EU postpones draft regulation for new genetic engineering

The reason: procedural shortcomings

13. April 2023

13 April 2023 / Various sources have reported that the European Commission will probably not be able to present a legislative proposal for the (de)regulation of plants obtained from ‘new genetic engineering’ (NGT) on June 7 as planned. This is because of procedural shortcomings, which also Testbiotech has already criticized several times. For example, the Commission has so far refused to comprehensively assess the risks to humans and the environment. It has also not presented adequate procedural concepts for a technology assessment and consumer freedom of choice.

The signal to stop proceedings came from within the EU Commission itself, i.e. from the Regulatory Scrutiny Board (RSB), which is an independent body within the Commission and responsible for quality assurance at the early stages of the legislative processes. According to various sources, this body identified serious problems with the way in which the responsible body within the Commission, DG SANTE, had obtained its expert opinions, conducted consultations and written its own reports. Similar conclusions had previously been reached in a report commissioned by the Federal Agency for Nature Conservation (BfN).

Testbiotech believes that halting the proposed legislation could significantly boost confidence in the institutions. It was all too obvious that DG SANTE had tried to ignore crucial issues within the legislative process. The consequence could have been a hasty and uncontrolled introduction of genetically engineered plants with considerable risks for humans and the environment, but also for breeding, agriculture and the food industry. If the opinion of the Regulatory Scrutiny Board now leads to effective measures, this would considerably enhance trust in the democratic credibility of the EU.

Testbiotech is calling for the legislative process to start again from the beginning. From a scientific point of view, there is no doubt that the risks and potentials of NGTs go far beyond what is expected from the results of conventional breeding. Therefore, mandatory risk assessment has to be applied. This was also confirmed by a ruling of the EU Court of Justice in 2018. Instead of simply carrying on with deregulation, it is important to discuss which methods and measures are necessary for harnessing the diverse technical potential of tools such as CRISPR/Cas, while at the same time setting clear legislative limits to the risks.

Christoph Then,, Tel + 49 151 54638040

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