3.100.  Since 2016, Montenegro has introduced measures prohibiting the importation of consignments of live animals and animal products originating in, or being transported through, Bulgaria, The former Yugoslav Republic of Macedonia, and Greece to prevent the spread of lumpy skin disease.[335] In the same year, it applied a ban on the importation and transit of poultry, birds and products of poultry and birds from Bulgaria and other countries to prevent the introduction of Newcastle disease (OG No. 74/16).[336] In 2016, Montenegro banned the import and transit of livestock, birds, and livestock and bird products from Hungary, Austria, Germany, France and other States with outbreaks of a highly pathogenic avian influenza virus (OG No. 74/16).[337]

3.101.  During the same period, Montenegro introduced more stringent veterinary control and check measures to prevent the introduction and spread of blue tongue disease, foot and mouth disease, classical swine fever, and other animal contagious diseases. The 2017 annual budget for obligatory measures for the protection of animal health stood at 1.38 million.[338]

3.102.  Regional cooperation agreements on the obligation to notify, report and take measures in case of disease exist with Serbia, and Bosnia and Herzegovina.[339]

3.103.  According to the authorities, under the Instrument for Pre-accession Assistance (IPA) 2018 Programming, which is yet to be approved, Montenegrin facilities and premises have to be improved to be fully in line with the EU requirements.[340] Financial resources received from the European Union are directed at the building and equipment of Border Inspection Posts and phytosanitary border points; upgrading and developing laboratories; implementing measures for the control and eradication of animal diseases; and elaborating the system for safe disposal of animal by‑products.[341]

3.104.  Since its WTO accession, Montenegro has not submitted any SPS notifications under the WTO Agreement on Sanitary and Phytosanitary Measures. According to the authorities, similarly to standards notification (Section 3.3.2.1.3), the reasons for non‑submission are that, in addition to its very low administrative capacities, Montenegro has been in the process of intensive transpositions of the EU acquis communautaire into its national legislation; it plans to address the issue of notifications in this area in the course of 2018. So far no specific trade concerns (STCs) involving Montenegro were raised at the meetings of the WTO SPS Committee by other Members. In July and October 2017 (STC 426), Montenegro raised a specific trade concern over the Russian Federation's measures on imports of its wine products to this market since 26 April of the same year due to an allegedly increased content of pesticides (Metalaxyl) and phthalate plasticizer particles despite no prior record of non-compliance of its wine products with the latter's standards. Despite bilateral meetings and the exchange of information, and Montenegro's request for a joint testing procedure of the confiscated wine, the restrictive measures remain in place. Montenegro's SPS enquiry point and notification authority is the AFSVPA.[342]

3.105.  Marking and labelling of food products is regulated by the Law on Food Safety (OG No. 57/15), and specific implementing regulations.[343] The Law provides for mandatory labelling and marking to ensure the traceability of food and feed, raw materials, and substances incorporated in food and feed. Similar requirements apply to food for animal consumption and final products at all stages of production and trade. Controls are carried out by sanitary, veterinary and phytosanitary inspectors.[344] Specific implementing regulations include, inter alia, the Regulation on Consumer Information on Food (OG Nos. 12/16 and 83/16). Its provisions also apply to food intended for the final consumer and/or supplying facilities of collective nutrition, such as catering facilities, hospitals, schools, etc. providing food for the final consumer.[345]

3.106.  To attain harmonization with the EU acquis, Montenegro has implemented and/or is in the process of implementing various product-specific regulations relating to labelling. These regulations include: the Regulation on the use of health and nutritional claims in the labelling, advertising and presentation of food (OG No. 6/17); the Regulation on the manner and conditions for placing on the market food for special nutritional uses (OG No. 10/17); the 2016 Regulation on conditions and rules for processing, packaging, transport and storage of organic products (OG No. 93/16); and the 2014 Regulation on the labelling of pesticides (OG No. 46/14).[346]

3.107.  Labels must contain the following information: title of the product, full address of the producer or full address of the importer, net quantity/weight/volume, ingredients, manner of storage and pertinent consumer warnings

