Law no. 84/2020 on the acceptance of decision II/1 of the parties, amending the “Aarhus convention on the right of the public to have information, to participate in decision-making and to address the court for environmental matters", ratified by law no . 8672, dated 26.10.2000. LAW No. 106, 2016 on the production, processing, certification and marketing of “bio products” ▪ Some provisions are introduced by this Law: ▪ Article 5 ”General principles” that exclude the use of GMOs and products produced from or with GMOs. ▪ Article 9 ”Prohibition of the use of GMOs” ▪ Some provisions for Genetically Modified Feed are introduced by the Food Law: LAW, No. 9863, dated 28.1.2008, “ON FOOD” (amended by Law No. 74/2013, dated 14.2.2013; No. 8/2019, dated 26.2.2019; No. 16/2020, dated 12.2.2020; No. 10/2022, dated 27.1.2021, published in the Official Gazette number 33, dated 28. 2. 2022. ▪ Some provisions for Genetically Modified Feed are introduced by the Food Law: ▪ Chapter XIV “Feed” Decision of Council of Ministers, No. 406, dated 20.5.2020 “On approval of the rules on labelling of feed used for food, including those consisting or containing GMOs", published in the Official Gazette number: 95, dated 27 May 2020. Responsibilities and functions set forth in law no. 9863, dated 28.01.2008 "On food", amended and DCM no. 708, dated 9.9.2020 "On the organization and operation of NFA“. With the new organization of the Ministry of Agriculture and Rural Development in July 2022, the GMO field is covered by the sector of Seeds, Seedlings and Fertilizer Products. Albania is not dealing yet with GM food safety assessment. However, food safety assessment provisions as well as provision on the commercialization of GM food as new food is lay down at Food Law No. 9863, date 28.1.2008 . Furthermore, Albania, as candidate for EU accession, it is working to approximate the regulatory framework in food standards and safety with the European legal framework. National Food Authority http://aku.gov.al/aku_new/ deals with the national administration in food safety and consumer protection. There is no regulations on stacked events. Albania does not produce any GM food or feed. Albania has not faced any LLP/AP situations in the last 10 years. Albania is in the process of developing regulations/policies on GM food labeling. In the market of the Republic of Albania, no authorizations have been given for the release on the market of food, food ingredients and feed that contain or consist of Genetically Modified Organisms (GMO). Albania need support for drafting The law "On Genetically Modified Organisms (GMOs)“. • The transposition of the regulations of GMOs is expected to be done within 2028. • Albania will evaluate the existing system and if necessary adapt it according to the needs for the implementation of the new law. It is also identified that there is a need to: • Assessment of laboratory capacity for GMO • Training administrative staff • Training of the inspectors for official controls • Rising awareness about GMOs • Monitoring plan

Compliance with the provisions of Article 5, for not applying the Protocol to the transboundary movement of living modified organisms which are pharmaceuticals for humans.

Import of LMOs are prohibited since 2011 in Albania for an undefined period, until the law changes.

This has been done before the recent reporting period. Also, question 62: Albania has partial preventive measures in place, including some risk assessment and inspection procedures, but a comprehensive system to prevent unintentional transboundary movements, fully aligned with the Protocol, is still under development.

Question 95: Accredited GMO/LMO detection labs in Albania: None at present Accredited labs exist in other fields (environment, food, medicine), but not for GMO/LMO genetic testing. Regulatory GMO testing is therefore handled by sending samples abroad to accredited labs, with results accepted if the lab is accredited by an internationally recognized body.

