Regulatory Options for New Genomic Techniques in the European Union

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Ambrogio, Yasmine ; Bartsch, Detlef ; Jorasch, Petra ; Kahrmann, Jens ; Kardung, Maximilian ; Nanda, Amrit ; Purnhagen, Kai ; Romeis, Jörg ; Rostoks, Nils ; Schneider, Xenia ; Unkel, Katharina ; Wesseler, Justus:
Regulatory Options for New Genomic Techniques in the European Union.
Brüssel , 2023 . - 26 S.

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Abstract

New Genomic Techniques (NGTs) represent a toolbox of modern plant breeding techniques that can facilitate the development of energy-saving, low-input and reduced-pollution agricultural production and industrial processing of raw materials, contributing to sustainability and a circular bioeconomy (FAO, 2022). In addition, policymakers in the EU have recognised that the technological progress with NGTs has triggered a discussion about regulatory innovation to ensure that the regulations are proportionate and non-discriminatory, fit for purpose, and ensure safe and sustainable use of new products (EC, 2021).
In Europe, regulatory uncertainty reduces investment in NGTs at several levels, including research, innovation, product development and scaling-up of production processes (Purnhagen & Wesseler, 2019). Despite the judgement by the Court of Justice of the European Union (CJEU) on the “mutagenesis” exemption (C-528/16, 2018, hereinafter “mutagenesis judgment”), plant breeding companies emphasise the uncertainty of future regulatory oversight, including timelines for product approvals (Jorasch, 2020). In the mutagenesis judgment, the Court had ruled that GMOs obtained by using mutagenesis techniques developed after 2001 would not be exempted from the application of Directive 2001/18/EC (hereinafter Directive). As a result, most NGT products are considered regulated GMOs in the EU (Purnhagen, 2019; Purnhagen et al., 2018). The development and uptake of new technologies in society is a multifaceted process that includes different regulatory, economic, social, and technological drivers which interact in various ways. Over the past three decades, molecular and genetic technologies have given rise to social controversies and regulatory impediments in many parts of the world, including the EU (Smith et al., 2021).
Amending the current GMO legislation for NGTs (for an overview of the current regulatory status, see Molitorisová et al., 2023) with a focus on targeted mutagenesis and cisgenesis is central to applying NGTs to develop products that benefit society safely and sustainably as aimed by the regulatory framework for food innovation (Monaco & Purnhagen, 2022).
Developments in biotechnology, namely the possibility of targeted changes within the plant genome (without the usage of exogenous genomic markers that would be needed to identify the applied breeding method), as well as a lack of definitions of key legal terms, add to regulatory uncertainty. The study conducted by the European Commission (EC) on NGT (EC, 2021) mentions the need for flexibility and proportionality, together with the need to develop proportionate NGT-specific risk assessment procedures adapted to the risk profiles of plants resulting from NGTs, as the current regulatory system involves implementation and enforcement challenges.
To address this regulatory uncertainty, we, in the GeneBEcon project, define and discuss six different regulatory options for NGT products, including the following aspects: (A) Authorisation; (B) Post-approval / Post-market-requirements; (C) Labelling; (D) Traceability; (E) Implication (EU / International / Liability / Economic Impact), and (F) Future Proof. We also assess the regulatory options for contained use (e.g., use of NGT microorganisms in fermenters or hydroponic facilities (Wesseler et al., 2022)), sole import authorisation from third countries into the EU, including enforcement at EU borders, full authorisation including cultivation inside the EU, along with control of unauthorised NGT organisms. All those aspects also interact with consumer preferences.