Activity Report 2010 The National Sanitary Veterinary and Food Safety Authority

. Activity Report 2010 The National Sanitary Veterinary and Food Safety Authority

.. 2011 Bucharest, Dudului street, no. 37, sector 6, postal code 060603, phone: 0374.150.200, fax: 021.312.49.67, e-mail: office@ansvsa.ro

Overview 1 Public health protection through monitoring from the farm to the 2 consumer s table Inspections, controls and technical audits 2 Public internal audit 5 President Control Body 6 Improving the control activity by strengthening the inter-institutional 7 collaboration Collaboration with other governmental institutions 7 Institutional collaboration with the European Food Safety Authority 9 Institutional collaboration with veterinary and food safety services in other countries 11 Public information 14 Animal health protection and promotion of Romania s commercial interests 18 Animal health and welfare 18 Supporting livestock breeders 21 Actions against intra-community trade and illegal animal imports 22 24 Steps to facilitate the participation of Romania in the community market and to increase the meat export and products New approaches to veterinary hygiene 31 Food safety and public heath protection 33 The Rapid Alert System for Food and Feed (RASFF) 35 Laboratory work a decisive factor for human and animal health 36 protection Institute for Diagnosis and Animal Health (IDAH) 38 Hygiene and Veterinary Public Health Institute (HVPHI) 42 Institute for Control of Biological Products and Veterinary Medicines (ICBPVM) 47 Scientific Council and Advisory Council 51 Assessment missions organized by the European Commission 53 Implementation of EU funded programs 55 Accessing European Funds 57 Budget 59 Budget on activities 59 Budget execution 60 Setting up of normative acts and transparency in decision making 60 Legal Department 61 Document Management 62.

List of abbreviations N.S.V.F.S.A = National Sanitary Veterinary and Food Safety Authority S.V.D = Sanitary Veterinary Directorate F.S.D = Food Safety Directorate I.C.D = Inspections and Control Directorate C.S.V.F.S.D = County Sanitary Veterinary and Food Safety Directorate R.A.S.F.F = Rapid Alert System for Food and Feed I.D.A.H = Institute for Diagnosis and Animal Health H.V.P.H.I = Hygiene and Veterinary Public Health Institute I.C.B.P.V.M = Institute for Control of Biological Products and Veterinary Medicines S.V.F.S.L. = Sanitary Veterinary and Food Safety Laboratory TRACES = TRADE CONTROL AND EXPERT SYSTEM (Information system created for the registration, validation and control of veterinary documents) E.F.S.A. = European Food Safety Authority F.V.O. = Food and Veterinary Office DGSANCO = Directorate General for Health and Consumers.

Activity Report 2010 Overview (N.S.V.F.S.A) operates as a specialized body of the central public administration, as e legal entity, being subordinated directly to the Prime Minister and has as main attributions: State sanitary veterinary service organization; Organization of public veterinary services throughout the country, based on an unitary concept, in order to ensure animal health, public health, animal protection, environmental protection and food safety; Establishing the state sanitary veterinary atributions and responsibilities; Development and promotion, in collaboration with other competent authorities involved, of the legal framework in the food safety and quality field; Participation in the activity of food standardization, grading and classification; Organizing the activity within the food safety and quality field, in collaboration with other concerned authorities, according to the limits of legal competence; Developing, in collaboration with other concerned authorities, an analysis, management and risk communication system related to the food safety and quality domain; Issuing scientific advice and scientific and technical assistance regarding the national and community legislation in areas that have a direct or indirect impact on food and feed safety. It provides independent information on all the issues in these areas and it communicates the risks;helping to achieve a high level of protection of 1

human life and health, taking into account the animals health and welfare, plant health and environmental protection; Collecting and analyzing data to allow the characterization and monitoring of risks which have a direct or indirect impact on food and feed safety; Providing scientific advice and scientific and technical assistance regarding human nutrition, taking into account the national and EU legislation, issuing scientific advice on matters related to plant health and welfare, as well as scientific notices regarding products, other than food and feed, in relation with genetically modified organisms; Issuing scientific opinions which serve as scientific basis for the development and adoption of measures in areas related to its scope; Elaboration of draft laws in order to achieve specific tasks. Public health protection through monitoring from the farm to the consumer s table Inspections, controls and technical audits The Authority s main objective is to protect public health by providing healthy food, healthy animals and a civilized food products trade, in respect of citizens and their interests. A quick and effective tool used for achieving this objective is verification, with various control themes, covering a wide range of units and business operators in the areas of food industry and livestock breeding. 2 CONTROLS 64.669 controls in the area of food from animal and non-animal origin, animal health and welfare, pharmacovigilance. Activity Report 2010

Activity Report 2010 SANCTIONS FINES - 7.159 civil penalties, amounting to RON 14.355.772; BUSINESS SUSPENSION REGULATIONS - 378; BUSINESS INTERDICTIONS - 327; WARNINGS - 5.604. FORMAL DETAINMENT of products unfit for human consumption; 419 tons of food of animal and non-animal origin; 645 liters of soft drinks, still water; 1.111.513 eggs; 69.144 products of non-animal origin. Total amount of detained products = 8.168.504 RON. SAMPLING 20.979 samples sanitation tests, contaminants, microbiological criteria, pesticides residues, genetically modified organisms, allergens, additiveswithin the Monitoring and control program on food safety for 2010 and according to the Numerical Plan. DETAILED ON CONTROL TOPICS VETERINARY HYGIENE INSPECTIONS 32.389 inspections in 27.976 units; 4.300 sanctions, amounting to 9.572.830 RON; 291 Business Suspensions Regulations; 227 Business Interdiction Regulations; 2.939 warnings. DETAINMENTS 174.351 kg of food of animal origin; 100 liters soft drinks, still water; 1.111.513 eggs. 3

Total amount of detained products = 4.949.638 RON. INSPECTIONS IN ANIMAL HEALTH AND WELFARE 8.166 inspections of facilities sanitary veterinary authorized and/or registered; 1.161 sanctions amounting to 1.549.790 RON; 24 Business Suspensions Regulations; 25 Business Interdiction Regulations; 592 warnings. INSPECTIONS IN THE PHARMACOVIGILANCE AREA 5.424 inspections; 88 sanctions, amounting to 68.900 RON; 85 warnings. FOOD SAFETY INSPECTIONS 18.690 inspections in 18.282 facilities ; 1.610 sanctions amounting to 3.164.252 RON ; 63 Business Suspensions Regulations; 75 Business Interdiction Regulations; 2.071 warnings. OFFICIAL DETAINMENTS 401 tons of food of non-animal origin; 545 liters soft drinks, still water; 69.144 products of non-animal origin. Total amount of detained products = 3.218.866 RON. 4 TECHNICAL AUDITS 25 audits at a central level; Activity Report 2010

Activity Report 2010 294 audits at a local level in order to assess the effectiveness of the official controls in the following areas: - Animal walfare; - Food hygiene, traceability, labeling, bottled water, non-animal food imports, - Residues, contaminants and veterinary drug use - Poultry salmonellosis, - Import and transit of animal products and livestock; - Hygiene of the animal origin food; - Bovine tuberculosis and brucellosis. These audits have been managed by the Inspection and Control Directorate within the N.S.V.F.S.A. Public internal audit 8 public internal audits. The activity began with the centralization of the activity reports for 2009 regarding the public internal audit, reports prepared at the level of the 45 subordinated public institutions and the subordinated public institutions request for funds to conduct the public procurement procedures and presenting them to the analysis committee. The audit department has carried out ad hoc audits in Bucharest, Ialomita C.S.V.F.S.D, Ilfov C.S.V.F.S.D and together with and at the S.V.D. request, financial audits aiming Bovine Spongiform Encephalopathy. There were also conducted audits regarding the management of the Sapard funds at a N.S.V.F.S.A level and a total of 16 C.S.V.F.S.D. Also, the staff of the audit department participated in the analysis process of the tenders submitted for the purchase and distribution of 5

vaccines, participated at the centralization of assets which make up the state s public domain, within N.S.V.F.S.A and the subordinated public institutions and within the committee formed as a result of the Court of Auditors report on the World Bank loan. Fundamentally, based on the risk analysis, was developed the audit plan for 2011 at the N.S.V.F.S.A level, plan which was sent to the subordinated public institutions in order to correlate with the plan drawn up locally. President Control Body The President Control Body, under the provisions of the N.S.V.F.S.A management, has carried out 170 inspections, one at I.D.A.H and N.S.V.F.S.A, 49 at the County Sanitary Veterinary and Food Safety Directorates, 119 at religious establishments and companies that have provided food for various religious events. Following the carried inspections, the notification of the disciplinary committee for a number of 47 cases was disposed. 6 Activity Report 2010

