EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL COUNTRY PROFILE OF CZECH REPUBLIC

Transcription

1 EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG (SANCO)/7700/2008 Final CP COUNTRY PROFILE OF CZECH REPUBLIC 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 TSE and Animal-By-Products (ABP) Control system for veterinary medicinal products (VMP) and residues Control system for imports of food of plant origin Control system for plant protection products (PPP) and residues 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 TSE and Animal-By-Products (ABP) Veterinary medicinal products (VMP) and residues Foodstuffs and food hygiene Imports of food of plant origin Plant protection products (PPP) and residues Animal welfare Plant health Overview of more recent inspections...82 ANNEX I - ACRONYMS, ABBREVIATIONS, SPECIAL TERMS AND WEBSITES...85 ANNEX II - STAFF RESOURCES...88 ANNEX III - TRAINING SYSTEMS

3 EXECUTIVE SUMMARY Overview The Ministry of Agriculture (MA) and the Ministry of Health (MH), are responsible for policy and legislation, and overall supervision of all controls on food safety, animal health, animal welfare and plant health in the Czech Republic. The role of the Interministerial Food Safety Co-ordination Unit, in place since 2002, has been consolidated in the 2007 Czech Food Safety Strategy. The Executive Committee of Supervisory Authorities acts as an advisory body to the Food Authority, which is responsible for approval of the Multi-annual National Control Plan. The State Veterinary Administration is responsible for controls on animal health, foodstuffs of animal origin, imports of live animals and products of animal origin, TSEs, animal by-products, residues of veterinary medicines and animal welfare. ISCVBM is responsible for authorising veterinary medicines, and for controls on their distribution, marketing and use. It also performs laboratory analyses for veterinary medicine residues in foodstuffs. The Czech Breeding Inspectorate is responsible for controls on the identification and registration of animals. The Czech Agriculture and Food Inspection Authority is responsible for controls on the production of foodstuffs of plant origin, and for most retail controls of foodstuffs. The Central Institute for Supervising and Testing in Agriculture is responsible for official controls on feedingstuffs. The State Phytosanitary Administration is responsible for the registration of plant protection products (PPPs), for control activities related to marketing and use of PPPs, and for plant health. The Public Health Promotion and Protection Section (PHPPS) of MH is responsible for supervision of food hygiene controls on catering. Control systems are centralised, with a direct chain of command between central services and regions. At regional level the State Veterinary Administration has 14 regions, ISCVBM has one sub-region, the Czech Agriculture and Food Inspection Authority has seven regions, the Central Institute for Supervising and Testing in Agriculture has seven regions and the Public Health Promotion and Protection Section of the Ministry of Health has 14 regions. Municipalities are responsible for sanctions related to animal welfare. Multi-annual National Control Plan (MANCP) The Multi-annual National Control Plan was prepared for the period The Food Authority of the Ministry of Agriculture co-ordinates the task of updating it. The first revision, consisting of minor amendments, took place in connection with the processing of the Annual Report on Controls for 2007, and was finalised in June 2008; the next revision is expected in connection with the preparation of the Annual Report on Controls for The Annual Report on Controls for 2007, required under Regulation (EC) No. 882/2004 has been submitted to the European Commission. 3

4 Audit Systems Internal audits take place in all Ministry of Agriculture bodies, and external audits take place in most of these bodies. The State Veterinary Administration and the Czech Agriculture and Food Inspection Authority have ISO 9001 quality management systems which are updated annually. The Central Institute for Supervising and Testing in Agriculture expects to be implementing ISO 9001 by the end of Internal audits cover regions and individual inspectors. Audit guidelines are available to most bodies to assist in performing audits. Other Issues Related to Implementation of Regulation (EC) No. 882/2004 Most control bodies have training systems which take training needs into account. Good systems for preparing documented procedures exist in all sectors. Systems are being improved on an ongoing basis to take risk into account in controls. Legal powers required under Regulation 882/2004 have been strengthened, by means of amendments to framework legislation. Systems are being improved on an ongoing basis to verify the effectiveness of controls, through supervision, audit, reporting and enhanced information systems. Inspections in the Czech Republic by the Food and Veterinary Office (FVO) Since 2003, the FVO has carried out 32 inspections and two general review missions in the Czech Republic. The following table givens an overview of the main sectors that have been or will be covered by these missions: SECTOR Total per sector 1. Animal Health Food of Animal Origin Imports of animal 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 Plant Protection Products Animal Welfare Plant Health 2 2 General Review Total sectors per year * Some missions included multiple sectors Total Total missions per year

