EUROPEAN COMMISSION HEALTH & CONSUMER DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH & CONSUMER DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG (SANCO)/7706/2008 CP Final FINAL COUNTRY PROFILE OF SLOVENIA ON FOOD AND FEED SAFETY, ANIMAL HEALTH, ANIMAL WELFARE AND PLANT HEALTH 14/01/

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 medicinal products (VMPs) and residues Control system for foodstuffs and food hygiene 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 Feedingstuffs and animal nutrition TSEs and Animal-By-Products (ABP) Veterinary medicinal products (VMPs) 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...98 ANNEX I ANNEX II ACRONYMS, ABBREVIATIONS, SPECIAL TERMS AND WEBSITES...99 OVERVIEW OF STAFF RESOURCES

3 EXECUTIVE SUMMARY Overview Three Ministries and their related agencies have responsibility for food safety, animal health, animal welfare and plant health: Ministry of Agriculture, Forestry and Food: Within the Ministry of Agriculture, Forestry and Food, the Directorate for Food Safety co-operates with the following bodies to implement the food safety policy: Veterinary Administration of the Republic of Slovenia (VARS) is mainly responsible for the safety of food of animal origin (as defined in the Veterinary Compliance Criteria Act), feed safety, animal health and animal welfare. Responsibility includes the preparation of legislation in these areas. Inspectorate of the Republic of Slovenia for Agriculture, Forestry and Food (IRSAFF) is responsible for safety of food of plant origin in primary production, including pesticide residues. Phytosanitary Administration of the Republic of Slovenia (PARS) is the central competent authority in the phytosanitary field. Its responsibilities include: plant health (harmful organisms), pesticides, seeds, plant propagating material and fertilizers. Ministry of Health The Health Inspectorate of the Republic of Slovenia (HIRS) is part of the Ministry of Health. It is responsible for the protection of public health through control of the implementation of legislation in three main areas - foodstuffs, nonfoodstuffs and communicable diseases. It is the main authority responsible for official controls throughout the food chain except for primary production of food, processing, import and wholesale trade of food of animal origin, and nonprepacked raw meat and fish in retail sale. It is also as national contact point for the Rapid Alert System for Food and Feed (RASFF). The Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (AMPMD) was established in January The Agency performs regulatory, professional and inspection activities in relation to the testing, production and trade of medicines and medical devices for human and veterinary use (excluding inspection activities linked to veterinary professional issues). It issues marketing authorizations in these areas. It is also the competent authority for the management of risk resulting from the use of these products. The National Chemicals Bureau is responsible for legislation on classification, packaging and labelling in relation to pesticides. Decisions on classification, packaging and labelling of plant protection products are the responsibility of PARS, in consultation with the NCB, while the controls are the responsibility of IRSAFF. Ministry of Environment and Spatial Planning The Ministry has responsibility for waste management, including partial responsibility for rendering of animal by-products. It is also responsible for the preparation of environmental legislation. 3

4 Inspectorate of the Republic of Slovenia for Environment and Spatial Planning (IRSEP) has responsibility for protection of water sources. It also administers environmental legislation. Environmental Agency of the Republic of Slovenia (EARS) is responsible for the implementation of waste management legislation, and in particular for issuing permits for the operation of landfills, incinerators, co-incinerators, collectors/transporters and other recovery and disposal plants, including those for obsolete pesticides. Multiannual Control Plan (MANCP) The first Multi-Annual Control Plan was implemented from 1 January 2007 for the period (updated in February 2008) and the first report according to Article 44 of Regulation (EC) 882/2004 was provided to the European Commission in July Audit Systems HIRS, VARS and IRSAFF have all implemented an internal audit system. A joint forum involving IRSAFF, VARS, PARS and MAFF for internal audit units has been set up. Specific audit training is foreseen for VARS inspectors in Inspections in Slovenia by the Food and Veterinary Office (FVO) Since 2003, the FVO has carried out 25 inspections and 2 general review missions in Slovenia. A further inspection is planned for The following table gives an overview of the main sectors that have been or will be covered by these inspections: SECTORS 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 0 9. Plant Protection Products Animal Welfare Plant Health 2 2 General Review Total sectors per year * Some inspections have multiple sectors 4

5 Total no. Inspections (exc. GRMs) Progress on FVO recommendations For the 25 completed inspections in Slovenia since 2003, final reports have been issued and action plans received from the Slovenian 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 has been made by the Slovenian authorities to deal with the weaknesses in control systems identified in the inspections. Of the 243 recommendations made in these reports, 167 have been closed. Of the remainder, in one case appropriate remedial action by the authorities was required and in 75 cases evidence was required to verify that promised actions had been taken. Progress on these recommendations was reviewed during a general review mission carried out by the FVO in September 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 1 0 For verification / In progress 75 5 Total number of recommendations The main areas of the control systems in Slovenia where issues still require to be addressed by the authorities include: Horizontal issues Internal audits are performed by the Veterinary Administration of the Republic of Slovenia (VARS), the Health Inspectorate (HIRS) and IRSAFF. The audit process is still under development and as yet there is limited evidence on how the findings are used to improve performance. VARS auditors are not yet trained and certified but this is planned for In relation to official laboratory tests, the authorities need to increase the number of validated screening and confirmatory methods, and where relevant, ensure that these are within the scope of accreditation of the laboratories. This applies in particular to methods for analysing a number of pesticides/metabolites, residues of veterinary medicines and GMOs. Sector specific issues In relation to animal welfare during slaughter (poultry slaughter houses), checklists and improved guidelines have been drawn up. However, the CA has yet to verify that the situation in the establishments is now satisfactory. 5

