TABLE OF CONTENTS INTRODUCTION... 3 SUMMARY... 4

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2 TABLE OF CONTENTS INTRODUCTION... 3 SUMMARY 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 Transmissible Spongiform Encephalopathy (TSE) and Animal By-Products (ABP) Control system for veterinary medicines and residues Control system for foodstuffs and food hygiene Control system for imports of food of plant origin Control system for plant protection products (PPP) and residues Control system for animal welfare Control system for plant health...45 ANNEX I STAFF RESOURCES ANNEX II ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS

3 INTRODUCTION This overview 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 based on information supplied by Poland. The aim is to present, in summary form, the latest information on how control systems for food and feed safety, animal health, animal welfare and plant health are organised in Poland. Chapter 1 describes the overall organisation of the Polish 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. Chapter 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 Poland, covering the whole chain of plant, animal and food production. As in Chapter 1, organisation charts are used to help the reader. Annex I provides details on the number of control staff in Poland. The statistics on staff resources have been provided by Poland on a non-standardised basis. The overview was updated following the most recent general follow-up mission in March 2009 and will be updated at regular intervals based on relevant information received by the Commission from the Polish authorities. Acronyms are used extensively throughout this overview for the sake of brevity. A list of acronyms, abbreviations, special terms and websites is given in Annex II as a guide for the reader. 3

4 SUMMARY The Republic of Poland has an organisational structure consisting of a central level, 16 Voivodships (regions), 379 Poviats (districts) and 2478 Gminas (municipalities). The central level has overall responsibility for the control systems for food and feed safety, animal health, animal welfare and plant health. Most of the implementation and enforcement activities are carried out at Voivodship and/or Poviat levels, with a vertical chain of command between central, Voivodship and Poviat levels. The Ministry of Agriculture and Rural Development and the Ministry of Health are the two principle central authorities. Cooperation and information exchange between the ministries is governed by cooperation agreements, which are replicated at regional and district levels. Within the Ministry of Agriculture and Rural Development, responsibilities are as follows: the Veterinary Inspectorate, under the Chief Veterinary Officer, is responsible for controls on animal health, animal welfare, food of animal origin, feed safety, veterinary medicinal products, and on import controls on food of animal origin. The State Plant Health and Seed Inspection Service is responsible for plant health matters; the Main Inspectorate of Agricultural and Food Quality is responsible for quality control of GMO foodstuffs carried out in processing plants; and the Agency for Restructuring and Modernisation of Agriculture is responsible for the farm holding registration system and operation of the central animal database, as well as being a paying agency. Within the Ministry of Health, the State Sanitary Inspectorate, under the Chief Sanitary Inspector, is responsible for controls on food of plant origin and shares responsibility with the Veterinary Inspectorate on certain controls on the food of animal origin. There are over 13,600 full-time equivalent staff involved in controls in Poland, with approximately 13,000 of these working at regional or district levels. In addition, various veterinary tasks are carried out by 5,479 contracted private veterinary practitioners. The first multi-annual national control plan, covering the years 2007 to 2009, was provided to the Commission in February The 2007 Annual Report was provided in September A coordination team, comprising representatives of the above-mentioned services and the Office of Competition and Consumer Protection, was set up to monitor implementation and to adjust or update the plan, as required. 4

5 1. COMPETENT AUTHORITIES AND OVERALL DISTRIBUTION OF RESPONSIBILITIES Ministry of Agriculture and Rural Development () The Department of Food Safety and Veterinary Matters is responsible for the transposition of Community legislation relating to: veterinary protection of public health; protection of animal health and welfare; and the quality of feedingstuffs. It is responsible for presenting legislation to Parliament. The Department of Breeding and Plant Protection is responsible for the transposition of Community legislation relating to plant breeding and seed production; plant protection; registration of plant protection products; health quality of biological material; protection of genetic resources; GMO; as well as fertilisers and fertilisation. The Veterinary Inspectorate, the Main Inspectorate of the State Plant Health and Seed Inspection Service (SPHSIS), and the Main Inspectorate of Agricultural and Food Quality Inspection (MIAFQI), are the Central Competent Authorities (CCA). Veterinary Inspectorate is responsible for controls on animal health, animal welfare, food of animal origin, feed safety, veterinary medicinal products, and on import controls on food of animal origin, through the Borders Office; SPHSIS is responsible for plant health matters; MIAFQI is responsible for controls at processors on the commercial quality and labelling of GMO in foodstuffs. The Ministry of Finance funds the services at central level. The regional and district levels are funded through the Voivodship, under the Ministry of Interior and Administration. Veterinary Inspectorate (VI) This service is headed by the Chief Veterinary Officer (CVO). At central level, the relevant operational units are: - Animal Health and Welfare Office - Food Safety Office - Feedingstuffs, Pharmacy and Rendering Office - Borders Office - Controlling Office (Audit) - The European Union and Foreign Cooperation Office - Legal Office - Organising Office (Human resources, Training, Administration) - Laboratories Policy Office The VI is operationally divided into General Veterinary Inspectorate (GVI), 11 Border Veterinary Inspectorates (BVI), 16 Voivodship (Regional) Veterinary Inspectorates (VVI) and 305 Poviat (District) Veterinary Inspectorates (PVI). These are headed by CVO, Border Veterinary Officers, Regional Veterinary Officers and District Veterinary Officers respectively. Agency for Restructuring and Modernisation of Agriculture (ARMA) ARMA is a paying agency with a network of offices in all regions and districts of the country. It is responsible for the registration system of holdings and the operation of the

