144 Amendments of Christophe CLERGEAU related to 2023/0226(COD)
Amendment 42 #
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 enable changes to be made to the genome at precise locations. Major advances in genetic engineering have already contributed to the widespread use of marker-assisted selection, which makes it possible to identify and mobilise interesting genes that are present in biodiversity. _________________ 32 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
Amendment 53 #
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 by means of genetic modification techniques referred to in Annex IB to Directive 2001/18/EC, but also in organisms with more complex modifications. Among NGTs, targeted mutagenesis and cisgenesis (including intragenesis) introduceshould bring about genetic modifications without inserting genetic material from non- crossable species (transgenesis). They rely only on the breeders’ gene pool, i.e. the total genetic information that is available for conventional breeding including from distantly related plant species that can be crossed by advanced breeding techniques, provided that the latter do not lead to the introduction of genetic material from non-crossable species. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at precise locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool. Modifications made at precise locations may result in the interruption of endogenous genes and may also be accompanied by unintentional genetic modifications at the targeted location or elsewhere in the genome.
Amendment 68 #
Proposal for a regulation
Recital 3
Recital 3
(3) There is ongoing public and private research using NGTs or other techniques such as marker-assisted selection on a wider variety of crops and traits compared to those obtained through transgenic techniques authorised in the Union or globally(33). This includes plants with improved tolerance or resistance to plant diseases and pests, plants with improved tolerance or resistance to climate change effects and environmental stresses, improved nutrient and water-use efficiency, plants with higher yields and resilience and improved quality characteristics. TIn spite of the difficulty in generating complex multifactorial traits, these types of new plants, coupled with the fairly easy and speedy applicability of those new techniques, could deliver benefits to farmers, consumers and to the environment which are at least equal to those that marker-assisted selection already offers. Thus, NGTs have 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), and the Bioeconomy Strategy (39), and to the Union’s strategic autonomy (40)lthough it is more the socio- economic conditions of production and consumption that determine sustainability transition pathways. _________________ 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.
Amendment 73 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) The development of NGTs will lead to increased control over plant reproductive material by a few multinationals which will exercise the patents they have been granted on genetic processes and extending them to the plants obtained. This development is not without risk for the sustainability of the plant breeding system operating in the European Union, which has allowed joint management of plant genetic resources that ensures that innovation is spread among a number of breeders of different sizes. The Commission has acknowledged the importance of this issue, into which there will need to be an additional investigation in order to assess the impact of patents on NGTs in terms of strategic autonomy for the European Union, concentration on the seed sector and preservation of cultivated biodiversity, but also the cost of food for consumers. In so far as all plant reproductive material that has been genetically modified may be the subject of one or more patents, traceability and labelling measures should be made compulsory for category 1 and 2 NGT plants and products in order, on the one hand, to enforce the rights of patent holders and, on the other, to ensure that other breeders, farmers and other economic agents are fully informed, since they might otherwise be led to make use of patented plants or products without their knowledge and risk being required by patent holders to pay royalties.
Amendment 83 #
Proposal for a regulation
Recital 6
Recital 6
(6) TRather than applying the Court of Justice judgment, by making NGT varieties subject to Directive 2001/18, the Council, in Decision (EU) 2019/190444, requested the Commission to submit, by 30 April 2021, a study in light of that judgment regarding the status of novel genomic techniques under Union law, and a proposal (accompanied by an impact assessment), if appropriate, depending on the conclusions of the study. _________________ 44 Council Decision (EU) 2019/1904 of 8 November 2019 requesting the Commission to submit a study in light of the Court of Justice’s judgment in Case C- 528/16 regarding the status of novel genomic techniques under Union law, and a proposal, if appropriate in view of the outcomes of the study (OJ L 293, 14.11.2019, p. 103).
Amendment 88 #
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 the absence of sufficient investment to upgrade the European Network of GMO Laboratories (ENGL). In certain cases, genetic modifications introduced by these techniques are incurrently regarded as not being easily distinguishable with analytical methods normally used from natural mutations or from genetic modifications introduced by conventional breeding techniques or by genetic modification techniques referred to in Annex IB to Directive 2001/18/EC, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The Union GMO legislation is also not conducive to developing innovative and bENGL network considers that the provision by notifiers of information (as provided for in Regulation (EC) No 1829/2003) and of reference material would make it possible to detect and trace NGT products. The matrix approach devised and used by ENGL also makes it possible to determine the natural or artificial origin of genefticial products that could contribute to sust or epigenetic modifications. More effective detection methods are being developed thanks to growing research efforts that were begun recently (late 2022). At all events, the avainlability, food security and resilience of the agri-food chain of detection methods cannot be regarded as a prerequisite for the establishment of appropriate traceability arrangements, which, moreover, may involve documentary traceability, as is the case for many products of high quality and with different designations. _________________ 45 Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C- 528/16, SWD(2021) 92 final.