3.108.  All GMOs or products containing, consisting of or deriving from GMOs remain subject to mandatory GMO labelling. Products must be marked with the following: GMO; product contains GMO; product consists of GMO; or product derives from GMO; and a unique identification code. Moreover, suppliers of GMOs are obliged to maintain a database and put in place a monitoring and identification procedure, to record each placement on the market, and the name of the person who provided or obtained GMOs (except for the end consumers) for a period of five years.[347] In line with its EU accession process, Montenegro is to implement a Rulebook on traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from GMOs in 2018.[348]

3.71.  Since its WTO accession, Montenegro's institutional setting in this area has remained relatively unchanged. The Department of Quality Infrastructure of the Directorate of Internal Market and Competition of MEK was established in 2016 and is in charge of coordination activities related to standards and technical regulations, as well as the supervision of quality infrastructure institutions (accreditation, standardization and metrology).[261]

3.72.  The Institute of Standardization of Montenegro (ISME), a non-governmental institution set up in 2007, remains responsible for planning and coordinating the national standards policy and is in charge of designing and adopting standards and related documents.[262] ISME regularly informs the public about the existing standards (national, European and international) and its standardization activities. Information on the existing standards is available on its web portal (www.isme.me).[263] According to the 2013 Decree on the Notification of Technical Regulations, Standards, Regulations on Information Society Services and Conformity Assessment Procedures (OG No. 11/13), ISME is an official enquiry point on standards and information provision under the WTO Agreement on Technical Barriers to Trade.[264] According to the European Commission, ISME is independent and able to fully implement European and international standards, but it faces challenges including a lack of adequate human and financial resources.[265]

3.73.  Six ministries are responsible for development and adoption of technical regulations in their areas of competence upon opinion of the MEK, which remains the domestic enquiry point for technical regulations and conformity assessment procedures.[266] Other standards-related organizations include: the Accreditation Body of Montenegro and the Bureau of Metrology (Section 3.3.2.1.2)

3.74.  The 2014-2018 Standardization Development Strategy for Montenegro is focused on: fostering the competitiveness of the domestic economy; increasing participation of interested parties in the development of Montenegrin standards; cooperating with the State; improving ISME's management; securing sustainable financing arrangements for the operation of ISME; providing training and raising the level of awareness of interested parties regarding standardization and standards implementation; developing standards in new standardized fields; and strengthening the administrative capacities of ISME.[267]

3.75.  The Montenegrin standardization system consists of mandatory standards contained in technical regulations developed by the six competent ministries, and voluntary standards designed by ISME.[268] Standards are developed by ISME and in the process of preparation of a technical regulation the relevant ministries in charge submit to ISME a request for information on existing national, international and European standards. Montenegro's regulations for industrial products are based either on the EU "Old Approach" (laying down detailed specific technical requirements) or the "New and Global Approach" (setting-up of essential requirements defined to meet health, safety, and environmental objectives). According to Montenegro Development Directions 2015‑2018, harmonization with international standards is crucial for the economy to achieve "smart" growth through increased competitiveness and attraction of foreign direct investment.[269] According to the authorities, standards related to Montenegro's development priorities are to be based on international standards; in the absence of adequate international standards, European standards are adopted.[270] Standard harmonization and full integration into the European and international standardization system remain a significant element of Montenegro's industrial policy until 2020. Full harmonization of technical regulations and standards would contribute to simplified procedures and better business access to domestic and foreign markets.[271]

3.76.  As of December 2017, about 7,000 (40.7% of all standards) Montenegrin standards (MESTs) were contained in technical regulations issued by the six competent ministries.[272] At the same time, a total of 17,191 MESTs were adopted (6,970 in 2012).[273] Montenegro had harmonized 3,082 MESTs according to the International Classification for Standards, and they were mainly allocated to environment, health protection, and safety (507), electrical engineering (308), construction materials and building (270), telecommunications, audio and video engineering (245), and health care technology (225).[274] There were only two national standards, and these were maintained due to the lack of equivalent international and/or European standards.[275] All other ISME standards are based on international or European standards; 16,999 MESTs are identical to European standards (CEN, CENELEC, ETSI (see below)) and the rest identical to international standards. Some MESTs are issued in Montenegrin while others are adopted under the "cover page" method (where the text of the standard is in another language, such as English).[276]

