Activities of Martin HÄUSLING related to 2023/0226(COD)
Plenary speeches (1)
Plants obtained by certain new genomic techniques and their food and feed (debate)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625
Amendments (200)
Amendment 43 #
Proposal for a regulation
Recital 1
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 help enable changes to be made to the genome at sprecise locationsfic 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. _________________ 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).
Amendment 52 #
Proposal for a regulation
Recital 2
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. Among NGTs, the development of NGT plants with targeted mutagenesis may lead to the introduction of 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 cros through the use of first generation genetic engineering techniques, such as Agrobacterium tumefaciens infection and particle bombardment. Whilst developers used by advanced breeding techniques. 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 already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene poolack-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.
Amendment 67 #
Proposal for a regulation
Recital 3
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, plant, including ones with imunproved 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 n sustainability benefits. However, to claim that onew 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 Earticular 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 Ssocial 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 finalconditions 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.
Amendment 74 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(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.
Amendment 81 #
Proposal for a regulation
Recital 5
Recital 5
(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. _________________ 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.
Amendment 90 #
Proposal for a regulation
Recital 7
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 chaiHowever, according to an expert opinion45a, there are significant methodological weaknesses to the Commission study, and it does not, for example, systematically analyse the state of research, nor make transparent the criteria for evaluating the material on which it is based, merely summarising it. Furthermore, the expert opinion found that the Commission's conclusions appear arbitrary and that it does not comply with some of the Commission’s own standards on, for example, Better Regulation. _________________ 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
Amendment 95 #
Proposal for a regulation
Recital 8
Recital 8
Amendment 112 #
Proposal for a regulation
Recital 9
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 Phaeophyceaeannual 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 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, on the condition that they no longer contain transgenes if these were introduced during their development. 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.
Amendment 114 #
(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.
Amendment 119 #
Proposal for a regulation
Recital 10
Recital 10
(10) The legal framework for NGT plants should share the primary 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 plac, based on the precautionary principle, as laid down in Article 191 of the Treaty on the Functioning onf 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 competitivenessEuropean 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 ofn the Union agri-food sector at Union and world levelmarket.
Amendment 125 #
Proposal for a regulation
Recital 11
Recital 11
(11) This Regulation constitutes lex specialis with regard to the Union GMO legislation. It introduces specific provisions for NGT plants and NGT products. However, where there are no specific rules in this Regulation, NGT plants and products (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, as well as legislation relating to food safety and environmental protection.
Amendment 145 #
Proposal for a regulation
Recital 14
Recital 14
Amendment 152 #
Proposal for a regulation
Recital 14
Recital 14
(14) NGTs plants that could also occur naturally or be produced by conventional breeding techniques and their progeny, 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 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 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 meands that their risks are comparable, thereby derogating in full from the Union GMO legislation and GMOn genetic engineering does not take away the need to assess and regulated requirements in sectoral legislation 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 if a NGT plant is equivthe potential ent to naturally occurring or conventionally bredvironmental and health risks of an NGT 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 a 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 thereforea, the Commission should be empowershould be adapted based ion accn ordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientificinary legislative procedure for the purpose of increasing the level of protection of human and techanicmal progress as regards the type and extent of genetic modificatihealth and the environment, based ons that can occur in nature or through conventional breedinge latest independent scientific studies.
Amendment 169 #
Proposal for a regulation
Recital 16
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 declarn authorisation of the category 1 NGT plant status should be obtained prior to deliberate release, including the placing on the market.
Amendment 178 #
Proposal for a regulation
Recital 18
Recital 18
Amendment 193 #
Proposal for a regulation
Recital 19
Recital 19
(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to strictfeasible deadlines to ensure that category 1 NGT plant status declarauthorisations are made within a reasonable time.
Amendment 202 #
Proposal for a regulation
Recital 20
Recital 20
(20) The verificauthorisation of category 1 NGT plant status is of technical nature and does not involve anyneeds risk assessment or, risk management considerations and the decision on the status is only declaratory. Therefore, wsufficient checks. When the procedure is conducted at Union level, such implementing decisions should be adopted by the advisoryexamination procedure, supported by scientific and technical assistance by the Authority.
Amendment 218 #
Proposal for a regulation
Recital 23
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, 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. _________________ 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).
Amendment 235 #
Proposal for a regulation
Recital 24
Recital 24
(24) Provision should be made to ensure transparencceability 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. Category 1 NGT plants tshat have obtained a category 1 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 farmersll be subject to the traceability system laid out in Regulation (EC) 1830/2003. Traceability measures are needed throughout the whole supply chain to enable food processors and operators to avoid the accidental or unavoidable adventitious presence of NGTs in their production process. These traceability requirements should facilitate both the withdrawal of products where unforeseen adverse effects on human health, animal health or the environment, including ecosystems, are established, and the targeting orf 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 NGTonitoring to examine potential effects, particularly on the environment. Traceability should also facilitate the implementation of risk management measures in accordance with the precautionary principle.
Amendment 242 #
Proposal for a regulation
Recital 24
Recital 24
(24) Provision shouldall be made to ensure transparency as regards the use of category 1 and category 2 NGT plant varieties, to ensure that production chains that wish to remain free from NGTs can do so and thereby safeguard consumer trust. All NGT plants that have obtained a category 1 NGT plant status declaration should varieties approved in the EU shall 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 NGTconsumers and farmers all NGT verified and authorised in the EU shall be labelled according to existing EU law including Directive 2001/18 and Regulation (EC) No 1830/2003.
Amendment 247 #
Proposal for a regulation
Recital 24 b (new)
Recital 24 b (new)
(24b) 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.
