3.100.  The FVA carries out regular official controls on imports of food of non-animal origin, including food contact materials, pursuant to Article 88 of the Law on Food Safety. The controls are carried out at an appropriate place, including the inspection post of entry of the products, the point of release for free circulation, warehouses, the premises of the importing business operator, or other points in the food chain. Currently, 11 Border Inspection Points of Entry are in operation on the borders with Serbia, Bulgaria, Greece, Albania, and Kosovo. Official controls applied to imports of food of non-animal origin include at least a systematic documentary check, a random identity check and, where appropriate, a physical check

3.101.  The FVA recently adopted several food safety monitoring programmes[121], which aim to ensure continuous monitoring and timely preventive detection of risks to human health, throughout the food safety chain. Security monitoring is conducted on different types or categories of foods, in relation to different parameters, and in other stages of the integrated chain. The programmes determine the presence and concentration of contaminants in food, the presence of residues of pesticides in and on food, the migration of certain substances from materials and products that come in contact with food, monitor the presence of GMO food, microbiological criteria and other food hazards, and the evaluate their impact on human health.[122]

3.102.  The Law on Veterinary Health lays down provisions concerning the organization and responsibility of the veterinary service; the principles and procedures for the implementation of activities related to the protection of people and animals against diseases transmitted by animals, products of animal origin, and animal by-products; and activities for combating contagious animal diseases, including zoonosis. It also lays down the measures for the control and eradication of animal diseases, and the general conditions for the placing on the market, import and transit of animals and animal products. The Law on Feed Safety lays down the general rules on feed hygiene, conditions and arrangements, ensuring the traceability of feed, and conditions and arrangements for the registration and approval of feed establishments. The Law on Animal By-Products regulates the categorization, collection, transport, removal, processing, use and storage of animal by-products from the aspect of animal health protection, veterinary public health and environmental protection

3.103.  The FVA carries out border veterinary controls on imported and transiting consignments of live animals, and animal products and by-products, based on its authority under the Law on Food Safety and the Law on Veterinary Health. The import and transit of live animals and products of animal origin are permitted only through approved Border Inspection Posts that meet requirements defined in the Law on Veterinary Health, regarding specific facilities, suitable equipment and suitable expert personnel necessary for carrying out veterinary inspections. Veterinary border controls on live animals and products of animal origin are carried out at ten designated Border Inspection Posts. During import, animals, and animal products and by-products are subject to a documentary check, an identity check and a physical check by an official veterinarian at the Border Inspection Post. Consignments in transit are subjected to a documentary check, an identity check and, if necessary, a physical check

3.104.  Animals, and animal products and by-products may be imported into North Macedonia under the following conditions: (a) they originate from a country or part of a country authorized to export the animal species or category of animal products or by-products to North Macedonia; (b) in the case of animal products and by-products, they were produced in an establishment authorized to export the respective category of animal products or by-products to North Macedonia; and (c) they are accompanied by a health certificate or other document. Imports of animals, or animal products or by-products may be banned, or conditions for imports may be amended, by decision laid down by the Chief Veterinary Officer in the case of an outbreak of a contagious animal disease or any other incident in the country of origin which may pose a risk to animal or public health in North Macedonia

3.105.  Food of animal origin may be imported into North Macedonia if: (a) it originates from an EU member State or part thereof, or a third country or part thereof which appears on the list of third countries from which the import into the European Union is approved, and the concerned list is prepared and updated by the European Commission; (b) it originates from a third country or part thereof which appears on the list prepared and updated by the FVA. The third country is put on the list if it was subject to control by the European Union or the FVA and, during the control, it was confirmed that the suitable guarantees were met. The third country is put on the list without being subject to control if the FVA, based on an analysis of the documentation, establishes that those suitable guarantees are met; (c) the establishment from which the product was dispatched and the establishment in which the product was obtained, prepared or stored, are present on the list of establishments of the EU member States, the list of establishments of third countries from which the import into the European Union is approved, and which is prepared and updated by the European Commission, and on the list of approved establishments of third countries prepared by the FVA

3.106.  The phytosanitary regulatory system of North Macedonia is composed of the following competent authorities: (a) the Phytosanitary Directorate; (b) the State Phytosanitary Laboratory; (c) the State Agriculture Inspectorate; and (d) the Directorate for Seeds and Seedling Materials