Amendment 91 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) In a statement in October 2022, the EFSA proposed six criteria for conducting a risk assessment for plants produced by targeted mutagenesis, cisgenesis and intragenesis. The first four criteria relate to the molecular characterisation of the genetic modification to the NGT plant: presence or absence of an exogenous DNA sequence (criterion 1), whether or not the DNA sequence derives from the breeders’ gene pool (criterion 2), type of integration (criterion 3), and whether or not any endogenous gene is interrupted (criterion 4). According to those criteria, the plant may be regarded as a plant with no exogenous DNA sequence or a cisgenic or intragenetic plant as a result of targeted insertion with or without interruption of endogenous genes. In the case of endogenous-gene interruption, two additional criteria round off the assessment: history of safe use (criterion 5) and the structure and function of the new allele (criterion 6). Where the history of safe use is not sufficiently established, the function and structure of the allele introduced should be carefully assessed. Ultimately, risk assessment cannot be based on the number of genetic modifications intentionally carried out; rather, it should be based on the impact of genetic modifications on the expression of the plant's genes, whether endogenous or exogenous.
Amendment 96 #
Proposal for a regulation
Recital 8
Recital 8
(8) It is therefore necessary to adopt a specific legal framework for GMOs obtained by targeted mutagenesis and cisgenesis and related products when deliberately released into the environment or placed on the market, while maintaining the central principles of GMO legislation that has been in place for over 20 years: sound information and freedom of choice for consumers and farmers, risk assessment and monitoring by health authorities, precautionary principle and reversibility, and coexistence of sectors.
Amendment 103 #
Proposal for a regulation
Recital 9
Recital 9
(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation shouldmust be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excluding microorganisms, fungi and animals for which the available knowledge is even more limited. For the same reason, this Regulation shouldmust 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 domust not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non- crossable species (transgenesis) should and any contaminating technique such as passaging through bridge species allowing foreign sequences into the genome of the target species) must remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgeneforeign sequences and their unintended effects. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.
Amendment 116 #
Proposal for a regulation
Recital 10
Recital 10
(10) The legal framework for NGT plants shouldmust 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 shouldmust enable the development and, health and environmental assessment and orderly placing on the market of labelled plants, food and feed containing, consisting of or produced from NGT plants and other products labelled as containing or consisting of NGT plants (‘NGT products’) s. So as to contribute to the innovation and sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and to enhance the competitiveness of the Union agri-food sector at Union and world level, the legal framework applicable to NGT plants must differentiate NGT plants having positive sustainability characteristics from those that induce increased consumption of herbicides because they have been made resistant to them and those that produce their own insecticides or pesticides.
Amendment 127 #
Proposal for a regulation
Recital 11
Recital 11
(11) This Regulation constitutes lex specialis with regard to the Union GMO legislation. It introduces specific provisderogations 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 shouldmust 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.
Amendment 130 #
Proposal for a regulation
Recital 12
Recital 12
(12) The potential risks of NGT plants vary, ranging from risk profiles potentially similar to conventionally-bred plants or plants obtained by the genetic modification techniques referred to in Annex 1B of Directive 2001/18/EC to various types and degrees of hazards and risks that might be similar to those of plants obtained by transgenesis. This Regulation shouldmust therefore lay down special rules to adjust the risk assessment and risk management requirements according to the potentialactually assessed risks or lack thereof posed by NGT plants and NGT products.
Amendment 137 #
Proposal for a regulation
Recital 13
Recital 13
(13) This Regulation shouldmust distinguish between two categories of NGT plants.
Amendment 149 #
Proposal for a regulation
Recital 14
Recital 14
(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniquesor through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC and their progeny when it respects the same criteria (‘category 1 NGT plants’) shouldmust be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equival or through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC, when they have a similar unmodified parent and thatwhen their risks are comparable, thereby derogating in fullpart from the Union GMO legislation and GMO related requirements in sectoral legislation. In order to ensure legal certainty, tThis Regulation should sets out the criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants or those obtained through the genetic modifications listed in Annex 1B to Directive 2001/18/EC, and lays down a procedure for competent authorities to verify and take a decision on the fulfillment of those criteria, prior to the release or placing on the market of NGT plants or NGT productson a case-by-case basis and on the basis of the unique characteristics of each NGT plant and not on ex ante criteria, in accordance with the principles of the Cartagena Protocol. Those criteria should be transparent, objective and based on science. They 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 empowermust be based on the OMICS approach in order to verify equivalence with conventional plants using standard biochemistry techniques in particular. They must also be based ion accordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientific and technical progress as regards the type and extent of genetic modifications that can occur in nature or through conventional breedingthe six criteria set out by EFSA, in particular the presence of exogenous DNA sequences and the disruption of endogenous genes.