Amendment 265 #
Proposal for a regulation
Recital 28
Recital 28
(28) Research and scientific knowledge related to the development of analytical detection methods, which allow the differentiation of NGT plant from conventional plants are still under development. The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), concluded that analytical testing is not considered feasible for all products obtained by targeted mutagenesis and cisgenesis (51 ). When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not yet allow the differentiation of the NGT plant from conventional plants. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier or the applicant, the modalities to comply with analytical method requirements should be adapted. This should be done in the implementing acts adopted pursuant to this Regulation. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analytical methods. Modalities for performing method validation may also be adapted. It should be noted that the availability of detection methods is not a pre-requisite for the establishment of a traceability system. _________________ 51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)
Amendment 269 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28a) Member States should support the development of such analytical methods and acknowledge that the lack of detection methods for certain NGTs is merely an analytical research gap at the moment and that such detection methods will be developed in the coming years if given sufficient funding and political support.
Amendment 275 #
Proposal for a regulation
Recital 29
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.
Amendment 283 #
Proposal for a regulation
Recital 30
Recital 30
(30) For reasons of proportionality, aAfter a first renewal of the authorisation, the authorisation should be valid for an un limited 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 of 10 years.
Amendment 288 #
Proposal for a regulation
Recital 32
Recital 32
Amendment 292 #
Proposal for a regulation
Recital 32 a (new)
Recital 32 a (new)
Amendment 294 #
Proposal for a regulation
Recital 33
Recital 33
Amendment 299 #
Proposal for a regulation
Recital 34
Recital 34
Amendment 308 #
Proposal for a regulation
Recital 36
Recital 36
(36) Herbicide tolerant plants are bred to be intentionally tolerant to herbicides, in order to be cultivated in combination with the use of those herbicides. If such cultivation is not done under appropriate conditions, it may lead to development of weeds resistant to those herbicides or to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, NGT plants featuring herbicide-tolerant traits should not be eligible for incentives under this framework. However, this Regulation should not take other specific measures on herbicide tolerant NGT plants, because such measures are taken horizontally in [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 Union]fall within the scope of the category 1 NGTs.
Amendment 317 #
(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 facilitatedregulated under existing EU law including Directive 2001/18 and Regulation (EC) No 1830/2003. 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 wshould undermine those goalsremain.
Amendment 330 #
Proposal for a regulation
Recital 39 a (new)
Recital 39 a (new)
(39a) To achieve the goal of ensuring the effective functioning of the internal market, EU-wide legally binding coexistence measures for category 1 and category 2 NGTs should be adopted.
Amendment 344 #
Proposal for a regulation
Recital 43
Recital 43
Amendment 350 #
Proposal for a regulation
Recital 45
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 assessmentspreparation and the presentation of the authorisation of category 2 NGT plants and of NGT food and NGT feed,1 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 ). _________________ 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).
Amendment 357 #
Proposal for a regulation
Recital 47 a (new)
Recital 47 a (new)
(47a) The European Green Deal, the ‘Farm to Fork’, and the EU Biodiversity Strategies put organic farming at the core of a transition to sustainable food systems, with a target to expand European agricultural land under organic production to 25% by 2030. This is a clear recognition of the environmental benefits of organic farming, for less dependency on inputs for farmers, and a resilient food supply and food sovereignty. This Regulation must not adversely undermine the pathway to a transition of European food systems to organic farming to 25% by 2030.
Amendment 358 #
Proposal for a regulation
Recital 47 b (new)
Recital 47 b (new)
(47b) According to a 2021 JRC study, 6 out of 16 pre-commercial NGT products are modified for herbicide tolerance. However, this Regulation should contribute to delivering on the objectives set out in the European Green Deal and Union and international pesticide reduction targets. Thus, this Regulation should ensure that herbicide tolerant NGT plants cannot be considered at NGT category 1.
Amendment 359 #
Proposal for a regulation
Recital 47 c (new)
Recital 47 c (new)
(47c) The precautionary principle, enshrined in Article 191 of the Treaty on the Functioning of the European Union, aims at ensuring a higher level of environmental protection and consumer health, in the context of food and human, animal and plant health, through preventative decision-taking in the case of risk. This Regulation needs to be in accordance with the precautionary principle as NGT plants shall be released and cultivated in the environment.
Amendment 360 #
Proposal for a regulation
Recital 47 e (new)
Recital 47 e (new)
(47e) Traceability requirements for food and feed produced from NGTs should be established to facilitate accurate labelling of such products, in accordance with the requirements of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, so as to ensure that accurate information is available to operators and consumers to enable them to exercise their freedom of choice in an effective manner as well as to enable control and verification of labelling claims. Requirements for food and feed produced from NGTs should be similar in order to avoid discontinuity of information in cases of change in end use.
Amendment 361 #
Proposal for a regulation
Recital 47 f (new)
Recital 47 f (new)
(47f) All European quality schemes and geographical indicators (GIs), which are important sectors in Europe which consumers have certain expectations of, should have the possibility to choose not to use NGTs in their standards.
Amendment 364 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
Amendment 370 #
Proposal for a regulation
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
(1) NGT plantsAnnual arable agricultural NGT plants that do not have the potential to persist, reproduce or spread in the environment;
Amendment 375 #
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
Amendment 377 #
Proposal for a regulation
Article 2 – paragraph 1 a (new)
Article 2 – paragraph 1 a (new)
The rules in Union legislation which apply to GMOs and in Union legislation on environmental protection and food safety, in so far that they are not derogated from by this Regulation, shall continue to apply to these plants and products.
Amendment 380 #
Proposal for a regulation
Article 2 – paragraph 1 c (new)
Article 2 – paragraph 1 c (new)
This Regulation shall not apply to transgenic plants or to progeny of transgenic plants.
Amendment 381 #
Proposal for a regulation
Article 2 – paragraph 1 d (new)
Article 2 – paragraph 1 d (new)
This Regulation shall not apply to NGT plants which are herbicide tolerant, insecticidal, antimicrobial, fungicidal or which have a changed composition.
Amendment 382 #
Proposal for a regulation
Article 2 – paragraph 1 e (new)
Article 2 – paragraph 1 e (new)
This Regulation shall not apply to gene technology which aims to modify the genome outside of the laboratory.
Amendment 383 #
Proposal for a regulation
Article 2 – paragraph 1 f (new)
Article 2 – paragraph 1 f (new)
This Regulation shall not apply to plants which have been modified with RNA interference technologies.