Activity Report 2010 Improving the control activity by strengthening the inter-institutional collaboration Collaboration with other governmental institutions 5 inter institutional protocols COLLABORATION PROTOCOLS has fortified its efforts with other governmental institutions, by initiating and concluding collaboration protocols, evidenced by carrying joint actions: The protocol on conducting joint control actions regarding the compliance of sanitary veterinary legislation on live animals transport, products and subproducts of animal origin on public roads, as well as combating animal thefts, concluded between The National Sanitary Veterinary and Food Safety Authority, the Ministry of Interior and Administration and the Ministry of Transport and Infrastructure; The protocol regarding the institutional collaboration between the Ministry of Regional Development and Tourism and The National Sanitary Veterinary and Food Safety Authority; The collaboration protocol between the National Sanitary Veterinary and Food Safety Authority and the National Union of Private Capital Employers- Employers Federation of Veterinarians. The collaboration protocol between The National Sanitary Veterinary and Food Safety Authority and the National Forum on Comparative Oncology; The collaboration protocol between The National Sanitary Veterinary and Food Safety Authority and the Romanian Pigeon Breeders Federation. 7

CONTROL ACTIONS IN COLLABORATION WITH OTHER INSTITUTIONS 5.256 controls, together with representatives of one or more institutions: 1.908 control actions conducted with representatives of the Consumer Protection Office; 1.742 with representatives of Public Health Departments; 2.697 with the County Police Inspectorate; 995 with the Fraud Squad; 2.508 with various other institutions: City Police, Border Police Customs Department, Territorial Labor Inspectorate, the Romanian Road Authority. THE SCOPE of these verifications were those related to: Controling animals and animal products traffic; Combating illegal trading activities by checking the certificate of origin, quality and food sanitation; Hygienic conditions in bread, pastry and confectionery facilities; Fruit and vegetables marketing conditions; Animal trade supervision in fairs; Food traceability; Clandestine slaughtering in sanitary veterinary unauthorized areas and verification of meat origin in the processing facilities; Verification of the legality of animal and non-animal products circulation in fairs and food markets by private producers; Inspections prior to First of May ; Inspections prior to Winter holidays; Inspections prior to Easter holidays; INTER- INSTITUTIONAL COLLABORATIONS FOR THE DEVELOPMENT OF PLANS AND PROGRAMS 8 N.S.V.F.S.A developed the Draft Contingency Plan for crisis management in the food safety area and is coordinating the Working Group which includes representatives of specialized Departments within the Activity Report 2010

Activity Report 2010 institution and of the Ministry of Agriculture and Rural Development, Ministry of Health, Ministry of Justice, Ministry of Administration and Interior, Ministry of National Defense, the National Customs Authority, the National Agency for Mineral Resources, the National Commission for Nuclear Activity Control and Ministry of Environment and Forests. The project will be approved in the Interministerial Committee in 2011. The development of the Single integrated multi-annual national control plan for food and feed in Romania, with the inclusion of all responsible authorities in the food official control system, was conducted during the reporting period of 2009, N.S.V.F.S.A being the coordinating authority for the implementation of this program. The development of the Contingency Plan for crisis management in the food safety area and of the implementation reports, allowed a dialogue improvement between all relevant authorities as well as an improvement of the food safety control system. Institutional collaboration with the European Food Safety Authority E.F.S.A. FOCAL POINT Given the previous activity (2007-2009) of the E.F.S.A Focal Point in Romania, as well as the good European inter-institutional collaboration, the Executive Director of the European Food SafetyAuthority - EFSA suggested continuing this work. Following this request, on January 2010, the N.S.V.F.S.A President extended the E.F.S.A Focal Point convention in Romania, by signing an addendum. According to the E.F.S.A Focal Point duties and responsibilities, in Romania were continued the information activities and the exchange of relevant information regarding risk assessment in Romania, in the other 9

Member States and E.F.S.A, regarding the issued opinions or the pending issuance of opinions on risk assessment, scientific activities in Romania and within the E.F.S.A Focal Point network, as well as other activities necessary for the proper functioning of the E.F.S.A Focal Point in Romania. Also, the E.F.S.A Focal Point continued to provide the interface between all the concerned parties, both on a national and E.F.S.A level and also the other Member States; it also continued to increase Romania s visibility on an European level, including increasing E.F.S.A s visibility in Romania. AREAS OF INTEREST ADRESSED IN 2010: Melamine and its migration; Presence of phosphorus in food; The use of herbs; Potential risks to food safety as a result of volcanic ash falling from Iceland; Sheep cheese wrapped in walnut leaves; Scientific data on opium alkaloids in poppy seeds; Allergic reactions caused by the easy to bake products containing hydrolysed wheat protein, etc. ZOONOSES MONITORING As a E.F.S.A. contact point, regarding the monitoring of zoonoses in Romania, the S.V.D specialists sent E.F.S.A the amendments of the Romania Country Report project on the monitoring of zoonoses, zoonotic agents, antimicrobial resistance and food borne infections and intoxications in 2009, within the deadline set by the European Commission. 10 E.F.S.A. PROJECT An action taken by N.S.V.F.S.A in this context has been supporting and coordinating the E.F.S.A./DATEX/2010/21 project - Development of a Activity Report 2010

Activity Report 2010 database for contaminants in food and electronic data transmission system (CHEMBASE), developed by the Dunărea de Jos University in Galati. The project was approved and is in progress since September 2010, the Food Safety Directorate being part of the project implementation team. Institutional collaboration with veterinary and food safety services in other countries An important direction for the Authority in 2010 was the development of institutional collaboration relations with the veterinary and food safety services in other countries. FIRST MEETING OF THE BLACK SEA TASK FORCE GROUP A very important event that took place in May, was the organization, in cooperation with the Department of European Affairs, of the first meeting of the "Black Sea Task Force" group. The proposal for the establishment of this group, having as main purpose defending public health by monitoring animal diseases in the countries in the Black Sea area, was submitted by the N.S.V.F.S.A on Romania s behalf and was accepted at the meeting of the veterinary services leaders in the EU s Member States, held in Brussels in May last year. Black Sea Task Force is a working group composed of representatives of Member States and third countries, interested in the epidemiological situation, administrative and decision-making capacity of veterinary services in the countries in the Black Sea area. This working group will work in close collaboration with the European Commission, the World Health Organization, the World Organisation for Animal Health, and the Food and Agriculture Organization of the United Nations. 11

The event was organized by The National Sanitary Veterinary and Food Safety Authority and the Department for European Affairs, in partnership with the Romanian College of Veterinarians, the University of Agricultural Sciences and Veterinary Medicine in Cluj, the Bucharest University of Agricultural Sciences and Veterinary Medicine, the Romanian Veterinarians Trade Union Federation and the National Forum of Comparative Oncology. The meeting was attended by experts of the European Commission within DG-SANCO, the Global Framework for the Progressive Control of Transboundary Animal Diseases (GF-TADs) representative and representatives of veterinary services in Bulgaria, the Czech Republic, Cyprus, Moldova, Ukraine, Poland, Portugal, Turkey, Greece, Lithuania and Georgia. 12 TWINNING PROJECTS On February 5, 2010, was held the official closing of the Twinning Project (RO2007/IB/AG-02) Strengthening the institutional capacity of the National Sanitary Veterinary and Food Safety in Romania The ability of veterinary services to monitor, eradicate and control animal diseases (RO2007/IB/AG-02). Participants in the project's official closing event included His Excellency, Vladimir Jarmolenko, Ambassador of Lithuania in Romania, the President of the National Sanitary Veterinary and Food Safety in Romania, representatives of the Ministry of Public Finance and the State Food and Veterinary Service of the Republic of Lithuania. Also in February, was held the official launch of the EU project Twinning Light Further improvement of the animal identification and registration system in Romania (RO2007/IB/AG/03-TL), held at the National Sanitary Veterinary and Food Safety Authority headquarters. Activity Report 2010

Activity Report 2010 WITH THE REPUBLIC OF SERBIA In November, the leadership of the Authority met in Timisoara with a delegation of the veterinary services of the Republic of Serbia. On this occasion, has been expressed the need for collaboration between the two countries through exchange of information, technical assistance, training in laboratory analysis and diagnosis and also organizing seminars on monitoring, control and eradication of certain transboundary diseases such as African swine fever or bird flu. To strengthen relations between the veterinary authorities of the two countries, the N.S.V.F.S.A. has initiated steps for Serbia s accession to the Black Sea Task Force, the working group set up primarily for the purpose of public health protection by monitoring animal diseases in the countries in the Black Sea area, whose initiator was Romania. During the meeting was presented the Program of eradication of classical swine fever, developed and applied in Romania, including the European Commission's decision to co-finance the program, as well as a brief history of the evolution of this disease in our country and the measures taken to eradicate the disease. WITH THE REPUBLIC OF MOLDOVA Also in November 2010, an official delegation of the Ministry of Agriculture and Food Industry of Moldova met at the headquarters of the National Sanitary Veterinary and Food Safety Authority with the president of the institution, two vice presidents and experts within the Authority. The purpose of the meeting was the signing of the Technical Cooperation between the Ministry of Agriculture and Food Industry of the Republic of Moldova and The National Sanitary Veterinary and Food Safety Authority in Romania, for special assistance on implementing the traceability of food products of animal origin, and thus food safety. 13

