Sittings · Document

Draft report (COM(2023)0411 – C9-0238/2023 – 2023/0226(COD)) 2023-11-19

Plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625

Committee on the Environment, Public Health and Food Safety

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Amendment 24

Günther Sidl

Proposal for a regulation

–

Proposal for rejection

The European Parliament rejects the Commission proposal.

Or. en

Justification

The current EU GMO regulations and directives have served a good purpose (environmental safety) and have been successful in doing so for the past twenty years. There are no good reasons for weakening this system, let alone abolishing it for the majority of new GM plants, in particular as these have no history of safe use. Indeed, our advancing knowledge of molecular genetics informs us that the genome of an organism functions as a delicately balanced, integrated network (Gupta et al., 2022; Schaefer et al., 2017), with complex traits being omnigenic in nature having the function of the entire genome at their basis (Boyle et al., 2017; Mathieson, 2021). That genes function as networks, implies that any modification at this level can have major consequences with respect to patterns of gene expression and an organism’s biochemistry. Thus, the latest science actually suggests that the law governing genetic modification including NGT should be re-appraised and strengthened rather than weakened.

Amendment 25

Sirpa Pietikäinen

Proposal for a regulation

–

Proposal for rejection

The European Parliament rejects the Commission proposal.

Or. en

Justification

- The deregulation of the new Category 1 NGT plants amounts to an a priori declaration of safety, which constitutes a serious risk blindness. This declaration is a false claim and a blatant neglect of the precautionary principle. - The criteria for defining Category I NGT plants as equivalent to conventional plants bear no relationship to the safety of the plants and their products for human health and the environment. - There is as yet little experience regarding the safety of new genomic techniques in food and in agricultural cultivation. Still, even highly modified plants with, for example, altered metabolism and composition will escape regulatory oversight under this proposal. This comes with the risk of plants entering the market containing novel toxins and allergens and reduced nutrient levels. The proposal makes no effort to assess or manage any risks from Category I NGT plants. - The proposal prevents scientists from identifying risks and following up with research, because it abolishes traceability and registration of molecular data of Category I plants. - Already, many problems have been documented for NGTs. For example, CRISPR applications have turned out to cause toxicity, mosaicism (genetic variation within the individual organism) and other unintended genomic abnormalities. - No sufficient allowance has been made for the detection and avoidance of inevitable unintentional genetic modifications of the target plants, especially those that arise due to the genetic modification processes used, and that have also been well documented. -Risk assessment based on the precautionary principle is case-by-case, since different effects might be observed in different NGT applications and/or species and/or in different receiving environments. The proposal abolishes all risk assessment for Category 1 NGT plants.

Amendment 26

Ivan Vilibor Sinčić

Proposal for a regulation

–

Proposal for rejection

The European Parliament rejects the Commission proposal.

Or. en

Amendment 27

João Pimenta Lopes

Proposal for a regulation

–

Proposal for rejection

The European Parliament rejects the Commission proposal.

Or. pt

Amendment 28

Marie Toussaint, Tilly Metz, Lydie Massard, Manuela Ripa, Thomas Waitz, Benoît Biteau, Pär Holmgren, Rosa D'Amato

Proposal for a regulation

–

Proposal for rejection

The European Parliament rejects the Commission proposal.

Or. en

Justification

By exempting category 1 NGTs, which will be make up the vast majority of NGTs, from GMO risk assessment, monitoring, traceability and consumer labelling, the Commission proposal fails to respect consumer rights as well as the precautionary principle, as laid down in the TFEU. Furthermore, there is no scientific basis underlying the criteria in Annex I which ‘determines’ if a NGT fulfils the criteria of ‘equivalence’ to conventional plants. The criteria have no bearing on safety, therefore there is no guarantee that GM plants meeting the criteria have a lower level of risk to human health and the environment.

The Commission proposal completely ignores the specific issues linked to the diffusion of patented material without proper traceability, or the potential issues linked to coexistence with non-GMO production. The exclusion of NGT products from existing GMO rules is also not supported by the alleged benefits of NGTs. In any case, to claim that one particular plant is sustainable due to its intended trait is not possible. Genuine sustainability can only be concluded after an assessment of the agricultural system in which plants are grown, as well as their complex relationships with the environment and under the economic and social conditions in which they are used.

Amendment 29

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Draft legislative resolution

Citation -1 (new)

Draft legislative resolution

Amendment

– The European Parliament rejects the Commission proposal.

Or. en

Amendment 30

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Draft legislative resolution

Citation 2

Draft legislative resolution

Amendment

– having regard to Article 43(2), Article 114 and Article 168(4)(b)of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9-0238/2023),

– having regard to Article 43(2), Article 114, Article 191 and Article 168(4)(b)of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9-0238/2023),

Or. en

Amendment 31

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Title 1

Text proposed by the Commission

Amendment

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 (Text with EEA relevance)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain precision breeding techniques and their food and feed, and amending Regulation (EU) 2017/625 (Text with EEA relevance)

Or. en

Justification

This change will have to be reflected in the entire text, including changes of abbreviations from NGT to PBT (or similar).

Amendment 32

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Title 1

Text proposed by the Commission

Amendment

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain newer genomic manipulation techniques and products derived of these plants (Text with EEA relevance)

Or. en

Amendment 33

Stanislav Polčák

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114 and 168(4) (b) thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, 168(4) (b) and 191(2) thereof,

Or. cs

Amendment 34

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114 and 168(4) (b) thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, 191 and 168(4) (b) thereof,

Or. en

Amendment 35

João Pimenta Lopes

Proposal for a regulation

Recital -1 (new)

Text proposed by the Commission

Amendment

(-1) Biotechnology is one of the most important technologies for the future and should be supported by a suitable policy framework, with ethical, environmental and health aspects also being taken into account. However, life should under no circumstances be patented, either in the form of reproductive techniques or by privatising genome sequences, because knowledge is of benefit to all.

Or. pt

Amendment 36

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital -1 (new)

Text proposed by the Commission

Amendment

(-1) Living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers thereby affecting other Member States. The effects of such releases on the environment may be irreversible.

Or. en

Amendment 37

João Pimenta Lopes

Proposal for a regulation

Recital -1 a (new)

Text proposed by the Commission

Amendment

(-1a) Ethical questions relating to the use and practice of science in the field of genetic engineering are a fundamental issue. First and foremost, the short-, medium- and long-term consequences of using such technologies must be examined. It will be undeniably important to gain further knowledge about the impact on the environment, climate, farming, biodiversity and food security. It will also be important to build bridges between science and the advances it produces and the development of agriculture and production in general avoiding sacrificing the future and ensuring that such choices follow the precautionary principle.

Or. pt

Amendment 38

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital -1 a (new)

Text proposed by the Commission

Amendment

(-1a) The protection of health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms (GMOs). Under the Treaty, action by the European Union relating to the environment should be based on the principle that preventive action should be taken.

Or. en

Amendment 39

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital -1 b (new)

Text proposed by the Commission

Amendment

(-1b) The precautionary principle is a general principle of EU law requiring the authorities in question, in the particular context of the exercise of the powers conferred on them by the relevant rules, to take appropriate measures to prevent specific potential risks to public health, safety and the environment, by giving precedence to the requirements related to the protection of those interests over economic interests.

Or. en

Amendment 40

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital -1 b (new)

Text proposed by the Commission

Amendment

(-1b) Respect for ethical principles recognised in a Member State is particularly important. Member States may take into consideration ethical aspects when GMOs are deliberately released or placed on the market as or in products.

Or. en

Amendment 41

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital -1 c (new)

Text proposed by the Commission

Amendment

(-1c) A sustainable food system is at the heart of the European Green Deal. Agroecology can provide healthy food while maintaining productivity, increase soil fertility and biodiversity, and reduce the footprint of food production. Organic farming in particular holds great potential for farmers and consumers alike. The sector creates jobs and attracts young farmers. Organic farming also provides 10-20 % more jobs per hectare than conventional farms, and creates added value for agricultural products. To make the most of this potential, under the Green Deal’s Farm to Fork and Biodiversity Strategies, the European Commission has set a target of ‘at least 25% of the EU’s agricultural land under organic farming and a significant increase in organic aquaculture by 2030’.

Or. en

Amendment 42

Christophe Clergeau

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(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.

_________________

32 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

Or. fr

Amendment 43

Martin Häusling

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(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 help enable changes to be made to the genome at specific locations with outcomes however that cannot be fully predicted, often with on-target and off-target unintended effects. and that may be more or less similar or different to plants obtained by conventional breeding.

_________________

Or. en

Amendment 44

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(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, progress in biotechnology has led to the development of newer genomic manipulation techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations. However, also these newer techniques may lead to unexpected outcomes that cannot be fully predicted and that may be equivalent or different compared to plants obtained by conventional breeding.

_________________

Or. en

Amendment 45

João Pimenta Lopes

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(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, however, the results cannot be fully foreseen and may be equivalent to or different from plants obtained using conventional selection.

_________________

Or. pt

Amendment 46

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(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 while experimental evidence confirms occurrence of off-target mutations.

_________________

Or. en

Amendment 47

João Pimenta Lopes

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

(1a) Trade in genetically modified organism varieties cannot directly or indirectly rely solely on monopolistic private multinational companies, which benefit the most from the mass use of those patented varieties, a situation that leaves farmers more dependent on seed producers and, therefore, reduces the Member States’ food and production sovereignty.