6 Recent FVO inspections All completed inspections to Slovenia have reached final assessment stage at the time of the general review mission in September Future FVO inspections The following inspections are planned for Slovenia in 2008: Ref No. Mission Date Sector Subject of Inspection Current Status Issue Date /11/2008 Feedingstuffs and animal nutrition Feed and compliance with requirements for feed hygiene Draft report in preparation 6

7 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 the Republic of Slovenia. The information in the country profile has been compiled from: written submissions and background documentation from the Slovenian competent authorities detailing how control systems are organised; the results of missions to Slovenia carried out in recent years by teams from the FVO and, in particular, a general review mission in Slovenia in September 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 Slovenian 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 Slovenia and 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 Slovenia since 2003 and, for each control system gives an assessment of progress on specific recommendations reviewed in the general review mission of September 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 Slovenian competent authorities. Acronyms are used extensively throughout this report for the sake of brevity. A list of acronyms, abbreviations, special terms and websites (where applicable) is given in an Annex I to the report as a guide for the reader. 7

8 1. COMPETENT AUTHORITIES AND OVERALL DISTRIBUTION OF RESPONSIBILITIES A national programme of food and nutrition policy for the period 2005 to 2010, was adopted by the government and the National Assembly and published in the official journal on 19 April This programme sets the goal of establishing an efficient food safety system and the overall national strategic objectives are elaborated in the MANCP. Responsibility for this is allocated to the Ministry of Health and the Ministry for Agriculture, Forestry and Food. The programme sets out three main goals to improve food safety: reducing microbiological contamination; reducing chemical contamination; reducing food infections and toxic poisonings. Measures for the achievement of these goals are being developed. Inter-Ministerial co-ordinating panels are being established including: a panel on pesticide residues; a panel for preparing the national multi-annual control plan (MANCP) / submission of the annual report to the Commission Three Ministries and their related agencies have responsibility for food and feed safety, animal health, animal welfare and plant health: Ministry of Agriculture, Forestry and Food; Ministry of Health; Ministry of Environment and Spatial Planning. Ministry of Agriculture, Forestry and Food Within the Ministry, the Directorate for Food Safety comprises the Safety and Quality of Food and Foodstuffs section, the Zootechnology section and the Animal Identification and Registration section. The main tasks of the Directorate are: preparing and implementing legislation in the zootechnical field, and in the field of feed (as regards quality, GMOs and primary production) and food in general; establishing and monitoring control systems for food and feed safety (as regards GMOs) and quality; ensuring food and feed traceability; establishing and managing central registers for animals and holdings; preparing the legal basis for co-existence of GMO with other types of farming; recognition of agricultural products or foodstuff designation; general labelling of foodstuffs and feed; procedures for informing producers and consumers about food and feed safety and quality. The Directorate co-operates with the following bodies within this Ministry in order to implement the food policy, to ensure a concerted control and supervision of food and 8

9 feed safety and quality and to provide efficient food and feed monitoring in the primary production of food of plant origin, including the first placing of these products on the market: the Veterinary Administration of the Republic of Slovenia; the Inspectorate of the Republic of Slovenia for Agriculture, Forestry and Food; the Phytosanitary Administration of the Republic of Slovenia. Veterinary Administration of the Republic of Slovenia (VARS) The competences and responsibilities of VARS are determined in the Veterinary Compliance Criteria Act (VCCA). These responsibilities mainly cover the following areas: food safety - food of animal origin (as defined in the VCCA); feed safety - health suitability of feed; animal health; animal welfare. Responsibility includes the preparation of legislation in these areas. The designation of competences and responsibilities for food safety is defined in Article 16 of the Act regulating the health suitability of foodstuffs, products and materials coming into contact with foodstuffs (OJRS 52/00, 42/02 and 47/04), and Article 5 of the Decree on the co-ordination of the work of ministries and bodies under their responsibility with responsibility for food or foodstuff safety and risk analysis (OJRS 56/2003). The designation of competences and responsibilities for feed safety and veterinary medicinal products is set out in the relevant chapters of the country profile. Under the Chief Veterinary Officer, eight technical Divisions operate at the central level: Animal Health and Welfare Division; Veterinary Public Health and Diagnostics Division; International Affairs Division; Animal Feed and Veterinary Medicinal Products Division; General Affairs Service; Quality Assurance and Internal Audit Service; Office for Internal Official Control; Office for Official Border Control (responsible for Border Inspection Posts). The office for Internal Official Control consists of ten regional offices, as follows: Celje (two branch offices); Ljubljana (one branch office); Koper; Kranj; Maribor (one branch office); Murska Sobota (one branch office); Nova Gorica; 9