5 Progress on FVO recommendations For 29 of the 32 completed inspections, final reports have been issued and action plans received from the Czech authorities setting out how they have responded or intend to respond to the reports' recommendations. These action plans have been assessed by the FVO to determine whether sufficient progress is being made by the Czech authorities to deal with the weaknesses in control systems identified in FVO inspections. Of the 274 recommendations made in these reports, 216 have been definitively closed. Of the remainder, none required remedial action and in 58 cases evidence was required to verify that promised actions has been taken. Progress on these recommendations was reviewed during a general review mission carried out by the FVO in June The following table summarises the results of this review. Pre-General review mission 2008 Post-General review mission 2008 Action taken / No longer relevant Outstanding / Action still required 0 0 For verification / In progress 58 8 Total number of recommendations The Czech authorities indicated during the 2008 general review mission that action would be taken to address all the issues below before the end of The main issues which remain to be addressed include: Sector specific issues For baby food, the implementation of pesticide analysis methods, new documented procedures, labelling controls and controls on warehouses. For animal welfare, updating the registration of laying hen holdings, actions in response to non-compliances, and the introduction of risk based controls on farms. For intra-community trade in live animals, alterations to the animal database. Recent FVO inspections that have not reached final assessment stage For three of the 32 FVO inspections in the Czech Republic, the process has not yet reached final assessment stage. The following table shows the stage that has been reached for each of these inspections. 5

6 2008 Inspections Ref No. Mission Date Sector Subject of Inspection Current Status Date /01/2008 Imports of animal and food of animal origin /02/2008 Foodstuffs and food hygiene /05/2008 Food of animal origin Food of animal origin Food of animal origin, Import/transit controls and border inspection posts Food hygiene (within the meaning of Regulation (EC) No 852/2004), traceability and labelling Salmonella in table eggs Food of animal origin, (meat and milk) Final report 14/07/2008 (EN) Final report 10/07/2008(CZ) Draft Report 03/07/2008 Completed 12/09/07 The main elements identified in these more recent inspections include: On food hygiene, under Regulation (EC) No. 852/2004, the planned frequency of controls for establishments without a previous history of non-compliance, is considered unsatisfactory. On Salmonella in table eggs, although the Czech Republic has the highest recorded incidence of salmonellosis in humans in the EU, no appropriate epidemiological investigation has yet been carried out. Some errors were noted in the sampling methodology which undermines the capacity of the monitoring programmes to individually separate positive flocks. 6

7 INTRODUCTION This draft 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 the Czech Republic. The information in the country profile has been compiled from: written submissions and background documentation from the Czech competent authorities detailing how control systems are organised; the results of missions to the Czech Republic carried out in recent years by inspection teams from the FVO and, in particular, a general review mission in June 2008 to analyse the full range of control systems for food safety, animal health, animal welfare and plant health. The country profile is presented in three parts: Part 1 describes the overall organisation of the Czech authorities and the respective responsibilities of the 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 the Czech Republic 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 the Czech Republic since 2003 and, for each control system, gives an assessment of progress on specific recommendations reviewed in the general review mission of June It also provides an overview of more recent FVO missions. The country profile will be updated at regular intervals based on the results of future FVO missions and other relevant information received by the Commission from the Czech authorities. Acronyms are used extensively throughout this country profile for the sake of brevity. A list of acronyms, abbreviations, special terms and websites is given in Annex I of the country profile as a guide for the reader. 7

8 1 COMPETENT AUTHORITIES AND OVERALL DISTRIBUTION OF RESPONSIBILITIES General Overview By means of a Government Resolution adopted in January 2007, the Ministry of Agriculture (MA), in co-operation with the Ministry of Health (MH), updated the Strategy to Assure Food Safety in the Czech Republic after Accession to the European Union that was issued in The updated document describes the short-term strategy for 2007 and 2008 and will be revised by the end of The strategy sets out strategic tasks and deadlines for individual tasks. Effective co-ordination of individual activities, ensuring a compact system capable of a flexible and effective response, is considered a precondition to success. Risk assessment, risk management and risk communication are basic principles of the strategy. It is not yet clear whether the task of updating the Multiannual National Control Plan will in future years incorporate this strategy document. Food Safety Co-ordination Unit The updated strategy consolidates the role of the inter-ministerial Food Safety Coordination Unit, in place since The objective of this unit is to co-ordinate activities of the ministries (especially MA and MH), the supervisory bodies (CAFIA, SVA, CISTA and SPA) and non-government organisations within their specified competences. This body is not responsible for the collation or analysis of official control results. The Co-ordination Unit meets approximately four times a year. Minutes of these meetings are published on the Food Safety Information Centre website ( and on the MA web site To support it, four working groups have been set up (for communication with consumers, RASFF, feedstuffs and laboratories). Five scientific committees (for veterinary, phytosanitary and environmental matters, for issues of animal nutrition, for food, and for GM food and feed) make risk-assessment contributions to the unit. Ministries In the Czech Republic, the two Ministries with responsibilities for legislation regarding food safety, animal health, animal welfare and plant health are the Ministry of Agriculture and the Ministry of Health. A table of acronyms and websites of all the bodies described in this country profile is contained in Annex I. The Czech Republic has two levels of administration for food control, which comprise Ministries or central administrations, and regions. The central administration is in charge of managing national food controls and co-ordination between services. Ministry of Agriculture The Ministry of Agriculture (MA) is responsible under national legislation for animal health, animal welfare and plant health. In addition, under the Food Act 110/1997, responsibility for foodstuffs is shared with the Ministry of Health. Six bodies (the State Veterinary Administration - SVA, the Institute for State Control of Veterinary Biologicals and Medicines ISCVBM, the Czech Breeding Inspectorate - CBI, Czech Agriculture and Food Inspection Authority - CAFIA, the Central Institute for Supervising and Testing in Agriculture - CISTA and the State Phytosanitary Administration - SPA) 8

