Amendementen Hazekamp over planten verkregen met bepaalde nieuwe genomicatechnieken en levensmiddelen en diervoeders daarvoor, en tot wijziging van Verordening (EU) 2017/625

Moties
Amendementen Hazekamp over planten verkregen met bepaalde nieuwe genomicatechnieken en levensmiddelen en diervoeders daarvoor, en tot wijziging van Verordening (EU) 2017/625

15 november 2023

Proposal for a regulation on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 of the Committee on The Environment, Public Health and Food Safety.

Amendement 1
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Draft legislative resolution
Citation -1 (new)

Amendment

– The European Parliament rejects the Commission proposal.

Amendment 2
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Draft legislative resolution
Citation 2

Draft legislative resolution

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

Amendment

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

Amendment 3
Anja Hazekamp, Clare Daly, Mnon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Title 1

Text proposed by the Commission

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

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

(Text with EEA relevance)

Amendment

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on plants obtained by certain newer
genomic manipulation techniques and products derived of these plants

(Text with EEA relevance)

Amendment 4
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Citation 1

Text proposed by the Commission

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

Amendment

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

Amendment 5
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital -1 (new)

Amendment

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

Amendment 6
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital -1 a (new)

Amendment

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

Amendment 7
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital -1 b (new)

Amendment

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

Amendment 8
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital -1 b (new)

Amendment

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

Amendment 9
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital -1 c (new)

Amendment

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

Amendment 10
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 1

Text proposed by the Commission

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

(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council (³²), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, progress in biotechnology has led to the development of newer genomic manipulation techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations. However, also these newer techniques may lead to unexpected outcomes that cannot be fully predicted and that may be equivalent or different compared to plants obtained by conventional breeding.

Amendment 11
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 2

Text proposed by the Commission

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

Amendment

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

Amendment 12
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 2 a (new)

Amendment

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

Amendment 13
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 3

Text proposed by the Commission

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

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

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

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

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

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

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

³⁹ European Commission, Directorate-General for Research and Innovation, A sustainable bioeconomy for Europe – Strengthening the connection between economy, society and the environment: updated bioeconomy strategy, Publications Office, 2018, https://data.europa.eu/doi/10.....

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

(3) There is ongoing public and private research using NGTs on a wider variety of crops and traits compared to those obtained through transgenic techniques authorised in the Union or globally(³³ ). This leads to promises about the development of plants with improved tolerance or resistance to plant diseases and pests, plants with improved tolerance or resistance to climate change effects and environmental stresses, improved nutrient and water-use efficiency, plants with higher yields and resilience and improved quality characteristics. These types of new plants, should they indeed be developed in the future, coupled with appropriate risk assessment, traceability, labelling and co-existence measures, together with the necessary legal adaptations in the field of intellectual property protection in order to exclude risks of monipolisation in the food chain, could potentially
deliver benefits to breeders. Thus, NGTs could have the potential to contribute to the innovation goals of the European Green Deal (³⁴ ) and of the ‘Farm to Fork’ (³⁵ ), Biodiversity (³⁶ ) and Adaptation to Climate Change(³⁷ ) Strategies, to global food security (³⁸ ), the Bioeconomy Strategy (³⁹ ) and to the Union’s strategic autonomy (⁴⁰ ).

Amendment 14
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 4

Text proposed by the Commission

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

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

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

Amendment

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

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

Amendment 15
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 5

Text proposed by the Commission

(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.

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

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

Amendment 16
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 6 a (new)

Amendment

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

Amendment 17
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 6 b (new)

Amendment

(6 b) The European Parliament has called^1a for a comprehensive analysis of the socioeconomic and environmental effects on the food system of patents on breeding processes, plant propagation material and parts thereof, including their potential to increase market concentration and monopolisation in the food chain, as well as their impact on the affordability and availability of food, and called for the EU and its Member States not to grant patents on biological material and to safeguard the freedom to operate and breeders’ exemption for varieties. It is therefore appropriate to ensure that patented plants are not subject to any exemptions of the Union GMO legislation. Furthermore, to address the threat patents pose to food security, the Commission should rapidly investigate the best route to ban the use of patents in the food chain. The Commission should present a legal proposal to achieve this by 31 December 2024.

