The Eswatini Biosafety Framework consists of a Policy on Biotechnology which was formulated prior to the Legislative framework. Then in terms of the legislative framework, Eswatini enacted the Biosafety Act of 2012 as amended in 2020. The scope of this legislative provides for the regulation of LMOs for contained use, environmental release and Food, feed and processing. Guidelines for emergency response measures for unintentional introduction into the environment have also been developed. Draft regulations have been formulated, but still pending endorsement by Parliament.

• Eswatini has a solid legislative foundation, but regulations and operationalization are still evolving, as some national measures are only partially in place. The Biosafety Act of 2012, as amended in 2020, provides the statutory basis for biosafety regulation. However, the supporting regulations are still in draft form and await approval and gazettement, which constrains comprehensive implementation. • The Eswatini Environment Authority (EEA) is the designated Competent Authority for biosafety. All regulatory decisions under the Act are made through this Competent Authority, drawing on technical reviews and risk assessments conducted by the National Biosafety Advisory Committee (NBAC). The NBAC provides scientific and technical advice to inform evidence-based regulatory decision-making. • A key regulatory challenge is the limited human resource capacity within the Competent Authority. Only a very small number of personnel are directly involved in the regulation of biosafety, placing significant constraints on the Authority’s ability to efficiently conduct oversight, and ensure effective enforcement. In addition, the EEA has not yet been decentralized, further limiting regulatory reach at the national level. • Biosafety has been mainstreamed into several sectoral policies, supporting inter-institutional coordination. Regulation of transboundary movements is implemented through collaboration between the Competent Authority and border management agencies at ports of entry, which inspect consignments and their accompanying documentation. Overall, while Eswatini has established the core legal and institutional mechanisms for biosafety regulation, strengthening human resource capacity and finalizing the regulatory framework remain critical priorities for the Competent Authority

Pharmaceuticals are regulated by the Medicines and Related Substances Control Act, 2016 and the Pharmacy Act, 1929 which are under the Ministry of Health

Eswatini continues to implement its biosafety regulatory framework in accordance with the obligations under the Cartagena Protocol on Biosafety. During the reporting period, no applications were received for Living Modified Organisms (LMOs) intended for transit. With respect to contained use, no new applications were submitted within the current reporting quarter. Previous regulatory actions included the assessment and authorization of LMOs for contained use, specifically field trials involving genetically modified cotton varieties imported from India. These trials were conducted in designated cotton-growing areas by the Eswatini Cotton Board in collaboration with the research unit of the Ministry of Agriculture, in compliance with established biosafety requirements.

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• To date, Eswatini has not exported any LMOs, nor has it handled LMOs in transit to other countries but handled imports. All LMO imports have been preceded by notifications from the exporting Parties, in line with the Protocol requirements. • During the current reporting period, Eswatini received one notification and an application for environmental release and placing on the market of MON 15985, MON 88913 and MON 15985 × MON 88913 cotton varieties from South Africa. Following a regulatory review and decision-making process, all three varieties were approved for environmental release in Eswatini. These approvals were granted subject to specific conditions, with a strong emphasis on product stewardship to ensure their safe and responsible use. To date, Eswatini, through the Cotton Board has imported 600 kg of the LMO quoted on the permit. The variety was Candia BGRF, supplied by Cotton Seed Enterprise (PTY) LTD Registration Number 2019/623800/07. The Date of Entry and Delivery: 14th October,2025. To date, 80 Hectares of these cotton varieties have planted.

• Eswatini imports both yellow and white genetically modified (GM) maize, for direct use as food, feed, and for processing (FFPs). On average, nine to ten regulatory decisions are issued per quarter to authorize the transboundary movement of these LMOs from South Africa. • The GM maize imported as FFPs comprises of events that have already been approved in South Africa. Permits authorizing the transboundary movement of LMOs for FFP use are issued by both South Africa and Eswatini in accordance with Protocol and national Regulatory requirements. • Based on sufficient experience and information to conclude regarding the safe use of these events imported from South Africa, the transboundary movements of LMOs for FFPs have been subjected to simplified measures under section 19 of the Biosafety Act, 2012. • Imported LMOs for FFPs are however required to be milled before placing on the market to avoid DNA transfer to potential maize landraces.

