STATE VETERINARY
ADMINISTRATION – STRUCTURE,
STATUTE, FUNCTIONS
Assoc. Prof. Dr. Gergana Nikolova
Dr. Ivanka Lazarova
“Public Veterinary Activities and Legislation”
Faculty of Veterinary Medicine
Trakia University – Stara Zagora, Bulgaria
1. Overview of the Bulgarian Food Safety Agency – competent
authority in the veterinary field
•Bulgarian Food Safety Agency (BFSA) is an integrated body for controls of safety and quality of food and feed in
Republic of Bulgaria.
•BFSA follows the best European practices for implementation of highest standards of controls in the areas of
safety and quality of food, food- and feed additives and drinks, veterinary medicine and animal welfare, plant
protection and fertilizers, phytosanitary controls, feed, border inspections and others.
•The BFSA experts perform strict controls throughout the whole food chain, i.e. from the field, farm and/or stable
up to the table on daily basis.
•BFSA exercises a consistent policy for cooperation with all interested parties countrywide and with their industrial
associations, in particular.
•Together with the stakeholders, BFSA develops and establishes standards aimed to raise the quality of certain
basic food products, such as bread and other bakery or pastry products, milk, milk- and meat products, together
with some other traditional Bulgarian foodstuffs.
•The BFSA is a legal entity with its headquarters in Sofia, a secondary budget manager within the Ministry of
Agriculture, Food and Forestry. Its structure and functions are regulated by the Rules of Organization for the
Bulgarian Food Safety Agency.
2. Functions and funding of BFSA.
•BFSA works in regular cooperation with the European Food Safety Agency (EFSA), with all other EU
authorities related anyhow with BFSA scope of activities and with all other EU Member States’ or third
countries’ competent authorities (CAs) responsible for food safety in their homelands.
•BFSA exercises controls and supervision of the compliance with any regulatory requirements concerning:
•• food and feed safety, but also the phytosanitary activities, products for plant protection and
fertilizers;
•• veterinary medical activities, animal health and animal welfare;
•• animal by-products not intended for human consumption;
•• feed;
•• raw materials and any foodstuffs excluding the bottled natural mineral, spring or table waters;
•• food-contact materials and objects;
•• compliance of quality of fresh fruits and vegetables with relevant EU standards applicable to
placing on the market.
•• assessment of compliance of quality characteristics of foodstuffs against the requirements laid
down in national standards, standards developed by respective industrial associations and approved by
the Competent Authority (i.e. by BFSA) and/or respective technological documentations;
•• laboratory-diagnostic and research activities;
•• risk assessment and risk communication;
•• training and qualification;
•• all other specific activities provided for by the Law on Bulgarian Food Safety Agency.
3. Structure of BFSA
•The BFSA is managed and represented by an Executive Director, who is appointed by the Prime Minister upon a proposal by the
Minister of Agriculture, Food and Forestry.
•The Executive Director implements the state policy in the areas of competence of the BFSA, manages, controls, represents and
organizes the activity of the Agency. He has the right to conclude contracts, to issue orders and other acts and penal decrees in
the process of execution of his powers. He is assisted by three Deputy Executive Directors, to whom he delegates rights by order.
The Deputy Executive Directors are appointed by the Prime Minister upon proposal by the Minister of Agriculture and Food. In the
absence of the Executive Director, he shall be replaced by the deputee appointed by him in each specific case.
3. Structure of BFSA.
•The resources are allocated to the Deputy Executive Directors as follows:
•1) Directorate for Food Control at the central office of BFSA; The National Diagnostic Research Veterinary
Institute at the BFSA in relation to food; Central Laboratory for Chemical Testing and Control at BFSA; The Central
Laboratory for Veterinary and Sanitary Expertise and Ecology at BFSA; Central Laboratory for Grain and Feed
Quality Assessment - Sofia at BFSA.
•2) Directorate for Animal Health and Welfare and Feed Control at the central office of BFSA; Directorate
"European Coordination, International Cooperation and Projects" at the central office of BFSA; Directorate for
Control of Veterinary Medicinal Products at the central office of BFSA; The National Diagnostic Research Veterinary
Institute at the BFSA regarding animal health, veterinary products and feed; Directorate for Information Technology
and Information Systems at the central office of the BFSA.
•3) Directorate for Plant Protection and Quality Control of Fresh Fruits and Vegetables at the central office
of BFSA; the Plant Protection, Fertilizers and Control Products Directorate; Central Plant Quarantine Laboratory.