3.107.  The Phytosanitary Directorate is a body within the Ministry of Agriculture, Forestry and Water Economy, and is responsible for the development of national policy and legislation with respect to plant health, plant protection products, and fertilizers. It is also responsible for the coordination and exchange of information among state authority bodies; deciding on administrative procedures for issues in the areas of plant health, plant protection products and fertilizers; relations with the European Union; and implementing the international conventions, agreements and contracts regarding plant health which North Macedonia has ratified

3.108.  The State Phytosanitary Laboratory is a body within the Ministry of Agriculture, Forestry and Water which conducts laboratory activities (analyses of pesticide formulation and residues of plant protection products, seeds, and diagnosis of samples of plant harmful organisms) according to annual phytosanitary monitoring programmes and monitoring programmes for plant protection products and residues of plant protection products in primary agricultural products, and tests seeds and seedling materials

3.109.  The State Agriculture Inspectorate is responsible for the control of food safety in the primary production of food of plant origin, plant health, and the implementation of measures for the prevention and containment of harmful organisms. It carries out controls pursuant to the Law on Plant Health, the Law on Plant Protection Products, the Law on Seeds and Seedlings, and the Law on New Plant Varieties. The Phytosanitary Inspection Department, under the State Agriculture Inspectorate, is responsible for internal and border phytosanitary inspection. It also issues phytosanitary certificates for the import and export of plants, plant products and plant protection products

3.110.  The Directorate for Seeds and Seedling Materials is a body within the Ministry of Agriculture, Forestry and Water Economy which develops policy and legislation in the area of seeds and propagation material

3.111.  Imports of certain types of plants, plant products and other controlled items, agricultural reproduction material, forest reproduction material, and means of protection of plants are subject to inspection at the point of entry. Provisions for conducting official import and export controls for plant health are laid down in the Laws on Plant Health; Plant Protection Products (based on EU Directive 91/414/EC); Fertilizers; Seed and Seedlings; and Protection of New Plant Varieties.[123]

3.112.  The authorities indicated that the following legal acts were adopted during the period under review, on the basis of the Law on Plant Health (Table 3.12)

3.113.  Imports of agricultural and forest plants, plant products, and seeds and plant propagating materials may be conducted only at the border crossing points specially assigned to perform phytosanitary checks in accordance with annual monitoring programmes. Importers are initially required to submit an Inspection Control Application, followed by quarantine pest sampling. Certified seeds and propagating material undergo phytosanitary inspection during vegetation periods by institutions appointed by the Minister of Agriculture, Forestry and Water Management, as well as by laboratories carrying out the analyses. In general, for imports of plants, plant products, and seeds and plant propagating materials plants, a Phytosanitary Certificate issued by the Ministry of Agriculture is required; there are no exceptions to this requirement. North Macedonia does not require additional certificates or sanitary registrations for products confirmed to be safe by recognized international authorities

3.114.  With respect to certain issues raised in the 2018 European Commission report on enlargement[124], the authorities indicated that several steps were recently taken to strengthen the capacity of the Phytosanitary Inspectorate to collect and analyse data, to develop a phytosanitary information and communication system, to enhance the effectiveness of phytosanitary inspection, and to meet international standards regarding the determination of pest status

3.93.  The main laws concerning the application of sanitary, veterinary and phytosanitary measures in North Macedonia are the Law on Food Safety[111]; the Law on Feed Safety[112]; the Law on Veterinary Health[113]; the Law on Veterinary Medicinal Products[114]; the Law on Animal By-Products[115]; the Law on Animal Health and Welfare[116]; the Law on the Identification and Registration of Animals[117]; the Law on Plant Health[118]; and the Law on Plant Protection Products.[119] At the time of writing, a draft law on phytopharmacy was under consideration in Parliament. The WTO national enquiry point for sanitary and phytosanitary measures is the Food and Veterinary Agency, and the national notification authority is the Ministry of Economy

