Policy analysis demonstrates regulatory and molecular characterisation gaps for Category 1 NGT plants, highlighting the need for updated EFSA verification standards.
Regulation (EU) 2026/1388 relocates the decisive analytical work for Category 1 NGT status into molecular characterisation, yet supplies no information requirements for demonstrating compliance with Annex I. The asymmetry in Article 6(3)(d) of the adopted text creates that gap. Two further structural features make it consequential: the disappearance of the similarity filter and parental-plant comparator, and the technique-based architecture of Annex I that leaves certain events open to alternative qualifications. This note maps those features against EFSA’s qualitative criteria and the preparatory documents, shows that the only existing EFSA technical standard on DNA sequencing quality of GM plants (EFSA Journal 2024;22(4):e8744) does not transfer to Annex I counting, and sets out operational recommendations for the dossier. It is written for teams preparing verification requests under Articles 6 and 7.
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Édouard Tourdot (2026) studied this question.
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