Amendment 384 #
Proposal for a regulation
Article 2 – paragraph 1 g (new)
Article 2 – paragraph 1 g (new)
This regulation does not apply to patented material or material for which a patent application is being processed.
Amendment 390 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
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 fromprepared outside of the breeders’ gene pool that temporarily may have been inserted during the developmcells and that there are no patents or exclusive rights covering the process used to develop the plant, and there are no patents or exclusive rights covering the plant or parts thereof, and no application has been tabled for such patents of the NGT plr exclusive rights to be granted;
Amendment 396 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
Amendment 399 #
Proposal for a regulation
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precisely defined locations in the genome of an organism, and in which no unintended changes take place elsewhere in the genome as verified by a full unbiased screening of the whole of the genome;
Amendment 404 #
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
Amendment 407 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
Amendment 422 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point a
Article 3 – paragraph 1 – point 7 – point a
(a) fulfils the criteria of equivalence to conventional plants, set out in Annex I, orhas been authorised in accordance with Chapter II, and
Amendment 424 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point a a (new)
Article 3 – paragraph 1 – point 7 – point a a (new)
(aa) is not covered by patents or exclusive rights and for which no application has been tabled for such patents or exclusive rights to be granted;
Amendment 425 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point a b (new)
Article 3 – paragraph 1 – point 7 – point a b (new)
(ab) does not have one or more of the traits listed in part 2 of Annex III;
Amendment 427 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b
Article 3 – paragraph 1 – point 7 – point b
(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;
Amendment 466 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point a
Article 4 – paragraph 1 – point 1 – point a
(a) has obtained a decision declaring that statusbeen authorised in accordance with Article 6 or 7Chapter II; or
Amendment 470 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
Article 4 – paragraph 1 – point 1 – point b
Amendment 503 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. TWhe Commission is empowered to 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 breedingre scientific studies show the need to update the criteria in Annex I in order to ensure the highest possible levels of protection of human and animal health and for the environment, the Commission shall come forward with a legislative procedure.
Amendment 514 #
Proposal for a regulation
Article 6 – title
Article 6 – title
Amendment 517 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. To obtain the declaration of category 1 NGT plant status referred to in Article 4(1), point (a), before undertaking a deliberate release of a NGT plant for any other purpose than placing on the market, the person intending to undertake the deliberate release shall submit an application request to verify whether the criteria set out in Annex I and conditions in this article are met (‘verificauthorisation request’) to the competent authority designated in accordance with Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the release is to take place in accordance with paragraphs 2 and 3 and the implementing act adopted in accordance with Article 27, point (b).
Amendment 521 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
Amendment 524 #
Proposal for a regulation
Article 6 – paragraph 3 – introductory part
Article 6 – paragraph 3 – introductory part
3. The verificauthorisation request referred to in paragraph 1 shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and shall include, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002:
Amendment 531 #
Proposal for a regulation
Article 6 – paragraph 3 – point d – introductory part
Article 6 – paragraph 3 – point d – introductory part
(d) a copy of the studies, which have been carried out and any other available material necessary to demonstrate that:
Amendment 535 #
Proposal for a regulation
Article 6 – paragraph 3 – point d – point i
Article 6 – paragraph 3 – point d – point i
(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted durentire genome sequence, performed via an unbiased long-read sequencing with the most accurate and up to date techniques to show that, among other things, the development of the plant, in accordance with the information requirements specified in the implemplant does not contain any transgenic material or transgenes, such as those which may have beent ing act adopted in accordance with Article 27, point (a)serted as part of the development of the plant;
Amendment 536 #
Proposal for a regulation
Article 6 – paragraph 3 – point d – point i a (new)
Article 6 – paragraph 3 – point d – point i a (new)
(ia) information in accordance with the requirements specified in the implementing act adopted in accordance with Article 27, point (a);
Amendment 537 #
Proposal for a regulation
Article 6 – paragraph 3 – point d – point i b (new)
Article 6 – paragraph 3 – point d – point i b (new)
(ib) an environmental risk assessment, carried out in accordance with Directive 2001/18;
Amendment 538 #
Proposal for a regulation
Article 6 – paragraph 3 – point d – point ii
Article 6 – paragraph 3 – point d – point ii
(ii) the NGT plant meets the criteria set out in Annex I, including through the submission of independent studies verifying the safety of the modifications outlined in annex I, paragraph 1, points 1 and 2;
Amendment 542 #
Proposal for a regulation
Article 6 – paragraph 3 – point d a (new)
Article 6 – paragraph 3 – point d a (new)
(da) a declaration from the applicant that there are: (i) no patents or exclusive rights covering the process used to develop the plant, (ii) no patents or exclusive rights covering the plant or parts thereof, and (iii) no application has been tabled for such patents or exclusive rights to be granted;
Amendment 543 #
Proposal for a regulation
Article 6 – paragraph 3 – point d b (new)
Article 6 – paragraph 3 – point d b (new)
(db) whether the NGT plant fits the criteria of a novel food and is therefore subject to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, and if so, that the requirements of Regulation (EU) 2015/2283 have been fulfilled;
Amendment 544 #
Proposal for a regulation
Article 6 – paragraph 3 – point d c (new)
Article 6 – paragraph 3 – point d c (new)
(dc) a declaration that the deliberate release would not be in breach of the Cartegena Protocol on biosafety under the UN convention on biological diversity, and a description of how the requirements are fulfilled;
Amendment 545 #
Proposal for a regulation
Article 6 – paragraph 3 – point d d (new)
Article 6 – paragraph 3 – point d d (new)
(dd) submission of a reference material and a validated detection method;
Amendment 546 #
Proposal for a regulation
Article 6 – paragraph 3 – point e
Article 6 – paragraph 3 – point e
Amendment 553 #
Proposal for a regulation
Article 6 – paragraph 3 – point f
Article 6 – paragraph 3 – point f
Amendment 554 #
Proposal for a regulation
Article 6 – paragraph 3 – point f
Article 6 – paragraph 3 – point f
(f) an identification of the parts of the verificauthorisation request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, pursuant to Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002.