3.94.  With respect to sanitary and veterinary policy, implementing regulations (rulebooks) were adopted during the period under review in relation to the import and transit of live animals and products of animal origin, pursuant to the Law on Veterinary Health, the Law on Food Safety, the Law on Animal Health and Welfare, the Law on Feed Safety, the Law on Animal By-Products, and the Law on Veterinary Medicinal Products. Rulebooks were also adopted in relation to the import and transit of food of non-animal origin, under the Law on Food Safety. In addition to these rulebooks, there have also been temporary bans on the import and transit of food, feed, animals and other products, pursuant to Article 81(2) of the Law on Veterinary Health and Article 2 of the Law on Food Safety. According to information provided by the authorities, 75 rulebooks were adopted during this period in the field of sanitary and veterinary policy, and there were 81 temporary bans on the import and transit of food, feed animals and other products. In the area of phytosanitary measures, 11 orders for the implementation of international standards were adopted during the period under review, on the basis of the Law on Plant Health

3.95.  Most changes made since the previous Review to the regulatory and institutional framework for the application of sanitary and phytosanitary measures were aimed at harmonization with international norms. In view of the accession process to the European Union, the Government is focusing on streamlining practices and implementing various measures related to the EU acquis, regarding field inspection services, official controls, food and feed safety, animal disease control, plant health and plant protection products, control of veterinary medicinal products, and enhancement of border post import control

3.96.  During the period covered by this review, North Macedonia concluded several international agreements related to sanitary and phytosanitary measures. In the areas of food safety and veterinary policy, the relevant agreements are the following: the protocol on mutual recognition and acceptance of certificates issued by accredited laboratories for food and feed between the Food and Veterinary Agency of the Republic of North Macedonia and the Ministry of Foreign Trade and Economic Relations of Bosnia and Herzegovina, signed in Skopje on 21 November 2014; the memorandum for cooperation between the Federal Service for Veterinary and Phytosanitary Surveillance of the Russian Federation, the Ministry for Agriculture, Forestry and Water Economy of the Republic of North Macedonia, and the Food and Veterinary Agency of Republic of North Macedonia, signed on 4 June 2015; the protocol between the Food and Veterinary Agency of the Republic of North Macedonia and the General Administration for Quality Supervision, Inspection and Quarantine of the People's Republic of China, in relation to the health requirements for quarantine applicable to frozen lamb meat intended for export from North Macedonia to the People's Republic of China, signed 26 November 2015; and the agreement for scientific and technical cooperation between the Food and Veterinary Agency of the Republic of North Macedonia and the Directorate General of Animal Health and Veterinary Medicines and the Directorate-General for Hygiene, Food Safety and Nutrition of the Ministry of Health of the Italian Republic in the field of veterinary public health, signed in Rome on 18 December 2018

3.97.  In the phytosanitary area the following agreements were concluded: the memorandum for cooperation between the Federal Administration for Veterinary and Phytosanitary Supervision of the Russian Federation and the Ministry of Agriculture, Forestry and Water Economy and Food and Veterinary Agency of the Republic of North Macedonia; the protocol between the Plant Health Directorate of the Ministry of Agriculture and Environment of the Republic of Serbia and State Agriculture Inspectorate of the Ministry of Agriculture, Forestry and Water Economy of the Republic of North Macedonia for border control of railway traffic on the PreshevoTabanovce Border Inspection Posts; the agreement between the Government of the Republic of North Macedonia and the Government of the Russian Federation for cooperation in the area of quarantine and plant protection; and the agreement between the Government of the Republic of North Macedonia and the Government of the Republic of Turkey for cooperation in the area of quarantine and plant protection

3.98.  The Food and Veterinary Agency (FVA) is the central competent authority for matters related to food and feed safety, veterinary policy, quality of food, animal by-products, and veterinary medicinal products. The authorities indicated that steps were recently taken to improve the FVA's capacity to comply with WTO obligations with respect to notifications.[120]

3.99.  The Law on Food Safety regulates the control of safety of food at all stages (production, processing, storage, transport, distribution, retail, and catering). It imposes general and specific conditions and obligations for food operators, their registration and approval, conditions for the import and export of food of animal and non-animal origin, and official controls and their funding, including the monitoring of residues and prohibited substances

3.84.  The legal framework for the application of technical regulations and standards in North Macedonia comprises the Law on Standardization[95]; the Law on Product Safety[96]; the Law on Metrology[97]; the Law on the Control of Articles of Precious Metals[98]; the Law on Accreditation[99]; and the Law on Market Surveillance.[100] During the review period, North Macedonia continued the process of harmonizing its technical regulations and standards with relevant EU rules, with a view to preparing itself for accession to the European Union

