Several scientific initiatives are underway to modernise and advance chemical environmental risk assessment (ERA), supporting the shift from conventional practices toward more mechanistic, integrated, and systems-based approaches. These developments aim to enhance ecological realism, improve predictive capacity, reduce reliance on animal testing, and foster greater alignment across sectors, ultimately contributing to better protection of biodiversity and the environment. Yet, translating these innovative approaches into regulatory practice remains challenging due to fragmented efforts and limited alignment between research and policy. To address this gap, the European Partnership for the Assessment of Risks from Chemicals (PARC) is fostering structured dialogue and stakeholder engagement to align research and innovation with regulatory needs. Within PARC, a proposed solution is the development of the MIND platform—Map, Integrate, Network, Drive—envisioned as a strategic and collaborative space that connects people, practices, and resources across disciplines and regulatory domains. MIND aims to encourage collaboration and knowledge sharing and integration, gradually connecting fragmented initiatives to build a more integrated and interoperable ERA knowledge ecosystem. By encouraging collaboration, improving data sharing, and enhancing policy relevance, MIND seeks to accelerate the uptake of advanced ERA approaches in regulatory practice, with a particular focus on safeguarding biodiversity. Over time, this may contribute to Europe’s sustainability objectives and the ambitions of the European Green Deal.

At the request of the European Commission, EFSA assessed the 2024 post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810, which expresses the Cry1Ab protein. Using a weight-of-evidence approach and considering information provided by the consent holder and the Competent Authorities of Portugal and Spain, EFSA concluded that the PMEM report provides no evidence of unexpected adverse effects on human and animal health, or on the environment associated with the cultivation of maize MON 810 in 2024. Refuge compliance was generally high in Spain and fully achieved in Portugal. However, uncertainty remains in situations where clusters of small maize MON 810 fields may collectively exceed the 5-ha threshold requiring refuge implementation. No evidence of practical resistance to Cry1Ab was identified in European corn borer populations sampled in north-eastern Spain in 2024. Nevertheless, the consistently low Cry1Ab susceptibility observed in Mediterranean corn borer populations from this area between 2022 and 2024, together with unexpected field damage reported in Girona in 2021 as well as indications of resistance alleles detected in 2024, indicate that a decrease in susceptibility cannot be excluded. EFSA also considers that the current resistance monitoring strategy lacks sufficient sensitivity for the early detection of resistance evolution. General surveillance activities, including farmer questionnaires in Spain and annual literature searches, did not identify unanticipated adverse effects. However, uncertainty remains regarding the potential exposure of highly sensitive non-target Lepidoptera to maize MON 810 pollen due to the lack of implementation data on isolation distances toward protected habitats. EFSA also identified methodological and reporting shortcomings in both case-specific monitoring and general surveillance, while welcoming the continued efforts of the Competent Authorities of Spain to address data gaps and support refinement of monitoring and risk management measures. After more than two decades of cultivation without evidence of unexpected adverse environmental effects, EFSA considers that general surveillance could be streamlined to focus on two core elements: (1) a strengthened farmer complaint system, complemented where appropriate by existing plant health and pest monitoring networks; and (2) transparent and comprehensive annual literature searches.

