The stakes are higher than they might appear. Life cycle assessment, or LCA, is the standardised method for quantifying the potential environmental impacts of products and services from raw material extraction through manufacturing, use, and disposal. Yet the method has long been constrained by limited access to primary data, meaning company-specific, measurement-based information. Most practitioners instead rely on secondary life cycle inventory datasets that often lack geographical, temporal, and technological representativeness. Previous studies have documented the consequences: assessments of electric mobility are hampered by scarce primary data for battery raw material supply chains, and researchers have repeatedly flagged persistent challenges in traceability and interoperability across inventory databases. The field has recurrently called for better access to primary data, along with standardised metadata covering temporal representativeness, location, technology specifications, and energy sources.

This is where digital product passports enter the picture. Originally conceived to support supply chain traceability, regulatory compliance, and circular economy objectives, passports could in principle reduce reliance on outdated secondary datasets by embedding harmonised, machine-readable, product-level information on material composition, product characteristics, and environmental indicators. The relationship is potentially bidirectional: while passports improve access to verifiable product-level data, LCA offers a science-based, standardised methodological framework for structuring and interpreting that information, including established principles for defining system boundaries and assessing data quality. The Leiden-led team set out to move beyond conceptual wish lists and ask how real, emerging passport initiatives actually perform in practice.

The 20 initiatives examined span batteries, electronics, construction products, textiles, and other material-intensive sectors, and include research projects, policy platforms, industrial implementations, and standardisation efforts. The sample was assembled purposively from publicly documented initiatives rather than as a systematic or exhaustive inventory, and the researchers grouped the LCA-relevant attributes they found into four categories: assessment results, product characteristics, production characteristics, and end-of-life characteristics. The good news is that several core attributes are now common across initiatives. Material composition, sometimes reported with absolute masses, recycled content, hazardous substances information, and product carbon footprints appear frequently and could provide a genuine basis for improved LCA practice. Notably, many of these attributes require limited incremental effort, because companies already collect them for compliance with regulations such as the restriction of hazardous substances directive and the REACH chemicals regulation.

The dominant logic across many initiatives is the exchange of aggregated product carbon footprints along the value chain. Frameworks such as the World Business Council for Sustainable Development’s Pathfinder and PACT, sectoral standards like Together for Sustainability in the chemical industry, and the automotive data space Catena-X all follow a similar inheritance-based calculation model: each supply chain actor calculates a cradle-to-gate carbon footprint based on its own processes, passes the aggregated result downstream, and the next user multiplies the received figure by the quantity of input product to derive its own footprint. This approach reduces the reporting burden considerably, but it creates comparability challenges. Consistent use of carbon footprints requires alignment in methodological and modelling choices, such as system boundaries and background inventory datasets, which is difficult to guarantee in heterogeneous supply chains. Although sectoral guidelines like the Catena-X carbon footprint rulebook and the Global Battery Alliance calculation framework attempt harmonisation, the researchers found that the analysed initiatives prioritise technical interoperability and data exchange formats over full end-to-end methodological alignment.

The deeper problem is granularity. Aggregated carbon footprints mask the processes, technological parameters, geographical conditions, and operational behaviours that drive environmental impacts. For most LCA-based decisions, such aggregation is overly simplified: researchers need process-specific data to identify impact hotspots across a product life cycle, assess whether impacts are merely shifted elsewhere, or design mitigation strategies. Yet generating and sharing process-specific inventory data is genuinely difficult in practice. It increases reporting burden, requires frequent updates, and may expose commercially sensitive information such as production efficiencies and technology choices. The trade-off, the authors argue, is not only technical but organisational and governance-related: the data that is most informative for LCA is often also the least shareable within supply chains. Some passport architectures already include tiered access rights to manage this tension, restricting detailed data to accredited actors such as regulators or auditors, which strengthens verification but may limit broader analytical use.

The asymmetry extends across life cycle stages. The analysed initiatives predominantly capture upstream and mid-stream product attributes, while providing limited coverage of production conditions, use-stage performance, and end-of-life outcomes. Factory energy use and sources, geographical and temporal metadata, and end-of-life parameters appear far less frequently than composition data. The researchers emphasise that this is not simply a design flaw but reflects structural differences in data controllability. Upstream and mid-stream information sits closer to the manufacturer’s sphere of influence and is often already collected for procurement, compliance, traceability, or quality control. In contrast, use and end-of-life outcomes depend on factors beyond direct producer control, including user behaviour, local infrastructure, and downstream waste management systems. As a result, downstream information in current passports mainly reflects intended use conditions, repair guidance, or recyclability claims rather than measured outcomes, marking a structural boundary to what passports can realistically provide at the point of product placement.

End-of-life modelling deserves particular attention. In LCA practice, end-of-life modelling combines factual data, such as recycling or landfilling rates, with scenario assumptions. If end-of-life impacts are embedded within an aggregated carbon footprint, they must be sufficiently disaggregated to separate assumed downstream scenarios from upstream processes. But dynamic, product-specific end-of-life performance data is rarely available in verifiable form and generally falls outside the practical scope of passport systems. Downstream actors are unlikely to feed operational data into individual passports, and many end-of-life outcomes are inherently modelled rather than measured. The authors caution that expecting passports to resolve these limitations risks conflating product-level information systems with broader waste-system monitoring infrastructures. Instead, they argue, passports should frame end-of-life information as scenario input: structured guidance on plausible product-specific pathways that supports more consistent downstream assumptions without exceeding industry’s reporting capacity.