The Biosafety Act, 2012 as amended in 2020] does provide for mechanisms for the review of decisions made (Section 21). The decision to review may be triggered by both the applicant (Party of exporter/notifier) or the Competent Authority (country of importer). A request to review or reasons for review of decision and notification are communicated within 90 days through a written decision or request. • To date, Eswatini has not yet reviewed or received a request to review a decision made. • The Act further does provide mechanisms for appeals on decision made, to which, none have been received yet.

• Section 19 of the Biosafety Act (2012, as amended 2020) allows LMOs to undergo simplified regulatory procedures when sufficient evidence and experience indicate they pose no significant risk to biodiversity or human health. • Imports of LMOs from approved events in South Africa, have been subjected to simplified regulatory procedures. • Environmental release environment and placing on the market of MON 15985, MON 88913 and MON 15985 × MON 88913 cotton varieties from South Africa were subjected to simplified procedures owing to the experience and vast weight of evidence demonstrating the history of safe use and cultivation in the region with similar environmental conditions.

None yet. Eswatini has however participated in COMESA initiatives on data transportability on LMOs. Bilateral of regional arrangements and decisions have however not been made.

The Biosafety Act, 2012 as amended 2020, calls for the Competent Authority (CA), EEA to ensure that all decisions made are backed up by a risk assessment. The Risk assessment process is conducted in a scientific manner and adopts the guidance materials as issued by the SCBD, and other guidance materials from AUDA-NEPAD for example. The National Biosafety Advisory Committee (NBAC) conducts and or review the risk assessment taking into consideration the information that has been submitted by the applicant as well as any other information that can be found in databases such as the Biosafety Clearing House (BCH), the Organization for Economic Co-operation and Development (OECD) and literature from accredited sources. Upon conclusion of the risk assessment and auditing process, the NBAC provides the CA with a risk assessment report that gives its opinion on whether a permit should be given or denied, with reasons. Risk assessment is carried out for all applications received for Confined field trials, introduction to the environment, Food, Feed and Processing as well as import, exports and on transit applications. In this reporting time, only one application was received for environmental release and placing on the market of MON 15985, MON 88913 and MON 15985 × MON 88913 cotton varieties from Bayer South Africa. Following a risk assessment review process, a decision was made, and all three varieties were approved for environmental release.

In this reporting time, there had been no known cases of LMOs within Eswatini’s jurisdiction that may have led to unintentional transboundary movement. LMOs released in Eswatini are genetically modified cotton, that is provided by Eswatini Cotton Board to selected commercial farmers, whose geographical location and monitoring is regulated by the same. All cotton planted in Eswatini, including GM cotton is sold back to the Cotton Board. Seeds from the ginnery are collected and processed as FFPs. Regarding unintentional transboundary movement into Eswatini, there were no formal cases recorded by the CP, however there are indications that such happened. As part of the monitoring efforts, an assessment of the prevalence of GM maize in both harvested grain from farmers and maize seed distributed within the country was conducted in 2022/2023 growing seasons. Sampling was done from suspected cases and areas near borderlines. The assessment revealed some prevalence of GM maize in harvested grain. The most prevalent modification was for herbicide tolerance with 50%, while Cry 1Ac and Cry 2A both had 25% each. All the insect-resistant results were also stacked events with the herbicide tolerance, while not all the herbicide-tolerant events were stacked events. This presented an indication of possible seed smuggling through the informal crossings of the country. It worth noting, that there has not been a permit for environmental release of any GM maize varieties yet. Efforts have been made to raise awareness with targeted farmers mostly at the periphery of the borderlines. Capacity has been strengthened with the agricultural extension officers, enforcement agencies as well as border management agencies to curb the observed unintentional transboundary movement. The capacity to monitor, and enforce through the informal crossings, is however limited and challenged.