Or. pt

Amendment 48

João Pimenta Lopes

Proposal for a regulation

Recital 1 b (new)

Text proposed by the Commission

Amendment

(1b) Since knowledge about the properties of each gene is incomplete and the number of variables is considerable, the impact of using such genetic techniques and their subsequent large-scale roll-out is not yet fully understood. Natural or organic crops, i.e. crops that have not been genetically modified by humans, existing alongside genetically modified crops poses the issue of gene flow, since pollination is often anemophilous, by way of the wind.

Or. pt

Amendment 49

João Pimenta Lopes

Proposal for a regulation

Recital 1 c (new)

Text proposed by the Commission

Amendment

(1c) The use of genetically modified organisms has led to an excessive use of pesticides and persistent fertilisers, which can lead to reduced soil fertility, aridity and low water holding capacity. Defending the genetic integrity of natural crops is therefore fundamental, given that the impact of large-scale agriculture on soil properties affects the hydrosphere, biosphere, atmosphere and climate and, over time, contributes to desertification, which poses a threat to long-term food security. The precautionary principle should therefore be followed with the introduction of new NGT varieties.

Or. pt

Amendment 50

João Pimenta Lopes

Proposal for a regulation

Recital 1 d (new)

Text proposed by the Commission

Amendment

(1d) The impact that consumption of GMOs and NGTs may have on animal feed and human food has not been sufficiently weighed up, particularly in the long term. There are no studies in the European Union that assess with any certainty the true impact of introducing such plant varieties on farming and food .

Or. pt

Amendment 51

João Pimenta Lopes

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(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). However, the processes used in cisgenesis (and in intragenesis) are the same as those used to carry out transgenesis (insertion of additional gene sequences). Moreover, the gene pool used by conventional breeders under practical conditions may include variations not found in a gene pool that can be harnessed through the direct (and potentially reproducible) transfer of genes through all types of genetic backgrounds and can therefore produce plants that may be difficult to obtain through conventional breeding methods. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at ‘precise’ locations in the genome of an organism but create space for random genetic alterations in other genes, given that cisgenesis techniques result in the insertion of genetic material in the genome of an organism. The results in terms of intentional and unintentional genetic alterations and biological effects cannot therefore be predicted. 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. However, the processes used in cisgenesis (and in intragenesis) are the same as those used to carry out transgenesis (insertion of additional gene sequences from another species). Moreover, the gene pool used by conventional breeders, when taking practical decisions, may include restrictions absent from a gene pool that can be harnessed through the direct (and potentially repeated) transfer of genes through all genetic backgrounds and can therefore produce plants that will be difficult to obtain through conventional breeding methods.

Or. pt

Amendment 52

Martin Häusling

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) NGTs constitute a diverse group of genomic techniques, and each of them can be used in various ways. Among NGTs, the development of NGT plants with targeted mutagenesis may lead to the introduction of genetic material from non-crossable species (transgenesis) through the use of first generation genetic engineering techniques, such as Agrobacterium tumefaciens infection and particle bombardment. Whilst developers use back-crossing to eliminate the introduced transgenes, this is not always successful. In addition to the introduction of transgenes, the outcomes in terms of intended and unintended genetic changes and biological effects of targeted mutagenesis cannot be fully predicted.

Or. en

Amendment 53

Christophe Clergeau

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(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 by means of genetic modification techniques referred to in Annex IB to Directive 2001/18/EC, but also in organisms with more complex modifications. Among NGTs, targeted mutagenesis and cisgenesis (including intragenesis) should bring about 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, provided that the latter do not lead to the introduction of genetic material from non-crossable species. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at precise locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material 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. Modifications made at precise locations may result in the interruption of endogenous genes and may also be accompanied by unintentional genetic modifications at the targeted location or elsewhere in the genome.

Or. fr

Amendment 54

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(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. 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. At the same time, the techniques used in cisgenesis are equal to those of transgenesis. Moreover, under practical conditions, the breeder's gene pool may prove restrictive in comparison with direct gene transfer and consequently result in new products unlikely to be obtained by conventional methods. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at precise locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material. 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 from a theoretically crossable species. It can however not be assumed that such changes result in plants equivalent to conventionally bred plants, and establishing the safety and risk of these NGT plants requires a direct comparison with isogenic, non-modified parental plant lines on a molecular level as well as on a physiological and anatomical level, established from actual evidence.

Or. en

Amendment 55

Günther Sidl

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

Or. en

Amendment 56

Pietro Fiocchi

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

Or. en

Amendment 57

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

Or. en

Amendment 58

João Pimenta Lopes

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2a) The introduction of plant varieties into the environment and/or into foodstuffs or feed for animals that may be different in their intended or unintended genotypes and phenotypes from those obtained by conventional breeding processes poses challenges to the regulatory authority, which must ensure safety for health and the environment. Such differences may not always be obvious or predictable and suitable data is therefore needed before conclusions about their safety can be drawn.

Or. pt

Amendment 59

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2a) However, the processes used in cisgenesis and intragenesis are the same as used in transgenesis, namely the insertion of additional gene sequences. Furthermore, the gene pool used by conventional breeders under practical conditions, may show restrictions that are absent in a gene pool that can be exploited by direct (and potentially repeated) gene transfer across all kinds of genetic backgrounds and therefore result in plants that are unlikely to be obtained by methods of conventional breeding.

Or. en

Amendment 60

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2a) Therefore, a case-by-case risk assessment has to be obtained for NGT plants in order to generate sufficient data on their intended and unintended genetic changes and related effects. The risk assessment shall require experiments under contained conditions and shall be undertaken in order to make informed decisions on NGT plant's status.

Or. en

Amendment 61

João Pimenta Lopes

Proposal for a regulation

Recital 2 b (new)

Text proposed by the Commission

Amendment

(2b) A risk assessment must be carried out on all NGT plants in order to produce adequate data on their intended and unintended genetic alterations and the effects that may arise from those alterations. This first stage of the risk assessment, which simply requires experiments under contained use conditions, should be used to take decisions about their status and the amount of data that will be needed for an overall risk assessment.

Or. pt

Amendment 62

João Pimenta Lopes

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(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 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).

deleted

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33 Insights and solutions stemming from EU-funded research and innovation projects on plant breeding strategies may contribute to address detection challenges, ensure traceability and authenticity, and promote innovation in the area of new genomic techniques. More than 1,000 projects were funded under the Seventh Framework Programme and successor Horizon 2020 programme with an investment of over 3 billion Euros. Horizon Europe support to new collaborative research projects on plant breeding strategies is also ongoing, SWD(2021) 92.

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

35 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, healthy and environmentally friendly food system, COM/2020/381 final.

36 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030: Bringing nature back into our lives, COM/2020/380 final.

37 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions forging a Climate-Resilient Europe - The New EU Strategy on Adaptation to Climate Change, COM(2021) 82 final

38 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, Safeguarding food security and reinforcing the resilience of food systems, COM (2022) 133 final; Food and Agriculture Organisation of the United Nations (FAO), 2022, Gene editing and agrifood systems, Rome, ISBN 978-92-5-137417-7.

39 European Commission, Directorate-General for Research and Innovation, A sustainable bioeconomy for Europe – Strengthening the connection between economy, society and the environment: updated bioeconomy strategy, Publications Office, 2018, https://data.europa.eu/doi/10.2777/792130.

40 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Trade Policy Review - An Open, Sustainable and Assertive Trade Policy, COM(2021)66 final.

Or. pt

Amendment 63

Pietro Fiocchi

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(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 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 ).

(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 potentially improved tolerance or resistance to plant diseases and pests, 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. Thus, NGTs might 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 ). However, most NGTs in the pre-commercial stage relate to pesticide tolerance. Increased herbicide use resulting from NGT cultivation in the European Union must be considered. Importantly, the different action pathways to fulfil the objectives of the European Green Deal (3) and of the ‘Farm to Fork’ (4), Biodiversity (5) and Adaptation to Climate Change(6) Strategies, to global food security (7), the Bioeconomy Strategy (8) and to the Union’s strategic autonomy (9), must not undermine one another.

_________________

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

Or. en

Amendment 64

Günther Sidl

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(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 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 ).

_________________

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

Or. en

Amendment 65

Lydie Massard

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(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 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 ).

_________________

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

Or. en

Amendment 66

Sirpa Pietikäinen

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(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 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 ).

(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 potentially improved tolerance or resistance to plant diseases and pests, 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. 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 ). However, most NGTs in the pre-commercial stage relate to pesticide tolerance. Increased herbicide use resulting from NGT cultivation in the European Union must be considered. Importantly, the different action pathways to fulfil the objectives of the European Green Deal and of the ‘Farm to Fork’, Biodiversity and Adaptation to Climate ChangeStrategies, to global food security, the Bioeconomy Strategy and to the Union’s strategic autonomy , must not undermine one another.

_________________

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

Or. en

Amendment 67

Martin Häusling

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(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 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 ).

(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, including ones with unproven sustainability benefits. However, to claim that one particular plant is sustainable due to its intended trait is not possible. Genuine sustainability can only be concluded after an assessment of the agricultural system in which plants are grown, as well as their complex relationships with the environment and under the economic and social conditions in which they are used. Importantly, the different action pathways to fulfil the objectives of international and European obligations on climate change and biodiversity, among others, must not undermine one another.