The way forward, according to the team, involves embedding established LCA principles directly into passport data models. That means integrating system boundaries, functional units, provenance rules, and data quality indicators, so that passport information remains interpretable and comparable across supply chains. Transparency in current LCA practice is itself uneven, with many datasets in widely used inventory databases lacking accessible documentation, consistent metadata, or traceable sources. Passports could help by requiring product-level data in machine-readable, interoperable formats with explicit provenance and methodological metadata, and by clearly labelling proxy data that can be replaced when verified primary information becomes available. Verification itself should be understood in a differentiated sense, ranging from self-declared and documented data to audited or measured values. Passports cannot eliminate diversity in LCA practice, the authors note, but they can make that diversity visible and auditable, turning opaque uncertainty into an attribute that can be examined and managed. Dynamic update mechanisms, such as change logs and timestamps, could further allow passports to function as living datasets rather than static records.

Ultimately, the researchers conclude, digital product passports and life cycle assessment can be mutually reinforcing: passports offer a pathway to structured, product-level information, while LCA provides the methodological backbone for interpreting it. Realising that complementarity requires deliberate shifts in design and governance, including moving beyond aggregated indicators towards disaggregated inventory data on energy use, critical raw material intensity, and provenance, while recognising that passports should complement rather than replace existing inventory databases. Harmonised reporting conventions aligned with ISO and Product Environmental Footprint principles would make assessments more representative, transparent, and reproducible. If those shifts materialise, the humble product passport could evolve from a static compliance tool into a dynamic infrastructure for actionable sustainability assessment, one that links product information with material, environmental, and socio-economic flows for regulators, auditors, repairers, recyclers, and consumers alike.

Subject of Research: Data structuring in digital product passport initiatives and their support for life cycle assessment

Article Title: Emerging digital product passport initiatives require improved data structuring to support life cycle assessment

Article References: Liang, Y., Mogollón, J. M., Cunha, S., Donati, F., Li, C., Mintjes, B., Kleijn, R., Climent, D. M., Wang, R., Muller, S., Mas-Fons, A., Xicotencatl, B. M., & Istrate, R. (2026). Emerging digital product passport initiatives require improved data structuring to support life cycle assessment. Journal of Industrial Ecology, 30(4), 2131-2139. https://doi.org/10.1007/s44498-026-00144-7

Image Credits: AI Generated

DOI: 10.1007/s44498-026-00144-7

Keywords: digital product passport, life cycle assessment, life cycle inventory, product carbon footprint, circular economy, ecodesign regulation, end-of-life modelling, data quality, supply chain traceability, industrial ecology, sustainability data, EU regulation

The special issue examines AI’s policy implications from five distinct angles. One study probes public trust and opinion within the European Union, another compares governance models in Singapore and France, a third frames global AI governance as a classic collective action problem, a fourth dissects regulatory challenges in the defense sector across the European Union and the United States, and a fifth investigates the ethical and legal implications of facial recognition technology in both democratic and autocratic states. Taken together, they map the fault lines where national sovereignty, ethical oversight, and international cooperation collide, and they suggest that no single country or institution can manage the technology alone.

The comparative analysis of national governance models reveals just how different the world’s responses have become. In a study of Singapore and France, Alibašić shows how international organizations and global governance frameworks shape national AI strategies in markedly different ways. Singapore has built an innovation-centric model, one that treats regulatory agility as a competitive advantage and leans heavily on market-driven experimentation. France, by contrast, has pursued an ethics-driven approach in which the state plays a leading role in setting boundaries and safeguarding public values. The contrast is not merely stylistic. It illustrates a fundamental tension in AI policy worldwide: whether the primary goal of regulation is to accelerate innovation or to constrain it in the name of rights, safety, and democratic accountability.

That tension becomes even sharper when the technology in question is designed for the battlefield. Parisini’s comparative study of the European Union and the United States in the defense sector underscores the fragmented nature of EU defense AI governance, which is spread across institutions and member states, and contrasts it with the far more centralized strategy of the US Department of Defense. The analysis identifies capability gaps within the EU that could be narrowed through stronger transatlantic cooperation, an argument that echoes the findings on Singapore and France about the importance of international coordination. In other words, whether the domain is civilian innovation or military capability, the same lesson emerges: jurisdictions that try to go it alone leave gaps that cooperation could close.

At the global level, the picture grows more daunting still. Olugbade situates these national differences within a broader framework, arguing that AI governance is fundamentally a collective action problem, one made worse by the non-cooperation of the three dominant powers: the United States, China, and the European Union. When the largest producers and deployers of AI cannot agree on shared rules, smaller states are left to choose among incompatible standards, and the technology flows through the cracks. Olugbade’s answer is a polycentric governance mechanism, a system in which multiple centers of authority, from national regulators to international organizations, each govern parts of the problem while reconciling national autonomy with global cooperation. Rather than waiting for a single worldwide treaty that may never arrive, polycentricity accepts overlapping jurisdictions and seeks alignment among them.

