BETA

69 Amendments of João PIMENTA LOPES related to 2023/0226(COD)

João PIMENTA LOPES

Proposal for a regulation
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The European Parliament rejects the Commission proposal.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital -1 (new)

(-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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

(-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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 1

(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council (32), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, significant progress in biotechnology has led to the development of new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations, however, the results cannot be fully foreseen and may be equivalent to or different from plants obtained using conventional selection. _________________ 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).

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 1 a (new)

(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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 1 b (new)

(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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 1 c (new)

(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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 1 d (new)

(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 .

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 2

(2) NGTs constitute a diverse group of genomic techniques, and each of them can be used in various ways to achieve different results and products. They can result in organisms with modifications equivalent to what can be obtained by conventional breeding methods or in organisms with more complex modifications. Among NGTs, targeted mutagenesis and cisgenesis (including intragenesis) introduce genetic modifications without inserting genetic material from non-crossable species (transgenesis). They rely only on the breeders’ gene pool, i.e. the total genetic information that is available for conventional breeding including from distantly related plant species that can be crossed by advancedHowever, 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 ~~technique~~methods. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at ‘precise’ locations in the genome of an organism~~. C~~ 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 ginteneti~~c material already present in the breeders’ gene pool~~onal 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) alre~~ady present in the breeders’ gene pool~~ 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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 2 a (new)

(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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 2 b (new)

(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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 3

(3) There is ongoing public and private research using NGTs on a wider variety of crops and traits compared to those obtained through transgenic techniques authorised in the Union or globally(33). This includes plants with improved tolerance or resistance to plant diseases and pests, plants with 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). _________________ 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.deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 3 a (new)

(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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 7

(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.deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 7 a (new)

(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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 9

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are ~~plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae~~annual agricultural crops with no potential to survive, reproduce and spread in the environment, excluding ~~micro~~other organisms~~, 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 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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 10

(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, without prejudice to the principle of precaution.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 11

(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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 13 a (new)

(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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 13 b (new)

(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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 13 c (new)

(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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 14

(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 toIn 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 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~~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 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 regardsthe 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 ~~occur~~be observed in nature or ~~throug~~in organisms obtained with conventional breeding techniques.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 15

(15) All NGT plants ~~that are not category 1 (‘category 2 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.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 16

(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.deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 17

(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

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 18

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

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 19

(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

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 20

(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

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 21

(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

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 22

(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. _________________ 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).deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 23

(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. As a result, category 2 NGT plants will be banned in organic production. However, 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 and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibited in organic production. _________________ 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).

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 24

(24) Provision should be made to ensure transparency as regards the use of ~~category 1~~ NGT plant varieties, to ensure that production chains that wish to remain free from NGTs can do so and thereby safeguard consumer trust. NGT plants that have obtained a ~~category 1~~n NGT plant status declaration should be listed in a publicly available database. To ensure traceability, transparency and choice for operators, during research and plant breeding, when selling seed to farmers or making plant reproductive material available to third parties in any other way, plant reproductive material of ~~category 1~~ NGT plants should be labelled as ~~category 1~~ NGT.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 25

(25) ~~Category 2~~ NGT plants should remain subject to the requirements of the Union GMO legislation given that on the basis of current scientific and technical knowledge, their risks need to be assessed. Special rules should be provided in order to adapt the procedures and certain other rules laid down in Directive 2001/18/EC and Regulation (EC) No 1829/2003 to the specific nature of ~~category 2~~ NGT plants and the differing levels of risk that they may pose.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 26

(26) ~~Category 2~~ NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, given the wide variety of those NGT plants, the amount of information necessary for the risk assessment will vary on a case-by-case basis. The Authority, in its scientific opinions on plants developed through cisgenesis and intragenesis48 and on plants developed through targeted mutagenesis49 recommended flexibility in data requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis’ (50), considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress. _________________ 48 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta, J, Fernandez Dumont A, Gennaro A, Lenzi, P, Lewandowska A, Munoz Guajardo IP, Papadopoulou N and Rostoks N, 2022. Updated scientific opinion on plants developed through cisgenesis and intragenesis. EFSA Journal 2022;20(10):7621, 33 pp. https://doi.org/10.2903/j.efsa.2022.7621. 49 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Mullins E, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Gennaro A, Paraskevopoulos K, Raffaello T and Rostoks N, 2020. Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis. EFSA Journal 2020;18(11):6299, 14 pp. https://doi. org/10.2903/j.efsa.2020.6299. 50 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Fernandez A, Gennaro A, Papadopoulou N, Raffaello T and Schoonjans R, 2022. Statement on criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 2022;20(10):7618, 12 pp. https://doi.org/10.2903/j.efsa.2022.7618.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 27

(27) Requirements on the content of notifications for consent for the placing on the market of products containing or consisting of GMOs other than food or feed and on the content of applications for authorisation for the placing on the market of genetically modified food and feed are laid down in different pieces of legislation. To ensure consistency between the notifications for consent and applications for authorisation for ~~category 2~~ NGT products, the content of such notifications and applications should be the same~~, except those concerning the assessment of food and feed safety assessment as these are only relevant to category 2 NGT food and feed.~~