9 operate under the authority of the Ministry of Agriculture. The ministry drafts veterinary and phytosanitary legislation and legislation associated with the production and labelling of foodstuffs. Within the ministry the principal sections are: The Agricultural Commodities Section (17200) co-ordinates control activities, the performance of supervisory control bodies and the harmonisation of legislation in the field of agricultural production. It co-ordinates, through Department No (the Department of the Central Register for Animals), the activities of the State Veterinary Administration (SVA) for animal health and identification, and activities of the Czech Breeding Inspectorate (CBI) for animal identification and registration. It co-ordinates through Department No (the Plant Commodities Department) the activities of the State Phytosanitary Administration (SPA), for plant health. It is responsible for risk assessment in relation to animal identification and holding registration. The Food Production Section, also known as the Food Authority (Section 17400), established in April 2005, co-ordinates control activities of supervisory control bodies and the harmonisation of legislation for food and feed hygiene. It manages the Executive Commission of MA Supervisory Bodies (SVA, CISTA, CAFIA and SPA), which meets every two months. The Food Authority is the MA partner for communication with MH. It is sub-divided into: The Food Production and Legislation Department ( which has two units, the Food of Animal Origin Unit and the Food of Plant Origin Unit) is responsible for drafting legislation (often with the Ministry of Health), for policy development, for risk management, for contact with international bodies such as Codex Alimentarius and the European Commission, for overseeing food production in the Czech Republic and for co-ordination of consumer protection. The Food Safety Department (17410) is responsible for risk assessment and risk communication, for co-operation with EFSA, for the organisation of the Food Safety Co-ordination Unit, for the Food Safety Information Centre and for co-ordination of RASFF. The Food Market Control Department is responsible for co-ordination with supervisory bodies which perform official controls under the hygiene package. In co-operation with these bodies, it also processes and updates the Multi-annual National Control Plan , and processes regular Annual Reports on the results of official controls. It is the contact point for this area in the Czech Republic. Appeals may be submitted to this department to review decisions taken by state supervisory bodies. It is responsible for overall liaison with European Commission missions to the Czech Republic involving MA. It manages the system of carcass classification according to the SEUROP system. There is also a detached department in the MA, known as the Central Commission for Animal Welfare, which reports directly to the Minister, recommends measures and coordinates animal welfare activities. 9

10 State Veterinary Administration The State Veterinary Administration (SVA) carries out control activities related to animal health, foodstuffs of animal origin, import controls of live animals and products of animal origin, TSEs, animal by-products, residues of veterinary medicines, and animal welfare. The SVA is managed by a Director General, the Chief Veterinary Officer. SVA has two sections, each managed by a Deputy Director-General: the Veterinary Section and the Economic/Administrative Section. The SVA Veterinary Section is composed of three departments. The Public Health, Veterinary Hygiene and Ecology Department (PHD), is responsible for official control of foodstuffs of animal origin, for beef labelling and for general hygiene controls in premises where raw animal products are handled (such as butchers shops and supermarket meat counters). It is also responsible for the co-ordination of laboratory activities carried out by the five State Veterinary Institutes (SVIs). The Animal Health and Animal Welfare Department (AHWD) has three divisions: the Animal Health Division and the Animal Welfare Division in Prague, and the Crisis Division in Brno, which is responsible for contingency plans and most disease eradication plans. The External Relations Department (ERD), through the Export and Import Division, manages import controls and one Border Inspection Post. The Economic/Administrative Section has four Departments: the Personnel Department (including recruitment and training), the Legislation Department, the Economic Department, and the Informatics Department (which is responsible for IT support and maintaining the SVA information system (ISSVA)). The Internal Audit and Control Department (IACD), the Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM), in Brno and the five State Veterinary Institutes (SVIs) (in Prague, Jihlava, Olomouc, České Budějovice and Hradec Králové) report directly to the CVO. In early 2008, the new SVA Information System of (ISSVA) came into use to monitor controls on animal disease prevention, disease outbreaks, animal welfare, inspections of animals at slaughter, game animals, food of animal origin, animal-by products, residues, and milk, and to maintain a register of issues under state veterinary supervision. In 2007, the first module of the IS SVA was transferred to a new database with a faster response. During 2008, SVA continued transferring the remaining parts of ISSVA to the new database. Co-operation between the MA and SVA has strengthened in the information technology (IT) field in 2008, under the scope of cross compliance. Cross compliance has led to changes both in veterinary supervision and in IT, arising from the introduction of risk analysis. A new module on animal health supervision in ISSVA is being prepared, and will be introduced into routine activity in Since 2003 there have been 14 Regional Veterinary Administrations (RVA). They supervise the 73 District Veterinary Inspectorates (DVI). Each RVA has two inspectorates, one for animal health and animal welfare, and one for public health and veterinary hygiene. Municipalities are responsible for legal proceedings and sanctions for animal welfare non-compliances. 10