6 central databases for holdings and animals (except for horses, where Polish Horse Breeders' Association is responsible), which have been established in accordance with the relevant EU requirements. State Plant Health and Seeds Inspection Service (SPHSIS) On the basis of the Law concerning Plant Health dated 18 December 2003, the State Plant Health and Seeds Inspection Service is responsible, amongst other matters, for controls of plant health and the marketing and use of pesticides. This is implemented at central level by the Main Inspectorate for the Plant Health and Seeds Inspection Service. At regional level, there are 16 Voivodship Inspectorates (VSPHSIS), 269 field units and 12 SPHSIS border inspection points. The Main Inspectorate supervises and controls VSPHSIS activities, coordinates inspections, prepares training programmes and draws up instructions and guidelines. It also evaluates appeals against VSPHSIS decisions, collaborates with on drafting legislation and maintains contacts with other competent authorities and scientific institutions. Agricultural and Food Quality Inspection This has a limited role in food safety, except for GMO, where it is responsible for controls at processors on the commercial quality of GMO in foodstuffs and for labelling, within the scope of Regulation (EC) 1830/2003 on traceability and labelling. It is managed by the Main Inspectorate and sixteen Voivodship Inspectorates. The Poviats are not involved. Ministry of Health This ministry is responsible for the coordination of food safety under a regulation dated 16 November 2007 and for the transposition of EU legislation in the areas of general food hygiene, pesticide residues, contaminants, veterinary medicinal products, and import controls of food of non-animal origin. It is responsible for presenting legislation to Parliament. The State Sanitary Inspection is headed by the Chief Sanitary Inspector. The Ministry of Health receives funding from the Ministry of Finance to cover the needs of the SSI at all levels. State Sanitary Inspection (SSI) This service is responsible for: official control of the hygiene of foodstuffs; pesticide residues in food; contaminants and imports of food of non-animal origin, materials and articles intended to come into contact with food; food additives; GMO in food; food supplements; and novel foods. The Department for Safety of Food and Nutrition is directly responsible for these areas at central level. It is also responsible for policy development, contact with international bodies (such as the European Commission and Codex Alimentarius, where it cooperates with MIAFQI which is the contact point for FAO/WHO) and overseeing food processing. Other responsibilities include: coordination of enforcement; supervision of subordinate levels; collating data on controls; and providing the national contact point for the Rapid Alert System for Food and Feed. The national contact sub-point is located in the GVI. The tasks of SSI are discharged at regional level by 16 Voivodship Sanitary and Epidemiological Stations (VSES), and at district level by 318 Poviat Sanitary and 6

7 Epidemiological Stations (PSES) and 10 Border Sanitary and Epidemiological Stations (BSES). Main Pharmaceutical Inspectorate The Main Pharmaceutical Inspectorate is responsible for the issuing and withdrawal of authorisations for the manufacture and importation of veterinary medicinal products. It supervises the manufacturing and importation of human and veterinary medicines. Ministry of Infrastructure The Road Transport Inspection, previously under the Ministry of Transport and now under the Ministry of Infrastructure, is responsible for controls on animal welfare during transport. It consists of the General Inspectorate of Road Transport and sixteen Voivodship Road Transport Inspectorates. It carries out checks of livestock vehicles as part of their roadside controls. Ministry of Finance The Customs Services cooperate with: GVI on controls of imports of animals, food of animal origin and feedingstuffs; SPHSIS on controls of exports and imports of regulated plants and plant material; and SSI on controls of imports of food of plant origin. National accreditation bodies The Polish Centre for Accreditation is a national body authorised for the accreditation of certification and inspection bodies, testing and calibration laboratories and other entities conducting conformity assessments and verifications. 7

8 Competent authorities overview The following chart gives an overview of the main competent authorities involved: NVRI MH VI SPHSIS MIAFQI SSI MPI GVI BO 10 Main Inspectorate Central Laboratory Laboratories NIPH-NIH FNI VSES RVL 16 Regional VVI 16 Regional VSPHSIS 16 Regional Laboratory Regional Laboratories 16 Regional VSES 16 District PVI 305 BVI 12 Field units 269 BIP 12 District PSES 318 BIP BSES 10 8

