Law on Genetically Modified Organisms (Official Gazette of Montenegro No. 22/2008, as amended e.g. No. 40/2011): establishes the core national framework for the use of GMOs and products containing/derived from GMOs, Law on Food Safety (Official Gazette of Montenegro No. 57/2015): provides the overarching food/feed safety framework relevant to GMO-related controls, traceability/market measures and competent authority functions. Law on Seed Material of Agricultural Plants (Official Gazette of Republic of Montenegro No. 28/2006; Official Gazette of Montenegro Nos. 61/2011, 48/2015): provides the legal basis for seed production/marketing controls and refers to the application of GMO legislation to GM seed material, Law on Planting Material (Official Gazette of Republic of Montenegro, no 28/2006; Official Gazette of Montenegro Nos. 61/2011, 48/2015): provides the legal basis for planting material production/marketing controls and cross-references GMO legislation (relevant for monitoring and control), Law on Environment (Official Gazette of Montenegro No. 52/2016, as amended e.g. 73/2019, 84/2024): includes provisions relevant to protection from adverse environmental impacts of GMOs and public access to environmental information. Law on Medicines (Official Gazette of Montenegro No. 80/2020, as amended by 84/2024 and 35/2025): includes specific provisions relevant to medicines containing GMOs. Bylaws: Government Regulation on the conditions and manner of use of genetically modified food and/or feed (Official Gazette of Montenegro No. 9/2019, in force from 16 February 2019): regulates use, traceability and labelling of GM food/feed. Rulebook on methods of sampling and laboratory feed testing on presence of geneticaly modified organisms (Official Gazette of Montenegro 57/15). Programme of control testing of seed and planting material for GMOs published each year since 201: establishes official control measures for the detection of potential GMO presence in imported and marketed seed and planting material.

The practical implementation of biosafety measures remains limited due to the absence of specialized biosafety experts and fully operational laboratory capacities. To date, no applications for the deliberate release or placing on the market of LMOs have been submitted, and all GMOs remain prohibited in Montenegro. Further strengthening of human and technical capacities is required to fully implement the Protocol.

Montenegro regulates both transit and contained use of LMOs under the Law on Genetically Modified Organisms. The Law covers transit through the territory of Montenegro and provides that transit is carried out in accordance with veterinary, plant health and customs regulations (Articles 1, 2 and 52). Contained use is regulated through a risk-based system (levels 1–4), registration of contained facilities, mandatory risk assessment and approval procedures (Articles 26–31). Import/transboundary movement is subject to authorization under the Law (Articles 21 and 46).

Montenegro has established a legal framework for the advance informed agreement (AIA) procedure through the Law on Genetically Modified Organisms. The Law requires prior authorization for any intentional transboundary movement of LMOs intended for deliberate introduction into the environment and prescribes notification requirements, completeness and accuracy of submitted information, and risk assessment prior to decision-making. Decisions are taken on a case-by-case basis, in accordance with the precautionary principle, including in situations of scientific uncertainty. To date, no notifications or applications for intentional transboundary movements of LMOs for introduction into the environment have been submitted, and therefore no decisions have been taken.

ontenegro regulates LMOs intended for direct use as food or feed, or for processing under the Food Safety Law (Official Gazette of Montenegro, No. 57/2015) and the Regulation on the Conditions and Manner of Use, Traceability and Labelling of Genetically Modified Food or Feed (Official Gazette of Montenegro, No. 9/2019).

Montenegro has established a legal mechanism for the review and modification of decisions related to intentional transboundary movement of LMOs under the Law on Genetically Modified Organisms (Official Gazette of Montenegro, No. 22/2008), which allows decisions to be reconsidered in light of new scientific or technical information. However, during the current reporting period, no decisions on intentional transboundary movement of LMOs were taken and therefore no reviews or changes of decisions were conducted.

Montenegro has a legal framework requiring risk assessment and risk management of LMOs; however, these mechanisms have not been applied in practice due to the absence of applications for approval of LMOs. Capacity-building activities, including UNEP-supported national workshops in 2023, have strengthened institutional awareness and basic technical knowledge, while laboratory analyses are conducted through accredited laboratories abroad.

Through inspection services (phytosanitary, veterinary and food inspection), the ban on GMOs, border controls, RASFF and international cooperation, a reactive response capacity exists, although it has not been tested by an actual event

Laboratory analyses, when required, are performed in an authorized accredited laboratory in Osijek, Croatia, as Montenegro does not have a domestic laboratory for GMO detection.

Competent national authorities and focal points are designated. Implementation has focused mainly on administrative functions and capacity-building, as no LMO cases have occurred.

Several categories of information are not available in the BCH because no decisions or cases related to LMOs have occurred in Montenegro during the reporting period

Montenegro regularly updates mandatory information in the BCH; however, substantive entries remain limited due to the absence of LMO applications or decisions.

Confidential information is protected in accordance with national legislation

Capacity-building activities were mainly supported through UNEP-funded projects and focused on institutional strengthening, awareness-raising and reporting under the Cartagena Protocol; further needs remain in laboratory infrastructure and technical expertise.

Public awareness and participation activities were mainly implemented through a UNEP-supported project focused on the preparation of the Fourth National Biosafety Report, including three national workshops held in 2023 for inspectors, customs officers, public officials and academic representatives. Activities were primarily informational and capacity-building in nature, as no LMO decision-making processes occurred during the reporting period

Montenegro is not a Party to the Nagoya–Kuala Lumpur Supplementary Protocol; therefore, no specific measures or activities under the Supplementary Protocol were undertaken during the reporting period.