10 Novo Mesto (one branch office); Ptuj; Postojna. These regional offices undertake administrative and control tasks. VARS issues an annual control programme for implementation by regional offices. It includes the type and description of tasks, the legal basis, the frequency of inspections, the places to inspect and the anticipated number of inspections. The control programme is drawn up by VARS primarily on a basis of a risk analysis. It is up to the regional offices to decide on the final programme of inspections. Regional offices report to VARS on a monthly basis, specifying the number of inspections, samples/measures taken, and fines collected. The Veterinary Compliance Criteria Act (OJRS 93/2005) was adopted on 21 October The veterinary legislation in Slovenia has since been divided into two sections, the national and the Community sections. Community veterinary legislation is governed by the Veterinary Compliance Criteria Act (VCCA) laying down veterinary compliance criteria, traceability and certification requirements applicable to animals, animal products and animal feed, veterinary compliance criteria and rules for marketing and use of veterinary medicinal products; veterinary checks, veterinary inspection and control, measures to be taken within the official veterinary controls, financing of veterinary checks and official veterinary controls; databases and IT system, and the specific administrative procedure. This Act designates the main competences of VARS. National legislation is governed by the Veterinary Practice Act (VPA) laying down certain aspects of the minimum animal health requirements and animal health fees, veterinary activities and implementation thereof, public authorisations of the Veterinary Chamber, concessions (use of private practitioners under contract), training in the veterinary sector, registers, databases and the IT system, competences of the respective national authorities, inspection and control activities, and the rights and obligations of legal and natural persons under the Act. Inspectorate of the Republic of Slovenia for Agriculture, Forestry and Food (IRSAFF) IRSAFF is the inspection body of the MAFF dealing with all inspection tasks in agriculture, except those under the responsibility of VARS. The organisation of IRSAFF has been more clearly defined to indicate which inspection service is involved for each control system (staff are now allocated to one of seven services). Article 5 of the Decree on co-ordination of the work of ministries in the area of food and foodstuffs safety and risk analysis (OJRS 56/2003) assigns responsibility to IRSAFF for the quality and safety of foodstuffs of plant origin in primary production, including pesticide residues. The new Agriculture Act (45/2008) allows IRSAFF to apply administrative sanctions in cases where there is non compliance with rules on animal identification and movement controls. The inspection service comprises eight regional units (and their branches) and the border inspection posts (BIPs). The eight regional units are as follows: Celje; Ljubljana; 10

11 Koper; Kranj; Maribor; Murska Sobota; Nova Gorica; Novo mesto. The inspectorate is composed of seven inspection services as follows: 1. Agriculture Inspection Service (ISAg) The AISg has responsibility for agriculture, quality assurance of mineral fertilizers, seedlings and propagating material of agricultural products of plant origin, plant protection products, animal husbandry, land consolidation programmes and exploitation of agricultural land and other rural development measures, permanent crops, orchards, vineyards, and hop production. It also has responsibility for agro-environmental measures, animal welfare, the proper use of plant protection products at primary production and cross compliance with good agricultural and environmental conditions, good agricultural and hygiene practice. 2. Phytosanitary Inspection Service (PIS) Together with the Phytosanitary Administration of the Republic of Slovenia (PARS) and the official laboratories, the Inspectorate constitutes the National Plant Protection Organization. Activities of the Phytosanitary Inspection Service: Inspection of the health status, quality and variety of plants moving in international traffic (import, export and re-export) and in the internal market; Inspection of the quality of fruit and vegetable at import; Inspection of PPP at import; Inspection at the place of production and surveys. 3. Forestry Inspection Service (FIS) This service is responsible for the inspection of nurseries that produce forestry plant propagating material and supervision of inspectors at the place of production of forestry plant propagating material. 4. Food Quality Inspection Service (ISQF) This service is responsible for quality control and labelling of foodstuffs as regards quality. 5. Feed Inspection Service (ISFC) This service supervises the quality control and labelling of feedstuffs including GM feed, and feed safety controls in primary production. 6. Wine inspection service (WIS) 11