_________________

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

Or. en

Amendment 68

Christophe Clergeau

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) There is ongoing public and private research using NGTs or other techniques such as marker-assisted selection 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 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. In spite of the difficulty in generating complex multifactorial traits, 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 which are at least equal to those that marker-assisted selection already offers. Thus, NGTs have 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 and the Bioeconomy Strategy (39), although it is more the socio-economic conditions of production and consumption that determine sustainability transition pathways.

_________________

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

Or. fr

Amendment 69

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(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 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 ).

(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 leads to promises about the development of plants with improved tolerance or resistance to plant diseases and pests, 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, should they indeed be developed in the future, coupled with appropriate risk assessment, traceability, labelling and co-existence measures, together with the necessary legal adaptations in the field of intellectual property protection in order to exclude risks of monipolisation in the food chain, could potentially deliver benefits to breeders. Thus, NGTs could have the potential to contribute to the innovation 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 ).

_________________

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

Or. en

Amendment 70

Stanislav Polčák

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(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([1]). This includes plants with improved tolerance or resistance to plant diseases and pests, 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, provided that they are used wisely and do not, on the contrary, lead to a disregard for the suitability of individual agricultural areas and plots of land for the cultivation of certain crops, 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 ([2]) and of the ‘Farm to Fork’ ([3]), Biodiversity ([4]) and Adaptation to Climate Change([5]) Strategies, to global food security ([6]), the Bioeconomy Strategy ([7]) and to the Union’s strategic autonomy ([8]).

_________________

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

Or. cs

Amendment 71

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(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 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 ).

(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 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 speedy applicability of those new techniques after their risk and safety is established on a case-by-case basis, 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 ).

_________________

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

Or. en

Amendment 72

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(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 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 ).

(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, 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 ).

_________________

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

Or. en

Justification

The 2021 JRC study shows that 6 out of 16 NTG products currently in the pre-commercial state relate to pesticide tolerance.

Amendment 73

Christophe Clergeau

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

(3a) The development of NGTs will lead to increased control over plant reproductive material by a few multinationals which will exercise the patents they have been granted on genetic processes and extending them to the plants obtained. This development is not without risk for the sustainability of the plant breeding system operating in the European Union, which has allowed joint management of plant genetic resources that ensures that innovation is spread among a number of breeders of different sizes. The Commission has acknowledged the importance of this issue, into which there will need to be an additional investigation in order to assess the impact of patents on NGTs in terms of strategic autonomy for the European Union, concentration on the seed sector and preservation of cultivated biodiversity, but also the cost of food for consumers. In so far as all plant reproductive material that has been genetically modified may be the subject of one or more patents, traceability and labelling measures should be made compulsory for category 1 and 2 NGT plants and products in order, on the one hand, to enforce the rights of patent holders and, on the other, to ensure that other breeders, farmers and other economic agents are fully informed, since they might otherwise be led to make use of patented plants or products without their knowledge and risk being required by patent holders to pay royalties.

Or. fr

Amendment 74

Martin Häusling

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

(3a) The arguable sustainability potential of NGT remains a hypothetical promise since there is extremely limited practical experience with NGT cultivation globally. On the contrary, the 2021 JRC study shows that 6 out of 16 NGT products currently in the pre-commercial stage relate to herbicide tolerance, which can lead to an increase in the use of complementary herbicides. Similarly, the speed, ease, and efficacy of these techniques for breeding are still largely hypothetical. The potential of NGTs can therefore be misleading. It is also important to note that there are multiple pathways to achieve the objectives of the European Green Deal, NGTs being merely one component of a complex policy mix, which should be evaluated in that larger context.

Or. en

Amendment 75

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

(3a) In this connection, it is necessary to step up support for public research both at Member State level concerning control over NGT plants, assessment of risks and effects on health and the environment and the discovery of solutions that reconcile an eco-friendly transition with food sovereignty.

Or. fr

Amendment 76

João Pimenta Lopes

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

(3a) Given that sustainability comprises many degrees of complexity, clear and transparent criteria are needed for a suitable technological assessment before conclusions can be drawn on the potential benefits of NGTs’ specific characteristics.

Or. pt

Amendment 77

Günther Sidl

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) The deliberate release into the environment of organisms obtained by NGTs, including products containing or consisting of such organisms, as well as the placing on the market of food and feed produced from these organisms, are subject to Directive 2001/18/EC and, Regulation (EC) No 1830/2003 (41 ) of the European Parliament and of the Council and, in the case of food and feed, also to Regulation (EC) No 1829/2003 (42 ), while the contained use of plant cells is subject to Directive 2009/1/EC, and transboundary movements of NGT plants to third countries are regulated by Regulation (EC) No 1946/2003 (‘the Union GMO legislation’).

_________________

41 Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p. 24).

42 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).

Or. en

Amendment 78

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) The deliberate release into the environment of organisms obtained by genetic manipulation, including products containing or consisting of such organisms, as well as the placing on the market of food and feed produced from these organisms, are subject to Directive 2001/18/EC and, Regulation (EC) No 1830/2003 (41 ) of the European Parliament and of the Council and, in the case of food and feed, also to Regulation (EC) No 1829/2003 (42 ), while the contained use of plant cells is subject to Directive 2009/1/EC, and transboundary movements of GM plants to third countries are regulated by Regulation (EC) No 1946/2003 (‘the Union GMO legislation’).

_________________

42 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).

Or. en

Amendment 79

Lydie Massard

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

(5) In its judgment in case C-528/16 Confédération paysanne and Others43 the Court of Justice of the European Union held that GMOs obtained by means of new techniques/methods of mutagenesis that had appeared or had been mostly developed since Directive 2001/18/EC was adopted could not be considered excluded from the scope of that Directive. The new genomic techniques and new mutagenesis methods do not have a long history of safe use. They would therefore have a comparable risk potential to the production of transgenic plants, in which foreign genetic material is introduced into the genome of organisms. In accordance with the precautionary principle, the GMO legislation would therefore have to be applied (Art.2 No.2 of Directive 2001/18; fourth, eighth and 25th recitals). These organisms and all products derived from them must therefore be subjected to a comprehensive safety assessment for humans, animals and the environment before being placed on the market. Likewise, they must be traceable and labelled.

_________________

43 Judgement of the Court of Justice of 25 July 2018, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, C-528/16, ECLI:EU:C:2018:583.

Or. en

Amendment 80

Günther Sidl

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

(5) In its judgment in case C-528/16 Confédération paysanne and Others43 the Court of Justice of the European Union held that GMOs obtained by means of new techniques/methods of mutagenesis that had appeared or had been mostly developed since Directive 2001/18/EC was adopted could not be considered excluded from the scope of that Directive, as the new mutagenesis techniques/methods have a comparable risk potential to the production of transgenic plants, in which foreign genetic material is introduced into the genome of organisms. In accordance with the precautionary principle, the regulations of the Genetic Engineering Law would therefore have to be applied (Art.2 No.2 of Directive 2001/18; fourth, eighth and 25th recitals). These organisms and all products derived from them must therefore be subjected to a comprehensive safety assessment for humans, animals and the environment before being placed on the market. Likewise, they must be traceable and labelled.

_________________

Or. en

Justification

According to the ruling of the European Court of Justice (ECJ) of July 25, 2018, organisms obtained by mutagenesis are in principle to be classified as genetically modified organisms (GMOs) and are therefore subject to the regulations of the Genetic Engineering Act (Directive 2001/18/EC). The reason given for this is that mutagenesis processes lead to a change in the genetic material of an organism that is not possible in a natural way.

Amendment 81

Martin Häusling

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

(5) In its judgment in case C-528/16 Confédération paysanne and Others43 the Court of Justice of the European Union held that GMOs obtained by means of new techniques/methods of mutagenesis that had appeared or had been mostly developed since Directive 2001/18/EC was adopted could not be considered excluded from the scope of that Directive. In accordance with the precautionary principle, the court ruling found that targeted mutagenesis should be subject to the existing GMO regulation. These organisms and all products derived from them must therefore be subjected to a comprehensive safety assessment for humans, animals and the environment before being placed on the market. Likewise, they must be traceable and labelled.

_________________

Or. en

Amendment 82

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

(5) In its judgment in case C-528/16 Confédération paysanne and Others43 the Court of Justice of the European Union noted that the definition of a GMO in Article 2(2) of Directive 2001/18 is made clear by a distinction between techniques the use of which results in genetic modification and techniques which are not considered to result in such genetic modification, and the Court held that GMOs obtained by means of new techniques/methods of mutagenesis that had appeared or had been mostly developed since Directive 2001/18/EC was adopted must be considered to be GMOs within the meaning of Article 2(2) of that Directive.

_________________

Or. en

Amendment 83

Christophe Clergeau

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(6) The Council, in Decision (EU) 2019/190444, requested the Commission to submit, by 30 April 2021, a study in light of that judgment regarding the status of novel genomic techniques under Union law, and a proposal (accompanied by an impact assessment), if appropriate, depending on the conclusions of the study.

(6) Rather than applying the Court of Justice judgment, by making NGT varieties subject to Directive 2001/18, the Council, in Decision (EU) 2019/190444, requested the Commission to submit, by 30 April 2021, a study in light of that judgment regarding the status of novel genomic techniques under Union law, and a proposal (accompanied by an impact assessment), if appropriate, depending on the conclusions of the study.