11 As set out in Annex II, SVA has a total of 1,531 staff, including 92 at central level, 1,036 in the 14 Regional Veterinary Administrations and 403 in the five veterinary laboratories (SVIs). Institute for State Control of Veterinary Biologicals and Medicines The Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM) is the competent authority for authorising veterinary medicinal products (VMPs), for issuing licenses to wholesalers of VMPs and to manufacturers of medicated feedingstuffs, and for controls on the distribution, prescription, dispensing and use of veterinary medicines. It reports to the Director General of SVA. It is located in Brno, with one small inspection team located in the Northern Bohemia region in the town of Louny. The Institute performs laboratory analyses for residues of VMPs in foodstuffs of animal origin. It also runs a national market surveillance programme under which each VMP authorised in the Czech Republic is sampled on the market and tested at least once every five years. ISCVBVM is also responsible for the implementation of the pharmacovigilance system at national level. It runs a quality management system based on ISO 9001:2000. The Institute has three main departments, the Marketing Authorisation Department, the Inspection Department (for controls of manufacturers and wholesalers, and market controls, and which includes the Pharmacovigilance unit since 2008), and the Laboratory Control Department (for residue monitoring). As set out in Annex II, ISCVBM employs 84 staff. Czech Breeding Inspectorate The Czech Breeding Inspectorate (CBI) is responsible for controls on the identification and registration of animals as prescribed by the Breeding Act 154/2000 and subsequent amendments. It has 59 staff, including 43 inspectors. Czech Agriculture and Food Inspection Authority The main responsibility of the Czech Agriculture and Food Inspection Authority is to control foodstuffs of plant origin. It also controls retail of foodstuffs of animal origin except from those retail sections of premises where raw materials of animal origin are treated (e.g. meat, milk, fish, poultry or eggs), where SVA is responsible. It also participates in the legislative process and collaborates with international bodies. It is comprised of a headquarters based in Brno, and five departments at central level (each with a director). The Control, Laboratories and Certification Department is responsible for food hygiene controls. This department is responsible for policy, and procedures in relation to official controls of foodstuffs, for collating data regarding official controls and for supervising official control activities of the regional inspectorates. This department is also responsible for co-ordinating laboratory activities carried out by its two laboratories based in the regional offices of Prague and Brno. CAFIA s other four departments are the Authority Office, the Law and Foreign Affairs Department, the Economic and Personnel Department, and the Technical and Informatics Department. 11

12 CAFIA has seven regional inspectorates, each inspectorate being responsible for two of the new regions in the Czech Republic, and reporting directly to the central administration. The seven regions are based in Brno, Prague, Tábor, Plzeň, Olomouc, Ŭsti nad Labem and Hradec Králové. Each region contains a control department, which is sub-divided into several units related to the products to be controlled. It has 85.5 full time equivalent staff employed in food safety controls at central level and at regional level, as set out in Annex II. A certified quality management system for the implementation of state control of foodstuffs is in place in CAFIA since August CAFIA has around 90 internal procedures, most of which regulate control activities. These are continuously updated to meet the documentation requirements of ISO 9001:2000. All staff, both at headquarters and in regional inspectorates, have intranet access to internal procedures, legislation and rapid alerts. They also have intranet access to the CAFIA information system and to the food safety information system of supervisory authorities of the Czech Republic (ISSA). Data is transmitted directly from inspectors laptops to the CAFIA information system. Since 2005, the information system is connected to the ISSA. While the ISSA is currently administered by CAFIA, it will be administered by the Ministry of Agriculture from January Central Institute for Supervising and Testing in Agriculture The Central Institute for Supervising and Testing in Agriculture (CISTA), based in Brno, is responsible (through the Division of Feed and Soil Safety and the Division of Agricultural Inspections of its Official Control Section) for official controls of feedingstuffs. It performs inspections on the production, import, use and quality of feed, feed additives and pre-mixes including on-farm production of feedingstuffs. It also maintains registers of feed business establishments. It has six regional inspectorate departments, four regional laboratory departments and five specialised laboratory departments. It employs 909 staff, 132 of whom are involved in feedingstuffs controls, including 47 of the 137 staff in the Section for Official Control, and 75 laboratory staff, as shown in Annex II. Around eighty percent of official control staff have a university education. Most CISTA staff work in other divisions not related to food safety, animal health, animal welfare or plant health. State Phytosanitary Administration The State Phytosanitary Administration (SPA) is managed by a Director and consists of the Director s unit and four sections: the Protection against Harmful Organisms Section (PHOS), the Plant Protection Products Section (PPPS), the Regional Departments Section (RDS) and the Staff Support Section. The Director s unit addresses legal and administrative issues, foreign relations, and incorporates the Internal Audit Unit, which is responsible for the introduction of a quality management system. 12