The use of plant protection products (PPPs) remains a major concern for biodiversity, ecosystem integrity, and human health, even under robust regulatory oversight. Current regulatory assessments are often fragmented: they typically examine single substances and single crops in isolation at local or simplified scales. As a result, they struggle to capture the cumulative and combined effects of multiple PPPs and the way exposure propagates and interacts across space and time (fields, crops, and seasons). Our previously proposed landscape-based Environmental Risk Assessment (ERA) framework offered an integrative solution. By jointly representing agricultural practices, environmental characteristics, species movement among habitats, and the combined impacts of multiple PPPs, the current framework delivers predictions that are more adapted to the field reality. These insights are valuable both for regulatory decision-making and for understanding how PPP risks contribute to the overall environmental stress. In this manuscript, we explore the needs, challenges, opportunities, and modelling tools for implementing a landscape-based ERA in both prospective (ex-ante) and retrospective (ex-post) contexts. Drawing on expert discussions and collaborative initiatives, we propose a conceptual framework with four pillars: (1) flexibility to meet diverse user and stakeholder needs, different decision contexts, and varying data availability; (2) ecological realism, the capacity to represent multiple stressors, cumulative effects, exposure pathways driven by species movement, and recovery dynamics; (3) data integration and transparency, combining monitoring and regulatory datasets for calibration, validation, uncertainty analysis, and reproducibility; and (4) regulatory uptake and interoperability, ensuring compatibility with existing ERA methodologies and producing outputs that can be interpreted and used at the landscape level across jurisdictions and tools. Beyond regulatory compliance, landscape-based ERA is a dynamic and adaptative system that provides a robust scientific basis for setting protection goals, designing targeted risk mitigation measures, shaping sustainable agricultural strategies, and communicating realistic, multi-stressor risk trade-offs to stakeholders and the public.

In the European Union, regulated products such as plant protection products (PPPs) must undergo prospective environmental risk assessment (ERA) and obtain regulatory approval before use. ERA evaluates the potential adverse effects regulated products may pose to the environment, aiming to ensure that their use does not result in unacceptable effects. Despite ongoing improvements accumulated empirical evidence shows that current chemical ERA practices fall short of ensuring sufficient environmental protection, highlighting the need for better alignment with real-world ecological and agricultural conditions. Advancing ERA requires not only integrating a more realistic understanding of environmental contexts, but also fostering interdisciplinary collaboration and engaging stakeholders through knowledge-sharing platforms and partnerships. Within this context, the Partnership for the Assessment of Risks from Chemicals (PARC) is exploring new avenues to transform PPP ERA through six key actions: (1) clarifying regulatory needs to ensure regulatory relevance and facilitate regulatory uptake of project outcomes; (2) benchmarking ERA against real-world data for calibration and explore ways to simplify ERA processes; (3) improving ERA comparability to enable cross-substance comparison and ranking; (4) increasing ecological realism to deliver more realistic, context-dependent ERA predictions along with effective risk mitigation and sustainable use measures; (5) updating and modernising ERA approaches to reduce uncertainty, unnecessary complexity, and animal testing; and (6) fostering the transition toward a systems-based approach by interconnecting stakeholders and integrating data, knowledge and expertise across regulatory frameworks. In doing so, PARC aims to advance PPP ERA toward a holistic, systems-based ERA framework that supports the progressive phase-out of animal testing. Together, these efforts emphasise the urgent need for an interdisciplinary ERA platform that integrates scientific knowledge across domains, enhances biodiversity protection against chemical stressors, and drives the transition toward systems-based ERA for PPPs.

The European Food Safety Authority (EFSA) provides independent scientific advice to EU risk managers on a wide range of food safety issues and communicates on existing and emerging risks in the food chain. This advice helps to protect consumers, animals and the environment. Data are essential to EFSA's scientific assessments. EFSA collects data from various sources including scientific literature, biological and chemical monitoring programmes, as well as food consumption and composition databases. EFSA also assesses data from authorisation dossiers for regulated products submitted by the industry. To continue delivering the highest value for society, EFSA keeps abreast of new scientific, technological and societal developments. EFSA also engages in partnerships as an essential means to address the growing complexity in science and society and to better connect and integrate knowledge, data and expertise across sectors. This paper provides insights into EFSA's data-related activities and future perspectives in the following key areas of EFSA's 2027 strategy: one substance-one assessment, combined exposure to multiple chemicals, environmental risk assessment, new approach methodologies, antimicrobial resistance and risk-benefit assessment. EFSA's initiatives to integrate societal insights in its risk communication are also described.