_________________

44 Council Decision (EU) 2019/1904 of 8 November 2019 requesting the Commission to submit 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, and a proposal, if appropriate in view of the outcomes of the study (OJ L 293, 14.11.2019, p. 103).

Or. fr

Amendment 84

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 6 a (new)

Text proposed by the Commission

Amendment

(6a) The European Parliament, in its reaction to the Farm to Fork strategy for a fair, healthy and environmentally-friendly food system, highlighted the precautionary principle and the need to ensure transparency and freedom of choice to farmers, processors and consumers, and stressed that any policy action on NGTs should include risk assessments and a comprehensive overview and assessment of options for traceability and labelling with a view to achieving proper regulatory oversight and should provide consumers with relevant information, including for products from third countries in order to ensure a level playing field.

Or. en

Amendment 85

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 6 b (new)

Text proposed by the Commission

Amendment

(6b) The European Parliament has called1a for a comprehensive analysis of the socioeconomic and environmental effects on the food system of patents on breeding processes, plant propagation material and parts thereof, including their potential to increase market concentration and monopolisation in the food chain, as well as their impact on the affordability and availability of food, and called for the EU and its Member States not to grant patents on biological material and to safeguard the freedom to operate and breeders’ exemption for varieties. It is therefore appropriate to ensure that patented plants are not subject to any exemptions of the Union GMO legislation. Furthermore, to address the threat patents pose to food security, the Commission should rapidly investigate the best route to ban the use of patents in the food chain. The Commission should present a legal proposal to achieve this by 31 December 2024.

_________________

1a European Parliament resolution of 14 June 2023 on ensuring food security and long-term resilience of the EU agriculture (2022/2183(INI)) P9_TA(2023)0238

Or. en

Amendment 86

João Pimenta Lopes

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) The Commission’s study on new genomic techniques (45) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can be disproportionate or inadequate. The study showed that this is particularly the case for plants obtained by these techniques, given the amount of scientific evidence that is already available, in particular on their safety. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products. In certain cases, genetic modifications introduced by these techniques are indistinguishable with analytical methods from natural mutations or from genetic modifications introduced by conventional breeding techniques, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The Union GMO legislation is also not conducive to developing innovative and beneficial products that could contribute to sustainability, food security and resilience of the agri-food chain.

deleted

_________________

45 Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16, SWD(2021) 92 final.

Or. pt

Amendment 87

Günther Sidl

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) The Commission’s study on new genomic techniques (45 ) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can be disproportionate or inadequate. The study showed that this is particularly the case for plants obtained by these techniques, given the amount of scientific evidence that is already available, in particular on their safety. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products. In certain cases, genetic modifications introduced by these techniques are indistinguishable with analytical methods from natural mutations or from genetic modifications introduced by conventional breeding techniques, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The Union GMO legislation is also not conducive to developing innovative and beneficial products that could contribute to sustainability, food security and resilience of the agri-food chain.

_________________

45 Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16, SWD(2021) 92 final.

Or. en

Amendment 88

Christophe Clergeau

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) The Commission’s study on new genomic techniques (45) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can be disproportionate or inadequate. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products in the absence of sufficient investment to upgrade the European Network of GMO Laboratories (ENGL). In certain cases, genetic modifications introduced by these techniques are currently regarded as not being easily distinguishable with analytical methods normally used from natural mutations or from genetic modifications introduced by conventional breeding techniques or by genetic modification techniques referred to in Annex IB to Directive 2001/18/EC, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The ENGL network considers that the provision by notifiers of information (as provided for in Regulation (EC) No 1829/2003) and of reference material would make it possible to detect and trace NGT products. The matrix approach devised and used by ENGL also makes it possible to determine the natural or artificial origin of genetic or epigenetic modifications. More effective detection methods are being developed thanks to growing research efforts that were begun recently (late 2022). At all events, the availability of detection methods cannot be regarded as a prerequisite for the establishment of appropriate traceability arrangements, which, moreover, may involve documentary traceability, as is the case for many products of high quality and with different designations.

_________________

45 Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16, SWD(2021) 92 final.

Or. fr

Amendment 89

Sirpa Pietikäinen

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) The Commission’s study on new genomic techniques (45 ) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can be disproportionate or inadequate. The study showed that this is particularly the case for plants obtained by these techniques, given the amount of scientific evidence that is already available, in particular on their safety. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products. In certain cases, genetic modifications introduced by these techniques are indistinguishable with analytical methods from natural mutations or from genetic modifications introduced by conventional breeding techniques, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The Union GMO legislation is also not conducive to developing innovative and beneficial products that could contribute to sustainability, food security and resilience of the agri-food chain.

(7) The Commission’s study on new genomic techniques (45 ) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can inconducive for the cultivation and release of GMOs into the environment and their placing on the market. The study showed that this is particularly the case for plants obtained by these techniques, given the amount of scientific evidence that is already available, in particular on their safety. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products. In certain cases, until the present day, genetic modifications introduced by these techniques can be considered indistinguishable with analytical methods from natural mutations or from genetic modifications introduced by conventional breeding techniques, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. However, the development of detection methods in the coming years is deemed highly possible by scientists and experts. Research and scientific knowledge in the realm of genetic engineering and detection technologies is continuously expanding. More research is needed to accelerate the development of such analytical detection methods. The availability of detection methods is not a pre-requisite for the establishment of traceability. Many existing quality schemes and labels are based on documentary traceability for which no detection methods are available nor needed.

_________________

45 Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16, SWD(2021) 92 final.

Or. en

Amendment 90

Martin Häusling

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) The Commission’s study on new genomic techniques (45 ) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can be disproportionate or inadequate. The study showed that this is particularly the case for plants obtained by these techniques, given the amount of scientific evidence that is already available, in particular on their safety. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products. In certain cases, genetic modifications introduced by these techniques are indistinguishable with analytical methods from natural mutations or from genetic modifications introduced by conventional breeding techniques, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The Union GMO legislation is also not conducive to developing innovative and beneficial products that could contribute to sustainability, food security and resilience of the agri-food chain.

_________________

45 Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16, SWD(2021) 92 final.

45a https://www.bfn.de/sites/default/files/2023-03/bng_finalreport_COMstudy_Feb2023.pdf

Or. en

Amendment 91

Christophe Clergeau

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission

Amendment

(7a) In a statement in October 2022, the EFSA proposed six criteria for conducting a risk assessment for plants produced by targeted mutagenesis, cisgenesis and intragenesis. The first four criteria relate to the molecular characterisation of the genetic modification to the NGT plant: presence or absence of an exogenous DNA sequence (criterion 1), whether or not the DNA sequence derives from the breeders’ gene pool (criterion 2), type of integration (criterion 3), and whether or not any endogenous gene is interrupted (criterion 4). According to those criteria, the plant may be regarded as a plant with no exogenous DNA sequence or a cisgenic or intragenetic plant as a result of targeted insertion with or without interruption of endogenous genes. In the case of endogenous-gene interruption, two additional criteria round off the assessment: history of safe use (criterion 5) and the structure and function of the new allele (criterion 6). Where the history of safe use is not sufficiently established, the function and structure of the allele introduced should be carefully assessed. Ultimately, risk assessment cannot be based on the number of genetic modifications intentionally carried out; rather, it should be based on the impact of genetic modifications on the expression of the plant's genes, whether endogenous or exogenous.

Or. fr

Justification

https://www.efsa.europa.eu/en/efsajournal/pub/7621

Amendment 92

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission

Amendment

(7a) Currently, the debate on using NGTs in plant breeding is held almost exclusively among scientists, scientific and industry organisations, and companies in the agri-food field, as well as a small number of NGOs. However, in shaping a new policy on NGTs, it is important to include the voice of citizens, not only because biotechnologies have the power to redesign life, but also because they offer the potential to reshape the practice of agriculture and the future of our food (system). The way we produce food involves questions of how we want to live on this planet and how we want to relate to other species. For purposes of democracy, citizens need to have a say on which public values are incorporated in a new policy for NGTs.

Or. en

Amendment 93

João Pimenta Lopes

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission

Amendment

(7a) The underlying causes of hunger are rarely related to low crop harvests themselves, but rather poverty, unequal access to food and unequal access to land and the means of food production, a lack of support for family farmers, low incomes and speculation in the cost of food placed on the market.

Or. pt

Amendment 94

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 7 b (new)

Text proposed by the Commission

Amendment

(7b) One of the few studies that have been performed to investigate the attitude of the public, concluded1a that in general, citizens’ views converged towards reservation and hesitation about the use of NGTs and genetic modification in crops. Citizens raised doubts mainly about the plausibility that these crops will contribute meaningfully to the solving of our current societal challenges in the food system, and whether they are indeed the right approach for dealing with these challenges. They wondered if alternative solutions may be better, and how these may come with less unforeseen, long-term risks for human health and ecosystems. Moreover, the citizens in this study questioned whether companies will in practice develop valuable varieties for society, as the logics of the corporate world tend to be focused on capital accumulation and on making profits. Citizens were unanimous in their view that regulation of NGT crops is necessary for diverse reasons: to prevent harms to the environment and human health, to give consumers freedom of choice, to guard against the potential of the technology to increase inequalities, and to ensure that the technology is directed towards contributing to solutions to societal problems. The latter is viewed as an important pre-condition for the introduction of NGT products onto the marketplace. According to citizens, NGTs should not be developed purely for commercial motives driven by the logic of the market. There needs to be a clear societal purpose for their introduction. In terms of policy, this would necessitate a case-by-case assessment of NGT crops for broader considerations such as purpose, and value to society.

