European Commission Adopts Proposal on Regulation of New Genomic Techniques
On 5 July 2023, the European Commission adopted its proposal for a regulation on plants obtained by certain new genomic techniques ('NGTs') (targeted mutagenesis and cisgenesis) and derived food and feed products.
NGTs (which include gene editing techniques such as CRISPR/Cas9) permit more targeted genetic changes than conventional breeding or traditional genomic techniques involving the introduction of genetic material from a non-crossable species, permitting the rapid development of plant varieties with beneficial characteristics.
Reflecting the lower risks of NGTs compared to traditional genomic techniques recognised by the European Food Safety Authority ('EFSA'), the proposal lays down a less burdensome European Union ('EU') regulatory framework than currently applicable for both the deliberate release into the environment of plants obtained by NGTs ('NGT plants') and the placing on the market of food and feed containing, consisting of, or produced from, those plants ('NGT food and feed').
Under the proposal, NGT plants and NGT food and feed are divided into two categories:
- Following a notification procedure, NGT plants declared to be equivalent to plants obtained by conventional breeding techniques and their derived NGT food and feed are exempted from the requirements of EU GMO legislation.
- All other NGT plants and their derived NGT food and feed remain subject to authorization, traceability, and labelling requirements under current EU GMO legislation, subject to certain adaptations, including lighter, more targeted authorization risk assessment requirements.
As currently worded, a finally adopted Regulation would begin to apply in EU Member States two years after its entry into force.
The proposal constitutes an important element of the European Green Deal, and the related Farm to Fork Strategy, in establishing a regulatory framework more conducive to promoting innovation in the development of plant and plant products, permitting more sustainable agricultural and food systems.
A 2018 judgment of the Court of Justice of the European Union (Case C-528/16) finding that more recently developed mutagenesis techniques were not exempted from the requirements of EU GMO legislation led to the publication of a Commission study in 2021, concluding that this legislation was “not fit for purpose” for certain NGTs. More specifically, the Commission noted that the authorization and risk assessment requirements under the legislation were disproportionate, discouraged innovation in related plant development, and needed to be adapted in the light of scientific progress.
In its explanatory memorandum accompanying the proposal, the Commission recognises that, given that a number of non-EU countries (notably Great Britain and Canada) have already relaxed their regulation of NGT plants and NGT food and feed, “the Union risks being excluded to a significant extent from the technological developments and economic, social and environmental benefits that these new technologies can potentially generate, if its GMO framework is not adapted to NGTs. In turn, this would lead to less strategic autonomy for the Union.” In addition to introducing a less burdensome regulatory regime, the proposal, therefore, introduces “regulatory incentives” to steer the development of those NGT plants and their derived NGT food and feed remaining subject to the EU GMO legislation towards “traits with the potential to contribute to a sustainable agri-food system,” such as increased resistance, improved nutritional characteristics, or increased yield (Article 22 and Recitals (33)). These incentives include an accelerated risk assessment procedure and the provision of “enhanced pre-submission advice” by EFSA to help developers prepare their authorization dossiers.
The prospect under the proposal of food and feed producers not having to label certain NGT food and feed products placed on the EU market as genetically modified is significant given the strong aversion to genetically modified products (particularly genetically modified food) of many EU consumers.
It should be noted that any NGT food and feed exempted from EU GMO requirements under any finally adopted Regulation would remain subject to the requirements of other EU food and feed legislation, including, in the case of NGT food, potentially the novel foods regulatory framework.
Following its adoption by the Commission, the proposal will be submitted to the European Parliament and the Council of the EU for examination. The Commission is expected to present the proposal to the ENVI Committee on 6 July 2023.
A consultation period for the Commission to receive feedback on the proposal is planned by the Commission.
Keller and Heckman’s European food and feed regulatory practice represents and assists clients in the food and feed industries in understanding and complying with their obligations under current and future regulations. For further information or advice on the European Commission's proposal on the regulation of new genomic techniques, please contact Craig Simpson.