9 Overview The following chart gives an overview of the distribution of responsibilities in relation to control systems and operational levels. More detailed descriptions of the allocation of responsibilities between authorities in relation to each control system are given in the following chapters. Sector Policy coordination 1. Animal Health ARMA 2. Food of Animal Origin MH 3. Imports of animal and food of animal origin MF Coordination of controls GVI ARMA GVI SSI GVI/BIO Customs Service Implementation of controls Laboratories Risk assessment, scientific advice VVI/PVI NVR/NRL NRL VVI/PVI VSES/PSES VVI/PVI/BVI Customs Chambers NVR/NRL NVR/NRL NRL NRL 4. Feedingstuffs /MF GVI/BIO Customs Service VVI/PVI/BVI Customs Chambers NVR/NRL, PPI, NFL NRL 5. TSEs/ABP MH, ME 6. Veterinary medicines - authorisation, marketing &distribution Veterinary - residues medicines 7. Foodstuffs and Food hygiene 8. Imports of food of plant origin 9. Plant protection products - authorisation, marketing and use Plant protection products - residues GVI/ARMA SSI GVI/PVI VVI/VSES/PSES NVR/NRL NRL MH MPI VPI NRL GVI VVI/PVI NVR/NRL NRL MH SSI VSES/PSES NFNI NIPH-NIH MH,, MF PPP Commission 10. Animal Welfare MoI SSI, GVI Customs Service MISPHSIS VSES/BSES Customs Chambers VSPHSIS/ Field Units NIPH-NIH No reference laboratory NRL NRL NRL MH SSI VSES/PSES/BSES NIPH-NIH NRL GVI RTI 11. Plant Health MISPHSIS VSPHSIS: Field Units VVI/PVI/BVI NVR/NRL NRL Central Lab MISPHSIS NRL 9

10 2. COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS 2.1. Control system for animal health DFSVM NVRI/NRL GVI AHWO ARMA VVI PVI Ministry of Agriculture and Rural Development Department of Food Safety and Veterinary Matters National Veterinary Research Institute-National Reference Laboratory General Veterinary Inspectorate Animal Health and Welfare Office Agency for Restructuring and Modernisation of Agriculture Voivodship Veterinary Inspectorate(s) Poviat Veterinary Inspectorate(s) Competent Authorities The GVI is competent authority for implementation of policy and control. Within the GVI, the Animal Health and Welfare Office is responsible for animal health matters. The GVI prepares guidelines and instructions and is responsible for the annual work plan. Holding registration, animal identification and movement controls ARMA is responsible for the registration system for animals and holdings, and for the movement of animals. The Laws of 2 April 2004 on the system of identification and registration of animals and their implementing regulations, govern the system for identification and registration of animals. Registration of cattle, sheep, goats and pigs and the issue of passports for cattle are done at Poviat level by local ARMA offices. All holdings of bovine, caprine, ovine and porcine animals in Poland must be registered. As at 1 December 2009 there were 6,179,728 cattle, 245,125 sheep, 44,728 goats and 12, pigs registered in the central database and in total 1,271,325 animal farms. 10

11 The Polish Horse Breeders Association (PZHK) is responsible for, inter alia: managing and updating the horse central database; keeping registers of horses for breeding and production; and for issuing passports. Identification of horses is compulsory and they cannot leave the holding of origin without a passport. The Association does not carry out on-the-spot controls itself; this is done by the PVI, who will communicate any discrepancies to the Association. At present, PVI do not have direct access to the PZHK's database, but receive from them, via the CVO, an extract from the Register of Horses in the form of an Excel table. On-the-spot inspections were performed on 10% of bovine holdings up to 2008, as required by Commission Regulation (EC) No. 1082/2003, and on 3% of ovine and caprine holdings comprising at least 5% of animals, in accordance with the Commission Regulation 1505/2006. From 2009, the level of controls of identity and registration of cattle has been reduced to 5% nationally. These inspections are carried out exclusively by official veterinarians: during inspections of milk production farms; during animal welfare inspections; and within the monitoring programme of bovine infectious diseases. Official veterinarians are required to check the identification details for bovines being sent to other Member States against the information held on the central database. The inspections also provide information to enable ARMA to conduct a risk-based selection of holdings for inspection. Animal health controls The CVO is responsible for drafting programmes for eradication control and surveillance of certain animal diseases. Such programmes are in place for rabies, enzootic bovine leucosis, bovine spongiform encephalopathy, avian influenza, Aujeszky's disease and salmonella in breeding flocks and laying hens of Gallus gallus. The implementation of a Salmonella control programme for broiler flocks began in However, with regard to turkeys for slaughter and breeding turkeys, the national Salmonella control programme will begin in In addition, a number of other diseases included in the monitoring regulation are monitored, such as classical swine fever, foot and mouth disease, swine vesicular disease, ovine and caprine brucellosis and fish diseases. Poland has been declared officially free of brucella melitensis, bovine brucellosis and bovine tuberculosis. Certain regions in Poland have been recognised as free of enzootic bovine leucosis. A monitoring programme for bluetongue vectors in homegrown cattle has been introduced in Poland. In accordance with the programme, samples are taken for examination three times during vector activity (May-September) in marked herds of cattle and sheep. Monitoring of Transmissible Spongiform Encepalopathy ended in Poland in February On the basis of Decision 2007/182/EC dated 19 March 2007, the number of animals specified for Poland were examined and the findings sent to the European Commission. The competent authority submits interim and final reports on the above mentioned programmes to the Commission each year. VI is responsible for carrying out veterinary checks in the intra-community trade of live animals, as well as for approval and supervision of approved sites. The VI and the SSI have an agreement to immediately inform each other about suspected or confirmed cases of zoonoses in either humans or animals. This agreement also applies to Voivodships and Poviats, which exchange information and cooperate in the investigation of food-borne disease outbreaks. 11