•The administrative management of the Agency is carried out by the Secretary-General. The Secretary General
coordinates and controls the activities of: Directorate "Financial and Economic Activity" at the central office of the
BFSA, Directorate "Legal Affairs" at the Central office of the BFSA, Directorate "Human Resources, Training and
Qualification" at the Central Office of the BFSA, Directorate " Administrative Servicing, Public Relations and
Investments "at the central office of BFSA.
•The implementation of the activities of the BFSA and the Executive Director is supported by the administration. The
administration is structured in the Central Administration (CA) and territorially exported structures, of which: regional
subdivisions - 28 Regional Food Safety Directorates (RFSDs), according to the administrative-territorial division of
the country; 5 Specialized structures for research and laboratory diagnostics.
3. Structure of BFSA.
•3.2. Central Office Administration
•The Central Administration is organized in: Internal Audit Unit; Finance Controller; General Administration and
Specialized Administration.
•3.2.1. Internal Audit Unit. Finance Controller.
• ● Internal Audit Directorate. The unit is directly under the authority of the Executive Director of the Agency. Priority
is given to the internal audit activities of all structures, programs, activities and processes within the Agency and the
authorizing officers with a lower budget of the Agency, in accordance with the methodology for public sector internal
audit approved by the Minister of Finance.
•The Financial Controller shall be directly subordinated to the Executive Director and shall exercise ex-ante control
over the legality of the Agency's financial operations.
•3.2.2. The General administration includes directorates providing the general administrative support for the activities
of the agency:
•● The "Financial and Economic Activity" Directorate develops a summary draft of the annual budget and a three-
year budget forecast of the Unified Budget Classification Agency (UBA) and by programs, develops the methodology
of accounting and financial policy in accordance with the Law on Accounting and other regulations on budgetary
policy.
•Organizes the procurement, accounting and storage of the Agency's headquarters tangible assets, their repair and
maintenance. Organizes and coordinates the establishment and operation of the financial management and control
systems of the Agency's financial activities, including the ex-ante control system and the double-signature system,
for the purpose of lawful and effective management of budgetary resources. Organizes and executes the annual
inventories at the Agency's Headquarters in the order and within the terms specified in the normative acts. Provides
financial and accounting services to the Central Office of the Agency, oversees the lawful and expedient spending of
the funds and the use of the Agency's assets, prepares and keeps payroll records of the employees of the Central
Executive Agency of the BFSA and makes payments thereon.
•Draws up lists of assets in the capital expenditure program and summarizes the agency's data.
3. Structure of BFSA.
•3.2. Central Office Administration
•General Administration
•● The “Legal Affairs” Directorate provides legal assistance to the administration for the legitimate exercise of its
functions and participates in the drafting of normative acts related to the activity of the Agency. Prepares or
participates in the drafting of opinions on draft normative acts submitted for approval by other agencies. Participates
in the preparation of acts and in the resolution of legal problems related to the international activities of the Agency.
•Proceeds before the judicial, arbitration and administrative bodies of legal disputes to which the agency is a party.
Prepares or coordinates the prepared responses to the proposals, complaints, signals and requests received from
the citizens and organizations, except for the ones received in the specialized structures and the RFSDs. Provides
legal assistance to the Executive Director for the lawful fulfillment of his / her powers, as well as when issuing penal
decrees by the Executive Director and gives instructions to the directors of the RFSDs in relation with the
implementation of the administrative penal activity of the Agency;
•Keeps records of court cases to which the Agency is a party; procurement by the Agency and the contracts
concluded.
•● The "Administrative Services, Protocol, Public Relations and Investments" Directorate provides the record
keeping services at the Central Office of the BFSA, organizes public relations and events and informs the public
about the activities performed by the Agency. Coordinates relationships and interactions with individuals and legal
entities, agencies and professional organizations relevant to the activities of the BFSA and at the same time takes
care of the transportation services of the Agency.
•The Directorate is organizing the publication of the popular veterinary magazine “Veterinary collection”. Coordinates
the preparation, management, monitoring of newly constructed sites and reconstruction of existing sites related to
the Agency's activities.
3. Structure of BFSA.
•3.2. Central Office Administration
•General Administration
•● The "European Coordination, International Cooperation and Projects" Directorate organizes and coordinates the
activities of the BFSA in relation to the commitments arising from the membership of the Republic of Bulgaria in the
European Union in the area related to its functions. Participates in the development of draft regulatory acts
implementing European legislation related to the Agency's activities.
•Its mission is to liaise with experts from the institutions of the European Union and international organizations, as
well as with experts from third countries on issues related to the Agency's activities. Participates in the preparation of
positions, guidelines, opinions, agreements, strategies, analyses, and other documents on issues related to the
activities of BFSA.