The Biosafety Act, 2012 requires that LMOs that are intended for intentional introduction into the environment, for CFTs, contained use and for FFPs be accompanied by documentation specific for the LMO, including storage and handling information. These are requirements are enforced at transboundary movement. The role of custom officers and the other boarder management agencies is periodically advocated. To execute this function, the EEA as the competent authority collaborates with the Eswatini Revenue Services-Customs division, and the other regulatory agencies like NAMBOARD, Ministry of Agriculture and Port health in the enforcement of these requirements. Periodic training sessions were held for customs officers and the other border management agencies. There is a very urgent need to strengthen the capacity to detect and identify such LMOs. There is currently one lab facility that can handle detection of LMOs. It is however challenged as well, with very limited lab personnel, equipment and not certified for LMO detection

The Biosafety Act of 2012, as amended, 2020] designate The Eswatini Environment Authority (EEA) as the National Competent Authority and the Focal Point. Collaboration among the institutional structures is well defined. The EEA, as the competent authority performs the coordination role. The National Biosafety Advisory Committee performing advisory function to the EEA, is multidisciplinary in its composition, drawing expertise from civil society, industry, scientist, farmers, trade and health experts.

Backload on pending information for uploading, change of dedicated staff for BCH hence uploading credentials and capacity were limited. Internet speed. Some data was held by other institution, however this assignment presented the opportunity to collate such data.

A backlog of pending information for uploading to the Biosafety Clearing-House (BCH) was experienced during the reporting period. This was primarily due to changes in dedicated BCH staff, which resulted in limited access to uploading credentials and reduced operational capacity. Technical constraints, including slow internet connectivity, further affected timely data submission. In addition, certain relevant data were held by other institutions, which contributed to delays. However, the reporting process provided an opportunity to engage with the relevant stakeholders and collate the outstanding information and update all pending information into the BCH.

In this reporting period, an application received for intentional environmental release, some information was subjected to this clause. The notifier triggered the request and was honoured by the regulator.

• In accordance with Article 22 of the Cartagena Protocol on Biosafety, the Kingdom of Eswatini has undertaken efforts to strengthen national capacities for the effective implementation of its biosafety framework. Notwithstanding these efforts, significant capacity building gaps remain and continue to affect the country’s ability to fully meet its obligations under the Protocol • Eswatini’s most recent biosafety capacity needs assessment was conducted in 2012. Since then, no comprehensive update has been undertaken to reflect emerging biotechnologies, evolving regulatory requirements, new obligations related to post-release monitoring and compliance. The absence of an updated assessment limits evidence-based planning and prioritization of capacity building interventions • Human capacity development remains constrained by insufficient and unsustainable financial resources, resulting in limited national expertise in key technical areas such as LMO risk assessment and risk management, detection and identification of LMOs, compliance and enforcement, and post release monitoring. These challenges are compounded by limited human resources and infrastructure within the competent authority, which affects coordination, information management, reporting to the Biosafety Clearing-House, and overall regulatory effectiveness. • Coordination of biosafety related capacity building initiatives across relevant institutions remains limited, largely due to financial constraints and the absence of a dedicated, long-term national biosafety capacity building programme. As a result, capacity building efforts are largely project-based, fragmented, and dependent on external funding. • Strengthening transboundary controls and post release monitoring capacity has been identified as a priority. Existing capacities at points of entry require enhancement, including training of border and customs officials, provision of appropriate detection tools, and development of standard operating procedures. Post release monitoring systems also require strengthening to ensure timely detection and management of potential adverse effects on biological diversity and human health. • Eswatini’s experience in accessing GEF funding for biosafety capacity building has been constrained by several factors. Biosafety competes with other national priorities under the GEF System for Transparent Allocation of Resources (STAR). In previous GEF programming cycles, country dialogues were not systematically conducted, and as such national focal points for the Cartagena Protocol were not always fully involved, limiting the integration of biosafety priorities into national GEF portfolios. • Additional challenges include the limited number of GEF agencies with specialized technical capacity in biosafety, as well as the competitive funding modalities of emerging mechanisms such as the Global Biodiversity Framework Fund (GBFF), whose selection criteria favour large, multi-disciplinary projects and make it difficult to secure support for targeted biosafety capacity-building initiatives.

