Frequently Asked Questions: Proposal on New Genomic Techniques

1. What are New Genomic Techniques (NGTs)?

New Genomic Techniques (NGTs) are innovative tools that can help increase the sustainability and resilience of our food system and support the goals of the European Green Deal and the Farm to Fork Strategy. They allow precise and efficient development of improved plant varieties that can be climate resilient, pest resistant, require less fertilisers and pesticides, or ensure higher yields.

Each of these techniques can be used in various ways to achieve different results and products. Some of the changes to products derived from NGTs might also occur in nature or through conventional breeding. Other products may have multiple and extensive modifications. In most cases, these new techniques lead to more targeted, precise, and faster changes than conventional breeding or established genomic techniques.

1. Why do we need NGTs?

Since the invention of agriculture, humans have been improving grains, fruits, vegetables ever since we started growing them. Plants have been crossed and selected to get the right characteristics to get better crops. New genomic techniques allow us to do exactly the same, but faster and with more precision.The techniques identify and select the right characteristics from the plant's own DNA or from a related plant.Breeders can then use NGTs to develop new characteristics or improve existing plants with greater precision and speed than with conventional breeding techniques.

1. How would NGT plants be treated under this new legislation?

NGTs describes a variety of techniques that alter the genetic material of an organism. They did not yet exist in 2001, when the EU legislation on genetically modified organisms (GMOs) was adopted.

Currently, plants obtained by NGTs are subject to the same rules as GMOs. To better reflect the different risk profiles of NGT plants, 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 will be subject to a verification procedure, based on criteria set in the proposal. NGT plants that meet these criteria are treated like conventional plants and therefore exempted from the requirements of the GMO legislation. This means that for these plants no risk assessment has to be made and they can be labelled in the same way as conventional plants.

Forall other NGTplants, the requirements ofthe current GMO legislation would apply. This means that they are subject to risk assessments, and they can only be put on the market following an authorisation procedure. For these plants there will be adapted detection methods and tailored monitoring requirements.

1. Does this proposal concern all NGTs?

No. This proposal only concerns plants produced by targeted mutagenesis and cisgenesis and their food and feed products. Targeted mutagenesis induces mutations in the genome without insertion of foreign genetic material (e.g., changes are made within the same plant species). Cisgenesis is an insertion of genetic material into a recipient organism from a donor that is sexually compatible with the recipient organism (e.g., changes are made between naturally compatible plants).

The proposal does not include plants obtained by NGTs that introduce genetic material from a non-crossable species (transgenesis). Such techniques remain subject to the existing GMO legislation.

1. How can NGTs benefit farmers, consumers and citizens?

NGTs can contribute to the transition to a more sustainable agriculture and food system and help reduce EU's external dependencies for agri-food production. NGTs can support these objectives in multiple ways by benefitting different actors along the entire food chain.

Farmers would benefit from increased availability of plants tailored to satisfy the needs of the sector, such as climate resilience, pest resistance, improved yield and reduced need for fertilisers and pesticides.

Consumers would be able to choose from more food products with improved taste, better nutritional properties, or reduced levels of allergy-causing substances while also purchasing products that have contributed to sustainability.

Finally, manufacturers and traders can also see advantages in reduced use of natural resources and reduced emissions associated with food transport and properties facilitating processing.

1. Why is the Commission proposing this new legislation?

Since the adoption of the EU's GMO legislation in 2001, and especially in the last decade, a variety of NGTs have been developed based on advances in biotechnology.

To have a better understanding of all these recent advances, the Council requested the Commission in November 2019 to provide a study on NGTs. The 2021 Commission study Concluded that the current rules – mainly the existing GMO legislation - lags behind scientific and technological progress and do not sufficiently facilitate the development and placing on the market of innovative NGT products. The EU needs an adapted framework for safe NGT plants benefitting farmers, consumers, and the environment.

The legislative proposal therefore establishes a regulatory framework for NGT plants, and their products. It proposes different procedures for the placing on the market of NGT plants.

1. What evidence did the Commission use to elaborate this legislative proposal?

The Commission has relied on EU-level scientific advisory bodies. Safety issues have been thoroughly addressed by the European Food Safety Authority, EFSA, which has adopted several scientific opinions on NGTs.

Furthermore, to assess how NGTs have evolved and to get an understanding of the current scientific state of the art, the Commission's Joint Research Centre (JRC) analysed the latest scientific developments relating to NGTs. It has also carried out research to map the development pipeline of NGTs with respect to crop species, traits, and stage of the Research & Development process and analysed impacts of specific NGT plant case studies.

The Commission also collected and considered evidence and views provided by a large range of stakeholders and experts in preparation of the impact assessment.

1. Are there products obtained by NGTs already on the market or close to market?

Outside the EU, several NGT plant products are already or in the process of becoming available on the market or. These products have various useful characteristics e.g., resistance to pests and diseases, resistance to environmental stress (including from climate change), improved nutritional qualities/taste/texture, and in less need of pesticides. For instance, less bitter mustard greens are on the market in the US and will soon be in Canada. Non-browning bananas with the potential to significantly reduce food waste and CO₂ emissions have already been approved in the Philippines.

A wide range of enhanced crops are also being developed, such as low-gluten wheat or virus-resistant maize.

1. How would the new legislation contribute to the objectives of the EU Green Deal and Farm to Fork strategy?

The proposal will create a legal framework so that NGTs can support the green transition of the agri-food system. It is designed to meet the demands of farmers for the development and commercialisation of new plant varieties with beneficial characteristics. These plants will help address new challenges posed by climate change and reduce the use of pesticides and fertilisers. The development of such varieties will help achieve the objectives of other EU policy initiatives, such as the Commission proposals on the sustainable use of pesticides and the revision of the EU waste framework Directive, which proposes legally binding targets to reduce food waste across the EU.