Amendment 557 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. If the verification request does not contain all the necessary information, Within 60 working days from the date of receipt of an authorisation request, the competent authority shall be declared inadmissible by the competent authority within 30 working days within the date of receipt of a verification request whether the authorisation request is admissible, or whether in the absence of the necessary information required pursuant to paragraph 3, it is inadmissible. The competent authority shall inform the requester, the other Member States and the Commission of its decision without undue delay of the inadmissibility of the verificauthorisation request and shall provide the reasons of its decision.
Amendment 562 #
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex Iparagraph 3 and prepare a verificauthorisation report within 360 working days from the date of receipt of a verification requestn which it has informed the Member States and Commission of its decision pursuant to paragraph 5. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.
Amendment 569 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make comments to the verificauthorisation report within 2045 days from the date of receipt of that report.
Amendment 577 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any comments from acases where comments are raised by another Member State or the Commission, within 10 working days from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verificauthorisation report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commissionforward the comment(s) to the MS and the Commission. The competent authorities and the Commission may discuss any outstanding issues within 60 days.
Amendment 586 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In cases where a comment is made by anotherthe absence of any comments from a Member State or by the Commission by the deadlineor if outstanding issues are resolved within the period referred to in paragraph 7 8, the competent authority that prepared the verification report shall forward the comment(s) to the Commission without undue delayreport shall, within 10 working days from the deadline referred to in para 7 or, in the case outstanding issues are resolved in para 8, adopt a decision establishing whether the NGT plant fulfils the conditions set out in article 5(1) and this article. It shall transmit the decision without delay to the notifier, the other Member States and the Commission.
Amendment 592 #
Proposal for a regulation
Article 6 – paragraph 9 a (new)
Article 6 – paragraph 9 a (new)
9a. In cases where comments are raised and maintained by another Member State or the Commission, the competent authority that prepared the report shall forward the authorisation report, and the comments to the European Food Safety Authority (‘the Authority’) without undue delay. The Authority shall deliver a statement on whether the notified NGT plant fulfils the conditions set out in Article 5(1) and under this article no later than 45 working days from the date of the referral. The Authority shall make available the statement to the Commission and the Member States.
Amendment 593 #
Proposal for a regulation
Article 6 – paragraph 9 b (new)
Article 6 – paragraph 9 b (new)
9b. Where the Authority is consulted in accordance with paragraph 9a of this Article, it shall, in accordance with Article 38(1) of Regulation (EC) No 178/2002, make public without delay the notification, relevant supporting information and any supplementary information supplied by the applicant, as well as its statement.
Amendment 603 #
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1On fulfilment of the conditions set out in Article 5(1) and in this article, the Commission shall prepare a draft decision authorising the NGT plant within 4560 working days from the date of receipt of the comment(s)statement of the Authority, taking the latter into account. The decision shall be adopted in accordance with the procedure referred tolaid down in Article 28(23).
Amendment 605 #
Proposal for a regulation
Article 6 – paragraph 11
Article 6 – paragraph 11
11. The Commission shall publish a summary of the decisions referred to in paragraphs 89, 9b new and 10 in the Official Journal of the European Union.
Amendment 612 #
Proposal for a regulation
Article 7 – title
Article 7 – title
Amendment 613 #
Proposal for a regulation
Article 7 – title
Article 7 – title
Amendment 615 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where a declaration of category 1 NGT plant status referred to in Article 4(1), point (a), has not already been made in accordance with Article 6, to obtain such a declarIn order to obtain an authorisation before placing on the market aof a category 1 NGT product, the person intending to place the product on the markeapplicant shall submit a verificn authorisation request to the Authority in accordance with paragraph 2 andfor determination that the NGT plant fulfils the conditions set out in Article 5(1), in paragraph 2 of this Article as well as the implementing act adopted in accordance with Article 27, point (b).
Amendment 624 #
Proposal for a regulation
Article 7 – paragraph 2 – point d – point i
Article 7 – paragraph 2 – point d – point i
(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted durentire genome sequence, performed via an unbiased long-read sequencing with the most accurate and up to date techniques to show that, among other things, the development of the plant, in accordance with the information requirements specified in the implemplant does not contain any transgenic material or transgenes, such as those which may have beent ing act adopted in accordance with Article 27, point (a)serted as part of the development of the plant;
Amendment 625 #
Proposal for a regulation
Article 7 – paragraph 2 – point d – point i a (new)
Article 7 – paragraph 2 – point d – point i a (new)
(ia) information in accordance with the requirements specified in the implementing act adopted in accordance with Article 27, point (a);
Amendment 626 #
Proposal for a regulation
Article 7 – paragraph 2 – point d – point ii
Article 7 – paragraph 2 – point d – point ii
(ii) the NGT plant meets the criteria set out in Annex I, including through the submission of independent studies verifying the safety of the modifications outlined in annex I, paragraph 1, points 1 and 2;
Amendment 628 #
Proposal for a regulation
Article 7 – paragraph 2 – point d – point ii a (new)
Article 7 – paragraph 2 – point d – point ii a (new)
Amendment 630 #
Proposal for a regulation
Article 7 – paragraph 2 – point d a (new)
Article 7 – paragraph 2 – point d a (new)
(da) a declaration from the applicant that there are: (i) no patents or exclusive rights covering the process used to develop the plant,( (ii) no patents or exclusive rights covering the plant or parts thereof, and (iii) no application has been tabled for such patents or exclusive rights to be granted;
Amendment 632 #
Proposal for a regulation
Article 7 – paragraph 2 – point d b (new)
Article 7 – paragraph 2 – point d b (new)
(db) whether the NGT plant fits the criteria of a novel food and is therefore subject to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, and if so, that the requirements of Regulation (EU) 2015/2283 have been fulfilled;
Amendment 635 #
Proposal for a regulation
Article 7 – paragraph 2 – point d c (new)
Article 7 – paragraph 2 – point d c (new)
(dc) a declaration that the placing on the market would not be in breach of the Cartegena Protocol on biosafety under the UN convention on biological diversity, and a description of how the protocol's requirements are fulfilled;
Amendment 636 #
Proposal for a regulation
Article 7 – paragraph 2 – point d d (new)
Article 7 – paragraph 2 – point d d (new)
(dd) a declaration that the placing on the market is in conformity with the Regulation on food information to consumers, as well as legislation on nutrition and health claims made on food, and a description on how the relevant provisions are fulfilled;
Amendment 638 #
Proposal for a regulation
Article 7 – paragraph 2 – point d e (new)
Article 7 – paragraph 2 – point d e (new)
(de) reference material and a validated sampling and detection method;
Amendment 639 #
Proposal for a regulation
Article 7 – paragraph 2 – point e
Article 7 – paragraph 2 – point e
Amendment 640 #
Proposal for a regulation
Article 7 – paragraph 2 – point e
Article 7 – paragraph 2 – point e
(e) an identification of the parts of the verificauthorisation request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, pursuant to Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002.