The Biosafety Act, 2012 establishes provisions for public awareness and participation in biosafety decision-making, including opportunities for stakeholders to submit comments and objections during regulatory processes. During the reporting period, several public awareness and engagement activities were undertaken. These included farmer dialogues, radio interviews and programmes, as well as targeted awareness initiatives involving agricultural extension officers. In addition, public consultation mechanisms were applied in decision-making processes for applications received. Public notices were disseminated through newspaper advertisements and social media platforms to invite public input. Stakeholders actively participated by submitting comments, which were duly considered and informed the decisions taken.

In this reporting quarter, there has been no interactions with non-parties

There had been discovered cases of illegal transboundary movement from molecular assessments done on harvested grain, however these analysis did not extend to establishing the origin. Indications, though are pointing to neighbouring state with free access to the GM seed since most of the lines have been deregulated. However, there has been no legal case.

The Biosafety Act requires that decisions on living modified organisms (LMOs) protect human health and biodiversity while also considering socio-economic impacts. Section 18 ensures that public inputs are incorporated through the decision-making process. In practice, socio-economic factors are being applied in regulatory decisions. For example, the recent assessment of genetically modified cotton varieties considered farmer uptake, seed costs, community acceptance, and farmer preparedness alongside environmental and health risks. While the legal and procedural framework is established, further practical experience will help refine the integration of socio-economic considerations in national decision-making

The Kingdom of Eswatini has benefited from collaboration with the African Union Development Agency – NEPAD (AUDA-NEPAD) in strengthening national oversight of biotechnology, particularly in relation to living modified organisms (LMOs). This support has largely been delivered through the African Biosafety Network of Expertise (ABNE), which provides technical assistance and capacity building to African Union Member States to develop functional, science-based biosafety regulatory systems. Through this partnership, Eswatini’s regulators and biosafety stakeholders have participated in national and regional training programmes focused on risk assessment, regulatory decision-making, and the review of applications involving LMOs. The technical backstopping and knowledge-sharing platforms facilitated by AUDA-NEPAD have contributed to strengthening institutional competence and enhancing the implementation of the national biosafety framework in line with international best practice. In addition, AUDA-NEPAD has supported preparatory coordination and technical support linked to meetings under the Convention on Biological Diversity and its protocols, including the Cartagena Protocol on Biosafety. Through these mechanisms, Eswatini has been better positioned to participate in global biosafety deliberations, including Conference of the Parties meetings, and to align its national regulatory approach with evolving international standards.

The amendment of the Biosafety Act in 2020 to give guidance on liability and redress

The 2020 amendment to the Act introduced significant reforms to Section 32, which governs liability and redress. The amendment transitioned the liability framework from a joint and several liability model to a fault-based approach. While the definition of “operator” continues to encompass all persons within the chain of activity, liability for redress is now attributed specifically to the operator determined to be at fault. From an implementation standpoint, these revised provisions have not yet been operationally tested, as no reported and verified cases of damage have triggered the redress mechanism under the amended framework. Consequently, practical jurisprudence and administrative practice in this area remain undeveloped. Furthermore, it is important to note that the country has not yet established dedicated financial security mechanisms to cover damage, as contemplated under the Supplementary Protocol on Liability and Redress. Consideration of such mechanisms remains a pending policy matter in the broader context of strengthening the national biosafety liability regime. Overall, while the core legislative amendments necessary to align domestic law with the principles of the Supplementary Protocol have been enacted, full operationalisation particularly with respect to financial security arrangements and tested enforcement practice remains in progress