13 SPA, through PPPS, is responsible for the registration of plant protection products (PPPs) and for control activities related to their marketing and use. It is also responsible, through PHOS, for plant health, both for imports and domestic trade. RDS is responsible for implementation related to both PPPs and plant health at regional level. PHOS includes a head office, two departments (Protection against Harmful Organisms Department and the Diagnostics Department) and two divisions (Plant Protection Methods Division and Mechanisation Division). PPPS is based in Brno and includes a head office and three departments (Co-ordination Evaluation Department, Registration Evaluation Department, and Post-Registration Control Department.) RDS, with its headquarters in Prague, includes a head office and seven Regional Departments (Prague, Plzeň, Tábor, Havlíčkův Brod, Louny, Brno and Opava) and four border inspection posts (at Prague airport, Praha Ruzyně; at the customs clearance post office in Prague; at Brno-Tuřany airport; and at Ostrava-Mošnov airport). Regional Departments are further subdivided into 69 District Divisions. Phytosanitary inspectors have as a minimum requirement a degree or diploma in agriculture, horticulture or biology, specialising in plant health and plant protection. The Staff Support Section includes a head office and three departments (IT Department, Economic Support Department, and Personnel and Education Department). SPA financial resources come from the state budget. Fees were introduced on 1 May 2005 for registration, official examinations, plant health inspections and SPA-issued plant passports. This fee revenue goes back to the state budget. It has 176 staff at central level and 274 at regional level, as set out in Annex II. Ministry of Health The Ministry of Health (MH), through the Public Health Promotion and Protection Section (PHPPS), is responsible for supervision of food hygiene controls on catering. The 14 Regional Public Health Offices (RPHOs) are responsible for implementation of controls. The Ministry is also responsible for identifying sources of disease outbreaks attributable to foodstuffs, and, for that purpose, it may perform investigations in establishments other than catering establishments, irrespective of the competencies of other inspection bodies. In the area of food safety, the Ministry is generally responsible for health risk assessment from foodstuffs in relation to humans and also for health risk assessment and controls of materials and articles coming into contact with foodstuffs. It is also responsible for health certification of staff involved in foodstuffs production. The Ministry also lays down requirements for food additives, flavourings, limits for food contaminants, and limits for pesticides residues. It shares responsibilities with the Ministry of Agriculture for setting limits for residues of veterinary drugs in foodstuffs, and stipulates requirements for irradiation of foodstuffs including dose limits. It is also responsible for legislation on foodstuffs for special nutrition purposes, for legislation on food supplements, for novel food and for controls on the marketing of novel food. The National Institute of Public Health in Prague (NIPH) provides expert support to MH for risk assessment and for the activities of the RPHOs. 13

14 The 14 Regional Public Health Offices (RPHO) manage and control 79 Local Health Offices (LHO). The 14 RPHOs employ 379 staff in food safety including those engaged in food contact materials controls, as set out in Annex II. Directorate General for Customs The Czech Customs Administration is subordinate to the Ministry of Finance. It consists of the Directorate General for Customs, eight Customs Directorates and 54 local offices. The Czech Customs Administration co-operates with SVA for imports of animals and food of animal origin, with CAFIA for imports of food of plant origin and with SPA for plant imports. Laboratories The Czech Accreditation Institute (CAI) is a recognised national accreditation body responsible for accreditation of testing and calibration laboratories, and of all types of certification bodies and inspection bodies. It is a member of EA (European co-operation for Accreditation) and a signatory of the EA Multilateral Agreements in all existing fields. The last evaluation of CAI was completed in A list of all accredited bodies including the detailed scope of accreditation is available on the CAI web site All animal health analyses performed in the Czech Republic are performed in five State Veterinary Institutes (SVIs). The NRL for FMD, AI and ND is the State Veterinary Institute (SVI) in Prague. The NRL for CSF is located in the SVI in Jihlava. The other three SVIs are located in the regions. Each laboratory keeps a list of accredited methods. Apart from medicated feed, feedingstuffs are tested in the CISTA National Reference Laboratory Division. This Division has four regional laboratories, and two specialised laboratories for feedingstuffs analysis. The proficiency testing department is responsible for internal technical audit in all laboratories. One accredited external laboratory has been appointed to test dioxins and dioxin-like PCBs in feed. All CISTA laboratories have been accredited by CAI according to ISO Four laboratories currently perform the analytical work of the national residue control plan, including medicated feed: the ISCVBM in Brno and the three SVIs in Prague, Jihlava and Olomouc. All four laboratories are also NRLs for certain substances or substance groups. Laboratory testing has been reorganised since ISCVBM is now designated for List A and List B2(d) substances. Responsibility for other List B2 substances has been transferred to the SVI Jihlava. All methods used by ISCVBM are validated, and the methods used by the SVIs are either validated or in the course of being validated. For food hygiene official controls, CAFIA performs analyses in two laboratories which are based in its regional offices of Prague and Brno. CAFIA also authorises external laboratories to carry out analyses which are not performed by own laboratories. All SVA official control samples are analysed in its five State Veterinary Institutes. There are 15 Ministry of Health laboratories, 14 of which are located in the Regional Public Health Offices. All the laboratories involved in official control of foodstuffs are accredited according to ISO by CAI. 14

