Sun. Jul 14th, 2024

The EU Commission is reviewing Europe’s genomic techniques regulatory framework, according to Claire Bury, Deputy Director-General at the EU Commission’s DG Sante, responsible for Food sustainability, at today’s Bayer Life Science talks “The Bio Revolution – What’s in it for Europe?

The Commission is going to use its toolsets of impact assessments and stakeholder consultations. The EU official drew a comparison to the EU’s complex approach to the regulation of Artificial Intelligence, a process she was involved in, previously.

The assessment will focus on plants, agriculture, and consumers, first, but could also move forward to animals and humans, at a later stage.

On 29 April 2021, the European Commission published a study regarding the status of New Genomic Techniques under Union law.

The Council of the European Union asked for this study, regarding the status of new genomic techniques under Union Law (Directive 2001/18/EC, Regulation (EC) 1829/2003, Directive 2009/41/EC and Regulation (EC) 1830/2003), in light of the Court of Justice’s judgment in Case C-528/16.

The study examined the status of New Genomic Techniques (NGTs), taking into account the state of the art knowledge and the views of the EU countries and stakeholders.

For this study, NGTs are defined as techniques capable to change the genetic material of an organism and that have emerged or have been developed since 2001, when the existing GMO legislation was adopted. The scope of the study included the use of NGTs in plants, animals and micro-organisms for agri-food, industrial and pharmaceutical applications.

The study includes
  • A scientific and market state-of-the-art analysis
  • Clarification of the legal status of organisms produced by NGTs
  • A state-of-play on the implementation and enforcement of the GMO legislation, as regards NGTs
  • Safety and risk assessment considerations
  • An overview of research and innovation in the field
  • EU countries and stakeholders views on potential benefits/opportunities and challenges/concerns associated with NGTs and their products, labelling, Small and Medium Enterprises (SMEs), intellectual property
  • Information on public dialogues and national surveys
  • Information on ethical aspects of NGTs and their products
Study methodology

The study has been performed by the Commission and includes external contributions via a targeted consultation.

The study was supported by:

In addition, it took into account expert opinions from:

Findings of the study
  • NGTs and their products have been rapidly developing in the last 20 years in many parts of the world, with some applications already on the market of some EU trade partners. More applications in various sectors are expected in the years to come; the large majority are being developed outside the EU.
  • Under the current EU regulatory system, there are implementation and enforcement challenges, in particular related to the detection and differentiation of NGT products that do not contain any foreign genetic material. This is a problem for enforcement authorities, operators and applicants.
  • There is considerable interest for NGT-related research in the EU. For many EU countries and stakeholders, the current regulatory framework has a negative impact on EU public and private research and innovation in NGTs.
  • There are indications about both benefits and concerns associated to NGT products and their current and future applications. NGT products have the potential to contribute to sustainable agri-food systems in line with the objectives of the European Green Deal and Farm to Fork Strategy. In the pharmaceutical sector, these techniques would allow faster, more affordable development of medicinal products and would have the potential to tackle currently unmet medical needs. The main concerns are related to their possible safety and environmental impact including on biodiversity, coexistence with organic and genetically modified -free agriculture, as well as labelling and consumers’ right to information and freedom of choice. Stakeholders have different and often opposing views on these aspects.
  • As concluded by the European Food Safety Authority, plant products with similar risk profiles can be obtained with conventional breeding techniques, targeted mutagenesis and cisgenesis.
  • For other NGTs or for applications in animals and micro-organisms, the necessary scientific knowledge is still limited or lacking, especially on safety aspects.
Main conclusions of the study

The study identified limitations to the capacity of the legislation to keep pace with scientific developments; these cause implementation challenges and legal uncertainties.

There are strong indications that the applicable legislation is not fit for purpose for some NGTs and their products, and that it needs to be adapted to scientific and technological progress. It may not be justified to apply different levels of regulatory oversight to similar products with similar levels of risk, as is the case for plants conventionally bred and obtained from certain NGTs.