Amendment 168 #
Proposal for a regulation
Recital 16
Recital 16
(16) Category 1 NGT plants and products should not be subject to all the rules and requirements of the Union GMO legislation and to all provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency for the competent authorities responsible for the assessment of the associated risks, the environmental assessment and monitoring, and in order to allow freedom of choice for both producers and consumers, a declaration of the category 1 NGT plant status shouldmust be obtained prior to deliberate release, including the placing on the market.
Amendment 174 #
Proposal for a regulation
Recital 17
Recital 17
(17) This declaration shouldmust be obtained prior to any deliberate release of any category 1 NGT plants for any other purpose than placing on the market, such as for field trials that are to take place in the territory of the Union, since the criteria are based on data that is available before the field trials and on tests in closed environments and does not depend on these field trials. When no field trials are to take place in the territory of the Union, operators shouldmust obtain that declaration before placing the category 1 NGT product on the market.
Amendment 181 #
Proposal for a regulation
Recital 18
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 in close cooperation with the European Food Safety Authority (‘the Authority’) as this would be less administratively burdensome for operators, and a decision should be taken at Union level only in case there are comments to the verification report by other national competent authorities. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.
Amendment 194 #
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 strict appropriate deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.
Amendment 203 #
(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.
Amendment 213 #
Proposal for a regulation
Recital 22
Recital 22
(22) Category 1 NGT plants should remain subject to any regulatory framework that applies to conventionally bred plants or to plants obtained through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC. As is the case for conventional plants and products, those NGT plants and their products will be subject to the applicable sectoral legislation on seed and other plant reproductive material, food, feed and other products, and horizontal frameworks, such as the nature conservation legislation and environmental liability. In this regard, category 1 NGT food featuring a significantly changed composition or structure that affects the nutritional value, metabolism or level of undesirable substances of the food will be considered as novel food and thus fall into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council (46) and will be risk assessed in that context. NGT plants or products presented as having properties for treating or preventing disease in human beings or as being suitable to be used or administered to human beings with a view to restoring, correcting or modifying physiological functions through pharmacological, immunological or metabolic action within the meaning of Article 1(2)(a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use should not benefit from the derogation for Category 1 NGTs. _________________ 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).
Amendment 226 #
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, it is necess based on the record of safe use and the limited knowledge available at the time with regaryd to clarify the status of category 1 NGT plants for the purposes ofidentification. As a result, NGT plants are banned in organic production. The use of new genomic techniques is currently incompatible with the conceptprinciples 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).
Amendment 236 #
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. NGT plants that have obtained a category 1 NGT plant status declaration should be listed in a publicly available database. TIn order to ensure traceability, transparency and choice ofor 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 at all stages between production and consumption of the final products, including processing, category 1 NGT plants and products must be labelled and traced. Traceability measures should make it easier to both withdraw products in the event of unforeseen effects on human health, animal health or the environment, and monitor the environmental effects. Traceability must also facilitate the implementation of crisis management measures in line with the precautionary principle.
Amendment 250 #
Proposal for a regulation
Recital 25
Recital 25
(25) Category 2 NGT plants shouldmust 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.
Amendment 258 #
(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.
Amendment 267 #
Proposal for a regulation
Recital 28
Recital 28
(28) 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 cisgenesis51. When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not allow the systematic 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. _________________ 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 277 #
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, athe monitoring plan for environmental effects should not be required ifalthough it may be adapted depending on whether or not 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 293 #
Proposal for a regulation
Recital 33
Recital 33
Amendment 298 #
Proposal for a regulation
Recital 34
Recital 34
Amendment 303 #
Proposal for a regulation
Recital 35
Recital 35
Amendment 309 #
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 under category 1. The same applies to NGT plants whose genetic modification has enabled them to produce insecticides or other pesticides.