12 Contingency plans EU-approved contingency plans are in place for classical swine fever, foot and mouth disease, avian influenza and Newcastle Disease. A contingency plan for bluetongue has been sent to the European Commission for ratification. These plans are based on a national model and are composed of three sections covering general information, operational procedures and annexes with contact lists of persons and institutions involved at regional and district level. Where an outbreak is confined to a district, the PVI takes control. Where it spreads to another district, the VVI becomes responsible, and where it spreads between regions the central office takes overall control. In 2008 and 2009 a series of simulation training exercises were carried out for the members of the Polish Veterinary Administration. The training was arranged as part of the Project Transition Facility 2005/ Strengthening veterinary administration, phase II. The simulation training sessions were carried out from 1 March to 31 October 2008 in various Voivodships. Official veterinarians at the Central, Voivodship and Poviat levels, as well as employees of other relevant services involved, such as the Police, Fire Service and local governments, took part in the training. External contagious disease experts also participated. They prepared and shared their conclusions and recommendations concerning future simulation exercises and training for eradication of contagious animal diseases as well as the updating of the contagious animal diseases contingency plans which they made available to the relevant authorities. Further simulation training took place in 2009 in the Silesian Voivodship on eradication of foot and mouth disease and on issues relating to the eradication of bluetongue, viral haemorrhagic septicaemia and American foulbrood. VI staff at regional and district level took part in the training. Trans-border simulation training is planned for 2010 on the eradication of animal diseases in the West Pomeranian and Lubuski Voivodships with the cooperation of the veterinary authorities in Brandenburg. Laboratories The NVRI/NRL is responsible for monitoring infectious diseases in animals. The sixteen RVL carry out serological testing under the national monitoring programme. All the laboratories are integrated in the contingency plans and laboratory staff participate in the National Crisis Team. The laboratories participate regularly in proficiency tests organised by the relevant Community Reference Laboratory. 12

13 2.2. Control system for food of animal origin (DFSVM) Consultation cooperation MH Legislation GVI (FSO) Technical advice NVRI/NRL SSI Guidelines, instructions, checklists & audit VVI + laboratories Co-ordination & control VSES + laboratories Supervision Control plan PVI (OV & PVP) Supervision, registration, approval & sampling PSES Control, registration Primary production & food processing establishments Retail sector DFSVM MH GVI NVRI/NRL FSO SSI VVI PVI VSES PSES OV PVP Ministry of Agriculture and Rural Development Department of Food Safety and Veterinary Matters Ministry of Health General Veterinary Inspectorate National Veterinary Research Institute-National Reference Laboratory Food Safety Office State Sanitary Inspection Voivodship Veterinary Inspectorate(s) Poviat Veterinary Inspectorate(s) Voivodship Sanitary and Epidemiological Station(s) Poviat Sanitary and Epidemiological Station(s) Official Veterinarians Private Veterinary Practitioners Competent authorities Ministry of Agriculture and Rural Development, in consultation with Ministry of Health, is responsible for supervising the official control of food of animal origin. 13

14 The GVI is competent authority for implementation of policy and control and is responsible for the supervision of production of foodstuffs of animal origin, including primary production, direct sale and retail establishments which carry out marginal, localised and restricted activity. In addition, the control of foodstuffs of animal origin manufactured or stored in a production plant which manufactures other food products, as well as control over the production of compound foodstuffs, may be entrusted to both VI and SSI. The PVI carry out most of the official tasks. The District Veterinary Officer may authorise private veterinary practitioners to carry out official tasks, such as ante-mortem and post-mortem inspections, sampling, issuing of health certificates and supervision of certain types of establishments. The GVI prepares guidelines, check-lists and instructions on: the frequency of inspection of food business operators officially supervised by the GVI, based on risk analysis; procedures to be followed by the PVI for registration, approval, conditional approval, or suspension and withdrawal of approval, of establishments, including specific arrangements for transitional establishments; controls of the microbiological sampling of food of animal origin and contact surfaces carried out by the establishments; the performance of official controls regarding traceability of animals, foodstuffs, substances intended to be added to food as well as marking of products of animal origin; the scope and method of carrying out National Residue Control Plan of prohibited substances, chemical, biological, drug residues and radioactive contamination in animals, in their secretions and excreta, in tissues or organs of animals, in foodstuffs of animal origin, in water intended for animals and in animal feeding stuffs; rules for handling Specified Risk Material in slaughterhouses and cutting plants; the scope and method of implementing the national Rapid Alert System for Food and Feed and the obligation to inform consumers about dangerous foodstuffs and feeds; official control methodology; procedures applied by official veterinary officers in the course of their supervision of raw milk control under Regulation (EC) No. 853/2004; the scope and method of implementation of the national programme of control tests for dioxins, furans, dioxin-like polychlorinated biphenyls in animals and products of animal origin. The main competent authority responsible for official controls in the baby foods sector is the SSI, except in the case of production of infant formulae, follow-on formulae and baby foods under the scope of Regulation (EC) 853/2004, where the competent authority is the VI. 14