12 This service supervises the quality control and labelling of wine. 7. Phytosanitary Administration of the Republic of Slovenia (PARS) The Phytosanitary Administration of the Republic of Slovenia is the central competent authority in the phytosanitary field. PARS has responsibility in the following areas: - plant health (harmful organisms); - registration, placing on the market and use of plant protection products (pesticides); - production, processing and placing on the market of agricultural seeds and plant propagating material; - protection and registration of plant varieties; - conservation of plant genetic resources; - technical requirements in relation to equipment for the application of plant protection products; - additional training of responsible persons, sellers and users of plant protection products; - quality of fertilizers. PARS is centrally organised and comprises three sections, of which the following two are relevant to the Country profile. Plant Health Section This section deals with administrative, technical and development functions governing protection of plants and plant products against harmful organisms, including the internal market and international trade under the International Plant Protection Convention. The Phytosanitary Inspection Service (within IRSAFF) is responsible for supervising and inspecting control programmes in the field. Section for Plant Protection Products and fertilisers This section deals with applications for authorisation of PPPs, co-ordinates with other competent authorities and expert bodies for evaluation of dossiers and issues the final authorisation licence; it also co-ordinates with the Commission working bodies concerning PPP and pesticide residues (responsibility for the control of their marketing and use lies with IRSAFF). Ministry of Health Within the Directorate for Public Health of the Ministry of Health, the Division of health and food safety is responsible for co-ordination, exchange of information and international matters in the fields of food safety and health suitability of foodstuffs under the responsibility of MH: preparation of legislation and overseeing its implementation, inter-ministerial co-ordination of work, preparation and co-ordination of projects for increasing networking and upgrading administrative capacity in the management of food safety and co-ordination of national monitoring programmes for pesticide residues in foodstuffs. Health Inspectorate of the Republic of Slovenia (HIRS) Regulations cover the implementation of Community requirements in relation to foodstuffs, the hygiene of foodstuffs and official food controls (OJ RS, no. 120/05, 12

13 66/06, 70/08) including Regulations (EC) 178/2002, 852/2004 and 882/2004. The Regulations define the obligations of food business operators and provides the framework for official controls, carried out by HIRS. HIRS is a constituent part of the Ministry of Health. The mission of the Health Inspectorate is the protection of public health. This overall goal is addressed through inspection and control of the implementation of legislation in three main areasfoodstuffs, non-foodstuffs and communicable diseases. In line with Article 16 of the Act regulating the health suitability of foodstuffs, products and materials coming into contact with foodstuffs (OJRS 52/00, 42/02 and 47/04) and with Article 5 of the Decree on co-ordination (OJRS 56/2003), in relation to foodstuffs, HIRS has the main responsibility as competent authority for official control of food, including drinking water, food additives, composition of foodstuffs, nutritional substances, and food contact materials. HIRS is responsible for official control throughout the food chain except official control of the primary production of foods, production of foods of animal origin, import, export, transport, transit, storage and wholesale of foods of animal origin and of the retail trade of non-prepacked raw meat, fish and other aquatic organisms. The Health Inspectorate operates also as National contact point for the Rapid Alert System for Food and Feed (RASFF). The Health Inspectorate operates on two levels (central and regional). At the central level HIRS is organised in three entities- Sector for strategy, methodology and planning (with field managers for sectoral areas); Service for organisation/personnel and financial affairs; Service for IT and quality. At regional level there are nine regional units- Celje; Ljubljana; Koper; Kranj; Maribor; Murska Sobota; Nova Gorica; Novo mesto; Dravograd. The Sector for strategy, methodology and planning at the central level and the 9 regional units comprise the operational inspectorate. Expert support is provided to HIRS by the National Institute of Public Health and by Regional Institutes of Public Health (RIPH), mainly RIPH Maribor. In order to ensure the high level of quality of service, HIRS has developed and implemented a management system in accordance with SIST ISO 9001:2000 for the field of its responsibilities. HIRS received official certification from Bureau Veritas on 19 October

14 Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (AMPMD) AMPMD was formed in January 2007 by a merger of the Agency for Medicinal Products and Medical Devices (Agencija za zdravila in medicinske pripomočke - ARSZMP), which operated under the Ministry of Health, and the National Institute for Pharmacy and Drug Research (Zavod za farmacijo in za preizkušanje zdravil - Ljubljana - ZAF). AMPMD as a new legal body assumes the rights and obligations of ARSZMP and ZAF, with sole responsibility for registration and quality control of VMPs (including human medicinal products). The Agency performs regulatory, professional and inspection activities in relation to the testing, production and trade of medicines and medical devices for human and veterinary use (excluding inspection activities linked to veterinary professional issues). It issues marketing authorizations in these areas. The Agency is also the competent authority for the management of risk resulting from the use of these products. National Chemicals Bureau Transposition of legislation on classification, packaging and labelling (in relation to PPPs) is the responsibility of the National Chemicals Bureau (NCB) of the Ministry of Health. Decisions on classification, packaging and labelling of plant protection products are the responsibility of PARS, in consultation with the NCB, while the controls are the responsibility of IRSAFF. The Ministry of the Environment and Spatial Planning (MESP) The MESP has responsibility for waste management, including partial responsibility for the rendering of animal by products. It is also responsible for the preparation of environmental legislation. Inspectorate of the Republic of Slovenia for Environment and Spatial Planning (IRSEP) Article 5 of the Decree on co-ordination of the work of ministries in the area of food and foodstuffs safety and risk analysis (OJRS, no. 56/2003) assigns responsibility for protection of water sources to IRSEP. It also administers environmental legislation. Environmental Agency of the Republic of Slovenia (EARS) The Environmental Office of EARS is responsible for the implementation of waste management legislation, and in particular for issuing permits for the operation of landfills, incinerators, co-incinerators, collectors/transporters and other recovery and disposal plants, including those for obsolete pesticides. Laboratory Services Laboratories that carry out analysis of samples taken by staff of the CAs carrying out official controls during the course of their duties include: National Veterinary Institute The National Veterinary Institute (NVI) is a part of the Veterinary Faculty of University of Ljubljana and performs the work of a public veterinary service. NVI includes a 14