15 The SPA laboratory for pesticide formulation analysis is located in Brno. It was accredited according to ISO by CAI in June The SPA Diagnostics Department has four laboratories dealing with plant pest diagnostics. SPA diagnostic laboratories have been accredited by CAI to ISO since January 2008 for the detection and identification of some pathogenic organisms. SPA has 12 reference laboratories and 22 service laboratories, which work on a commercial basis, usually for diagnostics of potato diseases, and for certification purposes. Besides its main plant pest diagnostics activities, the laboratory in Olomouc tests the effectiveness and biological properties of pesticides in the field. The CAFIA laboratory in Prague is the only laboratory performing analyses for pesticide residues in food of plant origin. Laboratory analysis for official controls on compounds for materials intended to come into contact with foodstuffs are performed by seven Health Institutes, which are accredited to ISO The National Reference Laboratory for Persistent Organic Pollutants is part of the Health Institute in Ostrava. Issues Related to Implementation of Regulation (EC) No. 882/2004 Multi-annual National Control Plan (MANCP) The Multi-annual National Control Plan was prepared for the period The first update was finalised in The Food Authority of the Ministry of Agriculture is the co-ordinating body. The next update is expected in connection with the preparation of the Annual Report on Controls for The Annual Report on Controls for 2007 has been submitted to the European Commission. Designation of competent authorities and operational criteria Co-ordination The Czech Republic has clearly designated the competent authorities responsible for official controls. Co-ordination takes place between the Food Authority of the Ministry of Agriculture and the control bodies attached to it, through the Executive Committee of Supervisory Authorities, which meets twice per year. The Commission has received details of this co-ordination. Details of co-ordination between Customs, SVA and CAFIA and the specific co-ordination for ABP controls, where competencies are more dispersed have also been provided. There is a direct chain of command between central and regional levels of all control bodies. Co-ordination takes place between these levels through instructions, guidelines, checklists, reporting, and increasingly, through the use of common information systems at central and regional level. Further work on co-ordination between the Ministries of Health and of Agriculture in relation to salmonella controls in the table egg sector is required. Competent Authority Audit Systems Internal audits take place in all Ministry of Agriculture bodies. These audits cover both regions and individual inspectors. Audit guidelines are available to most bodies to assist 15

16 in performing audits. SVA, CAFIA and CISTA have internal audit units which report to the Director General. SVA and CAFIA have ISO 9001 quality management systems which are externally audited each year. CISTA expects to be implementing ISO 9001 by the end of In 2007, the control system for food of animal origin was audited in five RVAs. In 2008, audits are planned in five RVAs for animal welfare and veterinary medicines (residues and registration/distribution), and in 2009, for animal health and for imports of animals and food of animal origin. In general, each RVA is audited once every three years. The 2007 audits resulted in recommendations to improve the effectiveness of some activities. CBI performed an internal audit in 2008 on inspections performed on animal identification, focussing on: the methodology of inspections; procedures; preparing inspection reports; and sanctions. CAFIA has 20 internal auditors. Approximately 20 internal audits are planned for each year, two of which on control systems. Audit reports are sent to the head of the unit being audited, the auditor, and the quality manager. While the SPA is not a competent authority to carry out audits under Article 4, it established an internal control system in 2007 to audit controls performed by regional departments. The SPA Division for Internal Audit, which reports to the Director, supervises this process. Laboratory capacity Most bodies which perform laboratory analyses have demonstrated adequate laboratory capacity. The accreditation process has been completed, or is well advanced in all bodies. Organisation of and implementation of official controls The Commission has been informed that for SVA, ISCVBM, CISTA, CBI, CAFIA and SPA, official controls were carried out using risk criteria which generally include the results of previous controls. Part 3.12 describes, for food hygiene, the relationship between frequency of inspections and the risk criteria. Delegation of specific tasks related to official controls Delegation of specific tasks is limited. Regional veterinary authorities appoint private veterinarians to perform controls on intra-community trade of semen and embryos. Official supervision of these veterinarians takes place twice a year. SVA have delegated to Customs the task of controlling imports of food of animal origin for personal consumption. The Ministry of Agriculture has commissioned a supervisory body to perform organic farming controls. Staff performing controls The Food Authority of the Ministry of Agriculture, through its training co-ordination body, has been harmonising training of its control bodies since 2007 and has prepared co-ordinated training programmes, particularly for areas mentioned in Chapter I Annex II of Regulation (EC) No. 882/2004. The first harmonised training course organised by 16

