NorthMacedonia:North Macedonia

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The competent authority for food safety in the Republic of North Macedonia is the Food and Veterinary Agency. Other administrative bodies involved in the food safety system are the Ministry of Agriculture, Forestry and Water Economy represented by the Phytosanitary Directorate and the State Agricultural Inspectorate. The basic legal act is the Law on Food Safety (LFS), which regulates the control over the safety of food at all stages (production, processing, storage, transport, distribution, retail and catering). Infringement provisions of food safety legislation are defined in the LFS. Serious infringements are qualified as criminal offences covered under criminal law and consumer damage claims under civil law, whereby the final decision rests with the courts. Governmental measures with regard to food safety are often based on scientific risk assessments.

The official controls are performed on the basis of previously conducted risk assessments and are based on the provisions laid down in the Law on Food Safety.

As regards risk assessment, in 2015, a National Council for Food and Feed Safety (National Council) was established by the Government of the Republic of North Macedonia. The council consists of members that represent relevant universities and scientific institutions in the country.

The role of the National Council is to provide scientific advice and scientific and technical support in relation to the policies in fields that have direct or indirect effects and influence on food and feed safety and animal health and welfare.

In addition, the National Council is responsible for providing independent opinions and recommendations and for sharing information related to risks in order to increase consumer confidence and improve the harmonisation between risk assessment and risk communication.

The functioning and operation of the National Council is organised into several dedicated Scientific Panels (SP):

• SP for animal health and welfare
• SP for biological hazards
• SP for contaminants in the food chain
• SP for dietetic foodstuffs, nutrition and allergies
• SP for additives and food enrichment products
• SP for plant protection products and residues thereof
• SP for plant health
• SP for feed additives or substances used in the animal feeding stuffs
• SP for food contact materials, enzymes, flavours and technological aids
• SP for genetically modified organisms.

In addition, the Department for Risk Assessment and Communication operates within the organisational structure of the Food and Veterinary Agency and serves as the secretariat of the National Council.

In the Republic of North Macedonia, there is a functional separation of risk assessment and risk management.

Food and Veterinary Agency

Name	Food and Veterinary Agency
Acronym	FVA
Activities	Food and feed safety Veterinary policy, public health policy Veterinary medicinal products Risk assessment Risk communication Risk management EFSA Focal Point RASFF contact point Codex Contact Point OIE Focal Points, CVO EC, DG SANTE, contact point and coordinator regarding EU affairs in food safety, veterinary and phytosanitary fields WTO SPS Enquiry Point
Responsibilities
Location	Skopje
URL	http://www.fva.gov.mk

The Food and Veterinary Agency (FVA) is the central competent authority responsible for performing tasks related to:

• food and feed safety;
• implementation, control, surveillance and monitoring of veterinary activities in the field of animal health and welfare;
• veterinary public health, including veterinary medicinal products, animal feedstuffs and animal by-products;
• control of National Reference Laboratories and authorised laboratories supporting the needs of the FVA;
• control of the quality of food, except for primary agricultural production of food of non-animal origin;
• official controls of feed and food of animal and non-animal origin – during production, processing, storage, transport, trade, import and export.

The FVA is the policy-making authority responsible for coordination of the legislation and control systems in the field of food and feed safety between the relevant institutions in the Republic of North Macedonia, as well as the competent institution for communication with the European institutions responsible for food and feed safety, veterinary and phytosanitary policy.

Ministry of Agriculture, Forestry and Water Economy

Name	Ministry of Agriculture, Forestry and Water Economy
Acronym	MAFWE
Activities	Agricultural policy Risk management
Responsibilities
Location	Skopje
URL	http://www.mzsv.gov.mk

The Ministry of Agriculture, Forestry and Water Economy (MAFWE) is responsible for the development and implementation of agricultural policy and safety of food and feed of plant origin during primary production.

As part of the MAFWE, the State Agriculture Inspectorate (SAI) is responsible for the control of primary production of food of plant origin, plant health, and implementation of measures for the prevention and containment of harmful organisms, as well as for control of the use of plant protection products in primary production and associated operations.

The Phytosanitary Directorate (PD) within the Ministry of Agriculture, Forestry and Water Economy is responsible for the national phytosanitary policy and for drafting legislation in the area of plant health and plant protection products (PPPs).

Faculty of Veterinary Medicine

Name	Faculty of Veterinary Medicine
Acronym	FVM
Activities	Laboratory analysis Risk assessment
Responsibilities
Location	Skopje
URL	https://fvm.ukim.edu.mk/en/

The Faculty of Veterinary Medicine in Skopje (FVM) is a public institution for higher education that operates within Ss. Cyril and Methodius University in Skopje, and is the leading national diagnostic, research and scientific institution in the field of veterinary medicine and food safety in the Republic of North Macedonia. The Faculty of Veterinary Medicine is authorised to perform laboratory analyses of samples collected during official controls conducted by the FVA.