The stakes of this fragmentation are not abstract. Robles and colleagues examine regulatory frameworks for facial recognition technology across a range of political regimes and document how unevenly such measures are applied. In democratic states, facial recognition raises acute concerns about civil liberties, wrongful identification, and the chilling of lawful assembly; in autocratic states, the same technology can become an instrument of surveillance and social control. The study’s central finding, the need for harmonized international standards, echoes a sentiment running through the entire special issue: without common benchmarks, the ethical floor for AI technologies will be set by the least restrictive jurisdiction, and the consequences will spill across borders.

Public trust emerges as the connective tissue binding all of these analyses together. Jensen and Chen focus on public sentiment toward AI within the European Union and identify class-based divides in how the technology is perceived, along with skepticism rooted in deficits of governance trust. Citizens who distrust the institutions regulating AI are unlikely to accept its deployment, however technically sound the safeguards may be. The authors propose citizen engagement and transparency initiatives as mechanisms to bridge this trust gap, a micro-level prescription that complements the macro-level analyses of global governance offered elsewhere in the issue. The implication is that legitimacy must be built at both ends of the scale: in the deliberations of international bodies and in the lived experience of ordinary people confronting algorithmic decision-making.

What makes the synthesis compelling is the convergence of these five studies on a shared set of themes: governance fragmentation, public trust, ethical considerations, and international cooperation. The comparative evidence suggests that harmonizing AI governance requires multilevel collaboration, both within regions such as the European Union and across global power blocs that currently view each other with suspicion. The collective warning is stark. Without coordinated global policies, AI governance will remain uneven, and that unevenness will put democratic accountability and international security at risk simultaneously. A technology that respects no borders cannot be governed effectively by institutions that stop at them.

The policy implications are concrete. The synthesis calls for enhanced international cooperation, stronger citizen engagement to foster trust, and the establishment of ethical standards for emerging technologies such as facial recognition. It also sketches institutional mechanisms that could translate high-level policy convergence into practice without demanding complete harmonization. Regulatory sandboxes, flexible spaces where governments can trial data-sharing protocols or algorithmic audits under shared principles while maintaining oversight, offer one path for incremental alignment. International AI observatories, hosted by multilateral organizations such as the OECD, UNESCO, or the UN Tech Envoy, could coordinate monitoring, ethics benchmarking, and risk assessment across jurisdictions. Capacity-building initiatives, including South–South knowledge transfer networks and AI policy toolkits tailored to institutional contexts, would support low- and middle-income countries that currently lack the regulatory infrastructure to engage on equal terms.

The research agenda that follows is equally clear. Future work should explore mechanisms for enforcing global AI standards while respecting national sovereignty, and should conduct empirical studies on whether polycentric governance frameworks actually deliver in practice. Multi-scalar research comparing AI implementation across local, national, and regional levels would reveal where governance gaps emerge and how they might be mitigated. The special issue as a whole advocates a multi-level, polycentric approach that bridges the gap between national autonomy and global regulatory alignment, setting the stage for AI governance that is both more robust and more democratically accountable. The alternative, a world in which each bloc writes its own rules and trusts no one else’s, is not a stable equilibrium but a slow-motion race to the weakest standard. The choice, the synthesis suggests, is still open, but the window for making it deliberately is narrowing with every deployment.

Subject of Research: Comparative analysis of global AI governance frameworks and polycentric policy coordination

Article Title: From fragmentation to polycentricity: a comparative synthesis on AI governance and global policy coordination

Article References: Woods, D. (2025). From fragmentation to polycentricity: a comparative synthesis on AI governance and global policy coordination. Global Public Policy and Governance, 5(2), 87-92. https://doi.org/10.1007/s43508-025-00118-8

Image Credits: AI Generated

DOI: 10.1007/s43508-025-00118-8

Keywords: artificial intelligence, AI governance, polycentric governance, global policy coordination, public trust, facial recognition technology, EU regulation, defense sector, collective action, regulatory sandboxes, international organizations, comparative public policy

To understand why this regulation matters, it helps to recall how far the underlying science has travelled since the current legal framework was drafted. Directive 2001/18/EC, the main legislation governing the environmental release of genetically modified organisms in the EU, dates back to 2001. At that time, the dominant method for creating a transgenic plant involved inserting foreign DNA more or less at random into the genome, typically through Agrobacterium-mediated transformation or particle bombardment. Regulators built a system around that reality: every organism carrying recombinant DNA was treated as a genetically modified organism, subject to case-by-case risk assessment, traceability requirements and labelling obligations, regardless of the size of the genetic change involved.

The tools available to plant scientists then changed beyond recognition. Site-directed nucleases, and above all the CRISPR-Cas systems that emerged from foundational work in the early 2010s, made it possible to edit genomes with base-pair precision. Researchers could now introduce small deletions, single-nucleotide substitutions or precisely defined insertions at chosen target sites, producing plants whose final genetic makeup may be indistinguishable from what conventional mutagenesis or natural variation could deliver. Oligonucleotide-directed mutagenesis and epigenetic modifications added further routes to targeted change. The conceptual foundation of the 2001 directive, which anchors regulation to the process used rather than the characteristics of the final product, suddenly sat uneasily alongside techniques that blur the line between engineered and naturally occurring variation.