3.85.  The Ministry of Economy is the main authority responsible for the adoption of technical regulations, including the transposition of the EU acquis. It is also the authority responsible for notifying the WTO and the EU Commission on technical regulations. Technical regulations are adopted by the Minister of Economy or the minister authorized by law as the competent authority for issues related to the production, marketing and release into free circulation of certain products or group of products. The evaluation of compliance with technical requirements is conducted by authorized legal entities. The Minister of Economy issues authorizations based on a criterion for accreditation in accordance with the Law on Accreditation. The authorized entities have the power to issue compliance certificates, upon written application by the interested legal or natural persons. North Macedonia acknowledges the foreign compliance documents and markings issued in accordance with the international agreements signed and ratified by it.[101]

3.86.  The Standardization Institute of the Republic of North Macedonia (ISRM), as the national standardization body, participates in international, European and regional organizations for standardization, promotes standardization activities, and brings together public and private stakeholders. It develops and adopts voluntary national standards and acts as the WTO enquiry point. It has adopted 28,898 standards, most of which are European standards.[102] It is a full member of the European Committee for Standardization (CEN) and European Committee for Electrotechnical Standardization (CENELEC). It is currently implementing its 2018-20 strategy for the development of standardization

3.87.  The Institute for Accreditation of the Republic of North Macedonia (IARM) is responsible for the monitoring and control of accredited authorities for compliance evaluation. It decides on the accreditation procedure and oversees compliance with accreditation requirements. The IARM has signed agreements with the International Accreditation Forum, the European Cooperation for Accreditation, and the International Laboratory Accreditation Cooperation. The recognition of certificates for ISO 9001 is underway. In 2017, the IARM continued to work on accrediting laboratories operating within state-funded higher education facilities and public health institutions. So far, it has accredited 206 conformity assessment bodies for calibration, testing, medicinal laboratories, and product and process certification and inspection

3.88.  The State Market Inspectorate is responsible for the monitoring and control of the enforcement of the provisions of the Law on Product Safety.[103] In 2017, it conducted more than 756 inspections in connection with the Law, (compared with 500 inspections in 2016), mostly on household appliances, certain construction products, toys, and children's clothing.[104] The Inspectorate coordinates its surveillance activities with other inspectorates and customs authorities. Pursuant to Article 8 of the Law on Market Surveillance, a National Coordinating Body on Market Surveillance was established in May 2018.[105] This Body is composed of representatives of various state inspection organs and ministries. In addition to the State Market Inspectorate, the members of this Coordinating Body are the State Labour Inspectorate, the State Inspectorate for Technical Inspection, the State Sanitary and Health Inspectorate, the Food and Veterinary Agency, the State Environment Inspectorate, the Agency for Electronic Communications, the Customs Administration, the Agency of Medicines, the Ministry of Transport and Communication, and the Ministry of Economy. The Coordinating Body signed a memorandum of understanding with the Customs Administration that lays down specific areas for cooperation regarding the control of products that enter the market of North Macedonia

3.89.  The Bureau of Metrology, under the Ministry of Economy, oversees the implementation of the Law on Metrology and the Law on the Control of Articles of Precious Metals. It inspects compliance with metrology standards, and issues export/import permits for precious metals. It is a member of the European Association of National Metrology Institutes, a signatory of the International Committee of Weights and Measures Mutual Recognition Arrangement, a member of the International Organization of Legal Metrology and an associate member of European Cooperation on Legal Metrology (WELMEC). The Bureau published its calibration and measurement capabilities in the fields of mass, volume and flow and thermometry

3.90.  Food labelling obligations are regulated by the Law on Food Safety[106] and related by-laws. The labelling requirements are the same for domestic and imported foodstuffs. In addition, imported products must display the address of the importer, the place of origin, and the country from which the product is imported. In addition to mandatory food labelling requirements set out in a Rulebook issued in 2005[107], labelling requirements defined by food category are prescribed by rulebooks that contain specific safety requirements or quality guidelines for particular food products.[108]

3.91.  Since the last Review, North Macedonia submitted one notification to the WTO Committee on Technical Barriers to Trade.[109]

3.92.  The authorities indicated that they aim to achieve full harmonization with the EU acquis in the area of products safety, during the period 2019-21, particularly through the transposition of EU New Approach Directives.[110]