Changes from plenary report to adopted text

RemovedDRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

AddedP9_TA(2024)0067

Changedon the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on plantsPlants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625feed

Removed(17037/1/2025 – C10-0102/2026 – 2023/0226(COD))

AddedCommittee on the Environment, Public Health and Food Safety

Removed(Ordinary legislative procedure: second reading)

AddedPE754.658

Change 1

RemovedThe European Parliament,

AddedAmendments adopted by the European Parliament on 7 February 2024 on the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 (COM(2023)0411 – C9-0238/2023 – 2023/0226(COD))

Removed– having regard to the Council position at first reading (17037/25 – C10-0102/2026),

Added(Ordinary legislative procedure: first reading)

Removed– having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Cypriot Parliament and the Hungarian Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity,

AddedTitle: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 and Directive 98/44/EC (Text with EEA relevance)

Removed– having regard to the opinion of the European Economic and Social Committee of 26 October 2023,

AddedRecital 1: (1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council (32), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, significant progress in biotechnology has led to the development of new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations. Major advances in genetic engineering have already contributed to the widespread use of marker-assisted selection, which makes it possible to identify and mobilise interesting genes that are present in biodiversity.

Removed– having regard to the opinion of the Committee of the Regions of 17 April 2024,

AddedRecital 1 a (new): (1a) Allowing for new genomic techniques and their results to be patented risks giving multinational seed companies even more power over farmers’ access to seeds. In a context where large companies already have a monopoly on seeds and increasingly control natural resources, this would deprive farmers of all freedom of action by making them dependent on private companies. For this reason, patents on these products must be banned.

Removed– having regard to its position at first reading on the Commission proposal to Parliament and the Council (COM(2023)0411),

AddedRecital 2: (2) NGTs constitute a diverse group of genomic techniques, and each of them can be used in various ways to achieve different results and products. They can result in organisms with modifications equivalent to what can be obtained by conventional breeding methods or in organisms with more complex modifications. Among NGTs, targeted mutagenesis and cisgenesis (including intragenesis) introduce genetic modifications without inserting genetic material from non-crossable species (transgenesis). They rely only on the breeders’ gene pool, i.e. the total genetic information that is available for conventional breeding including from distantly related plant species that can be crossed by advanced breeding techniques. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at targeted locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool.

Removed– having regard to Article 294(7) of the Treaty on the Functioning of the European Union,

AddedRecital 3: (3) There is ongoing public and private research using NGTs on a wider variety of crops and traits compared to those obtained through transgenic techniques authorised in the Union or globally(33 ). This includes plants with improved tolerance or resistance to plant diseases and pests, plants with tolerance to herbicides, plants with improved tolerance or resistance to climate change effects and environmental stresses, improved nutrient and water-use efficiency, plants with higher yields and resilience and improved quality characteristics. These types of new plants, coupled with the fairly easy and speedy applicability of those new techniques, could deliver benefits to farmers, consumers and to the environment. Thus, NGTs have the potential to contribute to the innovation and sustainability goals of the European Green Deal (34 ) and of the ‘Farm to Fork’ (35 ), Biodiversity (36 ) and Adaptation to Climate Change(37 ) Strategies, to global food security (38 ), the Bioeconomy Strategy (39 ) and to the Union’s strategic autonomy (40 ).

Removed– having regard to the provisional agreement approved by the committee responsible under Rule 75(4) of its Rules of Procedure,

AddedRecital 9: (9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae. Available knowledge on other organisms, such as microorganisms, fungi and animals, should be reviewed with a view to future legislative initiatives on them. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter ‘NGT plants’), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non-crossable species (transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene.

Removed– having regard to Rule 68 of its Rules of Procedure,

AddedRecital 10: (10) With full regard to the precautionary principle, the legal framework for NGT plants should share the objectives of the Union GMO legislation to ensure a high level of protection of human and animal health and of the environment and the good functioning of the internal market for the concerned plants and products, while addressing the specificity of NGT plants. This legal framework should enable the development and placing on the market of plants, food and feed containing, consisting of or produced from NGT plants and other products containing or consisting of NGT plants (‘NGT products’) so as to contribute to the innovation and sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and to enhance the competitiveness of the Union agri-food sector at Union and world level.

