Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16

Summary:

Report published by the European Commission on 29 April 2021, regarding the status of New Genomic Techniques (NGTs) under EU law.

Further information:

New Genomic Techniques (NGTs) are defined as techniques that are capable of altering the genetic material of an organism and that have emerged or have been developed since 2001, when the existing legislation on genetically modified organisms (GMOs) was adopted.

Through its Decision (EU) 2019/1904, the Council of the European Union asked the European Commission to submit, by April 2021, a study in light of the judgment issued by the Court of Justice of the European Union (CJEU) in Case C-528/16 regarding the status of new genomic techniques under EU law. It also asked the Commission to submit a proposal accompanied by an impact assessment, if appropriate in view of the outcomes of the study, or otherwise to inform it of other measures required as a follow-up to the study.

The study identified limitations to the capacity of the legislation to keep pace with scientific developments; these cause implementation challenges and legal uncertainties. There are indications that the applicable legislation is not fit for purpose for some NGTs and their products, and that it needs to be adapted to scientific and technological progress. It may not be justified to apply different levels of regulatory oversight to similar products with similar levels of risk, as is the case for plants conventionally bred and obtained from certain NGTs.

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Official

European Commission: Food Safety: EC study on new genomic techniques https://food.ec.europa.eu/plants/genetically-modified-organisms/new-techniques-biotechnology/ec-study-new-genomic-techniques_en

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