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 29

(29) Directive 2001/18/EC requires a monitoring plan for environmental effects of GMOs after their deliberate release or placing on the market but provides for flexibility as to the design of the plan taking into account the environmental risk assessment, the characteristics of the GMO, of its expected use and of the receiving environment. Genetic modifications in category 2 NGT plants may range from changes only needing a limited risk assessment to complex alterations requiring a more thorough analysis of potential risks. Therefore, post-market monitoring requirements for environmental effects of category 2 NGT plants should be adapted in the light of the environmental risk assessment and the experience in field trials, the characteristics of the NGT plant concerned, the characteristics and scale of its expected use, in particular any history of safe use of the plant and the characteristics of the receiving environment. Therefore, a monitoring plan for environmental effects should not be required if the category 2 NGT plant is unlikely to pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment.deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 30

(30) For reasons of proportionality, after a first renewal of the authorisation, the authorisation should be valid for an unlimited period, unless decided differently at the time of that renewal based on the risk assessment and the available information on the NGT plant concerned, subject to reassessment when new information has become available.deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 33

(33) Regulatory incentives should be offered to potential notifiers or applicants for ~~category 2~~ NGT plants and products containing traits with the potential to contribute to a sustainable agri-food system, in order to steer the development of ~~category 2~~ NGT plants towards such traits. The criteria to trigger these incentives should focus on broad trait categories with the potential to contribute to sustainability (such as those linked to tolerance or resistance to biotic and abiotic stresses, improved nutritional characteristics or increased yield) and should be based on the contribution to the value for sustainable cultivation and use as defined in [Article 52(1) of the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union52 ]. ~~The applicability of the criteria across the EU does not allow a narrower definition of traits to focus on specific issues or address local and regional specificities.~~ _________________ 52 COM(2023) 414 final.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 34

(34) Incentives should consist in ~~an accelerated procedure for risk assessment as regards applications handled by a fully centralised procedure (food and feed products) and~~ enhanced pre-submission advice to help developers prepare the dossier for the purpose of the environmental and food and feed safety assessments, without affecting the general provisions on pre-submission advice, notification of studies and consultation of third parties pursuant to Articles 32a, 32b and 32c of Regulation (EC) No 178/2002(53). _________________ 53 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 031 1.2.2002, p. 1).

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 37

(37) In order to enable NGT plants to contribute to the sustainability objectives of the Green Deal and the Farm to Fork and Biodiversity Strategies, cultivation of NGT plants in the Union should be facilitated. This requires predictability for breeders and farmers as regards the possibility to cultivate such plants in the Union. Therefore, the possibility for Member States to adopt measures restricting or prohibiting the cultivation of category 2 NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC would undermine those goals.deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 42

(42) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can be better achieved at Union level, so that NGT plants and NGT products may circulate freely within the internal market, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 43

(43) The types of NGT plants developed and the impact of certain traits on environmental, social and economic sustainability are continuously evolving. Therefore, based on the available evidence of such developments and impacts, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to adapt the list of traits that should be incentivized or discouraged to achieve the goals of the Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies.’deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Recital 45

(45) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the information required to demonstrate that a NGT plant is a category 1 NGT plant, as regards the preparation and the presentation of the notification for that determination, and as regards the methodology and information requirements for the environmental risk assessments of category 2 NGT plants and of NGT food and NGT feed, in accordance with the principles and criteria laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(). _________________ 55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 2 – paragraph 1 – point 1

(1) NGT agricultural plants;

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 2 – paragraph 1 – point 4 a (new)

(4a) Wild plants, trees and algae fall outside the scope of this Regulation.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 3 – paragraph 1 – point 2

(2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that it does not contain any genetic material originating from outside the breeders’ gene pool or prepared outside cells that temporarily may have been inserted during the development of the NGT plant, and there is no type of intellectual property associated with the plant, its properties or the technique used to create it;

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 3 – paragraph 1 – point 7

(7) ‘category 1 NGT plant’ means a NGT plant that: (a) fulfils the criteria of equivalence to conventional plants, set out in Annex I, or (b) is progeny of the NGT plant(s) referred to in point (a), including progeny derived by crossing of such plants, on the condition that there are no further modifications that would make it subject to Directive 2001/18/EC or Regulation 1829/2003;deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 3.º – paragraph 1 – point 8

~~(8) ‘category 2 NGT plant’ means a NGT plant other than a category 1 NGT plant;~~deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 3 – paragraph 1 – point 13

~~(13) ‘category 1 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 1 NGT plant;~~deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 3 – paragraph 1 – point 14

~~(14) ‘category 2 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 2 NGT plant;~~deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 4 – paragraph 1 – point 1

~~(1) the plant is a category 1 NGT plant and (a) has obtained a decision declaring that status in accordance with Article 6 or 7; or (b) is progeny of plant(s) referred to in point (a); or~~deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 4 – paragraph 1 – point 2

(2) the plant is a ~~category 2~~n NGT plant ~~and has been~~ authorised in accordance with Chapter III.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 5