During discussions, was established the composition of the Board of Directors, the date of the first technical meeting and were detailed issues regarding the composition of the Romanian specialists teams who will provide guidance for the creation and implementation in Moldova of an European system to ensure the traceability of products of animal origin. Public information This year also, the Authority has undertaken actions to strengthen and diversify the activities of informing citizens about food safety and to provide easier means of communication between the institution and consumers, for the benefit of both parties. 14 THE DEVELOPMENT OF THE INSTITUTION S WEBSITE For better information of the consumers, producers and processors in the food industry, and also livestock breeders, the N.S.V.F.S.A continuously updates and develops the website of the institution: www.ansvsa.ro, by posting the latest news and useful data. The basis of this activity was that informing and consulting consumers and those involved or interested in the activities of the institution; represent essential elements for protecting the consumers and also an important support of the specific activities undertaken by the Authority. Only a well-informed consumer can have a correct attitude towards the variety of food products on the market and can take a responsible decision in accordance with his interests, is able to actively participate in protecting public health, and in some cases he may contribute in the improvement of the food industry products and services quality. Activity Report 2010

Activity Report 2010 RISK COMMUNICATION The Authority performs risk communication based on the following principles: transparent communication, scientifically motivated, individualized for each audience. This process is carried out throughout the entire course of risk analysis, through the exchange of information between the risk assessors, risk managers, consumers, food and feed operators, academia and other concerned parties, including the explanation of the risk assessment results and the basis of the risk management decisions. An example are the Rapid System for Food and Feed alerts which aim to transmit the information necessary to be applied, in the shortest time possible, needed measures to control this risk and are also a basis for informing consumers on those products and on the measures that have been or should be applied in order to avoid any danger. PRESS RELEASES AND NOTICES The results of the Authority s activity and general public information are displayed on the website and further sent to the media. During 2010 were developed and made public 114 briefings or press releases. Mass media is a partner of unquestionable value for achieving the set goals. The collaboration between the N.S.V.F.S.A and the media, which have progressed significantly during 2010, will be strengthened and diversified by increasing the institutional transparency and adopting new communication approaches regarding public interest topics, in the specific areas of activity. 15

16 INFORMATION AND POPULATION EDUCATION CAMPAIGNS Through the direct actions of the Department of Communication, IT and Mass Media Relations and the 42 County Sanitary Veterinary and Food Safety Directorates, have been carried out campaigns to inform and educate the population- for instance, those related to Classical Swine Fever, Christmas or Easter holidays, the Estival Commandment or Winter Commandment. INFORMATION AND POPULATION EDUCATION CAMPAIGNS REGARDING CLASSICAL SWINE FEVER The specialized departments within the County Sanitary Veterinary and Food Safety Directorates have participated in this action, both by disseminating information materials through the help of the existing veterinary network, as well as by organizing meetings with animals owners, representatives of the pig breeders associations and representatives of the local hunters and fishermen s associations. Started in March 2010 and completed on July 1, 2010, the campaign involved the participation of specialists from the County Sanitary Veterinary and Food Safety Directorates in the meetings organized for this purpose, with the animal owners, representatives of the pig breeders associations and representatives of the local hunters and fishermen s associations. On the occasion of these meetings were distributed informative materials developed in cooperation with experts from Lithuania and printed by the Lithuanian Veterinary Authority, from the Romania Lithuania Twinning Program funds, held in May 2009 February 2010. The purpose of this campaign was to inform citizens and, in particular, pig breeders, on the sanitary veterinary legislation regarding the classical swine fever and the application of the biosecurity measures in order to prevent the emergence or spreading of this disease in households or farms. The final centralization of data received from the County Sanitary Veterinary and Food Safety Directorates shows that 2767 meetings were held in 2003 localities, attended by 54,185 persons. Activity Report 2010

Activity Report 2010 PUBLIC RELATIONS According to the legal provisions, a total number of 242 petitions were submitted in 2010 to the National Sanitary Veterinary and Food Safety Authority, according to the Law 233/2002 on approving the Government Ordinance no. 27/2002 regarding the regulation of the complaints settlement, received and registered by the Communication, IT and Mass Media Relations Department. Total number of petitions received in electronic format: 139 Total number of petitions received on paper : 103 Total number of petitions received from individuals: 125 Total number of petitions received from legal entities: 117 Petitions solved until 31. 12.2010 : 241 Petitions filed under Article. 7 of G.O 27/2002: 1 In terms of activity regulated by Law 544/2001 on free access to public information, the Communication, IT and Mass Media Relations Department, has received and recorded for 2010, a total of 245 requests. Total number of requests received in electronic format: 198 Total number of requests received on paper : 47 Total number of requests received from individuals: 143 Total number of requests received from legal entities: 102 Number of requests regarding the use of public money: 3 Number of requests regarding the performance of public duties: 24 Number of requests concerning legal acts: 213 Number of requests relating to the N.S.V.F.S.A management activity: 2 Number of requests relating to others / employment / site: 3 Number of requests solved until 31.13.2010: 245 17

Animal health protection and promotion of Romania s commercial interests Animal health and welfare STRATEGIC PROGRAM In January - in order to avoid potential stallings arising from the delay of implementing the actions provided in The program of supervision, prevention, control and eradication of animal diseases, of those transmissible from animals to humans, animals and environmental protection, other actions provided in other national programs, which The National Sanitary Veterinary and Food Safety Authority must implement, as well as their associated maximum rates for the year 2010,- was issued the Order on the implementation of the Government Decision for the approval of the Authority s Strategic Program. The Strategic Program and its implementing norms have been analyzed and discussed with both the scientific department and the social partners and included proposals coming from all the C.S.V.F.S.D s. STEPS TO DECLARE ROMANIA A FREE COUNTRY IN REGARD TO CERTAIN ANIMAL DISEASES 18 has asked the European Commission, in May, to acknowledge Romania as being bovine brucellosis free. The dossier submitted by our country was evaluated by the European Commission experts, pending to be approved. Activity Report 2010

Activity Report 2010 The N.S.V.F.S.A will ask the European Commission to declare Romania as being free of three other diseases: bovine tuberculosis, enzootic bovine leucosis and equine infectious anemia. By becoming a disease free country, there will be achieved substantial savings to the state budget by reducing the number of tests, complying with the requirements of the Organization of Animal Health. This will also provide significant support to the farmers in our country by increasing exports and Romania s importance on the EU animal trade market. Declaring Romania classical swine fever free has been and still is an important objective of the N.S.V.F.S.A. Therefore, the actions undertaken in this direction were continued and intensified. IMPROVING COMMUNICATION AND COLLABORATION BETWEEN LIVESTOCK BREEDERS AND THE TERRITORIAL AUTHORITY REPRESENTATIVES In February, the N.S.V.F.S.A. management convened a working meeting in Brasov, which was attended by animal health coordinators directors and deputy directors, within the County Sanitary Veterinary and Food Safety Directorates. The main theme of the meeting was the application of measures concerning classical swine fever control, given that Romania has stopped the vaccination against this disease. The Authority s president visited several counties to check how are being put into practice the decisions regarding the communication improvement between livestock breeders and the C.S.V.F.S.D representatives. A key issue debate during these visits was that of eliminating horses suffering of equine infectious anemia across the country and the preparation of files for compensating those specific animal owners. 19

AVIAN INFLUENZA MONITORING During avian influenza monitoring have been detected in the Tulcea County, in March, two avian influenza plague spots. The Authority quickly managed these situations by applying preventive measures, namely the killing and destruction of those birds and disinfecting those households, so that the disease has not spread and the plague spots have been extinct. Also as a result of the actions included in the Program of monitoring avian influenza in wild birds in the Danube Delta, in November, the Tulcea Sanitary Veterinary and Food Safety Directorate detected the presence of the avian influenza virus (H5N3) in 20 geese, used as sentinel birds. In both cases the N.S.V.F.S.A. has applied all the necessary measures to prevent the spread of the disease.. ANIMAL PROTECTION AND WELFARE Animal welfare and protection are very sensitive issues, which generate many challenges for the veterinary services. In this respect, the N.S.V.F.S.A has promoted in 2010 actions focused on developing guides, service notes, instructions, inspection procedures in order to implement the provisions of the existing legislation, and also actions focused on implementing the provisions of the Council Directive 2007/43/EC on the protection of chickens.a particular attention was paid to training personnel involved in animal welfare, particularly in the EU Twinning Programme RO07- IB-AG-01. 20 Activity Report 2010

