Plants from new genomic techniques: the Commission prepares acts under Regulation 2026/1388 — for category 2 plants the detection method is validated by the EU reference laboratory
On 31 August 2026 the European Commission opened a call for evidence ahead of a delegated act and an implementing act under Regulation (EU) 2026/1388 on plants obtained by certain new genomic techniques (NGT). The acts will lay down procedural and information requirements for verifying category 1 status and for notifications and applications concerning category 2 plants; feedback was accepted until 28 September 2026.
- Regulation (EU) 2026/1388 of 17 June 2026 applies from 17 July 2028 (Articles 29–31 from 16 July 2026). A category 1 NGT plant is one that meets the criteria of equivalence to conventional plants in Annex I and has none of the traits listed in Annex II, as well as its progeny without further modifications; all other NGT plants are category 2.
- Equivalence criteria: for targeted mutagenesis, substitution or insertion of no more than 20 nucleotides and deletion of any number of nucleotides are allowed, with at most three such modifications per protein-coding sequence (modifications in introns and gene regulatory sequences are excluded from the limit), and in total — together with cisgenesis modifications — no more than 20 per monoploid genome. The recitals recall the 2023 report of the European Network of GMO Laboratories (ENGL): products with identical DNA sequences obtained naturally, by conventional breeding or by certain NGTs cannot be distinguished by analytical methods.
- An application for authorisation of a category 2 NGT plant must include methods for sampling, detection, identification and quantification of the plant and, where applicable, of the plant in the food or feed. The method is tested and validated by the EU Reference Laboratory (EURL) for genetically modified food and feed; if the applicant duly justifies that an analytical method for identification and quantification cannot be provided, the method performance requirements are adapted in accordance with an implementing act, and the EURL assessment is made public.
- By 17 July 2028 the EURL, assisted by the ENGL, is to publish detailed guidance on these method provisions. Plants confirmed as category 1 are entered in a publicly available database and their plant reproductive material is to be labelled; small and medium-sized enterprises are also exempted from fees to the EURL and ENGL for validating detection methods (Article 23 and recital 47), but only for category 2 NGT plants and products with traits relevant to sustainability (Annex IV, Part 1).