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