European institutions saw the problem early. The first Working Group on New Plant Breeding Techniques was established by the European Commission in 2007, with the explicit aim of identifying legislation more appropriate to technologies developed after 2001. That group and its successors wrestled with a deceptively simple question: when a genome edit could equally have been produced by conventional breeding, should the plant be regulated as a genetically modified organism? For years the question produced legal opinions, reports and consultations but no binding answer, while breeders in North America, Japan, Argentina and elsewhere moved ahead under product-based or tiered regulatory approaches.

The turning point came from an unexpected direction. In 2018, the Court of Justice of the European Union ruled that organisms obtained by directed mutagenesis techniques fall within the scope of the GMO directive, exempting only those produced by conventional mutagenesis methods that had long been in use. The judgment meant that even a precise, transgene-free edit made with CRISPR was legally equivalent to a transgenic insertion from the 1990s. Scientists and plant breeders warned that the ruling effectively locked European researchers out of the most dynamic area of modern crop improvement, and petitions from the scientific community urged the Commission to revisit the framework. The episode became a defining case study in how process-based regulation can struggle to accommodate technological change.

The Commission responded in 2023 with a legislative proposal that distinguished between categories of plants obtained by new genomic techniques, drawing a line between edits that could have been achieved through conventional breeding and more complex alterations involving foreign genetic material. The proposal triggered intense negotiation over the criteria for the lighter-touch category, the treatment of patents on gene-edited traits, the verification of edits without transgenic intermediates, and the coexistence of new-technique plants with organic and conventional supply chains. Those debates shaped the text that the Council and Parliament ultimately approved, and they explain why adoption took as long as it did.

Regulation (EU) 2026/1388 now provides the operative answer. Plants obtained by certain new genomic techniques, and products derived from them, gain a dedicated legal pathway that reflects the nature and scale of the genetic modification involved. For the plant science community, the significance is as much symbolic as practical: the EU has acknowledged, in binding law, that the regulatory treatment of a plant should depend on what has actually been changed in its genome, not merely on the laboratory method used to change it. That shift in regulatory philosophy, from process to product characteristics, is the intellectual heart of the reform.

The practical consequences will unfold over the coming years. Breeders developing traits such as disease resistance, altered oil profiles, drought tolerance or improved nutritional composition through targeted editing will be able to plan commercialisation strategies under a framework designed for their tools rather than inherited from an earlier technological era. Public research institutes, which were among the loudest voices calling for reform, stand to benefit particularly, since the cost and uncertainty of the old GMO regime weighed most heavily on actors without the resources of multinational seed companies. At the same time, implementation will demand new technical capacities: detection and identification of edited plants in traded goods, verification dossiers, and post-market oversight all require methods and expertise that national authorities are only now beginning to build.

Open scientific questions remain. Distinguishing a targeted edit from spontaneous or induced mutation of the same kind is analytically demanding, and the technical literature continues to explore how sequencing-based and other approaches can support enforcement without imposing prohibitive burdens. The interaction between the new regulation and intellectual property law, especially the patentability of gene-edited traits versus the breeders’ exemption in plant variety rights, remains one of the most contested issues in the field. And the global regulatory landscape is far from harmonised, meaning that exporters and importers will need to navigate divergent definitions and thresholds across jurisdictions for years to come.

What the adoption of Regulation (EU) 2026/1388 demonstrates most clearly is that regulatory systems can, eventually, catch up with science, even if the journey is measured in decades rather than years. From the first Commission working group in 2007 to the final votes in 2026, the EU spent nearly twenty years reconciling a law written for transgenic technology with a world of precise genome editing. For plant scientists who watched the gap widen year after year, the new regulation is not merely a legal text but a signal that evidence-based argument can reshape policy. The challenge now shifts from drafting the rules to implementing them well, so that the promise of new genomic techniques, for agriculture, for research and for food security, can be realised within a framework the public can trust.

Subject of Research: EU regulation of plants developed with new genomic techniques

Article Title: Evolution and implementation of EU regulation on new genomic techniques

Article References: Cardi, T., & Vitale, A. (2026). Evolution and implementation of EU regulation on new genomic techniques. Nature Plants, 12(9), 1650-1655. https://doi.org/10.1038/s41477-026-02402-9

Image Credits: AI Generated

DOI: 10.1038/s41477-026-02402-9

Keywords: new genomic techniques, EU regulation, CRISPR, plant breeding, genetically modified organisms, Directive 2001/18/EC, genome editing, agricultural biotechnology, European Commission, plant science, food security, regulatory policy

The origins of device regulation in Europe are unusual, and arguably the root of many current problems. In the United States, legislation controlling pharmaceutical safety followed deaths from sulfanilamide syrup in 1937, and the first European Economic Community directive on medicines was a direct response to the thalidomide disaster of 1957 to 1962. American device legislation likewise grew out of a 1970 expert report chaired by Theodore Cooper, which attacked an unquestioning acceptance of safety claims unsupported by scientific fact. Europe’s device rules, by contrast, were not precipitated by any scandal and were not designed after objective analysis. They emerged from requests to the European Commission by manufacturers’ trade associations, and when the first Medical Device Directive was drafted in the late 1980s, policymakers applied the so-called New Approach adopted by the Council of Ministers in 1985, a framework intended to harmonise standards for industrial products across the common market, not to safeguard patients.