The European Food Safety Authority (EFSA) convened a scientific colloquium to support two mandates from the European Commission to: (1) review and update the terrestrial ecotoxicology guidance; and (2) develop a framework/guidance for assessing indirect effects on biodiversity, particularly those mediated through trophic interactions. The event brought together experts and stakeholders to explore how indirect effects of plant protection products (PPPs) can be better integrated into prospective environmental risk assessment (ERA). Scientific presentations highlighted the ecological complexity of indirect effects, the central role of trophic interactions, and the vulnerability of ecosystem services. Speakers advocated for a stepwise, systems-based approach to ERA, supported by modelling tools and landscape-scale assessments, to reflect real-world exposure scenarios and ecological dynamics. The panel debate reinforced the importance of model transparency, data sharing, interdisciplinary collaboration, and regulatory coherence. Thematic breakout groups explored four key topics: (1) integrating indirect effects into ERA; (2) mitigating risks through improved agronomic and landscape practices; (3) identifying regulatory and research needs; and (4) harmonising fragmented frameworks. Participants called for refined specific protection goals, better data sharing, and practical tools to link direct and indirect effects. They also emphasised the need for adaptive governance, early stakeholder engagement, and co-creation of guidance. The colloquium is part of a shift toward more inclusive, transparent, and ecologically relevant ERA processes. Insights gathered will inform EFSA's ongoing work and contribute to the development of a harmonised EU framework for assessing indirect effects of PPPs, supporting both biodiversity conservation and sustainable agriculture.

Abstract This editorial provides an update on research & innovation (R&I) needs that can support EFSA's regulatory science in the coming years. The paper presents research needs for EFSA's work in a number of domains: omics technologies; gut microbiome; new approach methodologies (NAMs); allergenicity risk assessment; aggregate exposure assessment and environmental risk assessment (ERA). In briefly describing R&I needs, the document also addresses emerging challenges and opportunities. The authors acknowledge that this overview is not exhaustive and refer to earlier publications for additional R&I needs, as well as to the roadmaps for a more in‐depth presentation. Finally, the document calls for transdisciplinary research, reflecting on the interdependencies between human, animal, plant and environmental health. This editorial will be valuable to stakeholders, research agenda setters and funders, both public and private, in formulating calls for research and project funding related to food safety.

At the request of the European Commission, the European Food Safety Authority (EFSA) assessed the 2023 post-market environmental monitoring (PMEM) report on the cultivation of the genetically modified maize event MON 810, which expresses the Cry1Ab protein. The report provides no evidence of adverse effects from maize MON 810 cultivation. It confirms high refuge compliance among farmers in Spain and Portugal. However, uncertainty remains on compliance in areas where clustered maize MON 810 fields exceed five hectares. No signs of practical resistance to Cry1Ab were found in corn borer populations sampled in north-eastern Spain in 2023, although reduced susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information collected through farmer questionnaires in Spain and scientific literature searches revealed no unanticipated adverse effects on human and animal health, or on the environment. However, EFSA remains concerned about the potential exposure of non-target lepidopteran species classified as 'very highly' or 'extremely' susceptible to Cry1Ab to harmful amounts of maize MON 810 pollen. Several recommendations from previous PMEM report assessments remain unaddressed and new shortcomings were identified. Particularly, EFSA emphasises the urgent need to: (1) increase the sensitivity of the insect resistance monitoring strategy; (2) implement mitigation measures to ensure exposure of non-target lepidoptera to maize MON 810 pollen remains at levels of no concern; (3) harmonise farmer questionnaires across Spain and Portugal; and (4) revise the remedial action plan. Finally, EFSA acknowledges the proactive initiatives undertaken by the Competent Authorities of Spain in support of the PMEM activities and encourages continued collaboration to strengthen monitoring and risk management measures.

Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2022 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Overall, the 2022 PMEM report provides no evidence of adverse effects of maize MON 810 cultivation. It shows a high level of compliance with refuge requirements by Spanish and Portuguese farmers growing maize MON 810, but uncertainty remains on compliance in areas where the clustered surface of maize MON 810 farms exceeds 5 ha. There are no signs of practical resistance to Cry1Ab in the field in corn borer populations collected in north-eastern Spain in 2022, although a decrease in Cry1Ab susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information retrieved through farmer questionnaires in Spain and from the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Uncertainties remain on whether 'very highly' and 'extremely' sensitive non-target lepidoptera are potentially exposed to harmful amounts of MON 810 pollen. EFSA notes that several recommendations made in the frame of the assessment of previous PMEM reports remain unaddressed and identified additional shortcomings in the 2022 PMEM report that require further consideration by the consent holder in future annual PMEM reports. Particularly, EFSA emphasises the urgent need to increase the sensitivity of the insect resistance monitoring strategy and implement mitigation measures to ensure that the exposure of non-target lepidoptera to maize MON 810 pollen is reduced to levels of no concern.