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

Amendment 18
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 7 a (new)

Amendment

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

Amendment 19
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 7 b (new)

Amendment

(7 b) One of the few studies that have been performed to investigate the attitude of the public, concluded^1a that in general, citizens views converged towards reservation and hesitation about the use of NGTs and genetic modification in crops. Citizens raised doubts mainly about the plausibility that these crops will contribute meaningfully to the solving of our current societal challenges in the food system, and whether they are indeed the right approach for dealing with these challenges. They wondered if alternative solutions may be better, and how these may come with less unforeseen, long-term risks for human health and ecosystems. Moreover, the citizens in this study questioned whether companies will in practice develop valuable varieties for society, as the logics of the corporate world tend to be focused on capital accumulation and on making profits. Citizens were unanimous in their view that regulation of NGT crops is necessary for diverse reasons: to prevent harms to the environment and human health, to give consumers freedom of choice, to guard against the potential of the technology to increase inequalities, and to ensure that the technology is directed towards contributing to solutions to societal problems. The latter is viewed as an important pre-condition for the introduction of NGT products onto the marketplace. According to citizens, NGTs should not be developed purely for commercial motives driven by the logic of the market. There needs to be a clear societal purpose for their introduction. In terms of policy, this would necessitate a case-by-case assessment of NGT crops for broader considerations such as purpose, and value to society.

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

Amendment 20
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 8

Text proposed by the Commission

(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.

Amendment

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

Amendment 21
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 9

Text proposed by the Commission

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excluding microorganisms, fungi and animals for which the available knowledge is more limited. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter ‘NGT plants’), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non-crossable species (transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis
need adaptation at the present

Amendment

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are annual arable plants without the potential to persist, reproduce and propagate in the environment, excluding microorganisms, fungi and animals. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis (hereinafter ‘NGT plants’), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material (cisgenesis, intragenesis and transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs need adaptation at the present time.

Amendment 22
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 10

Text proposed by the Commission

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

Amendment

(10) The legal framework for NGT plants should share the objectives of the Union GMO legislation to ensure a high level of protection of human and animal health and of the environment, in line with the precautionary principle and the One Health principle, for the concerned plants and products, so as to contribute to the sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity, Zero Pollution and Climate Adaptation strategies and the Organic action plan.

Amendment 23
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 13

Text proposed by the Commission

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

Amendment

deleted

Amendment 24
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallaca

Proposal for a regulation
Recital 14

Text proposed by the Commission

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

Amendment

deleted

Amendment 25
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallaca

Proposal for a regulation
Recital 15

Text proposed by the Commission

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

Amendment

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

Amendment 26
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 16

Text proposed by the Commission

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

Amendment

deleted

Amendment 27
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 17

Text proposed by the Commission

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

Amendment

deleted

Amendment 28
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 18

Text proposed by the Commission

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

Amendment

deleted

Amendment 29
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 19

Text proposed by the Commission

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

Amendment

deleted

Amendment 30
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 20

Text proposed by the Commission

(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

deleted

Amendment 31
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 21

Text proposed by the Commission

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

Amendment

deleted

Amendment 32
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 22

Text proposed by the Commission

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

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

Amendment

deleted

Amendment 33
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 23

Text proposed by the Commission

(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(⁴⁷ ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, category 2 NGT plants will be banned in organic production. However, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. The use of new genomic techniques is currently incompatible with the concept of organic production in the Regulation (EC) 2018/848 and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibited in organic production.

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

Amendment

(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(⁴⁷ ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, NGT plants are and should remain banned in organic production. It is necessary to ensure that the organic sector as a whole has the means to remain GMO-free. Member States should lay down rules to ensure and enforce sufficiently wide buffer zones between organic, conventional and NGT crops. Labbeling and traceability shall remain in place on all NGT plants and products containing them to ensure cross-contamination to organic plants and products is not taking place.

Amendment 34
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 24

Text proposed by the Commission

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

Amendment

(24) Provision should be made to ensure transparency as regards the use of 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 should be listed in a publicly available database. To ensure traceability, transparency and choice for consumers, food producers, farmers and other operators, plant reproductive material, plants, food and feed and products
of NGT plants should be labelled as GMO and NGT.

Amendment 35
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 25

Text proposed by the Commission

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

Amendment

(25) NGT plants should remain subject to the requirements of the Union GMO legislation given that on the basis of current scientific and technical knowledge, their risks need to be assessed.

Amendment 36
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 26

Text proposed by the Commission

(26) Category 2 NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, given the wide variety of those NGT plants, the amount of information necessary for the risk assessment will vary on a case-by-case basis. The Authority, in its scientific opinions on plants developed through cisgenesis and intragenesis⁴⁸ and on plants developed through targeted mutagenesis⁴⁹ recommended flexibility in data requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis’ (⁵⁰ ), considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress.

⁴⁸ EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta, J, Fernandez Dumont A, Gennaro A, Lenzi, P, Lewandowska A, Munoz Guajardo IP, Papadopoulou N and Rostoks N, 2022. Updated scientific opinion on plants developed through cisgenesis and intragenesis. EFSA Journal 2022;20(10):7621, 33 pp. https://doi.org/10.2903/j.efsa....