Activity Report 2010 Supporting livestock breeders LEGISLATIVE RULES An important goal in 2010 was to identify and implement practical and consistent ways to support livestock farmers and processors in the food industry and to facilitate trade with animals and animal origin products at a national level. In this respect were developed legislations to facilitate granting subsidies for pig farmers who own authorized and / or sanitary veterinary registered commercial farms, which comply with the biosecurity and animal welfare rules. Thus, were created legislative regulations for pigs from households to be sold within the locality, in other localities in the same county, in other counties or to veterinary approved livestock fairs, fairs whose operating period was set from December, 1 to May, 15. An innovation and a feature at the same time was creating the "type A" category of commercial operation, from which pigs can be sold to authorized slaughter facilities, but only to facilities authorized for nationwide product marketing. Switching from household farming to the Type A commercial farming system offers pig breeders the possibility to harness the animals in nationwide product marketing authorized slaughterhouses, the possibility of accessing funds, all these while complying with the traceability and the regulations of biosecurity and animal welfare in the farms they own. These acts, through the features they create, are also intended to detect the illegal pork trade which is dangerous for everybody s health. 21

Actions against intra-community trade and illegal animal trade 22 The certification of animal transactions is monitored daily in the TRACES system both by the N.S.V.F.S.A, by the advisers in the TRACES Bureau of Verification and Control and also by the TRACES county focal points. If non-compliances are observed in the certification of transport, the colleagues in the TRACES focal points in the Member States are asked by e- mail to remedy the problems and to modify or cancel the certificates. Through such interventions, most non-conformities are corrected on the spot. The correspondence exchanged at a central level can be verified in the archive of the TRACES Verification and Control Bureau If the remedy required further actions, the N.S.V.F.S.A management is notified to provide further actions. During 2010 the TRACES Verification and Control Bureau managed to stop illegal activities of intra-community trade. During the above-mentioned period, were recorded the following nonconformities: in poultry transactions, nonconformities were found in the trade activities with Austria (6 transports), Italy (14 transports) and Hungary (16 transports); in transactions with horses from the Netherlands; in bovine transactions (usually certification non-compliances related to bluetongue disease, in terms of exemptions from Regulation 1266/2007); Activity Report 2010

Activity Report 2010 concerning small ruminants (goats) and deer, were recorded nonconformities in transactions with animals coming from Austria;in transactions with sheep there was a case of animals coming from Spain; in transactions with pigs, the non-compliances that occurred were related to a wrong adress mentioned in the certificates. All shipments of live animals from third countries are veterinary controlled in the Border Inspection Units, approved for control of livestock, according to certain specific operational procedures issued in accordance with the Community laws, performing documentary verifications and identity and physical checks for each transport. Documentary control involves checking the veterinary health certificate to confirm that the animals come from a third country, approved by the European Commission to export within the European Union and that the certificate corresponds to the one required by Community law for that certain animal species. The identity control consists in the verification of the accordance between the accompanying documents and the animals submitted to control (the animal s identification number, the vehicle s identification number) The physical control is the clinical examination of animals for verifying their health status, including biological sampling, as appropriate, in order to verify the compliance with the health rules in the accompanying veterinary certificate. We mention the fact that in 2010, through the Romanian Border Inspection Posts were not carried out imports of cattle, sheep, goats and swine from third countries. The results obtained by the N.S.V.F.S.A inspectors in managing these cases were due to a good cooperation with the Financial Guard and the General Inspectorate of Romanian Police. 23

Steps to facilitate the participation of Romania in the community market and to increase the meat export and products Significant efforts have been undertaken to manage the entry of Romania in the intra-community trade with fresh pork and pork products, originating form nationally reared pigs. INTRA-COMMUNITY TRADE IN PORK MEAT IN LOHN SYSTEM A first step was the ban lifting imposed by the European Commission on Romania regarding the intra-community trade in pork products in lohn system. In this context, N.S.V.F.S.A authorized 5 establishments that could run the export complying with the provisions of the European Commission Decision. It is about the establishments from Prahova, Brasov, Constanta and Mures counties. has launched a national campaign on classical swine fever in order to inform the citizens and, especially, the pig farmers regarding the sanitary veterinary legislation about the classical swine fever and about the application measures of biosecurity to prevent the emergency or spread of this disease in backyards or farms. ASSESSMENT MADE BY THE EUROPEAN COMMISSION EXPERTS 24 The assessment of classical swine fever situation in Romania was carried out by the European Commission experts in March 2010, four months after stopping vaccination. Activity Report 2010

Activity Report 2010 The European experts have assessed the official control systems to implement the European requirements for surveillance, control and eradication of classical swine fever in domestic and feral pigs, the control measures for the dispatch of live pigs, fresh pork and some preparations and products of pork to other E.U Member States. After the inspection, it was found that N.S.V.F.S.A was well organized, and the systems for verifying the effectiveness of official controls were operational. It was also found that the systems for the detection and the control of Classical Swine Fever and for the pork products shipment to other E.U Member States were functional and that it had not been clinical outbreaks in recent years. There were evaluated the monitoring results obtained from the last outbreak (12 January 2008), the immediate notification of any suspicion, the response of the authorities, last year tested by the simulation exercises conducted in all the counties, strengthened with the inclusion of the National Center for Disease Control in the National Committee for Emergency Situations, which is coordinated by the Prime Minister of Romania. All verified aspects proved that Romania was ready to efficiently and effectively apply the European regulations specific to classical swine fever control, while the European experts` recommendations are implemented to ensure suitable applying of European regulations concerning the classical swine fever, the traceability and effective control of all stages of the food chain. The Romanian establishments that perform intra-community trade in pork products that use only pork originating from other E.U Member States, have developed and implemented traceability systems and procedures that have proved their ability to eliminate any related risk of Classical Swine Fever. 25

The recommendations received were immediately implemented by N.S.V.F.S.A by issuing additional guidance on measures of animal movements and to assure the biosecurity, the disposal of backyard waste from the pigs feeding, respecting pigs welfare at slaughter and to ensure the traceability of live animals and animal products As additional measures, the Authority has planned training for veterinary officials on the provisions of Decision 2009/885 on measures relating to trade between the Member States, marking and certification of meat and meat products, under European regulations. 26 STEPS TO FACILITATE THE EXPORT TO THIRD COUNTRIES It was aimed and made the necessary steps to diversify the market of animal products in Romania, through the development of export to third countries. The export requests from the Romanian producers targeted countries in the Middle East: Jordan, Saudi Arabia, Lebanon, Syria, Iraq, in Asia: China and Vietnam, countries in Africa: Libya, Liberia, South Africa, Nigeria, Angola, Tunisia Namibia; and the Balkans: Bosnia Herzegovina, Serbia, Albania, Kosovo, Croat. Following the negotiations between the National Sanitary Veterinary and Food Safety Authority and the central veterinary authority of the Hashemite Kingdom of Jordan, there were established veterinary certificates models for exports of cattle and sheep meat in this country. Following the discussions made by the experts, it was agreed on the veterinary certificates models for the poultry meat and products in Serbia and Croatia. About Syria, following the correspondence between the two authorities, it has been established the model for the sanitary veterinary certificate for the cattle meat export from Romania. Activity Report 2010

Activity Report 2010 It was also established the model for the sanitary veterinary certificate for cassings export to the Republic of Moldova. In the Republic of Lebanon, the dairy products export is carried out in accordance to the model of the sanitary veterinary certificate submitted by the Lebanese central veterinary authority, reviewed and accepted by N.S.V.F.S.A. Export operations have been conducted in Moldova, Turkey and the United States of America. Today, following the discussions with the central veterinary authorities from Hong Kong and the Republic of Lebanon, the establishment of certification models to perform the poultry, cattle and sheep export in these countries, are in progress. RELAUNCHING OF CATTLE AND SHEEP FRESH MEAT EXPORT IN JORDAN Another important achievement was the reply, starting in May, of cattle and sheep fresh meat export in Jordan. This decision was taken following the visit in Romania of a veterinarian delegation from the Veterinary Control Department of the Ministry of Agriculture of the Hashemite Kingdom of Jordan. The purpose of this visit was to consider the animal health and hygiene conditions from the establishments that slaughter the cattle and sheep, in order to verify the compliance with sanitary veterinary conditions and the food safety required by the Jordan part. Following the visit to Romania, the Central Veterinary Authority of the Hashemite Kingdom of Jordan and the National Sanitary Veterinary and Food Safety Authority agreed to resume the imports of cattle and sheep from Romania. 27

SUCCESSFUL STEPS FOR THE TRANSITIONAL PERIOD EXTENSION FOR 40 ESTABLISHMENTS The Romanian approach to extend the transitional period with another year, until 31 December 2011, for meat processing establishments, cold stores, eggs packing centers, fish processing establishments and fishery products, that had produced more than 70% from the necessary measures for modernizing and restructuration, under the European demands, it gave the desired results. The unanimous approval about the transitional period extension by the Member States representatives came as a result of the Romanian application and as a verification of the situation on the spot by the European Commission experts in October. The extension of the transitional period until 31 December 2011 is applicable for 40 establishments of food, namely: 36 from meat, 3 from fish and fishery products and 1 cold storage which will have the opportunity to finish their modernizing and restructuration programs and to match with the European demands and to participate in intra-community trade. THE FOOD ESTABLISHMENTS EVALUATION FOR INTRA-COMMUNITY TRADE AUTHORIZATION A special attention was paid to evaluation of food industry establishments for intra-community trade authorization. In this respect, the N.S.V.F.S.A. specialists have carried out 61 audit missions. The comparison between the agro-food establishments, in accordance with the structural Community demands between December 2009 and December 2010, is as follows: 28 Activity Report 2010