_________________

1a Rathenau Instituut (2023). Editing under provision – Dutch citizens’ views on new genomic techniques in food crops. Den Haag. Authors: Habets, M., I. Pirson, P. Macnaghten and P. Verhoef.

Or. en

Amendment 95

Martin Häusling

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 96

Christophe Clergeau

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) It is therefore necessary to adopt a specific legal framework for GMOs obtained by targeted mutagenesis and cisgenesis and related products when deliberately released into the environment or placed on the market, while maintaining the central principles of GMO legislation that has been in place for over 20 years: sound information and freedom of choice for consumers and farmers, risk assessment and monitoring by health authorities, precautionary principle and reversibility, and coexistence of sectors.

Or. fr

Amendment 97

Erik Poulsen, Asger Christensen, Emma Wiesner

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) Category 1 NGT plants and products obtained by targeted mutagenesis and cisgenesis and related products shall not be subject to the rules and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. Targeted mutagenesis Category 1 NGT plants and products shall be exempted in Directive 2001/18/EC Annex 1 B like other mutagenecis methods.

Or. en

Justification

We want to make it clear that this is not GMO and should therefore not be subject to GMO legislation.

Amendment 98

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) It is therefore appropriate to adopt specific provisions for GMOs obtained by targeted mutagenesis and related products.

Or. en

Amendment 99

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Recital 8 a (new)

Text proposed by the Commission

Amendment

(8a) This legal framework ensures high standards of transparency and involves stakeholders in setting up and monitoring the impact of regulation.

Or. fr

Amendment 100

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Recital 8 b (new)

Text proposed by the Commission

Amendment

(8b) This legal framework provides guarantees of prudence because at this stage, based on the scientific knowledge available, the impact and effects of NGT plants are not known. It is particularly important to monitor the consequences of an accelerated modification of organisms in relation to their natural plant cycle on the balance and stability of the living world.

Or. fr

Amendment 101

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Recital 8 c (new)

Text proposed by the Commission

Amendment

(8c) This legal framework ensures systematic and permanent traceability so as to ensure transparency, freedom of choice and information for users and consumers.

Or. fr

Amendment 102

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Recital 8 d (new)

Text proposed by the Commission

Amendment

(8d) This legal framework provides protection for the living world and opposes its ‘privatisation’ through a possible extension of patents to living organisms that would go beyond the necessary protection of techniques and methods.

Or. fr

Amendment 103

Christophe Clergeau

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(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, excluding microorganisms, fungi and animals for which the available knowledge is more limited. 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. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation must be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excluding microorganisms, fungi and animals for which the available knowledge is even more limited. For the same reason, this Regulation must 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 must 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 and any contaminating technique such as passaging through bridge species allowing foreign sequences into the genome of the target species) must remain subject to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the foreign sequences and their unintended effects. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.

Or. fr

Amendment 104

Jessica Polfjärd

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(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, excluding microorganisms, fungi and animals for which the available knowledge is more limited. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter ‘NGT plants’). 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. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time. However, on the basis of new scientific findings and knowledge, it is important to regularly assess whether this regulation could be applied to the abovementioned categories currently limited.

Or. en

Amendment 105

João Pimenta Lopes

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(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, excluding microorganisms, fungi and animals for which the available knowledge is more limited. 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. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are annual agricultural crops with no potential to survive, reproduce and spread in the environment, excluding other organisms for which the available knowledge is more limited. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis (hereinafter ‘NGT plants’), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species or insertions of additional genetic material prepared outside cells. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non-crossable species (transgenesis) or that contain additional genetic material prepared outside cells should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene or the additional genetic material inserted. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.

Or. pt

Amendment 106

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are annual arable plants without the potential to persist, reproduce and propagate in the environment, excluding microorganisms, fungi and animals. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis (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 (cisgenesis, intragenesis and transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs need adaptation at the present time.

Or. en

Amendment 107

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs categorized as annual arable crops with no potential to persist, reproduce and spread in the environment. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis (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 including 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. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.

Or. en

Amendment 108

Pernille Weiss

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(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 this. 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.

Or. en

Amendment 109

Erik Poulsen, Asger Christensen, Emma Wiesner

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(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. For other organisms, such as microorganisms, the available knowledge will be reviewed in view of a future proposal. 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. Moreover, the wider GMO legislation should be examined in view of the Commission conclusion that it is no longer fit purpose to ensure that requirements are science-based and proportional to the risk.

Or. en

Justification

The Explanatory Memorandum of the Proposal notes that “The Union risks being excluded to a significant extent from the technological developments and economic, social and environmental benefits that these new technologies can potentially generate, if its GMO framework is not adapted to NGTs.... Therefore, the Union’s regulatory framework should be adapted to make NGTs subject to the appropriate level of regulatory oversight.” it is therefore relevant to look into similar legislation on microorganisms, which is another important sector for Europe.

Amendment 110

Norbert Lins

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(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. The available knowledge for other organisms, such as microorganisms, fungi and animals, will be reviewed in view of a future proposal. 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. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.

Or. en

Amendment 111

Lydie Massard

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants annual agriculture plants , i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excluding microorganisms, fungi and animals for which the available knowledge is more limited. 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. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.

Or. en

Amendment 112

Martin Häusling

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are annual arable crops without the potential to persist, reproduce and propagate in the environment, excluding microorganisms, fungi, and animals and wild plants for which the available knowledge is more limited. For the same reason, this Regulation should only cover plants obtained by targeted mutagenesis, on the condition that they no longer contain transgenes if these were introduced during their development. GMOs produced by 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. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.

Or. en

Amendment 113

Stanislav Polčák

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(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, and should not apply to microorganisms, fungi and animals for which the available knowledge is more limited. For the same reason, this Regulation should cover plants obtained only 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. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.

Or. cs

Amendment 114

Martin Häusling

Proposal for a regulation

Recital 9 a (new)

Text proposed by the Commission

Amendment

(9a) Gene technologies which aim to modify the genome outside of the laboratory, as well as plants which have been modified with RNA interference technologies should be subject to the current GMO legislation, and not fall within the scope of this Regulation.

Or. en

Amendment 115

João Pimenta Lopes

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) 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.

(10) 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, without prejudice to the principle of precaution.

Or. pt

Amendment 116

Christophe Clergeau

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) The legal framework for NGT plants must 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 must enable the development, health and environmental assessment and orderly placing on the market of labelled plants, food and feed containing, consisting of or produced from NGT plants and other products labelled as 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, the legal framework applicable to NGT plants must differentiate NGT plants having positive sustainability characteristics from those that induce increased consumption of herbicides because they have been made resistant to them and those that produce their own insecticides or pesticides.

Or. fr

Amendment 117

Günther Sidl

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) 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, while fully respecting the precautionary principle.

Or. en

Justification

Amendment 118

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) 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, in line with the precautionary principle and the One Health principle, for the concerned plants and products, so as to contribute to the sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity, Zero Pollution and Climate Adaptation strategies and the Organic action plan.

Or. en

Amendment 119

Martin Häusling

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) The legal framework for NGT plants should share the primary objective of the Union GMO legislation to ensure a high level of protection of human and animal health and of the environment, based on the precautionary principle, as laid down in Article 191 of the Treaty on the Functioning of the European Union. The precautionary principle should be implemented as regards to adequate risk assessment and monitoring frameworks for the release of NGT plants into the environment and their placing on the market.

Or. en

Amendment 120

Lydie Massard

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) 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’).

Or. en

Amendment 121

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) 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, based on the precautionary principle, and to ensure the good functioning of the internal market for the concerned plants and products, while addressing the specificity of NGT plants. The precautionary principle should be implemented as regards to adequate risk assessment and monitoring frameworks for the release of NGT plants into the environment. 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.

Or. en

Amendment 122

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(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.

Or. en

Amendment 123

Jessica Polfjärd

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

Or. en

Amendment 124

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) 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 allow for flexibility and adaptation to ensure the continued yet monitored 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’) in order to enhance the competitiveness and profitability of companies especially small and medium-sized enterprises in the Union agri-food sector at Union and world level.

Or. en

Justification

It is crucial that the regulation remains future proof and that is why it should be updated regularly to reflect latest scientific progress. Many regulations include a clause or provisions for future updates and adjustments based on scientific advancements. The aspiration to be a legal framework that enables the development and placing on the market of innovative products that contribute to the sustainability objectives of the European Green Deal can only be achieved if the regulation embraces future adaptations.

Amendment 125

Martin Häusling

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(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 (including food and feed) 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.

Or. en

Amendment 126

João Pimenta Lopes

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(11) This Regulation constitutes lex specialis with regard to the Union GMO legislation, based on the principle of precaution. It introduces specific provisions for NGT plants and NGT products. However, where there are no specific rules in this Regulation, NGT plants and products (including food and feed) 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.

Or. pt

Amendment 127

Christophe Clergeau

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(11) This Regulation constitutes lex specialis with regard to the Union GMO legislation. It introduces specific derogations for NGT plants and NGT products. However, where there are no specific rules in this Regulation, NGT plants and products (including food and feed) obtained from them must 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.

