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.
- Commission’s study
- Executive summary
- Q&A
- Press release
- Letter to the Portuguese presidency
- EU statements presented at the 80th WTO/SPS Committee on 15 July 2021 – European Commission study on the status of new genomic techniques in the European Union
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:
- An overview from the European Food Safety Authority
- Two reports from the Commission’s Joint Research Centre (technology landscapeand current and future applications)
In addition, it took into account expert opinions from:
- Group of Chief Scientific Advisors
- European Network of GMO Laboratories
- European Group on Ethics in Science and New Technologies
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.