New techniques in biotechnology
New techniques in biotechnology
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.
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:
- 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 (ENGL), 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.