Bulgaria:Bulgaria

* Host institution of the national EFSA Focal Point. © worldfoodsafetyalmanac.bfr.berlin

The Food Law is the central legal foundation for food legislation in Bulgaria. Infringement of food regulations can lead to measures under criminal law and consumer damage claims under civil law, whereby the final decision rests with the courts. Government measures with regard to food safety are often based on scientific risk assessments. However, the final decision on the legality of governmental measures rests with the courts.

In Bulgaria, an institutional separation of risk assessment and risk management has been in place since 2016.

In January 2011, the Bulgarian Parliament, following a political decision, established a new public authority by adopting the Law on the Bulgarian Food Safety Agency (BFSA). BFSA, within the Ministry of Agriculture and Food (MAF), is responsible for the official control on safety of food and feed throughout the food chain. Together with the agency, a Risk Assessment Center was created.

Initially the RACFCH was established in 2011 and functioned within BFSA structure until 2016. Since 01 October 2016, following another political decision, the Law on RACFCH was adopted and the center was separated from the agency as an independent legal entity under MAF. RACFCH is the main authority in Bulgaria engaged in risk assessment and risk communication related to the food chain. Its risk assessments and scientific opinions are published on the Internet unless there are statutory provisions that prohibit it.

MAF is responsible for agricultural policy along the food chain. It prepares draft legislation related to food and feed safety and is responsible for implementing official controls of food and feed.

Ministry of Agriculture and Food

Name	Ministry of Agriculture and Food
Acronym	MAF
Activities	Risk management Risk communication EFSA CEN representative Codex Contact Point RASFF contact point
Responsibilities
Location	Sofia
URL	https://www.mzh.government.bg/en/

Within the Ministry of Agriculture and Food (MAF), the Agro-Food Chain Policy Directorate is responsible for the development, coordination and implementation of the state policy in the fields of quality and safety of food and feed, animal health, plant health and plant reproductive material, and border control on food chain safety. The Directorate is responsible for preparations and is involved in the development and coordination of draft legislative acts in the respective fields, coordination of control authorities within the Ministry, and in the coordination and preparation of a single multiannual national control plan in implementation of Regulation (EU) 2017/625. It also coordinates activities of the Ministry with the Ministry of Health, other agencies and branch organisations in the context of the quality and safety of food and feed, animal health, plant health and plant reproductive material, and border control along the food chain, and also coordinates activities between the Ministry and Bulgarian Food Safety Agency (BFSA). The Agro-Food Chain Policy Directorate is also responsible for market authorisation of genetically modified organisms (GMOs). It also serves as the national contact point in the Republic of Bulgaria for the following systems: Rapid Alert System for Food and Feed (RASFF), Administrative Assistance and Cooperation System (AAC), Food Fraud Network, the integrated computerised veterinary system called TRACES (Trade Control and Expert System), Plant Protection Products Application Management System (PPPAMS) of the European Commission, International Food Safety Authorities Network (INFOSAN), and maintains their functioning.

Ministry of Health

Name	Ministry of Health
Acronym	MH
Activities	Risk communication Risk management
Responsibilities
Location	Sofia
URL	http://www.mh.government.bg/en/

The Ministry of Health (MH) is responsible for health policy and safety of bottled natural mineral, spring and table water (Directive 2009/54/EC) and the investigation of foodborne outbreaks in humans. In the area of food safety, MH is involved in drafting EU horizontal legislation and is responsible for the harmonisation of that legislation into national provisions as well as the methodically guides, Regional Health Inspectorates. The national centres of public health (National Center of Public Health and Analyses, National Center of Radiobiology and Radiation Protection and National Centre of Infectious and Parazitic Diseases) under MH conduct risk assessment on issues related to human health.

The portfolio of MH encompasses, amongst other things, novel foods, baby food, foods for special medical purposes and health claims.

Ministry of Environment and Water

Name	Ministry of Environment and Water
Acronym	MOEW
Activities	Risk communication Risk management
Responsibilities
Location	Sofia
URL	https://www.moew.government.bg/en/

The Ministry of Environment and Water (MOEW) deals with environmental policy and the management and protection of water, including implementation of sector policies – water, waste, climate, air, nature, soils, noise, radiation; prevention activities – regulatory and control functions for prevention of pollution of environment.

For the implementation of these policies, the structure of the Ministry provides general and specialized administrations, including Executive Environment Agency, 4 Basin Directorates, 16 Regional Inspectorates of Environment and Water, 3 National Park Directorates, Enterprise for Management of Environmental Protection Activities, Managing Authority of Operational Program Environment, which administrates the funds for environment in Bulgaria.

