Considering the scientific progress made over the past decades, the European Commission understood the need to develop an updated and more effective legal framework applicable to GMOs (EU GMO legislation)3 following these Court of Justice decisions, which would also consider the more recent developed genomic techniques.
On 5 July 2023, the European Commission released its long-awaited package of measures “for a more sustainable use of plant and soil natural resources”. The package includes amongst others a draft regulation on plants obtained by certain new genomic techniques and their food and feed (the Proposal). The Proposal adapts the EU GMO legislation for plants and products, including food and feed, obtained from or including plants produced from two NGTs: targeted mutagenesis and cisgenesis. For plants and products obtained through the latter two NGTS, the Proposal introduces two categories of NGT plants and products, and sets up related procedural and labelling requirements. The Proposal provides criteria and principles for the environmental risk assessment (ERA), as well as incentives and a cultivation exemption for certain NGTs.
Categorisation
The Proposal distinguishes between (i) NGT plants, their progeny and products with modifications that could occur naturally or through conventional breeding methods (for example by crossing and selecting) (Category 1 NGTs) and (ii) other NGT plants, products, food and feed (Category 2 NGTs).
Whereas the requirements under the EU GMO legislation would not apply to Category 1 NGT plants and products, they would apply to Category 2 NGT plants and products to the extent that the Proposal does not derogate from those requirements.
Category 1 NGT plants and products
The Proposal establishes a verification procedure to confirm that the Category 1 NGT plants and products are equivalent to conventional plants. When considered equivalent, the EU GMO legislative framework does not apply to such plants and products. Plant reproductive material containing or consisting of the Category 1 NGT plants which is made available to third parties must however bear a label indicating “cat 1 NGT”, followed by the plant’s identification number. A European database will list the decisions and information on the plants and their genetic modifications.
Category 2 NGT plants and products other than food and feed
Contrary to Category 1 NGTs, Category 2 NGT plants and products other than food and feed are subject to the requirements included in EU GMO legislation. The Proposal nonetheless modifies the notification requirement for the deliberate release into the environment of Category 2 NGT plants and for the placing on the market of category 2 NGT products, in particular with respect to the ERA, the safety assessment and the monitoring plan requirements.
The Proposal also specifies that the GMO Directive’s provisions concerning the cultivation of GMOs do not apply to category 2 NGT plants, and thus that Member States would not be able to prohibit or restrict the cultivation of authorised Category 2 NGT plants in all or part of their territory.
Additionally, the Proposal contains incentives for Category 2 NGT plants containing traits relevant to sustainability. To benefit from these incentives, at least one of the intended traits of the Category 2 NGT plants and products conveyed by genetic modification must be listed in the Proposal.
What does this mean for the sector?
The sector has welcomed the differentiation between Category 1 and Category 2 plants and products, essentially exempting the Category 1 plants and products from the strict requirements, which apply today.
The Proposal furthermore also simplifies the procedural conditions for releasing certain products obtained by NGTs for Category 2 plants and products other than food and feed into the environment and placing them on the market (such as facilitating the environmental risk assessment, the safety assessment and the post-market monitoring plan). Finally, the Proposal shall hopefully create more transparency over NGTs, while providing incentives to develop plants that foster sustainability.
Criticisms voiced against the Proposal include that Category 1 plants and products, when considered equivalent to products obtained by conventional breeding methods, should not be subject to a specific regime. In addition, the equivalence assessment should not be limited to no more than 20 genetic modifications listed in the Proposal as this lacks a scientific basis.
In terms of next steps, the Proposal is still to be discussed by the Parliament and the Council before adoption, meaning that changes can still be expected.
This article was co-authored by Sofia Devroe.
1 See our summary available here.
2 Directive 2001/18 on the deliberate release into the environment of genetically modified organisms, “GMO Directive”, genetically modified organism abbreviated as “GMOs”.
3 Directive 2001/18 on the deliberate release of GMO into the environment, Regulation 1829/2003 on genetically modified food and feed, Regulation 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms, Directive 2009/41 on contained use of genetically modified micro-organisms,
