The roadmap (inception impact assessment) for the initiative on plants obtained by targeted mutagenesis and cisgenesis has now been published and is open for feedback.
High level on-line event on "New genomic techniques - the way forward for safe and sustainable innovation in the agri-food sector" - 29 November 2021
The European Commission is organising a high-level event to provide a forum for a transparent and constructive debate on how the EU could develop a regulatory framework on plants obtained by certain new genomic techniques (targeted mutagenesis and cisgenesis) that combines high levels of safety while reaping the benefits of innovation.
Three panels will discuss the contribution of new genomic techniques to sustainability, risk assessment as well as traceability/labelling of products resulting from new genomic techniques.
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 European Council requested the Commission to provide a study on new genomic techniques.
The study was published on 29 April 2021.
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 has initiated a policy action on plants produced by targeted mutagenesis and cisgenesis, which involves an impact assessment including a public consultation.
It aims for an appropriate regulatory oversight for the concerned plant products, ensuring a high level of protection of human and animal health and the environment, and enabling innovation and the contribution of safe new genomic techniques to the objectives of the European Green Deal and the Farm to Fork Strategy.
The Commission is engaged in a wide-ranging communication effort to share and discuss the outcome of the study and the ongoing initiative with the EU institutions and stakeholders in dedicated meetings:
- Agriculture and Fisheries Council, 26 May 2021
- EP ENVI Committee Public Hearing on new genomic techniques in the food sector, 10 May 2021
- EP AGRI Committee “New genomic techniques: study presented by the EC DG SANTE”, 22 June 2021.
- Ad hoc meeting of Member States' Competent authorities - "Joint Working Group meeting", 7 May 2021
- Ad hoc meeting of the Advisory Group on the Food Chain and Animal and Plant Health on Article 241 studies, 19 May 2021
- Informative session on New Genomic Techniques (NGTs) to Third Countries, 30 June 2021
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 on the EU countries' controls webpage. The European Commission organises regular discussion with Member States during Regulatory Committees, namely:
- 11 September 2018
- 18 October 2018
- 3 December 2018
- 7 March 2019
- 25 April 2019 (ad hoc meeting of Member States' Competent authorities - "Joint Working Group meeting")
- 18 September 2020 (ad hoc meeting of Member States' Competent authorities - "Joint Working Group meeting")
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 , a report on the detection of food and feed plant products obtained by new mutagenesis techniques.
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.