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New techniques in biotechnology

Commission organises a High level event on new genomic techniques (NGT) - 29 November 2021

SAVE THE DATE for a transparent and constructive debate on how the EU could develop a regulatory framework on new genomic techniques in the agri-food sector that combines high levels of safety with reaping the benefits of innovation. The Commission is organising the event to provide a public forum to discuss the announced initiative on plants obtained by targeted mutagenesis and cisgenesis, following the publication of the Commission NGT study.

More details on the programme and registration will follow.

The European Commission follows the continuous progress in modern biotechnology, to consider how the EU can benefit from innovation in the food and agricultural sector while maintaining high safety standards.

In the last decade, a variety of new techniques has been developed, based on advances in biotechnology.

In November 2019, the Council requested the Commission to provide a study on new genomic techniques.

The study has now been published.

The Council also asked the Commission to "submit a proposal, if appropriate in view of the outcomes of the study, or otherwise to inform the Council on other measures required as a follow-up to the study", ensuring that any proposal is accompanied by an impact assessment.

The next steps that the Commission intends to take are outlined in the letter to the Portuguese Presidency of the EU that accompanied the study.

Based on  the outcome of the study, the Commission plans to initiate a policy action on plants produced by targeted mutagenesis and cisgenesis, which will involve an impact assessment including a public consultation.

It will aim at a proportionate regulatory oversight, which would maintain a high level of protection of human and animal health and the environment and allow to gather benefits from innovation, in particular to achieve the goals of the European Green Deal and Farm to Fork Strategy.

The Commission is engaged in a wide-ranging communication effort to share the results of the study and to discuss its outcome and next steps with the EU institutions and stakeholders in dedicated meetings:

The Commission is also organising a high level event on new genomic techniques on 29 November 2021 (see top of the page).

Court of Justice ruling on new mutagenesis techniques

In July 2018, the Court of Justice of the European Union (CJEU) clarified that organisms from new mutagenesis techniques fall within the scope of the EU GMO legislation.

The Commission is now working with EU countries and stakeholders to implement the Court’s ruling. General information on enforcement can be found at the EU countries' controls webpage. The European Commission organises regular discussion with Member States during Regulatory Committees, namely:

Report on products from new mutagenesis techniques

In October 2018, the Commission requested the European Union Reference Laboratory for GM Food and Feed (EURL GMFF) to elaborate, together with the European Network of GMO Laboratories (ENGL), a report on the detection of food and feed plant products obtained by new mutagenesis techniques.

The report was published in March 2019 and can be consulted here. For more information on detection methods, click here. Information on the role of EURLs in general is available here.

Ongoing mandates

The European Commission has also given mandates to EFSA on gene drive, synthetic biology and on new mutagenesis techniques (you can perform searches on all of these topics via EFSA's database). In addition, the Commission requested the European Group on Ethics in Science and New Technologies to prepare an opinion on gene editing.

Previous EU initiatives on new biotechnology techniques

The European Commission organised a high-level conference on "Modern Biotechnologies in Agriculture – Paving the way for responsible innovation" on 28 September 2017 in order to stimulate an informed and open debate among all stakeholders.

The three Scientific Committees (SCHER, SCENIHR and SCCS) upon request from the Commission, published in 2014 and 2015 three opinions on synthetic biology, focusing on its scope and definition, risk assessment methodologies and safety aspects and research priorities.

In April 2017, the High Level Group of the Commission's Scientific Advice Mechanism (SAM) prepared an Explanatory Note on New techniques in Agricultural Biotechnology providing an overview of new techniques and explaining differences and similarities with conventional breeding and established techniques of genetic modification.

This explanatory note covers applications in animals, plants and microorganisms for food and feed production and outlines the agricultural application of new techniques in the fields of synthetic biology and gene drive.

The European Food Safety Authority (EFSA) issued two opinions in 2012 on cisgenesis/intragenesis and Zinc Finger Nuclease 3 and other site directed nucleases, assessing the potential risks of these techniques and the applicability of the existing EFSA guidance documents on GM plants for their risk assessment.

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