advisory Body for Marine Aquaculture MISACO Ministry of Health and Consumer Affairs LBM Live Bivalve Molluscs AC Autonomous Community CAG-AC Ministry of Agriculture and Livestock of the AC CP-AC Ministry of Fisheries of the AC (only in Galicia) CS-AC Ministry of Health of the AC ASA-AC Food Safety Agency of the AC Competent Authorities: National level MARM, through SGSPP of DGRAG, is responsible for legislation and for managing coordination of hygiene controls on primary production (up to the point of first processing). SGSPP manages the co-ordination body for primary production and is responsible for legislation and management of controls of milk quality in primary production. It manages co-ordination in relation to primary production of milk, through the Coordination Board for Raw Milk Quality (MSL). MARM, through SGCRLA of DGRPA of SGM, is responsible for managing coordination of controls on aquaculture and on LBM, in relation to production zones, harvesting and the first transport step. The MARM co-ordination body for fish and LBM controls is the National Advisory Body for Marine Aquaculture (JACUMAR), chaired by the Secretary General for Marine Affairs in MARM. The Conferencia Sectorial de Pesca, chaired by the Minister, and involving participation by the Ministers responsible for fisheries in the ACs, is the highest level of co-ordination. For all subsequent stages of LBM and fish processing, AESAN is the central body responsible for managing co-ordination of controls, and AESAN-CI is the co-ordination body. AESAN-CI co-ordinates with JACUMAR. AESAN is responsible for legislation and for managing co-ordination of all controls following primary production, including all slaughterhouses. AESAN-CI is the coordination committee for these controls. SGEST of MARM is responsible for traceability and labelling of certain animal products of primary production, such as bovine meat. The co-ordination body for traceability is the Co-ordination Board for Traceability of Products of Animal Origin (MCTPOA). Its legal base is RD 1698/2003, which established implementation rules for Community Regulations on labelling of beef. This RD requires the preparation of a National Coordinated Control Plan in consultation with the ACs to meet the requirements of Regulation (EC) No 1760/2000. Salmonella controls are described in chapter 2.1 of the country profile. Competent Authorities: Autonomous Community and local level ACs are responsible for implementation of all controls, by combining the activities of the CAG-AC, and the CS-AC or, in the case of three ACs, the Food Safety Agency of the AC (ASA-AC). Controls on LBM or fish are performed by the various CAG-ACs, except in Galicia, where a separate AC Ministry of Fisheries (CP-AC) performs these controls. 27

28 The delineation of responsibilities between CAG-AC, CS-AC, ASA-AC or CP-AC is a matter for each AC. Registration and approval of establishments A national list of approved establishments is in place since Procedures are not yet in place for the re-approval or reassessment of establishments in line with Regulation (EC) Nos 882/2004 (Article 31) and 853/2004(Article 4). Several establishments were approved without fulfilling all the requirements of Regulation (EC) Nos 852/2004 and 853/2004. Official controls and inspection at establishments Official controls of meat and milk establishments are organised into regional programmes. Systems are being developed by some ACs to establish the frequency of controls. Laboratories The CNA is NRL for most foodstuffs controls. The NRL for LBM diseases is the Institute for Marine Investigation (CSIC). The Community Reference Laboratory for Marine Biotoxins, (CRL-MB) located in Vigo is the NRL. It has recently been absorbed into AESAN. The NRLs for milk are CNA and the Agri-Food Laboratory in Santander (LAS). Progress towards accreditation of AC laboratories is described in Part 3 of the country profile. 28

29 2.3. Control system for imports of animals and food of animal origin MISACO (DGSPSE) (SGSE) MAPA (DGRAG) (SGASCF) MAP Controls Food of Animal Origin Controls Live Animals, and animal by-products 19 Directors (Health) 8 Regional Coordinators Delegate (AC) or Sub- Delegate (province) Monitoring & Authorising BIPs Monitoring & Authorising BIPs 41 BIPs Resources Staff Import Controls MISACO MARM MAP DGSP SGSE DGRAG SGASCF AC BIP Ministry of Health and Consumer Affairs Ministry of the Environment, Rural and Marine Affairs Ministry of Public Administration Directorate General for Public Health Sub-directorate General of External Health Directorate General for Agricultural and Livestock Resources Sub-directorate General for Health Agreements and Border Controls Autonomous Community Border Inspection Post Competent Authorities MARM and MISACO have direct technical and functional responsibility for import controls as central competent authorities. In MARM, SGASCF is responsible for animal health issues (imports of live animals and animal by-products). In addition, there are eight Regional-Co-ordinators, under the responsibility of SGASCF, each of whom is responsible for 2 to 4 BIPs in his respective region. In MISACO, SGSE is responsible for controls on imports of products of animal origin intended for human consumption. SGSE has 19 regional directors, one in each AC and autonomous city. 29

30 Staff resources for BIPs are shown in Annex 2, Tables 1 and 2, for MARM and MISACO respectively. Progress in recruiting additional staff is described in Chapter 3.3 of the country profile. Operationally, BIP staff report directly to MARM and MISACO through the Government Delegations. Although Ceuta and Melilla are part of Spain, they are considered as third countries for veterinary legislation. The Ministry of Public Administration (MAP), of Spain, through the Government Delegate appointed to each AC, or the Government Sub-delegate, appointed to the province, has had administrative competence over BIP staff since 1997, and pays for staff, infrastructure and equipment. BIPs staff are not part of the AC administration, but are part of the central state administration (MARM or MISACO). Import Controls Co-ordination meetings take place regularly between MARM, MISACO, MAP, the state customs authorities and the state ports and airports authorities. Spanish legislation continues to allow products of animal origin from Ceuta, which under veterinary legislation is considered as a third country, to be introduced into the EU without veterinary controls. A system of authorisation and monitoring of BIP installations and import control procedures is in place. The Spanish authorities have stated that 20 BIPs were inspected in 2004 (resulting in two temporary suspensions, one new authorisation and one temporary restriction of use), 39 in 2005 (resulting one delisting and one temporary restriction of use) and 31 in

31 2.4. Control system for feedingstuffs and animal nutrition Feedingstuffs Controls Feedingstuffs Import Controls Approval of Importers MARM DGRAG (SGCRAA) MARM DGRAG (SGASCF) Reporting Managing Co-ordination Management of BIPs Reporting CNCAA 8 Regional Coordinators Coordinated Plans RASSF SILUM 30 Entry Points Reporting NRLs Ring Tests Labs Results Ring Tests 17 ACs CAG-AC ~50 Territorial Veterinary Units Approval & reg of Establishments Import Controls Accreditation ENAC Management of Comarcal Activities ~400 Comarcales Controls Samples Inspections -Establishments -Intermediaries -On-farm production -Mobile Mixers -Farms MARM DGRAG SGCRAA SGASCF CNCAA AC CAG-AC NRL ENAC Ministry of the Environment, Rural and Marine Affairs Directorate General for Agricultural and Livestock Resources Sub-directorate General for Conservation of Resources and for Animal Feed Sub-directorate General for Health Agreements and Border Controls National Animal Feedingstuffs Co-ordinating Committee Autonomous Community Ministry of Agriculture and Livestock of the AC National Reference Laboratory National Body for Accreditation 31

32 Competent Authorities: National level MARM, through SGCRAA, is the CCA for animal nutrition, including GMOs in feedingstuffs. SGCRAA responsibilities include legislation, co-ordinating AC activities (including the preparation of the National Co-ordinated Animal Feedingstuffs Control Plan, and the Feedingstuffs Contingency Plan (POI)), and interacting with the European Commission. SGCRAA and SGASCF are the central authorities responsible for implementing import controls of feedingstuffs. There is a specific module for controls on points of entry within the Co-ordinated Control Plan. A national rapid alert alert network has been set up within the POI, with a specific communications module in the SILUM animal feed database; the legal basis for the information exchange system is at an advanced stage. A co-ordination office with eight regional co-ordinators is established in the SGASCF of DGRAG to supervise the whole system. Co-ordination and supervision of import controls takes place at central level between SGCRAA and SGASCF via inter-service consultations. DGRAG is the national contact point for the RASFF for feedingstuffs, and co-ordinates with other national CAs dealing with alerts, especially AESAN. The Contingency Plan clarifies RASFF responsibilities for animal feedingstuffs. The National Animal Feedingstuffs Co-ordinating Committee, CNCAA, composed of SGCRAA and the ACs, has been addressing supervision and co-ordination with the ACs and sectoral representatives since CNCAA now has a legal basis, with the adoption of RD 1144 of 6/10/2006. It met on six occasions in The Committee s main tasks are follow-up and co-ordination with the ACs on the implementation of Community and national rules on feedingstuffs, proposing modifications necessary to achieve effective compliance with control objectives, advising ACs, proposing studies and proposing co-ordinated control plans on animal feedingstuffs. Competent Authorities: Autonomous Community and local level ACs are responsible for implementation of controls in the feedingstuffs sector, approval and registration of establishments, controls on production, placing on the market and testing of feedingstuffs. Registration and approval of establishments and intermediaries The central government, in agreement with the ACs, has created an information system (SILUM) which assists in the uniform management of the feedingstuffs sector in all ACs. This system is fully operational and contains the register of authorised and registered establishments, information on laboratories and on the register of authorised importers. It may be consulted for information on many products (such as additives, permitted and prohibited raw materials, medicated pre-mixes, bioproteins and other substances). Furthermore, it has a specific module to manage the co-ordinated control plan and a module to manage the national alert network for animal feedingstuffs. Feedingstuffs legislation may also be accessed in this system. 32

33 Official controls ACs implement national legislation by means of their own regional provisions in line with general guidelines agreed in the Co-ordinated Animal Feedingstuffs Control Plans. ACs co-ordinate controls carried out by local services in their respective regions. ACs are required to send annual reports on their control activities to SGCRAA. These reports are used to evaluate the outcome of the control programmes, and the performance of the administrative services of the ACs. Consolidated data on controls performed in Spain during 2007 was provided during the 2008 GRM. Laboratories There are three NRLs for Feedingstuffs, all of which are attached to MARM: the Agri- Food Laboratory (LAA); the Central Veterinary Laboratory (LCVM) in Algete, Madrid; and the Central Veterinary Laboratory in Santa Fe, Granada (LCVGR). CNA also acts as a NRL for some feed analyses. SGCRAA has drawn up a list of 29 laboratories designated by the 17 ACs to perform analyses on feedingstuffs. These laboratories are usually attached to the Ministry of Agriculture of the AC (CAG-AC). Information on progress towards accreditation is contained in Part 3.4 of the country profile. 33

34 2.5. Control system for TSEs and Animal By-Products (ABP) TSE MARM (DGRAG) ((SGSPP & SGCRAA)) (Chair of CNSASV) MISACO (DGSPSE) Co-ord epidemiosurveillance, scrapie monitoring Feed ban Co-ordination AESAN Coordination -SRM CNSASV Co-ordination -legislative -advice - information gathering research 17 ACs CAG-AC CS-AC Delegated Competencies in some ACs Controls: -epidemiosurveillance -scrapie monitoring -feed ban ~50 Territorial Veterinary Units Establishment controls (Food An Origin) ~74 Territorial Health Service Units ADS ~400 Comarcales Local Units Controls Controls Controls MARM DGRAG SGSPP SGCRAA MISACO DGSPSE AESAN SRM CNSASV AC CAG-AC Ministry of the Environment, Rural and Marine Affairs Directorate General for Agricultural and Livestock Resources Sub-directorate General for Health of Primary Production Sub-directorate General for Conservation of Resources and for Animal Feed Ministry of Health and Consumer Affairs Directorate General for Public and External Health Spanish Food Safety and Nutrition Agency Specified Risk Materials National Committee for a Veterinary Alert System Autonomous Community Ministry of Agriculture and Livestock of the AC 34

35 CS-AC Ministry of Health of the AC Competent Authorities: National level: The CCAs responsible for co-ordinating TSE controls are the DGRAG of MARM and AESAN. DGRAG, through SGSPP, is responsible for BSE epidemio-surveillance and for scrapie monitoring, and for associated transposition. SGSPP also provides financing for the annual scrapie eradication and monitoring programme. SGCRAA of DGRAG is responsible for feedban controls through the National Co-ordinated Feedingstuffs Plan, and for associated transposition. AESAN is responsible for co-ordinating the control of SRM and other animal byproducts with the ACs, and for associated transposition of legislation. The National Co-ordinating Committee for Integrated Control of TSE, (CNPIC-TSE), has been convened twice since the adoption of RD 3454/2000 in December CNPIC-TSE s mandate was to periodically revise the National Co-ordinated TSE Programme through consultation with the ACs, and to monitor implementation. In recent times, its responsibilities have been assumed by the animal health coordinating committee CNSASV, or its working groups. Throughout 2007, TSEs were discussed in five CNSASV meetings, and in one working group meeting. Feedban co-ordination is explained in Part 2.4. A summary of the state of play from the 2007 FVO scrapie inspection is contained in chapter Competent Authorities : Autonomous Community and local level The ACs are responsible for implementation. CAG-AC is generally responsible for epidemio-surveillance, scrapie monitoring and feedban controls. CS-AC is generally responsible for SRM controls. Laboratories The Central Veterinary Laboratory in Algete, Madrid (LCVM) is the single NRL for TSEs in Spain. Laboratories for controls on feedingstuffs are described in Part

36 ABP MARM DGRAG (Chair of CN- SANDACH) MISACO MARM AESAN Co-ord fallen stock & ABP estabs CN-SANDACH Co-ord Coordination ABP in food establishments Env coordination Co-ordination - legislative -advice - information gathering - research 17 ACs CAG- AC CS-AC CMA- AC Fallen Stock Controls Food establishment controls Env Controls MARM DGRAG CN-SANDACH MISACO AESAN AC CAG-AC CS-AC CMA-AC Ministry of the Environment, Rural and Marine Affairs Directorate General for Agricultural and Livestock Resources National Committee on Animal By-Products Ministry of Health and Consumer Affairs Spanish Food Safety and Nutrition Agency Autonomous Community Ministry of Agriculture and Livestock of the AC Ministry of Health of the AC Ministry of Environment of the AC Competent Authorities: National level MARM, through its Secretariat of State for Rural and Water Affairs, is responsible for AC co-ordination along the ABP chain for non-food premises e.g. collection and disposal of fallen stock and for establishments as outlined in the ABP Regulation. MARM is also responsible for international affairs and for implementation of import controls of ABP. MARM is responsible, through its Secretariat of State for Climate Change, for coordination of controls on incineration, co-incineration and landfill. 36

37 The co-ordinating body is the National Committee on Animal By-Products (CN- SANDACH), chaired by MARM. AESAN holds the post of Vice-Chairman. CN- SANDACH reviews and proposes legislation, advises AC competent authorities, proposes scientific research and collects information on ABP. One meeting of CN SANDACH took place in One ABP co-ordination meeting between AESAN and MARM, and one ABP working group meeting also took place. Competent Authorities: Autonomous Community and local level The 17 ACs are responsible for implementation. The CAG-AC are usually responsible for fallen stock and ABP establishments; CS-AC are usually responsible for ABP in the food industry. AC controls are organised at three levels (Regional/provincial/local). In some ACs, ABP establishments may be authorised by the AC Consejeria of the Environment (CMA-AC). CS-AC are usually responsible for ABP in the retail sector, except for certain communities, where the municipal administration may be in charge (e.g. Madrid and Barcelona). Approval of ABP plants and other premises The Spanish authorities have stated that a database on authorised establishments, with access for the ACs, is now operational and is accessible at Official controls A manual of good practice for the different sectors (e.g. slaughterhouses, retail sectors, and incinerators), has been adopted. A manual on the disposal of fallen stock is available on the CCA website. The 2007 FVO inspection report found that controls on ABP commercial documents continued to be unsatisfactory since the 2006 inspection. A summary of the state of play in relation to the 2007 inspection is contained in Part

38 2.6. Control system for veterinary medicines and residues Residues of Veterinary Medicines Veterinary Medicines Authorisation Marketing and use AESAN (Chair of CNCICR) MISACO DGSPSE (SGSE) MARM DGRAG (SGSA) MISACO (DGFPS) EU Commission Co-ordination Min. Justice AESAN Co-ord AEMPS Control of Marketing Authorisation NRCP CNCICR Min. Interior MARM - Co-ordination - Preparation of NRCP - Info from ACs - Each AC prepares plan 4 NRLs CAG - AC 17 ACs CS- AC CAG - AC 17 ACs CS- AC Designation AC Routine Control Labs Accreditation Controls on agricultural distributors Controls on pharmacies ENAC Controls live animals and on farms Controls Animal Products AESAN CNCICR MISACO DGSPSE SGSE MARM DGRAG SGSPP DGFPS AEMPS NRL AC CAG-AC CS-AC ENAC Spanish Food Safety and Nutrition Agency Residues Co-ordination Body Ministry of Health and Consumer Affairs Directorate General for Public and External Health Sub-directorate General of External Health Ministry of the Environment, Rural and Marine Affairs Directorate General for Agricultural and Livestock Resources Sub-directorate General for Health of Primary Production Directorate General for Pharmaceuticals and Health Products Spanish Medicines Agency National Reference Laboratory Autonomous Community Ministry of Agriculture and Livestock of the AC Ministry of Health of the AC National Body for Accreditation Veterinary Medicinal Products (VMP) Competent Authorities: National level At national level, the Spanish Medicines Agency (AEMPS) is responsible for marketing authorisations for veterinary medicinal products (VMPs). AEMPS is an autonomous body affiliated to MISACO. There is no central body designated by law to co-ordinate 38

39 controls on the distribution and use of VMPs throughout Spain. A draft Royal Decree, on authorisation and registration of VMPs, is awaiting a decision from the Council of State. The legal basis for co-ordination of controls on the distribution and use of VMPs will be provided through another Royal Decree, which will be drafted and administered by MARM. The role of the Ministry of Interior in VMP controls during transport, or while held on farms, remains unclear. Competent Authorities: Autonomous Community and local level ACs are responsible for control of the distribution and use of VMPs. Within the ACs, CAG-AC and CS-AC are usually responsible for authorisation of, and controls on, wholesalers, authorised distributors operated by farmers associations and retailers or pharmacies selling VMPs. Responsibilities vary between ACs. Official controls on marketing/use According to Spanish legislation, premises distributing VMPs should be controlled at least once a year. Authorisation can be for a period of up to 5 years. All ACs have now designated a CA empowered to carry out controls on premises distributing VMPs, which is normally either the agriculture or health ministry. The use of medicines on farms is always under the control of the agricultural services of the ACs. A new manual of procedures for controls is expected in mid Residues Competent Authorities: National level MARM (DGRAG) and AESAN are the CCAs for residue controls in live animals and animal products. AESAN transposes community legislation on residues. In relation to the NRCP, MARM co-ordinates sampling activities on farms, and the communication of results. AESAN co-ordinates sampling in establishments. Results are communicated through the CNCICR. MARM (DGRAG) through SGSPP, and MISACO (DGSPSE), through SGSE, are responsible for import controls. The CNCICR, created in 1998, is the residues co-ordination body established by RD 1749/1998. The CNCICR is made up of representatives from MISACO, AESAN, MARM the Ministry of Justice, the Ministry of the Interior and each AC. The Chairman is the Executive Director of AESAN. It is assisted by the NRLs. The CNCICR is responsible for preparing the NRCP, based on information provided by each AC, for communicating this plan to the European Commission, for co-ordinating the activities of the central services and the ACs, and for convening co-ordinating meetings with the ACs to evaluate measures applied and results obtained in the ACs and their compliance with Community law. CNCICR may set up working groups which report to it on issues such as preparation of protocols, or evaluation of AC residue plans. The CNCICR annually reviews the implementation of the previous year s NRCP. While the CNCICR may make suggestions to improve implementation, it does not have any power to instruct ACs to take action in response to its proposals. 39

40 Competent Authorities: Autonomous Community and local level ACs are responsible for implementation of residue controls for the internal market. Each AC draws up its own residue control plan, following the suggestions of the co-ordination body, CNCICR. Official controls on residues Each AC designates one co-ordinator responsible for the preparation of its residues monitoring plan. Sampling of live animals is generally carried out by the services responsible for animal health in the CAG-AC. Sampling of animal products is carried out by the services responsible for food safety, the CS-AC. The CAG-AC is responsible for authorisation and registration of feed mills producing medicated feedingstuffs. Laboratories NRLs are designated by AESAN and by MARM. There are now three NRLs in Spain. The CNA is affiliated to AESAN. The LAA and the LCVGR are affiliated to MARM. The LCVM has discontinued its NRL function. More than 50 laboratories, each appointed by its corresponding AC, carry out routine analyses in Spain. 40

41 2.7. Control system for foodstuffs and food hygiene European Commission Official control results: RASFF AESAN Transposition AESAN-CI Preparing control procedures; Co-ordination of training; Advice Food Policy SCIRI Co-ordination: -Preparation of National Control Plan & AC plans Reporting results 17 ACs DGSP of CS-AC Rapid Alert 59 AC Laboratories Accreditation ASA-AC (3) ENAC Preparation of AC control plans Territorial Services Municipalities Local Services Controls Sampling AESAN-CI SCIRI AC CS-AC DGSP RASFF ASA-AC ENAC Spanish Food Safety and Nutrition Agency- Institutional Committee AESAN System for Monitoring Rapid Alerts Autonomous Community Ministry of Health of the AC Directorate General for Public Health of CS-AC Rapid Alert System Food Safety Agency of the AC National Body for Accreditation 41