15 central diagnostic laboratory (CDL), located in Ljubljana. The CDL is organised in the following units: 1. Unit for diagnostics of infectious and other diseases of animals; 2. Unit for food of animal origin; 3. Unit for reproduction and genetics; 4. Unit for pathology of animal nutrition and environmental hygiene; 5. Unit for control and testing of drugs. The NVI has seven regional units, located in: Ljubljana; Maribor /Ptuj (in two locations); Novo mesto; Nova Gorica; Kranj; Celje; Murska Sobota. The NVI performs the following analyses: Residues under the NRCP (the majority of analyses are performed in CDL in Ljubljana); BSE/TSE screening tests are performed in the CDL (unit for diagnostics of infectious and other diseases of animals in Ljubljana); confirmatory BSE and TSE tests and discriminatory BSE/TSE test are performed in the National Reference Laboratory (NRL) for TSEs (NRL for TSE - NVI located in Ljubljana); The official testing for the presence of processed animal proteins (PAP) is carried out in the Laboratory for Microbiological Examinations of Feed within the Unit for pathology of animal nutrition and environmental hygiene (of CDL); Screening tests of some animal infectious diseases are performed at regional units, while screening and confirmation tests are performed in CDL Unit for diagnostics of infectious and other diseases of animals; Microbiological, chemical and parasitological tests regarding safety of food of animal origin, feedingstuff and animal nutrition are performed at the CLD (confirmatory tests) and at regional units (screening); The unit for food of animal origin of CDL carries out analyses for the presence of marine biotoxins in food of animal origin (ASP, DSP and PSP). The NVI is ISO accredited by the Slovenian accreditation body. The updated scope of accreditation is available through /. The NVI is the only laboratory in Slovenia authorised to perform the rabies diagnostic tests, the vaccination programme monitoring tests and the tests prior to marketing of vaccines. It is authorised to perform analyses to check the effectiveness of vaccination against rabies in certain domestic carnivores and it organises the collection of foxes brought to the veterinary stations. NVI is designated as the NRL for CSF, AI, ND, fish diseases, bivalve mollusc disease, monitoring of effectiveness of rabies vaccination, Bluetongue, ASF, Brucellosis, 15

16 zoonoses (salmonella), marine biotoxins, viral and bacteriological contamination of bivalve molluscs, Listeria monocytogenes, Coagulase positive Staphylococci including S.aureus, Escherichia coli (including VTEC), Campylobacter, parasites, antimicrobial resistance, animal proteins in feeding stuffs, residues of veterinary medicines and contaminants in food of animal origin, TSEs, milk and milk products, heavy metals in feed and food, additives and mycotoxins. The laboratory of the Institute for animal health in Pirbright (UK) is also the NRL in relation to FMD and swine vesicular disease. This laboratory performs the confirmatory tests for these diseases. National Institute of Biology (NIB) The laboratory of the National Institute of Biology in Ljubljana, is accredited under ISO and has been designated as a NRL for the analysis of GMOs. National Institute for Public Health The National Institute for Public Health (NIPH) is based in Ljubljana. There are nine Regional Institutes of Public Health and seven of these have their own laboratories. NIPH undertakes the following analyses: microbiological testing; food additives; contaminants; GMO -qualitative analysis; pesticide residues; allergens; nutritional parameters; food contact materials; quality control of foodstuffs. A full accreditation listing is available on the website of the Slovenian accreditation body The laboratories for public health microbiology and chemistry are constituent units within the Center for Environmental Health. They are responsible for carrying out analysis of official samples (foodstuffs, food contact materials, drinking water, cosmetics, bathing waters) and determination of their compliance with legislation. Risk assessment for human health in the field of food is compiled by NIPH in cooperation with other institutions that carry out the process of risk assessment. Regional Institute of Public Health Maribor (RIPH MB) The RIPH MB undertakes the following analyses: microbiological testing; food additives; contaminants; GMO - qualitative and quantitative analysis; pesticide residues; 16

17 nutritional parameters; food contact materials; drinking water; some work for residues under the NRCP; quality control of foodstuffs; contaminants in soil and agricultural products of plant origin; The RIPH MB achieved ISO accreditation from the Slovenian accreditation body in December The updated scope of accreditation is available through Besides RIPH MB, there are eight other regional institutes of public health. In cases of food borne diseases, other regional institutes of public health Koper, Celje, Kranj, Nova Gorica, Murska Sobota, and Novo Mesto can also undertake microbiological tests except two of them, which do not have their own laboratories (RIPH Ljubljana and RIPH Ravne na Koroškem) Slovenian Agricultural Institute This laboratory undertakes analyses in the following areas: quality control analysis of PPPs and pesticide residue analysis for control of PPP residues in agricultural products of plant origin; harmful organisms (phytosanitary reference laboratory); certification body (planting material); quality control of animal feed; quality control of honey; analysis of seed material; contaminants in soil and agricultural products of plant origin. Central laboratories at the Agricultural Institute of Slovenia are accredited by French accreditation body COFRAC (Accreditation Certificate N o , according to the requirements laid down in the Standard SIST EN ISO/IEC in order to be able to carry out the following test methods: analyses of wine and must; analyses of alcoholic drinks; analyses of animal feeding stuffs; analyses of honey and; analyses of pesticide residues. Other laboratories National Institute of Biology (NIB): bacteriology reference laboratory, harmful organisms (phytosanitary), analysis of GM feed, food and seed; Slovenian Institute for hop research and brewing (SIHRB): mycology reference laboratory and certification body (planting material), harmful organisms (phytosanitary); Biotechnical faculty, Department of agronomy: Harmful organisms (phytosanitary); Regional Agriculture and Forestry institute, Nova Gorica (RAFI-NG): entomology reference laboratory, harmful organisms (phytosanitary); 17