The follow up to the study should confirm whether adaptation is needed and, if so, what form it should take and which policy instruments should be used in order for the legislation to be resilient, future-proof and uniformly applied.

The study has confirmed that NGT products have the potential to contribute to sustainable agri-food systems in line with the objectives of the European Green Deal and Farm to Fork Strategy. Any further policy action should aim at enabling NGT products to contribute to sustainability, while addressing concerns. At the same time, NGT applications in the agricultural sector should not undermine other aspects of sustainable food production, e.g. as regards organic agriculture.

Future policy action would also need to address the knowledge gaps and limitations identified in this study. Importantly, more effort should be made to inform and engage with the public on NGTs and assess their views.

Next steps

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.

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 will engage 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.

Stakeholders’ consultation

About the consultations

Stakeholder consultations are an important instrument for evidence-based policymaking. In this study, the Commission’s goal was to collect technical information, practical experiences and views on New Genomic Techniques (NGTs) from Member States and relevant EU-level stakeholders via targeted consultations. Both consultations were conducted in the form of online questionnaires.

  • The EU Member States draft questionnaire was discussed, finalised and endorsed at a Joint Working Group of Member States GMO competent authorities held in Brussels on 15 January 2020.. The final questionnaire was made available to the Member States via EUsurvey. The authorities were invited to consult further at national level in order to complement their replies.
  • The targeted stakeholder consultation involved EU-level stakeholder organisations that could be directly or indirectly impacted and/or have potential interest in NGTs (see list below). The questionnaire was discussed and finalised during a stakeholder meeting held in Brussels on 10 February 2020.. The final questionnaire was made available to stakeholders via EUsurvey.

Replies from Member States

  • EEA countries (spontaneous submissions)
  • Norway.

Replies from Stakeholders

107 stakeholders were invited to participate; 71 confirmed their interest and received the questionnaire; 58 provided replies