Bulgarian Food Safety Agency

Name	Bulgarian Food Safety Agency
Acronym	BFSA
Activities	Risk management Risk communication
Responsibilities
Location	Sofia
URL	https://bfsa.egov.bg/wps/portal/bfsa-web/home

The Bulgarian Food Safety Agency (BFSA) is a specialised body under MA that is responsible for the official controls of safety of food and feed throughout the food chain. BFSA incorporates the former National Veterinary Service, the former National Plant Protection Service, and the former National Grain and Feed Service, as well as the regional food health inspectors, who were responsible for the control of food of non-animal origin in the Regional Health Inspectorates (former Regional Inspectorates for Public Health Protection and Control) under MH and the quality compliance of fresh fruits and vegetables (under MA) with the European Commission standards for placing on the market.

BFSA is the competent government authority responsible for official controls in Bulgaria with respect to phytosanitary issues, plant protection products and fertilisers, veterinary activities, animal health and welfare, animal by-products not intended for human consumption, feedstuff, raw materials and foodstuff, with the exception of bottled natural mineral, spring and table water, materials and articles intended for contact with food, and the quality compliance of fresh fruits and vegetables with the European Commission standards for placing on the market. BFSA comprises 14 departments/directorates, which are aligned with the above-mentioned activities.

The agency’s central office is in Sofia. It also has 28 regional food safety directorates distributed across the country as well as five specialised structures: the National Diagnostic and Research Veterinary Institute, the Central Laboratory for Veterinary Control and Ecology, the Central Laboratory for Chemical Testing and Control, the Central Laboratory for Plant Quarantine, and the Central Laboratory for Qualification of Grain and Feed.

Risk Assessment Center on Food Chain

Name	Risk Assessment Center on Food Chain
Acronym	RACFCH
Activities	Risk assessment Risk communication EFSA Advisory Forum EFSA Focal Point
Responsibilities
Location	Sofia
URL	http://corhv.government.bg/?lang=_en http://focalpointbg.com

The Risk Assessment Center on Food Chain (RACFCH) was created by the adoption of the Law on RACFCH and its Code of Organisation in 2016. It is managed by a director and assisted by an Management Board (on which MAF and MH are represented). RACFCH is an independent legal entity within the structure of MAF, a second level budget unit to the Minister of Agriculture and Food. RACFCH provides independent scientific assessments of risks related to food safety, human health, animal health and welfare, food and feed additives, GMOs, dietetic products, nutrition and allergens, materials and articles intended for contact with food, enzymes, flavourings and supporting substances, biological hazards, contaminants, plant health and plant protection. RACFCH carries out activities for the approval, renewal, and review of approval of active substances, safeners and synergists with the terms and conditions of Regulation (EC) No. 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. RACFCH works in close collaboration with EFSA and other national and international scientific institutions in the food and feed risk assessment area. The EFSA Advisory Forum representative and the national EFSA Focal Point are located within RACFCH.

National Center of Public Health and Analysis

Name	National Center of Public Health and Analysis
Acronym	NCPHA
Activities	Risk assessment Risk communication
Responsibilities
Location	Sofia
URL	https://ncpha.government.bg/

The National Center of Public Health and Analyses (NCPHA) is a structure of the national health care system and carries out activities on: Protection of public health, Health promotion and disease prevention, Information provision of healthcare management. The mission of the National Center of Public Health and Analyses is to combine these diverse activities in the interest of better public health.

NCPHA is subordinate to MH and is responsible for epidemiological data on the dietary intake of the Bulgarian population and takes part in the development of European and national legislation in the field of chemical contaminants in the food chain, GMOs, food contact materials, food supplements, food additives, novel foods and bottled waters.

Regional and local levels

Bulgaria consists of 28 administrative regions with 264 municipalities. Inspections at regional and local levels are conducted by authorities that are subordinate to the central government (headquarters). Both MH and MAF have 28 regional services which report their activities to the central level in the ministries.

Article 36 institutions

Institutions involved in the EFSA network pursuant to Article 36 Reg. (EC) No. 178/2002

Risk Assessment Center on Food Chain (RACFCH) (EFSA Focal Point) AgroBioInstitute The Stephan Angeloff Institute of Microbiology, Bulgarian Academy of Sciences Institute of Food Preservation and Quality National Center of Public Health and Analyses (NCPHA) Trakia University Institute of Animal Science – Kostinbrod Institute of Plant Physiology and Genetics Institute of Cryobiology and Food Technology (ICFT) National University of Food Technologies Institute of Soil Science, Agrotechnology and Plant Protection Central Laboratory of Veterinary Control and Ecology Agricultural University Plovdiv Maritsa Vegetable Crops Research Institute National Diagnostic and Research Veterinary Medical institute (NDRVMI) Institute of Biology and Immunology of Reproduction “Acad. Kiril Bratanov” (BAS) Institute of Biodiversity and Ecosystem Research at the Bulgarian Academy of Sciences University of Forestry, Sofia Institute of Organic Chemistry with Centre of Phytochemistry (BAS)