Amendment 643 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The Authority shall acknowledge receipt of the verificauthorisation request to the requesterapplicant without delay, stating the date of receipt. It shall make available the verificauthorisation request to the Member States and to the Commission without undue delay and make public the verificauthorisation request, all relevant supporting information and any supplementary information supplied by the requesterapplicant, in accordance with article 38(1) of Regulation (EC) No 178/2002, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.
Amendment 644 #
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. If the verificauthorisation request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 360 working days within the date of receipt of a verificn authorisation request. The Authority shall inform the requesterapplicant, the Member States and the Commission without undue delay of the inadmissibility of the verificauthorisation request and shall provide the reasons of its decision.
Amendment 647 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the verificauthorisation request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its stateassessment on whether the NGT plant fulfils the criteria set out in Annex I and set out in this Article within 360 working days from the date of receipt of a verificn authorisation request. The Authority shall make available the statedraft assessment to the Commission and the Member States. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation shall also make its draft assessment public.
Amendment 649 #
Proposal for a regulation
Article 7 – paragraph 5 a (new)
Article 7 – paragraph 5 a (new)
5a. Member States, the Commission and the public may make comments on the draft assessment of the Authority within 45 days.
Amendment 650 #
Proposal for a regulation
Article 7 – paragraph 5 b (new)
Article 7 – paragraph 5 b (new)
5b. The Authority shall deliver its assessment on whether the notified NGT plant fulfils the conditions set out in Article 5(1), annex I and in this Article, taking into account the comments received from Member States, the public and the Commission, within 30 days from the deadline referred to in paragraph 5a new. The Authority shall make available the assessment to the Commission and the Member States. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its assessment public.
Amendment 652 #
Proposal for a regulation
Article 7 – paragraph 6
Article 7 – paragraph 6
6. The Commission shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 3045 working days from the date of receipt of the stateassessment of the Authority, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(23).
Amendment 660 #
The Commission shall set up and maintain an electronic system for the submission of verificauthorisation requests in accordance with Articles 6 and 7 and the exchange of the information under this Title.
Amendment 677 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d a (new)
Article 9 – paragraph 1 – subparagraph 2 – point d a (new)
(da) information about the genetic modification and the site(s) at which both intended and unintended modifications occur;
Amendment 679 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d b (new)
Article 9 – paragraph 1 – subparagraph 2 – point d b (new)
(db) the stage at which the NGT plant is at (deliberate release and/or placing on the market);
Amendment 681 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d c (new)
Article 9 – paragraph 1 – subparagraph 2 – point d c (new)
(dc) all risk assessment data and studies, including those pointing to potential adverse or unintended effects;
Amendment 684 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d d (new)
Article 9 – paragraph 1 – subparagraph 2 – point d d (new)
(dd) all techniques used in the development of the NGT plant;
Amendment 686 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point e a (new)
Article 9 – paragraph 1 – subparagraph 2 – point e a (new)
(ea) the risk assessment, carried out in accordance with Directive 2001/18;
Amendment 690 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point f a (new)
Article 9 – paragraph 1 – subparagraph 2 – point f a (new)
(fa) full details of the detection and sampling method.
Amendment 692 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point f b (new)
Article 9 – paragraph 1 – subparagraph 2 – point f b (new)
(fb) the name of the variety.
Amendment 694 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The database, including all information required under paragraph 1, shall be made publicly available and kept up to date, clearly accessible on the Commission website, as well as on dedicated webpages of each of the Member State's competent authorities.
Amendment 703 #
Proposal for a regulation
Article 10 – title
Article 10 – title
Labelling of NGT category 1 NGT plant reproductive material, including breeding material
Amendment 710 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Plant reproductive material, including for breeding and scientific purposes, as well as food, feed and other products that contains or consists of category 1 NGT plant(s), and iss well as their progeny, which are placed on the market or made available to third parties, whether in return for payment or free of charge, shall bear a label indicating the words ‘cat 1 NGT’genetically modified organism’, in accordance with the requirements laid down in Directive 2001/18 and regulation (EC) No 1830/2003, followed by the identification number of the NGT plant(s) it has been derived from.
Amendment 721 #
Proposal for a regulation
Article 10 a (new)
Article 10 a (new)
Amendment 723 #
Proposal for a regulation
Article 10 b (new)
Article 10 b (new)
Article 10b Cultivation opt-out possibility for Member States During the authorisation procedure of a given category 1 NGT or during the renewal of authorisation, a Member State may demand that the geographical scope of the written consent or authorisation be adjusted to the effect that all or part of the territory of that Member State is to be excluded from cultivation, according to Article 26b of Directive 2001/18/EC.
Amendment 724 #
Proposal for a regulation
Article 10 c (new)
Article 10 c (new)
Article 10c Measures to avoid the unintended presence of category 1 NGT plants Member States shall take appropriate measures to avoid the unintended presence of category 1 NGTs, including the possibility of applying the opt-out. Member States shall develop crop specific and adapted measures, based on the latest scientific knowledge and independent science, in order to avoid the unintended presence of category 1 NGTs. Member States shall instate a strict liability system and a compensation fund to compensate operators in the event of contamination.