15 Registration and approval of establishments Registration and approval of establishments are performed in accordance with Articles of the Act of 16 December 2005 on products of animal origin. Depending on the specific activity carried out, registration is done by either the VI or the SSI. CVO instruction No. GIWhig-500-3/08 of 20 March 2008, based on national legislation, lays down that all establishments considered "low capacity establishments" approved for the national market prior to 1 January 2006 be allowed to continue supplying the national market only, until they become fully compliant with the legislation in force. Otherwise, they will have to stop activities by 31 December This instruction requires District Veterinary Officers to inform food business operators to assess their establishments and to prepare a timetable to carry out appropriate remedial action, including the setting of deadlines for addressing deficiencies. As at 5 February 2009, there were 1,225 establishments in this category. The process is on-going for approving these (mostly meat) establishments, but it is not certain that the deadline of end-2009 for complying with EU legislation will be met in all cases. Registration of establishments is done at district level by the PVI or the PSES. Updated lists of establishments registered with the GVI are included in a centralised database. This database is being adapted to comply with the format defined in Annex III to Regulation (EC) No. 853/2004, although there has been a slowing down in this work, partly due to the economic crisis. Complete lists of establishments registered with the SSI are not yet available at central level. New software for this purpose is being prepared and SSI expects to have a single comprehensive system operational by mid Official controls and inspection at establishments District Veterinary Officers, or official veterinarians authorised by them, issue administrative decisions and carry out inspections in accordance with the provisions of Regulations (EC) No. 852/2004, (EC) No. 853/2004, (EC) No. 178/2002 and (EC) No. 1774/2002. Minimum frequencies for inspections to be carried out by the VVI and PVI are laid down in CVO instruction Nr GIWhig /07 of 14 August 2007, based on risk analysis. The District Veterinary Officers are responsible for the direct supervision of all establishments. Official veterinarians are permanently present in slaughterhouses during the slaughter process. Other food processing establishments are visited regularly, in accordance with the above CVO instruction. Ante-mortem inspection of animals for slaughter, as well as post-mortem inspection of carcasses and offal, including examination for Trichinella, is carried out by designated official veterinarians. Their work is supervised by District Veterinary Officers. Reports are drawn up in standardised format after each control. The SPIWET (checklist) inspection protocol, containing the requirements of national law, Regulation (EC) No. 178/2002, (EC) No. 852/2004 and (EC) No. 1774/2002 (Annex 2), is used for the assessment of establishments. More specific SPIWET inspection protocols containing requirements of particular sections of Regulation (EC) No. 853/2004 have been developed (sections I, II, VI, VIII, IX, X, XI). SPIWET inspection protocols have also been developed for assessing the work of District Veterinary Officers and private veterinary practitioners. 15

16 Official controls on health and identification mark and traceability In Poland official controls concerning health and identification marking requirements for products of animal origin are carried out according to community legislation. There are also national rules concerning marking requirements for example in case of emergency slaughter. Official controls are carrying out to enforce these requirements. The VI is responsible for supervising the implementation of Regulation (EC) No. 1760/2000 on beef labeling, insofar as slaughterhouses, cutting plants, minced meat plants and storage are concerned. The CVO instruction of 4 April 2007 regulates such activities. The SSI is responsible for the retail sector. 16

17 2.3. Control system for imports of animals and food of animal origin (DFSVM) Legislation MF Instructions Audits GVI (BO) Manual Audits Local agreements on cooperation Customs VVI + laboratories BVI Customs Chambers Supervision PVI Controls, approvals Exchange of information Controls Controls Customs (free) warehouses Imported consignments Controls DFSVM MF GVI BO VVI PVI BVI Ministry of Agriculture and Rural Development Department of Food Safety and Veterinary Matters Ministry of Finance General Veterinary Inspectorate Borders Office Voivodship Veterinary Inspectorate(s) Poviat Veterinary Inspectorate(s) Border Veterinary Inspectorate Competent authorities The GVI is the competent authority for implementation of policy and controls and supervision of BIPs and the recruitment of heads of BIPs. The Borders Office, reporting to the GVI, is responsible for import controls and for BIP. Import controls The GVI supervises and coordinates the BVI and PVI, whose responsibilities include the control of: customs-free warehouses; warehouses in free zones; customs warehouses approved for storing products of animal origin non-compliant with EU import requirements; and ship suppliers approved in accordance with Council Directive No. 97/78. The service also incorporates sixteen regional laboratories and their sixteen branches. 17

18 The GVI issues guidelines, recommendations and instructions on import controls methodology. BIP receive RASFF messages directly from the EU server and these are forwarded to the GVI contact sub-point. The Borders Office, comprising six staff, is responsible for supervising the import and transit control system. This office has commenced audits of BIP and customs warehouses for storing non-compliant products of animal origin and plans to carry out at least one full audit of each customs warehouse annually. Restrictions concerning imports of animals and products of animal origin have been integrated in the electronic customs declaration entry system, so that information on which goods are subject to veterinary control is available to customs officials. The system does not allow customs clearance of goods which have not been the subject of veterinary controls, as defined by the relevant acts of law. The information on seized products of animal origin at all border crossings is collected annually by GVI and sent to the Commission. Customs authorities cooperate with the Border Veterinary Inspectorate on the basis of guidelines prepared by Ministry of Finance in the case of products of animal origin not complying with EU import requirements. The guidelines concern customs warehouses and transit. Customs are directly responsible for control of imports of products of animal origin for personal consumption under Commission Regulation (EC) No 206/2009 of 5 March 2009 and control of non-commercial movement of pet animals (up to five animals) under Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May The Act of 7 January 2005 and Regulation of 17 April 2007 lay down the list of border checkpoints at which Customs perform an inspection of pet animals imported for non-commercial purposes. Some responsibilities for these controls are delegated to Border Guards, operating under the Ministry of the Interior and Administration. Checks on postal consignments are carried out in cooperation with the Polish State Post, under the Department of Post in the Ministry of Infrastructure. Prohibited items identified by Customs are reported directly to the local PVI or Border Veterinary Inspectorate. The local Voivodship authority, under the Ministry of Infrastructure, arranges for the destruction of illegally imported food, under VI supervision. It also provides information to travellers on prohibited items. A new electronic identification of vehicular traffic at border crossings has been introduced, which facilitates checks at road BIP. Details of listed BIP can be found in Commission Decision 2008/387/EC of 30 April 2008 (Official Journal of the European Communities L 136 of 24 May 2008) at: 18