Activity Report 2010 300 250 263 277 200 162 174 150 135 144 100 101 110 34 50 27 27 27 0 Units according to structural requests of E.U December 2009 Units according to structural requests of E.U June 2010 red meat poultry meat, eggs milk fish honey stocks In the processing units, the situation at the end of 2010 was as follows: 29

AUTHORISED ESTABLISHMENTS FOR INTRA-COMMUNITY EXCHANGES 183 305 34 63 27 71 151 Red Meat Milk Poultry meat Fish Eggs Honey Stocks Authorised establishments for national market - in transition untill 31.12.2011 1 3 1 35 133 Red Meat Milk Poultry meat Fish Stocks 30 Activity Report 2010

Activity Report 2010 New approaches to veterinary hygiene New challenges of the European Union policy about the food safety have stimulated the activity in veterinary hygiene, in the initiation and formulation of draft legislation related to the public veterinary health legislation, determining the application of priority measures for its adaptation and implementation at national level. One of these measures was to simplifying and reducing the time required for the sanitary veterinary authorization procedure of the establishments that produce, process, store, transport and/or distribute animal products. This one was transferred from N.S.V.F.S.A. responsibility to the county sanitary veterinary and food safety directorates. In this regard, it has been prepared and published the N.S.V.F.S.A. President Order No. 57/2010, which the sanitary veterinary authorization is issued by the county sanitary veterinary and food safety directorates, indicating that the activities from the establishments that produce, process, store, transport and/or distribute animal products meet the sanitary veterinary conditions set by the veterinary legislation of the European Union and the national one. N.S.V.F.S.A. management organized a meeting in March between experts of the institutions, Prof. Univ. Dr. Ilie VAN, the president of the Union of Poultry Breeders in Romania and Prof. Univ. Dr. Gheorghe Mencinicopschi, to solve the differences arising on so-called risks of the eggs consuming, eggs that are produced and marketed in Romania. The conclusion of the discussions was that the eggs produced in the Romanian farms, regardless of how chickens are reared, will not imply any health risk to consumers, as long as the sanitary veterinary rules and the food safety force are respected at theirs trade. 31

Those presented at the meeting took the decision of the Scientific Council of N.S.V.F.S.A., on the quality of the eggs produced in the Romanian farms. In the precursory Easter Holidays, to support the farmers and to assure the lamb sanitary veterinary controlled, N.S.V.F.S.A. approved the operation of a number of 229 locations for lambs and goat kid slaughter. In these establishments, the permanent sanitary veterinary monitoring was assured. To support the farmers and the local administration, the National Sanitary Veterinary and Food Safety Authority has prepared and published in June an order for the operation of live animals markets from backyards. The conditions of this order offer to small animlas breeders the possibility to trade their animals in areas with adequate facilities that are under constant sanitary veterinary supervision. In this way, a trade with live and healthy animals will be carried out respecting legal conditions regarding the public health. Also, there will be a sanitary veterinary monitoring more efficient; in order to prevent the occurrence or avoid the spread of animal diseases that could have serious economic consequences or that could endanger the human health. In this respect, the President of the Authority has carried out visits in territory, where he attended the meetings of the Directorate Colleges of the county sanitary veterinary and food safety directorates. On these occasions, the President of the Authority informed about the new perspective of the European Union regarding the strategy in health animal field and he asked the leadership C.S.V.F.S.D to come up with proposals to improve the national strategy, taking into account the new Community orientation and, especially, the novelty element, cost/benefit. 32 Activity Report 2010

Activity Report 2010 Food safety and public health protection The results obtained by N.S.V.F.S.A. after the specific control activities have demonstrated a significant number of operators in food industry that had not respected the sanitary veterinary and food safety legislation and that they had endangered the public health. Another relevant result was that many customers did not claim N.S.V.F.S.A. about the deficiencies found, which helped keep dangerous food products on the market. The direct communication access for any consumer claim could be done using a direct line telephone with the N.S.V.F.S.A is 0800.826.78 and e-mail address: callcenter@ansvsa.ro The establishment of a CALL CENTER of the Authority and of an e- mail address established an effective relationship between the citizens and the institution. A real advantage was the quickly intervention of the inspectors, maximum 48 hours in a sense, time being an important factor in stopping the marketing of food products not complying. To assist the consumers, N.S.V.F.S.A. developed and published the Order No. 5/2010 that provides that the persons and legal entities that offer products and services that are subject to a sanitary veterinary and food safety control are obligated to display in a visible place, at the entry and the exit of the establishment, and near the cash registers, in the marketing area, an announce with the direct phone number is: 0800.826.787 a free telephone line, and the addresses, phone/fax numbers and e-mail addresses of the sanitary veterinary and food safety directorates, in whose territorial area is natural or legal entity. 33

The direct phone number: 0800.826.787 may be called by the citizens who wish to notice the irregularities they observe in food safety field. The management of this service is in the power of Food Safety Directorate. During the time elapsed since the establishment of this telephone line, it has gained experience in communicating with the citizens, and in finding out the fields where they require this information and in establishing the steps that can lead to a resolution as quick as possible. During the period evaluated in this report, there have been received 515 calls. The resolution degree was 98.25%. In addition to the measures imposed by the Authority during the period preceding the Easter Holidays, it was established an action plan that was applied by the all Border Inspection Posts in our country. N.S.V.F.S.A. requested fiscal and commercial documents in order to deal with the Customs Authority, National Tax Administration Agency and the Ministry of Administration and Interior, according the protocols concluded between the Authority and these institutions. The aim was to combat the introduction of some dangerous food products for the consumers health in our country and to support the institutions in the battle against tax evasion. 34 CLAIMS A number of 190 claims received from citizens were redirected, because they fall under the jurisdiction of the Authority. Thus, 25 of them were sent to the Costumers Protection Offices, 53 to Public Health Departments, 9 to County Police Inspectorate, 3 to the Financial Guard, 100 to the Environment National Guard, Agriculture and Rural Development Departments, Municipalities and Prefectures, the Romanian Traffic Police and the Romanian Gendarmerie. Activity Report 2010

Activity Report 2010 NOTICES There were 502 notices sent by the N.S.V.F.S.A. to other institutions because the power exceeding: 97 to the County Police Inspectorates; 81 to the Financial Guard; 66 to the Public Health Departments; 110 to the Trade Register Offices; 148 to other institutions. Notifications referred to: - Financial Public Administration regarding unpaid fines; - Financial Guard or the Trade Register Office in the moment of reporting some acts of evasion; - the Public Health Department and the Environment National Guard regarding the inconvenience of reared pets in the apartments. There were notified the County Police Inspectorates to identify the cars used to transport the live animals without the documents required by the legislation and by the Fraud Investigative Service regarding the commission of any fraud. Rapid Alert System for Food and Feed (RASFF) N.S.V.F.S.A is the national coordinator of the Rapid Alert System for Food and Feed (RASFF) and is a National Contact Point of Romania in the European Network of RASFF. The goal of RASFF is to provide control authorities (N.S.V.F.S.A., National Authority for Consumer Protection, Ministry of Health, Ministry of Agriculture and Rural Development) a useful tool for exchanging information on measures taken to ensure food safety. Thus, the National Contact Point has coordinated the timely transmission of information that any rise or may rise, directly or indirectly, human health is diminished or eliminated. 35

SIMULATION OF ALERT To verify the effectiveness and speed of response of the structures responsible for the Rapid Alert System for Food and Feed (RASFF) a simulation was held in early April, simulating a food alert, the subject assumed to be a contaminated food product by usual presence in daily food intake and spread throughout the country. The evaluation showed that the response on the county level was within the parameters set out in operational manuals. The results were optimal, validating efficiency on inspectors and food safety services within N.S.V.F.S.A. as well as ensuring a rapid response in case of the food crisis. In 2010 were recorded, evaluated and archived in a database system a number of 271 notices of which 107 warning notices, 141 informative notifications and 23 notifications of rejection at the border. Laboratory work - a decisive factor for human and animal health protection 36 A main role in carrying out of specific activities of the National Sanitary Veterinary and Food Safety Authority has the National Reference Laboratories and the Sanitary Veterinary and Food Safety Laboratories which are organized within the County Sanitary Veterinary and Food Safety Directorates. These structures, in all their activities represent the authority on issues of veterinary diagnostic, expertise of animal and non-animal origin products and feed. Network of Sanitary Veterinary and Food Safety Laboratories of N.S.V.F.S.A offers to Romania a functional and effective infrastructure in line Activity Report 2010