Amendment 726 #
Proposal for a regulation
Article 11
Article 11
Amendment 730 #
Proposal for a regulation
Article 11 – paragraph 3 – point b
Article 11 – paragraph 3 – point b
Amendment 732 #
Proposal for a regulation
Article 11 – paragraph 4 a (new)
Article 11 – paragraph 4 a (new)
4 a. Information related to the development of detection methods, the name of the category 1 NGT plant variety, the classification of an NGT plant or products as a category 1 NGT plant or product, and the name of the requester company shall not fall under the information which may be treated as confidential.
Amendment 733 #
Proposal for a regulation
Article 11 – paragraph 5 – subparagraph 1 (new)
Article 11 – paragraph 5 – subparagraph 1 (new)
Notwithstanding paragraph 4, information which directly or indirectly relates to effects on human health, animal health or the environment, shall be made public by the Authority.
Amendment 734 #
Proposal for a regulation
Article 11 – paragraph 6
Article 11 – paragraph 6
6. The relevant provisions of Articles 39e, 39 and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.
Amendment 748 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
The rules which apply to GMOs in Union legislation, as well as food safety and environmental legislation, in so far as they are not derogated from by this Regulation, shall apply to category 2 NGT plants and category 2 NGT products.
Amendment 756 #
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant and falls within the scope of this Regulation, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
Amendment 765 #
Proposal for a regulation
Article 13 – paragraph 1 – point c – point vi
Article 13 – paragraph 1 – point c – point vi
(vi) where relevant, information on control, remediation methods, waste treatment and emergency response plans;
Amendment 768 #
Proposal for a regulation
Article 13 – paragraph 1 – point d a (new)
Article 13 – paragraph 1 – point d a (new)
(da) a declaration stating that: (i) there are no patents or exclusive rights covering the process used to develop the plant; (ii) there are no patents or exclusive rights covering the plant or parts thereof; (iii) no application has been tabled for such patents or exclusive rights to be granted;
Amendment 778 #
Proposal for a regulation
Article 14 – paragraph 1 – point d
Article 14 – paragraph 1 – point d
(d) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plantand that it falls within the scope of this Regulation, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
Amendment 781 #
Proposal for a regulation
Article 14 – paragraph 1 – point d a (new)
Article 14 – paragraph 1 – point d a (new)
(da) the entire genome sequence, performed via an unbiased long-read sequencing with the most accurate and up to date techniques to show that, among other things, the plant does not contain any transgenic material or transgenes, such as those which may have been inserted as part of the development of the plant;
Amendment 785 #
Proposal for a regulation
Article 14 – paragraph 1 – point h
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;
Amendment 794 #
Proposal for a regulation
Article 14 – paragraph 1 – point l
Article 14 – paragraph 1 – point l
(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifierconcluded by the Union Reference Laboratory, 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);
Amendment 798 #
Proposal for a regulation
Article 14 – paragraph 1 – point n
Article 14 – paragraph 1 – point n
(n) where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
Amendment 803 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
Amendment 810 #
Proposal for a regulation
Article 16
Article 16
Amendment 816 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The consent granted under Part C of Directive 2001/18/EC shall, after the firsteach 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 consent10 years.
Amendment 823 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 847 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2
Article 19 – paragraph 2 – subparagraph 2
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);
Amendment 848 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
Amendment 853 #
Proposal for a regulation
Article 19 – paragraph 3 – point b
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.
Amendment 856 #
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
Amendment 858 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1
Article 20 – paragraph 1 – subparagraph 1
Amendment 862 #
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
Amendment 865 #
Proposal for a regulation
Article 20 – paragraph 5
Article 20 – paragraph 5
Amendment 871 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
Amendment 877 #
Proposal for a regulation
Article 21 a (new)
Article 21 a (new)
Amendment 881 #
Proposal for a regulation
Article 22
Article 22
Amendment 906 #
Proposal for a regulation
Article 22 – paragraph 8
Article 22 – paragraph 8
Amendment 911 #
Proposal for a regulation
Article 22 – paragraph 8 – point c
Article 22 – paragraph 8 – point c
(c) where applicable, the Commission shall take into account the results of monitoring which was carried out in accordance with Article 14, point (h), or Article 19(3), of NGT plants harbouring the trait(s) conveyed by their genetic modification.
Amendment 916 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
Amendment 945 #
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
Amendment 951 #
Proposal for a regulation
Article 25 – paragraph 1 a (new)
Article 25 – paragraph 1 a (new)
The provisions for the risk assessment of stacked events of current GMO Regulation fully apply to category 2 NGT plants.
Amendment 952 #
The Commission, after consulting the Authority, shall propose adequate processes, criteria and methodologies for the assessment of systemic effects, such as combinatorial, cumulative and long-term effects, to be adopted by an implementing regulation in accordance with Article 27 and Article 28(3) in order to supplement Annex II.
Amendment 954 #
Proposal for a regulation
Article 26
Article 26
Amendment 970 #
Proposal for a regulation
Article 27 – paragraph 1 – introductory part
Article 27 – paragraph 1 – introductory part
The Commission shall adopt implementing acts supplementing the provisions laid down in this Regulation concerning:
Amendment 971 #
Proposal for a regulation
Article 27 – paragraph 1 – point a
Article 27 – paragraph 1 – point a
Amendment 977 #
Proposal for a regulation
Article 27 – paragraph 1 – point b
Article 27 – paragraph 1 – point b
(b) the preparation and the presentation of the verificauthorisation requests referred to in Articles 6 and 7;
Amendment 980 #
Proposal for a regulation
Article 27 – paragraph 1 – point c
Article 27 – paragraph 1 – point c
Amendment 988 #
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
Before adopting the implementing acts referred to in points (a) to (d), the Commission shall consult the Authorityaragraph 1, the Commission shall consult the Authority. Before adopting the implementing act(s) referred to in point (e), the Commission shall consult the Joint Research Centre with the European Union Reference Laboratory for Genetically Modified Food and Feed. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).