The organisational structure of the FVM consists of the following units:

Food Institute, with the following laboratories

• Laboratory for microbiology of food and feed
• Laboratory for quality control of food and feed
• Laboratory for residues and contaminants
• Laboratory for raw milk quality
• Laboratory for pharmacology and toxicology

Veterinary Institute, with the following laboratories:

• Laboratory for microbiology
• Laboratory for serology and molecular diagnostics
• Laboratory for parasitology and parasitic diseases
• Laboratory for transmissible spongiform encephalopathies
• Laboratory for diagnosis fish, bees and hunting wild game diseases
• Laboratory for pathology and patohystology
• Laboratory for pathophysiology
• Laboratory for rabies
• Laboratory for animal hygiene and environmental
• Cabinet for visual diagnostics

Institute for Reproduction and Biomedicine with the following laboratories:

• Laboratory for production, cryoconservation and control of semen
• Laboratory for assisted reproduction
• Plastination laboratory
• Laboratory for histology and embryology
• Laboratory for biochemistry and cell biology
• Animal genetics laboratory

The FVM laboratories are accredited according to MKC ISO/IEC 17025:2006. The FVM is also involved in the FVA’s risk assessment activities.

Institute of Public Health

Name	Institute of Public Health
Acronym	IPH
Activities	Laboratory analysis Risk assessment
Responsibilities
Location	Skopje
URL	http://www.iph.mk/en/

The Institute of Public Health of the Republic of North Macedonia (IPH) is a national health institution in the field of preventive health care. The aim of the institute is to promote the health and general welfare of the human population through scientifically-based knowledge, best practices, information and organisational partnerships and sustainable impact on public health policies. The institute is authorised to conduct laboratory analyses of food and feed samples collected by state food inspectors. The IPH is accredited according to ISO/IEC 17025. The IPH also supports the FVA and risk assessment activities.

State Phytosanitary Laboratory

Name	State Phytosanitary Laboratory
Acronym	SPL
Activities	Laboratory analysis
Responsibilities
Location	Skopje
URL	http://www.mzsv.gov.mk

The State Phytosanitary Laboratory (SPL) conducts laboratory activities (analysis of pesticides formulation and residues of PPPs, seeds, and diagnosis of samples for harmful plant organisms) in accordance with annual phytosanitary monitoring programmes and monitoring programmes for plant protection products and residues of plant protection products in primary agricultural products, as well as testing of seed and seedling materials.

Livestock Institute

Name	Livestock Institute
Acronym	LI
Activities	Laboratory analysis Risk assessment
Responsibilities
Location	Skopje
URL	http://www.mzsv.gov.mk

The Livestock Institute (LI), an integral part of Ss. Cyril and Methodius University in Skopje, conducts scientific and applied research and is involved in educational activities. The scientific and research nature of the institute aims towards upgrading the livestock production and related fields in the Republic of North Macedonia. The institute is involved in the coordination and implementation of the identification, control of the production and reproduction features, testing, evaluation and control of the quality of feed for all domestic animal species.

Faculty of Agricultural Sciences and Food

Name	Faculty of Agricultural Sciences and Food
Acronym	FASF
Activities	Laboratory analysis Risk assessment
Responsibilities
Location	Skopje
URL	http://www.fznh.ukim.edu.mk/

The Faculty of Agricultural Sciences and Food (FASF) is an integral part of Ss. Cyril and Methodius University in Skopje. The faculty is responsible for educational activities for the first, second and third cycles of study, scientific and research activities in the field of biotechnical sciences, soil and hydrology, plant protection, plant production, apiculture, fruit production, livestock production, fishery, forestry, biotechnology, food technology, production of animal products and other fields related to the faculty’s scope of work.

Regional and local levels

Ten regional independent public health centres/laboratories perform chemical, toxicological and microbiological analyses of food and water.

Control and inspection activities are coordinated and supervised by the FVA’s central headquarters.

28 regional offices of the FVA operate at the regional and local level to inspect food of non-animal and animal origin, animal health and welfare.

Official veterinarians based at 11 Border Control Points (BCPs) perform import controls on food and live animals.

Article 36 institutions

Institutions involved in the food safety system in the Republic of North Macedonia:

Food and Veterinary Agency (FVA), Phytosanitary Directorate, MAFWE State Agricultural Inspection, MAFWE Veterinary Institute, Faculty of Veterinary Medicine – Skopje Food Institute, Faculty of Veterinary Medicine – Skopje State Phytosanitary Laboratory, MAFWE Institute for Public Health of the Republic of North Macedonia, Skopje and 10 Regional Centres for Public Health Laboratory for Biochemistry and Molecular Biology, Faculty of Agricultural Sciences and Food Research Centre for Genetic Engineering and Biotechnology, MASA Faculty of Pharmacy, Ss. Cyril and Methodius University, Skopje Faculty of Medicine, Ss. Cyril and Methodius University, Skopje Institute for Microbiology and Parasitology Institute for Medical and Experimental Biochemistry Institute for Epidemiology and Biostatistics with Medical Informatics Institute for Preclinical and Clinical Pharmacology with Toxicology