Or. fr

Amendment 128

Lydie Massard

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) The potential risks of NGT plants vary, ranging from risk profiles similar to conventionally-bred plants to various types and degrees of hazards and risks that might be similar to those of plants obtained by transgenesis. This Regulation should therefore lay down special rules to adjust the risk assessment and risk management requirements according to the potential risks or lack thereof posed by NGT plants and NGT products.

deleted

Or. en

Amendment 129

Günther Sidl

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 130

Christophe Clergeau

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) The potential risks of NGT plants vary, ranging from risk profiles potentially similar to conventionally-bred plants or plants obtained by the genetic modification techniques referred to in Annex 1B of Directive 2001/18/EC to various types and degrees of hazards and risks that might be similar to those of plants obtained by transgenesis. This Regulation must therefore lay down special rules to adjust the risk assessment and risk management requirements according to the actually assessed risks or lack thereof posed by NGT plants and NGT products.

Or. fr

Amendment 131

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

Or. en

Amendment 132

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Recital 12 a (new)

Text proposed by the Commission

Amendment

(12a) The potential risks of NGT plants must be measured regularly in order to analyse their capacity to meet the needs of society without minimising their impact on the health of the different populations concerned and on the environment. Biovigilance and sociovigilance networks shall be set up in each Member State to facilitate the assessment of the ex-ante and ex-post effects of NGT plants.

Or. fr

Amendment 133

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) This Regulation should distinguish between two categories of NGT plants.

deleted

Or. en

Amendment 134

Lydie Massard

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) This Regulation should distinguish between two categories of NGT plants.

deleted

Or. en

Amendment 135

Günther Sidl

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) This Regulation should distinguish between two categories of NGT plants.

deleted

Or. en

Justification

Amendment 136

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) This Regulation should distinguish between two categories of NGT plants.

(13) This Regulation should distinguish between two categories of NGT plants. The status of each NGT plant is verified case by case by adequate data showing equivalence (category 2 NGT plants) or significant difference to plants derived from conventional breeding (category 2 NGT plants).

Or. en

Amendment 137

Christophe Clergeau

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) This Regulation should distinguish between two categories of NGT plants.

(13) This Regulation must distinguish between two categories of NGT plants.

Or. fr

Amendment 138

João Pimenta Lopes

Proposal for a regulation

Recital 13 a (new)

Text proposed by the Commission

Amendment

(13a) To evaluate the status of NGT plants, it is necessary to know the ‘indoor risk assessment’ data (which requires experiments under contained conditions involving molecular characterisation and greenhouse experiments) to check the two categories of NGT plants. Given that field trials or food consumption trials are not required for the ‘indoor risk assessment’, such data can be supplied and evaluated in a shorter period of time without excessive cost.

Or. pt

Amendment 139

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 13 a (new)

Text proposed by the Commission

Amendment

(13a) Since significant number of NGT plants may be released into a shared environment clear methodologies must be developed in order to study potential interactions and carrying capacity of an environment related to organisms not adapted by evolutionary processes.

Or. en

Amendment 140

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Recital 13 a (new)

Text proposed by the Commission

Amendment

(13a) NGT plants with the potential to persist, reproduce or spread in the environment, within or beyond the fields, should be evaluated with highest scrutiny in respect to their impact on nature and the environment.

Or. en

Amendment 141

João Pimenta Lopes

Proposal for a regulation

Recital 13 b (new)

Text proposed by the Commission

Amendment

(13b) Given that many NGT plants with different characteristics and from a variety of species may be released into the same environment, clear criteria and methods should be established to assess potential interactions and avoid overloading ecosystems with organisms that have not adapted through evolutionary processes. NGT plants that have the potential to survive, reproduce or spread in the environment (within or outside fields) must have their impact on nature and the environment assessed with greater scrutiny. If there is any doubt as to the risks and impacts that may result, they must be banned from being released into the environment.

Or. pt

Amendment 142

João Pimenta Lopes

Proposal for a regulation

Recital 13 c (new)

Text proposed by the Commission

Amendment

(13c) The status of each NGT plant should be checked by clearly establishing what makes it considerably different from plants derived from conventional reproductive methods.

Or. pt

Amendment 143

Günther Sidl

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘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 fulfillment 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 breeding.

deleted

Or. en

Justification

Our advancing knowledge of molecular genetics informs us that the genome of an organism functions as a delicately balanced, integrated network (Gupta et al., 2022; Schaefer et al., 2017), with complex traits being omnigenic in nature having the function of the entire genome at their basis (Boyle et al., 2017; Mathieson, 2021). That genes function as networks, implies that any modification at this level can have major consequences with respect to patterns of gene expression and an organism’s biochemistry. Thus, the latest science actually suggests that the law governing genetic modification including NGT should be re-appraised and strengthened rather than weakened. The proposal is not in accordance with science- and evidence-based risk assessment and management best practice, because there is as yet little experience regarding the safety of new genetic engineering techniques in food and in agricultural cultivation. Instead, the proposal provides a list of non-scientific “equivalence criteria” that are overly broad and that simply redefine the vast majority of new GMOs as “equivalent to conventional plants” (Category 1, Annex I).

Amendment 144

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 145

Martin Häusling

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Our advancing knowledge of molecular genetics informs us that the genome of an organism functions as a delicately balanced, integrated network (Gupta et al., 2022; Schaefer et al., 2017), with complex traits being omnigenic in nature having the function of the entire genome at their basis (Boyle et al., 2017; Mathieson, 2021). That genes function as networks, implies that any modification at this level can have major consequences with respect to patterns of gene expression and an organism’s biochemistry. Thus, the latest science suggests that the law governing genetic modification including NGT should be re-appraised and strengthened rather than weakened. The proposal is not in accordance with science- and evidence-based risk assessment and management best practice, because there is as yet little experience regarding the safety of new genetic engineering techniques in food and in agricultural cultivation. Instead, the proposal provides a list of non-scientific “equivalence criteria” that are overly broad and that simply redefine the vast majority of new GMOs as “equivalent to conventional plants” (Category 1, Annex I).

Amendment 146

Pietro Fiocchi

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘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 approach to ascertain if a NGT plant meets the condition of equivalence to naturally occurring or conventionally bred plants and lay down a procedure for competent authorities to verify and take a decision on the fulfillment of applicable 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 as benchmark 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 the approaches and any applicable criteria for the equivalence verification at least every three years in light of scientific and technical progress as regards the type and extent of genetic modifications that can occur in nature or through conventional breeding. During the development of a NGT plant, genetic material originating from outside the breeders’ gene pool might have been temporarily inserted (transiently or stably in an intermediate plant). In order to verify the NGT status of a plant, information is necessary to show absence of such temporarily inserted sequences from outside the breeders’ gene pool.

Or. en

Amendment 147

João Pimenta Lopes

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) In order to ensure legal certainty and safety for health and the environment, this Regulation should set out the criteria and establish suitable methods to ascertain the impact that a NGT plant has on the reproduction of 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. Decision-making should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques and the site of the intended or unintended genetic alterations and associated biological effects. The methods needed for the ‘indoor risk assessment’ (for example for whole genome sequencing and to carry out omics, greenhouse and environmental chamber experiments) must be proposed by the European Food Safety Authority (EFSA) and established by an implementing regulation. They should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques.

Or. pt

Amendment 148

Lydie Massard

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent which includes that they are not patented and that their risks are comparable as a risk assessment has shown, 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 fulfillment 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.

Or. en

Amendment 149

Christophe Clergeau

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques or through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC and their progeny when it respects the same criteria (‘category 1 NGT plants’) must be treated as plants that have occurred naturally or have been produced by conventional breeding techniques or through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC, when they have a similar unmodified parent and when their risks are comparable, thereby derogating in part from the Union GMO legislation and GMO related requirements in sectoral legislation. This Regulation sets out the criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants or those obtained through the genetic modifications listed in Annex 1B to Directive 2001/18/EC, and lays down a procedure for competent authorities to verify the fulfilment of those criteria, on a case-by-case basis and on the basis of the unique characteristics of each NGT plant and not on ex ante criteria, in accordance with the principles of the Cartagena Protocol. Those criteria should be transparent, objective and based on science. They must be based on the OMICS approach in order to verify equivalence with conventional plants using standard biochemistry techniques in particular. They must also be based on the six criteria set out by EFSA, in particular the presence of exogenous DNA sequences and the disruption of endogenous genes.

Or. fr

Amendment 150

Sirpa Pietikäinen

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) NGT plants and their progeny obtained by conventional breeding techniques (‘category 1 NGT plants’) shall not fall under the scope of the Union GMO legislation and GMO related requirements in sectoral legislation. Nonetheless, NGTs plants, obtained by targeted mutagenesis or cisgenesis, or a combination thereof, remain genetically modified plants. There is no scientific basis for assimilating NGTs to conventional breeding methods, nor products obtained by NGTs to conventional products. The genetic engineering process used to obtain NGT plants and products itself may lead to unintended effects that can entail potential risks. Whether a certain modification or trait could be obtained by other means than genetic engineering does not take away the need to assess and regulate NGTs and products obtained by NGTs in accordance with the precautionary principle. In order to ensure legal certainty, this Regulation should set out the criteria to ascertain the risk profile of an NGT plant and lay down a procedure for competent authorities to verify and take a decision on the fulfillment 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 and should include thresholds for both size and number of genetic modifications to the genome of NGT plants. The adaptation of these criteria may have significant implications on the scale of the NGT plants and products which may fall under the scope of category 1 or 2 NGT plants and products, and therefore, should be adapted based on an ordinary legislative procedure.