3.77.  Since 2014, Montenegro's Agency for Electronic Communications and Postal Services has been a full member of the European Telecommunications Standards Institute (ETSI). ETSI produces globally applicable standards for information and communication technology (ITC), including fixed, mobile, radio, converged, broadcasting and internet technologies.[277] ISME remains a correspondent member of the International Organization for Standardisation (ISO) and an associate member of the International Electrotechnical Commission (EIC).[278] Montenegro has been an affiliate of the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) since 2008 and 2009, respectively.[279]

3.78.  On a bilateral level, in February 2014 ISME signed cooperation agreements with the Turkish Standards Institution (TSE) and in September 2016 with the Standardization Administration of China (SAC). A 2015 MoU between ASTM International and Montenegro is aimed at assisting Montenegro with the development of standards supporting health, safety, the environment and economic growth.[280]

3.79.  Depending on the risk of the product, conformity assessment can be performed by manufacturers or bodies authorized/designated by the competent ministries. Montenegrin authorized/designated conformity assessment bodies (CABs) are responsible for conformity assessment for the needs of public administration and manufacturers with the MEK playing a coordination role (Article 11 of the Law on Technical Requirements for Products and Conformity Assessment, OG No. 53/11).[281] After the conformity assessment procedures conducted by the CABs have been completed and the relevant test/calibration/inspection reports or certificates issued, the CABs attest to the conformity of the products concerned with technical regulations.[282] Conformity assessment procedures and certificates issued by foreign CABs are accepted as equivalent upon the evaluation of a declaration of conformity and a technical dossier as well as evaluation on whether conformity assessment procedures performed by foreign CABs fulfil the goals and requirements of the domestic technical regulation. Conformity assessment documents issued by EU notified bodies are accepted as equivalent in Montenegro. As at December 2017, there were 35 accredited CABs, including 22 testing laboratories, 6 inspection bodies, 2 calibration laboratories, 1 certification body for products, and 4 certification bodies for management systems.[283]

3.80.  Montenegro's national accreditation system includes the national accreditation body (Accreditation Body of Montenegro (ATCG)) (see below), accredited CABs, the relevant competent authorities and other parties directly or indirectly related to accreditation (see below).[284] Its Accreditation System Development Strategy for 2015-2018, is inter alia aimed at: adopting and implementing the EU accreditation‑related policies and rules; fulfilling the obligations arising from membership of the European Union and international organizations for accreditation; upgrading administrative and technical capacities of the national accreditation body (ATCG); encouraging the use of accreditation when implementing public policies; and, strengthening international accreditation-related cooperation.[285] Since 2014, the Programme for Enhancing Regional and Local Competitiveness through Harmonization with International Standards of Business (Table 3.7), has aimed to maximize MSMEs' competitiveness through harmonization of product-related international standards and providing support for conformity assessment accreditation. It has operated a reimbursement scheme covering a large part of related costs.[286]

3.81.  The ATCG, established in 2007 as an independent and not-for-profit organization and supervised by both the MEK and the Ministry of Finance, keeps and updates its Register of Accredited CABs.[287] It conducts its activities in accordance with the Law on Accreditation (OG Nos. 54/10 and 43/15) to, inter alia, strengthen the cross-border accreditation policy.[288] Given the insufficient number of Montenegrin assessors and experts, whenever necessary the ATCG contracts assessors and experts from other national accreditation bodies.[289]

3.82.  The limited human and financial resources of ATCG appear to affect the implementation of the 2015-2018 strategy by impeding it from raising public awareness on the benefits of accreditation and preventing it from participating in the activities of the European Cooperation for Accreditation (EA), although this situation is about to improve.[290] The ATCG is a signatory to bilateral cooperation agreements with the national accreditation bodies of Serbia (ATS), the former Yugoslav Republic of Macedonia (IARM), Bosnia and Herzegovina (BATA), Croatia (HAA), Albania (DA), Moldova (MOLDAC), and Bulgaria (BAS). Metrology