Amendment 310 #
Proposal for a regulation
Recital 37
Recital 37
Amendment 322 #
Proposal for a regulation
Recital 38
Recital 38
(38) The special rules laid down in this Regulation concerning the authorisation procedure for category 2 NGT plants are expected to result in more cultivation in the Union of category 2 NGT plants compared to the situation so far under the current Union GMO legislation. That renders necessary for Member States’ public authorities to define coexistence measures to balance the interests of producers of conventional, organic and GM plants and thereby allow producers a choice between different types of production, in line with the Farm to Fork Strategy’s target of 25 % of agricultural land under organic farming by 2030. In order to ensure that the coexistence measures are consistent, the Commission should draw up an implementing act to cover, in particular, the size of buffer strips between conventional plants and NGT plants, for each type of crop.
Amendment 352 #
Proposal for a regulation
Recital 45
Recital 45
(45) In order to ensure uniform conditions for the implementation of this Regulation, implementingdelegated 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 Council55. _________________ 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 398 #
(3a) 'conventional plants' means plants obtained by conventional breeding techniques excluding genetic modifications and techniques of genetic modification listed in Annex IB to Directive 2001/18/EC like mutagenesis and cell fusion;
Amendment 409 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene pool’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crossesnaturally be cross-pollinated;
Amendment 412 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene pool’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, and induced polyploidy and bridge crosses;
Amendment 423 #
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 and Annex IV, and has at least one of the intended characteristic(s) conveyed by the genetic modification that is contained in Part 1 of Annex III and does not have any one of those listed in Part 2 of Annex III, or
Amendment 428 #
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 tha criteria of equivalence set would make it subject to Directive 2001/18/EC or Regulation 1829/2003t in Annex 1 and Annex 4 are still satisfied;
Amendment 432 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b a (new)
Article 3 – paragraph 1 – point 7 – point b a (new)
(ba) is not presented as having properties for treating or preventing diseases in human beings and may not be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2.(a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Amendment 456 #
Proposal for a regulation
Article 3 – paragraph 1 – point 15 a (new)
Article 3 – paragraph 1 – point 15 a (new)
(15a) 'variety' means a variety as defined in Article 5(2) of Regulation (EC) 2100/94.
Amendment 471 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
Article 4 – paragraph 1 – point 1 – point b
(b) is progeny of plant(s) referred to in point (a) on the condition that the criteria of equivalence set out in Annex 1 and Annex 4 are still satisfied ; or
Amendment 477 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2 a (new)
Article 4 – paragraph 1 – point 2 a (new)
(2a) an extended producer responsibility (EPR) scheme has been settled at European or national level to ensure the financing of risks and possible future damages of human health, animal health or the environment or cross- contamination of organic food and non GMO-food are financed in line with the polluter pays principle.
Amendment 498 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 518 #
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 a request to verify whether the criteria set out in Annex I are met (‘verification 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 implementingdelegated act adopted in accordance with Article 27, point (b)6.
Amendment 523 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Where a person intends to undertake such a deliberate release simultaneously in more than one Member State, that person shall submit the verification request to the competent authority of one of thoseeach Member States.
Amendment 525 #
Proposal for a regulation
Article 6 – paragraph 3 – point b a (new)
Article 6 – paragraph 3 – point b a (new)
(ba) the denomination of the variety;
Amendment 526 #
Proposal for a regulation
Article 6 – paragraph 3 – point c
Article 6 – paragraph 3 – point c
(c) a description of the trait(s) and characteristics which have been introduced or modified, including disclosure of the sequence of the genetic modification;
Amendment 529 #
Proposal for a regulation
Article 6 – paragraph 3 – point c a (new)
Article 6 – paragraph 3 – point c a (new)
(ca) a declaration on possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2. (a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use;
Amendment 530 #
Proposal for a regulation
Article 6 – paragraph 3 – point c b (new)
Article 6 – paragraph 3 – point c b (new)
(cb) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;
Amendment 532 #
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 during the development of the plant, in accordance with the information requirements specified in the implementingdelegated act adopted in accordance with Article 27, point (a)6;
Amendment 541 #
Proposal for a regulation
Article 6 – paragraph 3 – point d – point ii a (new)
Article 6 – paragraph 3 – point d – point ii a (new)
(iia) the results of the in-door safety assessment set out in Annex IV.