While pesticide use is subject to strict regulatory oversight worldwide, it remains a main concern for environmental protection, including biodiversity conservation. This is partly due to the current regulatory approach that relies on separate assessments for each single pesticide, crop use, and non-target organism group at local scales. Such assessments tend to overlook the combined effects of overall pesticide usage at larger spatial scales. Integrative landscape-based approaches are emerging, enabling the consideration of agricultural management, the environmental characteristics, and the combined effects of pesticides applied in a same or in different crops within an area. These developments offer the opportunity to deliver informative risk predictions relevant for different decision contexts including their connection to larger spatial scales and to combine environmental risks of pesticides, with those from other environmental stressors. We discuss the needs, challenges, opportunities and available tools for implementing landscape-based approaches for prospective and retrospective pesticide Environmental Risk Assessments (ERA). A set of “building blocks” that emerged from the discussions have been integrated into a conceptual framework. The framework includes elements to facilitate its implementation, in particular: flexibility to address the needs of relevant users and stakeholders; means to address the inherent complexity of environmental systems; connections to make use of and integrate data derived from monitoring programs; and options for validation and approaches to facilitate future use in a regulatory context. The conceptual model can be applied to existing ERA methodologies, facilitating its comparability, and highlighting interoperability drivers at landscape level. The benefits of landscape-based pesticide ERA extend beyond regulation. Linking and validating risk predictions with relevant environmental impacts under a solid science-based approach will support the setting of protection goals and the formulation of sustainable agricultural strategies. Moreover, landscape ERA offers a communication tool on realistic pesticide impacts in a multistressors environment for stakeholders and citizens.

Background: New Approach Methodologies (NAMs) comprise in silico and in vitro methods applied as alternative to animal testing. Even though NAMs are already fully implemented as research tools, their use in regulatory risk assessments (RA) is limited currently. To promote the regulatory uptake/acceptance of NAMs, a paradigm shift in risk assessment approaches, and a proper dialogue between risk assessors and risk managers is needed. Scope and approach: Several reviews addressed the use of NAMs for chemical RA in generic terms, but without providing specific considerations on their use for food/feed safety assessments. Therefore, in this review, we give insights on the potential use of NAMs for regulatory purposes in the EU. We summarise relevant projects and activities on NAMs coordinated by the European Food Safety Authority (EFSA), which is the agency of the Eu-ropean Union that contributes to the safety of the European food and feed chain. The review informs on future developments on the use of NAMs in human health chemical RA, and touches on their use for the assessment of protein toxicity and allergenicity, as well as environmental risks. Main findings and conclusions: Reducing animal testing and filling some RA gaps via NAMs is almost a reality. Moreover, there is a growing body of evidence confirming that the inclusion of mechanistic information im-proves risk assessments. EFSA's projects address the main challenge of using intermediate effects observed in non-animal models for safety assessments, especially those linked to adverse effects that are insufficiently covered or uncovered by animal apical endpoints.

This report summarises the main discussions, conclusions and recommendations of the 'One Society' track of the 'ONE - Health, Environment & Society - Conference 2022' (21(st)-24(th) June 2002; Brussels and online), which was organised by the European Food Safety Authority. The four themes in the One Society track focused on risk communication, social science, engagement, including collaboration, the EU research agenda, and open science: more specifically, their integration into our understanding of existing and emerging food safety risks within agri-food systems, and as part of the 'One Health' context. The conclusions suggested that understanding food safety risks within 'One Health' requires collaboration and co-production of risk assessment and research objectives, data, methodologies and translation into policy with all interested actors, including the general public. Furthermore, effective implementation of open science practices and inter-agency collaboration are key to ensuring that policy and governance conditions can be optimised within the context of the transdisciplinary research environment in which the 'One Health' concept is embedded. Among main outcomes, the 'One Society' track clearly highlighted the need to: i) realise the EU's collaborative food safety knowledge ecosystem, as no single actor can master the level of complexity alone, ii) consistently apply an 'audience-first' approach and use participatory formats from science to policymaking; iii) dedicate resources to build bridges with research projects; and iv) make open science a reality and a 'default' principle for regulatory science.

Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2021 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Evidence provided in the PMEM report shows that farmers growing maize MON 810 in Spain complied partially with refuge requirements, while full compliance was achieved in Portugal. Cry1Ab susceptibility tests performed on European and Mediterranean corn borer populations collected from north-eastern Spain in 2021 indicated no symptoms of resistance evolution to maize MON 810. However, unexpected damage to maize MON 810 plants was observed in a field trial in the province of Girona (north-eastern Spain), which may point to the presence of resistance alleles in this region. Information retrieved through farmer questionnaires and the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Overall, EFSA concludes that the evidence reported in the 2021 PMEM report does not invalidate its previous conclusions on the safety of maize MON 810. The possible presence of Cry1Ab resistance alleles at frequencies leading to damage to maize MON 810 plants in Girona requires twofold actions: (1) increase monitoring efforts in this area; and (2) implement remedial measures to limit the suspected evolution and spread of resistance. As in previous years, EFSA identified shortcomings on resistance monitoring that need revision. In particular, full refuge compliance must be achieved in Spain. Moreover, the sensitivity of the monitoring plan must be increased, which can be achieved by replacing the current susceptibility assays by periodic F2 screens. EFSA also recommends the consent holder to revise the farmer questionnaires to account for the emergence of teosinte as a noxious agricultural weed in maize MON 810-growing areas in Spain.

Abstract Genetically modified maize GA21 × T25 was developed by crossing to combine two single events: GA21 and T25. The GMO Panel previously assessed the two single maize events and did not identify safety concerns. No new data on the single maize events were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in maize GA21 × T25 does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that maize GA21 × T25, as described in this application, is as safe as its conventional counterpart and the non‐GM reference varieties tested, and no post‐market monitoring of food and feed is considered necessary. In the case of accidental release of viable maize GA21 × T25 grains into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize GA21 × T25. Post‐market monitoring of food and feed is not considered necessary. The GMO Panel concludes that maize GA21 × T25 is as safe as its conventional counterpart and the non‐GM reference varieties tested, with respect to potential effects on human and animal health and the environment.

As engineered gene drive technologies continue to advance, many actors are actively considering how environmental risk assessments (RAs) for gene drive organisms should be conducted, and how stakeholder engagement opportunities should be provided. There is, however, a lack of clarity concerning what constitutes engagement on gene drive RA and, furthermore, what forms of engagement already exist around gene drive RA. To address this gap, we reflect on the actions of a risk assessor (the European Food Safety Authority, EFSA) and a gene drive developer (Target Malaria) to understand: 1) the RA-related decisions that each are making concerning gene drive technology for mosquitoes and other harmful insects, 2) the existing role of engagement in those decisions, and 3) the implications for our understandings of engagement and RA. We found, first, that both EFSA and Target Malaria have already made many RA-related decisions, even though any preparation and evaluation of a formal RA for gene drive mosquitoes remains far off. This finding supports the idea that gene drive RA involves multiple processes and decisions in different forms across the entire technology and regulatory development process. Second, we found that both EFSA and Target Malaria have already integrated engagement into their respective RA-related decisions in different ways, reflecting their different roles. We conclude by considering how EFSA and Target Malaria could improve their existing RA-related engagement by explicitly considering disciplinary diversity and worldview diversity in their related decision making.