Activity Report 2010 with European standards. The laboratories perform accredited analysis in quality system, the only recognized as support for official control. N.S.V.F.S.A by the technical coordination of the National Institutes of Sanitary Veterinary and Food Safety Reference Laboratories, pharmacovigilance and animal nutrition, worked to increase the analytical capacity of laboratories and accreditation of new methods of analysis. It also helped to develop the guidelines of the Framework Programme for surveillance of veterinary medicinal products authorized for trade in Romania and procedures in the field of animal nutrition and veterinary medicinal products. In 2010, it worked to improve legislation on the marketing of nutritional supplements, cosmetics, other veterinary products, using the microbial strains and in special legal regime of the plants, narcotics and psychotropic substances and preparations used in veterinary medicine. Regarding the control activity in this field, the annual National control plans for residues, feed, veterinary medicinal products and pesticides were drawn up. 37

Institute of Diagnostic and Animal Health (I.D.A.H) Institute for Diagnosis and Animal Health is a public institution with legal personality operating as reference authority at national level on issues of diagnosis, veterinary surveillance, animal health and veterinary forensics science. I.D.A.H. carry out methodological coordination and control of sanitary veterinary diagnostic laboratories activities, testing their technical skills, research, learning, homologation and using in laboratory practice of new methods and techniques for diagnosis, establishing or confirmation of diagnosis in special circumstances, diagnosis expertise, statistics, risk analysis and sanitary veterinary prognosis. 38 Laboratory analysis and monitoring of diseases caused by pathogens such as infectious and parasitic During the year, I.D.A.H. has received, evaluated and processed a total of 25,311 primary samples. 117,820 were made by laboratory tests for diagnosis and surveillance and 33,594 laboratory tests for diagnostic expertise. A total of 1,128 pathogens were isolated and identified being done in this regard 28,731 laboratory analyses, 1,077 pathogens have been identified as phenotypic and genotypic by carrying out 29,290 laboratory tests. Collection of pathogens I.D.A.H was enriched with 217 strains of pathogens. There have been 14,105 laboratory analyses for Salmonella spp. antibioresistance monitoring and 10,764 laboratory analyses for antibioresistance monitoring of other types of pathogenic bacteria. In the I.D.A.H. were produced 28 national standards, 253 liters of culture medium 32 liters of cell culture. Activity Report 2010

Activity Report 2010 Diagnostic Methods During 2010, 16 new laboratory diagnosis methods were assimilated and five original laboratory diagnosis methods have been developed, and 213 laboratory diagnostic methods were evaluated and re- accredited by RENAR. Also, 4 diagnosis manuals were drawn up and another 25 ones were revised. To harmonize the laboratory diagnosis with international standards and to maintain proficiency in laboratory diagnosis, the specialists within I.D.A.H. have participated to 87 activities organized by the Community Reference Laboratories or other accredited institutions or international organizations in the field. Within those activities have been performed 15,161 laboratory analyses on 608 test samples. The results were 100% "fair" or "very good", according to the results of the qualification system, with one exception, a result was 70% "fair" for identification test of antigens by RIHA, organizer VLA Weybridge. To verify the diagnosis value of laboratory testing were performed 11,105 laboratory tests for 45 diagnostic kits and 11 reagents. To monitor diseases caused by pathogens such as infectious and parasitic diseases including transmissible from animals to humans, 239 veterinary medical biostatistics actions were carried out. Research and specific papers During 2010, Institute specialists were involved in running of 4 research projects. I.D.A.H. specialists were involved in drawing up of the 40 original scientific papers, of which 21 were released on the occasion to scientific 39

events (congresses, symposia, workshops, etc.), and 19 have been published in scientific journals in the field. Within I.D.A.H. have been drawn up 13 summaries, 38 reviews of articles and scientific papers published in international scientific press. I.D.A.H specialists started designing and writing a number of 3 scientific books for specific areas of activity of the I.D.A.H. I.D.A.H. specialists` activity also included the elaboration of a total of 23 thematic newsletters which were sent to the County Sanitary Veterinary and Food Safety Laboratories (C.S.V.F.S.L.- s) for internal use. Audits, evaluations and inspections 40 I.D.A.H. specialists were asked and participated in 14 audits for accreditation, of which 13 are actions at the request of C.S.V.F.S.L.-s and one action being carried out on the request of a private laboratory. To assess the activity of laboratory for approval for the diagnosis of disease, identification of pathogens and/or of some risk factors, 9 actions of C.S.V.F.S.L.-s were carried out. At the request of N.S.V.F.S.A., I.D.A.H specialists participated at 4 inspections and control actions in the specific field. I.D.A.H specialists gave technical advice on the areas competence in the case of 138 requests. Due to circumstances of special epidemiological situation, I.D.A.H. specialists participated at 12 departure actions in the field and 120 samples for laboratory diagnosis was sampled. Also, two tests epidemiological profile were carried out. Activity Report 2010

Activity Report 2010 Participation at F.V.O. (Food and Veterinary Office) missions During the audits and inspections carried out in Romania in 2010 by experts FVO, I.D.A.H was involved in actions for the following areas: to asses the implementing Salmonella control programs for breeding hens, laying hens and broilers; classical swine fever; Intra-Community trade in equidae. F.V.O. experts noted and appreciated the constant and progressive improvement, both of the specific activity and the activity of technical and methodological coordination of C.S.V.F.S.L.-s, which sets the stage for a higher standard of adequate and effective monitoring of health status livestock in Romania. Developing and maintaining skills in specific areas of activity I.D.A.H. organized in this respect 47 trainings with specialists of County Sanitary Veterinary and Food Safety Laboratories, to develop and maintain their skills in specific fields of activity. Also I.D.A.H. has conducted 38 intercomparison schemes, in order to test the capacity of diagnostic of C.S.V.F.S.L.-s, resulting in calibrating 5,633 test samples. Intercomparison schemes were grouped into categories corresponding to areas of activity of the I.D.A.H. Following a formal request, two trainings of some specialists working in private laboratories were carried out. 41

Hygiene and Veterinary Public Health Institute (H.V.P.H.I.) H.V.P.H.I. is the reference institute in the field of laboratory control of animal products, certain animal and non-animal food and feed and works in sectors and areas of activity set by veterinary legislation in force, as well as the central body of technical and methodological guidance. ANALYSES FOR OFFICIAL SAMPLES WITHIN SURVEILLANCE PROGRAMME FOR ANIMAL ORIGIN PRODUCTS AND FEED 2,542 : 160 microbiological analyses; 521 chemical composition analyses; 313 analyses to detect residues of veterinary drugs and hormonal substances under NRCP; 135 analyses for feed control; 92 analyses to detect of contaminants; 231 analyses to determine the radioactivity and the detection of ionizing radiation therapy. 42 ANALYTICAL ACTIVITY FOR TESTS OF SELF CONTROL AND AT ECONOMIC AGENTS REQUEST CONSISTS OF CARRYING OUT OF 6,052 analyses: 1,936 microbiological analyses; 1,210 chemical composition analyses ; 132 analyses for determination residues of veterinary medicinal products; Activity Report 2010

Activity Report 2010 993 analyses for feed control; 271 analyses for determination of contaminants (2 non - compliances); 1,510 analyses for the determination of radioactivity and detection of ionizing radiation therapy. Analyses performed in 2010 at H.V.P.H.I. results in the following: 10000 9018 No of trials 9000 8000 7000 6000 6052 5000 3556 4000 3000 2000 1000 72 28 2 6 2 8 26 41 0 0 0 41 0 0 2452 1936 1510 1210 993 1160 132 271 231 92135 313521 1769 1739 1140 365 449 0 No appropriate results/on demand No. unappropriate results On demand Strategic Programme No analysis/field Microbiology Chemistry Residues Feed Toxycology Radioactivity Total In addition to routine laboratory tests, H.V.P.H.I as N.R.L performs confirmation analyses of positive results obtained by County Sanitary Veterinary and Food Safety Laboratories and serotyping analyses of strains of pathogens isolated by these. Of these, 323 confirmation analyses were performed for samples of food products and 5 analyses for feed samples. 43

Confrming of MSPV of the postive results obtained by LS.V.S.A. in 2010 328 323 350 300 250 70 70 200 150 2 1 1 5 2 100 50 Total confirmations Feed Food 0 Listeria Monocytogenes Salmonella Zn Streptomycina H.V.P.H.I, as National Reference Laboratory for feed and animal origin products, participated at inter-comparison schemes organized by the Community Reference Laboratories. Also, participation in the FAPAS scheme was continued, with good results. In 2010, H.V.P.H.I specialists participated at 31 tests of competence (for 72 evaluated tests): 23 tests organized by EURL, 5 tests organized by the Central Science Laboratory, York - UK (FAPAS) and 3 tests from other organizations. 44 Activity Report 2010

Activity Report 2010 Tests 2010 EURL; 23; 74% Other; 3; 10% FAPAS; 5; 16% Developing and maintaining skills in specific areas of activity Specialists within C.S.V.F.S.L.-s were trained regarding determination of total volatile basic nitrogen, a method that is part of the National Surveillance Program for 2010. Other training topics were physical-chemical methods which experts responsible for tests intended to implement in the laboratory: determination of histamine in fish and fish products by HPLC, determination of dyes by HPLC, physical-chemical determinations for honey, physical-chemical determinations for meat and meat products, physical-chemical determinations for water. As a result of some requests, 7 specialists within approved sanitaryveterinary private laboratories were trained to carry out physical -chemical trials on food products of animal origin. 45