Amendment 547 #
Proposal for a regulation
Article 6 – paragraph 3 – point e
Article 6 – paragraph 3 – point e
Amendment 549 #
Proposal for a regulation
Article 6 – paragraph 3 – point e a (new)
Article 6 – paragraph 3 – point e a (new)
(ea) an environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);
Amendment 550 #
Proposal for a regulation
Article 6 – paragraph 3 – point e b (new)
Article 6 – paragraph 3 – point e b (new)
(eb) a monitoring plan for environmental effects as mentioned in Parts 1 and 2 of Annex II;
Amendment 551 #
Proposal for a regulation
Article 6 – paragraph 3 – point e c (new)
Article 6 – paragraph 3 – point e c (new)
(ec) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant. The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2) or assess whether the information provided by the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph;
Amendment 552 #
Proposal for a regulation
Article 6 – paragraph 3 – point e d (new)
Article 6 – paragraph 3 – point e d (new)
(ed) samples of the category 1 NGT plant and their control samples, and information as to the place where the reference material can be accessed;
Amendment 555 #
Proposal for a regulation
Article 6 – paragraph 3 – point f a (new)
Article 6 – paragraph 3 – point f a (new)
Amendment 556 #
Proposal for a regulation
Article 6 – paragraph 3 – point f b (new)
Article 6 – paragraph 3 – point f b (new)
(fb) any other relevant information relating to the file, including possible refusal, withdrawal or acceptance of previous requests or national or European decisions;
Amendment 558 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within 30 working day2 months within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.
Amendment 559 #
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 I and prepare a verification report within 30 working dayAnnex IV. For that purpose, the competent authority shall forward the request to the European Food Safety Authority (“The Authority”) without undue delay. Within 6 months, the Authority shall make a statement on whether the plant is a NGT plant fulfilling the criteria set out in Annex I, including whether it contains any genetic material originating from outside the breeders’ gene pool. The statement shall be forwarded to all Member States, to the Commission, and shall be made public. After receiving this statement, the competent authority shall prepare a verification report within 3 months from the date of receipt of athe verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.
Amendment 570 #
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 verification report within 20 day3 months from the date of receipt of that report.
Amendment 583 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any comments from a Member State or the Commission, within 10 working daysone month from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification 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 Commission.
Amendment 591 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In cases where a comment is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the comment(s) to the Commission and to the other Member States, without undue delay.
Amendment 600 #
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 1 NGT plant within 45 working day3 months from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 604 #
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 8 and 10 in the Official Journal of the European UnionWithin 15 days following their submission or issuance, the competent authority of the Member State where the verification request was submitted to and, where relevant, the Commission shall make public the verification request, the verification report referred to in paragraph 6, the comments referred to in paragraph 7 and the decisions referred to in paragraphs 8 and 10.
Amendment 614 #
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 declaration bBefore placing on the market a NGT product, the person intending to place the product on the market shall submit a verification request to the Authority in accordance with paragraph 2 and the implementing act adopted in accordance with Article 27, point (b).
Amendment 616 #
Proposal for a regulation
Article 7 – paragraph 2 – point b a (new)
Article 7 – paragraph 2 – point b a (new)
(ba) the denomination of the variety;
Amendment 618 #
Proposal for a regulation
Article 7 – paragraph 2 – point c
Article 7 – paragraph 2 – point c
(c) a description of the trait(s) and characteristics which have been introduced or modified, including disclosure of the sequence of genetic modification ;
Amendment 620 #
Proposal for a regulation
Article 7 – paragraph 2 – point c a (new)
Article 7 – paragraph 2 – point c a (new)
(ca) a declaration on possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2. (a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use;
Amendment 621 #
Proposal for a regulation
Article 7 – paragraph 2 – point c b (new)
Article 7 – paragraph 2 – point c b (new)
(cb) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;
Amendment 629 #
Proposal for a regulation
Article 7 – paragraph 2 – point d – point ii a (new)
Article 7 – paragraph 2 – point d – point ii a (new)
(iia) the results of the in-door safety assessment set out in Annex IV
Amendment 631 #
Proposal for a regulation
Article 7 – paragraph 2 – point d a (new)
Article 7 – paragraph 2 – point d a (new)
(da) an environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);
Amendment 633 #
Proposal for a regulation
Article 7 – paragraph 2 – point d b (new)
Article 7 – paragraph 2 – point d b (new)
(db) a monitoring plan for environmental effects as mentioned in Parts 1 and 2 of Annex II;
Amendment 634 #
Proposal for a regulation
Article 7 – paragraph 2 – point d c (new)
Article 7 – paragraph 2 – point d c (new)
(dc) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant. The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2) or assess whether the information provided by the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph;
Amendment 637 #
Proposal for a regulation
Article 7 – paragraph 2 – point d d (new)
Article 7 – paragraph 2 – point d d (new)
(dd) samples of the category 1 NGT plant and their control samples, and information as to the place where the reference material can be accessed;
Amendment 641 #
Proposal for a regulation
Article 7 – paragraph 2 – point e a (new)
Article 7 – paragraph 2 – point e a (new)
(ea) a declaration on the non- applicability of Regulation (EU) 2015/2283 of 25 November 2015 on novel foods, or on the correct application of possible obligations arising from this Regulation;
Amendment 642 #
Proposal for a regulation
Article 7 – paragraph 2 – point e b (new)
Article 7 – paragraph 2 – point e b (new)
(eb) any other relevant information relating to the file, including possible refusal, withdrawal or acceptance of previous requests or national or European decisions.