Under that New Approach, the evaluation of evidence demonstrating that a device conformed with requirements was outsourced to independent, private inspection companies known as notified bodies. Those organisations remain central to the system today: manufacturers must submit technical documentation, quality management systems and clinical evaluation reports to a notified body for all medium-risk Class II and high-risk Class III devices, and for nearly all in vitro diagnostics, before receiving the certificates of conformity required for CE-marking and market access. With hindsight, the authors argue, applying an industrial harmonisation model to high-risk medical devices was a poor decision. Notified bodies effectively act as quasi-regulators, deciding whether devices are approved, yet as private companies operating in a competitive marketplace they are not bound by European requirements for public access to documents. Their dual role also limits the advice they can give to the very companies whose products they assess, because of inherent conflicts of interest, and oversight by national authorities has often been inadequate.

The original directive’s rules were deliberately written in rather abstract terms, leaving manufacturers to decide for themselves what clinical studies were needed. Concerns accumulated over decades: standards varied between notified bodies, some devices reached patients with insufficient evidence, and serious complications and deaths were reported from high-risk implantables approved on claims of equivalence to existing devices without any new clinical investigation. A public consultation launched by the Commission in 2008 eventually produced the Medical Device Regulation, which came into force in 2021, alongside the In Vitro Diagnostic Medical Devices Regulation. The MDR aimed to raise standards of evidence for high-risk devices, but its central requirement remained vague, asking only for clinical data providing sufficient clinical evidence. Common specifications, which would have set mandatory scientific standards for particular device types, were never realised, apparently due to limited regulatory capacity. Instead, guidance documents issued by the Medical Device Coordination Group are voluntary, interpretation varies between member states, and the type of clinical evidence required for new high-risk devices, whether observational or experimental, is still not defined.

The MDR also created unintended consequences for patients. Massive recertification requirements and unpredictable, protracted conformity assessments drove up costs, and manufacturers withdrew some essential products from the market, including well-established technologies and devices designed for children. A perception spread that Europe had become hostile to device innovation, and the Austrian National Public Health Institute is now monitoring device availability on behalf of the Commission. The scheduled five-year review of the legislation was brought forward after intense lobbying from industry and other stakeholders, culminating in the December 2025 draft regulation. At a High-Level Conference on Medical Devices: Innovation and Patient Safety held in Brussels in March 2026, European Commissioner for Health Olivér Várhelyi declared that a major overhaul was absolutely necessary, but insisted it must come without compromising on patient safety. How to reconcile those goals is the central question of the reform.

One project has supplied much of the evidence base for answering it. CORE–MD, Coordinating Research and Evidence for Medical Devices, was funded by the EU Horizon Europe programme from 2021 to 2024 and led by the European Society of Cardiology together with the European Federation of National Associations of Orthopaedics and Traumatology, with support from the Biomedical Alliance in Europe. Every stakeholder group, including national regulatory agencies and notified bodies, contributed to an extensive review of the system. The consortium confirmed deficiencies in the evidence available for high-risk devices, a dearth of randomised trials and a high risk of bias in many published studies. It proposed a progressive framework matching observational studies and controlled trials to each stage of a device’s life-cycle, and separately described alternative methodologies under the banner of large simple trials, including registry trials and pragmatic studies, which could make rigorous randomised evidence feasible at realistic cost.

The contrast with medicines regulation is instructive. The US Food and Drug Administration and the European Medicines Agency both implement scientific approaches to support regulatory decision-making, whereas for devices the EU has emphasised interpretation of legal rules applied by a patchwork of independent organisations. The authors argue that reform should set explicit standards for demonstrating clinical efficacy where needed for high-risk therapeutic implants, while retaining simpler safety and performance requirements for low-risk devices. Clinical evidence should represent women as well as men, and safe, effective technologies should be equitably accessible to all patients, including children and those with rare conditions. The in vitro diagnostics regulation needs its own tailored policies rather than a copy of the device framework: the authors call for relaxed restrictions on sharing laboratory-developed tests between health institutions, and for the abolition of IVDR Article 5.5 d, which forbids use of an in-house test if an equivalent CE-marked product exists, a rule they say stifles diagnostic innovation in favour of market monopolies.

