3.73.  The regulatory SPS framework was updated in parts during the review period. Law No. 9863/2008 on Food continues to regulate general food safety, Law No. 10465/2011 continues to apply to veterinary services with some amendments, while a new Law on Plant Protection was adopted in 2016 and amended in 2022.[154]

3.74.  The Directorate for Food Safety in the Ministry of Agriculture and Rural Development is the national notification authority for SPS matters as regards the WTO and CEFTA. In addition to this Directorate, the Ministries of Health, Environment, and Agriculture and Rural Development are also responsible for drafting laws. The National Food Authority (NFA), also under the Ministry of Agriculture and Rural Development, is responsible for the control of food and animal feed.[155] SPS measures are drafted by relevant competent authorities using a risk‑based approach

3.75.  In the area of food safety, and as a result of amendments to the Food Law in 2022, consignments of food of animal origin are no longer inspected by border veterinary food safety inspectors, but by those responsible for the control of food and animal feed (i.e. NFA, Article 16). Such controls are usually carried out at border inspection posts according to the provisions of the Food Law and include inspections of food labels and control of product labels. Imports falling under a cooperation agreement in the Western Balkans are controlled at destination point. The NFA licences all food business operators as a precondition to import or export, and also those that produce food or feed (Section 2.4). Imports of animal products are only permitted from establishments and countries that are listed for export to the European Union unless there is a prior agreement in place. Imports of non‑animal food items can originate anywhere

3.76.  Regarding animal health, Law No. 10465/2011 on Veterinary Services continues to apply, having been amended in 2020 and 2022. The revisions in 2020, inter alia, initiated the reform and integration of the veterinary services at local and national levels. It also established a National Agency for Veterinary and Plant Protection, organized in four Regional Directorates, that will take over additional monitoring responsibilities and be the single responsible body to carry out veterinary controls in Albania. Imports, exports, and transit of live animals, veterinary medical products, and non-food animal products require a veterinary certificate[156] and are subject to veterinary control by border veterinary inspectors of the NFA. These continue to be based on a manual from 2006 and a Minister's order from 2011. Only registered veterinary medical products can be imported, and to be accepted for registration in Albania, products have to be registered for marketing in the European Union. Live animals are kept in quarantine for at least 21 days upon importation

3.77.  Regarding plant health, the new Law No. 105/2016 was amended in 2022 in light of recent changes to the relevant EU legislation. According to the authorities, the changes in 2022 allow for a continued approximation via implementing legislation, such Order No. 113/2022 of the Minister of Agriculture and Rural Development, setting out protective measures against pests and their entry. Imports of plants and plant products (as well as those in transit) must be accompanied by a phytosanitary certificate and continue to be inspected at border posts by NFA inspectors for the protection of plants and agricultural inputs. Such controls are mandatory for wood packaging and pallet material as well (Article 11). To be imported, plant protection products have to be registered in Albania, which requires their prior registration for marketing in an EU member State. Imports must be accompanied by a certificate of analysis of the active substances and an import licence of the economic operator. The technical manager of the importer being a graduate of the Faculty of Agronomy in Albania continues to be a condition to obtain such a licence. Exports require a phytosanitary export certificate, with exports of fruits and vegetables also falling under Law No. 105/2016

3.78.  The Minister of Agriculture and Rural Development also issued some pest‑specific ordinances in 2022 (aimed at limiting the spread of Xylellafastidiosa and tomato brown rugose fruit virus (ToBRFV)). The diagnosis of pests is done according to the diagnostic standards of the International Plant Protection Convention (IPPC). Phytosanitary issues are covered by the Strategy for Agriculture, Rural Development and Fisheries, 2021‑27

3.79.  There is no specific legal framework in place to regulate the release of genetically modified organisms (GMOs) into the environment, but the Law on Food regulates the marketing of food containing GMOs under certain circumstances. In 2020, new rules regarding animal feed labelling, including those containing GMO, were approved.[157]

3.80.  Albania is a member of the Codex Alimentarius Commission, the World Organisation for Animal Health (WOAH, formerly OIE), the European and Mediterranean Plant Protection Organization (EPPO), and a contracting party to the IPPC. It has also signed three regional phytosanitary cooperation agreements between 2018 and 2022

3.81.  During the review period, Albania filed 16 SPS notifications to the WTO in 2016 and 2017, mostly relating to the notification of emergency measures

3.60.  The framework relating to standards and technical regulations remains largely unchanged from the previous Review with the exception of a new Law on Metrology (Law No. 126/2020) adopted in 2020

3.61.  The General Directorate of Standardization (DPS), reporting to the Ministry of Finance and Economy, is the national standards body in charge of standardization activities and remains responsible for the development and adoption of standards. It also remains the notifying authority and enquiry point for the WTO. Following some amendments to the Law on Standardization (Law No. 9870/2008) in 2020, it plays the same role under CEFTA, and is also tasked with implementing obligations relating to EU directives and regulations in the area of standardization. Council of Ministers Decision No. 382/2018 spelled out some elements of standardization activities in more detail, and was amended in 2021 to reflect requirements of EU Regulation 1025/2012 on European Standardization, inter alia, regarding transparency and participation. DPS is a full member of the European Telecommunication Standards Institute (ETSI), an affiliate member of the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (CENELEC)[146], and an associate member of the International Electrotechnical Commission (IEC)

3.62.  Standards are developed and approved by the DPS, with inputs from relevant stakeholders and from public consultations. Based on proposals by the technical committees at DPS, a Technical Board approves new standards to be developed in a work programme. Draft standards are published for comments, before being finalized by a relevant technical committee at DPS, composed of various stakeholders.[147]