42 Competent Authorities: National level AESAN is the CCA for the co-ordination of foodstuffs and food hygiene controls (including pesticide residues and contaminants in food, and irradiated food), excluding import controls. AESAN is also responsible for GMO controls in relation to food safety under Regulation (EC) No 1829/2003. MISACO remains responsible for import controls of foodstuffs, international relations and agreements. AESAN is responsible for drafting legislation through an Inter-ministerial Committee on Food Regulations. Co-ordination between AESAN and the CS-ACs is organised through the Institutional Committee of AESAN (AESAN-CI), as described in Part 1 of the country profile. The committee normally meets every two months; special meetings may be organised on the chairman's initiative or at the request of a third of its members. The AESAN Technical Consensus Group meet every 2 months, and have responsibilities inter alia for co-ordination of laboratories, ratio of inspectors to establishments, risk assessment, contaminants, and salmonella. Competent Authorities: Autonomous Community and local level The 17 ACs and the Municipal Authorities (MAs) of the ACs are responsible for implementation. In certain instances, the local municipal administration, which operates autonomously, may carry out official control of foodstuffs, in respect of inspection and sampling. ACs may enact additional detailed legislation, provided that it is within the framework of national legislation. Guidance on the interpretation of this legislation is provided by the central services of the ACs. ACs are responsible for their own organisational structures and resources and for co-ordinating and implementing food safety controls within their geographical areas. Official controls of food premises In the ACs, the CS-AC, through their respective DGSPs, or, as appropriate, the ASA-AC, issue instructions/technical programmes/guidelines to territorial services or districts. Territorial services, often covering a province, are usually organised into smaller more local areas, as shown in Table 5 of Annex 2, covering one or more municipalities. They are responsible for performing the official control of foodstuffs and have a degree of autonomy, within the guidelines issued by the central services, for organising the resources available. Good Hygiene Practice Guides Some 30 HACCP Guides, and 5 Guides to Good Practice are in use at national level, in addition to guides in use in the autonomous communities. Rapid Alert System for Food and Feed The AESAN system for managing rapid alerts related to foodstuffs is SCIRI (Sistema Co-ordinado de Intercambio Rápido de Información). The Executive Director of AESAN and the Sub-director General of SGCAPCO are the National Contact Points (NCP) for RASFF. In parallel, the DGSP-AC are the SCIRI contact points in the ACs. An internal procedure has been agreed with the ACs to facilitate management of the system. 42

43 Laboratories The CNA and the LAA are the NRLs for foodstuffs. Progress towards accreditation of the AC laboratories is described in Part 3.7 of the country profile. 43

44 2.8. Control system for imports of food of plant origin RASFF AESAN Coordination MISACO (DGSPSE) (SGSE) Co-ord meetings Customs Management of BIPs; Instructions Ref Lab CNA 19 Directors (Health) Technical advice Some routine analysis Monitoring & Authorising BIPs ENAC Accreditation Control Labs Routine Analysis 49 BIPs authorised for Imports Import Controls Sampling MISACO DGSPSE SGSE AESAN BIP CNA ENAC Ministry of Health and Consumer Affairs Directorate General for Public and External Health Sub-directorate General of External Health Spanish Food Safety and Nutrition Agency Border Inspection Post National Reference Laboratory National Body for Accreditation Competent Authorities MISACO is responsible for implementing import controls of all foodstuffs. Controls take place for irradiated food, mycotoxins, GMOs, pesticide residues and 3-MCPD contamination. SGSE issues instructions for inspection and sampling activities at the points of import. AESAN has no implementation role, but as the national contact point for RASFF in Spain, it co-operates with SGSE. AESAN, through the NRL (CNA), has also supported MISACO in preparing to implement GMO legislation on imports. ACs have no responsibilities for import controls of food, apart from the laboratories described below. Control activities and enforcement actions are discharged by the peripheral services of SGSE, at the points of import. For aflatoxin controls, the number of designated points of 44

45 entry has been reduced from 49 to 15. In most cases these are physically located at the same BIPs referred to in Part 2.3 of the Country Profile. Import Controls Spain has a clearly defined structure of CAs responsible for import controls, with vertical communication pathways in place. The customs clearance system requires that all imported foodstuffs is notified to and approved by the relevant peripheral services of SGSE. Meetings take place at central level between the customs authorities, the port and airport authorities and SGSE. Controls for GMOs take place at two BIPs (Barcelona and Bilbao) which are the major import points for products containing GMOs. All imported foodstuffs of plant origin undergo undergo documentary controls, but identity and physical checks are performed only when required. Instructions are in place on the frequency of controls. The frequency and method of sampling are generally in compliance with Community rules. Instructions are in place for dealing with noncompliant lots. Laboratories CNA and LAA are the NRLs for GMOs and pesticide residues. CNA is the NRL for mycotoxin analysis in foodstuffs. Ten routine control laboratories have been approved by the ACs for aflatoxin analysis, of which seven are accredited. There are 21 laboratories for mycotoxin analysis (six already accredited) in 10 ACs. Two laboratories, including CNA, are equipped and accredited for 3-MCPD analyses. Although there is no official laboratory equipped for the analysis of irradiated food products, negotiations were completed in 2006 to use the research laboratory of the Ministry of Science and Innovation (formerly the Ministry of Education and Science). 45

46 2.9. Control system for pesticides Authorisation, Marketing and use Pesticide Residues Transposition CEPF Transposition RASFF MARM (DGCEA Authorisation of PPPs Co-ordination MARM (DGRAG) (SGMP) Auth Process MISACO (DGSPSE) MARM PPP Import Controls Import Controls Residues MISACO (DGSPSE) CCR Co-ord MARM (DGRAG) AESAN AESAN -CI PPP Working groups Preparation National Control plans Co. Ordination of National Control Plans marketing & use 17 ACs CAG-AC CS-AC -Transposition. -Joint CCAs for classification packaging & labelling Res ults LAA (NRL) ENAC Accred itation ENAC Establish MRLs Acc. CAG- AC 17 ACs CS-AC Co-ordinate pesticide residue controls ~50 Territorial Agriculture Units Agreements between SEPRONA and some ACs ~74 Territorial Health Service Units 4 Regional Labs 15 Regional Labs ~50 Territorial Agriculture Units ~74 Territorial Health Service Units SEPRONA Controls on use Controls on marketing & authorisation. Residue Controls at-origin Residue Controls in the market CEPF Commission for Evaluation of Phytosanitary Products MARM Ministry of the Environment, Rural and Marine Affairs DGRAG Directorate General for for Agricultural and Livestock Resources SGMP Sub-directorate General for Means of Production DGCEA Directorate General for Quality and Environmental Assessment of MARM MISACO Ministry of Health and Consumer Affairs DGSPSE Directorate General for Public and External Health AESAN Spanish Food Safety and Nutrition Agency CCR Joint Commission on Plant Protection Product Residues AESAN-CI Spanish Food Safety and Nutrition Agency- Institutional Committee ENAC National Body for Accreditation AC Autonomous Community CAG-AC Ministry of Agriculture and Livestock of the AC CS-AC Ministry of Health of the AC LAA Agri-Food Laboratory in Madrid SEPRONA Civil Guard Environmental Protection Service 46

47 Control of marketing and use Competent Authorities: National level DGRAG of MARM, through SGMP, is responsible for transposition of Directive 91/414/EEC on placing PPPs on the market, and for authorisation of PPPs. The Spanish authorities consider that SGSE has some competencies for controls on pesticide imports, based on Royal Decree 1418/1986 (on external health functions of MISACO). MARM also has competencies under Royal Decree 2163/1994 (on authorisation of PPPs). Customs also have competencies under this Royal Decree for controls on imports. Until now, SGMP has co-ordinated with the ACs in the preparation and implementation of control programmes through the Plant Health Working Groups (GTFs). A new Royal Decree on co-ordination of official controls on PPPs is expected to enter into force in Article 5 provides for the establishment of a co-ordinating committee. Competent Authorities: Autonomous Community level ACs are responsible for implementing all other controls. Controls on marketing (including classification, packaging and labelling, and whether the PPP is authorised) are generally by CAG-AC or by the Civil Guard Environmental Protection Service (SEPRONA). Controls on use of PPPs are usually by CAG-AC or SEPRONA. The CAG-AC also manages the official register of PPP establishments. Each province has an office, where producers and distributors of PPPS are obliged to register. Some ACs have signed collaboration agreements with SEPRONA. DGRAG co-ordinates the logistics for the collection and transfer of samples to laboratories. Authorisation of PPP The authorisation procedure by DGRAG involves reports from DGSPSE of MISACO and from DGCEA of MARM, which hold exclusive competencies for classification, packaging and labelling, in accordance with Directive 1999/45. Reports are also received from the advisory body, the Commission for Evaluation of Plant Protection Products (CEPF), which includes representatives of four ministries (including MISACO), research centres and various bodies, including the ACs. DGA is responsible for maintaining a register of PPPs, which is available at Official controls on marketing/use SGMP co-ordinates and consults with ACs in drafting national plans for the control of marketing and use of PPPs. The national plans set out the number and type of controls, and of samples to be taken by each AC, as well as the laboratories to be used. Manuals of procedure for controls on marketing and use are being revised to take the requirements of Regulation (EC) No 882/2004 into account. DGRAG sends annual reports to the Commission on AC controls, in accordance with Article 17 of Directive 91/

48 Law 43/2002, on Plant Health, establishes sanctions for non-compliances related to PPP marketing and use. Specific procedures for inspections and sanctions are set out in Royal Decree 1945/1983, and in Law 30/1992. Each AC establishes its own measures for sanctions through its respective CAG-AC. Laboratories The NRL, which is the central Agri-Food Laboratory of MARM in Madrid (LAA), and four regional laboratories conduct formulation analyses. They analyse PPP samples taken in the market place for identity and content of active substance only. LAA has increased the scope of its accreditation under ISO 17025, from two methods covering two active substances, by applying to ENAC for "open" accreditation. Thirty five active substances were accredited by February Residues Competent Authorities: National Level AESAN and MARM are jointly the CAs for transposition of EU legislation for pesticide MRLs in foodstuffs of plant origin. AESAN is the CA for transposition relating to pesticide MRLs in baby food. The Joint Commission on Plant Protection Product Residues (CCR) made up of DGSPSE of MISACO, DGRAG of MARM and AESAN, adopts EU MRLs, and establishes national and provisional MRLs. When Annexes II and III of Regulation (EC) No 396/2005 enter into force in September 2008, the functions of the Joint Commission will cease. DGSPSE remain responsible for control of pesticide residues on imported foodstuffs. AESAN is now the point of contact with the Commission for sending results of controls on pesticide residues in food of plant origin. Competent Authorities: Autonomous Community Level ACs are responsible for implementation of MRL controls. The legal basis for implementation may include EU, national law and AC law. CAG-AC is responsible for controls at-origin, and CS-AC for controls on the market. Co-ordination may take place between CAG-AC and CS-AC in some ACs, e.g. through the Comision Mixta in Valencia, or through the Interdepartmental Committee for Pesticides in Cataluña. Official controls on residues The National Pesticide Residues Control Programme in Spain integrates controls performed by the ACs. This programme is made up of two sub-programmes, one at origin, on primary production, and another on the market. DGRAG is responsible for co-ordination of controls at origin, and AESAN is responsible for co-ordination of controls on the market. The programme of controls "at-origin" sets a number of samples to be taken at points where farmers deliver their crops to secondary operators. Noncompliances from controls "at-origin" lead to controls on farms, and increased checks during the "at-origin", and marketing stages. The 2008 plan developed by ACs and coordinated by AESAN-CI, includes unauthorised products. The authorities plan to have a single control plan for the whole food chain. 48

49 The Executive Director and the Sub-director General of SGCAPCO of AESAN are the national contact points (NCP) for RASFF. Laboratories LAA of MARM is the NRL for pesticide residue analysis for food of plant origin. Progress of routine control laboratories towards accreditation is described in Part 3.9 of the country profile. 49

50 2.10. Control system for animal welfare BIP Controls on animal transport MARM (DGRAG) (SGEST) Policy Legislation Co-ordination (future) NGOs CEBPAP Co-ordination on Welfare at Slaughter AESAN Preparation of National & AC Control Plans: Prep. Of Guidelines CAG-AC 17 ACs CS-AC Sanctions (future) ~50 Territorial Veterinary Units Agreements between Civil Guard and some ACs ~74 Territorial Health Service Units ~400 Comarcales Civil Guard Local Units AW Controls On farm & Transport AW Controls Transport AW Controls Slaughter MARM DGRAG SGEST NGO AESAN CEBPAP BIP AC CAG-AC CS-AC Ministry of the Environment, Rural and Marine Affairs Directorate General for Agricultural and Livestock Resources Sub-directorate General for Farms and Traceability Systems Non-Governmental Organisation Spanish Food Safety and Nutrition Agency Spanish Co-ordination Committee for Animal Welfare Border Inspection Post Autonomous Community Ministry of Agriculture and Livestock of the AC Ministry of Health of the AC 50

51 Competent Authorities: National level MARM, through SGEST of DGRAG, is responsible for animal welfare. Responsibilities include transposition, communications with the Commission, and managing coordination with ACs. Every 2 years, MARM sends the Commission the results of onfarm inspections, as required by Community legislation (Directive 98/58/EEC). Annual reports are also sent in relation to animal transport (Directive 91/628/EEC). The new Animal Welfare Law 32/2007, which provides a legal basis for sanctions, entered into force in December AESAN plays a role with SGEST in jointly drafting legislation on animal welfare in slaughterhouses. The Spanish Committee for Animal Welfare (CEBPAP), chaired by the Director of DGRAG, was set up with a legal basis in Real Decreto 751/2006 (on animal transport) of June It includes representatives of the 17 ACs, AESAN, organisations representing the livestock sector and NGOs. Five co-ordination meetings took place between the beginning of December 2006 and the end of During the same period two working group meetings took place, one on animal welfare during transport, and one on animal welfare at-slaughter. The framework control plan for the period was adopted in December Guidance documents and checklists for animal welfare inspections on-farm, in slaughterhouses and during transport, are under preparation, and are expected to be adopted in a co-ordination meeting with the ACs. It is expected that ACs will use these documents as a basis for preparing their own documented procedures. The Spanish authorities have started to consider in the CEBPAP co-ordination committee the specific actions necessary to verify the effectiveness of animal welfare inspections. Competent Authorities: Autonomous Community level Implementation is the responsibility of the ACs. They may also adopt their own legislation. The CAG-AC is usually the competent authority for animal welfare on-farm and during transport in the AC, and grants authorisations of transporters and approvals of livestock vehicles. Although the CAG-AC is the competent authority in each AC for animal welfare, the CS-AC usually performs controls for animal welfare at slaughter. Official controls on farm The Directors General of ACs with more than one province usually meet regularly with the Directors of their provincial services. The role played by local veterinary units in each AC is related to controls on farms and on transport, within the particularities of each AC organisational system. Official controls during transport MARM is responsible for SIRENTRA, the national database for transporters and means of transport for live animals, under Regulation (EC) No 1/

52 The Civil Guard Traffic Association, or SEPRONA or the police of the AC may perform controls on animal welfare during transport in the ACs. Official controls at slaughter Although DGRAG is the CCA for animal welfare, they have received no reports on animal welfare controls performed by ACs at slaughter. It is not yet clear whether AESAN receive such reports from all ACs, or whether each AC has such reports available as a basis for assessing the effectiveness of inspections, as required under Regulation (EC) no 882/2004. There are co-ordination agreements in place in most ACs between their respective CS-ACs (responsible for slaughter controls) and CAG-ACs (responsible for transport controls). 52

53 2.11. Control system for plant health Plant Health Controls Plant Health Import Controls Policy Legislation MAPA (DGRAG) SGSPP SGASCF 6 NRLs Managing Plant Health Co-ordination. Authorisation & management of BIPS National Coordinator Customs 14 Working groups Support to CFN CFN 11 Regional Coordinators Co-ordination. Agreeing on -National Plans -Contingency Plans -Manuals Coordination Analyses results 16 ACs CAG-AC Control 16 Central Plant Health Services 39 BIPs Import Controls 29 AC labs Management of provincial services 37 Provincial Plant Health Services Controls MARM DGRAG SGSPP Ministry of the Environment, Rural and Marine Affairs Directorate General for Agricultural and Livestock Resources Sub-directorate General for Health of Primary Production 53

54 SGASCF NRL CFN AC CAG-AC BIP Sub-directorate General for Health Agreements and Border Controls National Reference Laboratory National Plant Health Committee Autonomous Community Ministry of Agriculture and Livestock of the AC Border Inspection Post Competent Authorities: National level MARM, through SGSPP of DGRAG is the CCA for plant health. SGSPP represents Spain at international level, is in charge of plant health policy, and is responsible for transposing the relevant EU legislation and for managing co-ordination. Co-ordination of activities is discussed at national level within the National Plant Health Committee (CFN), established in It is chaired by the Director General of DGRAG, includes representatives from all ACs and meets at least quarterly. CFN is supported by 14 working groups, which deal with specific production sectors. SGASCF is operationally responsible for import controls related to harmful organisms for plant health. Competent Authorities: Autonomous Community level Spain is made up of 17 ACs, of which only 16 are included in the EU plant health system. Until now, the Canary Islands AC is considered as a third country with respect to the EU and a phytosanitary certificate is necessary for plants and plant products originating there. Currently, the CCA is developing a Pest Risk Analysis according to Council Directive 2000/29/EC, in preparation for submitting a request to the Commission to include the Canary Islands as part of the EU for plant health purposes. Each AC has a Central Plant Health Service and some ACs (Andalucía, Castilla y León, Castilla-La Mancha, Cataluña, Extremadura, Galicia, Pais Vasco, and Valencia) have also provincial offices (Provincial Plant Health Services). There are no comarcal or local units. Thus, the Central Services for Plant Health of each AC and, as appropriate, the Provincial Plant Health Services are responsible for plant health controls. Plant passport system and internal market checks At national level, AC activities have been harmonised by the agreement reached within CFN on 31 October 2006 between SGAISV (now SGSPP) and ACs, and by the manual of procedures on internal market controls adopted in the CFN in September 2005, which, in Section 8, specifically refers to the issue of consistent implementation by ACs. (A manual of procedures on potato diseases, adopted in the CFN in June 2006, is also fully applicable in all ACs.) This agreement commits the ACs to send to SGSPP of DGRAG by 30 January each year, a plan of activities containing a forecast of inspections, and a report containing the results of the previous year's inspection activities, including the number of samples taken. Analysis and discussion of each AC's plan of activities and the results of previous controls, take place during CFN co-ordination meetings. ACs plan their work within specific plant 54

55 health programmes and priorities are defined, based on what is agreed within the CFN, and on the results of the previous campaign. Quarterly meetings are organised at AC level between all provincial plant health offices, also involving municipalities when necessary. Import controls SGASCF is operationally responsible for import controls. There are 39 BIPs where plant health controls are performed. For import control purposes, Spain is divided into seven plant health zones. Co-ordination is carried out through one national and 11 regional coordinators. These regional co-ordinators are responsible for supervising and harmonising the application of the national and EU legislation at BIP level. The national co-ordinator is mainly responsible for export related activities. Laboratories The AC diagnostic laboratories are responsible for analysis of samples taken as part of internal market controls. There are 29 AC laboratories, at lease one per AC, with the exception of Madrid, which has an agreement with other laboratories. In addition, the NRLs perform analysis of non-routine samples, of organisms which are difficult to identify, confirmatory analyses, and analyses in cases where a harmful organism has been detected for the first time in Spain. In all these cases the AC or the BIP laboratories send the samples to the NRLs. At present there are six NRLs, covering each group of harmful organisms. The NRL for insects is Escuela Técnica Superior de Ingenieros Agrónomos of Madrid Polytechnical University. The NRL for nematodes is Centro de Ciencias Medioambientales de Madrid - Consejo Superior de Investigaciones Científicas of the Ministry of Education and Science. The two NRLs for viruses are the Instituto Valenciano de Investigaciones Agrarias (for woody plant species) and the Escuela Técnica Superior de Ingenieros Agrónomos of Valencia Polytechnical University (for non-woody plant species). The NRL for bacteria is Instituto Valenciano de Investigaciones Agrarias. The NRL for fungi is the Escuela Técnica Superior de Ingenieros Agrónomos of Valencia Polytechnical University. 55

56 3. FOLLOW-UP OF FVO INSPECTIONS This part of the country profile gives an overview of the action taken on the recommendations made by the FVO to the Spanish authorities in its inspection 1 reports. At the time of the general review mission to Spain in February 2008, a total of 579 recommendations had been made in the 78 finalised inspection reports for Spain in the period since Prior to the 2008 general review mission, the Commission had closed 487 of these recommendations either on the basis of action taken 2 by the Competent authority or because they were no longer relevant. The remaining 92 recommendations were followed up during the 2008 general review mission in February These consisted of 25 recommendations classified in the 2006 country profile as either in progress or action still required and 67 recommendations requiring follow up from inspection mission reports which had reached the closeout stage since the previous general review mission of November In the case of these more recent recommendations the response of the Competent Authorities was considered to be unsatisfactory in 17 cases and verification of promised action by the Competent Authority was considered necessary in 50 cases. The position is summarised in the following table: Pre-General Review Mission 2008 Post-General Review Mission 2008 Action taken / No longer relevant Outstanding / Action still required 19 8 For verification / Total number of recommendations This assessment is based on information and documentation received and reviewed during meetings with the Competent Authorities in the course of the 2008 general review mission. Given the nature and scope of the general review mission, no verification through inspection on the spot was carried out. The assessment undertaken through the general review mission is considered complementary to other follow up actions and verifications that may be necessary and carried out as part of future sectoral inspections by the FVO. In this regard, unless otherwise indicated, recommendations classified as in progress" or "action still required" are not considered to require any immediate specific legal or administrative action on the part of the Commission. These 1 Those in respect of which the technical assessment by the FVO had been finalised ( closeout ) at the time of the general review mission. 2 For the purpose of the country profile the terms: "Action taken," "In Progress", No longer relevant and "Action still required" are defined as follows: "Action taken": Appropriate measures to address the recommendation have been implemented by the Competent Authority. The recommendation is therefore closed. "No longer relevant": For administrative, technical or legal reasons follow up of the recommendation is no longer "In Progress": appropriate. The recommendation is therefore closed. Appropriate measures to address the recommendation have been initiated by the Competent Authority but not all of the measures have been implemented. The recommendation therefore remains open. "Action still required": Appropriate measures to address the recommendation have not been initiated by the Competent Authorities. The recommendation therefore remains open. 3 It should be noted that the number of recommendations in this overview does not represent, of itself, a measurement of the degree of responsiveness by the Competent Authorities or of the seriousness of problems. Some recommendations may be related to minor technical aspects while others may refer to more problematic, systemic, issues. 56

