I thank the Chairman for his invitation to update the members of the committee on the Commission proposal for a regulation on new genomic techniques, NGTs. These new genomic techniques are commonly known as NGTs or gene editing techniques and are new technologies that have developed over the last two decades.
Targeted mutagenesis and cisgenesis are considered NGTs and are the subject matter of the Commission's legislative proposal. Targeted mutagenesis results in modifications to the DNA sequence at targeted locations in the genome of an organism. Cisgenesis allows the insertion of genetic material in the genome from a sexually compatible, or crossable, organism.
NGTs differ from traditional genetically modified organisms, GMOs, obtained through transgenesis, as transgenic techniques involve the insertion of genetic material from non-crossable organisms. The potential for NGTs to deliver crops with improved traits in a faster way than conventional breeding can deliver benefits for farmers, consumers and the environment.
Plant applications of NGTs have developed rapidly and will 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 pests and diseases, improved tolerance to environmental and climate change effects, improved nutrient use efficiency, and improved quality and nutritional characteristics.
The European Court of Justice, in its judgment of 25 July 2018, clarified that plant varieties bred using NGTs fall under the scope of Union GMO legislation. This judgment led to the European Council requesting the Commission to submit a study regarding the status of NGTs under Union law, and a proposal, if appropriate, in view of the outcome of the study.
The Commission delivered the requested study in April 2021. The study concluded that current Union GMO legislation is no longer fit for purpose and needs adaptation to scientific and technological progress for some NGTs and products derived from NGTs. The study concluded that the current regulatory environment for NGTs is not conducive to developing innovative and beneficial products that could contribute to sustainability, food security and resilience of the agrifood chain.
On 5 July 2023, the Commission adopted its proposal for a regulation on plants obtained by certain NGTs and derived food and feed products. The proposal was adopted following an extensive and comprehensive process undertaken by the Commission, including stakeholder consultation that included a public consultation, a targeted stakeholder survey, interviews and focus groups on sustainability and traceability. At the heart of the proposal is the objective to maintain a high level of protection of human and animal health and the environment and to enable the development and placing on the market of NGT plants and plant products contributing to EU innovation and sustainability objectives. The main provision of the proposal is that it makes the deliberate release and placing on the market of NGT plants subject to one of two procedures, the first being notification to establish equivalence with conventional products for category 1 NGT plants and the second being authorisation under Union GMO legislation but with some adaptations for category 2 NGT plants.
Ireland’s position on the proposal has been one of support. Our position has been informed by a number of factors, including: the scientific opinion from the European Food Safety Authority, EFSA, that NGT plants are as safe as conventionally bred plants; our ongoing engagement with the interagency GMO group; the outcome of our public national consultation, which showed strong support for the proposal; the synergies of the proposal with broader policies such as the European Green Deal and the farm to fork strategy; and the need to embrace new technology and innovation to meet the various challenges facing the agricultural sector, as highlighted in the Food Vision 2030 strategy.
The Spanish Presidency organised an intensive schedule of meetings to progress the proposal. A compromise text was voted on at the agriculture and fisheries, AGRIFISH, Council meeting in December. Ireland supported the compromise text. However, sufficient support for a general approach was not achieved. The main areas where agreement could not be reached related to the potential impact of patenting of varieties bred by NGTs, and the labelling of food and feed products produced from category 1 NGTs. The Belgian Presidency is continuing efforts to progress the proposal. It has circulated an updated compromise text in recent days.
The European Parliament adopted its first reading of the Commission’s proposal on 7 February of this year, with a further update on 24 April. The main amendments adopted by the Parliament on the Commission proposal include: the exclusion from patentability of plants produced by NGTs; and mandatory labelling of both category 1 and category 2 NGT products at each stage of their placing on the market.
The next step in the legislative process is the trilogue, which intends to bring together the three texts into a single agreeable compromise text which will be passed into law. The three texts are: the Council’s amended text; the Parliament’s amended text; and the Commission’s original submission. However, the trilogue process will not begin until a new Parliament and Commission are in place, and until the Council has agreed on its own compromise text.
To conclude, I again thank the Chairman for the opportunity to update the committee on the status of the Commission’s proposal on NGTs. My colleagues and I are happy to answer questions that members of the committee may have.