17 MA, covering seven of the 13 themes from Annex II, took place in The Food Authority is planning to deliver a follow-up course in 2008 to address the remaining six themes. Most training programmes prepared by MA bodies are designed to meet identified training needs. All bodies prepare annual training programmes. For some such as CAFIA and SPA, a minimum percentage of staff budgets is allocated to training. Some bodies, such as SVA, have an information system which records staff training profiles. Other bodies, such as SPA, report regularly to the ministry on progress. The Ministry of Health organises training courses at central level in accordance with its training plan. Regional Departments prepare their own training courses at regional and local levels, and report twice a year on progress in delivery. Transparency and confidentiality Most Ministry of Agriculture bodies have websites which contain information about the body and its activities. Information on the results of control activities is publicly available for some issues, such as for animal welfare controls on the SVA website, and for animal identification controls on the Czech Breeding Inspectorate website. In addition, SPA reports on monitoring harmful organisms are published. Bodies such as SVA and CAFIA provide press releases and information on radio and TV at national and regional level. SVA must inform the public about "extraordinary veterinary measures" for animal health, such as for avian influenza. Control and verification procedures, and reports SVA and CAFIA indicated that there was a legal basis for operators to provide access to premises and to co-operate. SVA, CAFIA, ISCVBM and SPA have methodological instructions for the performance of controls. Further details are provided in part 3 of the country profile. CAFIA instructions are revised annually. In the case of SVA, procedures are in place for evaluating the effectiveness of controls performed at regional level for animal welfare. Some Czech authorities (SVA and SPA) also indicated that improved access to information systems at management level, and the increased use of audit, provided a basis for improving the effectiveness of controls. Reports SVA, CBI and CAFIA prepare a control report to management for each inspection. Most control reports are downloaded to databases, which are accessible at central and regional level. 17

18 Enforcement measures Legal powers for action in case of non-compliance are in most sectors governed by framework laws. In addition, some bodies, such as CAFIA, have internal provisions to co-ordinate and harmonise these activities within the given framework. Most of the main framework laws, including the Veterinary Act, the Breeding Act, the Pharmaceutical Act, the Animal Welfare Act, the Act on Feedingstuffs, the Food Act, and the Plant Health Act, have been amended to take Articles 54 and 55 of Regulation 882 into account. Progress is ongoing in order to ensure that sanctions are effective, proportionate and dissuasive. In this regard, discussions to harmonise sanctions in the regions are taking place between SVA and the RVAs. In the case of CISTA, all infringements are handled by its Law Department. For CBI, administrative actions or sanctions are implemented after approval at Director level. SVA and CAFIA are working on improvements in databases and computer systems to improve the effectiveness of follow-up to non-compliances. In most cases, the control bodies have the responsibility and powers to implement sanctions. Municipalities are responsible for implementing sanctions for animal welfare. For animal health non-compliances, SVA use the "Extraordinary Veterinary Measures" instrument. In the food production sector, its instruments include: corrective measures; temporary suspensions of production; and bans on production. These are all implemented at RVA level. When ISCVBM detect non-compliances during controls on veterinary medicines, SVA is responsible for enforcement. CAFIA have provided information on actions taken in 2007 in response to noncompliance. 18

19 The following chart gives an overview of the distribution of responsibilities in relation to control systems and operational levels. More detailed descriptions of responsibilities in relation to each control system are given in the following chapters. Sector Policy co-ordination Co-ordination of controls Implementation of controls Laboratories Risk assessment, scientific advice 1. Animal Health MA SVA SVA SVA MA&SVA 2. Food of Animal Origin MA SVA SVA SVA MA 3. Imports of animal and food of animal origin 4. Feedingstuffs and animal nutrition MA SVA SVA & Customs SVA MA MA CISTA & SVA CISTA & SVA CISTA & SVA MA, CISTA & SVA 5. TSEs/ABP MA SVA & CISTA SVA, CISTA, MIT, MH, ME 6. Veterinary medicines - authorisation, marketing &distribution Veterinary medicines - residues 7. Foodstuffs and Food hygiene 8. Imports of food of plant origin 9. Plant protection products - authorisation, marketing and use Plant protection products - residues MA & MH ISCVBM & SVA SVA & CISTA MA, CISTA & SVA ISCVBM & SVA ISCVBM MA & ISCVBM MA & SVA SVA ISCVBM & SVA ISCVBM & SVA MA & MH CAFIA, SVA, MH (PHPPS) CAFIA, RPHO, SVA CAFIA, MH, SVA MA & SVA MA & MH MA CAFIA CAFIA CAFIA MA MA & MH CAFIA CAFIA CAFIA MA & MH MA & MH SPA SPA SPA MA & MH 10. Animal Welfare MA (CCAW) SVA SVA, MUNICIPALITIES - MA & SVA 11. Plant Health MA SPA SPA SPA MA & SPA 19

20 2 COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS 2.1. Control system for animal health MA SVA (AHWD) CMBC RVA DVI CBI SVI NRL Ministry of Agriculture State Veterinary Administration (Animal Health and Welfare Department) Czech Moravian Breeding Corporation Regional Veterinary Administration District Veterinary Inspectorate Czech Breeding Inspectorate State Veterinary Administration National Reference Laboratory Competent Authorities MA, through the Central Animals Registration Unit (MA 17211) of its Commodities Section, is responsible for policy and adopts legislation after initial drafting by SVA. 20