3.83.  Montenegro's Strategy for Development of Metrology in 2016-2018 is, inter alia, aimed at: ensuring metrological traceability; improving the procedures for standards/measuring instruments calibration and compliance assessment procedures for legal measuring instruments; reinforcing metrological supervision; and complying with the EU legislation.[291] The MEK remains responsible for the supervision and monitoring of issues related to metrology, while the Bureau of Metrology (BoM), founded in 2006, continues to perform expert and related administrative affairs in the field of legal, scientific and industrial metrology as Montenegro's National Metrology Institute (NMI) in accordance with the Strategy and the regulatory framework in this area.[292] The BoM is accredited by the ATCG and the Croatian Accreditation Agency (HAA). It also represents Montenegro in regional and international organizations: EURAMET full membership, OIML corresponding member, WELMEC associate member, CGPM associate member, and IAAO member. In July 2016, the BoM obtained a licence for performing scientific‑research activities in the field of technical-technological and interdisciplinary sciences. During the review period, national calibration laboratories were established and developed within the BoM, of which eight are recognized as competent for carrying out calibrations for the ATCG and the HAA.[293]

3.84.  Human and financial resources limitations in this area also constitute constraints to Montenegro's ability to make regular TBT notifications to the WTO. Montenegro's two notifications in this area date back to 2013 (Section 2.3.1); they consist of a statement on the implementation and administration of the Agreement on Technical Barriers to Trade under Article 15.2 and the acceptance of the Code of Good Practice.[294] The authorities consider that as technical regulations refer to MESTs that are based on international or European standards for a specific product or product group they do not create a technical barrier to trade; they are to address the issue of notification requirements in this area in the course of 2018. So far, there have been no specific trade concerns (STCs) raised at the Committee on Technical Barriers to Trade either by Montenegro with respect to other Members' measures, or by other Members with respect to Montenegrin measures.[295] In 2012, a workshop, aimed at promoting a better understanding of the TBT Agreement and the challenges of its implementation, was held in Montenegro.[296]

3.85.  Montenegro's legislative system adopts and updates the relevant SPS laws and regulations to ensure compliance with the EU acquis. The main law affecting food standards is the Law on Food Safety (OG No. 57/15), which replaced the 2007 Law (OG No. 14/07). The 2015 amendments to the 2007 Law were mainly aimed at establishing a more efficient system with clearly defined competences and responsibilities, simplifying the chain of command, achieving better coordination and communication, and facilitating the training of employees.[297] The amendments accorded all competences to the Ministry of Agriculture and Rural Development (MARD) and provided for the establishment of its new Administration for Food Safety, Veterinary and Phytosanitary Affairs (AFSVPA).[298] The AFSVPA was formed by merging the Veterinary and Phytosanitary Administrations of MARD and the Division for Food Safety of the Ministry of Health (MoH). It consists of three sectors: the Sector for Food Safety (responsible for food safety, feed safety and inspection of food and feed); the Veterinary Sector (responsible for animal health and welfare, animal by-products and veterinary inspection); and, the Sector for Phytosanitary Affairs (responsible, inter alia, for plant health protection, seeds, planting materials, GMO, plant variety protection, plant products, fertilizers and phytosanitary inspections). Montenegro is a member of the World Organization for Animal Health (OIE), the Food and Agriculture Organization and the Codex Alimentarius Commission as well as a signatory to the International Plant Protection Convention (IPPC).[299]

3.86.  All imported and domestic food and animal feed must comply with the relevant requirements set out under the 2015 Law (Article 18). Moreover, since 2007, Article 41 of the Law has obliged the business operator to establish, apply and continuously maintain procedures based on the principles of Hazard Analysis and Critical Control Point (HACCP) at all stages of production, processing and distribution of food.[300] According to a 2013 European Commission report, the majority of large capacity establishments apply HACCP principles. However, small establishments have most problems with applying these principles. Therefore, training is ongoing to raise awareness on the implementation of HACCP principles within small-scale establishments.[301]

3.87.  As from 2015, all business operators engaged in primary production of food must be registered with the AFSVPA. As at 1 September 2017, there were: 2,342 producers in the Register of food business operators engaged in primary food production; 282 facilities for food production and storage of food under controlled conditions in the Register of approved facilities; and 1,427 newly registered facilities (2016/2017) in the Register of Registered Facilities in accordance with the newly-issued Ordinance listing the activities that are approved and registered.[302] Maximum residue levels