Removed– having regard to the recommendation for second reading of the Committee on the Environment, Climate and Food Safety (A10-0175/2026),

AddedRecital 11: (11) This Regulation constitutes lex specialis with regard to the Union GMO legislation. It introduces specific provisions for NGT plants and NGT products. However, where there are no specific rules in this Regulation, NGT plants and products obtained from them should remain subject to the requirements of the Union GMO legislation and the rules on GMOs in sectoral legislation, such as Regulation (EU) 2017/625 on official controls or the legislation on certain products like plant and forest reproductive material.

Removed1. Approves the Council position at first reading;

AddedRecital 13 a (new): (13a) NGT plants with the potential to persist, reproduce or spread in the environment, within or beyond fields, should be evaluated with the highest level of scrutiny in respect of such plants’ impact on nature and the environment.

Removed2. Notes that the act is adopted in accordance with the Council position;

AddedRecital 14: (14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny (‘category 1 NGT plants’) should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable, thereby derogating in full from the Union GMO legislation and GMO related requirements in sectoral legislation. In order to ensure legal certainty, this Regulation should set out the criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants and lay down a procedure for competent authorities to verify and take a decision on the fulfilment of those criteria, prior to the release or placing on the market of NGT plants or NGT products. Those criteria should be objective and based on science. They should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques and should include thresholds for both size and number of genetic modifications to the genome of NGT plants. Since scientific and technical knowledge evolves rapidly in this area, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientific and technical progress as regards the type and extent of genetic modifications that can occur in nature or through conventional …

Removed3. Instructs its President to sign the act with the President of the Council, in accordance with Article 297(1) of the Treaty on the Functioning of the European Union;

AddedRecital 14 a (new): (14a) Taking into account the high complexity of plant genomes, the criteria for considering that a NGT plant is equivalent to a naturally occurring or conventionally bred plant should reflect the diversity of plants genomic size and their characteristics. Polyploid plants contain more than two homologous chromosomes. Within that category of polyploid plants, tetraploid, hexaploid, and octoploid have 4, 6 and 8 sets of chromosomes respectively. Polyploid plants tend to exhibit greater numbers of genetic modifications compared to monoploid plants. For those reasons, any limit to the total number of individual modifications per plant should reflect the number of chromosomes set in a plant (“ploidy”).

Removed4. Instructs its Secretary-General to sign the act, once it has been verified that all the procedures have been duly completed, and, in agreement with the Secretary-General of the Council, to arrange for its publication in the Official Journal of the European Union;

AddedRecital 18: (18) Since the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants are unrelated to the type of activity that requires the deliberate release of the NGT plant, a declaration of the category 1 NGT plant status made prior to its deliberate release for any other purpose than placing on the market in the territory of the Union should also be valid for the placing on the market of related NGT products. In view of the high uncertainty existing at the field trial stage about the product reaching the market and the likely involvement of smaller operators in such releases, the verification procedure of category 1 NGT plant status prior to field trials should be conducted by national competent authorities as this would be less administratively burdensome for operators, and a decision should be taken at Union level only in case there are comments to the verification report by other national competent authorities. Where verification request is submitted prior to the placing on the market of NGT products, and if there are reasoned objections by other Member States, the procedure should be conducted in consultation with the Commission and the European Food Safety Authority (‘the Authority’) in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Removed5. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

AddedRecital 18 a (new): (18a) In order to effectively select new varieties that help the agricultural sector increase food security, as well as sustainability, adaptation and resilience in relation to the consequences of climate change, it is necessary to consider the specificity of polyploid plants, which are plants that contain more than two genomes. For such plants, the maximum number of genetic modifications allowed for inclusion in category 1 NGT should be proportionate to the number of genomes they contain.