• CIOPORA

Will the EU Change its Stance on New Genomic Techniques?

Brussels, April 29 - Following the study on New Genomic Techniques (NGT) ordered by the Council and published on April 29, the European Commission concluded that there is sufficient evidence and scientific basis to initiate a targeted policy action on plants derived from certain NGT, in particular those resulting from the targeted mutagenesis and cisgenesis.


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While maintaining the objectives of the current legislation as to the health safety of NGT products, the study echoes the concerns long raised by the stakeholders and researchers alike, acknowledging the challenges of the current restrictive regulatory approach effectively putting a "ban" on NGT products in the EU. Recognizing that the policymaker may not have kept up with the rapid developments in biotechnology, the study lists the regulatory uncertainty, the disadvantages to the EU public and private research, possible trade limitations and disruptions, and challenges to enforcement of the current policy as reasons for the reevaluation. The study states that the European Food Safety Authority (EFSA) has not so far been able to identify any new hazards in the application of certain NGT (site-directed nuclease type 1 and type 2, ODM, cisgenesis) as compared to conventional breeding and established genomic techniques. The study concludes that while "the use of NGTs raises ethical concerns, (...) so does missing opportunities as a result of not using them", in particular in view of the European Green Deal and the Farm to Fork strategy.


In a letter to the Portuguese presidency, the Commission announced its intent to reevaluate its current treatment of plants produced by means of NGT. The policy action on plants will aim at a proportionate regulatory oversight by adapting the risk assessment and authorization procedures and the labeling/traceability requirements. An inception impact assessment is expected to be published in the third quarter of 2021.