Internal and external audits In 2010 were developed internal audits, according to the established programme that included all the standard requirements of SR ISO 17025/2005, as well as direct evaluations of the trials that have been unsuccessful. Non-conformities found in the scheduled audits refer in particular, to some problems created by non-allocation of adequate funds, necessary for providing training for staff, procurement of reagents, consumable materials, performance equipment and support for their monitoring (verification, calibration, etc..), as well as deficiencies in records. 46 In the additional audits were analyzed the causes that have generated unsatisfactory results of proficiency testing, aiming to avoid perpetuating as much as possible and implicitly maintaining of confidence in the quality analysis of H.V.P.H.I, and also preparation of DGSANCO Mission 2010-8441, in order to evaluate the control of residues and contaminants and the use of veterinary medicinal products in food producing animals. S.V.F.S.L.-s Alba, Timis, Cluj, Suceava and Calarasi were evaluated regarding residues determining. The laboratories from C.S.V.F.S.D Bucharest and Calarasi were evaluated directly and by inter - laboratory test, from the point of view of heavy metals determining. Due to lack of funds, S.V.F.S.L. Iasi was evaluated only by testing. An analysis for analytical capabilities of territorial laboratories on the following determinations: histamine, alkaline phosphatase, TVB-N and fat (Mojonier) was performed. Activity Report 2010

Activity Report 2010 Expertise actions for approval of health laboratories 41 evaluations in technical committees with representatives of N.S.V.F.S.A Among these, 31 were private laboratories and 10 laboratories from the C.S.V.F.S.D - s. After the evaluation of made trainings and taking into consideration proposed and non-carried out trainings in 2010, the necessary trainings for 2011 were established to meet the requirements foreseen in E.U Regulations, specialization and improving of staff in the implementation of a new determination in the field of food and feed control, as well as preparing for approval of organization of inter laboratory tests. Institute for Control of Biological Products and Veterinary Medicines (I.C.B.P.V.M) Institute for Control of Biological Products and Veterinary Medicines, subordinated to the National Sanitary Veterinary and Food Safety Authority, is reference authority at European and national level, in the field of assessment and laboratory control of veterinary medicinal products, biocides, feed additives, reagents, diagnosis kits and other veterinary products. 47

Evaluation of veterinary medicinal products and other veterinay products In 2010, for the evaluation activity of technical documentation in order to grant trading authorization for veterinary medicinal products, was registered a 334 valid requests, was draw up a total of 1,501 notifications to aplicants and 324 evaluation reports which were the basis for issuing trading authorization. 304 requests for amending of trading authorizations for which were issued 203 notifications and trading decisions.was received. Also, collecting, validation and archiving a number of 678 risk evaluation reports were carrried out. EVALUATION 128 technical documentations for biocide products were evaluated, to which were sent 77 notifications to owners in order to fill in documentaion and 35 evaluation accounts for biocide products that were submitted to the National Commission for Biocides, in order to obtain the notice of placing on the market. 36 technical documentations for reagents and diagnosis kits were evaluated and 26 final reports were carried out, with issuing trading authorization. 48 Activity Report 2010

Activity Report 2010 Laboratory Control of Medicinal Products Laboratory activity consists of analyzing of 320 series of veterinary medicinal products, diagnosis kits, reagents and other veterinary products, in total more than 1,571 tests, validation of 17 analytical methods and drawing up of 9 reports for estimation of uncertainty of measurement. Sampling for 191 sets of veterinary medicinal products in order to ongoing the programme for Surveillance and Control for 2010 was carried out. Accreditation Process of Laboratories The accreditation process of laboratories within I.C.B.P.V.M. consists of carrying out and review of 111 documents and performing of 20 internal audits to determine compliance of the activities with the international reference requirements and of the specific audited processes. The audit for RENAR accreditation was carried out to verify compliance of activities made in laboratory with the requirements of standard SR EN ISO 17025 and all the nonconformities found have been remedied. Also the system for quality management carried out by experts appointed by the Romanian Society for Quality Assurance (RSQA) to verify compliance of activities from institute with standard requirements 9001:2008 has been re-certified. 49

International cooperation I.C.B.P.V.M participated at the activities of European Network of Official Medicines Control Laboratories (OMCL) in view of sampling and testing of samples for the ongoing of European Program of sampling and testing centralized authorized products, for 2010, developed by the European Directorate for the Quality of Medicines (EDQM), two collaborative studies - CEP, two studies for intercomparison the results and five trainings within European OMCL. Also in 2010 the collaborations between I.C.B.P.V.M and EU Telematics (EC) continued. The project was initiated in 2007 in order to ensure an effective and secure communication between the European Commission, European Medicines Agency (EMA) and the competent authorities in the pharmaceutical field. Drawing up normative acts In 2010, Institute for Control of Biological Products and Veterinary Medicines initiated and participated with Directorate for Technical Coordination of Reference Institutes, L.S.V.S.A, Pharmacovigilance and Animal Nutrition, at drawing up of ten normative acts projects, from which six were published in the Official Gazette of Romania, First Part, one project is in a public debate and four of these are in the expertise and promotion procedure of N.S.V.F.S.A. Also, six orders projects were developed and sent to N.S.V.F.S.A. to be expertised and promoted. 50 Activity Report 2010

Activity Report 2010 Scientific Council and Advisory Council An important objective of 2010 was to improve the dialogue with civil society and scientific community. In this respect, Authority s management organized regular meetings, both of the Scientific Council and Advisory Council. Co-optation of new members in the structure of Advisory Council, representatives of producers, processors, animal breeders, and food industry trade unions, led to increased transparency concerning institution s activity and to improvement of relations with representatives of producers and animal breeders. An important contribution in the activity of National Sanitary Veterinary and Food Safety Authority is the expertise of Scientific Council, formed of recognized personalities in the Authority s fields of competence. Council emits scientific notes and gives technical and scientific assistance concerning national and community legislation in the areas that have influence directly or indirectly above food safety and animal feed. In 2010 five meetings of Scientific Council took place, analyzing important subjects for which were issued scientific opinions. These include West Nile virus, growth factors contained in milk, that stimulate cell growth and multiplication, stressed hens issue, scientific program of N.S.V.F.S.A. Cooperation with operators in the food industry was developed and diversified through regular consultations and meetings, either at the meetings of the Advisory Council, or by participating of management or institution representatives to meetings organized by the associations. 51

In this respect we mention the participation of President of N.S.V.F.S.A. at the Annual General Meeting of ROMPAN, which was also attended by representatives of the Ministry of Agriculture and Rural Development, National Authority for Consumer Protection, Financial Guard, ROMALIMENTA and Food Industry Trade Union Federation. Whitin the work Autority s management indicated to those present the results of controls made in 2009 by the N.S.V.F.S.A. inspectors, in the area of miller and bakery and the main identified deficiencies and weaknesses. In April, the President of N.S.V.F.S.A., also invited representatives of the managements of supermarket networks, in a meeting to discuss collaboration approaches for development the activity sector from the Authority s fields of competence. Within the meeting, the Authority's proposal was to organize in every supermarket or hypermarket, a district or a special stand where they should exposed for marketing traditional products specific to various regions of the country, as a way to promote Romanian traditional products. The goal was to give producers of Romanian traditional products the opportunity of an extended market, consumers the opportunity to buy, from supermarkets, traditional products that were checked from sanitary - veterinary and food safety point of view, and to supermarket networks a diversification of marketed products. To promote the training of specialists in the food industry as far back in school, N.S.V.F.S.A. has responded to a request come from the food business operators to participate at candidates selection, which will receive scholarships in food safety. 52 Activity Report 2010

Activity Report 2010 Assessment missions organized by the European Commission During the year 2010 the following assessment missions of the European Commission carried out: The financial audit mission organized by the European Commission regarding expenditure incurred by Romania in order to carry out active surveillance for Transmissible Spongiform Encephalopathies in 2007 and 2008. The assessment mission of the Food and Veterinary Office 2010-8573 Directorate General for Health and Consumers regarding the official control systems on the additives and materials intended to come into contact with food. Assessment of the official control systems for materials intended to come into contact with food and additives. Mission organized by the Directorate General for Health and Consumers no. 2009-8417, in order to evaluate the activity of veterinary services for control the classical swine fever. The mission was part of a general audit in Romania carried out under the provisions of Regulation (EC) no. 882/2004 on official controls for feed and food products. The specific audit assessed the implementation of the approved program for monitoring and controlling classical swine fever (CSF) and the implementation of the requirements provided by the Commission Decision 2008/855/EC regarding the intracommunity trade with fresh pork, pork products and preparations. The mission of the Food and Veterinary Office DGSANCO no. 2010-8389 in order to evaluate the implementation of controls on animal welfare on farms and during transport in the context of a general audit. The mission to assess the import/transit control systems and border inspection posts. 53

