Regulatory Requirements for the Identification, Detection and Quantification of Gene-Edited Products in Light of the (R)evolution of New Genomic Techniques: State of the Art and Prospects for Changes

The key requirement for GMO authorisation is the submission of analytical methods for the detection, identification and quantification (DIQ), which has proven challenging in the case of New Genomic Techniques (NGTs). Currently available non-analytical approaches, such as blockchain traceability and...

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Main Authors: Aleksandra Hubar-Kołodziejczyk, Kai P. Purnhagen
Format: Article
Language:English
Published: Cambridge University Press
Series:European Journal of Risk Regulation
Subjects:
Online Access:https://www.cambridge.org/core/product/identifier/S1867299X25000078/type/journal_article
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author Aleksandra Hubar-Kołodziejczyk
Kai P. Purnhagen
author_facet Aleksandra Hubar-Kołodziejczyk
Kai P. Purnhagen
author_sort Aleksandra Hubar-Kołodziejczyk
collection DOAJ
description The key requirement for GMO authorisation is the submission of analytical methods for the detection, identification and quantification (DIQ), which has proven challenging in the case of New Genomic Techniques (NGTs). Currently available non-analytical approaches, such as blockchain traceability and probabilistic analysis, while potentially useful for monitoring, are insufficient for authorisation purposes. The lack of reliable DIQ methods hinders the authorisation of NGT products and raises concerns for both organic and conventional agriculture, where the presence of NGT products goes undetected. Therefore, the existing GMO regulatory framework requires reevaluation to address the challenges posed by NGTs while ensuring compliance with the broader EU food law framework.
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publisher Cambridge University Press
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spelling doaj-art-de85942957de4855b476f0f126b5fdff2025-08-20T13:13:34ZengCambridge University PressEuropean Journal of Risk Regulation1867-299X2190-824911710.1017/err.2025.7Regulatory Requirements for the Identification, Detection and Quantification of Gene-Edited Products in Light of the (R)evolution of New Genomic Techniques: State of the Art and Prospects for ChangesAleksandra Hubar-Kołodziejczyk0Kai P. Purnhagen1https://orcid.org/0000-0002-9902-7347Faculty of Life Sciences: Food, Nutrition and Health (Campus Kulmbach), University of Bayreuth, Bayreuth, Germany Faculty of Law, University of Bayreuth, Bayreuth, GermanyFaculty of Life Sciences: Food, Nutrition and Health (Campus Kulmbach), University of Bayreuth, Bayreuth, Germany Faculty of Law, University of Bayreuth, Bayreuth, GermanyThe key requirement for GMO authorisation is the submission of analytical methods for the detection, identification and quantification (DIQ), which has proven challenging in the case of New Genomic Techniques (NGTs). Currently available non-analytical approaches, such as blockchain traceability and probabilistic analysis, while potentially useful for monitoring, are insufficient for authorisation purposes. The lack of reliable DIQ methods hinders the authorisation of NGT products and raises concerns for both organic and conventional agriculture, where the presence of NGT products goes undetected. Therefore, the existing GMO regulatory framework requires reevaluation to address the challenges posed by NGTs while ensuring compliance with the broader EU food law framework.https://www.cambridge.org/core/product/identifier/S1867299X25000078/type/journal_articledetectiongenetially modified organismsidentificationnew genomic techniques
spellingShingle Aleksandra Hubar-Kołodziejczyk
Kai P. Purnhagen
Regulatory Requirements for the Identification, Detection and Quantification of Gene-Edited Products in Light of the (R)evolution of New Genomic Techniques: State of the Art and Prospects for Changes
European Journal of Risk Regulation
detection
genetially modified organisms
identification
new genomic techniques
title Regulatory Requirements for the Identification, Detection and Quantification of Gene-Edited Products in Light of the (R)evolution of New Genomic Techniques: State of the Art and Prospects for Changes
title_full Regulatory Requirements for the Identification, Detection and Quantification of Gene-Edited Products in Light of the (R)evolution of New Genomic Techniques: State of the Art and Prospects for Changes
title_fullStr Regulatory Requirements for the Identification, Detection and Quantification of Gene-Edited Products in Light of the (R)evolution of New Genomic Techniques: State of the Art and Prospects for Changes
title_full_unstemmed Regulatory Requirements for the Identification, Detection and Quantification of Gene-Edited Products in Light of the (R)evolution of New Genomic Techniques: State of the Art and Prospects for Changes
title_short Regulatory Requirements for the Identification, Detection and Quantification of Gene-Edited Products in Light of the (R)evolution of New Genomic Techniques: State of the Art and Prospects for Changes
title_sort regulatory requirements for the identification detection and quantification of gene edited products in light of the r evolution of new genomic techniques state of the art and prospects for changes
topic detection
genetially modified organisms
identification
new genomic techniques
url https://www.cambridge.org/core/product/identifier/S1867299X25000078/type/journal_article
work_keys_str_mv AT aleksandrahubarkołodziejczyk regulatoryrequirementsfortheidentificationdetectionandquantificationofgeneeditedproductsinlightoftherevolutionofnewgenomictechniquesstateoftheartandprospectsforchanges
AT kaippurnhagen regulatoryrequirementsfortheidentificationdetectionandquantificationofgeneeditedproductsinlightoftherevolutionofnewgenomictechniquesstateoftheartandprospectsforchanges