19 2.4. Control system for feedingstuffs and animal nutrition (DFSVM) RASFF GVI (AFPRO) National Control Plan VVI + laboratories Legislation Instructions audit BVI Central Laboratories NVRI/NRL National Laboratory for Feedingstuffs Supervision PVI Controls sampling Plant Protection Institute Controls, approvals, sampling (also GMO in feedingstuffs) Producers, traders, farms Imported consignments DFSVM GVI AFPRO NVRI/NRL VVI PVI BVI RASFF Ministry of Agriculture and Rural Development Department of Food Safety and Veterinary Matters General Veterinary Inspectorate Animal Feedingstuffs, Pharmacy and Rendering Office National Veterinary Research Institute-National Reference Laboratory Voivodship Veterinary Inspectorate(s) Poviat Veterinary Inspectorate(s) Border Veterinary Inspectorate Rapid Alert System for Feed and Food Competent authorities The Department of Food Safety and Veterinary Matters within the Ministry of Agriculture and Rural Development is responsible for developing national policy for animal feed at central level. A Parliamentary Act on Animal Feedingstuffs incorporates the changes introduced in Regulations (EC) No. 882/2004 and (EC) No. 183/2005. The GVI is competent authority for implementing policy and controls. In practice, direct supervision of animal feedingstuffs and approvals is carried out at PVI level. Their activities are controlled and coordinated by the GVI and VVI, through the Animal Feedingstuffs, Pharmacy and Rendering Office. Import controls are carried out by the Border Veterinary Inspectorate. Customs authorities do not allow imports of feedstuffs 19

20 which have not been subject of relevant official control. Control of GMO in feedingstuffs is also handled by the GVI. Registration and approval of establishments and intermediaries Under Regulation (EC) No. 183/2005, all operators in the sector of animal feedingstuffs are obliged to be registered or approved by a PVI. This information is stored in the central database maintained by the Animal Feedingstuffs, Pharmacy and Rendering Office. As of December 2008, approximately 3,000 operators were approved and 330,000 registered. Approximately 1.2M entities produce animal feedingstuffs for own use, of which some 60% applied for registration. Official controls The official contact sub-point for RASFF in the GVI is the Food Safety Office for Food of Animal Origin and a contingency plan for emergencies in feed has been adopted. A single annual National Control Programme for official controls of animal feedingstuffs is prepared at central level on the basis of results of previous controls, risk assessment and Commission instructions. This includes: sampling plans; guidelines; methods to be applied; and tests to be carried out. Frequency of controls is established by the District Veterinary Officer on the basis of risk assessment and results of previous controls, at least once per year for 2% of farmers keeping food-producing animals. Official veterinarians include animal feed as part of their on-farm checks. Besides the periodic checks specified in the frequency programme, official veterinarians undertake other visits on a case-by-case basis, according to the requirements of the situation, such as: suspicion of illegality; the extent of an own-control system; past results; risks posed by types of feed produced; volume of production; and complaints made. The emphasis for controls in 2008 was to increase checks on farms producing own mixes. Training on new laws and procedures is organised every two months for Regional Veterinary Officers, who in turn inform District Veterinary Officers. In addition, twinning training projects have been arranged with Italy and the Netherlands, under PHARE. In 2008, the Animal Feedingstuffs, Pharmacy and Rendering Office and the Danish competent authority organized project PL2005/IB/AG/09/TL on Strengthening veterinary administration in the scope of control over animal feedingstuffs and soil fertilizers. A manual was issued as training material for PVI. At GVI central level, four staff have specific responsibilities for controls on animal feedingstuffs, with 22 staff in the VVI and 304 staff in the PVI also involved in controls. A further 304 inspectors for feedingstuffs and rendering have been recruited at PVI level. In 2008, 16 training sessions were provided for all new veterinary staff. With regard to feed imports, Customs carry out similar controls as for import of animals and food of animal origin. Laboratories Laboratory tests of animal feedingstuffs are carried out by the RVL and three reference laboratories, the NVRI/NRL, the Plant Protection Institute (PPI) and the National Laboratory for Feedingstuffs (NLF). The RVL are currently undergoing an accreditation process. The NVRI/NRL, PPI and NFL organise ring tests for the official control laboratory methods/procedures used in an official control. 20

