Questions and Answers: Study on New Genomic Techniques

New genomic techniques constitute a diverse group of techniques and each technique can be used in various ways to change the genome (an organism’s complete set of genetic instructions) and achieve different results and products. The objectives of the user and the technique determine the type and magnitude of the genome modification, which can range from limited changes to multiple and more extensive modifications.

In the case of mutagenesis, changes occur without inserting genetic material.

In cisgenesis or intragenesis, changes happen by rearranging the genetic material of the same organism, or by inserting genetic material from organisms that can cross in nature, e.g. introduce genetic material from a wild potato into a cultivated potato or from a boar to domesticated pigs. The latter is a technologically advanced way of what is traditionally done in selective breeding.

NGTs can also be used in the same way as older, established techniques of genetic modification, i.e. to insert genetic material into an organism from other organisms that are sexually incompatible (transgenesis), e.g. a gene from an insect into a plant.

Organisms produced by NGTs are very diverse. Compared to the original unmodified organism, they can have few small changes that might also occur in nature or through conventional breeding, or they can have multiple and extensive modifications, including the insertion of foreign genetic material from organisms that are sexually incompatible.

In the first instance, these organisms resemble organisms produced by conventional breeding; this is the case with certain applications of targeted mutagenesis and cisgenesis. In the second case, they are similar to organisms produced by established techniques of genetic modification, used in the last two decades.

• Organisms produced by conventional breeding are not GMOs in the EU; depending on the type of product and use, they might be regulated under different EU legislation.
• Organisms produced by classical mutagenesis, using irradiation or chemical mutagens, are GMOs, but are exempted from the obligations of the GMO legislation, due to a long history of safe use at the time of the introduction of the legislation in 2001.
• Organisms produced by established genetic modification techniques and NGTs are GMOs subject to the rules of the GMO legislation.

Currently there is no product obtained by NGTs marketed in the EU.

There are a few products marketed outside the EU: a soybean with a healthier fatty acid profile, a tomato fortified with gamma-aminobutyric acid, and a bacterium for fertilising agricultural soil.

Many products are in a pre-market phase, and even more are under development.

The study was prepared by the Commission following a request from the Council of the European Union which, on 8 November 2019, asked the Commission to carry out "a study in light of the Court of Justice's judgment in Case C-528/16 regarding the status of novel genomic techniques under Union law".

The Council recognised that, while the ruling of the Court of Justice of the EU clarified the scope of the GMO legislation with respect to mutagenesis techniques, it also raised practical questions with consequences, not only for Member States’ national competent authorities, but also for the EU industry, in particular the plant breeding sector, research and beyond.

The Council also requested the Commission, to submit a proposal, if appropriate in view of the outcome of the study, or otherwise to inform the Council on other measures required as a follow-up to the study. The study published on 29 April is not accompanied by a legislative proposal but paves the way for future policy action.

The study focuses on the use of NGTs in plants, animals and microorganisms, in a broad variety of potential uses including the agri-food, medicinal and industrial sectors.

The objective of this study is to provide clarity on NGTs, in the form of updated and comprehensive information on a broad variety of topics (legal status, research and potential applications, safety, potential benefits and concerns, ethics, public awareness) and assist in deciding, if appropriate, any further action in this policy area.

The study was conducted by the Commission and informed by contributions, via targeted consultations of Member States’ competent authorities and EU-level stakeholders.

A wide range of participants were involved in the consultation, representing, in a balanced manner, different interests and views. The Commission followed a transparent and participatory consultation process, in line with Better Regulation guidelines, and involved the Member States and stakeholders in the finalisation of the questionnaires.

The study was also supported by a technical contribution from the European Food Safety Authority (EFSA) and two reports from the Commission’s Joint Research Centre (JRC) on the technology landscape and current and future applications of NGTs. In addition, it took account of expert opinions from the Group of Chief Scientific Advisors and the European Network of GMO Laboratories. The study also reports on the recent Opinion on the Ethics of Genome editing by the European Group on Ethics in Science and New Technologies.

For NGT applications in plants, EFSA concluded that there are no new hazards specifically linked with targeted mutagenesis and cisgenesis, compared with conventional breeding. In addition, EFSA concluded that unintended effects during modification of the genome with targeted mutagenesis are of the same type, and fewer, than the unintended effects occurring with conventional, non-GM breeding techniques.