  1. Alliance for Regenerative Medicine (ARM).
  2. Animal Health Europe
  3. Aquaculture Advisory Council (AAC)
  4. Arbeitsgemeinschaft für Gentechnik-frei erzeugte Lebensmittel (ARGE) & Verband Lebensmittel ohne Gentechnik (VLOG)*.
  5. ARCHE NOAH*.
  6. Association of Manufacturers and Formulators of Enzyme Products (AMFEP).
  7. Bio-based Industry Consortium (BIC)
  8. Birdlife international
  9. International Community of Breeders of Asexually Reproduced Horticultural Plants (CIOPORA)
  10. Comité Européen des Entreprises Vins (CEEV).
  11. Committee of Professional Agricultural Organisations (COPA).
  12. Compassion in World Farming EU (CIWF).
  13. Confederation of European Paper Industries (CEPI)
  14. Corporate Europe Observatory (CEO).
  15. Cosmetics Europe
  16. Dachverband Kulturpflanzen- und Nutztiervielfalt e.V.*
  17. EU association of specialty feed ingredients and their mixtures (FEFANA).
  18. EU Fish Processors and Traders Association (AIPCE-CEP)
  19. EU Vegetable Oil and Protein Meal Association (FEDIOL).
  20. EuroCommerce.
  21. Eurocoop.
  22. Eurogroup for Animals.
  23. EuropaBio.
  24. European Academies’ Science and Advisory Council (EASAC).
  25. European Agricultural Machinery Association (CEMA).
  26. European Aquaculture Technology and Innovation Platform (EATIP)
  27. European Association of cereals, rice, feedstuffs, oilseeds, olive oil, oils and fats and agrosupply trade (COCERAL).
  28. European Association of Professional Portside Storekeepers (UNISTOCK Europe).
  29. European Association of Sugar Manufacturers (CEFS).
  30. European Biopharmaceutical Enterprises (EBE)
  31. European Bioplastics
  32. European Chemical Industry Council (CEFIC)
  33. European Cocoa Association (ECA)
  34. European Consortium for Organic Plant Breeding (ECO-PB).
  35. European Consumer Organisation (BEUC).
  36. European Coordination via Campesina (ECVC).
  37. European Council of Young Farmers (CEJA)
  38. European Crop Care Association (ECCA)
  39. European Crop Protection Association (ECPA)
  40. European Environmental Bureau (EEB).
  41. European Fat Processors and Renderers Association (EFPRA)
  42. European Federation for Cosmetic Ingredients (EFCI)
  43. European Federation of Associations of Health Product Manufacturers (EHPM)
  44. European Federation of Biotechnology (EFB).
  45. European Federation of Pharmaceutical Industries and Associations (EFPIA).
  46. European Feed Manufacturers’ Federation (FEFAC).
  47. European Fermentation Group (EFG).
  48. European Flavour Association (EFFA)
  49. European Flour Millers (EFM).
  50. European Food and Feed Cultures Association (EFFCA).
  51. European Former Foodstuff Processors Association (EFFPA)
  52. European Forum of Farm Animal Breeders (EFFAB).
  53. European Landowners Association (ELO).
  54. European Livestock and Meat Traders Union (UECBV)
  55. European Mobile Seed Association (EMSA)
  56. European Network of Scientists for Social and Environmental Responsibility (ENSSER).
  57. European Nurserystock Association (ENA).
  58. European Organic Certifiers Council (EOCC)
  59. European Organisation of Cosmetic Ingredients, Industries and Services (UNITIS)
  60. European Plant Science Organisation (EPSO).
  61. European Potato Trade Association (EUROPATAT).
  62. European Poultry Meat Sector (AVEC)
  63. European Primary Food Processing Industry (PFP).
  64. European Professional Beekeepers Association (EPBA)
  65. European Renewable Ethanol Producers (ePURE)
  66. European Society for Blood and Marrow Transplantation (TBPM)
  67. European Society of Gene and Cell Therapy (ESGCT)
  68. European Specialist Sport Nutrition Alliance (ESSNA)
  69. European Sustainable Agriculture through Genome Editing (EU-SAGE).
  70. European Traders in Agri-Food Commodities (CELCAA)
  71. European Vegetable Protein Association (EUVEPRO)
  72. Euroseeds.
  73. Farmhouse and Artisan Cheese and Dairy Producers European Network (FACE Network)
  74. Federation of European Academies of Medicine (FEAM)
  75. Federation of European Aquaculture producers (FEAP)
  76. Federation of European Rice Millers (FERM).
  77. Federation of Veterinarians of Europe (FVE).
  78. Food and Water Action Europe.
  79. Food Supplements Europe (FSE)
  80. FoodDrinkEurope (FDE).
  81. FoodFirst International Action Network (FIAN International).
  82. FoodServiceEurope
  83. Friends of Earth Europe (FoEE).
  84. General Committee for Agricultural Cooperation in the European Union (COGECA).
  85. Greenpeace Europe.
  86. Health and Environment Alliance (HEAL)
  87. Independent Retail Europe
  88. Institute for Independent Impact Assessment of Biotechnology (Testbiotech).
  89. Interessengemeinschaft für gentechnikfreie Saatgutarbeit (IG Saatgut)*.
  90. International Association of Horticultural Producers (AIPH).
  91. International Biocontrol Manufacturers Association (IBPMA)
  92. International Confederation of European Beet Growers (CIBE).
  93. International Federation of Organic Agriculture Movements Europe (IFOAM EU).
  94. International Flower Trade Association (UF).
  95. International Fragrance Association (IFRA)
  96. International Natural and Organic Cosmetics Association (NATRUE).
  97. International Platform of Insects for Food and Feed (IPIFF)
  98. International Society for Cell and Gene Therapy (ISCT)
  99. Maiz’Europ’ (CEPM).
  100. Medical Nutrition International Industry (MNI)
  101. Pesticide Action Network Europe (PAN)
  102. Plants for the Future — European Technology Platform (PlantETP).
  103. Pollinis*.
  104. Slow Food.
  105. SMEunited
  106. Starch Europe.
  107. Total Diet & Meal Replacements Europe (TDMR Europe)

* coordinating and representing national associations in various Member States.

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