•The Directorate coordinates the audits of Directorate F "Health and Food Audits and Analyses" at DG SANTE
(formerly the Food and Veterinary Office) of the European Commission, and third countries in the Republic of
Bulgaria. Participates in the development and implementation of projects funded under EU and third country
programs. Organizes visits of foreign delegations and coordinates the participation of BFSA experts in events held in
other countries. Prepares the necessary documents and organizes the abroad missions of the Agency's employees.
•• The “Human Resources, Training and Qualification” Directorate methodologically manages and
coordinates the activities of the specialized structures and the RFSDs related to human resources, coordinating the
typical job descriptions of the employees of the Agency. Prepares the documents related to the emergence,
modification and termination of the employment contracts of the employees of the Agency's headquarters. At the
same time prepares and updates the job schedule and the personal schedule of the posts of the employees in the
central office of the Agency;
•Participates in the development of programs for the initial training of the Agency's newly recruited staff, and also
develops general programs, organizes and coordinates the completion of training and upgrading courses of the
Agency's staff. Maintains a database of the programs of higher education establishments or research institutes
approved by the Executive Director and keeps records of the approved programs. Collaborates with higher
education institutions and other organizations in relation to the practical training of students at the Agency.
3. Structure of BFSA.
•3.2. Central Office Administration
•General Administration
•● The “Information Technology, Information Systems and Communication Security” Directorate
participates in the development and implementation of the Agency's information strategy, examines the
information needs at different levels of the management structure and prepares proposals for the
development of new information systems, improvement of existing and related technology. Introduces
and uses information systems, software products and equipment, organizes the maintenance of
information systems and equipment used, coordinates the purchase of new hardware. It examines the
need for and coordinates the implementation of registers, databases and new modern technologies in
order to increase the security and efficiency of existing information and communication systems, as well
as the introduction of new software solutions.
•The Directorate supervises and coordinates the reengineering of administrative service delivery
processes with a view to switching to electronic provision, and is responsible for the maintenance of
electronic administrative services in accordance with the Law on eGovernment and the implementing
regulations. Maintains service registers of users for access to the agency's computer network and
computer equipment, organizes and manages information security. Methodically manages and controls
all structural units of the Agency in terms of the use of information systems, computer and office
equipment and communications, provides comprehensive information security.
3. Structure of BFSA.
•3.2.3. Specialized Administration includes six directorates and one directorate general, which are
specialized in providing highly specific areas of the agency's extensive operations.
•● The for “Verification of Official Control” Directorate-General is directly subordinated to the Executive
Director and assists him in the implementation of state policy related to the Agency's activities. It
consists of the “Audit of Official Control” Department and the “Verification and Administrative Control of
the Activities of the RFSDs” Department, which controls and coordinates the activities of the regional
directorates for food safety. Collects and evaluates information to identify options to prevent, eliminate
or reduce to an acceptable level the risk for the public health throughout the food chain. A key task is to
coordinate actions among other public authorities to prevent and eradicate zoonoses, especially
dangerous infections and other human health risk situations across the food chain.
•Experts from the Department for Verification and Administrative Control of the Activities of the RFSDs
organize and participate in complex and thematic inspections of the BFSA units, carry out unannounced
inspections on alerts, requests and complaints against illegal or unlawful actions or omissions of the
RFSD employees and upon constatation of violations proposes to the Executive Director of the Agency
for corrective measures. They analyze the effectiveness of the overall activities of the RFSD.
3. Structure of BFSA.
•3.2.3. Specialized Administration includes six directorates and one directorate general, which are
specialized in providing highly specific areas of the agency's extensive operations.
•● The “Plant Protection and Quality Control of Fresh Fruits and Vegetables” Directorate organizes,
supervises and methodologically coordinates the activities of the Agency and the RFSD in the field of
plant protection, quality and safety of fresh fruits and vegetables.
••
•The “Plant Protection Products and Fertilizers” Directorate participates in the development of draft
regulatory acts regulating the authorization of plant protection products and fertilizers, soil improvers,
bioactive substances and nutrients.
•The Directorate organizes and controls the procedure of authorizing plant protection products and
registration of fertilizers. Makes proposals to amend and withdraw the marketing authorizations for
PPPs and the fertilizer registration certificates. Coordinates and controls the implementation of the
measures of the National Action Plan of the Republic of Bulgaria for the Sustainable Use of Pesticides,
which is adopted by a decision of the Council of Ministers.
3. Structure of BFSA.
•3.2.3. Specialized Administration includes six directorates and one directorate general, which are
specialized in providing highly specific areas of the agency's extensive operations.
