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New Genomic Techniques (NGTs) provide new opportunities to alter the genetic material of an organism allowing the rapid development of plant varieties with specific characteristics. These techniques can lead to more targeted and precise modifications to the genome than conventional breeding. These modifications could or could not be produced in nature or obtained by conventional breeding.
Targeted mutagenesis and cisgenesis are considered NGTs. Targeted mutagenesis and cisgenesis do not introduce genetic material from non-crossable species.
Plant applications of NGTs have developed rapidly and are expected to continue to do so on a global scale. There is ongoing public and private research using NGTs on a variety of crops and traits including crops with higher yields, improved tolerance or resistance to biotic (pests and diseases) and abiotic (environmental and climate change effects) stress, improved nutrient and water use efficiency and improved quality characteristics.
The potential for NGTs to deliver crops with improved traits in a faster way than conventional breeding can deliver benefits to farmers, consumers and the environment and can contribute to addressing current challenges in the agri-food system such as food security, climate change and biodiversity reduction.
Plant varieties bred using NGTs are currently regulated under Union GMO legislation.
In its judgement of 25 July 2018, the Court of Justice of the European Union held that genetically modified organisms (GMOs) obtained by means of new techniques/methods of mutagenesis that have appeared or have been mostly developed since Directive 2001/18/EC (Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms) was adopted could not be considered excluded from the scope of that Directive.
In November 2019, the European Council requested the Commission to submit a study in light of the European Court of Justice judgment regarding the status of NGTs under Union law, and a proposal (accompanied by an impact assessment), if appropriate, in view of the outcomes of the study.
The Commission delivered the requested study in April 2021 on the status of NGTs under EU law. The study concluded that current Union GMO Legislation is no longer fit for purpose and is in need of adaptation to scientific and technological progress for some NGTs and products derived from NGTs.
The study concluded that the authorisation procedure and risk assessment requirements for GMOs are not adapted to the variety of potential organisms and products that can be obtained with targeted mutagenesis and cisgenesis, the current GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products and is also not conducive to developing innovative and beneficial products that could contribute to sustainability, food security and resilience of the agri-food chain.
On 05 July 2023, the European Commission adopted its proposal for a Regulation on plants obtained by certain NGTs and derived food and feed products. The scope of this initiative are 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.
The general objectives of the proposal are to:
• maintain a high level of protection of human and animal health and of the environment
• to enable the development and placing on the market of plants and plant products contributing to EU innovation and sustainability objectives
• to ensure the effective functioning of the internal market in NGT plants and products and food and feed containing, consisting, or produced from NGT plants, and enhance the competitiveness of the EU agri-food sector at the Union and global levels, including a level playing field for its operators.
The proposal makes the deliberate release and placing on the market of NGT plants subject to one of two procedures: notification to establish equivalence with conventional products (Category 1 NGT plants) or authorisation in accordance with Directive 2001/18 or Regulation 1829/2003 (Category 2 NGT plants).
The notification procedure is to verify whether products obtained by targeted mutagenesis or cisgenesis could also occur naturally or by conventional breeding and is based on specific criteria including the number and type of genetic modifications.
NGT plants determined to meet the notification criteria (Category 1 NGT plants) are exempted from the requirements of the GMO legislation and are subject to the provisions applicable to conventional products. However, they remain prohibited in organic production.
Transparency about category 1 NGT plants is ensured in a public database, through the labelling of seeds and in the variety catalogues of the Plant Reproductive Material/Forestry Reproductive Material legislation.
For products which do not meet the criteria of the notification procedure (Category 2 NGT plants), the procedures of the GMO legislation apply (authorisation under Directive 2001/18/EC and Regulations 1829/2003 and 1830/2003), but with some adaptations.
The main adaptations include greater proportionality of data requirements for risk assessment, the modalities to comply with detection method requirements and the possibility to tailor to the risk profile monitoring requirements and the need for regular renewal.
Regulatory incentives apply for category 2 NGT plants containing traits that could contribute to the overall performance of varieties as regards sustainability, provided they do not contain herbicide-tolerant traits.
Category 2 NGT plants and products remain subject to traceability and labelling requirements under current GMO legislation with the possibility to add a factual statement on the intended purpose of the genetic modification.
Member States are required to adopt coexistence measures to avoid the unintended presence of Category 2 NGT plants in conventional or organic crops.
The possibility for Member States to restrict or prohibit cultivation pursuant to Directive 2001/18 does not apply to Category 2 NGT plants.
The Commission conducted the following consultations in the preparation of the proposal:
● feedback on the Commission’s Inception Impact Assessment (24 September 2021 – 22 October 2021)
● Commission’s public consultation (29 April 2022 – 22 July 2022)
● targeted stakeholder survey (28 June 2022 – 05 September 2022)
● interviews (June 2022 – December 2022)
● focus groups on sustainability and traceability (22 and 23 September 2022).
The proposed Regulation can be viewed or downloaded here:
The Annexes of the proposed Regulation can be viewed or downloaded here:
gmo_biotech_ngt_proposal_annex
The Impact Assessment accompanying the proposed Regulation can be viewed or downloaded here:
Feedback in writing should be submitted to the Department of Agriculture, Food and Marine via e-mail with reference to “NGT Proposal” to: ngtconsultation@agriculture.gov.ie .
All submissions should include a short summary of not more than 300 words setting out the main points therein. Submissions from organisations or groups should include a brief background on the membership, aims and objectives of that organisation or group.
All written feedback to the proposal should be submitted by 4.00pm on 25 September 2023. Any submissions received after this deadline will not be taken into consideration.
We are committed to engaging with stakeholders in a clear, open, and transparent manner. Any person or organisation can make a submission in relation to this consultation. All submissions and feedback will be considered by the Department Agriculture, Food and the Marine.
Please note that it is intended that all submissions received may be made available under the Freedom of Information Act 2014 (FOI) and will be published on the Department Agriculture, Food and the Marine website.
In responding to this consultation, parties should clearly indicate where their responses contain personal information, commercially sensitive information, or confidential information which they would not wish to be released under FOI or published on the department’s website.
We would like to draw your attention to the Department Agriculture, Food and the Marine's Data Protection Data Privacy Notice which is available on our website and explains how and when we collect personal data, why we do so and how we treat this information. It also explains your rights in relation to the collection of personal information and how you can exercise those rights.