The mission to assess the official control systems for food hygiene, traceability, labeling and bottled water and to assess the import controls on non animal origin food; (follow up mission recommendations 2008-7833 and 2008-7920. Assessment mission on training and planning for situations of nuclear accidents or radiological emergency organized by IAEA (the International Atomic Energy Agency) Emergency Preparedness Review Mission EPREV. Mission to assess the control of residues and contaminants and use of the veterinary medical products to animals from which food is obtained. Mission of specific audit organized by the European Commission in order to evaluate the national control programmes for zoonotic Salmonella in flocks poultry (breeding hens, laying hens, broilers and turkeys). Mission to assess the implementation of measures on official controls related to feed legislation. Mission to assess the official controls on food of animal origin, especially meat and milk. Mission to assess the controls related to animal health regarding intra-eu trade with live equidae. 54 Activity Report 2010

Activity Report 2010 Implementation of EU funded programs During the year 2010, the National Sanitary Veterinary and Food Safety Authority managed a smooth running of the following projects: PHARE PROGRAMS PHARE RO2006/018-147.03.02.09 Purchase of IT and communication equipment for development and strengthening the National Sanitary Veterinary and Food Safety Authority s capacity in SRA and TRACES (Trade Control and Expert System). PHARE RO2006/018-147.03.02.10 - Purchase of equipment to further strengthen the veterinary sector. PHARE RO2006/018-147.03.02.12 Supply EST kits. PHARE RO2006/018-147.03.02.13 - Purchase of equipment for epidemiology, surveillance, prevention and control of transmissible diseases to animals and zoonoses, eco-toxicology, detection of Genetically Modified Organisms and genotyping for sheep breeds. TRANSITION OPPORTUNITIES Appropriate activities have been undertaken to implement the following projects approved: Twinning further improvement of the implementation and official control measures concerning animal by-products and animal welfare rules, Twinning - strengthening veterinary services for capacity development to monitor, eradicate and control animal diseases, 55

Twinning Light further improvement of animal identification and registration system in Romania, Purchase of equipment (laboratory equipment) for residue control. PROGRAMMES FOR CO-FINANCING PROJECTS SUPPORTED FROM EUROPEAN FUNDS The Sanitary Veterinary Directorate within the Authority has developed technical and financial reports for interim and final six programmes cofinanced from European funds held in 2009: Surveillance programme for avian influenza in poultry and wild birds in Romania - EUR 139.639,24; Bluetongue surveillance programme in Romania - EUR 49.136,92; National Programme for prevention, control and eradication of Transmissible Spongiform Encephalopathies - EUR 106.325,86; The eradication, control and monitoring programme of classical swine fever EUR 2.500.000; Romania's National Control Programme for zoonotic Salmonella infections in breeding hens; Romania's National Control Programme for zoonotic Salmonella infections in laying hens. The refunded amounts for the last two programmes were EUR 17.907,5. The European Commission refunded eligible expenditures for 2009 amounting to Eur 2.813.009,52. This amount will be refunded in 2011 and it will be paid to the Romanian State Budget. 56 Activity Report 2010

Activity Report 2010 Accessing European Funds Food Safety Directorate has developed four Project files within the Sectoral Operational Programme - Development of Administrative Capacity (OP-DAC): Development of administrative capacity by developing working procedures and specific databases for data analysis processes, assessment and warning on animal and non animal products, as well as activities of the National Sanitary Veterinary and Food Safety Authority. Improvement, by increasing the effectiveness and efficiency of official control systems on food safety in Romania, at county level and the EU border, for their compliance with national and European legislation and improve the content of the reports regarding the control activities officially carried out. Efficiency of structures involved in the management of crisis situations generated by the food consumption with impact on public health. improving interinstitutional coordination and ensure consistency of decisionmaking process at technical and managerial level, in matters of food safety. All these Project files have been approved by the Project Management Authority for OP-DAC (Operational Programme for development of Administrative Capacity) within the Ministry of Interior and Administrative Reform. The General Sanitary Veterinary Directorate drawn up and submitted to the European Commission nine projects on programs of monitoring, eradication and control of certain animal diseases for assessment and approval, for co-financing purposes. 57

After the approval of projects, the European Commission has allocated to Romania a maximum of EUR 8.280 million, representing the projects co-financing. This amount that has to be refunded in 2012 will be paid to the Romanian State Budget. 1. Project on Surveillance programme for avian influenza in poultry and wild birds in Romania for the year 2011 - EUR 350.000; 2. Project on Bluetongue surveillance programme in Romania for the year 2011 EUR 100.000; 3. Project on National Programme for prevention, control and eradication of Transmissible Spongiform Encephalopathies for the year 2011 EUR 1.850.000; 4. Project on the eradication, control and monitoring programme of classical swine fever for the year 2011 EUR 480.000; 5. Project on the surveillance, control and eradication programme for rabies in foxes in Romania for the year 2011 EUR 5.000.000; 6. Project on Romania's National Control Programme for zoonotic Salmonella in breeding hens for the year 2011; 7. Project on Romania's National Control Programme for zoonotic Salmonella in laying hens for the year 2011; 8. Project on Romania's National Control Programme for zoonotic Salmonella in broilers for the year 2011; 9. Project on Romania's National Control Programme for zoonotic Salmonella in turkeys for the year 2011; For the last four projects, the co-financed amount aimed to be achived is EUR 500.000. 58 Activity Report 2010

Activity Report 2010 Budget Budget on activities The final budget of the National Sanitary Veterinary and Food Safety Authority until December 31 st 2010 was 601.645 million lei and it was distributed as follows: Total Current expenditure - 578.372 million RON: - Personnel costs - 246.938.000 RON; - Expenditure on goods and services - 290.667.000 RON; - Transfers (nonrefundable PHARE funds programmes ) - 9.144.000 RON; - Projects financed from external nonrefundable funds (ENF) - 10.573.000 RON; - Other expenditure (compensations for animals slaughtered to prevent and combat disease outbreaks - 21.050.000 RON. 10% 1% 1% 3% 40% Personnel costs Goods and services Capital expenditure PHARE programmes 45% External Nonrefundable Funds programmes Other expenditure 59

Budget execution Budgetary commitments: 601.645.000 RON; Payments made: 556.195.147 RON; Legal commitments to pay: 13.051.147 RON. 800000000 600000000 400000000 200000000 0 Current expenditure Budgetary commitments Payments made Legal commitments to pay Setting up of normative acts and transparency in decision making 60 initiated a number of 58 normative acts, including: one Law, one Government Emergency Ordinance, two Government Decisions. also initiated and published in the Official Gazette of Romania a number of 54 Orders of the President of the The National Sanitary Veterinary and Food Safety Authority. Activity Report 2010

Activity Report 2010 The drafts of these normative acts were posted on the website of the institution: www.ansvsa.ro for public debate, according to the provisions of Law no. 52 / 2003 on decisional transparency in public administration. To encourage citizen participation in administrative decision-making and legislative drafting process, the following e-mail address was set up: comentariu.legislatie@ansvsa.ro, to receive written proposals, suggestions or views on the draft of the normative act subject to public debate. During the year, a total number of 24 comments were taken from this e-mail address and sent to the initiating structures of the said Authority in order to be acknowledged. has also legally examined a number of 15 normative acts initiated by other public institutions and published in the Official Gazette of which: one Government Emergency Ordinance, five Government Decisions and eight common Orders signed by the President of the National Sanitary Veterinary and Food Safety Authority. Three normative acts drafts were also legally examined, initiated by other public institutions and unpublished until now in the Official Gazette of Romania, including: a bill and two drafts on Government Decisions. Legal Department During 2010, civil servants of the Legal Department secured interests of the National Sanitary Veterinary and Food Safety Authority in litigation cases in which it was part, at different stages of the proceedings. In disputes which were delivered judgments, where the plaintiffs actions were admitted, civil servants of the Legal Department formulated 61

means of appeal provided by law. In case of files that by the date hereof have not been informed decisions delivered in first instance, an appeal provided by law will be made. The 149 cases in which the National Sanitary Veterinary and Food Safety Authority was part and which have been definitively and irrevocably settled in favor of the National Sanitary Veterinary and Food Safety Authority, in 2010, had for its object: complaint of violation, monetary compensation, notice to pay or payment order, the obligation to make claims, refusal to grant rights, public procurement disputes, review, appeal for annulment, public information communication. Document Management In 2010 within the National Sanitary Veterinary and Food Safety Authority a total number of 19.768 documents was managed; among which a number of 15.272 documents entered the Unique Input/Output Register of the Registry Department and a number of 4.496 documents was issued and exit from the Authority. 62 Activity Report 2010

Activity Report 2010. 2011 Bucharest, Dudului street, no. 37, sector 6, postal code 060603, phone: 0374.150.200, fax: 021.312.49.67, e-mail: office@ansvsa.ro.