57 recommendations will remain the subject of monitoring by the Commission to assess progress. If as a result of this monitoring the Commission considers the situation in regard to any of these recommendations warrants additional action on its part, it will take the appropriate measures. The following table gives an overview of FVO missions to Spain and the assessment in relation to the 92 recommendations identified for further follow up during the 2008 general review mission. The findings in relation to individual recommendations are presented in a separate chapter for each control system. Summary of follow-up status The following symbols are used in the summary table below: X: no recommendations identified for follow-up during the FVO general review mission of October 2006 A: recommendations on which action has been taken P: recommendations on which action is still in progress R: recommendations on which action is still required N: recommendations which are no longer relevant * recent inspections for which responses from the CCAs are awaited or are being assessed by the FVO S: scheduled FVO mission Inspection reference number and objectives of the inspection Animal health Food of animal origin Imports of animals and food of animal origin Feedingstuffs and animal nutrition TSEs\ABP Veterinary medicines and residues Foodstuffs and food hygiene Imports of food of plant origin Pesticides Animal welfare Plant health 1041/1999 Food production - bivalve molluscs 1023/1999 Food production: fresh meat 1028/1999 Disease erad. programmes B. melitensis 1045/1999 Border Inspection Posts: Live Animals & Animal Products 1059/1999 Protected zones - Erwinia amylovora 1100/1999 Food production - milk/products 1122/1999 Animal Disease Trichinella Controls 1142/1999 Residues in Live Animals and Animal Products X X X X X X X X 57

58 Inspection reference number and objectives of the inspection Animal health Food of animal origin Imports of animals and food of animal origin Feedingstuffs and animal nutrition TSEs\ABP Veterinary medicines and residues Foodstuffs and food hygiene Imports of food of plant origin Pesticides Animal welfare Plant health 1165/1999 Disease eradication /control programmes - Brucella abortus 1190/1999 Residues dioxins in Animal Products X X 1213/1999 Poultry meat X 1240/1999 Plant pest outbreak Rhynchophorus Ferrugineus Olivier Ornamentals, incl. Bonsaïs 1029/2000 Border Inspection Posts: Live Animals & Animal X Products 1104/2000 Animal welfare Transport and Staging Points 1087/2000 Food production: Fresh meat (porcine) X 1076/2000 Food production - wild game, farmed game meat X and rabbit meat 1061/2000 Food production: red meat products, minced meat & X preparations 1123/2000 Internal market - Forest plants/products 1170/2000 TSE surveillance, rendering, feedingstuffs X ban 1198/2000 Food production - poultry meat/ products/preparations X 1251/2000 Pesticides: Control of Marketing & Use, and Residues in Foodstuffs 1305/2000 TSEs X 3158/2001 Evaluation of CA in MS - potatoes 3163/2001 Disease contingency plans: FMD and CSF X 3181/2001 Disease erad. /control programmes X - B. melitensis 3191/2001 Food production - milk/products X 3216/2001 Food Hygiene HACCP X X X X X X 58

59 Inspection reference number and objectives of the inspection Animal health Food of animal origin Imports of animals and food of animal origin Feedingstuffs and animal nutrition TSEs\ABP Veterinary medicines and residues Foodstuffs and food hygiene Imports of food of plant origin Pesticides Animal welfare Plant health 3279/2001 Community Reference Laboratory on Marine X Biotoxins 3304/2001 BSE X 3344/2001 Animal welfare - On-farm (pigs, calves and laying hens) 3379/2001 Disease outbreak - CSF X 3467/2001 Fishery products and bivalve molluscs X 8524/2002 Disease eradication control programmes (Bovine X Brucellosis) 8538/2002 Traceability of Beef and Beef Products X 8553/2002 Animal welfare During Transport and at Slaughter 8557/2002 Border inspection posts: Live Animals and Animal X Products 8583/2002 Food production - table eggs/products X 8600/2002 Contaminants: Controls of PAH Contamination in X Vegetable Oils 8631/2002 TSEs X 8643/2002 Disease outbreak - CSF X 8735/2002 Border inspection posts: Implementation of X Safeguard Measures 9084/2003 Disease contingency plans (FMD,CSF & BT) X 9094/2003 Disease eradication control programmes Bovine 1P Tuberculosis 9103/2003 Controls on GMO Food and Feedingstuffs X 9110/2003 Import controls - food of non-animal origin 9123/2003 Feedingstuffs 1P 9215/2003 Animal welfare during transport and at slaughter 9252/2003 Import controls - plants/plant products 9259/2003 Food Hygiene 1P X X X 2P X 59

60 Inspection reference number and objectives of the inspection Animal health Food of animal origin Imports of animals and food of animal origin Feedingstuffs and animal nutrition TSEs\ABP Veterinary medicines and residues Foodstuffs and food hygiene Imports of food of plant origin Pesticides Animal welfare Plant health 7024/2004 Fishery products and Live Bivalve Molluscs 2P 1R 7041/2004 TSE: feedingstuffsban X 7088/2004 Plant Health in MS potatoes 7128/2004 Disease eradication control programmes: Brucella 1P melitensis 7228/2004 Traceability of Beef and Beef Products 1P 7230/2004 Animal Welfare for Laying hens and During Transport 7264/2004 Control of Residues in live animals/animal products and of VMPs 7308/2004 Import controls - food of non-animal origin 7319/2004 Pesticides: Control of marketing and use, and of residues in food 7248/2004 Animal By-products X 7352/2004 Border inspection posts: Live Animals and Animal X Products 7548/2005 Animal welfare Pigs and Laying hens 7571/2005 Internal market - Plant X 7632/2005 GMO Food and Feedingstuffs Controls 2P 1R 7660/2005 Import Controls: BIPs: X 7661/2005 Import Controls: Illegal Imports X 7607/2005 Disease Eradication Programme: Rabies 1P 7702/2005 Scrapie X 7707/2005 Bovine Brucellosis Eradication X 7733/2005 General review X X X X X X X X X X X 8069/2006 BSE 2A 13P 8088/2006 Animal By-products X 8174/2006 Intra-Community Trade in Live Animals * 1A 1P 3R X X 1P 1A 4P X 60

61 Inspection reference number and objectives of the inspection Animal health Food of animal origin Imports of animals and food of animal origin Feedingstuffs and animal nutrition TSEs\ABP Veterinary medicines and residues Foodstuffs and food hygiene Imports of food of plant origin Pesticides Animal welfare Plant health 8062/2006 Import Controls & BIPs 1A 12P 8196/2006 Controls on Bluetongue 3A 1P 8205/2006 Food of Animal Origin: Meat & Milk X 8143/2006 Salmonella in Eggs 3V 8128/2006 Import Controls Food & Feed -Plant Origin 1A 2P 8286/2006 General review X X X X X X X X X X X 8230/2006 Ovine & Caprine Identification System 1A 7P 7179/2007 Pesticides 1A 7P 3R 7328/2007 Animal Welfare 1A 9P 7448/2007 Food of Animal Origin: Meat & Milk * 7251/2007 ABP * 7367/2007 Bovine Brucellosis * 7519/2007 Scrapie * 7929/2008 Food of animal origin (meat and milk) and * * Imports 7697/2008 General review X X X X X X X X X X X 7642/2008 Fishery products 7781/2008 Residues/VMPs 7844/2008 Additives/Food contact materials S S S 7803/2008 Semen & embryos S 7766/2008 Animal welfare S 7907/2008 Plant health S 7723/2008 Feed S 7787/2008 Contingency plans S 7752/2008 Import controls S 61

62 Inspection reference number and objectives of the inspection Animal health Food of animal origin Imports of animals and food of animal origin Feedingstuffs and animal nutrition TSEs\ABP Veterinary medicines and residues Foodstuffs and food hygiene Imports of food of plant origin Pesticides Animal welfare Plant health 7856/2008 Food Hygiene 7792/2008 TB and Brucellosis 7816/2008 Meat and milk; baby food S S S 62

63 3.1. Animal health Since 1999, the FVO has completed 15 inspections in Spain in relation to animal health. Out of 94 recommendations contained in the reports of these missions, 15 were identified for follow up during the 2008 general review mission, 3 of which were carried over from the country profile of 2006, and 12 were contained in reports that had reached closeout stage since the 2006 general review mission. Recommendations carried over from the country profile of Spain of November 2006 MR 9094/2003 of 05/05/2003 on Disease eradication control Programmes Tuberculosis Reference no. and Recommendation Findings (13674) In preparation for the 2008 GRM, the FVO requested To increase the number information on the number of epidemiological studies of epidemiological performed in 2007 in the 4 ACs where the number of studies of infected epidemiological studies was unsatisfactory or unavailable herds. during the 2005 or the 2006 GRMs (Andalucia, Madrid, Castilla La Mancha and the Basque region). The Spanish authorities confirmed that 50 surveys took place in Madrid, 182 in Castilla La Mancha, 8 in the Basque Country and 54 in Andalucia. The final report on the 2007 Spanish tuberculosis eradication programme will be submitted to the European Commission on 30 April next. The report will indicate the level of compliance of these ACs with the requirements of EU legislation for epidemiological studies. Progress made by Spain in addressing this recommendation will be monitored during the FVO specific audit on bovine brucellosis and TB. Update MR 7128/2004 of 27/06/2004 on Disease eradication control programmes: Br. Melitensis Reference no. and Findings Assessment Recommendation (18534) During the 2008 GRM, the Spanish authorities stated that To continue the process they would provide FVO with an updated in early March of accreditation of all 2008, with deadlines for accreditation for Br melitensis laboratories involved in testing in each AC. They would also remind ACs that all the BM eradication routine control laboratories (RCLs) would have to be programme. accredited before the end of The table has not yet been provided. Progress made by Spain in accrediting all laboratories used for brucellosis controls will be monitored during the FVO specific audit on bovine brucellosis and TB. 63

64 MR 7607/2005 OF 4/10/2005 on Rabies controls Reference no. and Recommendation (23234) To consider the prioritisation of controls on pet animals entering or re-entering the Community, in particular in places of entry with a high flow of passengers and a low rate of checking. Findings Since the 2006 GRM, positions for 10 additional veterinarians have been approved for the locations described in the 2006 Country Profile. These positions have not yet been filled. These extra 10 veterinarians in the 6 principal BIPs in Spain will form part of a BIP veterinary team, which will be permanently mobile whenever its presence is necessary at travellers' points of entry, as defined by Regulation (EC) No 998/2003. For all points of entry where there is no BIP, it will be necessary to request the assistance of the veterinary services from the nearest BIP. This issue is also addressed through recommendation of 8062/2006 on import controls. Update Recommendations reaching closeout note stage since the 2006 general review mission. MR 8196/2006 of 12/06/2006 on BLUETONGUE Reference no. and Recommendation (26586) To respect the requirements for the establishment surveillance zones as laid down in Article 8 of Council Directive 2000/75/EC. Findings The Spanish authorities stated that the restricted zones on Spanish territory and the measures to be adopted there have been identified, with the approval of the Commission, assisted by SCOFCAH, as laid down in Article 8(3) of Directive 2000/75/EC, as amended by Regulation (EC) No 1266/2007. This process has essentially been guided by geographical, ecological and meteorological factors which determine the presence and distribution of the vector and the investigation of any outbreaks. Update Action taken In Spain, vaccination has been used as the principal instrument of control against BT and a mass vaccination of all ovine and bovine animals has been implemented throughout the restricted zone. With a view to guaranteeing the absence of viral circulation in the zones adjacent to the restricted zones, a surveillance programme has been managed in these zones, which includes an increase in the number of clinical inspections on sheep farms, strengthening the serological surveillance programme, through an increase, both in numbers and frequency, of samples from sentinel animals and from Livestock Control Programmes, and an intensive programme of entomological surveillance to detect as soon as posible any variation in the geographic distribution of the Culicoides vector. In this way during 2007, a reinforced surveillance was achieved in the zones contiguous with the restricted zone, based on the establishment of at least 300 sentinel bovines per province, sufficient to detect a 1% disease prevalence with a confidence level of 95%. The animals have been checked 64

65 MR 8196/2006 of 12/06/2006 on BLUETONGUE Reference no. and Recommendation (26587) To legally define the circumstances in which Bluetongue virus circulation must be confirmed and to describe these circumstances precisely in the Bluetongue operations manual in order to harmonise the measures applied nationally whenever virus circulation is confirmed. (26588) To urgently implement an audit system as laid down in Article 4 of Regulation (EC) No 882/2004. Findings monthly, except between 1 July and 30 November, when they have been sampled fortnightly, coinciding with the period of highest activity of the vector. The serological surveillance programme is complemented by random analysis of a sufficient number of samples from Livestock Control Programmes to detect an expected prevalence of 0.5 % with a confidence level of 95%, in the three periods of greatest risk, (end of spring, summer and autumn). On the other hand, in the areas contiguous with the restricted zones, active surveillance has been complemented with a passive clinical surveillance based on clinical inspections in at least 150 sheep holdings in each AC, selected at random from among those which may be close to cattle holdings. Visits have taken place in the two periods considered to be of highest risk, spring and late summer/autumn. The Spanish authorities stated that all these measures would guarantee that, in cases where the virus arrives in these zones adjacent to the restricted zone, detection, would be as early as possible. The MARM Practical Manual of Operations against Bluetongue has been revised to take account of the new definition of "case of bluetongue" contained in Regulation (EC) No 1266/2007. The revised Manual is being used by each of the 17 ACs, following adaptation to each AC's specific situation. A new version has been finalised (dated March 2008) and it has now been placed on the RASVE website: manuales/manual%20lengua%20azul.pdf Audits are not yet being performed for bluetongue. The overall progress made on audit in Spain is described in Part 1 of the country profile. Update Action taken 65

66 MR 8196/2006 of 12/06/2006 on BLUETONGUE Reference no. and Recommendation (26592) To ensure that epidemiological investigations as required by Article 7 of Council Directive 2000/75/EC are carried out in holdings where BT virus circulation is confirmed and in any case of BT positive results (PCR). Findings A questionnaire has been included in the Practical Manual of Operations against Bluetongue to perform the initial epidemiological investigation (Annex IV), and another for the definitive epidemiological investigation (Annex VIII) for the holdings affected. This measure is going to be modified later according to the epidemiological situation in the affected zone. The Manual has been updated periodically to take account of the evolution of the disease, and in accordance with the most recent national and EU legislation. On 30 April 2007 the Manual was sent to the Commission for evaluation. The March 2008 version of the manual is on the RASVE website (as referred to in recommendation 26587), making this information available to all ACs. The Spanish authorities stated that epidemiological surveys have been carried out in ACs whenever a new serotype of the Bluetongue virus appears in a new area (such as for the notification of serotype 1 in ACs in the south of Spain and later in the Basque Country, or of serotype 8 in Cantabria). In these cases, corresponding epidemiological investigations have always taken place, not only to identify the possible origin of the disease, but also to investigate animal movements from holdings within the zones affected in the 60 days prior to the detection of the source, in order to identify whether the disease could have extended to other areas. The other ACs have been informed of the results of these epidemiological investigations. Update Action taken MR 8230/2006 of 27/11/2006 on Sheep and goat identification Reference no. and Recommendation Findings Update (28390) To urgently ensure that Official Veterinarians do not certify data of which they have no personal knowledge, or which cannot be ascertained by them (Article 3 (2) and 3 (3) of Council Directive 96/93/EC). NOTE: RECOMMENDATIONS AND ARE ADDRESSED TOGETHER The Spanish authorities, in their response to the final report stated that the Procedural Manual For Intracommunity Trade In Productive Livestock had been prepared so that veterinarians in Local Veterinarian Units would be familiar with certification requirements for each species. The latest (February 2008) version of the manual was provided soon after the GRM. The Spanish authorities stated that the manual would be distributed to the ACs and to all implementing bodies. MR 8174/2006, on intra-community trade of live animals, also addresses this issue, through its recommendation 13, on the need to ensure continuous training on TRACES and certification. The Spanish authorities in their response to that mission, stated that each Annex of the Control Plan for Intra-Community Trade in Animals (relating to the control of the various livestock species) includes a section on the issuing of intra-community trade health 66

67 MR 8230/2006 of 27/11/2006 on Sheep and goat identification Reference no. and Recommendation Findings certificates, which explains the TRACES system. In addition, training courses were held in 2007 in some ACs (Basque Country, Aragon, Palma de Mallorca, Castilla La Mancha -Toledo, Galicia). A further TRACES course took place at MARM's central office in November 2007, attended by 31 representatives from 12 ACs (all except Castilla La Mancha, Cataluna, Murcia, Basque Country and La Rioja) for Regional Coordinators, the aim being to improve knowledge for issuing certificates. It remains to be demonstrated whether there are management systems in place in each AC to ensure that training received by AC central level staff, is cascaded to all staff who prepare certificates in the field. It also remains to be demonstrated whether any ACs are performing checks on certification by LVUs. Update (28398) To urgently apply the other conditions for sheep and goats entering ICT, as described in Council Directive 91/68/EEC, and including: Conditions of residency and standstill from the holding of origin (Articles 4a, 4b, 4c); Classification, approval and supervision of approved assembly centres and approved dealer s premises (article 8a and 8b); Health conditions of the holding of origin or the holding of animals in contact, as described in Article 4 (d)); Respect of the conditions of operation of assembly centres and Dealer s, including their approval, inspections, category of animals, residency; Controls and supporting documentation described in Article 9 (2) to 9 (6). In addition to the information above, the Procedural Manual stresses the need for assembly centres and dealers' premises to be specifically approved for intra-community trade. All points contained in this recommendation are addressed in the manual. The same issues remain to be addressed as in the last two paragraphs of recommendation (AC management systems for training, and AC checks on LVUs). 67

68 MR 8230/2006 of 27/11/2006 on Sheep and goat identification Reference no. and Recommendation (28392) To ensure effective and efficient coordination between the CCA and the RCAs, in order: Findings Six meetings of the co-ordination body CNIGRE took place in Decisions on implementing legislation on identification and registration are taken in CNIGRE. Aspects related to electronic identification of ovine and caprine animals are treated in the CEIEA. Update to guarantee that provisions of the Regulation are correctly and consistently applied in all the Spanish territory; to guarantee that appropriate follow-up actions are taken in all the Spanish territory, in the light of the recommendations from Community controls (Article 45 (5) (b) of Regulation (EC) No 882/2004. (28393) To review the alternative system for identification (as authorised by Article 4 (3) of the Regulation), and its application, in order: - A) to enforce the conditions as described in Annex A (7) to the Regulation (including the use of approved ear-tags); Note: "Alternative system for identification" refers to group identification - C) to ensure that no means of identification are replaced without the permission of the Copies of CNIGRE and CEIEA minutes were provided during the GRM, which described measures proposed by SGEST of MARM to address some recommendations from this FVO report. Although issues arising from this FVO report was an item on the agenda in most CNIGRE meetings, there was insufficient time to address these issues in some of the more recent meetings. The Spanish response to parts A, B, C and D of this recommendation did not contain an overview of the extent to which this recommendation was being addressed in all 17 ACs, and, where relevant, the timeframe necessary to achieve full compliance in each of the ACs. A) In preparation for the GRM the Spanish authorities were requested to provide a table indicating the deadlines confirmed by each AC for when controls would take place (or had already commenced) to ensure that the conditions contained in Section A.7 of the Annex are fully enforced. The Spanish response contained satisfactory information from two ACs, Cataluna and Extremadura, which clarified that the system for distribution of group eartags was under official control. The Spanish response contained partially satisfactory information from 7 ACs (Asturias, Balearic Islands, Canary Islands, Castilla y Leon, Madrid, Navarra, La Rioja) but these ACs need to take further action to demonstrate full compliance. The Spanish response contained no information from 3 ACs (Cantabria, Galicia, Valencia) and contained unsatisfactory information from 5 ACs, which did not demonstrate actions to address the recommendation (Andalucia, Aragon, Castilla La Mancha, Murcia and the Basque Country). C) In preparation for the GRM, the Spanish authorities were invited to provide a table indicating for each AC the deadlines by which a system would be introduced to ensure that the permission of the CA was obtained for the 68

69 MR 8230/2006 of 27/11/2006 on Sheep and goat identification Reference no. and Recommendation Findings Update CA, and that the system for the replacement of means of identification does not compromise traceability (requirements of Article 4 (6) of the Regulation); Note: "Alternative system for identification" refers to group identification - D) to ensure that information on any replacement of tags is recorded in the holding registers as required by Annex B (1) to the Regulation Note: "Alternative system for identification" refers to group identification replacement of all means of identification, including group identification. The response provided by the Spanish authorities was unsatisfactory for 16 ACs. Information provided by 8 ACs related to individual, rather than to group identification (Andalucia, Aragon, Asturias, Canary Islands, Cantabria, Cataluña, La Rioja, and Madrid); for 6 ACs the system for replacement in the case of group identification compromises the traceability of the animals back to the holding of birth (Castilla La Mancha, Castilla y Leon, Extremadura, Murcia, Navarra, and Valencia); for the Balearic Islands the system described is insufficiently clear to demonstrate action taken to address this recommendation; no evidence of controls being in place was provided for Galicia. D) In preparation for the GRM the Spanish authorities were requested to provide a list the ACs who had confirmed that they had performed controls in 2007 to address this recommendation. The Spanish response contains satisfactory information from the 2 ACs of Catalonia and Extremadura, although it remains to be demonstrated whether these two systems allow controls on the use of group eartags. The information contained in the Spanish response from the other 9 ACs was unsatisfactory, either because the response to recommendations A or B has not demonstrated that an adequate system is in place, or because the AC response does not address the issue. The Spanish response contains no information from the other 6 ACs (Andalucia, Canary Islands, Cantabria, Basque Country, La Rioja, and Valencia). (28394) To ensure that all sheep and goats entering ICT have been identified according to Article 4 (2) of the Regulation, before they leave the holding on which they are born. The Procedural Manual For Intracommunity Trade In Productive Livestock includes the need for ovines to be identified in accordance with Regulation (EC) No 21/2004. Guidelines on the implementation of EU legislation on sheep and goat identification, were adopted unanimously at the CNIGRE meeting of 18 February A copy of the guidelines was provided. The guidelines mention the obligation of individual identification from the holding of birth. However, the guidelines do not identify the requirement that once animals have left the holding of birth with group identification, they cannot in a subsequent holding receive individual identification in view of ICT requirements. In preparation for the GRM, the Spanish authorities were requested to provide information on the actions taken by 69

