Deliverable 1.1 – Legal framework for NGT detection and traceability strategies

Please note that this deliverable has not yet been approved by the European Commission.

This report represents the results of work undertaken to achieve Task 1.1, which aims to thoroughly assess the legal prerequisites for Detection, Identification and Quantification methods and traceability mechanisms applicable to the products of New Genomic Techniques (NGTs) (D1.1). The findings from this analysis will be directly applied to the detection methods and traceability approaches developed within this project, enabling their classification based on legal compliance and their suitability for intended applications. This foundational analysis will inform the policy recommendations to be issued at the conclusion of the project. The report focuses on the legal basis for the DIQ methods development, the technical aspects of methods design and boundaries to the changing of the GMO framework in the European Union. The analysis presented within the report does not cover the official controls framework, which falls outside the scope of this report. The report consists of six chapters. The first chapter examines the origins of the legal criteria governing the performance of DIQ methods. It explores the fundamental concepts of EU law concerning the balancing of conflicting values that determine the level of protection within the GMO framework. The discussion focuses on the fundamental rights of entities involved in administrative proceedings, namely, the right to good administration, the right to an effective remedy, the right to a fair trial, and the right to defence. At the same time, it considers the EU’s commitment to ensuring a high level of protection for health, the environment, and consumers, all of which have shaped the current legal prerequisites applicable to DIQ methods. The second chapter discusses the functions of the legal criteria governing DIQ methods. It focuses on maintaining a high level of protection for health and the environment and on facilitating effective risk management activities. The chapter examines the authorization procedure, compliance with EU GMO food legislation, and issues of liability. It demonstrates that DIQ methods are not only intended to safeguard the environment and citizens’ rights but also to ensure that entities subject to the GMO legal framework can have their affairs managed in an objective and efficient manner. The third chapter defines and distinguishes between traceability and DIQ methods, each of which arises from distinct regulatory objectives. It illustrates how the implementation of traceability and DIQ methods may differ, while also highlighting the ways in which they complement one another. The chapter aims to establish a foundation for the subsequent analysis of the legal prerequisites governing DIQ methods. The fourth chapter analyses the regulatory requirements for DIQ methods applicable to GMOs within the EU authorization procedure. It outlines the requirements for DIQ methods in both food and feed authorization processes, as well as in the context of the deliberate release of GMOs. The chapter emphasizes the analytical and enforcement functions of DIQ methods, while also presenting alternative approaches to distinguishing NGTs from other products and highlighting their lack of legal compatibility within the current regulatory framework in terms of authorization. The fifth chapter addresses the technical challenges involved in the detection, identification, and quantification of NGTs. It defines key terms and presents various analytical approaches that may be applied to detect, identify, and quantify NGTs. The chapter highlights the current lack of suitable analytical methods that meet the legal criteria established under the existing GMO framework. The final chapter discusses the prospects for reform and the limits of amending GMO legislation to ensure its enforceability in relation to NGTs. It examines both the technical and political challenges associated with revising the current legal framework, including the operation of the committee procedure. The chapter also considers the broader legal context in which DIQ methods operate, addressing their implications for related regulatory regimes, such as those governing conventional and organic agriculture, as well as for enforcement provisions. In addition, it explores the CJEU’s case law on scientific evidence, focusing on its form, quality, and the specific requirements that must be taken into account. The legal considerations outlined in this report provide valuable insights into the current regulatory environment governing NGT products within the European Union. By analysing the underlying principles, procedural mechanisms, and technical challenges associated with the detection, identification, and quantification of such products, the report contributes to a deeper understanding of the legal framework’s capacity and limitations. These reflections aim not only to clarify the existing regulatory landscape but also to inform and guide future legislative and policy developments in the evolving field of biotechnology governance.