21 SVA, through the Animal Health and Animal Welfare Department (AHWD), is responsible for the organisation and supervision of animal health controls. The RVAs are responsible for implementation of animal health controls, through the DVIs. Some other bodies have a role in animal identification as described below. The SVA information system (ISSVA), introduced in 2005, includes modules on animal disease prevention and epidemio-surveillance, and animal disease recording. ISSVA can retrieve data on animal identification and registration from the Central Database. Holding registration, animal identification and movement controls The Breeding Act Nº 154/2000, subsequent amendments, and secondary legislation is the main legislation on holding registration, animal identification and movement controls. The Czech-Moravian Breeders Corporation (CMBC) maintains the Central Databases for cattle and pigs, under a contract with the Central Animals Registration Unit of MA. Information contained in the cattle, pigs, sheep and goats database is fully accessible to the veterinary services in the regions. The necessary software to control movements of pigs and sheep has become fully operational and accessible by the SVA since the 2006 general review mission. An exception (for farms with one pig) remains valid for the Czech Republic based on Commission Decision 2006/80/EC. Animal identification and holding registration controls are carried out by Czech Breeding Inspectorate (CBI) and SVA. Risk based animal identification controls on breeders are performed only by CBI, without prejudice to controls performed by SVA as described below. CBI has a programme of scheduled inspections based on risk analysis and special inspections imposed by the Minister of Agriculture may be carried out. Training of the inspection bodies took place in April An order on the procedures to be followed during inspections carried out in cattle holdings was issued in April 2004 by the Ministry of Agriculture. SVA integrates animal identification controls with other animal health controls performed at the same time. Both CBI and SVA co-operate and share information. CBI has stated that corrective measures have to be taken for non-conformities. For instance, animal movements are banned and sanctions are applied for Breeding Act violations. MA may impose special inspections for other issues. Both authorities provide training to inspectors once a year and additionally, if necessary. They use detailed procedures for inspections. Reports on inspections of cattle holdings, and since 2007, of sheep and goat holdings, are regularly sent to the European Commission. CBI stated that in 2005, controls took place on 24% of the cattle holdings in the Czech Republic (6,493 out of 27,027). Data provided by CBI during the 2008 general review mission indicates that while the number of controls on holdings has increased over the period , the percentage of discrepancies (including late notifications) has declined during the same period. The Czech-Moravian Breeders Corporation (CMBC) is responsible for poultry flock registration and operates a database, which is now fully operational and accessible to SVA. 21

22 Under the 2006 amendment to the Breeding Act, new implementing legislation dealing with animal identification and registration was approved. This legislation also regulates identification and registration of sheep and goats. SVA has direct access to the database. The necessary software to control the number of slaughtered sheep is now fully operational and accessible by the SVA. Animal health controls SVA, through AHWD, is responsible for all animal health controls. SVA draft the annual programme for animal health controls and disease prevention for approval by the Ministry of Agriculture. The plan is prepared with the participation of key stakeholders on the basis of disease incidence, and the results of the previous year s controls. The national plan assigns a numbers of controls to each RVA. In relation to the former OIE list A diseases, Highly Pathogenic Avian Influenza in poultry occurred in Classical swine fever was found in a wild boar in 1999 and the last outbreak of FMD occurred in The AI surveillance programme in wild birds and poultry, as approved by Commission Decision 2007/782/EC, is being implemented throughout the country. The CSF monitoring programme for wild boar is implemented country-wide in the framework of Methodology for Health Control, as last approved by the Ministry of Agriculture in November Bovine tuberculosis and brucellosis are notifiable diseases and the last outbreaks were registered in 1964 and in 1995 respectively. The country was declared officially free of these two diseases and of Brucella mellitensis, bovine leucosis and Aujeszky s disease by Commission Decision 2004/320/EC. All aborting cows are blood tested twice, at intervals of days, using the complement fixation test and the rose Bengal test. A new system of notifications of abortions to the control database has been introduced, enabling the SVA to check notifications directly. A system is in place to monitor the performance of private veterinarians carrying out duties within the national prophylaxis programme. All RVAs have been instructed to co-operate with hunting associations regarding trichinosis in feral pigs. The rabies eradication programmes, carried out since 1989, have proved to be effective, and the disease was eradicated in The 2005 and 2006 programmes have been successfully implemented. Rabies oral vaccination is still carried out at the borders with Slovakia and Poland, and intensive monitoring of the efficiency of the vaccination situation is regularly applied, with good results. Contingency plans SVA, through AHWD, is responsible for all contingency plan controls. Contingency plans for FMD, CSF, AI and ND have been approved by the European Commission. It is not clear how many other contingency plans for diseases of the OIE former List A have been forwarded to the Commission, or how many remain to be forwarded to the Commission for approval. SVA updates the methodology of CSF monitoring annually. Following the FVO mission in September 2005, the disease contingency plans were amended in relation to vaccination strategy, information on 22