18 Regional Agriculture and Forestry institute, Maribor (RAFI-MB): harmful organisms (phytosanitary); Regional Agriculture and Forestry institute Novo mesto (RAFI-NM); National institute of chemistry Slovenia (THC content in hemp); University of Primorska, Science and Research Centre of Koper. National reference laboratories National reference Designated analytical activities laboratories DESIGNATED BY VARS NVI, Gerbičeva 60, Scope of activities (food and feed, animal health) 1000 Ljubljana, - mycotoxins Slovenia - heavy metals - Escherichia coli, including Verotoxigenic E. coli (VTEC) - Campylobacter - Listeria monocytogenes - Coagulase positive Staphylococci, including Staphylococcus aureus - parasites (in particular Trichinella, Echinococcus and Anisakis) - antimicrobial resistance - zoonoses (Salmonella) - transmissible spongiform encephalopathies (TSE) - milk and milk products - monitoring of marine biotoxins - monitoring of the viral and bacteriological contamination of bivalve molluscs - residues of veterinary medicines and contaminants in food of animal origin - animal proteins in feeding stuffs - foot and mouth disease (not for handling live virus) - rabies ( including monitoring the effectiveness of rabies vaccination) - classical swine fever - african swine fever - swine vesicular disease (not for handling live virus) - bluetongue - viral diseases of fish - diseases of molluscs - brucellosis - avian influenza - newcastle disease RIPH MB, Prvomajska 1, 2000 Maribor, Slovenia RIPH NG, Vipavska cesta 13, Rožna Dolina, 5000 Nova Gorica, Slovenia NIPH, Grablovičeva 44, 1000 Ljubljana, Slovenia The laboratory for sanitary chemistry NIPH, The laboratory for sanitary chemistry Trubarjeva 2, 1000 Scope of activities (food and feed) - residues of pesticides food of animal origin and commodities with high fat content - residues of pesticides single residue method - dioxins and PCBs in feed and food - residues of veterinary medicines and contaminants in food of animal origin Scope of activities (food) Residues of veterinary medicines and contaminants in food of animal origin (amitraz and organophosphorus compounds in honey) Scope of activities (food): residues of veterinary medicines and contaminants in food of animal origin (mercury in fish). DESIGNATED BY MH Scope of activities (food): analyses - pesticide in cereals 18

19 Ljubljana, Slovenia - pesticides in fruit and vegetables - food contact material NIB, Večna pot 101, 1000 Ljubljana, Slovenia NVI, Gerbičeva 60, 1000 Ljubljana, Slovenia NIB, Večna pot 101, 1000 Ljubljana, Slovenia Agricultural Institute of Slovenia, Hacquetova 17, 1000 Ljubljana, Slovenia Scope of activities (food) -GMO analyses (qualitative and quantitative) DESIGNATED BY MAFF Scope of activities (feed, food) - feed additives (zootechnical additives) - water in poultrymeat Scope of activities (feed) - GMO analyses (qualitative and quantitative) Scope of activities (feed) - feed additives (nutritive additives, vitamins, amino acids and oligoelements) - quality parameters Multi-annual National Control Plan For the purpose of preparing the single integrated multi-annual control plan (including any subsequent review/modification) a panel was established between the Ministry of Agriculture, Forestry and Food and the Ministry of Health. The first Single Integrated Multi-annual Control Plan was implemented from 1 January 2007, updated in February 2008 and a third version (in Slovenian) is to be issued in early The first report according to Article 44 of Regulation (EC) 882/2004 was provided to the European Commission on 31 July Official controls with regard to harmful organisms in plants are also included. The national contact point for communication regarding the Single Integrated Multiannual Control Plan for the period is the Veterinary Administration of the Republic of Slovenia, which also has responsibility for the co-ordination of amendments to the plan according to Article 42/3 of Regulation (EC) 882/2004. The requirements of Regulation (EC) No 882/2004 such as documented procedures, verification procedures and internal audits have been integrated into the controls of various sectors. However, the CA acknowledged that these need to be further developed. Competent Authority Audit Systems Audit system in HIRS HIRS has implemented an internal audit system. An audit plan must be agreed by the Board of the Chief Health Inspector and is an obligatory part of HIRS annual business plan. Internal audits are assessed in light of their results, to ensure that they are, among other things, achieving the objectives of Regulation EC/882/2004. Internal audits as referred to Article 4 (6) of Regulation (EC) No 882/2004 are carried out in line with Standard SIST EN ISO at all HIRS's entities and all control bodies to which HIRS has delegated certain tasks within official control. 19