The proposal promotes innovation to contribute to sustainability by introducing for instance tolerance or resistance to plant diseases and pests (biotic stresses), plants with improved tolerance or resistance to climate change effects and extreme temperatures or droughts (abiotic stresses), improved nutritional characteristics or increased yield.

The proposed legislation is expected to entail moreinvestments in agricultural biotechnology from the public sector, SMEs, and plant breeders. A special focus is put on ensuring easier and faster marketing of innovative products. This will offer a broader variety of crops to farmers and citizens.

1. Does the proposal guarantee high standards of safety for humans, animals and the environment?

Absolutely. The legislative proposal ensures a high level of protection of human and animal health and the environment. One of the main priorities of the Commission is to ensure that food in the EU is and remains safe.

In its scientific opinions, EFSA concluded that there are no new hazards specificallylinked with targeted mutagenesis and cisgenesis in plants. EFSA noted that some plants produced with these techniques may undergo small changes that might also occur in nature or through conventional breeding. Others may have multiple and extensive modifications that are similar to those in plants produced by established techniques of genetic modification used in the last two decades. EFSA therefore considers that the risk assessment of these techniques should be adapted to the techniques in question. EFSA developed, also at the request of the Commission, a statement on criteria for risk assessment. In addition, EFSA concluded that unintended modifications of the genome following targeted mutagenesis are of the same type, but fewer, than those occurring with conventional breeding techniques.

Based on EFSA's conclusions, the Commission is proposing that plants that are comparable to conventional plants (according to criteria defined in the proposal) are treated in the same way and not subject to a further risk assessment. Plants with complex combinations of mutations will, however, remain subject to a risk assessment and must be authorised before they can be placed on the market.

This approach ensures that all NGT plants released or placed in the EU market are safe.

1. Will there be transparency on NGT products placed on the EU market?

Yes. The legal proposal ensures transparency of all NGT products authorised on the EU market.

NGT products subject to an authorisation procedure would remain subject to the traceability and labelling requirements of the current GMO framework.

NGT plants that are similar to those occurring naturally or obtained by conventional breeding would not be subject to the labelling requirements of the GMO framework. They would be labelled in the same manner as conventional plants.

To ensure transparency and freedom of choice for farmers, all NGT plants will be listed in a public database. In addition, their seeds and other plant reproductive material will be labelled, and information on NGT plant reproductive material will be listed in the common catalogues of plant varieties so that farmers can freely choose to use such plants or not.

1. What measures are proposed to support SMEs?

The proposal intends to reduce red tape for companies and SMEs. In practice the proposed legislation will reduce the complexity, duration, and costs of authorisation applications. It also eliminates nearly all costs for NGTs subject to the verification procedure. This is very beneficial for SMEs.

Support measures will also be available, especially for SMEs. For instance, they will receive scientific advice before submission of an application The risk assessment procedures will be simplified as well.

This new framework will also make it much easier to place a wider range of traits or niche crop species important for local production on the market.

1. What does the proposal mean for organic production?

NGT plants will be prohibited in organic production.

For NGT plants subject to authorisation, the legislative proposal maintains the traceability and labelling requirements of the GMO legislation. Today, GMOs are banned in organic production by the EU Organic Production Regulation. In addition, the proposal makes the adoption of coexistence measures at national level mandatory. Member States have to adopt measures so that different types of cultivation can exist side by side, e.g., distances between the fields.

To exclude NGT plants from organic production – even those that have been verified to be comparable to conventional plants - organic and GM-free farmers can consult a public register of all NGT products and seed labelling in common catalogues of varieties.

1. Are you deregulating GMOs?

Absolutely not. The new rules concern NGTs only, which are distinct from GMOs. The new rules regulate NGTs in the EU and ensures that all NGT plants will be subject to a regulatory oversight that is tailored to their risk profile and will ensure that all NGT plants on the EU market are as safe as conventionally bred varieties. It will also provide transparency about NGT plants and products on the EU market. GMOs continue to be regulated by the EU legislation on GMOs, which remain unchanged.

1. Does the proposal address issues related to patents and intellectual property rights?

The legislative proposal concerns the release and placing on the market of NGT plants but does not regulate issues of intellectual property.

The Commission acknowledges that it is important to calibrate a balanced framework which supports farmers' and breeders' access to patented techniques and material, promotes seed diversity at affordable prices, and safeguards breeding and cultivation of unpatented conventional and organic crops, while also strongly encouraging innovation in plant breeding by preserving investment incentives, such as patents.

The Commission will assess, as part of a broader market analysis, the impact that the patenting of plants and related licensing and transparency practices may have on innovation in plant breeding. It will also assess their impact on breeders' access to genetic material and techniques, on availability of seeds to farmers and on the overall competitiveness of the EU biotech industry. The Commission will report on its findings by 2026. It will identify possible challenges in the sector and serve as basis to decide on any possible follow-up actions.

1. How will the Commission monitor the impacts of the new legislation?

Several indicators have been developed to monitor and evaluate the progress towards the objectives of this initiative and its economic, environmental, and social impacts. They include indicators to monitor impacts on organic agriculture and on consumers acceptance of NGT products. Data on most indicators would be collected and published annually and used to produce regular monitoring reports.

The Commission will set a detailed programme to monitor - based on the above indicators - the impacts of this Regulation. The first monitoring report should be published no sooner than 3 years after the verification/authorisation of the first NGT product. An evaluation of the legislation should follow at the earliest 2 years after.

For more information

New Genomic Techniques proposal

NGTs page

Press release on the package

Factsheet on NGTs

Animation on NGTs

EFSA page