Or. en

Amendment 151

Pietro Fiocchi

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

Or. en

Amendment 152

Martin Häusling

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) NGTs plants, obtained by targeted mutagenesis or cisgenesis, or a combination thereof, remain genetically modified plants. There is no scientific basis for assimilating NGTs to conventional breeding methods, nor products obtained by NGTs to conventional products. The genetic engineering process used to obtain NGT plants and products itself may lead to unintended effects that can entail potential risks. Whether a certain modification or trait could be obtained by other means than genetic engineering does not take away the need to assess and regulate NGTs and products obtained by NGTs in accordance with the precautionary principle. In order to ensure legal certainty, this Regulation should set out the criteria to ascertain the potential environmental and health risks of an NGT plant and lay down a procedure for competent authorities to 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. The adaptation of these criteria may have significant implications on the scale of the NGT plants and products which fall under the scope of category 1 or 2 NGT plants and products, and therefore, should be adapted based on an ordinary legislative procedure for the purpose of increasing the level of protection of human and animal health and the environment, based on the latest independent scientific studies.

Or. en

Amendment 153

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘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 and safety for health and the environment, adequate methodology shall be defined 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 fulfillment 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. 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 breeding.

Or. en

Amendment 154

Francesca Peppucci

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘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 fulfillment 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, extent, size and number of genetic modifications that can occur in nature or through conventional breeding.

Or. en

Amendment 155

Stanislav Polčák

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘category 1 NGT plants’) should be treated in the same way 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 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 essentially equivalent to naturally occurring or conventionally bred plants and lay down a procedure for competent authorities to verify and take a decision on the fulfillment 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 breeding.

Or. cs

Amendment 156

Jan Huitema, Karin Karlsbro, Emma Wiesner, Ulrike Müller

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(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 fulfillment 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 breeding.

Or. en

Justification

If the limit of 20 genetic modifications for category 1 NGT plants is cumulative over generations, it will restrict breeders’ possibilities to introduce new modifications using NGTs at a later stage in a breeding programme. This in turn will limit what could be achieved when combining complex traits . Therefore, progeny of category 1 NGT plants should remain category 1 if additional modifications fulfil the equivalence criteria as set out in Annex I.

Amendment 157

Jessica Polfjärd

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

Or. en

Justification

Progeny of Category 1 NGT plants should still be considered as NGT 1 if additional modifications fulfil the equivalence criteria set out in annex I. Breeders improve on commercial varieties, in order to reach gradual result in productivity over time. If the threshold of 20 genetic modifications for NGT 1 plants are cumulative over generations, it will aggravate for the breeders to introduce new modifications using NGTs at a later time in future breeding programmes. This risks limiting the range of what could be achieved when combining complex traits (e.g. disease resistance).

Amendment 158

Erik Poulsen, Asger Christensen, Jan Huitema, Emma Wiesner

Proposal for a regulation

Recital 14 a (new)

Text proposed by the Commission

Amendment

(14a) In view of the high complexity of plant genomes, the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants should reflect the diversity of plants genomic size and their characteristics. Polyploid plants contain more than two homologous chromosomes. Within this, 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. Based on this any limit to the total number of individual modifications per plant should reflect the plants “ploidy”, meaning the number of chromosomes set in a plant.

Or. en

Justification

The recital provides an explanation to how the limitations set out in Annex 1 should be understood and a general explanation of the complexity of plant genomes.

Amendment 159

Günther Sidl

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15) All NGT plants that are not category 1 (‘category 2 NGT plants’) should remain subject to the requirements of the Union GMO legislation because they feature more complex sets of modifications to the genome.

deleted

Or. en

Justification

Amendment 160

João Pimenta Lopes

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15) All NGT plants should remain subject to the requirements of the Union GMO legislation and the overall risk assessment because they feature more complex sets of modifications to the genome or have a genotype and/or phenotype that is unlikely to be obtained through conventional or natural reproductive processes. The amount of additional data needed to draw a conclusion about the safety of those plants can be decided based on data in their ‘indoor risk assessment’ as the first step in the approval process.

Or. pt

Amendment 161

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15) All NGT plants should remain subject to the requirements of the Union GMO legislation because they feature complex sets of modifications to the genome.

Or. en

Amendment 162

Lydie Massard

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15) All NGT plants should remain subject to the requirements of the Union GMO legislation because they feature more complex sets of modifications to the genome.

Or. en

Amendment 163

João Pimenta Lopes

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

deleted

Or. pt

Amendment 164

Günther Sidl

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Amendment 165

Lydie Massard

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 166

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 167

Norbert Lins

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) Category 1 NGT plants and products should not be subject to the rules and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency, a declaration of the category 1 NGT plant status should be obtained prior to deliberate release, including the placing on the market. NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘category 1 NGT plants’) should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques. The biological material of plant breeding, which may also occur in nature, must be widely available for plant breeding. Category 1 plants, their derived seed, their plant material, associated genetic material such as genes and gene sequences, and plant traits shall be excluded from patentability.

Or. en

Amendment 168

Christophe Clergeau

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) Category 1 NGT plants and products should not be subject to all the rules and requirements of the Union GMO legislation and to all provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency for the competent authorities responsible for the assessment of the associated risks, the environmental assessment and monitoring, and in order to allow freedom of choice for both producers and consumers, a declaration of the category 1 NGT plant status must be obtained prior to deliberate release, including the placing on the market.

Or. fr

Amendment 169

Martin Häusling

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

Or. en

Amendment 170

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) Category 1 NGT plants and products must not be subject to the rules and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency, a declaration of the category 1 NGT plant status should be obtained prior to deliberate release, including the placing on the market.

Or. en

Amendment 171

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) This declaration should be obtained prior to any deliberate release of any category 1 NGT plants for any other purpose than placing on the market, such as for field trials that are to take place in the territory of the Union, since the criteria are based on data that is available before the field trials and does not depend on these field trials. When no field trials are to take place in the territory of the Union, operators should obtain that declaration before placing the category 1 NGT product on the market.

deleted

Or. en

Amendment 172

Günther Sidl

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Amendment 173

João Pimenta Lopes

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

deleted

Or. pt

Amendment 174

Christophe Clergeau

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) This declaration must be obtained prior to any deliberate release of any category 1 NGT plants for any other purpose than placing on the market, such as for field trials that are to take place in the territory of the Union, since the criteria are based on data that is available before the field trials and on tests in closed environments and does not depend on these field trials. When no field trials are to take place in the territory of the Union, operators must obtain that declaration before placing the category 1 NGT product on the market.

Or. fr

Amendment 175

Lydie Massard

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) This declaration should be obtained prior to any deliberate release of any NGT products for any other purpose than placing on the market, such as for field trials that are to take place in the territory of the Union, since the criteria are based on data that is available before the field trials and does not depend on these field trials. When no field trials are to take place in the territory of the Union, operators should obtain that declaration before placing the NGT product on the market.

Or. en

Amendment 176

João Pimenta Lopes

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(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 the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

deleted

Or. pt

Amendment 177

Lydie Massard

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 178

Martin Häusling

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 179

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 180

Günther Sidl

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Amendment 181

Christophe Clergeau

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) 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 in close cooperation with the European Food Safety Authority (‘the Authority’) 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 the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Or. fr

Amendment 182

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(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 the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted in consultation with the Commission and the European Food Safety Authority (‘the Authority’) only if there are reasoned objections by other Member States in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Or. it

Amendment 183

Jan Huitema, Karin Karlsbro, Emma Wiesner, Ulrike Müller

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(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 the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted in consultation with the Commission and the European Food Safety Authority ('EFSA') only if there are reasoned objections by other Member States in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Or. en

Justification

Category 1 NGT plants' status declarations should be established without delay. Therefore, the procedure should be conducted by the national competent authorities, unless there is a reasoned objection by a Member State. This will help ensure a faster and less bureaucratic verification process.

Amendment 184

Stanislav Polčák

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) Since the criteria for considering that a NGT plant is essentially 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 national competent authorities of other Member States. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Or. cs

Amendment 185

Sirpa Pietikäinen

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) Since the criteria for considering the risk profile of a NGT plant 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 the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Or. en

Amendment 186

Francesca Peppucci

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(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. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted in consultation with the Commission and EFSA, only if there are reasoned objections from other Member States, in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Or. en

Amendment 187

Jessica Polfjärd

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(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 reasoned objections to the verification report by other national competent authorities. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Or. en

Amendment 188

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Recital 18 a (new)

Text proposed by the Commission

Amendment

(18a) With a view to effectively selecting new varieties that help the agricultural sector to increase food security and sustainability and to adapt to and ensure resilience to the consequences of climate change, the specific nature of polyploid plants – those containing more than two genomes – needs to be considered. This is the case, for instance, with wheat, potato, sugar beet, banana, kiwi, peanut, rapeseed, etc. For polyploid plants, the maximum number of genetic modifications allowed for inclusion in category 1 NGT should be proportionate to the number of genomes they contain.

Or. it

Amendment 189

Francesca Peppucci

Proposal for a regulation

Recital 18 a (new)

Text proposed by the Commission

Amendment

(18a) In order to effectively select new varieties that help the agricultural sector increase food security, as well as sustainability, adaptation and resilience to the consequences of climate change, it is necessary to consider the specificity of polyploid plants, i.e. those 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.