The European Medicines Agency is set to play a much larger role. The MDR already established Expert Panels of independent clinicians and scientists who provide non-binding opinions on notified bodies’ clinical evaluations of selected high-risk devices. The Screening Panel has judged that roughly ten per cent of high-risk submissions require a full scientific opinion; sixteen have been published, most identifying deficiencies in clinical evidence, yet every reviewed device was still granted market access, prompting calls for transparency about how notified bodies act on expert recommendations. A recent analysis of thirty-four opinions found that nearly half of expert comments concerned the sufficiency of clinical evidence supporting benefit–risk determinations. Under the draft regulation, the panels’ remit will expand to advising the Commission, member states, notified bodies and manufacturers, contributing to guidance and common specifications, and designating breakthrough and orphan status for promising devices. The authors welcome this but warn that delivery is impossible without major investment: the Commission unit coordinating the regulations has only one medically qualified officer, while notified bodies employed 4,099 full-time staff in conformity assessment in 2025.

The deeper prescription is cultural as much as legislative. The authors endorse a definition of regulatory science as the use of scientific approaches to determine which policies and standards best assure safety and efficacy, so that approved technologies improve individual outcomes and public health without disproportionate over-regulation. They want regulatory science to become a recognised subspecialty for clinicians, laboratory scientists, epidemiologists, statisticians and engineers, supporting the EMA and notified bodies alike, with medical associations supplying high-quality evidence from comprehensive device registries. CORE–MD insights already shaped consensus recommendations submitted to the Commission by the Biomedical Alliance on behalf of thirty-five professional associations. Among their warnings: easing conditions for establishing equivalence would repeat a mistake that caused major problems under the old directive, and deleting the standard of sufficient clinical evidence risks more subjectivity rather than consistency. A new high-risk implantable, they argue, should not enter an existing class without a randomised trial against an active comparator or evidence from objective performance criteria. With equivalent standards promoted globally through the International Medical Device Regulators Forum, Europe has a chance to break free from recurrent legislative revisions, if it commits to funding regulatory science as a public good.

Subject of Research: Reform of the European Union regulatory framework for medical devices and in vitro diagnostics

Article Title: Empowering regulatory science for medical devices in Europe

Article References: Empowering regulatory science for medical devices in Europe. (n.d.). https://doi.org/10.1016/j.lanepe.2026.101876

Image Credits: AI Generated

DOI: 10.1016/j.lanepe.2026.101876

Keywords: medical devices, EU regulation, MDR, IVDR, notified bodies, European Medicines Agency, regulatory science, CORE-MD, clinical evidence, in vitro diagnostics, CE-marking, patient safety

The authors argue that the explanation for this paradox cannot be found in the biology of the edited plants themselves. Instead, they contend, it lies in the way the technology is embedded within broader social structures. To make that argument, they reach back several decades, before CRISPR was invented, to the work of the German-born Canadian physicist and philosopher of technology Ursula M. Franklin, who lived from 1921 to 2016. In her book The Real World of Technology, first delivered as lectures in 1989 and published in 1990, Franklin developed a framework that the Freiburg researchers believe helps explain why genome-edited crops have met such different receptions on either side of the Atlantic and across sectors of application.

Franklin’s central insight was that technologies are never merely tools. In her view, every technology is in fact an entire system, shaped jointly by regulation, markets, institutions and culture. A genome-editing enzyme such as Cas9 is, on this reading, only the visible tip of a much larger formation that includes patent regimes, seed markets, food-safety authorities, agricultural traditions, media narratives and consumer expectations. Franklin’s work explored how such technological systems influence power, authority and everyday life, and in this respect her thinking echoes ideas developed earlier by social historians and philosophers such as Michel Foucault, Lewis Mumford and Jacques Ellul, all of whom analyzed technology as a force that organizes society rather than a neutral instrument within it.

Applying this framework to CRISPR reveals why the risk-based argument familiar from plant science has failed to settle the debate. European regulation of genome-edited plants has its origins in a 2018 ruling of the Court of Justice of the European Union, which held that organisms produced by new mutagenesis techniques fall within the scope of existing genetically modified organism legislation. That judgment entrenched a regulatory pathway built on traceability and labelling requirements established for transgenic organisms, including the traceability and labelling framework laid down by European rules from 2003. Under such a system, a plant whose genome differs from a conventionally bred counterpart by only a small deletion or point mutation can nonetheless be classified, tracked and labelled as a genetically modified organism, even though the molecular outcome is one that traditional breeding could also have produced.

From a technical standpoint, the distinction is indeed difficult to defend on scientific grounds. Genome editing with CRISPR–Cas typically introduces small insertions, deletions or base substitutions at targeted loci. Conventional mutagenesis breeding, which has been practiced for decades using chemical or radiation treatments, produces random mutations across the genome and is exempt from the strict genetically modified organism rules in many jurisdictions. Site-directed nuclease editing is, in effect, a more precise version of mutagenesis, with far fewer unintended changes to monitor. The 2014 analysis by Frank Hartung and Jürgen Schiemann, cited in the commentary, examined precisely these questions of equivalence and risk. Yet, as the Freiburg team emphasizes, the regulatory treatment of a product does not track its biological properties but its production process—a decision that is legal and political rather than scientific.