20 To meet the legislative requirements regarding delegation of tasks to control bodies as referred to Article 5.2 (c) of Regulation (EC) No 882/2004, HIRS requires that the laboratories are accredited. The body responsible for the transport of official samples to designated official laboratories has a certificate in accordance with Standard SIST EN ISO Audit system in VARS In 2006, VARS implemented an internal audit system operated by the Quality Assurance and Internal Audit Service of VARS. The Service employs 2 full-time and 1 part-time staff. A further 16 professional workers (from VARS Main Office), have been appointed to provide professional assistance/support when required. A manual has been established (updated 18 June 2008) which lays down standard procedures for the implementation of internal audits by the Quality Assurance and Internal Audit Service. Internal audit is undertaken in the 10 ROs, the 6 BIPs and the VARS divisions. VARS auditors have not yet been fully trained and certified. However, this is planned for The audit process is to be further improved, to ensure that there is effective follow up to the recommendations made in the audit reports. In some areas (TSE, animal feed, VMPs and animal reproduction), there is only one member of staff competent to join the audit group. Alternative arrangements need to be found to allow audits in these areas to be performed without conflict of interest. Audit system in IRSAFF IRSAFF has implemented an internal audit system. At present the audit team comprises two people (1 generalist and 1 specialist). The generalist is a member of the audit group and the specialist member is from the Chief Inspectors office. Internal audits are planned according to the number inspectors available to perform on-the-spot checks and are conducted at IRSAFF control bodies once every 4-5 years. National Accreditation Body The Slovenian Accreditation (SA) is a public institute carrying out the tasks of a national accreditation body in Slovenia under the terms and conditions applicable to public services and on the basis of the Accreditation Act (OJRS 59/99). 20

21 The following chart gives an overview of the distribution of responsibilities in relation to control systems and operational levels in Slovenia. Sector Policy co-ordination Co-ordination of controls Implementation of controls Laboratories Risk assessment, scientific advice 1. Animal Health MAFF (DFS/SIR)VARS 2. Food of Animal Origin 3. Import of animals and food of animal origin 4. Feedingstuffs - imports Feedingstuffs - production / farms 5. TSEs/ ABPs 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 - residues Plant protection products - authorisation, marketing and use MAFF/VARS/MH MAFF/VARS/MF/C ARS MAFF/VARS VARS VARS (RO) NVI NVI/VARS VARS/IRSAFF- ISQF/HIRS VARS (RO)IRSAFF- ISQF/HIRS NVI/NIPH/RIPH MB VARS/CARS VARS-BIPs NVI/NIPH/RIPH MB/RIPH NG VARS/CARS/IRSAFF- ISFC VARS (RO)IRSAFF- ISFC/CARS MAFF/VARS VARS/IRSAFF-ISFC VARS (RO)IRSAFF- ISFC MAFF/VARS MAFF/VARS/MESP /MH/MF/CARS MAFF/VARS/MH/ AMPMD VARS VARS/HIRS/IRSEP/ IRSAFF VARS/AMPMD/OMCL VARS (RO) VARS(ROs& BIPs) HIRS/IRSEP VARS (RO)AMPMD/0MCL NVI/AIS/NIB NVI/AIS/NIB NVI NVI OMCL MAFF/VARS VARS VARS (ROs) NVI/RIPH MB/RIPH NG/NIPH MAFF/VARS/MH HIRS/VARS/IRSAFF- ISQF, ISAg HIRS/VARS (ROs)/IRSAFF-ISQF, ISAg MH/MAFF/MF HIRS/CARS/IRSAFF-PIS HIRS/IRSAFF- PIS/CARS MH/MAFF/PARS/ MESP MAFF/PARS/MESP/ MH/NCB HIRS/IRSAFF- ISAg/IRSEP HIRS/IRSAFF-ISAg NIPH/RIPH MB/NVI/NIB NIPH/RIPH MB/NIB NIPH/RIPH MB/AIS NVI/NIPH/VARS NVI/VARS NVI/AIS/VARS NVI/AIS/VARS NVI/VARS NVI/VARS NVI/VARS/AMP MD NVI/VARS/AMP MD NIPH NIPH NIPH IRSAFF/IRSEP IRSEP/IRSAFF AIS/RIPH MB PARS/NCB 10. Animal Welfare MAFF/VARS VARS VARS (ROs) & VARS (Mobile Unit) 11. Plant Health MAFF/PARS IRSAFF-PIS/PARS IRSAFF- PIS/AIS/SIHRB/IRSA FF AIS/SIHBR/NIB Regional Institute (NG) NVI/VARS PARS/AIS/ SIHRB/NIB More detailed descriptions of allocation of responsibilities between the authorities in relation to each control system are given in the following chapters. 21