70 MR 8230/2006 of 27/11/2006 on Sheep and goat identification Reference no. and Recommendation Findings each AC to address this recommendation. The response of 6 ACs is satisfactory. Balearic and Canary Islands, Madrid and Valencia stated that they have no ICT for sheep and goats. Relevant instructions have been issued to control staff in Castilla La Mancha and Extremadura. The Spanish response for 3 ACs is partially satisfactory. For Galicia, and the Basque Country, while there is no ICT from assembly centres, it remains to be demonstrated whether there is any ICT trade from holdings other than holdings of birth. For La Rioja, the documentation provided does not demonstrate that instructions have been issued to OVs that eartags may only be put on animals at the holding of birth. The Spanish response for 6 ACs did not demonstrate that this recommendation was being addressed (Andalucia, Aragon, Asturias, Catalonia, Murcia and Navarra). The Spanish response contained no information from 2 ACs: Cantabria and Castilla y Leon. Update (28395) A) to ensure that all models of holding registers and movement documents comply with Articles 5 (1) and 6 (1) of the Regulation; A) Articles 9.4 and 10.6 of the Royal Decree 947/2005 establish that the CAs of the ACs must communicate the models of holding registers and movement documents approved in their territory. In their Action Plan in response to the mission report the CCA stated that they had checked that all holding registers and movement documents contained all minimum elements required by Regulation (EC) No 21/2004 and RD 947/2005. The Spanish authorities stated that models of registers and movement documents would be published on the MARM webpage from 01/01/2008 in order to comply with new European legislative requirements. A copy of the webpage was provided during the GRM which included information on 11 ACs (Andalucia, Aragon, Canarias, Cantabria, Cataluña, Extremadura, Galicia, Murcia, Navarra, La Rioja, and Valencia). Action taken 70

71 MR 8230/2006 of 27/11/2006 on Sheep and goat identification Reference no. and Recommendation Findings Update B) to transmit to the other Member States and to the Commission all models used on their territory, as required by Articles 5 (6) and 6 (5) of the Regulation. to communicate clearly to the Commission the identity of the Competent Authorities responsible for ensuring compliance with the Regulation, as required by Article 11 (1) of the Regulation. C) To inform the Commission of the derogation granted on the Spanish territory for sheep and goat identification in case of extensive or free-range farming, as requested by Article 4 (1) of the Regulation. (28396) To ensure that the movement documents can be and are filled in with complete and accurate information in all the Spanish territory. B): The Commission and the MS can access information from the CCA, SGEST of MARM, for identification and registration of ovine and caprine animals through the link with the webpage of the Commission. According to Art of the 1978 Spanish Constitution, the State has exclusive competence on international relations. In this case MARM is the only CA in this area. The Spanish authorities confirmed that in January 2008 they had provided the European Commission services with the list of the CAs of the ACs responsible for Regulation (EC) No 21/2004 in their territory, as laid out in the control plan. They also confirmed that under Royal Decree 1371/2006, DGRAG, through SGEST, was the "competent authority responsible for ensuring compliance.." under Article 11.1 of the Regulation. C) The Spanish authorities obtained information from all ACs related to the derogations granted according to Article 4.1 of the Regulation, and sent it to the Commission in January The mission found that in a number of cases, the information relating to the date of movement and the number of animals transported was not correct. since the documents were in fact pre-movement authorisations filled by the official veterinarian (OV) on the basis of intention, rather than documents completed on the basis of the actual numbers of animals and the date of the movement. For those ACs where the OV issues pre-movement documents, the control systems in place to ensure that the pre-movement document is updated, where necessary, to reflect the actual movement which takes place, have not been demonstrated. (28397) Guidelines for inspections of identification and To ensure efficient and registration of ovine and caprine animals in effective cooperation slaughterhouses were adopted in the 16 th CNIGRE coordination meeting on 18 February An assessment with the CA responsible for official of the guidelines indicates that they do not contain controls at the information on the type of action to be taken when nonconformities are detected or that they do not ensure slaughterhouses so that conditions of the consistency in evaluating the relative importance of nonconformities (for example if the code of origin is not the Regulation are correctly applied and 12 digit-code, if some ID is missing, or if only one of the supervised in these required 2 eartags is affixed to the animal). establishments; Before the GRM, it was not yet clear what steps had been taken in each AC to ensure that these CNIGRE guidelines, 71

72 MR 8230/2006 of 27/11/2006 on Sheep and goat identification Reference no. and Recommendation Findings adopted by representatives of the AC Ministries of Agriculture, would be implemented by the food business operators, and controlled by the official veterinarians in the slaughterhouses, who are generally attached to the AC Ministries of Health. The Spanish authorities were thus requested to indicate the measures in place in each AC to ensure cooperation with the CA responsible for official controls at the slaughterhouse in order to ensure that the conditions of the Regulation are correctly applied. Update The Spanish authorities provided a satisfactory response from 2 ACs (Galicia and Castilla Y Leon), indicating that detailed instructions were in place, and that guidelines for enforcement measures were in place for cases of noncompliance. The Spanish authorities provided a partially satisfactory response from 6 ACs, indicating that co-operation takes place between the AC Ministries of Health and Agriculture but further work remains to be done (Balearic Islands, Canary Islands, Castilla La Mancha, Cataluña, Extremadura, and Navarra). The Spanish response contained unsatisfactory information from 6 ACs, who did not demonstrate adequate co-operation in relation to controls on sheep and goat identification at the slaughterhouse (Andalucia, Aragon, Asturias, Madrid, Murcia and Valencia). The Spanish response contained no information from 3 ACs (Cantabria, La Rioja and the Basque Country). 72

73 3.2. Food of animal origin Since 1999, the FVO has completed 17 inspections in Spain in relation to food of animal origin. Out of 137 recommendations contained in the reports of these missions, 7 were identified for follow up during the 2008 general review mission, 4 of which were carried over from the country profile of 2006 and 3 were contained in reports that had reached closeout stage since the 2006 general review mission. Recommendations carried over from the country profile of Spain of November 2006 MR 7228/2004 of 17/10/2004 on Traceability Reference no. and Recommendation (19232) To further improve the operation of the national database for bovine animals, in order to verify the accuracy of the information at National and Regional Database level and to allow appropriate access to its information. Findings Update Royal Decree 728/2007 establishing and regulating the Action taken general register of livestock movements and the general register for animal identification, was published in June On 1 February 2008, data was transferred from SIMOGAN (the bovine database) to REMO and to RIIA. In 2007 data was transferred from SIMOPORC (the pig database) to REMO. The Spanish authorities stated that SITRAN, the integrated system for animal traceability, which incorporates REGA, REMO and RIIA, is now operational in all ACs. MR 7024/2004 of 10/5/2004 on Live bivalve molluscs and fishery products Reference no. and Recommendation (20032) Live bivalve molluscs The CCA should consider establishing clear guidelines (such as the trigger values proposed by the CRL) on the precise basis for reclassifying production areas, particularly in cases when production areas were temporarily downgraded and then subsequently reinstated. Findings A JACUMAR co-ordination meeting was convened in January 2008 to address the three recommendations contained in this country profile. Legal Situation The minutes of the meeting recorded that the ACs of Galicia and Valencia specifically refer to the relevant EU legislation (Regulation (EC) Nos 852/2004, 853/2004 and 854/2004 and 2073/2005) in their Orders for classifying production areas. The other ACs are in the process of revising their legal texts, and have indicated their intention to have new texts drafted in The minutes recorded statements from all ACs that in any case, they had adapted their control plans to reflect the criteria set out in EU legislation. During the GRM, the Spanish authorities stated that an order would be published at national level in 2008 to give binding legal effect to the EU legislation described above. The Spanish authorities provided tables during the GRM 73 Update

74 MR 7024/2004 of 10/5/2004 on Live bivalve molluscs and fishery products Reference no. and Recommendation Findings summarising the measures in place for microbiological, monitoring purposes in the 8 coastal ACs which produce LBM. Murcia has no LBM production areas. Update Microbiological controls and methods The microbiological controls table indicates that for 7 of the ACs (Andalucia, Asturias, Balearic Islands, Valencia, Cantabria, Cataluña, and Galicia) the E. coli limits defined in Regulation (EC) No 2073/2005 are being followed for Class A and Class B LBM production areas. (Information is missing for 4 of these ACs Andalucia, Asturias, Valencia and Cataluña -on the E. coli limits for Class C production areas.) In the Basque Country, a total coliform method is used to determine the classification of LBM production areas. This is not in compliance with the Regulation (EC) No 2073/2005, which specifies the E. coli method. The method of analysis used to determine E. coli is in compliance with Regulation (EC) No 2073/2005 (MPN determined in accordance with ISO ) in one AC (Galicia). The authorities of one other AC (Basque Country) have indicated their intention to use this method, though without indicating a timetable. (20033) Live bivalve molluscs The CAs should continuously review the adequacy of the monitoring programmes put in place (in particular, the frequency of testing for toxic phytoplankton, biotoxins and microbiology), taking into account the levels of production and the number of species harvested. None of the other ACs have indicated that they are using ISO , or alternative methods allowed in accordance with Article 5 of Regulation (EC) No 2073/2005. The Spanish authorities provided tables during the GRM summarising the measures in place in 8 coastal ACs for phytoplankton, biotoxin and microbiological monitoring purposes. a) Phytoplankton monitoring All ACs indicated that they performed phytoplankton monitoring. b) Biotoxin Monitoring (i)frequency of sampling Paragraph 5, of Chapter II, B of Annex II of Regulation (EC) No 854/2004, requires that the sampling frequency for toxin analysis should be weekly unless a risk assessment on toxins or phytoplankton occurrence suggests a very low risk of toxic episodes. For Andalucia, the sampling frequency for biotoxins was stated to be fortnightly or monthly. For Asturias, weekly or fortnightly. For Valencia, fortnightly or monthly. For Cantabria, monthly. For Cataluña, weekly or fortnightly. The Spanish authorities, in their response to the draft country profile, reported that after performing a risk analysis in the coastal zone Bal 1/03 of Mallorca, the Balearic Islands authorities had established a weekly 74 Action still required

75 MR 7024/2004 of 10/5/2004 on Live bivalve molluscs and fishery products Reference no. and Recommendation Findings sampling and analysis frequency. Update (20034) Live bivalve molluscs The NRLs should be fully responsible and have the necessary powers to coordinate the activities of the national laboratories conducting i) the analyses of marine biotoxins and ii) the viral and bacteriological analysis of bivalve molluscs. Furthermore, the NRL in association with the CCA, should establish officially recognised For the Basque Country, the sampling frequency for biotoxins was stated to be "in Summer and in Autumn"- the frequency was not specified. For Galicia, the sampling frequency for biotoxins was stated to be daily or weekly. While the minutes of the January 2008 co-ordination meeting indicate that Andalucia and Cantabria use historical data as an input for determining sampling frequency, evidence has not yet been provided to demonstrate that a risk assessment has taken place in the 6 ACs whose sampling frequency is less than weekly (Andalucia, Asturias, Valencia, Cantabria, Cataluña and the Basque Country). (ii)number of Biotoxin Groups analysed by ACs With the exception of Valencia and the Basque Country, all ACs perform analyses for the 7 groups of toxins which must be analysed under Annex III, Section VII, Chapter V of Regulation (EC) No 853/2004 (Health Standards for LBMs). Of these 7 groups of toxins, the AC of Valencia is performing analyses for only one group (ASP). Although they have indicated that they will start to perform analyses for the other 6 groups soon, the starting date remains unknown. The authorities of the Basque Country have indicated that while they perform biotoxin analyses for ASP and PSP, they do not perform analyses for the other 5 groups of biotoxins. In preparation for the GRM, the FVO requested a table of all laboratories (both at national and AC level) involved in testing LBMs (biotoxins and/or microbiology), indicating the test methods used, whether they meet the requirements of EU legislation, and the status of accreditation of the laboratories. (i) Marine Biotoxins Analyses 8 coastal ACs have LBM production. 7 ACs (Andalucia, Balearic Islands, Basque Country, Cantabria, Cataluña, Asturias and Galicia) use accredited laboratories with validated methods for marine biotoxins. It has not been demonstrated that the validated methods are those contained in Annex III of Regulation (EC) No 2074/2005. (Asturias uses the Intecmar laboratory of the AC of Galicia. For the Basque Country, requests for analyses were being sent to an accredited laboratory, since a date for the accreditation of its Public Health laboratory was not yet available.) 75

76 MR 7024/2004 of 10/5/2004 on Live bivalve molluscs and fishery products Reference no. and Recommendation tests/methods so that this information can be clearly communicated to all official control laboratories. In particular, Commission Decision 2002/225/EC should be implemented in full, using the methods established by the CRL in Vigo. Findings 1 AC (Valencia) expects to be accredited in (ii) Microbiological Tests: The Community legislation now in force is Commission Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs, which states in point 1.25 of Annex I, Chapter1, that the analytical reference method for E Coli analyses should be ISO TS As shown in recommendation above, the method of analysis used to determine E coli is in compliance with Regulation (EC) No 2073/2005 (MPN determined in accordance with ISO ) in one AC (Galicia). The authorities of one other AC (Basque Country) have indicated their intention to use this method, though without indicating a timetable. Update During the general review mission, none of the other 6 coastal ACs with LBM production areas, had indicated that they were using ISO , or alternative methods allowed in accordance with Article 5 of Regulation (EC) No 2073/2005. In their response to the draft country profile, the Spanish authorities stated that the Balearic Islands indicated that while they didn t intend to seek accreditation for E. coli, they were using the French standard XP V for E coli. They stated that for the Basque Country, requests for analyses were being sent to an accredited laboratory, since a date for the accreditation of its Public Health laboratory was not yet available. 76

77 Recommendations reaching closeout note stage since the 2006 general review mission. MR 8143/2006 of 2/10/2006 on Salmonella in the table egg sector Reference no. and Recommendation (26811) The CA should ensure that in packing centres the provisions related to the indication of the best before dates for table eggs, as defined in Commission Regulation (EC) No 2295/2003, Article 9 (2), are respected; (26812) The CA should ensure that in egg product establishments the prescribed tests for certain organic acids are carried out in accordance with Regulation (EC) No 853/2004, Annex III, Section X, Chapter II, Part IV; Findings/Assessment/ AESAN-CI set up a specific Salmonella working party for the egg sector in March 2006, also involving MARM and the ACs. Its report, containing a diagnosis of the 2006 situation and proposals for improvements (including recommendations arising from the mission), was finalised in November. During the GRM, the Spanish authorities stated that each of the 17 ACs had an Official Plan for Monitoring Food Establishments, including eggs and egg product establishments, based on official controls on auto-control systems. Many ACs had confirmed that they had issued relevant instructions to their services. Six ACs (Aragon, Balearic Islands, Castilla La Mancha, Cataluna, Murcia and Valencia) had a system of verification or audit for egg packing centres in 2007, or planned to introduce one in In their response to the draft country profile, the Spanish authorities provided evidence of the actions taken to address this recommendation by an additional 6 ACs (Andalucia, Canary Islands, Extremadura, Madrid, Basque Country, and La Rioja). The information provided indicated that control plans had been prepared, inspections had taken place and instructions or protocols had been issued to address this recommendation. There are no egg product establishments in La Rioja, Aragon, Cantabria and Extremadura, and the single establishment in Asturias will soon cease activity. In their response to the mission report, the Spanish authorities stated that the other 12 ACs had notified AESAN that this recommendation would be taken into account in official egg product inspections in their territory. They stated that these 12 ACs had official plans for inspecting food establishments, which address this issue. 7 ACs (Madrid, Castile-La Mancha, Galicia, Catalonia, Andalusia, Balearics and the Basque Country) had issued communications to their inspection services reminding them of and/or conveying instructions to step up checks on the prescribed tests for certain organic acids in both inspections and audits. In addition Madrid has a specific guide to support egg products inspection and Catalonia had developed a programme to monitor authorisation conditions for egg product establishments, including tests for organic acids. The FVO, in preparation for the GRM, requested the Spanish authorities to provide information on actions taken by all ACs to address this recommendation, including whether each AC had issued instructions, the results of 2007 controls, and resultant actions taken, and the systems in place to verify that these tests were being performed. At the time of the GRM, almost all ACs with egg products 77 Update

78 MR 8143/2006 of 2/10/2006 on Salmonella in the table egg sector Reference no. and Recommendation Findings/Assessment/ establishments were taking steps such as those described above to address this recommendation. However only a small number of ACs (Catalonia and Castilla y Leon) had provided information to demonstrate that they had systems in place to verify that these tests were being carried out. Update In their response to the draft country profile, the Spanish authorities confirmed that most ACs had verified that these tests were being carried out. For Navarra, Galicia, and Valencia, although relevant instructions are in place, it remains to be clarified whether controls actually take place to verify that the prescribed tests are taking place in the establishments. (26813) The CA should ensure that laboratories, including NRL, performing analyses taken during official controls are assessed and accredited in accordance with the requirements of Article 12 of Regulation (EC) Nº 882/ taking into consideration the requirements of Article 18 of Commission Regulation (EC) Nº 2076/2005, especially because of its paramount importance for the analysis and testing of Salmonella as in Article 11 of Regulation (EC) No 2160/2003. The Spanish authorities stated that all official laboratories are at different stages in the accreditation process and in many cases require quality and technical quality management training and assessment before presenting the formal application to ENAC. Although some laboratories had already submitted their applications to have the methods for Salmonella monitoring programmes accredited, the majority were still in the process of preparing documents, assessing current staff situations, calibrating equipment, validating methods and monitoring environmental conditions. Once the initial situation has been appraised, the documentation prepared and the system implemented, the laboratory management reviews the progress and an internal check is carried out (the current stage, for many laboratories) after which the application is submitted to ENAC and the external audits are carried out. The Spanish authorities indicated that they expected all laboratories to be accredited before 31 December 2009, as required by the transitional provisions for the application of Regulation (EC) No 882/2004 (Article 18 of Regulation (EC) No 2076/2005). In their response to the draft country profile, the Spanish authorities provided a table showing the ACs progress towards accreditation for Salmonella testing. The table shows that 11ACs already have at least one accredited laboratory with appropriate validated methods for Salmonella testing: (Andalucía (3), Aragón (2), Asturias, Castilla La Mancha, Cataluna (5), Galicia, Madrid (6), Navarra (2), Basque Country (4), La Rioja and Valencia (2)). The NRL, in the CNA of AESAN, is also accredited. Four ACs (Balearic Islands, Canary Islands Castilla y León, and Murcia) plan to have at least one accredited laboratory by the end of 2009 at the latest. No information was provided for 2 ACs (Cantabria, and Extremadura). 78

79 3.3. Imports of animals and food of animal origin Since 1999, the FVO has completed 8 inspections in Spain in relation to imports of animals and food of animal origin. Out of 71 recommendations contained in the reports of these missions, 13 were identified for follow up during the 2008 general review mission, all of which were contained in a report that had reached closeout stage since the 2006 general review mission. Recommendations reaching closeout note stage since the 2006 general review mission. MR 8062/2006 of 12/06/2006 on Import Controls and Border Inspection Posts Reference no. and Recommendation Findings Update (26230) To review national legislation in order to ensure correct application of import controls of POAO from Ceuta and Melilla with respect to Articles 1 and 3 of Directive 97/78/EC. (26232) To ensure the complete application of Regulations (EC) No 998/2003 and 745/2004. The Spanish authorities stated that the various departments involved, coordinated by the Ministry of Foreign Affairs and Cooperation, would resolve this issue. This issue was also addressed during the January 2008 mission, for which the Draft Report was issued in March Instruction 1/2006, was produced to clarify problem areas with respect to dogs, cats and ferrets, and includes the conditions of entry for birds and other animals not covered by Regulation (EC) No 998/2003. In the framework of the Plan of Measures to Improve Border Health Services (PMMSSE) 18 new posts were created for the BIPs with the highest passengers flow, with responsibilities for ensuring the application of Regulation (EC) No 745/2004 in respect of personal luggage contents. 10 Canine Unit teams for the detection of high-risk products of animal origin in passengers luggage have been created: 5 units are now in place, 4 in Algeciras, Almería, Málaga, Melilla, and one remaining in Madrid to act as a coordination, substitution and emergency unit. The remaining 5 units will be deployed in Madrid, Barcelona, Alicante and Tarifa BIPs, with one unit again remaining in Madrid for co-ordination, substitution or emergencies. Thirty pocket microchip readers were purchased and distributed to facilitate checks on pets brought into Spain from third countries, 16 to Animal Health Inspectors and nine to various Customs offices. DGRAG has prepared a draft of Instruction 6/2007 (on the destruction of products seized from the personal luggage of travellers from third countries), and is now awaiting the opinion of the State Attorney on allocating responsibilities for financing the destruction costs of seized products. A 79