The policy landscape, however, has begun to shift. In 2023 the European Commission put forward a proposal for a regulation on plants obtained by certain new genomic techniques and their food and feed, seeking to differentiate between categories of genome-edited plants according to the type of genetic change involved. That process culminated in June 2026 with Regulation (EU) 2026/1388 on plants obtained by certain new genomic techniques and their products, which amends the earlier 2017/625 regulation on official controls. This legislative move represents an attempt to build a more differentiated system, one that can distinguish targeted edits indistinguishable from conventional breeding outcomes from more extensive modifications. For the commentary’s authors, the episode illustrates Franklin’s point in real time: the technology’s fate is being decided not in the laboratory but in the architecture of rules, institutions and market arrangements that surround it.

What, then, would a sustainable innovation system for CRISPR in plant science look like? The commentary’s argument suggests several components. First, regulation must be technically coherent, meaning that the category into which a plant falls should reflect the nature and scale of the genetic change rather than the method used to create it. Second, transparency and traceability need to serve public trust rather than functioning as ends in themselves; if consumers cannot see how decisions are made, labelling schemes risk becoming symbolic battlegrounds rather than informative tools. Third, the benefits of the technology must be distributed in ways that farmers, breeders and consumers can recognize, since an innovation system that concentrates value in a few patent holders is unlikely to sustain broad social license. Fourth, public engagement has to treat citizens as participants in shaping the system, not merely as audiences to be persuaded of its safety.

The contrast between medicine and agriculture sharpens this point. In therapeutic applications, genome editing is evaluated within a well-established institutional framework of clinical trials, ethics committees and health technology assessment, and it addresses conditions that individual patients and their families experience as urgent and personal. In plant breeding, by contrast, the same molecular intervention is situated within agricultural systems marked by long-running debates over industrial farming, seed ownership, pesticide use and the concentration of the food supply. The technology is not judged in isolation; it inherits the anxieties and political commitments attached to the system it enters. Franklin’s framework makes this inheritance explicit, and it explains why campaigns that focus exclusively on communicating the molecular facts have repeatedly failed to move public opinion in the European agricultural context.

The economists’ perspective adds a further layer. The commentary invokes Kenneth Boulding, whose work on economic imagery and evolution emphasized that societies live by narratives and images as much as by material flows. Genome-edited plants, in this light, compete not only on agronomic performance but on the story they are embedded in—are they a continuation of human stewardship of crops, or an escalation of corporate control over the food chain? Building a durable innovation system means attending to that narrative infrastructure deliberately: who is seen to benefit, who is seen to decide, and what risks are seen to matter. The authors’ use of Franklin and Boulding signals that the scientific community must engage these questions on their own terms rather than dismissing them as misunderstandings of the science.

Ultimately, the Freiburg commentary makes a claim that reaches beyond plant biology to the governance of emerging technologies in general. CRISPR–Cas is a genuinely transformative tool, capable of precise, targeted and increasingly diverse genetic interventions, and its technical trajectory continues to accelerate. Whether that capability translates into societal benefit in agriculture depends on assembling the surrounding system—regulation, markets, institutions and culture—into a configuration that is scientifically sound, economically viable, socially trusted and ethically defensible. The new European regulatory framework of 2026 offers an opening, but the deeper lesson from Franklin is that no single ruling settles the matter. A sustainable innovation system is not a finished artifact but an ongoing practice of aligning technological capability with public values, and the genome-editing debate in plant science is now one of its most instructive real-world tests.

Subject of Research: Societal and regulatory dimensions of CRISPR genome editing in plant breeding

Article Title: CRISPR beyond biology: building a sustainable innovation system

Article References: Barbez, E., Boldt, J., & Kleine-Vehn, J. (2026). CRISPR beyond biology: building a sustainable innovation system. Nature Plants, 12(9), 1648-1649. https://doi.org/10.1038/s41477-026-02410-9

Image Credits: AI Generated

DOI: 10.1038/s41477-026-02410-9

Keywords: CRISPR, genome editing, plant breeding, Ursula Franklin, EU regulation, new genomic techniques, agricultural biotechnology, science policy, public acceptance, GMO legislation, innovation systems, Nature Plants

Researchers Prosper Dzidzienyo, Saeed Rahimpour and Luana Dessbesell, writing in Environmental and Sustainability Indicators, have developed what they call a Traceability Degree Score, a systematic framework for grading individual pieces of product data on how reliably they can be captured, verified and exchanged along a supply chain. Rather than asking whether data exists, the framework asks whether each data element can be systematically linked to its point of origin, checked for accuracy and transmitted across supply chain partners in a digitally structured format. That distinction matters, because the authors’ analysis of a full textile lifecycle suggests that most of the data needed for passports currently sits in a grey zone: present in some form, but far from trustworthy or interoperable.

The framework rests on four indicators drawn from maturity-model theory, information quality research and supply chain traceability standards. The first is standardisation, which measures whether data are defined and reported in harmonised formats with persistent identifiers, so that a batch number means the same thing to a pulp mill in Finland and a retailer in Paris. The second is automation, assessing whether information is captured by sensors and enterprise systems rather than typed in by hand. The third is reliability, which captures whether measurements are accurate, consistent and independently verifiable. The fourth, blockchain readiness, is deliberately misnamed in the eyes of no one: it does not assume distributed ledgers are required, but instead evaluates whether data are structured, uniquely identifiable and linked to discrete lifecycle events, properties that any immutable, event-based traceability architecture would demand. Each data element is scored from one to five on every indicator, and the four scores are averaged into a single composite value.