3.88.  Since 2015, MARD remains responsible for regulating pesticide residues in foodstuffs, in accordance with the maximum residue levels (MRLs) set out in the Law on Food Safety, the Law on Plant Protection Products (OG Nos. 51/08, 40/11 and 18/14) and the 2015 Regulation on maximum residue levels (MRLs) of pesticides in or on plants, plant products, food or feed (OG No. 21/15 and 44/15).[303] The Regulation lists MRLs of pesticides in products of plant and animal origin used as fresh, processed and/or combined food or animal feed (Annex I); in or on food and feed for animals (Annex II); and for products for which a MRL is not determined (Annex III) (www.ubh.gov.me/biblioteka/sektor_3/).[304] All information and data on plant protection products and residue of plant protection products are collected and inserted in a database maintained by the competent authorities and used for regulating trade in this area (Article 43). Importation of plant protection products registered in Montenegro is allowed by companies, other legal persons, or entrepreneurs registered in the Register of importers (Article 41) (Section 3.1.2.1). As of 1 September 2017, the register contained 30 such importers.[305] Food importers do not have to provide lists of food ingredients and additives to MARD. Import tolerances for agrochemicals not already registered for use in Montenegro are subject to the relevant EU MRL; in the absence of such MRL, the default MRL of 0.01 ppm applies

3.89.  Since 2009, Montenegro has conducted annual monitoring of pesticide residues in line with EU recommendations.[306] As from 2012, 62 training activities on the use of pesticides have taken place. The MARD budget for the 2016 Programme on Phytosanitary measures stood at 190,018, of which 10,000 was allocated to monitoring pesticide residues in food of plant and animal origin, 6,000 to fruit, and 5,000 to vegetable crops.[307] Food additives

3.90.  The 2015 Law on Food Safety defines and regulates food additives.[308] As prescribed by the Law, the secondary legislation the Regulation on food additives (OG No. 19/16) provides for quality requirements and conditions for the use of additives. The Regulation defines the food additives, classifies different types of additives that can be used in food, prescribes the conditions for their use, labelling, placing on the market and their specification (Articles 1 and 10 of the Regulation) (http://www.ubh.gov.me/biblioteka/sektor_1/lista_aditiva/).[309] Only additives from Lists I and II of the Regulation can be used and placed on the market under specific conditions whenever applicable. Food additives are grouped into 27 classes (Appendix I) and are listed with detailed specifications (Appendix II). Article 8 stipulates that additives cannot be used in unprocessed food, food for new-borns and children, processed food based on cereals, and food for special medical purposes unless specifically determined for these purposes. There is no national production of food additives in Montenegro. Controls of food additives are performed by authorized laboratories in cooperation with sanitary and veterinary inspectors (see below).[310]

3.91.  A 2016 Regulation on vitamins, minerals and other food additives defines and classifies the sorts and types of vitamins, minerals and other substances that can be added to food and foodstuffs, including various requirements that must be met, such as the manner and conditions for the correct labelling and placing on the market. As of December 2017, Montenegro had a positive list of 156 vitamins/minerals and their forms.[311] Genetically modified products

3.92.  Montenegro's legislation on genetically modified products applies equally to domestic and imported products. The Law on Food Safety provides a definition of genetically modified food and/or animal feed and prescribes and/or prohibits its placement on the market unless specific conditions are fulfilled (Article 71).[312] The 2008 Law on Genetically Modified Organisms (OG No. 22/08), setting the conditions for the use of GMOs and products containing/consisting of or deriving from GMOs, remains unchanged.[313] The November 2016 Regulation on methods for sampling and laboratory testing of animal feed for the presence of genetically modified materials (OG No. 69/16) prescribes the methods for food sampling (official controls, inspection) and laboratory testing for the purpose of research/analysis on the effective presence of genetically modified materials (food safety issues). Montenegro ratified the Cartagena Protocol on Biosafety to the Convention on Biological Diversity in October 2006.[314]