80 MR 8062/2006 of 12/06/2006 on Import Controls and Border Inspection Posts Reference no. and Recommendation Findings copy of the draft was provided. Update (26233) To ensure full implementation of Directive 96/43/EC in relation to the level of inspection fees, in particular for Canary Islands. (26236) To improve supervision of ship suppliers and customs/free warehouses to ensure that all provisions of Directive 97/78/EC and related Decisions for non-eu-conforming consignments are implemented. (26237) To ensure that the veterinary supervision of rejected consignments and the disposal of kitchen waste is applied in line with the provisions of Directive 97/78/EC and Regulation (EC) No 1774/2002 and related Decisions. (26239) To increase and to monitor the number of BIP staff to ensure adequate staffing in relation to the relevant tasks in accordance with Directives 91/496/EEC and 97/78/EC and Decision 2001/812/EC. The Royal Decree concerning veterinary fees, initially expected to be published in 2007, is now expected to be published before September The implementation of the correct level of inspection fees will then take place throughout Spain. A comprehensive new manual, including procedures for health controls at borders on products of animal origin for human consumption, as well as provisions on transhipment, has been drafted by SGSE of MISACO and sent to stakeholders. When finalised, it will be put on the website. Completion is foreseen by the end of June Circular 1/2007, on the management of kitchen waste from international means of transport, is currently being implemented. As is the case for Draft Instruction 6/2007 (referred to in recommendation 26232, on the destruction of products seized from the personal luggage), the Draft Circular on rejected consignments is also awaiting the opinion of the State Attorney on financing the destruction costs of these rejected consignments. The number of approved posts has been increased by 181 through a resolution of the Interministerial Commission on Remuneration (CECIR) of 1 February 2007, within the framework of the Plan of Measures to Improve Border Health Services (PMMSSE). The resolution also provides for 24 hour inspection 365 days per year in Alicante Port, Algeciras Port, Barcelona Airport, Cartagena Port, Madrid Airport, Vigo Port and Vitoria airport, and an extension of coverage from 14:00 to 20:00 in Barcelona Port, Las Palmas Airport, Las Palmas Port, Santa Cruz de Tenerife Port and Valencia Port, with special arrangements for Sundays. The number of approved inspector posts has been increased from 91 to 144 for SGSE of MISACO, and from 33 to 51 for SGASCF of MARM. The number of approved assistant inspector posts has been 80 Action taken

81 MR 8062/2006 of 12/06/2006 on Import Controls and Border Inspection Posts Reference no. and Recommendation Findings increased from 49 to 102 for SGSE, and from 0 to 7 for SGASCF. 38 new administrative posts have been approved for SGSE, and 12 for SGSA, now SGSPP. An overview table was provided, showing the number of new staff and the number of staff assigned to work special hours. These personnel will be allocated to the 15 main BIPs selected on the basis of trade volume. Recruitment for these posts is ongoing and all these posts are expected to be filled, including transfers of existing staff, by the end of the first quarter of Update (26240) To nominate official veterinarians under whose authority the BIPs are placed in accordance with Article 6 (b) of Directive 97/78/EC and Article 1 (1) of Decision 2001/812/EC. The CECIR resolution referred to above includes the creation of posts for Coordinadores de Inspección de Sanidad Exterior and Coordinadores de Inspección de Sanidad Animal in those BIPs where an official veterinarian did not exist with responsibility for each of these inspection services. Posts for Coordinadores de Inspección de Sanidad Exterior have thus been created for each of the main 15 BIPs included in the PMMSSE plan, and 2 posts for Coordinadores de Inspección de Sanidad Animal have been created for Las Palmas Port/Airport and Bilbao Port/Airport. In addition, taking into account the competences of various ministries in BIP staffing and activities, the PMMSSE plan also provides for the creation of the role of Head of BIP in each of the selected 15 BIPs, to "improve the organisation and co-ordination of the services". MAP, in coordination with MARM and MISACO is drafting job descriptions for the Heads of BIPs. For the remaining 25 BIPs which account for 10% of imports, it is foreseen to change the job descriptions of some existing personnel to attribute responsibilities consistent with the requirements of this recommendation. The completion of this action is foreseen by the end of June (26241) To consider what measures are necessary to further implement a system for the identification and selection of the consignments of veterinary interest, especially regarding The ATRAE Project, developed by the State Ports Authority (Puertos del Estado) is at an advanced stage, but it will not resolve the problem of access to cargo manifests Some ports already allow inspectors to have access to cargo manifests. A meeting with the Port authorities was planned for the 21 of February to discuss this issue. The Spanish authorities undertook to provide the FVO with a report of the outcome 81

82 MR 8062/2006 of 12/06/2006 on Import Controls and Border Inspection Posts Reference no. and Recommendation Findings Update electronic systems for the analysis of relevant intelligence, as laid down in Articles 6 and 7 of Commission Regulations (EC) Nos 136/2004 and 282/2004, and to ensure that pre-notification is received in advance of physical arrival of the consignment as required by Article 2 of the same Regulations. of the meeting. (26242) To ensure that relevant information is entered in TRACES for all consignments and to ensure that the TRACES application is implemented in accordance with Commission Decision 2004/292/EC. (26243) To ensure that documentary, identity and physical checks, including laboratory tests, are carried out, and that veterinary decisions taken are in accordance with provisions of Directives 91/496/EEC, 96/23/EC, 97/78/EC and the related Regulations and Decisions. (26244) To take action to review BIPs not visited to correct the shortcomings in the infrastructures, equipment, hygiene, documentation, registration and records MARM has been complying with the requirement to enter information into TRACES in accordance with this decision. However, SGSE of MISACO has not yet started to enter data into TRACES. A meeting between MISACO and DG SANCO took place in May 2008 to discuss this issue. MISACO stated that they expected to establish communications links between SISAEX, the Spanish IT system, and TRACES before the end of They indicated that they would send an official letter to DG SANCO as soon as possible, outlining the interim measures they proposed to take until the communications link is established. DGRAG of MARM awarded a contract to a private company related to "Technical assistance to Perform Quality Plan Activities for Sanidad Exterior". This contract addresses both premises and procedures, and will be completed by the end of Satisfactory information was provided in response to the mission report for all BIPs except for the Iberian Inspection Centre at Barajas Airport. For the WFS Inspection Centre at Madrid Barajas airport, a storage system for NHC products requiring temperature control, and defrosting equipment have been purchased. For the Iberian Inspection Centre at Barajas airport, the planned modifications (to complete the works necessary to 82

83 MR 8062/2006 of 12/06/2006 on Import Controls and Border Inspection Posts Reference no. and Recommendation Findings Update at Algeciras port, ICs Iberia and SFS in Madrid airport and Valencia airport in order to comply with the requirements laid down in Directives 91/496/EEC and 97/78/EC and Decision 2001/812/EC. address shortcomings identified during the FVO mission) have not taken place. A meeting planned for 19 February 2008 with the airport authorities on this issue had to be postponed. The Spanish authorities undertook to closely follow-up this issue, and to inform the FVO of any developments as soon as possible. (26245) To rectify the deficiencies noted with respect to Decision 2001/812/EC for the facilities visited at Alicante port, in particular concerning the NHC NT storage room. (26246) To rectify the deficiencies noted for facilities, equipment, hygiene, documentation, registration and records at BIPs visited in order to comply with the requirements laid down in Directives 91/496/EEC and 97/78/EC and Decision 2001/812/EC. The construction of new premises for the Alicante Port BIP, including the warehouse for storage at room temperature of ABP not for human consumption, is currently under way. Completion is foreseen during 2008 and the FVO will be promptly informed. In relation to the Spanish request of 25 February 2008 for approval of new facilities for HC and NHC-NT in Alicante port, a letter was sent by the FVO to the Spanish authorities on 5 March 2008, requesting clarifications on a number of issues. A response is awaited. Letters have been sent by SGSPP to the BIPs of Gran Canaria airport and Vigo port, with the aim of updating the situation concerning the correction of the deficiencies. The Spanish authorities are awaiting responses, and undertook to inform the FVO of the latest situation as soon as possible. 83

84 3.4. Feedingstuffs and animal nutrition Since 1999, the FVO has completed 1 inspection in Spain in relation to feedingstuffs and animal nutrition. Out of 7 recommendations contained in the report of this mission, 1 was identified for follow up during the 2008 general review mission, which was carried over from the country profile of Recommendations carried over from the country profile of Spain of November 2006 MR 9123/2003 of 01/12/2003 on Feedingstuffs Reference no. and Recommendation (16332) To ensure a transparent process for the designation of the laboratories involved in the feedingstuffs controls and set out provisions to supervise and guarantee the quality levels of their analytical performance. Findings The Spanish authorities stated that co-ordination on laboratory issues takes place both in the animal feed coordination committee, CNCAA, and in the Co-ordination Comittee for Analysis in Agriculture, Fish and Food (CLAAPA), co-ordinated by the Subdirectorate General for Agri-Food Laboratories of DGIMA of MARM. CLAAPA deals with issues related to analytical control activities, including accreditation. The Spanish authorities stated that notwithstanding the above, it was a matter for the competent authorities of each AC to define concrete objectives for each laboratory assigned responsibilities for official control analyses. They also stated that no new NRL designations had been made since the list of NRLs had last been submitted to the European Commission in An updated table, prepared by SGMPG of MARM, was provided during the GRM, showing the progress made towards accreditation since the 2006 GRM. At national level (Administracion General Del Estado- AGE) there are five laboratories, all of which became accredited in At AC level, there are 29 laboratories performing analyses in the 17 ACs. Ten of these (in 8 ACs) are accredited, and another one, in Navarra, is in the final stages. Although most of the other laboratories (in the remaining 9 ACs) have started the accreditation process, target dates for completing the process (to meet the December 2009 deadline contained in Commission Decision 2076/2005) are not yet available. Update 84

85 3.5. TSEs/ABP Since 1999, the FVO has completed 9 inspections in Spain in relation to TSEs/ABP. Out of 99 recommendations contained in the reports of these missions, 15 were identified for follow up during the 2008 general review mission, all of which were contained in reports that had reached closeout stage since the 2006 general review mission. Recommendations reaching closeout note stage since the 2006 general review mission. MR 8069/2006 of 23/01/2006 on BSE Reference no. and Recommendation With regard to the competent authorities (24650) To further enhance efficiency and effectiveness of coordination between all CA involved in control, prevention and eradication of BSE to ensure compliance with Art. 4(3) of Regulation (EC) No 882/2004. (24651) To introduce procedures in line with Art. 8(3) of Regulation (EC) No 882/2004 to verify compliance with the BSE monitoring programme as implemented by the AC and implementation of efficient official controls to demonstrate and ensure that restrictions and general obligations on the feed ban and the requirements on SRM are effectively enforced. Findings The Spanish authorities provided a copy of the annual report on controls on PAPs in It contains in its Annex a summary of information justifying alterations to each AC s 2006 plan, and containing recommendations from each AC for future plans. Information was also provided on the number of feedban controls planned and performed by all 17 ACs in A general description of progress made on introducing the audit system is included in Part 1 of the country profile. The description is based on the Spanish authorities' reponse to the draft country profile. In preparation for the GRM, the Spanish authorities were invited to provide a table listing the actions taken by each AC to ensure verification of compliance with BSE monitoring requirements. Information on systems already in place, and progress towards the introduction of procedures was provided during the GRM by 11 ACs. No information was provided during the GRM by 6 ACs: Andalucía, Aragón, Madrid, Murcia, Navarra, and the Basque Country. Update Action taken In response to the draft country profile, the Spanish authorities provided information on measures taken by 4 of these 6 ACs: Aragón, Madrid, Murcia, and the Basque Country. The Sub-directorate for Public Health in Aragon provided information on measures for SRM controls (guidelines, instructions, and supervision). The Madrid authorities stated that a protocol on SRM controls in slaughterhouses was being completed every 4 months; procedures and instructions were being updated. Murcia 85

86 MR 8069/2006 of 23/01/2006 on BSE Reference no. and Recommendation Findings stated that it had a procedure for SRM controls, which was complemented by the new "Second level Audits" (to Article 8.3 of Regulation (EC) No 882/2004), which were examining SRM controls. The Basque authorities stated that audits of establishment controls by its Department of Health included SRM controls. Update Information has not been provided for 2 ACs: Andalucia and Navarra. With regard to BSE epidemio-surveillance (24652) To ensure that all cattle displaying symptoms compatible with BSE and for which no alternative diagnosis can be established are considered as official clinical suspects and notified accordingly as required by Art. 3(h) and 12 (2) of Regulation (EC) No 999/2001. In response to the mission report the Spanish authorities stated that they would continue with the training programme on BSE symptoms for veterinarians and livestock keepers, carry out and distribute to the ACs comparisons of suspect animals notified, and distribute audiovisual material and references for continuing training of AC staff. This was an ongoing process for In preparation for the GRM, the Spanish authorities were requested to provide a table summarising the actions taken by each of the 17 ACs to address this recommendation, and showing for each AC whether there is any evidence or indicator (such as an increase in the number of notified clinical suspects) that the initiatives taken have increased the level and reliability of reporting and notification of BSE clinical suspects. The Spanish response contained responses from 5 ACs, who considered that there was no evidence to show whether these training programmes had improved the reliability of reporting of BSE clinical suspects. The Spanish response contained no information from 7 ACs on the impact of these measures. Even in ACs where there is a large cattle population, no evidence has yet been provided to show an increase in the number or percentage of notified clinical suspects; the effectiveness of the measures taken by ACs to improve awareness of BSE symptoms thus remains to be demonstrated. (24653) To ensure monitoring and testing of all fallen stock in line with provisions laid down in point 3, Chapter A of Annex III to Regulation (EC) No 999/2001. In preparation for the GRM the Spanish authorities were requested to provide a table summarising the actions taken by each of the 17 ACs to address this recommendation, and indicating for each AC the percentage of reported dead cattle older than 24 months that had not been sampled and not tested for BSE. Percentages were not provided for unsampled fallen stock from the following 7 ACs: Andalucia, Balearic Islands, Canary Islands, Castilla La Mancha, Castilla y 86

87 MR 8069/2006 of 23/01/2006 on BSE Reference no. and Recommendation Findings Leon, Navarra, and Valencia. Update For 3 ACs, more than 20 % of fallen stock >24 months were not sampled: Aragon, Cataluna and Murcia. For 4 ACs the percentage of fallen stock >24 months which were not sampled was less than 20: Asturias, Cantabria, Extremadure and Rioja For 3 ACs the percentage of fallen stock >24 months which were not sampled was stated to be zero:galicia, Madrid and the Basque Country. Some ACs provided information explaining the high percentages within the AC. (24654) To ensure a harmonised approach throughout Spain as regards classification in the appropriate subpopulations of animals slaughtered for human consumption tested for BSE in line with provisions laid down in point 2, Chapter A of Annex III to Regulation (EC) No 999/2001. The Spanish authorities confirmed that they had distributed the new epidemiological surveillance handbook to the ACs, and that they had allocated to each AC the number of animals to be sampled in each subpopulation. They stated that the ACs must classify animals in sub-populations in accordance with the criteria laid down in the surveillance handbook, and that there would be an annual comparison and check on compliance for all autonomous communities. A copy of the February 2006 version of the manual was provided. In preparation for the GRM, the Spanish authorities were requested to identify whether each of the 17 ACs is using the new handbook to classify these sub-populations as described in the recommendation. Eleven of the 17 ACs confirmed that they were using the manual, either directly or as a basis for preparing their own documented procedures. Information was not provided by the other 6 ACs (Andalucía, Balearic Islands, Canary Islands, Castilla y León, Navarra, and Valencia) to demonstrate that they were using it. (24655) To enhance the coordination and regular verification of the BSE epidemio-surveillance in order to ensure full compliance with all provisions laid down in Regulation (EC) No 999/2001 to guarantee submission to the Commission of reliable data in the annual report concerning the BSE testing and eradication programme in line with Art. 6(4) of Regulation In response to the mission report the Spanish authorities stated that they would continue using and improving the system for sending reports through the RASVE and TSE network application and would carry out regular assessment of these reports. During the GRM, the Spanish authorities provided documentation demonstrating the level of co-ordination and regular verification of BSE epidemio-surveillance. An assessment of this documentation indicates that the level of performance varies between ACs. It has not been demonstrated that MARM has a system in place to ensure that reliable data is received from all 17 ACs. 87

88 MR 8069/2006 of 23/01/2006 on BSE Reference no. and Recommendation (EC) No 999/2001. Findings Update With regard to the total feed ban (24656) To provide sufficient guarantees that all general implementing conditions as laid down in part III of Annex IV to Regulation (EC) No 999/2001 are complied with, in particular with respect to up-to-date listing of all relevant establishments and dedication and cleaning of storing facilities and means of transport. In response to the mission report the Spanish authorities stated that all specific observations made in the establishments visited by the inspectors during the mission had been addressed with a view to rectification and improvement at national level. The activities were already included in the Coordinated Programme of Animal Feed Controls. During the GRM, the Spanish authorities provided a copy of the annual report on controls on PAPs in It contains in its Annex a summary of information justifying alterations to each AC s 2006 plan, and containing recommendations from each AC for future plans. In response to an FVO request in preparation for the GRM, they also provided information in the form of 6 tables from the ACs on establishments and farms producing and/or using various restricted feed inputs as defined in Regulation (EC) No 1292/2005. In most cases, information was missing in these tables from between 5 and 8 ACs. Information from Asturias and the Balearic Islands was missing in all tables. The Spanish authorities have not yet indicated a date by which these tables will be satisfactorily completed by all ACs. (24657) To further enhance the risk-based strategy used to draw up the national plan for controls of the feed ban to bring it more in line with general obligations laid down in Art. 3 of Regulation (EC) No 882/2004 and to render the use of criteria to set priorities and the planned arrangements to be implemented more auditable. (24658) To ensure that circulation of Category 3 ABP containing ruminant material whose rendered fats could be destined for use as feed material is accompanied In response to the mission report, the Spanish authorities stated that the 2006 plan under the Coordinated Programme of Animal Feed Controls addresses the risk requirements of Article 3 of Regulation (EC) No 882/2004, and Commission Recommendation of 14 December 2005, on the Coordinated Inspection Programme in the Field of Animal Nutrition for 2006, in accordance with Council Directive 95/53/EC. Data was provided during the GRM showing the results of feeban controls for all 17 ACs for 2006, and preliminary data for controls during the first half of The Spanish authorities stated that for 2007, the ABP co-ordinating committee (CN-SANDACH) revised a document on PAP controls. The Spanish authorities confirmed during the GRM that agreement had been reached in the ABP co-ordination committee (CN-SANDACH) to have a standardised document on minimum information to be provided on ABP (including documentary checks), and that this was provided in the context of the last FVO mission (on ABP). This document has been sent to all ACs, and is 88

89 MR 8069/2006 of 23/01/2006 on BSE Reference no. and Recommendation Findings with commercial available on the ABP website. documentation that complies with provisions A Royal Decree was being debated in February 2008 laid down in Chapter III with a view to addressing traceability aspects of ABP, of Annex II to and requirements for authorisation of ABP transporters. Regulation (EC) No 1774/2002 on specification of the species of origin of the material. (24659) To have efficient measures in place to verify that implementation of targeted controls along the feed chain, including imported feedingstuffs, means of transport, rendered fats used as feed material and prevention of crossfeeding at farm level can ensure that restrictions on the use of feed materials of animal origin in feedingstuffs are effectively enforced in compliance with Regulation (EC) No 999/2001. With regard to the laboratory network (24660) To ensure a harmonised handling of BSE diagnosis in clinical suspects in line with methods and protocols laid down in Chapter C of Annex X to Regulation (EC) No 999/2001. In their response to the mission report, the Spanish authorities stated that all the specific observations made in the establishments visited by the inspectors during the mission had been addressed with a view to rectification and improvement of these aspects at national level. In addition, The National Commission for ABP had developed the national ABP control plan throughout the chain from primary production to disposal, including transport for the period 2007/2011; one of the aspects to be audited on the premises of the different operators (involved in the management, recovery and disposal of ABP) was their correct compliance with their documentary and recording obligations (including crosscontamination at farm level). The Spanish authorities were invited to provide information on the actions actually taken by each AC since the mission to verify effective implementation of targeted controls. In their response to the draft country profile, the Spanish authorities indicated that audits were planned in accordance with the table showing the audit programme for the period , as described in Part 1 of the country profile. The audit programme includes a list of the control programmes, and the autonomous communities being audited. The Spanish authorities stated that distribution of the new Epidemiological Surveillance Handbook, which deals with this aspect, had been done, and that ACs must make confirmatory diagnoses in all cases of clinical suspicion in accordance with Regulation (EC) No 999/2001. Eleven of the 17 ACs confirmed that they were using the manual, either directly or as a basis for preparing their own documented procedures. Update Confirmations were not received from the other 6 ACs (Andalucía, Balearic Islands, Canary Islands, Castilla y León, Navarra, and Valencia) that they were using it. 89

90 MR 8069/2006 of 23/01/2006 on BSE Reference no. and Recommendation (24661) To introduce measures to verify that the quality of samples taken has no significant impact on the sensitivity of rapid tests used for monitoring BSE in fallen stock. Findings The Spanish authorities confirmed that the new Epidemiological Surveillance Handbook (referred to also in recommendation 24654) which addresses this recommendation, had been distributed to all ACs, and that ACs had to make confirmatory diagnoses in all cases of clinical suspicion in accordance with Regulation (EC) No 999/2001. A mandatory feedback system from the NRL on the quality of samples had been finalised. Update Action taken The Spanish authorities stated that the issue of quality of samples was also checked during the FVO scrapie mission in The report of the scrapie mission showed that the laboratory in the AC of Castilla y Leon also had a system in place (similar to the NRL) to record the quality of samples received, and to provide feedback to the sample-taker. (24662) To ensure accreditation of all designated laboratories in relation to the tests they perform, whether for BSE testing or feed ban controls, in line with Art. 12 of Regulation (EC) No 882/2004. Information on accreditation laboratories for feed analyses is contained in chapter 3.4 of the country profile. In response to the pre-draft country profile, the Spanish authorities provided a document showing progress towards accreditation of AC laboratories under the remit of SGSPP, including those performing BSE tests. The document included responses from 9 ACs, and showed that 7 of the ACs either already had an laboratory accredited for BSE testing, or planned to have one before the end of 2009 deadline contained in Regulation (EC) No 2076/2005: Asturias, Cantabria, Castilla La Mancha, Cataluña, Galicia, Madrid, and La Rioja. In addition, the NRL at Algete expects to be accredited in the first half of With regard to SRM (24663) To ensure that sufficient instructions are issued and training provided to guarantee appropriate awareness of the operators and effective official controls throughout Spain to avoid any contamination in places where SRM is removed and to ensure compliance with all other requirements on SRM laid down in Annex XI to Regulation (EC) No Information is not yet available on progress towards accreditation for BSE tests in the other 10 ACs. Note: Recommendation has also been addressed through recommendations 3 and 5 of MR on ABP and gelatine. In response to the final report, the Spanish authorities stated that in June 2006 Order PRE/1868/2006 was published, regulating the destruction of SRM. They also stated that each AC Public Health Department has its instructions, which are sent out from the Central to the Peripheral Departments, and which are updated in line with any published changes in EU legislation. They stated that the handbooks/procedures compiled for pursuing the activities of the Official Veterinary Services included instructions for the correct removal, identification and management of ABP, including 90