•● The “Animal Health and Welfare and Feed Control” Directorate methodologically supervises and
coordinates the activities of the RFSDs in several areas, including health care in animal husbandry,
production and storage of germinal products, marketing, trade, exchange and transportation of animals
and germinal products and the production, disposal and storage of animal by-products and products
derived therefrom.
•Other areas of activity are ensuring the compliance with the rules for the protection and welfare of
animals, veterinary practice and disinfection, disinsection, deratization and devastation in livestock
establishments and in the control and eradication of infectious diseases.
•The Directorate prepares the State Prevention Program (SPP) and the List of Infectious Diseases and
the Animal Disease Surveillance and Eradication Programs (ADSEPs).
• Methodologically supervises and controls the activities of the RFSDs in the implementation of
measures for the prevention, control and eradication of animal diseases and the protection of people
against zoonoses. Develops programs for the prevention, control and eradication of animal diseases
and the protection of public health from zoonoses and submits them for approval by the Executive
Director. Prepares disinfection, disinsection, deratization and devastation schemes and submits them
for approval by the Executive Director. Controls the activity of the facilities for storage and disposal of
animal by-products. Coordinates, methodologically supervises and controls the activities of the RFSDs
in relation to the identification of animals and the registration of livestock breeding establishments and
establishments for the production, storage and marketing of feed; quality, safety, hygiene and labeling of
feed, GMOs, control in crisis situations.
3. Structure of BFSA.
•3.2.3. Specialized Administration includes six directorates and one directorate general, which are
specialized in providing highly specific areas of the agency's extensive operations.
•● The “Control of Veterinary Medicinal Products” Directorate conducts expert evaluation of the
registration documentation for the veterinary medicinal products (VMPs) requested for the issuance,
renewal and change of marketing authorizations. Participates in the development of regulations, model
documents and procedures related to the official control of veterinary medicinal products.
•The Directorate participates in the procedures for granting or changing licenses for the production and
marketing of wholesale and retail veterinary medicinal products. Submits information in the database of
the European Medicines Agency on the marketing authorizations for VMPs and certificates of good
manufacturing practice.
•Coordinates and controls the information submitted to the pharmacovigilance system and provides the
European Medicines Agency with information on suspected serious adverse reactions due the use of
VMPs observed throughout the country. The Directorate makes proposals to the Executive Director of
BFSA for revocation of licenses and for blocking and withdrawal of batches of VMPs from the market in
the cases provided for in the Law on Veterinary Activities.
•In its work to achieve responsible, safe and efficient use of the VMPs, the Directorate aims at
protecting public health, animal health, the environment and promoting animal welfare by ensuring the
safety, quality and efficacy of veterinary medicinal products. It works to improve the process of licensing
VMPs through the introduction of a risk management system; expanding the training programs for the
Directorate's experts in order to increase their qualification and competence.
3. Structure of BFSA.
•3.2.3. Specialized Administration includes six directorates and one directorate general, which are
specialized in providing highly specific areas of the agency's extensive operations.
•● The “Food Control” Directorate coordinates the activities of the Regional Food Safety Directorates
for the control of the safety and quality of raw materials, food, materials and articles intended to come
into contact with food. Coordinates the control activities in both intermediate storage and animal by-
products processing plants. Observes animal welfare during slaughter. Maintains registers and develops
sample documents for its activities. The Directorate produces reports and opinions on safety, quality
and control issues of raw materials, food, materials and articles intended to come into contact with food.
•The Directorate participates in the preparation of draft regulatory acts related to the implementation of
food safety control. Where necessary, performs food safety checks, in collaboration with other
competent authorities or independently. Participates in the development of risk assessment criteria and
controls their proper implementation. The Directorate prepares, organizes the implementation and
participates in the development of the Unified National Multiannual Control Plan (UNMCP), Guides for
the implementation of good manufacturing practices, Hazard Analysis and Critical Control Points, risk
assessment criteria, National Food Contingency Plan, draft standards. Exchanges information through
the RASFF system.
•Prepares reports on the results of the control checks carried out and on the implementation of the
National plan for the implementation of food safety controls. Participates in the development of food
quality and safety programmes. Coordinates and plans the activities of the RFSDs in screening and
access to foods with or entirely made from genetically modified organisms.
3. Structure of BFSA.
•3.2.3. Specialized Administration includes six directorates and one directorate general, which are
specialized in providing highly specific areas of the agency's extensive operations.
