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New techniques in biotechnology

  • 5 JULY 2023
Proposal for a new Regulation on plants produced by certain new genomic techniques
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  • 5 JULY 2023
Proposal for a new Regulation on plants produced by certain new genomic techniques - Annex
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Commission proposal on plants obtained by certain new genomic techniques

The European Commission has adopted a proposal for a new Regulation on plants produced by certain new genomic techniques. The proposal, adopted on 5 July 2023, is part of a package of legislative proposals to support the EU's Farm to Fork and Biodiversity strategies.

The main objectives of the proposal are:

  • Maintaining a high level of protection of health and the environment;
  • Steering developments towards contribution to sustainability goals in a wide range of plant species, especially for the agri-food system;
  • Creating an enabling environment for research and innovation, especially for SMEs.

The proposal covers plants that contain genetic material from the same plant (targeted mutagenesis) or from crossable plants (cisgenesis, including intragenesis); transgenic plants (which contain genetic material from non-crossable species) will remain subject to the GMO legislation as it stands today.

The main measures of the proposal include:

The proposal creates two distinct pathways for NGT plants to be placed on the market.

  • NGT plants that could also occur naturally or by conventional breeding ('category 1 NGT plants') would be subject to a verification procedure, based on criteria set in the proposal. NGT plants that meet these criteria would be treated like conventional plants and exempted from the requirements of the GMO legislation. Information on category 1 NGT plants would be provided through the labelling of seeds, in a public database and through the relevant catalogues on plant varieties.
  • For all other NGT plants ('category 2 NGT plants'), the requirements of the current GMO legislation would apply. They would be subject to risk assessment and authorisation before could be put on the market. They would be traced and labelled as GMOs, with the possibility of a voluntary label to indicate the purpose of the genetic modification. The risk assessment, detection method and monitoring requirements would be adapted to different risk profiles and regulatory incentives would be available for NGT plants featuring traits that can contribute to sustainability goals.

To become law, the Regulation must be adopted by the Member States in the Council and the European Parliament, following the ordinary legislative procedure.

The proposal was open for feedback by interested parties from 7 July to 5 November 2023. A summary of the feedback received is here.

Impact assessment and supporting studies

The proposal is accompanied by an impact assessment, supported by an external study, JRC case studies on several applications of NGTs and the scientific work of EFSA in the area of new genomic techniques:

Consultation activities

To support the impact assessment on plants obtained by targeted mutagenesis and cisgenesis, the Commission is carrying out various consultation activities. More information is available in the relevant consultation strategy.

The public consultation for the initiative on plants obtained by targeted mutagenesis and cisgenesis was published on Friday, 29 April 2022 and remained open for a period of 12 weeks until Friday, 22 July 2022; the factual summary of the public consultation has now been published. The public consultation is complemented by a range of targeted consultation activities. You can find more details about all consultation activities in the dedicated Q&A page.

Roadmap

The roadmap (inception impact assessment) for the initiative on plants obtained by targeted mutagenesis and cisgenesis has been published. The feedback period has now ended.

High level on-line event

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

High level online event on "New genomic techniques - the way forward for safe and sustainable innovation in the agri-food sector"

Background

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:

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:

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.

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, which was published in 2023.

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.

Related links

Further information