Or. en

Amendment 190

João Pimenta Lopes

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to strict deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.

deleted

Or. pt

Amendment 191

Günther Sidl

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 192

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 193

Martin Häusling

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to feasible deadlines to ensure that category 1 NGT plant status authorisations are made within a reasonable time.

Or. en

Justification

Authorities should have sufficient time to do the necessary checks on NGT plants. The Commission proposal is far from realistic planning for the authorities.

Amendment 194

Christophe Clergeau

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to appropriate deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.

Or. fr

Amendment 195

Stanislav Polčák

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.

Or. cs

Amendment 196

Lydie Massard

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to strict deadlines to ensure that NGT products status declarations are made within a reasonable time.

Or. en

Amendment 197

João Pimenta Lopes

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(20) The verification of category 1 NGT plant status is of technical nature and does not involve any risk assessment or risk management considerations and the decision on the status is only declaratory. Therefore, when the procedure is conducted at Union level, such implementing decisions should be adopted by the advisory procedure, supported by scientific and technical assistance by the Authority.

deleted

Or. pt

Amendment 198

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 199

Lydie Massard

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 200

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 201

Günther Sidl

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 202

Martin Häusling

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(20) The authorisation of category 1 NGT plant status needs risk assessment, risk management considerations and sufficient checks. When the procedure is conducted at Union level, such implementing decisions should be adopted by the examination procedure, supported by scientific and technical assistance by the Authority.

Or. en

Amendment 203

Christophe Clergeau

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(20) The verification of category 1 NGT plant status is of technical nature and the decision on the status is only declaratory. Therefore, when the procedure is conducted at Union level, such implementing decisions should be adopted by the advisory procedure, supported by scientific and technical assistance by the Authority.

Or. fr

Amendment 204

João Pimenta Lopes

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Decisions declaring the category 1 NGT plant status should assign an identification number to the NGT plant concerned in order to ensure transparency and traceability of such plants when they are listed in the database and for the purpose of labelling of plant reproductive material derived from them.

deleted

Or. pt

Amendment 205

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 206

Günther Sidl

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Amendment 207

Lydie Massard

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 208

Anders Vistisen

on behalf of the ID Group

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

Or. en

Amendment 209

Erik Poulsen, Asger Christensen, Jan Huitema, Emma Wiesner

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Decisions declaring the category 1 NGT plant status should assign an identification number to the NGT plant concerned in order to ensure transparency and traceability of such plants when they are listed in the database. The information listed shall include information on the technique(s) used to obtain the trait(s).

Or. en

Justification

Listing the specific techniques is relevant because it gives particularly organic farmers (as well as conventional) the option to only use seeds which have been made with specific techniques, and to avoid other techniques that they do not see as compatible with their farming methods

Amendment 210

João Pimenta Lopes

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) Category 1 NGT plants should remain subject to any regulatory framework that applies to conventionally bred plants. As is the case for conventional plants and products, those NGT plants and their products will be subject to the applicable sectoral legislation on seed and other plant reproductive material, food, feed and other products, and horizontal frameworks, such as the nature conservation legislation and environmental liability. In this regard, category 1 NGT food featuring a significantly changed composition or structure that affects the nutritional value, metabolism or level of undesirable substances of the food will be considered as novel food and thus fall into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council (46) and will be risk assessed in that context.

deleted

_________________

46 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).

Or. pt

Amendment 211

Günther Sidl

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

deleted

_________________

Or. en

Justification

Amendment 212

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

deleted

_________________

Or. en

Amendment 213

Christophe Clergeau

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) Category 1 NGT plants should remain subject to any regulatory framework that applies to conventionally bred plants or to plants obtained through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC. As is the case for conventional plants and products, those NGT plants and their products will be subject to the applicable sectoral legislation on seed and other plant reproductive material, food, feed and other products, and horizontal frameworks, such as the nature conservation legislation and environmental liability. In this regard, category 1 NGT food featuring a significantly changed composition or structure that affects the nutritional value, metabolism or level of undesirable substances of the food will be considered as novel food and thus fall into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council (46) and will be risk assessed in that context. NGT plants or products presented as having properties for treating or preventing disease in human beings or as being suitable to be used or administered to human beings with a view to restoring, correcting or modifying physiological functions through pharmacological, immunological or metabolic action within the meaning of Article 1(2)(a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use should not benefit from the derogation for Category 1 NGTs.

_________________

Or. fr

Amendment 214

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) Category 1 NGT plants should remain subject to any regulatory framework that applies to conventionally bred plants. As is the case for conventional plants and products, those NGT plants and their products will be subject to the applicable sectoral legislation on seed and other plant reproductive material, food, feed and other products, and horizontal frameworks, such as the nature conservation legislation and environmental liability. In this regard, category 1 NGT food featuring a changed composition, metabolism or structure that affects the nutritional value, metabolism or level of undesirable substances of the food, inter alia novel toxins or allergens will be considered as novel food and thus fall into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council (46 ) and will be risk assessed in that context.

_________________

Or. en

Amendment 215

Stanislav Polčák

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

_________________

Or. cs

Amendment 216

Lydie Massard

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) NGT plants should remain subject to any regulatory framework that applies to conventionally bred plants. As is the case for conventional plants and products, those NGT plants and their products will be subject to the applicable sectoral legislation on seed and other plant reproductive material, food, feed and other products, and horizontal frameworks, such as the nature conservation legislation and environmental liability. In this regard, NGT food featuring a significantly changed composition or structure that affects the nutritional value, metabolism or level of undesirable substances of the food will be considered as novel food and thus fall into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council (46 ) and will be risk assessed in that context.

_________________

Or. en

Amendment 217

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

deleted

_________________

47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

Or. en

Justification

Provisions related to organic farming shall not be dealt with in this Regulation.

Amendment 218

Martin Häusling

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(47 ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC, which have been exempted from the legal requirement of Directive 2001/18 on the ground of their ‘long history of use’. As a result, category 2 NGT plants will be banned in organic production. However, as category 1 NGT plants will not be subject to the legal requirements of Directive 2001/18/EC in this Regulation, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. The use of new genomic techniques is currently incompatible with the concept of organic production in the Regulation (EC) 2018/848, with the precautionary approach on the use of inputs allowed in organic production, put forward by the principles of organic farming, and with consumers’ perception and expectations of organic products. According to the Regulation (EC) 848/2018, organic production is based on the principles of health, ecology, fairness and care. The principle of care entails that a precautionary approach is applied for considering which inputs can be allowed in the organic production process. The principle of fairness entails that plant breeding should be based on the needs of farmers, processors and consumers, and that innovation in plant breeding should not be hampered by monopolistic intellectual property rights such as patents on seeds associated with genetic engineering. The principle of ecology underlines that organic producers should take a systematic approach to innovation and resilience, mobilizing a range of agricultural practices and measures to develop robust agroecological systems, beyond the reliance on specific plant varieties or crops. The use of category 1 NGT plants should therefore be also prohibited in organic production.

_________________

Or. en

Amendment 219

Ulrike Müller

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

47a https://www.dfg.de/download/pdf/dfg_im_profil/geschaeftsstelle/publikationen/stellungnahmen_papiere/2023/statement_genomic_techniques.pdf

Or. en

Amendment 220

João Pimenta Lopes

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

Or. pt

Amendment 221

Anders Vistisen

on behalf of the ID Group

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 222

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Ondřej Knotek

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

Or. en

Justification

As category 1 NGT plants are equivalent to conventionally bred plants, their use should be permitted in organic production. Whether to use these plants or reproductive material thereof would be up the respective breeders and farmers. Next to this general rationale, any limitations related to the use of category 1 NGT plants for organic production should be decided within the framework of Regulation (EU) 2018/848 on organic farming for the purpose of legal consistency.

Amendment 223

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 224

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 225

Pascal Canfin, Max Orville

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 226

Christophe Clergeau

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

Or. fr

Amendment 227

Günther Sidl

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

Or. en

Justification

Amendment 228

Francesca Peppucci

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 229

Lydie Massard

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 230

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 231

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Recital 23 a (new)

Text proposed by the Commission

Amendment

(23a) This regulatory framework does not provide certainty on the issue of patents on genetic material, plant traits and characteristics associated with genetic engineering. Mandatory traceability provisions for both category 1 and 2 NGT plants and products are important temporary safeguards as they contribute to the identification of NGTs throughout the entire supply chain.

Or. en

Justification

MIRAR DE NUEVOOO!!

Amendment 232

Pietro Fiocchi

Proposal for a regulation

Recital 23 a (new)

Text proposed by the Commission

Amendment

(23a) All European quality schemes and geographical indicators (GIs) should have the possibility to choose not to use NGTs in their standards.

Or. en

Amendment 233

Pietro Fiocchi

Proposal for a regulation

Recital 23 b (new)

Text proposed by the Commission

Amendment

(23b) Organic and conventional operators should have the right and freedom not to use NGTs in their production process and throughout their supply chain. This Regulation shall lay out adequate provisions to ensure the freedom of choice for operators not to use NGT plants and seeds, both category 1 and 2, in their production processes. Any additional financial and legal burden to ensure the GMO and NGT-free status of production should not fall on farmers and operators who do not wish to use NGTs. Economic losses incurred due to the adventitious presence of GMOs shall not fall on NGT-free conventional and organic operators. In most cases of adventitious presence, it is impossible to establish the causes, faults, and therefore responsibilities. Thus, this Regulation shall establish coexistence measures, laying the basis for national liability provisions and compensation funds.

Or. en