Background: On 21-24 June 2022, the European Food Safety Authority, together with the European Centre for Disease Prevention and Control, the European Chemicals Agency, the European Environment Agency, the Eu-ropean Medicines Agency, and the Joint Research Centre of the European Commission, held the "ONE - Health, Environment & Society - Conference 2022".Scope and approach: The conference brought together experts and stakeholders to reflect on how scientific advice related to food safety and nutrition will need to develop to respond to a fast-changing world. The event also explored how institutions that provide such advice should best prepare for the challenges ahead, and how they can contribute to policy targets and societal demands for safe, nutritious and sustainable food.Key findings and conclusions: Overall, participants concluded that food safety assessments must be further advanced to remain fit for purpose and increase their relevance to society. To address the growing complexity in science and society, new ways of working that connect and integrate knowledge, data and expertise across a wide range of disciplines, sectors and actors must be embraced. One Health provides a valuable conceptual framework for advancing food safety assessments by ensuring the delivery of more integrated, cross-sectoral and collabo-rative health assessments. These assessments may help to better inform policies that support the transition to-wards a sustainable food system. As such, One Health could serve as a steppingstone to sustainable food. Urgent action is now required to define how the One Health principles can be implemented in food safety and nutrition.

Teosinte, wild maize relatives originating from Mexico and Central America, emerged as a noxious agricultural weed in France and Spain. In 2016, the European Food Safety Authority (EFSA) issued a technical report that assessed the available scientific information on teosinte for its relevance for the environmental risk assessment (ERA) and risk management (RM) of genetically modified (GM) maize MON810, Bt11, 1507 and GA21 for cultivation. It was concluded that the impact of insect resistance and/or herbicide tolerance in GM teosinte hybrid progeny (potentially acquired through hybridisation between GM maize and teosinte) on target and non-target organisms, the abiotic environment and biogeochemical cycles would be very low under EU conditions. Following a request of the European Commission, EFSA evaluated whether the ERA conclusions and RM recommendations of EFSA (2016) remain applicable, or require revision in light of new scientific evidence on teosinte that has become available since the publication of EFSA (2016). A protocol was developed to clarify the interpretation of the terms of reference of the mandate and make them operational. The assessment relied on evidence retrieved via an extensive literature search and from reports of the Competent Authorities of France and Spain, and on hearing expert testimonies. A limited collection of 18 publications of varying relevance and quality was retrieved and assessed. Based on this evidence, it is concluded that the ERA conclusions and RM recommendations of EFSA (2016) remain applicable, except those pertaining to the use of glyphosate-based herbicides on maize GA21 which should be considered under Regulation (EC) No 1107/2009. In infested agricultural areas (especially in regions where maize MON810 is widely grown), weed management measures implemented to monitor, control and/or eradicate teosinte must remain in place, as they will contribute to further reduce the low vertical gene flow potential between GM maize and EU teosinte.

The ability to engineer gene drives (genetic elements that bias their own inheritance) has sparked enthusiasm and concerns. Engineered gene drives could potentially be used to address long-standing challenges in the control of insect disease vectors, agricultural pests and invasive species, or help to rescue endangered species. However, risk concerns and uncertainty associated with potential environmental release of gene drive modified insects (GDMIs) have led some stakeholders to call for a global moratorium on such releases or the application of other strict precautionary measures to mitigate perceived risk assessment and risk management challenges. Instead, we provide recommendations that may help to improve the relevance of risk assessment and risk management frameworks for environmental releases of GDMIs. These recommendations include: (1) developing additional and more practical risk assessment guidance to ensure appropriate levels of safety; (2) making policy goals and regulatory decision-making criteria operational for use in risk assessment so that what constitutes harm is clearly defined; (3) ensuring a more dynamic interplay between risk assessment and risk management to manage uncertainty through closely interlinked pre-release modelling and post-release monitoring; (4) considering potential risks against potential benefits, and comparing them with those of alternative actions to account for a wider (management) context; and (5) implementing a modular, phased approach to authorisations for incremental acceptance and management of risks and uncertainty. Along with providing stakeholder engagement opportunities in the risk analysis process, the recommendations proposed may enable risk managers to make choices that are more proportionate and adaptive to potential risks, uncertainty and benefits of GDMI applications, and socially robust.