Crop Biotech Update

Academic, Science-based Reforms Proposed to Give Way for Gene Editing Under EU Rules

March 8, 2023

A law expert from the University of Passau in Germany explains that there is currently no validated method of identifying gene-edited plants that carry only naturally occurring mutations or those that can be achieved through conventional mutagenesis. Hence, reforms based on a scientific and academic point of view are being proposed to make room for gene editing under the European Union's (EU) regulatory framework for genetically modified organisms (GMOs).

The proposed reforms consist of three levels:

  1. Tier 1 – Only a pre-market notification will be required for GM plants developed through conventional breeding, including conventional random mutagenesis techniques. This will be applicable to the plants and their products for experimental purposes and release to the market. An exhaustive list of the plants and products that will qualify for Tier 1 will be created.
  2. Tier 2 – GM plants and their products that are non-transgenic will be evaluated on a case-by-case basis to determine if GMO authorization is required. The applicants will be required to submit all the necessary information about the GM plants and their products to competent authorities who will conduct a risk assessment related to human health and the environment.
  3. Tier 3 – Transgenic GM plants will be required to go through full GMO authorization.

The aim is to improve the current GMO regulations' impracticability in relation to gene editing. They are also meant to address the trade asymmetry between the EU and its major partners like the United States, Argentina, India, and Japan, who do not regulate gene-edited products as GMOs. This asymmetry entails costs and may also lead to trade disruption.

For a better understanding of the proposed reforms, read the article in Frontiers in Genome Editing.

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