21 The laboratories of the NVRI/NRL in Pulawy and the NFL Station branch in Lublin, within the Zootechnical Institute in Cracow, are responsible for coordination of GMO analysis in feedingstuffs. The NFL and NVRI/NRL are the National Reference Laboratory for GMO in animal feedingstuffs. The RVL in Poznan, Opole and Bialystok also carry out GMO analysis in animal feedingstuffs since January

22 2.5. Control system for Transmissible Spongiform Encephalopathy (TSE) and Animal By-Products (ABP) TSE DFSVM GVI AFPRO AHWO NVRI/NRL LHF ARMA VVI PVI Ministry of Agriculture and Rural Development Department of Food Safety and Veterinary Matters General Veterinary Inspectorate Animal Feedingstuffs, Pharmacy and Rendering Office Animal Health and Welfare Office National Veterinary Research Institute-National Reference Laboratory Laboratory for Hygiene of Foodstuffs Agency for Restructuring and Modernisation of Agriculture Voivodship Veterinary Inspectorate(s) Poviat Veterinary Inspectorate(s) Competent authorities The GVI is the competent authority for controls on TSE, through the Animal Feedingstuffs, Pharmacy and Rendering Office and the Animal Health and Welfare Office. 22

23 The PVI may designate private veterinary practitioners to carry out certain official tasks, such as ante-mortem and post-mortem examinations and some disease control tasks. Epidemio-surveillance A number of training sessions on epidemio-surveillance have been carried out and a contingency plan is in place. Under the monitoring programme, samples for BSE testing are taken in slaughterhouses, in rendering plants or, if appropriate, at farm level (from suspect animals and fallen stock). In the rendering plants, the sampling is carried out by the official veterinarians. ARMA makes payments for collection of fallen animals. During 2007, a total of 603,810 of animals were tested. The system of reporting the number of samples is constantly modified to conform to Commission requirements. The GVI has introduced a system of central and regional monitoring of BSE sampling. This is done by regional and national coordinators, who provide materials, resources and harmonised forms, supervise training and sample collection, and ensure the flow of information. The CVO has issued an instruction on BSE surveillance, covering all epidemiological aspects related to suspicion, confirmation, eradication and further control. The instruction is regularly revised and up-dated. Another CVO instruction requires that the cattle identification and registration database must always be used to support BSE controls. Specified Risk Material (SRM) Steps have been taken to control the flow of SRM from removal to disposal. Harmonised forms and a SPIWET checklist are used for these controls, which the PVI carry out. SRM is normally collected and processed together with other Category I material. Total Feed Ban An instruction from the CVO established an official control programme for the detection of Processed Animal Protein (PAP) in feedingstuffs in accordance with EU requirements. It states that the frequency of controls should be established by the PVI, on the basis of risk assessment and results of previous controls. All consignments of imported fishmeal are to be controlled. The national control programme for feed provides for a specified number of samples of animal feedingstuffs to be checked for the presence of prohibited PAP. At the same time, a guide on risk analysis has been prepared, allowing the introduction of a feed sampling programme at points where cross-contamination is likely to occur. All PVI veterinarians have been instructed to prepare inspection plans and to take samples as part of official monitoring and inspection, based on this instruction. The central level determines the number of samples to be taken in each region on the basis of the size of the region, its volume of production and the number of irregularities discovered. The VVI then allocates the samples to be taken by each PVI using similar criteria, although the number of operators is also considered. The main decisions regarding the targeting of samples are taken by the PVI. An amendment to the Decree of Veterinary Requirements for Soil Improvers entered into force on 25 December It requires farmers intending to purchase soil improvers to seek prior approval from the District Veterinary Officer and to mark Category 2 and 3 animal meal intended for use as a soil improvers in a mixture of meal and lime-based fertiliser. 23

24 The CVO informed those involved in the feed chain of their obligations under Regulation (EC) No. 183/2005. All District Veterinary Officers were provided with relevant training and meetings for industry and officials were arranged at regional level. In February 2008, a Polish/Danish Twinning Light Project began, covering training on HACCP, GMO, risk assessment in feedingstuffs and fertiliser procedures. Relevant guides for good manufacturing practice, including HACCP, have been produced. Laboratories The NVRI/NRL is responsible for coordinating and supervising the activities of the RVL, as well as providing technical assistance to the GVI. Samples are examined by rapid BSE tests in six RVL in Crakow, Wroclaw, Gdansk, Leszno, Siedlce and Warsaw. The RVL in Siedlce is the latest RVL established for TSE examination. The NRL examines BSE suspects, carries out confirmatory tests and organises ring-tests. The Laboratory for Hygiene of Feedingstuffs at the NVRI/NRL is NRL for the detection of PAP in feed. Sixteen RVL are responsible for testing feed for PAP. Microscopic Analysis Test (MAT) is used and the NRL has to confirm inconclusive results and positive results upon request. 24