~~Status of category 1 NGT plants 1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants. 2. (EU) 2018/848, the rules set out in its~~ Articles 5 (f) (iii) and 11 shall apply to category 1 NGT plants and to products produced from or by such plants. 3. adopt delegated acts in accordance with Article 26 amending the criteria of equivalence of NGT plants to conventional plants laid down in Annex I in order to adapt them to scientific and technological progress as regards the types and extent of modifications which can occur naturally or through conventional breeding.deleted For the purposes of Regulation The Commission is empowered to

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 6

~~[...]~~deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 7

~~[...]~~deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 9

Database of decisions declaring the 1. The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6). The database shall contain the following information: (a) name and the address of the requester; (b) the designation of the category 1 NGT plant; (c) a summarised description of the technique(s) used to obtain the genetic modification; (d) a description of the trait(s) and characteristics which have been introduced or modified; (e) an identification number, and (f) the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriate. 2. The database shall be publicly available.Article 9 deleted category 1 NGT plant status

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 10.º – title

Labelling of ~~category 1~~ NGT plant reproductive material~~, including breeding material~~

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 10 – paragraph 1

Plant reproductive material, including for breeding and scientific purposes, that contains or consists of ~~category 1~~ NGT plant(s) and is made available to third parties, whether in return for payment or free of charge, shall bear a label indicating the words ‘~~cat 1~~ NGT’, followed by the identification number of the NGT plant(s) it has been derived from.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 11

1. The requester referred to in Articles 6 and 7 may submit a request to the Member State competent authority or to the Authority, as appropriate, to treat certain parts of the information submitted under this Title as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6. 2. The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1. 3. The competent authority or the Authority, as appropriate, may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the disclosure of such information is demonstrated by the requester to potentially harm its interests to a significant degree: (a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002; (b) DNA sequence information; and (c) breeding patterns and strategies. 4. The competent authority or the Authority, as appropriate, shall, after consultation with the requester, decide which information is to be treated as confidential and shall inform the requester of its decision. 5. Member States, the Commission and the Authority shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public. 6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis. 7. In the event of a withdrawal of the verification request by the requester, Member States, the Commission and the Authority shall respect the confidentiality as granted by the competent authority or the Authority in accordance with this Article. Where the withdrawal of the verification request takes place before the competent authority or the Authority has decided on the relevant confidentiality request, Member States, the Commission and the Authority shall not make public the information for which confidentiality has been requested.Article 11 deleted Confidentiality

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Chapter III – title

III ~~Category 2~~ NGT pPlants and ~~category 2~~ NGT products (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout).

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 14 – paragraph 1 – point h

(h) where appropriate, a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the notifier considers that the NGT plant does not need a monitoring plan, the notifier may propose not to submit a monitoring plan;deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 17

Duration of the validity of the consent 1. The consent granted under Part C of Directive 2001/18/EC shall, after the first renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for an unlimited period, unless the decision referred to in Article 17(6) or (8) provides that the renewal is for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent. 2. The last sentence in Article 17(6) and (8) of Directive 2001/18/EC shall not apply.Article 17 deleted after renewal

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 19 – paragraph 1 – point b

(b) the food or the feed complies with the criteria referred to in Article 4(1) or Article 16(1) of Regulation (EC) No 1829/2003, respectively, based on an assessment of the risk to biodiversity and on a safety assessment of the food or feed carried out in accordance with the principles and criteria laid down in Parts 1 and 3 of Annex II to this Regulation and with the implementing act adopted in accordance with Article 27, point (c).

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 19 – paragraph 2

2. By way of derogation from Articles 5(3), point (i), and 17(3), point (i), of Regulation (EC) No 1829/2003, an application for authorisation shall be accompanied by methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant and, where applicable, for the detection and identification of the NGT plant in the NGT food or feed. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant or concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);deleted

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 19 – paragraph 3 – point b

(b) ~~where appropriate,~~ a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan. This duration may be different from the duration of the authorisation. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the applicant considers that the NGT plant does need a monitoring plan, the applicant may propose not to submit a monitoring plan.

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 21

By way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) No 1829/2003, after the first renewal, the authorisation shall be valid for an unlimited period, unless the Commission decides to renew the authorisation for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.Article 21 deleted Duration of the validity of the authorisation after renewal

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 22.º – paragraph 8 – point b

(b) the Commission shall conduct an up-to-date scientific literature review of the impact on environmental, social and economic sustainability and impact on health of the trait(s) it intends to add to or delete from the list in Annex III;

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 25

Article 2~~6b of Directive 2001/18/EC shall not apply to category 2 NGT plants.~~5 deleted Cultivation

2023/11/19
Committee: ENVI

João PIMENTA LOPES

Proposal for a regulation
Article 31

References in other Union legislation With regard to category 2 NGT plants, references in other Union legislation to Annex II or Annex III to Directive 2001/18/EC shall be construed as references to Parts 1 and 2 of Annex II to this Regulation.Article 31 deleted

2023/11/19
Committee: ENVI