3.93.  In the past, several institutions (e.g. the Ministry of Sustainable Development and Tourism) have had GMO-related responsibilities thus rendering the regulatory framework and its implementation cumbersome.[315] AFSVPA has taken the responsibility for the authorization of testing laboratories, approval of use of GMOs for experimental purposes and authorization for GMOs in food. The Environmental Protection Agency is responsible for approving the intentional introduction into the environment of GMOs. No applications have been received so far and the National Council for Biological Safety has not yet granted authorizations or monitored GMO cultivation in Montenegro. At present, no local GMO food is authorized in the domestic market. According to the authorities, national legislation provides for an adequate control framework; however, as of 2015, there were no accredited laboratories to test GMOs and tests are performed in accredited laboratories in Serbia or laboratories accredited for GMO testing in other countries.[316]

3.94.  Imports of GMOs and wild species of flora and fauna require a permit either from MARD or the Ministry of Sustainable Development and Tourism (new species).[317] Sanitary inspections are conducted by a sanitary inspector (health issues), veterinary inspector (veterinary issues), a phytosanitary inspector (phytosanitary issues) or the authority responsible for environmental protection (environmental protection). The sanitary inspector performs the checks at customs warehouses and/or in free zones (Section 3.2.4.3). The phytosanitary inspector is empowered to ban importation, exportation and transit if relevant regulations are not met.[318] It is compulsory to indicate/label additives, enzyme preparations or seed materials that are genetically modified or contain GMOs.[319]

3.95.  Montenegro's main laws on quarantine requirements for imports include the Law on Plant Health Protection (OG Nos. 28/06, 28/11 and 48/15) and the Veterinary Law (OG Nos. 30/12 and 48/15). Relevant regulations and rulebooks have been issued to ensure compliance with the EU acquis. The Law on Plant Health Protection regulates, inter alia, the protection of plants, measures on the prevention of the introduction, spread and control of harmful organisms, and checks of plant health and plant health consignments.[320] The Veterinary Law regulates the conditions and manner of carrying out veterinary activities as well as animal health protection, and measures related to the protection of public and animal health.[321] Since 2015, animal, plant and fisheries quarantine and inspection are handled by AFSVPA (Section 3.3.2.2.1).[322] Phytosanitary measures

3.96.  Importers (and exporters) of consignments must be registered and imports must be accompanied by a phytosanitary certificate issued by a competent authority in the exporting country.[323] The implementation of a Plant Passport System began in 2015; as of 1 September 2017, 616 subjects were registered. Imports (and exports) of plants and plants products are subject to documentary, identity and plant health checks by 13 phytosanitary inspectors at Montenegro's 13 official entry points.[324]

3.97.  The Law on Plant Health Protection provides for a list of quarantine harmful organisms relevant for Montenegro and a list of harmful organisms to be monitored.[325] According to the 2016 Programme on phytosanitary measures, special control measures are applied to the imports of potatoes, some herbs, and certain plants.[326] Import bans for phytosanitary reasons affect: potatoes from Mexico and countries of Central and South America for seed and consumption; specific plants from certain EU countries, Asia and North America; certain types of wood from non‑EU countries; logs and timber from the United States and some EU countries; corn stalks and sorghum straw from African countries; and soil, compost and substratum mixed with soil or compost, with plants or without plants, from non-European countries.[327]

3.98.  Since 2012, Montenegro has prohibited the importation of tubers of potatoes from Egypt (to prevent the introduction of the harmful organism Ralstonia solanacearum); certain plants originating in India; and certain plants from some regions in Italy and France (to prevent the introduction and spread of Xylella fastidiosa).[328] During the same period, Montenegro introduced more stringent import requirements for wooden packaging from China, citrus fruits from Brazil, and certain herbs and plants due to the threat of introduction and spread of harmful organisms.[329] Sanitary measures

3.99.  Animal and animal products are subject to inspection and quarantine wherever applicable.[330] Veterinary inspectors supervise the safety of products of animal origin in production, international trade, wholesale and retail trade. They are also in charge of checking wild and aquaculture fish and their products including snails. Veterinary health checks are performed at the place of dispatch.[331] Importation of consignments of live animals and animal products must be accompanied by international certificates of animal and public health.[332] If an animal or an animal product does not comply with the domestic requirements, an official veterinarian can order its quarantine or temporary storage.[333] Under the Veterinary Law and the Food Safety Act, Montenegro can introduce protective measures restricting or banning imports, exports or transit of animals, products of animal origin, food for animals and animal by-products in cases of risk of introduction of infectious diseases (Article 55 of the Veterinary Law).[334]