New Regulation on Plants Produced by Genomic Techniques

Last week, the European Commission published a proposal for a new Regulation on plants produced by certain new genomic techniques as part of a parcel of legislative proposals related to the EU’s Farm to Fork and Biodiversity strategies.

The proposal aims to:

• Maintain a high standards of health and environmental protections;
• Steer developments in a wide range of plant species, especially in the agri-food system, towards contribution to sustainability goals;
• Create an enabling environment for research and innovation, especially for SMEs.

The proposal covers plants that contain genetic material from the same plant (targeted mutagenesis) or from crossable plants (cisgenesis, including intragenesis). Transgenic plants (which contain genetic material from non-crossable species) will remain subject to the GMO legislation as it stands today.

Some key parts of the proposal include:

The creation of two distinct pathways for NGT plants to be placed on the market:

• NGT plants that could also occur naturally or by conventional breeding (‘category 1 NGT plants’) would be subject to a verification procedure, based on criteria set in the proposal. NGT plants that meet these criteria would be treated like conventional plants and exempted from the requirements of the GMO legislation. Information on category 1 NGT plants would be provided through the labelling of seeds, in a public database and through the relevant catalogues on plant varieties.
• For all other NGT plants (‘category 2 NGT plants’), the requirements of the current GMO legislation would apply. They would be subject to risk assessment and authorisation before they could be put on the market. They would be traced and labelled as GMOs, with the possibility of a voluntary label to indicate the purpose of the genetic modification. The risk assessment, detection method and monitoring requirements would be adapted to different risk profiles and regulatory incentives would be available for NGT plants featuring traits that can contribute to sustainability goals.

It should be noted that the proposal must still be adopted by the Member States in the Council and the European Parliament, before it will become law.

The website of the European Commission contains further information, including: an Impact assessment and supporting studies; details of Consultation activities; Roadmap for the initiative; Background to the proposal; Details of a European Court of Justice ruling on new mutagenesis techniques; and, a Report on products from new mutagenesis techniques, as well as a list of Related links.