Proposal for a Regulation on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625

Author (Corporate)
Series Details COM (2023) 411
Publication Date 05/07/2023
Content Type , ,

Summary:

Legislative initiative tabled by the European Commission on 5 July 2023, focusing on plants produced by certain new genomic techniques (NGTs). It also introduces amendments to Regulation (EU) 2017/625. This is a text with EEA relevance.

Further information:

NGTs provide new opportunities to alter the genetic material of an organism allowing the rapid development of plant varieties with specific characteristics. They constitute a diverse group of techniques, each of which can be used in various ways to achieve different results. In many cases, these new techniques can lead to more targeted and precise modifications to the genome than conventional breeding or established genomic techniques and these modifications could or could not be produced in nature or obtained by conventional breeding techniques.

Targeted mutagenesis and cisgenesis (including intragenesis) are considered NGTs They are different from established genomic techniques because they have novel features, for example, higher precision and speed in introducing the desired genetic modifications and the insertion of genetic material only from a crossable species. Targeted mutagenesis and cisgenesis do not introduce genetic material from non-crossable species (transgenesis) whereas this is the case with established genomic techniques. In addition, in some cases, products containing or consisting of plants with genetic modifications introduced by NGTs cannot be differentiated from products containing or consisting of plants bred with conventional breeding methods by analytical methods, whereas this is always possible for established genomic techniques.

In Case C-528/16, the Court of Justice of the European Union (EU) held that Directive 2001/18/EC cannot be interpreted as excluding from its scope Genetically Modified Organisms (GMOs) obtained by means of new techniques/methods of mutagenesis which have appeared or have been mostly developed since that Directive was adopted. Trough Decision (EU) 2019/1904, the Council of the European Union requested a study in light of that judgment, which was eventually published in April 2021. It concluded that the existing GMO legislation was not fit to regulate NGT plants obtained by targeted mutagenesis or cisgenesis, and products (including food and feed) derived from them and that that legislation needed to be adapted to scientific and technical progress in this area.

This draft law reflects the outcome of that study. It focuses on plants produced by targeted mutagenesis and cisgenesis (including intragenesis), products containing or consisting of these plants and food and feed containing, consisting or produced from these plants. It reflects demand in the EU and globally for NGT plants, because of their potential to contribute to addressing existing challenges in the agri-food system. TheĀ Farm to Fork (F2F) strategy specifically identifies new techniques as a possible tool to increase sustainability of agri-food systems and contribute to guaranteeing food security.

The proposed Regulation was adopted by the European Commission on 5 July 2023, as part of a legislative package focusing on the sustainable use of key natural resources.

Source Link Link to Main Source https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2023:411:FIN
Alternative sources
  • https://food.ec.europa.eu/system/files/2023-07/gmo_biotech_ngt_proposal.pdf
Related Links
Official
EUR-LEX: SWD(2023)411: Staff Working Document accompanying the Proposal - Subsidiarity Grid https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2023:411:FIN
EUR-LEX: SWD(2023)412: Staff Working Document accompanying the Proposal - Impact Assessment https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2023:412:FIN
EUR-LEX: SWD(2023)413: Staff Working Document accompanying the Proposal - Executive Summary of the Impact Assessment https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2023:413:FIN
European Commission: Genetically Modified Organisms: New techniques in biotechnology https://food.ec.europa.eu/plants/genetically-modified-organisms/new-techniques-biotechnology_en
European Commission: Press Release, 05/07/2023: European Green Deal: more sustainable use of plant and soil natural resources https://ec.europa.eu/commission/presscorner/detail/en/ip_23_3565
European Commission: Frequently Asked Questions: Proposal on New Genomic Techniques (5 July 2023) https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_3568

News
EurActiv, 20/06/2023: EU moves towards looser rules on certain gene edited crops https://www.euractiv.com/section/agriculture-food/news/eu-moves-towards-looser-rules-on-certain-gene-edited-crops/
Science Business, 22/06/2023: Leak indicates Commission is about to move forward on excluding genetically edited plants from GMO rules https://sciencebusiness.net/news/Biotech/leak-indicates-commission-about-move-forward-excluding-genetically-edited-plants-gmo-rules
EUObserver, 22/06/2023: Organic farms, consumer rights 'at risk' in new GMO opt-outs https://euobserver.com/green-economy/157174
RFI News, 03/07/2023: Brussels looks to relax curbs on genetically modified crops https://www.rfi.fr/en/business-and-tech/20230703-brussels-looks-to-relax-curbs-on-genetically-modified-crops
Reuters, 05/07/2023: EU seeks to relax gene-edited crop restrictions https://www.reuters.com/markets/commodities/eu-seeks-revised-gmo-rules-loosen-curbs-gene-edited-crops-2023-07-05/
Bloomberg, 05/07/2023: EU Ignites Battle Over Relaxed GMO Crop Rules in Green Push https://www.bloomberg.com/news/articles/2023-07-05/gmo-rules-relaxation-in-europe-pits-farming-industry-against-green-activists-ljplosuy
Le Monde, 05/07/2023: The European Commission wants to deregulate the 'new GMOs' https://www.lemonde.fr/en/environment/article/2023/07/05/the-european-commission-wants-to-deregulate-the-new-gmos_6043971_114.html
ERR News, 05/07/2023: Scientists await relaxation of EU GMO rules, but the issue is contentious https://news.err.ee/1609026431/scientists-await-relaxation-of-eu-gmo-rules-but-the-issue-is-contentious
Associated Press (AP News), 05/07/2023: The European Union is moving toward gene tech in food production to counter climate change and shortages https://apnews.com/article/eu-europe-gmo-food-biotechnology-frankenfood-c2743c110c92d46cd1693bcf9bfad53a
TVP World, 05/07/2023: EU proposes to relax restrictions on GMO crops https://tvpworld.com/71070140/eu-proposes-to-relax-restrictions-on-gmo-crops
Euronews, 05/07/2023: Brussels wants to relax rules for gene edited crops https://www.euronews.com/my-europe/2023/07/05/brussels-wants-to-relax-rules-for-gene-edited-crops

Commentary and Analysis
Corporate Europe Observatory, 19/06/2023: Media reaction: Leaked proposal to deregulate new GMOs https://www.corporateeurope.org/en/2023/06/media-reaction-leaked-proposal-deregulate-new-gmos
Farm Europe: News, 20/06/2023: NGTs: a step in the right direction by the European Commission https://www.farm-europe.eu/news/ngts-a-step-in-the-right-direction-by-the-european-commission/
Politico, 03/07/2023: Super crops are coming: Is Europe ready for a new generation of gene-edited plants? https://www.politico.eu/article/super-crops-eu-ready-for-new-generation-of-gene-edited-plants-gmo/
Greenpeace: Press Release, 05/07/2023: GMO deregulation disregards safety and consumer rights, Greenpeace https://www.greenpeace.org/eu-unit/issues/nature-food/46731/gmo-deregulation-disregards-safety-and-consumer-rights-greenpeace/
Slow Food, 06/07/2023: New GMOs: the European Commission Puts Agribusiness Interests Ahead of Farmers, Consumers and the Environment https://www.slowfood.com/new-gmos-the-european-commission-puts-agribusiness-interests-ahead-of-farmers-consumers-and-the-environment/

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