91 MR 8069/2006 of 23/01/2006 on BSE Reference no. and Recommendation 999/2001. Category 1. Findings Update In response to a request from the FVO to provide information during the GRM for each AC as to whether they had issued relevant instructions or, whether additional training had been provided the Spanish authorities provided information from 11 ACs, including the 4 ACs (Asturias, Castilla y Leon, Cataluna, and Extremadura) visited by the FVO mission team. Information from the other 6 ACs (Andalucía, Aragon, Madrid, Murcia, Navarra and the Basque Country) was not provided during the GRM. In their response to the draft country profile, the Spanish authorities provided further information on measures being taken by the ACs, including 4 of the ACs from which information had not been provided during the GRM (Aragon, Madrid, Murcia and the Basque Country). Twelve ACs, confirmed conclusively that they had issued relevant instructions. Eight ACs (including Madrid and Murcia) confirmed conclusively that they had provided additional relevant training. No information was provided during this process by 2ACs: Andalucía, and Navarra. (24664) To put measures in place to ensure coordination and verification of the effective implementation of frequent official controls as regards removal, handling and dispatch of SRM in order to guarantee effective enforcement throughout Spain of all requirements laid down in Annex XI to Regulation (EC) No 999/2001. Note: Recommendation has also been addressed through recommendation 13 of MR on ABP and gelatine. In response to an FVO request to indicate whether verification tools had been put in place in each AC, the Spanish authorities provided information indicating that 8 ACs had verification systems in place or were planning to introduce them in 2008: Aragon, Castilla La Mancha, Castilla y Leon, Cataluna, Extremadura, Galicia, the Basque Country and Valencia. 91

92 3.6. Veterinary medicines and residues Since 1999, the FVO has completed 3 inspections in Spain in relation to veterinary medicines and residues. Out of 20 recommendations contained in the reports of these missions, five were identified for follow-up, all of which were carried over from the country profile of These have been classified below based on an assessment carried out through specific audit reference 7781/2008 of March MR 7264/2004 of 14/06/2004 on Control of veterinary medicines and residues in live animals and animal products. Reference no. and Recommendation Findings Assessment (18731) To ensure that samples collected in the context of the National Residue Control Plan are analysed in accredited laboratories using appropriate, validated methods (18733) To ensure that methods of analysis for group A methods are validated to the standards laid down in Commission Decision 2002/657/EC, within the deadline specified in that Decision (18751) To ensure that all VMPs authorised for use in food producing animals or included in the AEMPS vademecum contain only pharmacologically active substances included in Annexes I, II or III of Regulation (EC) No 2377/90. (18752) To take action to ensure that horses treated with VMPs authorised only for use in animals not intended for human consumption are not subsequently slaughtered for human consumption (18770) To take action to ensure that in all autonomous communities, a suitable competent authority is designated and empowered to carry out authorisation of and controls on premises distributing and dispensing VMPs or manufacturing medicated In their response to the draft country profile, the Spanish authorities stated that they would address this recommendation in the framework of the general audit, which incorporates the specific report 7781/2008 on residues. In their response to the draft country profile, the Spanish authorities stated that they would address this recommendation in the framework of the general audit, which incorporates the specific report 7781/2008 on residues. The Spanish authorities provided details of the designated competent authorities for all ACs in their reply to the pre-mission questionnaire for mission Action still required (a similar recommendation is contained in report 7781/2008) The Commission has initiated specific follow-up measures in the case of issues arising from this recommendation Action still required (a similar recommendation is contained in report 7781/2008) The Commission has initiated specific follow-up measures in the case of issues arising from this recommendation (a similar recommendation is contained in report 7781/2008) Action still required (a similar recommendation is contained in report 7781/2008) The Commission has initiated specific follow-up measures in the case of issues arising from this recommendation Action taken 92

93 MR 7264/2004 of 14/06/2004 on Control of veterinary medicines and residues in live animals and animal products. Reference no. and Recommendation Findings Assessment feedingstuffs. reference 7781/

94 3.7. Foodstuffs and food hygiene Since 1999 the FVO has carried out 5 inspections in Spain in relation to foodstuffs and food hygiene. Out of 17 recommendations contained in the reports of these missions, 4 were considered for further follow-up during the 2008 general review mission, all of which were carried over from the country profile of Recommendations carried over from the country profile of November 2006 MR 9259/2003 of 17/11/2003 on General food hygiene Reference no. and Recommendation Findings Update (16691) The In preparing for the 2008 GRM the FVO requested an update of the competent information provided during the 2006 GRM on progress towards authorities should accreditation of each official control laboratory performing analyses for ensure that all food hygiene in each AC in 2008, and (where the laboratory was not yet official control accredited, in accordance with the requirements of Regulation (EC) No laboratories meet the 2076/2005) requirements of ISO - whether the laboratory had demonstrated that it had initiated the 17025, (Art.3.1 of accreditation procedure and Council Directive 93/99/EEC). - whether the relevant competent authority had been provided with satisfactory guarantees on the quality control systems in place for food hygiene analyses. AESAN provided a table showing the accreditation and validation status of the NRL and of 57 laboratories in all 17 ACs. This table, which was slightly updated in response to the draft country profile, in general indicates that progress has been made in all ACs towards accreditation of laboratories, with the possible exception of Castilla y Leon, where a timetable is not yet available for 6 of the 9 laboratories performing official controls. The Spanish authorities have not indicated whether these 6 laboratories will continue to perform official control analyses when the transition period expires. In Andalucia, 5 are accredited, 2 will be accredited in In Aragon 2 are accredited, 2 will be accredited in 2008/2009. In Asturias the 2 laboratories are accredited. In Cantabria accreditation of one laboratory is scheduled for For the Canary Islands (CI), one will be accredited in 2008/2009, and the second will be accredited in In Castilla La Mancha, 1 laboratory is accredited, 5 will be accredited by the end of 2008 In Castilla Y Leon there are 9 laboratories, 2 of which are accredited, and 1 of which will be accredited by the end of Timetables are not available for the remaining 6. In Cataluna all 5 laboratories are accredited. In Valencia 2 laboratories are accredited, and one plans to be accredited in In Extremadura the 1 laboratory plans to be accredited in In Galicia all 3 laboratories are accredited. In the Balearic Islands the 1 laboratory will be accredited in In Madrid, 5 laboratories are accredited In Murcia, 1 laboratory will be accredited in 2009 In La Rioja (1), Navarra (2) and the Basque region (4), all laboratories are accredited. 94

95 MR 9259/2003 of 17/11/2003 on General food hygiene Reference no. and Recommendation Findings Update For situations where the laboratory is not yet accredited, the Spanish authorities have not demonstrated that the relevant competent authority has been provided with satisfactory guarantees on the quality control systems in place for food hygiene analyses, as required under Article 18 (b) of Regulation (EC) No 2076/2005. MR 7632/2005 of 6/03/2005 on GMO food and feed controls Reference no. and Recommendation (21450) The competent authorities of Spain should ensure that all imports of products for food or feed use and potentially containing GMO are checked according to Article 9 of Regulation (EC) No 1830/2003 and Article 4.3 of Council Directive 89/397/EEC. In particular, attention should be given to imported products not declared as feed stuffs and not destined or ready for human consumption. (21453) The competent authorities of Spain should ensure consistent reporting of inspection activities and followup actions from the regions to the central competent authority, AESAN. Findings During the 2006 General Review Mission the Subdirectorate-General for Border Health Controls indicated that an instrument would be adopted in 2007 to update the list of products subject to health controls at Spanish borders. The list was intended to include all food and food ingredients likely to contain genetically modified organisms. This followed a conclusion in the FVO report that the scope of inspections at the point of entry was limited to those products contained in the 1994 Ministerial Order, and that considerable amounts of raw materials such as soybeans and maize could enter Spain without inspection. The Spanish authorities have not yet indicated whether this instrument has been adopted. In preparation for the 2008 GRM the FVO requested a summary of the results of inspection activities and follow-up actions in each AC in 2006 and Feed MARM provided a table which showed the results of controls on GMO in feed in 2006 and samples were analysed for GMOs in 2006, including 387 samples in 15 ACs, and 60 samples at points of entry. Information was not available on whether any feed samples had been taken in 2006 in 2 ACs: Canary Islands, and Murcia. The MARM table also showed that 394 feed samples had been taken in 2007 in 14 ACs (all except Balearic and Canary Islands, and Murcia), and 54 samples had been taken at points of entry. Update Action still required Food AESAN provided a table during the GRM showing that reports on GMO controls in food were sent by most ACs, with the exception of Andalucía, Madrid, Murcia, Navarra and the Basque Country. La Rioja and Galicia did not conduct activities on GMOs either in 2006 or in In Aragón and Castilla y León, specific plans for the control of 95

96 MR 7632/2005 of 6/03/2005 on GMO food and feed controls Reference no. and Recommendation (21454) The competent authorities of Spain should ensure that official GMO laboratories are complying with the general criteria of ISO as required by Article 3.1 of Council Directive 93/99. Findings GMO in food were established, while in other ACs documentary controls and controls on labels are performed within the inspection activities for food safety (Programa de Vigilancia de Alimentos). Specific follow-up initiatives were indicated by 4 ACs (Aragón, Canarias, Cantabria, and Valencia). Canarias AC notified the non-compliance found to the Dirección General de Consumo. In their response to the draft country profile, the Spanish authorities provided additional information from a number of ACs. While Andalucia and Murcia had GMO sampling programmes in 2006, they didn't prepare such programmes in For the Basque Country, normal official controls incorporate instructions relating to traceability and labelling; there is no specific programme for GMOs. In preparation for the 2008 GRM, the FVO requested information on the laboratories used throughout Spain to perform GMO analyses, and their progress towards accreditation. The Spanish authorities stated that the Laboratorio Arbitral Agroalimentario (LAA of MARM) had been accredited since May 2006 for GMO analysis, and was included as the NRL in Regulation (EC) No 1981/2006. LAA had been attending workshops and meetings since then, in addition to participating in various validation activities organised by the JRC in Ispra. In response to the draft country profile, AESAN provided a table which included a list of laboratories performing controls on GMOs for 12 ACs, and their progress towards accreditation. Update Nine ACs (Aragon, Cantabria (private), Castilla y Leon (private), Extremadura (private), Balearic Islands (private), Valencia, Canary Islands (uses Valencia lab), Basque Country (uses an accredited lab, outside its public Health Department) and Madrid (private)) either have laboratories which are accredited for GMO controls, or send samples to accredited laboratories. Two ACs (Asturias and Castilla La Mancha) plan to achieve accreditation in The AC of Cantabria plans to achieve accreditation in Information has not been provided as to whether the remaining ACs have initiated and are pursuing accreditation procedures for official controls of GMO, with a view to achieving accreditation before the end of Neither has information been provided as to whether these ACs have made arrangements to have GMO testing, for official control purposes, done in accredited laboratories in other locations. 96

97 3.8. Imports of food of plant origin Since 1999 the FVO has carried out 3 inspections in Spain in relation to imports of food of plant origin: Of a total of 11 recommendations contained in the reports of these inspections, 3 were considered for further follow-up during the 2008 general review mission, all of which were contained in reports that had reached closeout stage since the 2006 general review mission. MR 8128/2006 of 6/11/2006 on Import Controls on Food and Feed of non-animal origin Reference no. and Recommendation (27270) Ensure that the premises of all DPIs fulfil the requirements of Article 4 of Commission Decision No 2006/504/EC (27271) Ensure that the special treatment of consignments is performed under the control of the CA, as required by Article 20 of Regulation (EC) No 882/2004. Findings In response to the mission report the Spanish authorities stated that all DPIs had been requested in writing to fulfil the requirements. Two DPIs had not yet replied. The Spanish authorities stated that if there was no reply within a month, the CCA intended to delete them from the DPI list. In preparation for the GRM, the FVO requested details of the number of DPIs which had now been formally approved, and the deadlines for the remaining DPIs to complete work. During the GRM, the Spanish authorities stated that 6 DPIs now fulfilled the necessary requirements. Of the remaining 9 DPIs, 7 have submitted proposals and 2 have deficiencies for which no proposals have yet been received. The mission team during mission 8128/2006, found that special treatments of non-compliant consignments were not performed under the control of the CA. In response to the mission report, the Spanish authorities stated that Instruction 83/IM/2006 would be amended to ensure that the special treatment of consignments is performed under the control of the CA. Another amendment would provide for the reporting of analytical results to include values for aflatoxin B1 and total aflatoxin content, the level of recovery and the measurement of uncertainty. During the GRM the Spanish authorities stated that the instruction had been amended to address these issues, and undertook to provide a copy. Update (27273) Ensure that the rejection notifications are immediately communicated to the Commission, as required by Article 50 of Regulation (EC) No 178/2002. At the time of the mission some RASFF rejection notifications were notified to the Commission up to 6 months after initial sampling. In response to the mission report, the Spanish authorities stated that the DPI at Valencia Harbour would inform the CCA about rejections on a daily basis. During the GRM, the Spanish authorities stated that considerable upgrading had taken place in the Valencia Harbour DPI, both in terms of infrastructure and staffing, and that this had led to a significant reduction in the time taken to notify the Commission about rejected consignments. Action taken AESAN stated that the Executive Director of AESAN is the national point of contact for RASFF, and is responsible for the management of all notifications. The alert network in Spain is part of the SCIRI information exchange system. AESA-CI approved a 97

98 MR 8128/2006 of 6/11/2006 on Import Controls on Food and Feed of non-animal origin Reference no. and Recommendation Findings procedure on 28 May 2006 requiring the immediate transmission of rejection notifications, in accordance with Article 50.3 (c)of Regulation (EC) No 178/2002. AESAN operates in accordance with this procedure to transmit information to the EU Commission as soon as information is received from SGSE. Update MARM stated that DGRAG is responsible at national level for managing RASFF as it relates to feed. It has set up a Feedingstuffs Contingency Plan (Plan Operativo de Intervention-POI). There is a specific module for controls on points of entry within the Coordinated Control Plan. A national rapid alert alert network has been set up within the POI, with a specific communications module in the SILUM animal feed database; the legal basis for this information exchange system is at an advanced stage. 98

99 3.9. Pesticides Since 1999, the FVO has completed 3 inspections in Spain in relation to pesticides. Out of 31 recommendations contained in the reports of these missions, 11 were identified for follow up during the 2008 general review mission, all of which were contained in reports that had reached closeout stage since the 2006 general review mission. MR 7179/2007 of 19/02/2007 on Pesticides Reference no. and Recommendation 1. The competent authorities should ensure that amendments to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels are transposed and national legislation providing for coordination of control measures under Regulation (EC) No 882/2004 is introduced without undue delay. Findings Commission Directives 2006/53/EC, 2006/59/EC, 2006/60/EC, 2006/61/EC and 2006/62/EC on pesticide MRLs were incorporated into Spanish law by Order Pre/876/2007 of 30 March. Commission Directives 2006/92/EC, Commission Directive 2007/7/EC, 2007/8/EC, 2007/9/EC, 2007/11/EC and 2007/12/EC on pesticide MRLs were incorporated into Spanish law by Order Pre /2170/2007 of 13 July. In their response to the draft country profile, the Spanish authorities stated that the subsequent Directives had been incorporated into agricultural legislation through Order Numbers PRE/508/2008 and PRE 695/2008. In February 2008, the Spanish authorities stated that the Royal Decree on the co-ordination of official controls on PPPs, was then being processed by MARM, as was the Ministerial Order creating the Co-ordination Committee. These texts had been agreed by MARM and the ACs after undergoing various amendments in the course of Update In their response to the draft country profile, the Spanish authorities stated that the publication of this Royal Decree had been delayed, due to the necessity to further adapt it, since controls on pesticide residues were governed by legislation other than Regulation (EC) No. 882/ The competent authorities should ensure that efficient and effective coordination takes place between all competent authorities carrying out official controls for pesticide residues, in accordance with Article 4 (3) of Regulation (EC) No 882/2004. Progress in adopting draft legislation, which will provide a legal basis for co-ordination between the central authorities (MARM) and the ACs, is described in recommendation 1 above. General information was provided on co-ordination between the AC competent authorities responsible for official controls of pesticide residues. In their response to the draft country profile, the Spanish authorities stated that formalised co-ordination arrangements had been set up in most ACs. Andalucia, Aragon, Asturias, Castilla La Mancha, Catalonia, Extremadura, Madrid, and Valencia had their own legislation governing co-ordination. In the Canary Islands and Murcia, co-ordination was taking place through Committees or Working Groups which had not been established under AC legislation, and in La Rioja, through its Food Safety Plan. In Murcia, a Co-ordination Body was being established. In the other ACs, co-ordination was takeing place through informal channels. 99

100 MR 7179/2007 of 19/02/2007 on Pesticides Reference no. and Recommendation 3. The competent authorities should ensure that all monitoring results, including follow-up, are routinely reported to the Commission as required by Articles 4(3) and 7(3) of Council Directives 90/642/EEC and 86/362/EEC respectively. 4. The competent authorities should consider taking into account the draft Guidance document on notification criteria for pesticide residues findings to the Rapid Alert System for Food and Feed (RASFF) (SANCO/3346/2001, rev 7), including systematic consumer risk assessments for adults and children. Findings Monitoring data for 2006 were submitted by the CA. The corresponding report on the results of controls had been sent earlier to the Commission. In their response to the draft country profile, the Spanish authorities stated that data on pesticide residues had been submitted by all ACs. AESAN stated that an agreed document had been prepared in conjunction with the competent authorities in official control of pesticide residues on plants. The document, which included procedures for risk assessment, was attached to the revised action plan. In their response to the draft country profile, the Spanish authorities stated that this document had been approved at the AESAN Institutional Committee meeting of 29 January 2008, and that it was being implemented by all ACs since that date. Update Action taken 5. The competent authorities should ensure that (i) all laboratories involved in the official control of pesticide residues are designated in accordance with Article 12 of Regulation (EC) No 882/2004, and (ii) all designated laboratories comply with Article 12 of Regulation (EC) No 882/2004, or are availing of the derogation foreseen in Article 18 of Commission Regulation (EC) No 2076/2005. The quality control system in the laboratories availing of Article 18 should be based on the SANCO guidelines for 'Quality Control Health Service Laboratories AESAN provided information during the GRM on the accreditation status of laboratories used for official controls of pesticides residues by the AC health services/food safety agencies (CS-ACs). Information was provided on 33 laboratories. 8 ACs had at least one accredited laboratory (Andalucia, Cantabria, Cataluña, Valencia, Extremadura, Galicia, Madrid, and Basque Country ) The Spanish authorities in their response to the draft country profile reported that the Basque authorities send samples to accredited laboratories for analyses which are not within the scope of accreditation of its Public Health authorities' laboratory. 4 ACs expect to achieve accreditation for at least one laboratory before the end of 2009 (Asturias, Castilla y Leon, La Rioja, and Murcia) For 5 ACs, either no information has been provided (Balearic Islands), or a timetable for achieving accreditation has not been provided (Aragón, Canary Islands, Castilla La Mancha and Navarra). Agriculture Services Laboratories MARM provided information during the GRM on the accreditation status of laboratories used for official controls of pesticides residues 100

101 MR 7179/2007 of 19/02/2007 on Pesticides Reference no. and Recommendation Procedures for Pesticide Residue Analysis' (Document No SANCO/10232/2006). Findings at central level, and by the CAG-ACs. The LAA in Madrid, which is the NRL, is accredited. 9 ACs had at least one accredited laboratory (Andalucia, Aragón, Castilla y Leon, Cataluna, Galicia, Murcia, La Rioja, Valencia, and the Basque Country). Update 3 ACs had laboratories which were undergoing the accreditation process (Asturias, Canary Islands, Navarra). The dates when accreditation was expected to be achieved were not known. The remaining 5 ACs either had no accredited laboratories for pesticide residues tests and had not yet started the accreditation process, or had provided no information on their laboratories. In their response to the draft country profile, the Spanish agricultural services stated that the NRL was performing analyses of samples from those ACs which had not yet adopted appropriate decisions on accreditation. They also provided an updated table of laboratories, and their progress towards accreditation. 6. In cases where monitoring shows noncompliance, the competent authorities should ensure that appropriate enforcement actions are taken in accordance with Article 54 of Regulation (EC) No 882/2004 and should consider taking into account the analytical uncertainty, established in accordance with the SANCO guidelines for 'Quality Control Procedures for Pesticide Residue Analysis' (Document No SANCO/10232/2006). 7. In accordance with Article 6 of Regulation (EC) No 882/2004, the competent authorities should ensure that staff receive appropriate training so that samples are taken in accordance with Commission Directive 2002/63/EC. During the GRM, MARM stated that the adoption of measures set out in Article 54 of Regulation (EC) 882/2004 was guaranteed by Article 48 of Law 43/2002, on plant health; sanctions were covered in Articles of this law, and in the sanctions procedure of Royal Decree 1945/1983, as previously referenced. Information about procedures for follow-up of non-compliances was provided by all ACs with the action plan and its revision. The Spanish authorities indicated that some, but not all, ACs take analytical uncertainty into account when interpreting results. In their response to the draft country profile, the Spanish authorities stated that the Canary Islands authorities were taking analytical uncertainty into account when interpreting results. Information was provided (for all ACs and for the import control body) with the action plan and its revision of 1 February of the 17 ACs confirmed that they were following the sampling procedures laid down in Royal Decree 290/2003, which transposed Commission Directive 2002/63/EC. In their response to the draft country profile, the Spanish authorities stated that Murcia and the Basque Country were also following these procedures. 101