22 2. COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS 2.1. Control system for animal health Ministry of Agriculture, Forestry and Food Directorate for Food Safety National Veterinary Institute Inspectorate of the Republic of Slovenia for Agriculture,Forestry and Food - ISAg Veterinary Administration of the Republic of Slovenia Input to Work Plans Sector for animal identification and registration SIR VOLOS database Animal Health and Animal Welfare Sector Internal Inspection Sector Work Plans Controls on animal identification and registration RVOs (10) Regional offices with separate Animal Health and Animal Welfare Departments 3 Regional Offices without this division (KP, KR and NG) Sampling/ analysis 8 Regional Units NVI Approved Veterinarians Controls Controls Holdings/establishments 22

23 Competent Authorities VARS is the CA. Within the Animal Health and Welfare Division of VARS (AHWD), the Animal Health Section comprises five staff. In addition to VARS, private veterinary practices are responsible for certain animal health measures, under contract with VARS. A 10-year concession agreement was signed in 1998 between VARS and veterinary organisations (practices) covering services provided by private practitioners within the monitoring programme. Under the Veterinary Compliance Criteria Act (OJRS 93/2005), private veterinary practitioners may be authorised by the CVO to undertake certain tasks under the supervision of VARS. A separate work plan is prepared annually by VARS for the 111 authorised contracted veterinary practices. Tasks of these contracted veterinary practices include: determination of health status; veterinary checks at agricultural holdings; tagging; entry of identification and registration data; disease eradication; basic diagnostics; conducting seminars on diseases; implementing rules on vaccination monitoring; animal welfare. In 2006, a new requirement of visiting every holding once a year was introduced for contracted veterinarians. The purposes of these visits include the determination of health status that is to be entered directly into the VOLOS database. In 2006, the Central Information System (CIS) was set up at VARS, which includes the epidemiology software (EPI). EPI software is a system intended for the monitoring of, reporting on and notification of animal diseases as part of tasks of the Animal Health Section at VARS. This internet application links the veterinary organisations carrying out sampling, the National Veterinary Institute conducting the testing, and the Veterinary Administration of the Republic of Slovenia, which is responsible for monitoring the disease situation and health status within the country. Holding registration, animal identification and movement controls The database is managed by the Animal Identification and Registration Sector (SIR). A central database of holdings and keepers is in place, including cattle, pig, sheep and goat, and bee keepers. There is now a simplified registration system in place for small pig holdings. 23

24 The central register of bovine animals is operated as a single central database. In addition to the records on births, deaths and movements of animals, the database includes records of on-the-spot checks and the health status of holdings. The central register of ovine/caprine animals, porcine animals and apiaries is also in place. The keepers are obliged to report the data of animal movements and once per year the number of animals on the holding, either via the premium application, or via a specific form. Cattle must be tagged within 20 days of birth, sheep and goats are tagged at the latest by nine months (extensive herds), six months (intensive herds) or before first movement. Pigs are tagged at the latest, prior to movement. Passports and on-farm registers have been compulsory for bovine animals since Bovine animals are entered in the register within 7 days after tagging. All movement must be entered within 7 days. For movements off the farm, the farmer sends the related form to the local veterinary station (LVS), or agricultural centre, where data is entered into the database. The database is linked with several other databases in the public sector such as regional offices, collection centres for fallen stock, veterinary organisations and some slaughterhouses which can enter data on animal identification and registration, or movements. RVOs, NVI laboratories and veterinary practices have direct access to the central database. The LVS keep records of movements (of farm) for three years. Movements onto the farm are reported by the receiver (for bovines also the National Veterinary Institute-National Hygiene Service, (NVI-NHS), and slaughterhouses). Animal registration and movement registration is organized as a public service. The authorised veterinary practices and agricultural centres plus authorised animal keepers record the births (cattle) and movement notifications between holdings in Slovenia using an on-line electronic system. Information on slaughtered cattle is recorded directly by slaughterhouse operators via the internet. While data entry is decentralized, data maintenance (correction, other than simple corrections) is processed centrally. The remainder of the notifications (usually more complicated cases) are processed by officials within SIR. Responsibility for on-farm checks is shared among the VARS, the Agriculture Inspectorate Service within the Inspectorate of the Republic of Slovenia for Agriculture, Forestry and Food, (IRSAFF) and the Paying Agency controllers (IACS). Holdings are selected on the basis of risk analysis. The results of these inspections are recorded directly in the central database. Animal health status The Republic of Slovenia has been recognised as officially free from brucellosis in small ruminants (B. melitensis), and enzootic bovine leukosis by Commission Decision 179/2005/EC. In 2007 the Republic of Slovenia was also recognised as free from bovine brucellosis ((Commission Decision 399/2007/EC). In 2008, work is to be continued on establishing the conditions for recognition as officially free from Tuberculosis. Commission Decision 2007/782/EC approved inter alia the programmes for the eradication, control and monitoring of rabies (still present in the fox population), classical swine fever (CSF), avian influenza, TSEs, BSE and Scrapie for 2008 and following years. The programmes of monitoring Bluetongue (a priority for 2008) and entomological control of vectors are carried out in the entire territory of Slovenia. To date, the disease 24