Amendment 645 #
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. If the verification 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 verification request. The Authority shall inform the requester, the Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.
Amendment 646 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within 30 working day6 months from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and the Member States without undue delay. Member States may make comments on the statement within 2 months from the date of receipt of that statement. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement, and where relevant, comments made by Member States, 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.
Amendment 651 #
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 30 working day months from the date of receipt of the statement of the Authority, taking the latter into account. The decision shall be adoptedMember States may make comments on the draft decision within 2 months from the date of receipt of that draft decision. The decision shall be adopted within the 3 following months, in accordance with the procedure referred to in Article 28(2).
Amendment 654 #
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. The Commission shall publish a summary of themake public its draft decision in, the Official Journal of the European Uncomments referred to in paragraph 6, and its decision.
Amendment 668 #
Proposal for a regulation
Article 9 – title
Article 9 – title
Amendment 670 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1
Article 9 – paragraph 1 – subparagraph 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)register for the purpose of recording the information related to all products consisting of, made of, or containing Cat.1 NGT plant.
Amendment 671 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – introductory part
Article 9 – paragraph 1 – subparagraph 2 – introductory part
The databaseregister shall contain the following information:
Amendment 672 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point b
Article 9 – paragraph 1 – subparagraph 2 – point b
(b) the designation and specification of the category 1 NGT plant;
Amendment 673 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point b a (new)
Article 9 – paragraph 1 – subparagraph 2 – point b a (new)
(ba) the denomination of the variety ;
Amendment 674 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d
Article 9 – paragraph 1 – subparagraph 2 – point d
(d) a description of the trait(s) and characteristics which have been introduced or modified, including possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action;
Amendment 676 #
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) a copy of the studies, which have been carried out and any other available material to demonstrate that: (i) the plant is a NGT plant; (ii) the NGT plant meets the criteria set out in Annex I; (iii) the results of the in-door safety assessment set out in Annex IV;
Amendment 680 #
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 sequence of the genetic modification;
Amendment 682 #
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) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;
Amendment 683 #
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) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant;
Amendment 685 #
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 opinion or statement of EFSA, as referred to in Article 6 (10) and Article 7(5), and
Amendment 697 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The databaseregister shall be publicly available.
Amendment 704 #
Proposal for a regulation
Article 10 – title
Article 10 – title
Amendment 711 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Amendment 731 #
Proposal for a regulation
Article 11 – paragraph 3 – point b
Article 11 – paragraph 3 – point b
(b) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the genetic modification ; and
Amendment 735 #
Proposal for a regulation
Article 11 – paragraph 6 a (new)
Article 11 – paragraph 6 a (new)
6 a. Notwithstanding paragraphs 3, 5 and 6 of this Article: (a) where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the competent authority may disclose the information referred to in paragraph 3; and (b) information which forms part of the opinions or statements of the Authority or the conclusions of the assessment reports and which relate to foreseeable effects on human health, animal health or the environment shall nevertheless be made public. In that case, Article 39c of Regulation (EC) No 178/2002 shall apply.
Amendment 736 #
Proposal for a regulation
Article 11 – paragraph 7 a (new)
Article 11 – paragraph 7 a (new)
7 a. Third parties may submit request to the National competent authority, to the Commission or to the Authority to access confidential information with substantiated argumentation, such as significant concerns about the environment, animal or human health.
Amendment 737 #
Proposal for a regulation
Article 11 a (new)
Article 11 a (new)
Article11a Measures to avoid the unintended presence of category 1 NGT plants 1. Member States shall take appropriate measures to avoid the unintended presence of category 1 NGT plants in other products on the basis of a delegated act proposed by Commission in accordance with Article 26 to define notably the size of the buffer strip for each sort of crops and the obligation of NGT growers to inform organic and certified non-GMO growers with field plots next to those where NGT plants are grown. Member States shall develop the definition of crop specific and adapted measures as a matter of subsidiarity, based on the latest scientific and experimental knowledge, to avoid the unintended presence of category 1 NGT plants. 2. Member States shall instate a strict liability system and a compensation fund to compensate operators in the event of contamination in accordance with the principal of the extended producer responsibility. 3. The Commission shall gather and coordinate information based on the studies at EU and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of NGT, conventional and organic crops.