25 ABP (DFSVM) MH ME Legislation GVI (AFPRO) Audit, instructions, checklists SSI Audit, instructions Environmental authorities VVI VSES Supervision Supervision, audit Controls on waste PVI PSES Controls approval/registration ABP processing plants, slaughter-houses, pet food, intermediate and incineration plants, hauliers, ABP users, technical plants, catering facilities, buyers of MBM as soil improvers Controls Retail outlets wholesale Not covered by ABP Regulation DFSVM MH ME GVI AFPRO SSI VVI PVI VSES PSES Ministry of Agriculture and Rural Development Department of Food Safety and Veterinary Matters Ministry of Health Ministry of the Environment General Veterinary Inspectorate Animal Feedingstuffs, Pharmacy and Rendering Office State Sanitary Inspection Voivodship Veterinary Inspectorate(s) Poviat Veterinary Inspectorate(s) Voivodship Sanitary and Epidemiological Station(s) Poviat Sanitary and Epidemiological Station(s) Competent Authorities The GVI is the competent authority for Animal By-Products (ABP) and is the main body responsible for policy implementation and enforcement in this sector, through the Animal Feedingstuffs, Pharmacy and Rendering Office. 25

26 The SSI is responsible for supervision and controls on food of animal origin at retail and wholesale level. For waste falling outside the scope of the ABP regulation, the specific authorities under the Ministry of the Environment are responsible. Approval of ABP plants and other premises Plants to be approved under the ABP Regulation have to pass a prior satisfactory inspection. The plants send a request to the competent PVI and an official veterinarian carries out the inspection and issues the approval or refusal, depending on the outcome of the inspection. Independent hauliers of ABP also have to be authorised. Approved plants and other authorised entities are then entered on a GVI official list, which is available on both its own and the EU website. There are almost 2,100 approved ABP plants and other related premises. Official Controls GVI has drawn up specific official check lists (SPIWET) to be used during the on-thespot visits to each type of plant, such as processing, intermediate, storage, incineration, co-incineration and pet food plants, independent hauliers, kennels and fur farms. Special attention is given to the existence of agreements between rendering plants and hauliers. The instructions include the forms to be used by ABP plants and also set the minimum frequency of inspections for the various categories and types of establishments, as follows: - once a month for Category 1 processing plants; - quarterly for other processing plants; - twice a year for slaughterhouses, pet food, intermediate and incineration plants; - once a year for hauliers, ABP users, technical plants, catering facilities and BIP; - every two years for buyers of meat and bone-meal (MBM) as soil improvers. Monthly reports are compiled on the amounts of ABP produced in establishments and these are submitted by the PVI to central level. CVO has instructed officials to perform microbiological checks on processed products of animal origin and to issue administrative decisions requiring deficiencies in ABP plants to be corrected. The rendering capacity of the Category I rendering plants is approximately 160,000 tonnes per year. 26

27 2.6. Control system for veterinary medicines and residues MH NVRI/NRL NRL GVI ORMP VVI PVI MPI Ministry of Agriculture and Rural Development Ministry of Health National Veterinary Research Institute-National Reference Laboratory National Reference Laboratory General Veterinary Inspectorate Office for Registration of Medicinal Products Voivodship Veterinary Inspectorate(s) Poviat Veterinary Inspectorate(s) Main Pharmaceutical Inspectorate Veterinary Medicinal Products (VMP) Competent Authorities Ministry of Agriculture and Rural Development is responsible for legislation on the marketing and use of VMP, as well as for controls on residues of veterinary medicinal products/unauthorised substances in food of animal origin. Ministry of Health is the lead ministry for legislation and approval of VMP. 27

28 Authorisation of VMP The Main Pharmaceutical Inspectorate, within Ministry of Health, is responsible for issuing, refusal to issue and withdrawal of authorisations for the manufacture and importation of VMP. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is a State fiscal unit under the Minister for Health. The Office is responsible for assessing the quality, efficacy and safety of veterinary medicinal products, the monitoring of adverse effects caused by veterinary medicinal products, the maintenance of a central register of veterinary clinical investigations, and the maintenance of a register of manufacturers of active substances which may be used in producing veterinary medicinal products with anabolic, antiseptic, antiparasitic, anti-inflammatory, hormonal and psychotropic properties. Official controls on marketing/use VVI are responsible for routine controls on VMP wholesalers at least once a year, and on veterinary clinics at a rate of 10% per year. PVI are responsible for routine controls on farms (10% per year) and feed mills (twice a year). On 1 May 2007, an amendment to the Pharmaceutical Law transferred the supervision of manufacturing and importation of VMP to the Main Pharmaceutical Inspectorate. Most of the VMP for food-producing animals are 'prescription-only'. VMP are classified in three categories: medicines which are administered by practitioners only; medicines which are 'prescription only'; and 'over the counter' medicines. VMP in the first two categories are only available in veterinary clinics. Similarly, feed mills can only obtain pre-mixes from authorised traders on prescription from veterinary practitioners. According to new legislation, medicated feeding stuffs can only be manufactured by specially approved feed mills. The Act of 22 July 2006 on feedingstuffs also permits dealers to manufacture intermediary products and trade in medicated feedingstuffs, as well as manufacturing medicated feedingstuffs from intermediary products for own use. Residues Competent Authorities The GVI is the competent authority for the control of residues in live animals and animal products, with responsibilities broken down as follows: The GVI at central level is responsible for preparing (with the help of the NRVI/NRL), issuing and supervising the annual National Residue Control Plan (NRCP); The VVI are responsible for supervision of the NRCP at regional level; The PVI, together with eight veterinary laboratories and the NRVI/NRL, are responsible for the implementation of the NRCP; BVI are responsible for sampling food of animal origin imported from third countries into territory of EU. 28