EU publishes Legal framework for New Genome Techniques (NGTs)
Following on from our last circular GN/2026/111, the EU has published Regulation 1388/2026 on plants obtained from New Genome Techniques (NGTs) and their products on Friday 26th June.
The regulation will enter into force on 17 July 2028.
The legislation applies to NGT plants, food and feed and products and aims to ensure a high level of protection of animal and human health and the environment.
There are two categories of NGTs with different legal obligations:
Category 1 NGTs are considered as conventional and not subject to EU GMO legislation. The criteria of equivalence is set out in Annex 1.
Traits referred to having tolerance to herbicides and insecticide substance are excluded from NGT1 status – Annex II
If there is no declaration of NGT1 plant in EU , the person intending to place the product on the market shall submit a verification request to the authority prior to placing NGTs on the market. There are no traceability and labelling requirements for NGT1 but labelling at seed bag level.
To safeguard consumer trust and ensure transparency a database will be set up on use of NGT1 Plants and the database should include declaration, information on the techniques used to obtain the traits, patent information provided by the requestor.
Category 2 EU GMO rules apply to category 2 NGTs and their products which are more complex NGTs. An application for authorisation shall be accompanied by the studies, including DNA sequencing, peer reviews and any other relevant info, environmental risk assessment, monitoring plan before cultivation or placing on the market. Labelling will be required and may also mention traits conveyed by the genetic modifications. Incentives for category 2 NGTs and products containing relevant traits for sustainability – see Annex IV
There will be a code of conduct drawn up by 17 July 2028 containing commitments by patent owners to increase transparency between breeders and farmers. Every five years, the Commission will prepare a report on the functioning of the code of conduct starting 17 July 2033.
The Commission and member states will monitor sustainability impacts of NGT plants from positive/negative impact on the environment and social/environment impact
he regulation will enter into force on 17th July 2028. However, some provisions will already enter into force beforehand on 16th July 2026. They relate to Article 29 on guidance to assist requestors, notified and applicants, EURL guidance, guidance for operators, breeders, and farmers. Article 30 on code of conduct, and article 31 on the establishment of an NGT expert group on effect of the patenting of NGT plants.
The above is a short summary. Please refer to the original text for full details at: Regulation (EU) 2026/1388 of the European Parliament and of the Council of 17 June 2026 on plants obtained by certain new genomic techniques and their products, and amending Regulation (EU) 2017/625 (Text with EEA relevance)
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