102 MR 7179/2007 of 19/02/2007 on Pesticides Reference no. and Recommendation Findings During the GRM, the Spanish authorities indicated that many ACs had organised training courses, or intended to do so in Update 8. The competent authorities should consider substantially increasing the range of validated analytical methods for detection of pesticide residues and metabolites being sought, so as to better reflect those substances being marketed and used. 9. The competent authorities should ensure the introduction of co-ordinated and comprehensive inspection and enforcement procedures for controlling the marketing of plant protection products, including follow-up, in accordance with Article 17 of Council Directive 91/414/EEC and clarify the competencies and procedures for importation of plant protection products. In their response to the draft country profile, the Spanish authorities stated that new courses had taken place in Andalucia (Almeria), and in Cataluna (Tarragona). A co-ordinated training plan was being organised. The Spanish authorities provided information during the GRM about the analytical scope for all ACs. The average analytical screen in the EU of 2005 (146 pesticides) was being reached in only three ACs. The Spanish authorities, in their reply to the draft country profile, stated that they had reviewed the lists of active substances to verify whether ACs had the capacity to analyse some of the pesticides withdrawn from the market, and whether this review would result in a significant increase in the range of substances covered by validated methods. The Spanish authorities stated that although some ACs do not reach the EU average, they considered that the objective of investigating pesticides residues was being achieved, since all pesticides were being marketed throughout the whole country. In their response, the Spanish authorities referred to the draft Royal Decree regulating coordination of official controls on PPPs and their residues, as described in recommendation 1 above. They also stated that there were written and oral agreements with SEPRONA to perform controls on trade and transport of illegal PPPs in the ACs of greatest risk (Andalucia, Valencia, Murcia and Navarra). They stated that the results were satisfactory, taking into account the number of seizures and arrests, which were undergoing legal procedures. The CA also stated that the implementation of the National Monitoring Plan on the Marketing of Plant Protection Products was based on the Procedures Manual prepared jointly by the ACs and MARM. This manual was updated in 2004 and a new revision was being planned in order to bring it into line with a new EU pesticides Regulation. The extent to which the new manual will specifically address the issue of inspection and enforcement procedures, or whether each AC will independently draw up its own inspection and enforcement procedures, remains to be demonstrated. Information about the level of implementation of the current Procedures Manual was provided for only 4 ACs. Action required Action required still still 10. The competent In their response, the Spanish authorities referred to the draft Royal authorities should Decree regulating coordination of official controls on PPPs and ensure the introduction their residues, as described in recommendation 1 above. They also of co-ordinated and stated that there were written and oral agreements with SEPRONA, comprehensive which provided for taking samples of soil, water or vegetables. inspection and enforcement In addition, Order APA/326/2007 establishing obligations for 102 Action required still

103 MR 7179/2007 of 19/02/2007 on Pesticides Reference no. and Recommendation procedures for controlling the use of plant protection products, including the use of illegal products and follow-up, in accordance with Article 17 of Council Directive 91/414/EEC. Findings farmers to register information on the use of PPPs, entered into force on 9 May A copy was provided. The CA also stated that the implementation of the National Monitoring Plan on the Use of Plant Protection Products was based on the Procedures Manual published jointly by ACs and MARM. This manual was updated in 2004 and a new revision was being planned in order to bring it into line with a new EU pesticides Regulation. The extent to which the new manual will specifically address the issue of inspection and enforcement procedures, or whether each AC will independently draw up its own inspection and enforcement procedures, remains to be demonstrated. Update Information about implementation of the current Procedures Manual was provided for only 4 ACs. 11. The competent authorities should ensure that the annual report to the Commission in the framework of Article 17 of Council Directive 91/414/EEC includes results from all autonomous communities. The Spanish authorities stated that "the corresponding report was sent to the Commission by on 12 July It is not yet clear whether this report contains results from the competent authorities of all 17 ACs. 103

104 3.10. Animal welfare Since 1999, the FVO has completed 7 inspections in Spain in relation to animal welfare. Out of 53 recommendations contained in the reports of these missions, 18 were identified for follow up during the 2008 general review mission, 8 of which were carried over from the country profile of 2006, and 10 were contained in reports that had reached closeout stage since the 2006 general review mission. Recommendations carried over from the country profile of November 2006 MR 9215/2003 of 09/12/2003 on Animal welfare during transport and at slaughter Reference no. and Recommendation (16516) Ensure that the transport of unfit animals to both collection centres and slaughterhouses is deterred. In particular, effective procedures should be adopted to enforce Article 3 of Council Directive 91/628/EEC (the current legislation is Regulation (EC) No 1/2005) and Article 12 of Directive 93/119/EC. (23015 of MR 7548/2005) Findings (RECOMMENDATIONS of MR 9215/2003 AND OF MR 7548/2005 HAVE BEEN ADDRESSED TOGETHER) In preparation for the GRM, the Spanish authorities were requested to provide a table summarising the procedures issued by each of the 17 ACs to their control services, and the dates they were issued. MARM's response during the GRM was that since the Framework Control Plan to Verify Compliance with Animal Welfare Legislation (which would be used as the base document for controls) had been approved only in December 2007, the ACs had not yet modified their protocols, which in any event, would include those related to transport. They also stated that CEBPAP, the co-ordination body, is working on a consolidated animal welfare transport document, which was presented in meetings of 9 October and 12 December At the time of the GRM, the document was under consultation with the ACs and would be submitted to the next co-ordination meeting, scheduled for 16 April A common procedure would be agreed in the coordination body, which would be adapted by each AC for its own use. Timeframes for having the document adopted in the coordinating committee, and for having it implemented in all 17 ACs were not yet available. Addressed under Recommendation of MR 9215/2003 Update Ensure that travelling times for poultry meet the maximum journey time laid down in Chapter II of the Annex to Directive 91/628/EEC. In particular, in the case of 104

105 MR 9215/2003 of 09/12/2003 on Animal welfare during transport and at slaughter Reference no. and Recommendation spent hens, further consideration should be given regarding their fitness for the intended journey (Article 3 (1)(b) Directive 91/628/EEC). Findings Update (16517) Means of transport should comply with all the requirements of parts A and D of Chapter I of the Annex to Directive 91/628/EEC, in particular unloading equipment at markets Journey times as laid down in Chapter VII of Directive 91/628/EEC MARM stated that the ACs had been in ongoing contact should be respected, in with MARM in transferring their registration data to the particular attention SIRENTRA database. All ACs had completed the should be given to: registration of transporters, but some, for technical documentation which reasons, had not been able to transfer data (Catalonia, accompanies the Castilla y Leon, Galicia and Basque Country) or had not animals indicating the yet transferred all data (Extremadura). 7 ACs had date and time of published a specific Orden for the registration of departure (Article 4 of transporters (Asturias, Cantabria, Castilla y Leon, Directive 91/628/EECthe Catalonia, Extremadura, Navarra and La Rioja). The other current legislation ACs were using Law 30/1992, on the Common is Regulation (EC) No Administrative Procedure, and Royal Decree 751/2006 as 1/2005); the feasibility legal bases. The database was published, with some data of the journey before available for public access, and other data having restricted approval of route plans, access: respecting also Commission Decision 2003/483/EC; registers at assembly centres for cattle should contain all the information required by Article 11 of Directive 64/432/EEC. Royal Decree 751/2006 of 16 June, provides a legal basis for the authorisation and registration of animal transporters. The SIRENTRA database for the registration of transporters became operational in January In preparation for the GRM the FVO requested a table summarising for each of the 17 ACs the actions taken to complete the registration and authorisation of transporters, whether the database was fully operational and publicly available in the AC, and whether the AC legal acts to create the database for transporters complied with national legislation. MARM further stated that they were considering updating the document SGOBPG/BA/5/2004 for the approval of vehicles, prepared before the entry into force of Regulation (EC) No 1/2005. There were also various checklists on animal transport in the supporting documentation to the Framework Plan. 105

106 MR 7230/2004 of 09/02/2004 on Animal welfare - laying hens and during transport Reference no. and Recommendation (17094) Adequate controls on route plans are performed to ensure compliance with Article 5(A) (2) of Directive 91/628/ EEC, and effective measures are taken to ensure their return. Information on the existence of route plans is provided through the ANIMO system (Article 5(A)(2)(c) of Directive 91/628/ EEC) to the CAs of destination. (The current legislation is Regulation (EC) No 1/2005) Findings Council Regulation (EC) No 1/2005 now provides the legal basis for this recommendation. In preparation for the GRM, the FVO requested the Spanish authorities to confirm whether there was a single national procedure for controls of journey logs for all ACs, the situation for each AC as to whether they were implementing such procedures (with relevant starting dates), and the number of such controls performed in The Spanish authorities provided copies of the documented procedures on animal transport in the ACs. They stated that 11 ACs (Aragón, Asturias, Cantabria, Castilla y León, Cataluña, Galicia, Murcia, Navarra, Basque Country, La Rioja and Valencia) had specific instructions on journey logs. They stated that the number of controls on journey logs was included in the overall report to the European Commission, although not specifically identified. MARM provided a copy of the document that CEBPAP, the co-ordination body, had adopted in December 2007 for the management of journey logs and route plans. It remains to be demonstrated whether all ACs will amend their existing procedures, or introduce new procedures to take account of this document, or whether timeframes are available for ensuring that controls addressing these recommendations take place in accordance with documented procedures in all 17 ACs. Update MR 7548/2005 of 27/2/2005 on Animal welfare for pigs and laying hens Reference no. and Recommendation (23011) Ensure that training courses are available for pig farmers as required by Article 5(a) of Directive 91/630/EEC. (23012) Ensure that comprehensive guidance is provided on checking the requirements of Directive 91/630/EEC (pigs) in particular those introduced by amendments in 2001 Findings MARM provided a table showing that training had been provided for pig farmers in 16 ACs. No such training was provided in the Canary Islands in 2006 or (RECOMMENDATIONS AND 23013, BOTH OF WHICH RELATE TO GUIDANCE, HAVE BEEN ADDRESSED TOGETHER) In preparation for the GRM, the Spanish authorities were requested to list the ACs which were using the guidance documents MAPA/BA/GR/5/2006 (Guide for Animal Welfare inspections for Pig Farms) and MAPA/BA/GR/4/2006 (Guide for Animal Welfare inspections for Laying Hens), which were both agreed at the co-ordination meeting of , to perform controls. MARM stated that ACs had been using these documents 106 Update Action taken

107 MR 7548/2005 of 27/2/2005 on Animal welfare for pigs and laying hens Reference no. and Recommendation Findings as a basis for preparing their own procedures. A list of documents used for animal welfare inspections in all 17 ACs was provided, largely composed of Actas de Inspección, and Protocolos de Inspección. The date when each document was adopted was not always available. Update (23013) Ensure that comprehensive guidance is provided on checking the requirements of Directive 99/74/EC (laying hens), as previously recommended in report 7230/2004, in particular on determining the maximum capacity for each building and the slope of cages. The table showed that instructions or guidelines were available for on-farm animal welfare controls for pigs in 5 ACs: Castilla y Leon, Extremadura, Galicia, Navarra and La Rioja, and for on-farm animal welfare controls for laying hens in 4 ACs: Castilla y Leon,Galicia, Navarra and La Rioja. The Spanish authorities stated that the new Framework Plan approved in December 2007 had supporting documentation related to the maximum capacity and slope of cages in laying hen holdings. They also stated that as a result of the new Framework Plan, the documents MAPA/BA/GR/5/2006 and MAPA/BA/GR/6/2006 were being revised to include some additional elements. These would be further discussed in the co-ordination meeting scheduled for 16 April Addressed under Recommendation (23014) Ensure that when a deficiency in relation to EU requirements is detected: In preparation for the 2008 GRM, the Spanish authorities were requested to provide an updated table of the ACs who had sent completed documents recording infringements to MARM, including details of effective follow-up actions. a) The details of the MARM stated that ACs were not sending punctual infringement are notifications to MARM on their relations with other adequately recorded ACs. When an issue involved several ACs, it was including, where addressed in the co-ordination committee. MARM stated Directive 99/74/EC is that ACs sent reports on inspections to them, for further applicable, the precise transmission to the Commission. location of the flock. To improve co-ordination, two measures had been b) As previously proposed. Study visits between ACs had been discussed 107

108 MR 7548/2005 of 27/2/2005 on Animal welfare for pigs and laying hens Reference no. and Recommendation recommended in report 3344/2001, that effective follow-up action is undertaken in as short a time frame as possible. In particular, urgent action should be taken to address problems with overstocking of laying hens. c) All infringements in relation to EU minimum standards are reliably reported (Article 6 of Directive 98/58/EC and Decision 2000/50/EC). Findings in the October and December 2007 co-ordination meetings, and the ACs were considering how to put this into practice. The Spanish authorities stated that the new animal welfare law, with powers of sanctions in all ACs, would facilitate taking decisions on follow-up to inspections. In response to an FVO request in preparation for the GRM, the Spanish authorities provided a table summarising the reports relating to animal welfare received from the ACs for the years In relation to Decision 2000/50/EC on animal welfare on-farm, reports to MARM were incomplete from 7 ACs: Aragon, Asturias, Canary islands, Cantabria, Madrid, Basque Country and Valencia. Update Note: Decision 2000/50 has been repealed by Decision 2008/776 Recommendations reaching closeout note stage since the 2006 general review mission. MR 2007/7328 of 5/03/2007 on Animal welfare at slaughter Reference No. and Recommendation 2. Efficient and effective coordination exists between the authorities responsible for animal welfare at central and local levels, as required by Article 4(3) of Regulation (EC) No 882/2004. Findings/Assessment/ In preparation for the 2008 GRM the Spanish authorities were requested to summarise the information provided by ACs during co-ordination body meetings to address FVO report recommendations, and to summarise the arrangements ACs had in place for co-operation between the public health and animal welfare authorities. Information was also requested on the role of the contact point in Spain, as prescribed under Article 24 of Regulation (EC) No 1/2005, on animal welfare during transport. Update The Spanish authorities stated that the point of contact under Article 24 of Regulation (EC) No 1/2005 is All information received from other MS or from the European Commission is distributed from this address. A table was provided listing the contact addresses and phone numbers of the relevant points of contact in the ACs. They stated that there are various forms of co-ordination within the ACs. In some cases autonomous legislation had been adopted, such as in the Balearic Islands. In others, meetings take place in the framework of administrative co-operation established 108

109 MR 2007/7328 of 5/03/2007 on Animal welfare at slaughter Reference No. and Recommendation Findings/Assessment/ under Articles 4 and 5 of Law 30/1992 (see part 1 of CP). Update Information was provided by all 17 ACs in relation to coordination between their respective Ministries of Agriculture, and Health/Food Safety Agencies. Most ACs have co-ordination agreements in place. Some ACs (such as Aragon, Asturias and Catalonia) have demonstrated the actions already taken, or planned for 2008, by these internal AC co-ordination bodies to address animal welfare issues. Further work is ongoing in most ACs to demonstrate the effectiveness of these coordination bodies in addressing animal welfare issues. 3. Adequate training on animal welfare requirements at slaughter and transport is provided to inspectors in slaughterhouses as required by Article 6 of Regulation (EC) No 882/2004. In response to the mission report, MARM stated that on 20 and 21 March 2007, a training course for trainers comprising sixteen teaching hours had been held, attended by 38 officials from all the ACs. They stated that although the ACs already organised training courses, these would be reviewed to ensure that inspectors were being properly trained. During the GRM the Spanish authorities provided a copy of the provisional course of February 2007 for training of trainers on animal welfare at slaughter. In preparation for the GRM, the Spanish authorities were requested to indicate the actions already taken, or proposed in 2008, by each of the 17 ACs to ensure that all inspectors in slaughterhouses were trained in accordance with Article 6 of Regulation (EC) No 882/2004. Almost all ACs provided information on relevant training provided in 2007 or planned for In their response to the draft country profile, AESAN stated that information on training was provided to the FVO in preparation for mission reference 7766/2008. They also stated that Extremadura had planned 2 workshops in 2008 for 60 slaughterhouse veterinarians, each of 30 hours duration, and provided details of training for Castilla-La Mancha. 4. Official controls Note: Recommendation No from mission implementing 9215/2003 on animal welfare during transport and at Directive 93/119/EC slaughter, had a similar recommendation: "Information are carried out and guidance should be more readily available to following documented inspectors". procedures, as required by Article 8(1) of The Spanish authorities stated during the GRM that a Regulation (EC) No draft of the document on electrical stunning of poultry in 882/2004. In waterbaths was discussed in the CEBPAP co-ordination particular, Competent meeting of 23 January It was now undergoing Authorities should consultation with the ACs, and was expected to be define the strength and approved in the April 2008 co-ordination meeting. duration of current required in waterbath This subject would also be addressed in the course 109

110 MR 2007/7328 of 5/03/2007 on Animal welfare at slaughter Reference No. and Recommendation stunners and the national rules applicable to gas stunning of rabbits as required, respectively, by Annex C, Section II, point 3.B (1) and Article 13(d) of Directive 93/119/EC. Findings/Assessment/ organised by MARM, scheduled for February 2008, to be attended by veterinarians with daily practical experience in this matter. In preparation for the GRM, the Spanish authorities were requested to provide for each of the ACs, the list of documented procedures being implemented for animal welfare controls in all slaughterhouses. In relation to gas stunning of rabbits, the Spanish authorities stated during the GRM that there was just one rabbit slaughterhouse in Spain (in Catalonia) and that the Catalonian authorities were preparing documented procedures which would be discussed at the next coordination meeting. Update In their response to the draft country profile, AESAN stated that information addressing this recommendation had been provided to the FVO in preparation for mission reference 7766/2008. They also provided a copy of the instructions and documented procedures being used by La Rioja. They also stated that the Canary Islands had prepared new documented procedures in June 2008 on animal welfare controls at-slaughter. 5. Effectiveness of inspections carried out is verified, as required by Article 8(3)(a) of Regulation (EC) No 882/2004. In response to a FVO request for information during the GRM, the Spanish authorities provided a table summarising the reports relating to animal welfare received from the ACs for the years DGRAG had received no reports from any AC on implementation relating to Directive 93/119, on animal welfare at slaughter. It was not clear whether AESAN was receiving any such reports. The Spanish authorities stated that this issue had been addressed in co-ordination meetings, and that an initial analysis indicated that complementary actions by CEBPAP were required. A round table discussion had thus been organised for the course of February 2008 to specifically address the 3 levels of inspection, supervision and audit. The discussions would consider how certain ACs had addressed this issue, would gather further information and would propose more specific actions. In their response to the draft country profile, the Spanish authorities stated that this information would be sent in the framework of the annual report under Article 44 of Regulation (EC) No 882/ The results of inspections are notified to food business operators as required MARM stated that during previous inspections cases were found where due to the lack of a legal basis, procedures leading to sanctions were not launched, and 110 Action taken

111 MR 2007/7328 of 5/03/2007 on Animal welfare at slaughter Reference No. and Findings/Assessment/ Recommendation by Article 9(3) of the operator may not have been informed. Regulation (EC) No 882/2004. The situation had now changed. Controls were now being implemented in accordance with the new Law 32/2007, which provided a legal basis for sanctions. Whenever an Acta was completed by an inspector, a copy was now being given to the business operator. 7. Ante-mortem inspections of poultry are carried out in compliance with Annex I, Section IV, Chapter V, Part A, point 1 (a) of Regulation (EC) No 854/ Conditions of transport of poultry comply with Article 3, second paragraph (c) and (g) and Annex I, Chapter II, point 1.1 (c) and point 1.2 of Regulation (EC) No 1/2005. In response to the mission report the Spanish authorities stated that this matter was discussed by the Coordination Body on 12 June During the GRM, DGRAG stated that in some ACs (usually those with low poultry populations) the antemortem inspection was taking place at the slaughterhouse, rather than on the farm. They also stated that ante-mortem certificates used by the ACs had been reviewed, and that some were found to be non-compliant. A new model had been discussed in a co-ordination meeting, and all ACs had agreed to review their certificates to ensure compliance with (EC) No 854/2004. In their response to the mission report, the Spanish authorities stated that in the 2008 inspection plan for the protection of animals during transport, inspections would be targeted at means of transport and containers for poultry so that any shortcomings could be rectified. During the GRM, the Spanish authorities provided a copy of the 2008 Framework Control Plan for Animal Welfare, which made reference in Annex II, point 3, to the need for each AC competent authority to have documented procedures in place. The information provided did not demonstrate the number of ACs which had finalised their individual animal welfare (transport) plans and were implementing them. Update During the GRM the Spanish authorities indicated that ACs would decide on the number of inspections based on common risk criteria. The Spanish authorities stated during the GRM that it was reasonable to assume that documented procedures for transport of poultry would be adopted by ACs at the April 2008 co-ordination meeting. 9. Corrective actions The Spanish authorities stated that Law 32/2007 of 7 are taken in case of November, had been adopted to ensure that legal infringements to provisions for animal welfare infringements would be requirements of compatible with existing AC legislation, and with the Directive 93/119/EC Spanish Constitution. and Regulation (EC) The Spanish authorities stated during the GRM that it No 1/2005 as required was likely that ACs would arrange short training courses by Article 8(3)(b) of to familiarise their staff with procedures arising from the Regulation (EC) No new 2007 Animal Welfare Law. 882/2004. In their response to the draft country profile, the Spanish 111