•● ● The “Border Control” Directorate ensures the implementation and enforcement of the requirements
of current European and national legislation in:
•- the import, export and transit of live animals, germinal products, raw materials and foodstuffs of
animal origin, animal by-products and products derived therefrom and specific plant products, feed
materials, feed additives, premixtures and compound feed;
•- import and transit of plants and plant products;
•- imports of food of non-animal origin;
•- imports of organic food.
•Official border controls shall include veterinary border control, border phytosanitary control and border
controls on imports of food of non-animal origin and food contact materials and articles.
•The control of trade consignments subject to border veterinary and phytosanitary control is carried out
at eight approved border inspection posts: Captain Andreevo, Varna Port, Bourgas Port, Sofia Airport,
Kalotina, Gyueshevo, Zlatarevo and Bregovo. Four of the approved border inspection posts: Captain
Andreevo, Varna Port, Bourgas Port and Sofia Airport have been designated as border points for the
import of food of non-animal origin. Each border post, building and technical equipment, staff,
procedures and documentation are subject to periodic audits by the European Commission.
•Official border controls include the execution of documentary, identification and physical checks,
including sampling for analysis and corrective measures in case of non-compliance with the legislative
requirements.
4. Territorially distributed structures
•Within the structure of the Bulgarian Food Safety Agency there are specialized units for research and
laboratory diagnostics. Business operators and consumers are offers services by highly qualified
specialists who carry out numerous analyzes in the field of food safety, feed, animal husbandry and crop
production.
•4.1. National Diagnostic Veterinary Medical Research Institute (NDVMRI) – located at Sofia.
•NDIVMI is managed and represented by a director, a habilitated person in the specialty "Veterinary
Medicine". A Scientific Council for Veterinary Medicine has been established at the National Research
Institute on the requirements of the Law for the Development of the Academic Staff in the Republic of
Bulgaria with a term of four years, with its members being habilitated researchers.
•Priority in the activity of the institute is the research orientation. It was created in the early twentieth
century. The main directions in which it developed were imperatively imposed by the development and
interests of the society. Today they are expressed in the development of tools and methods of
diagnostics, programs for the prevention and eradication of emerging and re-emerging diseases in the
country. An important task of the Institute is to guarantee the quality and safety of food products. For this
purpose modern screening methods for microbiology and chemical safety, proving the presence of
mycotoxins, pesticides, heavy metals and others have been introduced. Methods and tools for
environmental protection are being developed. To carry out these activities, the Institute has modern
facilities, equipment and highly qualified staff. It employs researchers and specialists with higher
education - veterinarians, biologists, physicists, chemists and others. NDVMRI is a national reference
centre. It includes national reference laboratories for animal health and safety of raw materials and
foodstuffs of animal origin. The NDVMRI is the a reference laboratory in the country for the diagnosis of
transmissible spongiform encephalopathies in animals (mad cow disease, scrapie, etc.).
4. Territorially distributed structures
•4.2. The Central Laboratory for Veterinary Expertise and Ecology (CLVEE) carries
out research, applied and laboratory activities. The laboratory is accredited and
managed by a director. The scope of accreditation includes testing of raw materials
and products of animal origin and biological fluids, raw materials and products of
plant origin, feed and feed additives, drinking and surface water, alcoholic and non-
alcoholic beverages, fruit juices, nectars and concentrates. About 70 different
analyzes of residues of veterinary medicinal products and environmental pollutants
and physico-chemical analyses are carried out at the CLVEE.
•4.3. Central Laboratory for Plant Quarantine (CLPQ) – located at Sofia carries out
phytosanitary laboratory testing of plants, plant products and nutrients, final
diagnosis and identification of pests.
4. Territorially distributed structures
•4.4. Central Laboratory for Chemical Testing and Control (CLCTC) is a specialized
structure with the status of Directorate at the Bulgarian Food Safety Agency (BFSA),
managed and represented by a director. Its main activity is related to the control of
non-animal food for contaminants. The Laboratory performs analyses of pesticide
residues, mycotoxins and environmental contaminants, plant protection products,
mineral and organic fertilizers from local production and imports, in accordance with
the physicochemical parameters, according to regulatory documents.
•It is authorized to control plant production for the content of hazardous chemicals
and the quality of agrochemicals. The laboratory is complex in nature and controls
both agricultural products - pesticides and fertilizers, as well as raw materials and
food of plant origin.
•4.5. The Central Laboratory for Grain and Feed Quality is a specialized structure of
the BFSA for the implementation of the state policy in the field of the control on the
quality and safety of grain and feed. The structure performs analyses of cereals,
legumes, oilseeds and products from their processing, premixes, feed, raw materials
and additives, including food for all types of pets.