Moreover, the type of modifications introduced with targeted mutagenesis and cisgenesis can also take place naturally in the environment without human intervention.

EFSA has not yet assessed the safety of targeted mutagenesis and cisgenesis beyond plant applications, nor the safety of other techniques.

Under EU law, organisms produced by NGTs are GMOs.

On 25 July 2018, the European Court of Justice concluded that the GMO legislation applies to organisms produced by new mutagenesis techniques which have appeared or have been mostly developed since the current EU GMO legislation is in place (2001). Based on the judgement of the Court, the study clarifies that also organisms whose genome has been altered via cisgenesis, intragenesis and epigenome editing are GMOs, and must fulfil the obligations of the EU GMO legislation.

Yes.

In the agri-food sector, NGTs can make plants resistant to pests and diseases, needing less chemical pesticides (e.g. fungi-resistant maize or potato), or resistant to the effects of climate change (e.g. rain resistant wheat or drought-tolerant rice). NGTs can also improve the nutrient content of vegetables for healthier diets (e.g. soybean oil with healthier fatty acid content), or reduce content of harmful substances such as toxins and allergens (e.g. potatoes with reduced acrylamide content).

The study identifies plant NGT products currently being marketed or in development that are fit to contribute to the objectives of the European Green Deal and the Farm to Fork and biodiversity strategies as well as to the Sustainable Development Goals of the United Nations.

Similarly, farm animals can be made more resistant to certain diseases, increasing their health and welfare.

Yes.

NGTs can be used to refine and improve the production of useful substances from microorganisms, with applications in cosmetics, biofuels, food ingredients and pharmaceutical substances.

In the pharmaceutical sector, NGTs can be employed for the development of vaccines and therapies for hereditary diseases and cancer.

The study compiles a wide range of views from national authorities and EU-level stakeholders, including business associations, scientific organisations and NGOs.

Some views expressed in the study claim that the proposed benefits of NGTs in agriculture are hypothetical and could also be achieved by means other than biotechnology.

Concerns relating to the possible safety and environmental impact of NGT products have been raised by various respondents. Concerns were also raised on the coexistence of different types of agricultural production. The organic/GM-free businesses reported potential threats to their business model, including difficulties in traceability and labelling and consequently in maintaining consumer trust, whereas one of the objectives of the Green Deal and Farm to Fork Strategy is to increase organic farming in the EU. Issues of consumers’ right to information and freedom of choice were also raised.

Concerns related to negative consequences from not using NGT products have also been raised in the study.

Yes, there are implementation and enforcement challenges.

As regards the detection of NGT products that do not contain any foreign genetic material, the general analytical screening strategy employed for conventional GMOs might not be applicable. In addition, it may not be possible to confirm if changes in the genome occurred by natural mechanisms or techniques not subject to the GMO legislation (e.g. radiation or chemical mutagenesis), or if they are resulting from NGTs, which are subject to the GMO legislation.

Moreover, while the study provided further clarification on the legal status of NGT products, based on the ruling of the Court of Justice of the EU, the study also identified persisting legal uncertainties in relation to new techniques and new applications.

In addition, the current risk assessment procedures, embedded in the existing legislation, are rigid and limit a case-by-case evaluation, preventing adaptation to scientific progress.

The study identified a series of challenges relating to the capacity of the legislation to keep pace with scientific developments, which make its implementation difficult. There are strong indications that the current GMO legislation is not fit for plants produced by targeted mutagenesis and cisgenesis, and that it needs to be adapted to scientific and technological progress in order to be resilient, future-proof and uniformly applied. The study also shows 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.

Yes.

The Commission intends to initiate a policy action tailored to plants derived from targeted mutagenesis and cisgenesis.

In the coming months, an impact assessment, including a public consultation, will be carried out in accordance with Better Regulation rules, to examine potential policy options. The Commission initiative intends to maintain high safety standards and reap the benefits from innovation by enabling NGTs to contribute to the sustainability and resilience of the EU agri-food system and benefit society. The impact assessment will also examine the concerns expressed about NGTs during the consultation on the study, and how they can be addressed.

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 Council, the European Parliament and stakeholders in dedicated meetings.