Amendment 739 #
Proposal for a regulation
Article 11 b (new)
Article 11 b (new)
Article 11b Duration of the validity of the declaration If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter.
Amendment 770 #
Proposal for a regulation
Article 13 – paragraph 1 – point d a (new)
Article 13 – paragraph 1 – point d a (new)
(da) a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC;
Amendment 786 #
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 notifiercompetent authority considers thatif the NGT plant does not need a monitoring plan, the notifier may propose not to submit ashould require a lighter monitoring plan;
Amendment 807 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
The written consent referred to in Article 19 of Directive 2001/18/EC shall either specify monitoring requirements, as described in Article 19(3) point (f) or state that monitoring is not requiredcould be lighter. The written consent shall provide the adequate grounds that justifies that a monitoring plan is lighter. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not required by the consent.
Amendment 820 #
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, unles10 years, unless after three renewal rounds the decision referred to in Article 17(6) or (8) provides that the renewal is for a n unlimited 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.
Amendment 824 #
Proposal for a regulation
Article 17 – paragraph 2 a (new)
Article 17 – paragraph 2 a (new)
2a. If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter.
Amendment 846 #
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 orand 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 854 #
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 assessmeIn case the application is a request for renewal and if based on the results of the monitoring report or regarding the findings of the environmental risk assessment of any released Cat 2 NGT plant or food or feed containing or consisting of Cat 2 NGT plant, 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 acompetent authority may propose not require the continuation of the monitoring plan.
Amendment 860 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1
Article 20 – paragraph 1 – subparagraph 1
By way of derogation from Article 6(1) and (2) and Article 18(1) and (2) of Regulation (EC) No 1829/2003, the Authority shall deliver an opinion onassent the application for authorisation referred to in Article 19 of this Regulation within six months as from the receipt of a valid application.
Amendment 864 #
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2) or assess whether the information provided by. If the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph, the Union reference laboratory shall proceed to his own research and analyses to confirm the claimed unfeasibility. In that case, the decision of the Union reference laboratory shall be motivated and be made public.
Amendment 869 #
Amendment 875 #
Proposal for a regulation
Article 21 – paragraph 1 a (new)
Article 21 – paragraph 1 a (new)
1. The authorisation shall be valid for a limited period of 10 years, unless the Commission decides after three renewal rounds by way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) N° 1829/2003 to renew the authorisation for an unlimited 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.
Amendment 876 #
Proposal for a regulation
Article 21 – paragraph 1 b (new)
Article 21 – paragraph 1 b (new)
If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis or if the , the competent authority may withdraw its decision. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter.
Amendment 884 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
Amendment 889 #
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
Amendment 893 #
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
Amendment 896 #
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
Amendment 900 #
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
Amendment 904 #
Proposal for a regulation
Article 22 – paragraph 6
Article 22 – paragraph 6
Amendment 905 #
Proposal for a regulation
Article 22 – paragraph 7
Article 22 – paragraph 7
Amendment 908 #
Proposal for a regulation
Article 22 – paragraph 8
Article 22 – paragraph 8
Amendment 926 #
1. Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003on the basis of a delegated act proposed by Commission in accordance with Article 26 to define notably the size of the buffer strip for each sort of crops and the obligation of NGT growers to inform organic and certified non-GMO growers with field plots next to those where NGT plants are grown. Member States shall develop the definition of crop specific and adapted measures as a matter of subsidiarity, based on the latest scientific and experimental knowledge, to avoid the unintended presence of category 2 NGT plants. 2. Member States shall instate a strict liability system and a compensation fund to compensate operators in the event of contamination in accordance with the principal of the extended producer responsibility. 3. The Commission shall gather and coordinate information based on the studies at EU and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of NGT, conventional and organic crops.
Amendment 947 #
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plantNGT plants. Article 23 of Directive 2001/18/EC shall apply for all NGT mutatis mutandis.
Amendment 958 #
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
2. The power to adopt the delegated acts referred to in Article 5(3)6(1), Article 6(3), Article 11a and Article 22(8)4 shall be conferred on the Commission for a period of 5 years from [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period.