112 MR 2007/7328 of 5/03/2007 on Animal welfare at slaughter Reference No. and Recommendation 10. A system of controls is set up to ensure that killing of fur animals is carried out in compliance with the requirements of Annex F of Directive 93/119/EC. Findings/Assessment/ authorities stated that in Castilla-La Mancha, noncompliances had been communicated to the CAG-AC, which was responsible for sanctions and had taken the necessary measures. In Extremadura, the workshops referred to in recommendation 3 were addressing this issue. In their response to the mission report, the Spanish authorities stated that although these farms were already included in the Control Plan, the 2008 inspections plan would be modified and would specifically include fur farms, with a view to increasing their level of inspection in The Spanish authorities stated during the GRM that this point had been included in the Framework Plan for Controls. Official controls on fur animals were considered to be the same as for other farm animals, the exception being that additional controls were necessary for slaughter which takes place on farms. Update A specific checklist would be included in the support document to the Framework Plan. 11. Adequate arrangements are in place to ensure that killing of animals for disease controls do not cause any avoidable excitement, pain or suffering, as required by Article 3 of Directive 93/119/EC. The Spanish authorities stated that since September 2007, an inspection protocol had been in place in Galicia (which contains the majority of Spain's fur farms) for such farms. Details of other fur farms were available in the REGA database. In their response to the mission report the Spanish authorities stated that all Contingency Plans and the Coordinated State Alert Plan would be reviewed to ensure that they include all the relevant information. The Coordination Board would also prepare and distribute a note outlining the information which must be included in AC plans on the subject. Contingency Plans have been revised, but aspects related to this recommendation have not been finalised, since it has been identified that the key problem is the lack of information in the ACs on practical aspects relating to implementation of the plans. For logistical reasons, this information must be prepared and managed at AC level. Additional information is being gathered, and a presentation will take place on this point at the course of February Work is ongoing with SGSPP to complete this point as soon as possible. It is hoped that MARM will have finalised its input by 1 March It is expected that by then, a letter will have been sent to the AC competent authorities addressing this issue. 112

113 3.11. Plant Health Since 1999, the FVO has completed 7 inspections in Spain in relation to plant health. Out of 39 recommendations contained in the reports of these missions, none was identified for follow up during the 2008 general review mission Overview of more recent inspections In addition to 78 finalised inspection reports and recommendations arising from these reports which are dealt with in chapters above, 5 further inspections which had not reached the "closeout" stage at the time of the general review mission in February 2008 had been carried out. The recommendations contained in these reports will be followed up and assessed in the next update of the country profile. The following tables give a brief summary of state of play on these inspections as of April MR 8174/2006 of 21 March 2006 on Animal health requirements for Intra-Community trade in live animals The final report has been sent to the Spanish authorities, an action plan has been received and the report has now reached the "close out" stage. Overall, the report concluded that the Spanish control system in place for intra-community trade in live animals did not fully comply with Community requirements. Deficiencies were noted in particular in the following areas: lack of audit systems between the different CAs and shortage of documented procedures, sheep identification, implementation of the animal health requirements for maintaining the officially free/free status of holdings for bovine tuberculosis and brucellosis, supervision of approved assembly centres, the use of TRACES and certification. The assessment of the action plan received from the Spanish authorities indicates that while the National Control Plan for Intra-Community Trade in live animals, or the corresponding Procedural Manual, address most of the recommendations, it remains to be demonstrated whether each of the 17 ACs has confirmed that it implements controls in accordance with these documents. Furthermore, neither the Control Plan, nor the Manual contains specific provisions on implementation of audits (Article 4.6 of Regulation (EC) No 882/2004), or on the need for competent authorities to have procedures in place to verify the effectiveness of official controls (Article 8.3). MR 7367/2007 of 4 June 2007 on the Bovine brucellosis eradication programme The final report has been sent to the Spanish authorities, an action plan has been received and the report has now reached the "close out" stage. Overall, the report concluded that the eradication programme was in general correctly implemented and the epidemiological data indicated that the situation was improving in most of the ACs. However, serious shortcomings were detected in relation to the controls carried out by the public health CA responsible for dairies and red meat establishments in both ACs visited, as well as in relation to the operational hygiene of the slaughterhouse visited. The action plan received from the Spanish authorities provides a satisfactory response to all recommendations. Further follow up is necessary to assess the system in place at central level to effectively co-ordinate progress by all ACs towards full implementation, and to verify the actions taken by each AC to effectively implement commitments, including, in particular, aspects related to audit, control and verification procedures. 113

114 MR 7448/2007 of 23 April 2007 on food of animal origin, in particular meat and milk The final report was sent to the Spanish authorities in July The initial assessment of the action plan response indicated that information on the actions taken by many of the ACs to address the report recommendations was missing, and a request for additional information was sent to the Spanish authorities on 4 February The Spanish authorities provided the additional information in June Overall, the report concluded that little improvement had been noted since the previous mission. The official controls over food business operators' (FBOs) compliance with general and specific rules on the hygiene of food of animal origin, and the implementation of these rules by FBOs, were still inadequate. The CA was still making progress to complete the framework for official controls over the food chain and the enforcement of FBOs' obligations. The control of raw milk quality in one AC visited was unacceptable and, due to insufficient action with regard to residues of inhibitory substances, the protection of consumers was not fully guaranteed. In June 2007 the Spanish Authorities presented an Action Plan on controls on milk hygiene to the European Commission, with the agreement of the AC public health and agricultural authorities. This would provide a new basis for official controls on raw milk in Spain. An interim DG SANCO mission found that the Spanish authorities had made real efforts to improve the situation in the milk sector. The Spanish action plan seemed to be achieving positive results, but further work was necessary to monitor actions taken by ACs to review somatic cell and total plate counts. A Royal Decree on controls in the milk sector was adopted in December A Raw Milk Control Plan has been approved. Serious problems were identified with animal welfare at slaughter in two establishments visited with insufficient action taken by the OV. The Spanish response to the FVO request for additional information, received in June 2008, will be taken into account in a further FVO mission planned for the end of MR 7251/2007 of 22 May 2007 on ABP and gelatine The final report has been sent to the Spanish authorities, an action plan has been received and the report has now reached the "close out" stage. Overall, the report concluded that: For ABP, steps have been taken to ensure better compliance with Regulation (EC) No 1774/2002 in the future through the production of a national control plan for ABP and guidelines for official controls and approvals; all this will help to harmonise the system throughout Spain. However, the current control system for ABP was not yet fully effective, as most of the afore-mentioned measures had not entered into force and there were a number of shortcomings For gelatine, there was a largely satisfactory control system in place for the chain of gelatine, although the correct channelling of raw materials for the production of both gelatine intended and not intended for human consumption could be affected by some weaknesses in approvals and official controls, respectively. The assessment of the action plan received from the Spanish authorities indicates that the CA has not satisfactorily addressed 7 of the 16 recommendations contained in the report. In particular, a recommendation on commercial documents still requires an urgent response, and information on actions taken or planned by each AC to address recommendations is not yet known. MR 7519/2007 of 2 October 2007 on TSEs in sheep and goats The final report was sent to the Spanish authorities on 28 March Overall, the report concludes that some progress has been made in several areas since the 2005 inspection, in particular concerning diagnostic procedures for clinical suspects, the quality of samples and the laboratory network. However, the co-ordination between the different CAs involved was unsatisfactory and the level of implementation of TSE surveillance in small ruminants varied significantly between the different ACs. While the situation in Castilla y León was largely satisfactory, compliance with the relevant rules was deficient in Andalucía, where there were shortcomings concerning clinical suspects, monitoring targets and representative samples. 114

115 ANNEX 1 - ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS ABP AC AGE APE ASF BIP BSE/TSE CA CCA CSF EFSA FMD FVO GRM HACCP RCL MAT MRL NCP NRCP NRL Animal By-Products Autonomous Community General State Administration Peripheral State Administration (Delegations or Sub-Delegations of the Government in the ACs) African Swine Fever Border Inspection Post Bovine Spongiform Encephalopathy / Transmissible Spongiform Encephalopathy Competent Authority Central Competent Authority Classical Swine Fever European Food Safety Authority Foot and Mouth Disease Food and Veterinary Office General Review Mission Hazard Analysis and Critical Control Points Routine Control Laboratory Microscopic analytical method for the determination of constituents of animal origin for the official control of feedingstuffs according to Directive 2003/126/EC Maximum Residue Level National Contact Point (for RASFF) National Residues Control Plan National Reference Laboratory OFFC Regulation (EC) No. 882/2004 OIE OV PAP PPP RASFF RD SCIRI Office International des Epizooties Official Veterinarian Processed Animal Proteins Plant Protection Product Rapid Alert System for Food and Feedingstuffs Real Decreto Co-ordinated System for Rapid Alert (in parallel with RASFF each AC is a NCP) SCOFCAH Standing Committee on the Food Chain and Animal Health SRM VMP Specified Risk Materials Veterinary Medicinal Product 115

116 ACRONYMS FOR STRUCTURE AND ORGANISATION MARM SGMRA DGRAG SGSPP SIR SGCRAA SGEST SGASCF SGMP DGIMA SGLAAA SGMP DGRPA SGCRLA DGOP DGCEA SGT Ministry of the Environment, Rural and Marine Affairs Ministerio de Medio Ambiente y Medio Rural y Marino Organigram: Secretariat General for Rural Affairs Secretaria General de Medio Rural Directorate General for Agricultural and Livestock Resources Dirección General de Recursos Agrícolas y Ganaderos Subdirectorate-General for Health of Primary Production Subdirección General de Sanidad de la Produccion Primaria Health Rapid Reaction Network of SGSPP Servicio de Intervencion Rapida Subdirectorate General for Conservation of Resources and for Animal Feed Subdirección General de Conservacion de Recursos y Alimentacion Animal Subdirectorate-General for Farms and Traceability Systems Subdirección General de Explotaciones y Sistemas de Trazabilidad Sub-directorate General for Health Agreements and Border Controls Subdirección General de Acuerdos Sanitarios y Control en Frontera Sub-directorate General for Means of Production Subdirección General de Medios de Producción Directorate General for Food Industries and Markets Dirección General de Industrias y Mercados Alimentarios Subdirectorate General for Agri-Food Laboratories Subdirección General de Laboratorios Agroalimentarios Secretariat General for Marine Affairs Secretaria General del Mar Directorate General for Fishery Resources and Aquaculture Dirección General de Recursos Pesqueros y Acuicultura Subdirectorate General for the Conservation of Coastal Resources and Aquaculture Subdirección General de Conservación de Recursos Litorales y Acuicultura Directorate General for Fishing Affairs Dirección General de Ordenación Pesquera Directorate General for Quality and Environmental Assessment Dirección General de Calidad y Evaluación Ambiental Technical Secretariat General Secretaria General Técnica MISACO DGSPSE SGSE Ministry of Health and Consumer Affairs Ministerio de Sanidad y Consumo Organigram : Directorate General for Public and External Health Dirección General de Salud Publica Subdirectorate General of External Health 116

117 DGFPS AEMPS SGMUV of AEMPS SGIC of AEMPS AESAN SGCAAPCO SGGRA SGCC MI SEPRONA MAP MECI Subdirección General Sanidad Exterior Directorate General for Pharmaceuticals and Health Products Direccion General de Farmacia y Productos Sanitarios Spanish Medicines Agency Agencia Española de Medicamentos y Productos Sanitarios Subdirectorate General for Veterinary Medicinal Products (of AEMPS) Subdirección General de Medicamentos de Uso Veterinario Subdirectorate General for Inspection and Control (of AEMPS) Subdirección General de Inspección y Control Spanish Food Safety and Nutrition Agency Agencia Española de Seguridad Alimentaria y Nutrición Subdirectorate General for Co-ordination of Alerts and Programming Official Controls Subdirección General de Co-ordinación de Alertas Alimentarias y Programación del Control Oficial Subdirectorate General for Food Risk Management Subdirección General de Gestión de Riesgos Alimantarios Subdirectorate General for Scientific Co-ordination Subdirección General de Coordinación Científica Ministry of the Interior Ministerio del Interior Civil Guard Environmental Protection Service Guardia Civil SEPRONA Servicio de Protección de la Naturaleza Civil Guard Traffic Association Guardia Civil Agrupación de Tráfico Ministry of Public Administration Ministerio de Administraciones Publicas Ministry of Science and Innovation Ministerio de Ciencia y Innovación ENAC National Body for Accreditation (Entidad Nacional de Acreditation) Autonomous Community or local level CAG-AC CMA-AC CP-AC DGG-AC SCV-AC STV-AC Ministry of Agriculture and Livestock of the AC Consejería de Agricultura y Ganadería Ministry of Environment of the AC Consejería de medio ambiente Ministry of Fisheries of the AC (only in Galicia) Consejería de pesca Directorate General for Livestock of the AC Dirección General de Ganadería Central Veterinary Services (of the AC) Servicio Centrales Veterinarios Territorial Veterinary Services (in each province or territorial service unit of the AC) 117

118 Autonomous Community or local level CS-AC DGSP-AC ASA-AC LVU ADS Servicios Territoriales Veterinarios Ministry of Health of the AC Consejería de Sanidad (y Bienestar Social) Directorate General for Public Health of the AC Dirección General de Salud Pública Food Safety Agency of the AC Agencia de Seguridad Alimentaria Local Veterinary Units; Comarcal Offices for Animal Health Unidades Veterinaria Local; Oficinas Comarcal de sanidad animal Livestock Health Protection Group (Farmers Co-operative structures for Animal Health) Agrupación de Defensa Sanitaria 118

119 CISNS AESAN-CI CEIEA CS ADR CLAAPA CNCICR CNSASV CNIGRE CNPIC-TSE CN- SANDACH CNSOA CNCAA CEBPAP MCTPOA CFN JACUMAR GTF CEPF MCL CO-ORDINATING BODIES Inter-territorial Health Council Consejo Interterritorial del Sistema Nacional de Salud AESAN Institutional Committee (Co-ordinating Body) Comisión Institucional de AESAN Spanish Committee for Electronic Identification of Animals Comité Español de Identificación Electrónica de los Animales Inter-territorial Council for Agriculture & Rural Development Conferencia Sectorial de Agricultura y Desarrollo Rural Co-ordination Committee for Analysis in Agriculture, Fish and Food Comisión de Laboratorios de Análisis para la Agricultura, Pesca y Alimentacion National Co-ordinating Committee for Residues or Substances in Live Animals or their Products Comisión Nacional de Co-ordinación de la Investigación, Control de Residuos o Sustancias en Animales Vivos y sus Productos National Committee for a Veterinary Alert System Comité Nacional del Sistema de Alerta Sanitaria Veterinaria Co-ordination Committee for Animal Identification and Registration of Livestock Farms Comité Nacional de Identificación del Ganado y Registro de Explotación de las Especies de Interés Ganadero National Co-ordinating Committee for Integrated Control of TSE Comision Nacional del Programa Integral Co-ordinado de Vigilancia y Control de las encefalopatias National Committee on Animal By-Products not Destined for Human Consumption Comision Nacional de Subproductos de Origen Animal no Destinados a Consumo Humano National Committee on Animal By-Products Comisión Nacional de Subproductos de Origen Animal Animal Feedingstuffs Co-ordinating Committee (legal base under preparation) Comisión Nacional de Co-ordinación en Alimentación Animal Spanish Co-ordination Committee for Animal Welfare Comité Español De Bienestar Y Proteccion de Los Animales de Producción Traceability Co-ordination Board for Products of Animal Origin Mesa de Trazabilidad de Productos de Origen Animal National Plant Health Committee Comité Fitosanitario Nacional National Advisory Body for Marine Aquaculture Junta Nacional Asesora de Cultivos Marinos Phytosanitary Working Groups (controls on PPPs) Grupos de Trabajo Fitosanitarios Evaluation Committee for PPPs Comisión de Evaluación de Productos Fitosanitarios Co-ordination Board for Raw Milk Quality Mesa de Co-ordinacion de Calidad de la Leche Cruda 119

120 LCVM LCVGR LAA LAS CISA-INIA CNA CRL-MB- Vigo PH-MADRID CSIC- MADRID IVIA- Moncada VALENCIA VALENCIA National Reference Laboratories MARM Central Veterinary Laboratory at Algete, Madrid Laboratorio Central de Veterinaria de MARM de Algete, Madrid MARM Central Veterinary Laboratory at Santa Fe, Granada Laboratorio Central de Veterinaria de Santa Fe, Granada MARM Agri-Food Laboratory Laboratorio Arbitral-Agroalimentario de MARM MARM Agri-Food Laboratory of Santander (NRL for milk and milk products) Laboratorio Agroalimentario de Santander, LNR de leche y productos lácteos. Animal Health Research Centre-National Agricultural Research Institute of the Ministry of Science and Technology Centro de Investigación en Sanidad Animal Instituto Nacional de Investigaciones Agrarias National Food Centre (Affiliated to AESAN) Centro Nacional de Alimentacion Community Reference Laboratory for Marine Biotoxins in Vigo Laboratorio Comunitario de Referencia para biotoxinas marinas Plant Health NRL for Insects (Agricultural Engineering School of Madrid Polytechnical University) LNR para artrópodos (Escuela Técnica Superior de Ingenieros Agrónomos de la Universidad Politécnica de Madrid) Plant Health NRL for Nematodes (Environmental Science Centre of Madrid Higher Board for Scientific Research of the Ministry of Science and Innovation) LNR para nematodos (Centro de Ciencias Medioambientales de Madrid-Consejo Superior de Investigaciones Científicas del Ministerio de Ciencia y Innovación) Plant Health NRL for Bacterial Organisms and viruses in woody plant species (Valencian Institute for Agricultural Research) LNR para bacterias y para virus, viroides y fitoplasmas en especies vegetales leñosas (Instituto Valenciano de Investigaciones Agrarias) NRL for plant viruses in non-woody plant species (Higher Technical School of Agricultural Engineering of Valencia Polytechnical University) LNR para virus, viroides y fitoplasmas en especies vegetales no leñosas (Escuela Técnica Superior de Ingenieros Agrónomos de la Universidad Politécnica de Valencia) NRL for fungi: (Higher Technical School of Agricultural Engineering of Valencia Polytechnical University) LNR para hongos (Escuela Técnica Superior de Ingenieros Agrónomos de la Universidad Politécnica de Valencia) 120

121 ANNEX 2 - RESOURCES Table 1: Overview of Resources in Ministry of the Environment, Rural and Marine Affairs Directorate DGRAG SGSA, now SGSPP Control Activity Number of Staff Involved in Specified Control Activity University Degree Technician Administrator Total Epidemiologia Red de Alertas Sanitaria(RAS) Higiene Ganadera Laboratories Sanidad Exterior (Headquarters) 3 3 BIPs staff and coordinators in field DGA SGOBPG SGMPG SGPGVO An ID & Welfare, Traceability Feedingstuffs 6 6 Semen and Embryos? Milk Hygiene at Farm Level 3 3 SGMPA Pesticides SGAISV Plant Health BIPs Staff and Coordinators in field DGEMP SGGFEA LBM & Aquaculture Food Safety Controls TOTAL Note: The re-distribution of resources in MARM has not yet been finalised, following its reorganisation in Consequently this table remains the same as in the 2006 country profile, including the former names and the staff numbers of the various subdirectorates. 121

122 Table 2: Overview of resources in the Ministry of Health and associated bodies MISACO (DGSPSE) Control University Degree Technician Administrator Total Activity Import Controls 14 (veterinarians) BIPs staff & co-ordinators TOTAL 352 AESAN Department/ Unit President+ support Executive Director + support Secretary General University Degree Technician Administrator Totals SGGRA SGCAAPCO SGCC TOTALS AEMPS Control University Degree Technician Administrator Total Activity SGMUV SGIC TOTAL

123 Table 3: Staff Resources in the AC Ministries of Agriculture and Livestock responsible for animal health controls Central Services Local Services Laboratories Delegated Competencies Autonomous Community Veterinarians Auxiliaries Other Technical Staff Veterinarians Auxiliaries Veterinarians Auxiliaries Other Technical Staff ADS Vets performing Official controls Contract Staff other than Vets Contract Veterinarians ANDALUCÍA ARAGÓN ASTURIAS BALEARES CANARIAS CANTABRIA CASTILLA - LA MANCHA CATALUÑA CASTILLA Y LEÓN EXTREMADURA GALICIA MADRID MURCIA NAVARRA PAÍS VASCO LA RIOJA VALENCIA CEUTA 1 1 MELILLA Totals Consolidated Totals 707 2, ,856 2, ,

124 Table 4: Staff Resources in AC Ministries of Health Central Services Local Services Laboratories Staff in Large Municipalities Autonomous Community Staff with University Degree Veterinarians Pharmacists Others* Staff with University Degree Veterinarians Pharmacists Others* ANDALUCÍA ARAGÓN ASTURIAS BALEARES CANARIAS CANTABRIA CASTILLA - LA MANCHA CATALUÑA CASTILLA Y LEÓN EXTREMADURA GALICIA MADRID MURCIA NAVARRA PAÍS VASCO LA RIOJA VALENCIA CEUTA MELILLA Consolidated Totals

125 Table 5: Structures in the Autonomous Community Ministries of Agriculture and Livestock (Animal Health Sections) and in the AC Ministries of Health CAG-AC: Local Level CS-AC: Local Level Autonomous Community No. of Provinces No. of Territorial Veterinary Service Units No. of Comarcas or Local Veterinary Units No. of ADS No. of Territorial Service Units No. of Local units No. of Cities with own Food Hygiene Controls ANDALUCÍA ARAGÓN ASTURIAS BALEARES CANARIAS CANTABRIA CASTILLA - LA MANCHA CATALUÑA CASTILLA Y LEÓN EXTREMADURA GALICIA MADRID MURCIA NAVARRA PAÍS VASCO LA RIOJA VALENCIA TOTALS