Amendment 990 #
Proposal for a regulation
Article 28 – paragraph 2
Article 28 – paragraph 2
Amendment 999 #
Proposal for a regulation
Article 30 – paragraph 2
Article 30 – paragraph 2
2. The report shall also address anyidentify and address any biodiversity and environmental, human and animal health, socio-economic, changes to agronomic practices and ethical issues that may have arisen with the application of this Regulation.
Amendment 1004 #
Proposal for a regulation
Article 30 – paragraph 3
Article 30 – paragraph 3
3. For the purpose of the reporting referred to in paragraph 1, the Commission, by [24 months after the date of entry into force of this Regulation] at the latest, shall establish, after consulting the competent authorities of the Member States in accordance with Directive 2001/18/EC and Regulation (EC) No 1829/2003, a detailed programme for monitoring, based on indicators, the impact of this Regulation. It the impact of this Regulation, including data, studies and indicators relating to increased corporate control of the plant breeding sector and patents, allergenic potential of NGTs, invasiveness, levels of herbicide use and impacts on non-target organisms. The design of the programme shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence.
Amendment 1007 #
Proposal for a regulation
Article 30 – paragraph 4
Article 30 – paragraph 4
4. No soonlater than twoone years after the publication of the first report referred to in paragraph 1 the Commission shall carry out an evaluation of the implementation of this Regulation andwith regard to respect for the precautionary principle, as well as its impact on human and animal health, biodiversity and the environment, consumer information and transparency, the functioning of the internal market, including concentration of the seed sector and impacts of patents, and economic, environmental and social sustainability.
Amendment 1010 #
Proposal for a regulation
Article 30 – paragraph 5
Article 30 – paragraph 5
5. The Commission shall present a report on the main findings of the evaluation referred to in paragraph 4 as well as on the findings of the monitoring programme referred to paragraph 3 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Where required to ensure a high level of protection of human and animal health and the environment, in line with precautionary principle, the report shall be accompanied by a legislative proposal for amendment of relevant provisions of this Regulation.
Amendment 1023 #
Proposal for a regulation
Article 32 a (new)
Article 32 a (new)
Regulation (EU) 2015/2283
Article 2 – paragraph 2
Article 2 – paragraph 2
Amendment 1024 #
Proposal for a regulation
Article 32 d (new)
Article 32 d (new)
Directive 2002/55/EC
Article 9 – paragraph 5 a (new)
Article 9 – paragraph 5 a (new)
Article 32d Amendment to Directive 2002/55/EC In Article 9, the following paragraph is inserted: ‘5a. Member States shall ensure that varieties containing or consisting of a category 1 or a category 2 NGT plant within the meaning of Regulation [please insert reference to this Regulation] are clearly indicated as varieties that have been genetically modified in the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in his sales catalogue that the variety has been genetically modified.’
Amendment 1025 #
Proposal for a regulation
Article 32 a (new)
Article 32 a (new)
Directive 2002/55/EC
Article 17 – subparagraph 3
Article 17 – subparagraph 3
Amendment 1026 #
Proposal for a regulation
Article 32 c (new)
Article 32 c (new)
Directive 2002/53/EC
Article 9 – paragraph 5 a (new)
Article 9 – paragraph 5 a (new)
Amendment 1027 #
Proposal for a regulation
Article 32 a (new)
Article 32 a (new)
Directive 2002/53/EC
Article 17 – subparagraph 3
Article 17 – subparagraph 3
Amendment 1028 #
Proposal for a regulation
Article 32 b (new)
Article 32 b (new)
Directive 1999/105/EC
Article 10 – paragraph 2 – point j a (new)
Article 10 – paragraph 2 – point j a (new)
Article 32b Amendment to Directive 1999/105/EC In Article 10(2) of Directive 1999/105/EC, the following point is inserted: ‘(ja) in the case of material of the ‘tested’ category, whether it contains or consists of a category 1 or category 2 NGT plant within the meaning of Regulation [please insert reference to this Regulation].’
Amendment 1029 #
Proposal for a regulation
Article 32 a (new)
Article 32 a (new)
Directive 68/193/EEC
Article 5f
Article 5f
Article 5f 32a (new) Amendment to Directive 68/193/EEC Article 5f is replaced by the following: "‘1. Member States shall ensure that genetically modified varieties which have been accepted are clearly indicated as such in the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in their vine sales catalogue that the variety is genetically modified and states the purpose of the modification. 2. Member States shall ensure that varieties containing or consisting of a category 1 or category 2 NGT plant within the meaning of Regulation [please insert reference to this Regulation] are clearly indicated as varieties that are genetically modified in the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in his sales catalogue that the variety is genetically modified.’" Or. en (31968L0193)
Amendment 1036 #
Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 1
Article 34 – paragraph 2 – subparagraph 1
It shall apply from [24when all implementing acts required according to Article 27 are adopted, but no sooner than [36 months from the date of entry into force of this Regulation].
Amendment 1047 #
Proposal for a regulation
Annex I – subheading 1
Annex I – subheading 1
Criteria of equivalence of NGT plants to conventionallassification of category 1 NGT plants
Amendment 1048 #
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
A NGT plant is considered equivalent to conventional plantsmay be classified as category 1 when it differs from the recipient/parental plant by no more than 20one set of intentional genetic modifications of the types referred to in points 1 to 5, in an-3 and if no additional modification, intentional or unintentional , is present in any gene sequence or regulatory DNA sequence sharing, or DNA sequence similarity withs important in chromosomal activities and development, such as crossing over and speciation, that is not at the targeted site that can be predicted by bioinformatic tools. A plant can only be chosen as a parental plant if it is not already an NGT plant or an otherwise genetically modified plant.
Amendment 1059 #
Proposal for a regulation
Annex I – point 1
Annex I – point 1
(1) substitution or insertion of no more than 205 nucleotides; (which is sufficient to cause the knockout or correction of a chosen gene or regulatory sequence) of or at a specific targeted sequence and if the resulting gene sequence does not give rise to a novel RNA or protein e.g. due to a frameshift mutation in or at the targeted sequence, and where the outcome of these substitutions or insertions were intended and have been shown to be safe for human health and the environment, and to be of no further or additional regulatory or metabolic or trait consequence.