Amendment 963 #
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
3. The delegations of power referred to in Article 5(3)6(1), Article 6(3), Article 11a and Article 22(8)4 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 968 #
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
6. A delegated act adopted pursuant to Articles 6(1), Article 56(3), Article 11a and Article 22(8)4 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.
Amendment 972 #
Proposal for a regulation
Article 27 – paragraph 1 – point a
Article 27 – paragraph 1 – point a
Amendment 975 #
Proposal for a regulation
Article 27 – paragraph 1 – point b
Article 27 – paragraph 1 – point b
Amendment 989 #
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 Authority. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).
Amendment 993 #
Proposal for a regulation
Article 29 – title
Article 29 – title
Guidance and ex ante evaluation
Amendment 994 #
Proposal for a regulation
Article 29 – paragraph 2 a (new)
Article 29 – paragraph 2 a (new)
Amendment 1030 #
Proposal for a regulation
Article 32 a (new)
Article 32 a (new)
Amendment 1035 #
Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 1
Article 34 – paragraph 2 – subparagraph 1
It shall apply from [24when delegated acts referred to in Article 6(1), Article 6(3), Article 11a, Article 24 and 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 1044 #
Proposal for a regulation
Annex I – title
Annex I – title
Criteria of equivalence of NGT plants to conventional plants 1. 1. A NGT plant is considered equivalent to conventional plants when it differs from the unedited parent plant by no more than 20 genetic modifications of the types referred to in points 1 to 2 within the whole genome of the host plant. (1) substitution or insertion of no more than 20 nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ; (2) deletion of target inversion of any number of nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ; 2. Alongside these process-based criteria, equivalence shall be verified on the basis of the results the genetic modifications produce on the plant. When compared to the unedited parent of the same species grown in the same conditions, result- based criteria shall be set out as follows : (1) the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and (2) the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; and (3) biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired.
Amendment 1045 #
Proposal for a regulation
Annex I – title
Annex I – title
Criteria of equivalence of NGT plants to conventional plants A NGT plant is considered equivalent to conventional plants if, when compared to the unedited parent of the same species grown in the same conditions : - the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and - the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; provided any alteration of biochemical pathways, examined through gene ontology analysis, does not give rise to any adverse compositional consequences, and - biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired; provided any novel biochemicals or proteins produced by the plant does not present adverse effects on the plant itself, on any other forms of life it is known to interact with or bound to consume it.
Amendment 1046 #
Proposal for a regulation
Annex I – title
Annex I – title
Criteria of equivalence of NGT plants to conventional plants A NGT plant is considered equivalent to conventional plants if, when compared to the unedited parent of the same species grown in the same conditions : - the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and - the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; and - biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired.
Amendment 1058 #
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
A NGT plant is considered equivalent to conventional plants when it differs from the recipient/unedited parental plant by no more than 20 genetic modifications of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools2 within the whole genome of the host plant.
Amendment 1060 #
Proposal for a regulation
Annex I – point 1
Annex I – point 1
(1) substitution or insertion of no more than 20 nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded;
Amendment 1070 #
Proposal for a regulation
Annex I – point 2
Annex I – point 2
(2) deletion of target inversion of any number of nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ;
Amendment 1072 #
Proposal for a regulation
Annex I – point 3
Annex I – point 3
Amendment 1094 #
Proposal for a regulation
Annex I – point 4
Annex I – point 4
Amendment 1099 #
Proposal for a regulation
Annex I – point 5
Annex I – point 5
Amendment 1145 #
Proposal for a regulation
Annex II – Part 1 – paragraph 5
Annex II – Part 1 – paragraph 5
Amendment 1190 #
Proposal for a regulation
Annex III – Part 2 – paragraph 1
Annex III – Part 2 – paragraph 1
Traits excluding the application of the incentives referred to in Article 22: - tolerance to herbicides. - plants producing insecticides and pesticides
Amendment 1193 #
Proposal for a regulation
Annex III a (new)
Annex III a (new)
ANNEX IIIa In-door safety assessment A Cat.1 NGT plant is considered safe, without having to go through field trials, if the following confined experiments have been undertaken and provide evidence that: (1) the whole genome sequencing and profiling shows the intended and unintended genetic modifications have not adversely modified the function of one or more genes; and (2) the whole transcriptome sequencing realized on the relevant part of the plant shows the intended and unintended genetic modifications have not adversely modified biochemical pathways, leading in particular to adverse compositional consequences, verified e.g. through gene ontology analysis; and (3) biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the intended and unintended genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of toxic or allergenic novel biochemicals or proteins for the plant itself, any other forms of life it is known to interact with or bound to consume it.