The new legislation will enter into force 20 days after it has been published in the EU Official Journal. All economic operators will have two years to adapt and implement it. In the meantime, the specific details of implementing and delegated acts (acts adopted by the European Commission to supplement or amend non-essential elements of existing EU laws) must be worked out, including requirements for documentation, identification and control. The outcome of these measures will be highly relevant for farmers, breeders, food operators and certification systems across Europe.
A separate legal framework for New GMOs
Until now, plants obtained through New Genomic Techniques have been regulated under the existing EU GMO framework. The new regulation changes this by creating a separate regime for certain NGT plants and products. The “Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed and amending Regulation (EU) 2017/625” constitutes lex specialis with regard to the EU’s GMO legislation Directive 2001/18/EC (lex generalis). This means that NGT plants have their own regulation but remain defined as GM plants.
Two categories of New GMOs
The adopted regulation divides New GMOs into two categories:
Category 1 NGT plants are those with modifications that could also arise naturally or through conventional breeding or are considered equivalent to conventional breeding, respectively. They are defined as crops that contain up to 20 genetic modifications (an arbitrary and very high threshold). Category1 NGT plants are exempt from the requirements of EU GMO legislation.
Category 2 NGT plants are all other NGT plants or those that don’t meet the equivalence criteria. They will continue to have to comply with its stricter rules.
Category 1 NGTs = most NGTs
For Category 1 plants, significant changes to the plant DNA are possible, for example: deleting entire gene segments, inserting related genes (“cisgenesis”) or inserting up to 20 nucleotides – at up to 20 locations in the DNA. National authorities (such as the German Federal Agency for Nature Conservation and the French Agency for Food, Environmental and Occupational Health and Safety) criticize the proposed 20x20 rule for its methodological and conceptual weaknesses. The assumption that all mutations can be produced “naturally” with enough effort and time contradicts biological and statistical findings and is therefore, according to many scientists, not scientifically sound*.
NGT1 plants will be subject to a verification procedure - a Member State has to confirm that the criteria for NGT1 classification have been met - but not to any risk assessment. Only NGT plant and reproductive material must be labelled as ‘cat 1 NGT’, followed by the identification number of the NGT plant(s) it has been derived from. This information will be included in variety catalogues and in any database and marketing documentation where the plant reproductive material is offered. NGT 1 plants ‘should’ also be listed in a publicly accessible database, including information on the technique or techniques used to obtain the trait or traits.
Transparency for food business and consumers abandoned
In future, only farmers and breeders will be informed whether a New GMO is an NGT1 plant, but feed and food business operators and consumers will not be. Regarding detection methods, an analytical method ‘should’ be provided by the notifier or applicant, but this requirement is so weak that presumably nothing will come of it.
For category 1 NGTs neither traceability nor coexistence measures are applicable (measures between agriculture and food production with and without New GMOs in order to restrict the predictable permanent contamination of Non-GMO production with New GMOs) and opt out (the right of Member States to prohibit or restrict cultivation on their territory) is also not possible. The vast majority of New GMOs are considered to be NGT1 plants.
Category 2 NGT plants will remain subject to EU GMO regulation, including an authorisation procedure with a risk assessment “light” and requirements for traceability and labelling as well as detection methods. In addition to the GMO label, category 2 plants may carry a second label listing all the traits contained in the plant. This is intended to enable companies to highlight the sustainability of their GM crops. Plants containing traits like tolerance to herbicides and the production of a known insecticidal substance automatically fall under category 2. Member states are allowed to opt out of cultivating category 2 NGT plants on their territory, and they may adopt measures to avoid their unintended presence in other food and feed chains (i.e. coexistence measures).
Imports
Imports from third countries must meet the requirements of the EU’s New GMO regulation.
Deregulation impact for the food sector and consumers
The new legislation, as agreed by Commission, Council and Parliament, will deregulate the vast majority of NGT crops to the detriment of food business operators and consumers. It abolishes the vital “precautionary principle” for NGT1 plants, under which GMOs have been subject to comprehensive risk assessment, both to protect consumers and the environment. By removing traceability and labelling, category 1 NGTs (in other words: the vast majority of New GMOs in development pipelines) remain invisible to consumers and to the food sector. They will not be indicated on packaging and, therefore they do not have to face the judgement of the market.
The role of standards & Non-GMO labelling
From a marketing and transparency perspective, even if products under the new legislation are not required to disclose the presence of New GMOs, they can still state what they do not contain. This is precisely where national EU Non-GMO labelling standards play a vital role. Originally developed to close a gap in EU GMO labelling law - where GMO feed must be labelled but animal products derived from it, such as milk, meat and eggs, do not - Non-GMO labelling could increasingly expand into new market segments, from animal-derived products to plant-based foods.
*Read more: Mundorf, J., Simon, S. & Engelhard, M. The European Commission’s regulatory proposal on new genomic techniques in plants: a focus on equivalence, complexity, and artificial intelligence. Environ Sci Eur 37, 143 (2025).
Photo credit: Photo by Dan Meyers on Unsplash