3.63.  Once adopted, Albanian Standards are published on the website of the DPS and in the National Standards Catalogue. Since 2016, around 13,000 European Standards and 4,500 international standards have been adopted as national standards. According to the authorities, of the nearly 40,000 Albanian Standards adopted, more than 90% are aligned with European Standards

3.64.  Technical regulations are adopted by Council of Ministers Decisions. They are either based on EU Regulations or Directives and Harmonized Albanian Standards or other national standards. Harmonized Albanian Standards simply reflect an underlying Harmonized European Standard[148] and are adopted by the DPS before a European technical regulation is transposed into domestic law, with the list of Harmonized Albanian Standards (or changes to them) published in the Official Gazette. At the end of 2022, 29 technical regulations were in place in Albania, 16 of which were issued during the review period. All technical regulations are harmonized with the EU technical regulations, according to the authorities, with most of them based on Albanian Harmonized Standards (using the system of presumption of conformity)

3.65.  All goods subject to a technical regulation need to demonstrate compliance before being marketed. For imports, such compliance must be demonstrated as part of their clearance. According to the Law on Marketing and Market Surveillance of Non‑food Products, consignments require a declaration of conformity from the manufacturer and the conformity marking affixed on the product in case products are subject to Albanian Harmonized Standards or European Harmonized Standards where the presumption of conformity applies. [149] For goods subject to a technical regulation not based on a harmonized standard (such as detergents, textile, crystal glass, aerosol dispensers, or footwear), detailed requirements such as those regarding the labelling, display of information, or composition are specified in respective legal acts

3.66.  Complementing the conformity system, a system for market surveillance remains in place, with Law No. 10489/2011 spelling out the system for non-food products. In 2016, an Inspectorate for Market Surveillance, reporting to the Ministry of Finance and Economy, was established. It is tasked, inter alia, with overseeing the market for non‑food consumer products in terms of safety, consumer protection, copyrights and related rights (Section 3.3.7), and energy labelling.[150] According to a recent assessment by the European Commission, the Albanian legislation regarding market surveillance is partially aligned with the EU acquis.[151]

3.67.  The national accreditation body performing the accreditation of testing, calibration, and medical laboratories, as well as inspection and certification bodies remains the General Directorate of Accreditation (DPA) in line with Law No. 116/2014 on Accreditation of Conformity Assessment Bodies in the Republic of Albania. According to the authorities, accreditation is undertaken in accordance with European and international standards. At the end of 2022, there were 102 accredited conformity assessment laboratories and bodies. DPA is member of the European co‑operation for Accreditation (EA) and has signed the EA MLA, accepting equivalence of accreditation systems and the reliability of conformity assessment results by accredited Conformity Assessment Bodies (CABs), in fields of testing (2015), inspection (2018), management system certification (2018), and persons certification (2020). As a result, DPA recognizes the conformity assessment results issued by CABs accredited by peer‑evaluated accreditation bodies under the EA MLA

3.68.  DPA is also full member of ILAC in the field of testing (2016) and inspection (2018) and is an accreditation body member of the IAF and signatory member of IAF MLA in the field of management system certification (2018) and persons certification (2022). In addition, DPA has signed MoUs with accreditation bodies in a number of neighbouring and European countries and signed a trilateral agreement covering the acceptance of conformity assessment results (similar to that covered by the EA MLA) with North Macedonia and Serbia in 2021, related to CEFTA provisions. While the SAA foresees the conclusion of an Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) between Albania and the European Union, negotiations had not yet started by the middle of 2023

3.69.  Replacing an earlier law from 2008, the new law on Metrology (Law No. 126/2020) and its implementing regulation aim to strengthen the metrological system overall, and to improve consumer protection and public health. The General Metrology Directorate (DPM) under the Ministry of Finance and Economy as national metrology body is a member of a number of international organizations in the field of metrology, including the European Association of National Metrology Institutes (EURAMET). Laboratories of National Measurement Standards at DPM operate according to a Quality Management System that complies with the requirements of standard ISO/IEC 17025:2017 according to the authorities, based on a EURAMET peer review. Since 2019, DPM has registered the measurement and calibration capabilities in the database of the International Bureau of Weights and Measures in the fields of mass, volume, and pressure according to the requirements of the International Committee for Weights and Measures MRA.[152]

3.70.  Since 2018, food products are labelled in line with Council of Ministers Decision No. 434/2018 on food labelling and consumer information, replacing an earlier 2008 Regulation. The Decision is partially aligned with requirements of the relevant EU Regulation 1169/2011, aims to increase consumer protection, and includes a requirement to present nutritional information and ingredients. According to the authorities, the decision also aims to increase consumer protection and product quality, and facilitate the movement of food products. Law No. 105/2014 on Drugs and Pharmaceutical Services (which was amended in 2021 and early 2023) regulates the labelling of pharmaceutical products, while Law No. 26/2017 regulates the labelling of cosmetics

3.71.  In 2016, Albania adopted a new law on organic production, labelling, and control, replacing an earlier law from 2008.[153] Imports can be marketed as organic if importers demonstrate that products have been produced with equivalent practices as spelled out in the law, with products certified as organic by a EU member State control body (or one considered equivalent to them) automatically considered as equivalent in Albania (Article 37). According to the authorities, a new law on organic production is being drafted to reflect recent changes in EU legislation, and is expected to be adopted in 2024

3.72.  During the review period, Albania filed 19 TBT notifications to the WTO, mostly under Article 2.9