Amendment 1069 #
Proposal for a regulation
Annex I – point 2
Annex I – point 2
(2) deletion of any number of nucleotides; at one particular targeted site or between two particular targeted sites and where no novel RNA or protein is produced, and where the outcome these deletions were intended and have been shown to be safe for human health and the environment and of no further or additional regulatory or metabolic or trait consequence.
Amendment 1080 #
Proposal for a regulation
Annex I – point 3 – point a
Annex I – point 3 – point a
(a) targeted insertion of a contiguous DNA sequence existing within the breeder’s gene poolspecies;
Amendment 1085 #
Proposal for a regulation
Annex I – point 3 – point b
Annex I – point 3 – point b
(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gfrom the same species and where that sequence is derived from the same gene and where this sequence pool; is not the result of a previous targeted or untargeted genetic modification.
Amendment 1095 #
Proposal for a regulation
Annex I – point 4
Annex I – point 4
Amendment 1096 #
Proposal for a regulation
Annex I – point 5
Annex I – point 5
Amendment 1109 #
Proposal for a regulation
Annex II – Part 1 – paragraph 1
Annex II – Part 1 – paragraph 1
The environmental risk assessment shall be carried out in accordance with the precautionary principle and the principles set out in Annex II to Directive 2001/18/EC.
Amendment 1110 #
Proposal for a regulation
Annex II – Part 1 – paragraph 2 – introductory part
Annex II – Part 1 – paragraph 2 – introductory part
The type and amount of information necessary for the environmental risk assessment of category 2 NGT plants laid down in Annex III of Directive 2001/18/EC and for the food and feed safety assessment of category 2 NGT food and feed shall be adapted to their risk profile. Factors to be consideredis laid down in Annex III of Directive 2001/18/EC. Factors to be covered by the risk assessment include:
Amendment 1120 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point a
Annex II – Part 1 – paragraph 3 – point a
(a) problem formulation including hazard identification and characterisation;
Amendment 1122 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point b
Annex II – Part 1 – paragraph 3 – point b
(b) exposure characterisation and assessment;
Amendment 1126 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point c a (new)
Annex II – Part 1 – paragraph 3 – point c a (new)
(ca) risk management strategies
Amendment 1128 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point c b (new)
Annex II – Part 1 – paragraph 3 – point c b (new)
(cb) overall risk evaluation
Amendment 1131 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point a – introductory part
Annex II – Part 1 – paragraph 4 – point a – introductory part
(a) problem formulation, hazard identification and characterisation
Amendment 1133 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point a – point i a (new)
Annex II – Part 1 – paragraph 4 – point a – point i a (new)
(ia) information relating to the recipient plant or, where appropriate, to the parental plants;
Amendment 1134 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point a – point i b (new)
Annex II – Part 1 – paragraph 4 – point a – point i b (new)
(ib) information relating to the genetic modification and their intended effects
Amendment 1137 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point a – point ii
Annex II – Part 1 – paragraph 4 – point a – point ii
(ii) molecular characterisation to check for intended and unintended effects. The information shall be provided by collating already available data from scientific literature or from other sources or generating scientific data where necessary by performing appropriate experimental and bioinformatic studies.
Amendment 1139 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point b – paragraph 1
Annex II – Part 1 – paragraph 4 – point b – paragraph 1
Information shall be provided to cover all relevant exposure routes to humans, livestock, and the environment. Exposure on the likelihood of each identified potential adverse effect. This shall be evaluated taking into consideration, as relevant, the characteristics of the receiving environment(s), the intended function, the dietary role, the expected level of use of the food and feed in the EU and the scope of the application for authorisation.
Amendment 1143 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point c – paragraph 1
Annex II – Part 1 – paragraph 4 – point c – paragraph 1
The applicant shall base its risk characterisation of NGT plants and foods and feed on information from hazard identification, hazard characterisation and exposure assessment. The risk shall for each protection goal (including specific protection goals) be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk. Where relevant, the uncertainty for each identified risk shall be described and the uncertainties associated with this estimate.
Amendment 1147 #
Proposal for a regulation
Annex II – Part 1 – paragraph 5
Annex II – Part 1 – paragraph 5
Amendment 1151 #
Proposal for a regulation
Annex II – Part 2 – point 1
Annex II – Part 2 – point 1
(1) Analysis of agronomic, phenotypic and compositional characteristics according to Annex II of Directive 2001/18/EC
Amendment 1154 #
Proposal for a regulation
Annex II – Part 2 – point 8
Annex II – Part 2 – point 8
(8) Effects on human and, animal health and the food and feed chain
Amendment 1159 #
Proposal for a regulation
Annex II – Part 3 – point 1 a (new)
Annex II – Part 3 – point 1 a (new)
(1a) Analysis of potential for persistence and invasiveness resulting from transport, loss, and spillage
Amendment 1162 #
Proposal for a regulation
Annex II – Part 3 – point 2
Annex II – Part 3 – point 2
(2) Ecotoxicology and Toxicology
Amendment 1165 #
Proposal for a regulation
Annex II – Part 3 – point 4
Annex II – Part 3 – point 4
(4) Nutritional assessment, including impacts on human and animal microbiomes
Amendment 1168 #
Proposal for a regulation
Annex III – Part 1
Annex III – Part 1
Amendment 1189 #
Proposal for a regulation
Annex III – Part 2 – paragraph 1
Annex III – Part 2 – paragraph 1
Traits excluleading the application of the incentives referred to in Article 22: tolerance to herbicideso exclusion from NGT category 1: tolerance to herbicides, higher use in pesticides, higher use in fertilizers, antimicrobial resistance (including through the use of antibiotic marker genes), higher greenhouse gas emissions, higher susceptibility to plant diseases, potential invasiveness, lack of spatio- temporal control.