To test the approach, the researchers constructed a detailed case study of a man-made cellulosic textile, a fabric made from 80 percent certified renewable wood and 20 percent recycled textile waste, both sourced in Finland. This hybrid of bio-based and circular material streams was chosen precisely because it mirrors the sourcing complexity that passport regulation is meant to address. Drawing on EU regulatory texts, the CIRPASS project’s passport prototypes, stakeholder consultations and life cycle assessment literature, the team identified 336 individual primary data elements spread across ten lifecycle nodes, from forestry and pulping through fibre, yarn, fabric and garment production to distribution, consumer use and end-of-life.

The results are striking for how unevenly traceability is distributed. Half of all data elements scored at the moderate level, meaning they exist in structured form but lack the full automation, verification or interoperability that seamless passport integration requires. Only 20 percent achieved the highest maturity, being digitally standardised, automatically captured, externally verified and ready for distributed ledger transmission. A quarter showed limited traceability, hampered by manual entry or inconsistent templates, while the remainder were essentially untraceable, concentrated in the consumer-use and end-of-life phases. In other words, the single most important stage for circular decisions — what happens to a garment after the sale — is exactly where the data infrastructure is weakest.

The node-by-node comparison sharpens that picture. Distribution and retail scored highest, with a mean traceability degree of 4.30, closely followed by dissolving pulp production at 4.28 and textile recycling at 4.13. The authors attribute the retail result to the quiet success of existing logistics standards: GS1 identifiers, batch numbering and trade barcodes have been standardised for decades, so the data foundations there are already mature. Manufacturing nodes such as fibre production, fabric making, yarn spinning and garment assembly landed in an intermediate band between 3.78 and 3.89, reflecting partial digitisation within factories but limited data exchange between companies. Raw material sourcing scored 3.55, while consumer use collapsed to 2.00 and end-of-life managed only 3.13. No single node achieved uniformly high scores across all four indicators, a finding the researchers say confirms that traceability maturity cannot be reduced to digitalisation alone.

The study also exposes a structural tension at the heart of the EU’s circular economy agenda. Digital Product Passports are explicitly intended to enable downstream value retention — reuse, repair and recycling — yet the phases where those decisions are made are the ones with the poorest data readiness. Consumer behaviour, device heterogeneity and the absence of standardised reporting at the end of a product’s life mean the data trail simply frays out. The researchers note that harmonised data definitions alone are insufficient: many nodes scored well on standardisation while lagging badly on automation and blockchain readiness, showing that agreeing on what to record is a very different problem from being able to record it reliably at scale.

Methodologically, the framework fills a gap that previous approaches left open. Earlier efforts to prioritise passport data, including ranking systems based on importance, availability and sensitivity, largely captured stakeholder perceptions of what data matters. Industry 4.0 maturity models, meanwhile, assess whole organisations rather than individual data points. By scoring data elements themselves, the new approach converts qualitative regulatory demands — data must be verifiable, data must be machine-readable — into a consistent numerical index that can pinpoint exactly where along a supply chain investment is most needed. The authors stress that the framework is technologically neutral: blockchain readiness measures architectural compatibility, not adoption, and European regulations remain agnostic about implementation technology.

The researchers acknowledge limitations. The case scores were derived from secondary sources reflecting average industrial realities in a Finnish context, and values would shift across regions, technologies and firms; the point of the exercise is to demonstrate a reproducible method rather than to deliver fixed numbers. The assessment is also a snapshot in time, whereas passport requirements and data systems will both evolve rapidly, calling for longitudinal studies and operational pilots. Inter-rater reliability and automated scoring are flagged as priorities for future work, as is validation across other product categories — the framework operates at the level of generic data elements, making it directly applicable to batteries, electronics, construction materials and other sectors that the passport regulation will eventually touch.

Still, the message for industry and policymakers is clear. As passport implementation accelerates, the readiness of product data is not a binary yes or no but a measurable, multi-dimensional capability that currently varies wildly across the lifecycle of even a well-documented textile. With only one in five data elements in the case study achieving full traceability maturity, and with the circular economy’s most critical decision points sitting at the bottom of the maturity curve, the gap between regulatory intent and operational data reality is wide. Diagnostic tools like the Traceability Degree Score offer a way to map that gap precisely — and, the authors argue, a way to close it with targeted investment rather than hopeful assumptions.

Subject of Research: A traceability assessment framework for primary data elements in textile digital product passports

Article Title: A framework for evaluating the traceability of primary data elements for textile digital product passports

Article References: Dzidzienyo, P., Rahimpour, S., & Dessbesell, L. (2026). A framework for evaluating the traceability of primary data elements for textile digital product passports. Environmental and Sustainability Indicators, 32, Article 101514. https://doi.org/10.1016/j.indic.2026.101514

Image Credits: AI Generated

DOI: 10.1016/j.indic.2026.101514

Keywords: digital product passports, textile supply chains, traceability, EU regulation, ESPR, circular economy, data quality, blockchain readiness, standardisation, automation, man-made cellulosic textiles, sustainability indicators