c) Albania has engaged — formally or informally — with neighboring countries and EU member states on biosafety policy alignment, capacity strengthening, and risk assessment practice. Examples include: • Technical exchanges with EU member states on risk assessment methods and regulatory frameworks (often under EU accession harmonization processes). • Cooperation with regional partners in the Western Balkans on harmonizing biosafety approaches. While not always formalized as stand-alone bilateral biosafety treaties, these arrangements take the form of: • Memoranda of Understanding (MoUs) between ministries • Joint workshops or expert missions • Shared training programs on risk assessment and regulatory implementation Such cooperation is consistent with Article 20(3)(b) of the Protocol, which encourages Parties to facilitate cooperation. Albania participates in regional environmental and biosafety collaboration frameworks involving: • Western Balkan countries (e.g., Kosovo*, North Macedonia, Montenegro, Serbia) • Regional working groups on biosafety, biodiversity, and environmental law harmonization e) Legal and Regulatory Measures • As of the latest reporting, Albania has not yet established specific domestic legislation explicitly regulating the transit of LMOs. • The national biosafety framework, still under preparation, is expected to define conditions, documentation, and notifications for transit, consistent with Article 6 of the Protocol. Administrative Capacity • No formal procedures currently exist to require advance notification, risk assessment, or specific approval for LMOs merely transiting Albanian territory. • Transit shipments of LMOs are generally handled under standard customs and transport regulations, but without specific biosafety oversight. • Albania relies on international obligations to ensure that transit does not pose risks to the environment, but formal enforcement mechanisms for transit decisions are not yet in place. • LMOs intended solely for transit can move through Albania, subject to general import/export and customs procedures, but there is no separate Article 6(1) LMO transit permit or notification system in force. • The country’s competent authorities may become involved if transit raises safety, health, or environmental concerns, but no structured protocol exists yet. f) Albania does not yet have specific legislation that fully regulates the import of LMOs for contained use. • The draft national biosafety framework is expected to define: o Permitting procedures for LMO import for contained use • Risk assessment requirements • Conditions for handling, storage, transport, and monitoring within facilities • Currently, general customs and environmental regulations apply, but they do not specifically address the biosafety requirements for contained use LMOs. • Albania has designated competent authorities and a national focal point for biosafety. • However, there is no fully operational system to process applications or decisions regarding import of LMOs for contained use. • Administrative functions such as: o Performing risk assessments • Issuing import authorizations • Monitoring compliance within facilities are not yet in place. g) Currently, if an LMO release occurs that could potentially cross borders, Albania does not have a structured mechanism to notify affected countries, though general environmental and health reporting systems may provide partial information. Notifications would need to comply with the Biosafety Clearing-House (BCH) format once the legal and administrative framework is operational. h) To date, no cases of illegal transboundary movement of LMOs have been officially reported by Albania to the BCH. Any enforcement action would fall under general customs, environmental, or health regulations rather than a specific LMO/biosafety legal framework. i) At present, any import of LMOs intended for environmental release is effectively not regulated under a dedicated biosafety system. j) Since there is no dedicated LMO regulatory system in operation, Albania cannot yet provide detailed information on the application of domestic regulations to specific LMO imports. Any oversight of imports currently occurs under general customs, environmental, or health regulations, which do not provide the specificity or documentation required by Article 14(4). k) At present, LMOs intended for domestic use as food, feed, or processing are effectively unregulated under a dedicated biosafety framework. Any imports or domestic uses are managed under general customs, food safety, or agricultural regulations rather than a Cartagena Protocol-compliant process. l) Albania currently does not have a formal regulatory system for reviewing or approving imports of LMO-FFPs. Oversight is managed under general customs, agricultural, or food safety regulations. Draft biosafety framework plans to establish formal procedures, risk assessment, and approval mechanisms. m) No official declaration or framework for LMO-FFPs has been submitted to the Biosafety Clearing-House (BCH). Planned in draft national biosafety law. n) No formal mechanism exists in Albania to review or revise prior decisions regarding intentional transboundary movement. Decision-making procedures are not yet implemented. o) Albania has no established procedures for simultaneous notification and movement of LMOs. Draft regulations are expected to define such cases and conditions. p) No exemptions have been defined; Albania does not yet regulate which LMOs may bypass the AIA procedure. q) Albania has no domestic system to generate or report summaries of risk assessments or environmental reviews for LMOs. Such reporting is planned under the draft biosafety framework.

Question 119: During the recent reporting period, Albania focused on strengthening its biosafety system by developing legal and regulatory frameworks, enhancing scientific capacity for risk assessment and management of LMOs, and building institutional coordination among competent authorities and national focal points. Activities included training laboratory personnel in LMO detection, improving information management for the Biosafety Clearing-House, raising stakeholder awareness, and enhancing monitoring and enforcement capabilities. These combined efforts aim to establish a functional national biosafety framework aligned with the Cartagena Protocol. Question 120: During the current reporting period, Albania carried out assessments to identify gaps in legal, scientific, technical, and institutional capacities for implementing the Cartagena Protocol. These assessments helped prioritize training, laboratory upgrades, and regulatory improvements. Question 124: Recent notifications and workshops under the Cartagena Protocol (e.g., capacity-building forums, nominations for risk assessment training in 2025) indicate ongoing engagement in capacity-building processes during the 2020–2025 period. While formal national legislation on biosafety is still being finalized, these actions show that Albania has been actively identifying and prioritizing capacity-building needs within the 2020–2025 reporting cycle to address gaps in risk assessment, BCH participation, and institutional coordination.

During the recent reporting period, Albania has made progress in raising awareness and building capacity for public participation in biosafety. Efforts included stakeholder workshops, training programs, and use of online resources, as well as partial integration of biosafety in education for regulators and technical staff. However, formal mechanisms for public access to information, structured consultation processes, and a national communication strategy remain under development, and there is no dedicated national biosafety website. Decisions on LMOs are not yet systematically published, and public awareness of the Biosafety Clearing-House is limited. These gaps are being addressed through ongoing GEF-supported capacity-building and the draft national biosafety framework.

Albania has preventive and enforcement mechanisms through general environmental and customs laws, but dedicated LMO-specific penalties are not yet operational. No illegal LMO movements have been detected or reported in the recent period.

Answer to Question 155 e): Yes, to some extent, project based focused Regulatory frameworks, training, public awareness, and institutional capacity. But still there are Gaps remaining: Fully accredited labs, formalized administrative procedures, and routine LMO monitoring