⁴⁹ EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Mullins E, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Gennaro A, Paraskevopoulos K, Raffaello T and Rostoks N, 2020. Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis. EFSA Journal 2020;18(11):6299, 14 pp. https://doi. org/10.2903/j.efsa.2020.6299.

⁵⁰ EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Fernandez A, Gennaro A, Papadopoulou N, Raffaello T and Schoonjans R, 2022. Statement on criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 2022;20(10):7618, 12 pp. https://doi.org/10.2903/j.efsa....

Amendment

(26) NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, given the wide variety of NGT plants, the amount of information necessary for the risk assessment will vary on a case-by-case basis. The Authority, in its scientific opinions on plants developed through cisgenesis and intragenesis⁴⁸and on plants developed through targeted mutagenesis⁴⁹ recommended flexibility in data requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis’ (⁵⁰ ), considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress.

Amendment 37
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 27

Text proposed by the Commission

(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

(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 NGT products, the content of such notifications and applications should be the same.

Amendment 38
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 28

Text proposed by the Commission

(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 cisgenesis (⁵¹ ). When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not 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.

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

(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 yet 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 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, the notifier or the applicant should be required to ensure one, and provide the exact information needed for the laboratories to differentiate the specific NGT. Furhermore, the Commission and Member States should develop better analytical testing methods. 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 39
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 29

Text proposed by the Commission

(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

(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 NGT plants may range from changes only needing a more limited risk assessment to complex alterations requiring a more thorough analysis of potential risks. Therefore, post-market monitoring requirements for environmental effects of NGT plants could 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.

Amendment 40
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 30

Text proposed by the Commission

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

Amendment

deleted

Amendment 41
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 32

Text proposed by the Commission

(32) To increase transparency and consumers’ information, operators should be allowed to complement the labelling of category 2 NGT products as GMO with information on the trait conferred by the genetic modification. In order to avoid misleading or confusing indications, a proposal for such a labelling should be provided in the notification for consent or in the application for authorisation and should be specified in the consent or in the authorisation decision.

Amendment

deleted

Amendment 42
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 33

Text proposed by the Commission

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

⁵² COM(2023) 414 final

Amendment

(33) Regulatory incentives could be offered to potential SME notifiers or applicants for certain NGT plants and products containing traits with the potential to contribute to a sustainable agri-food system, in order to steer the development of NGT plants towards such traits. The criteria to trigger these incentives should exclusively focus on broad trait categories with the evidence-based potential to contribute to sustainability (such as those linked to tolerance or resistance to biotic and abiotic stresses), and should be based on the contribution to the value for sustainable cultivation and use as defined in [Article 52(1) of the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union⁵²].

⁵² COM(2023) 414 final

Amendment 43
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 34

Text proposed by the Commission

(34) Incentives should consist in an accelerated procedure for risk assessment as regards applications handled by a fully centralised procedure (food and feed products) and enhanced pre-submission advice to help developers prepare the dossier for the purpose of the environmental and food and feed safety assessments, without affecting the general provisions on pre-submission advice, notification of studies and consultation of third parties pursuant to Articles 32a, 32b and 32c of Regulation (EC) No 178/2002(⁵³ ).

⁵³ Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 031 1.2.2002, p. 1).

Amendment

(34) Incentives could consist in an accelerated procedure for risk assessment as regards enhanced pre-submission advice to help SME developers prepare the dossier for the purpose of the environmental and food and feed safety assessments, without affecting the general provisions on pre-submission advice, notification of studies and consultation of third parties pursuant to Articles 32a, 32b and 32c of Regulation (EC) No 178/2002(⁵³ ).

Amendment 44
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 35

Text proposed by the Commission

(35) Additional incentives should be afforded when the notifier or applicant is a small or medium-sized enterprise (SME), to promote access to the regulatory procedures by these enterprises, support diversification of developers of NGT plants and encourage the development by small breeders of crop species and traits by means of NGTs, by granting fee waivers for the validation of detection methods to SMEs and more extensive pre-submission advice covering also the design of studies to be carried out for the purpose of risk assessment.

Amendment

(35) Additional incentives could be afforded when the notifier or applicant is a small enterprise, to promote access to the regulatory procedures by these enterprises, support diversification of developers of NGT plants and encourage the development by small breeders of crop species and traits by means of NGTs, by granting fee waivers for the validation of detection methods to small enterprises and more extensive pre-submission advice covering also the design of studies to be carried out for the purpose of risk assessment.

Amendment 45
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 36

Text proposed by the Commission

(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].

Amendment

(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. Practice shows that such cultivation leads to development of weeds resistant to those herbicides and to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, plants featuring herbicide-tolerant traits should not be regarded as NGT plants.

Amendment 46
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 37

Text proposed by the Commission

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

Amendment

deleted

Amendment 47
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 38

Text proposed by the Commission

(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.

Amendment

(38) The special rules laid down in this Regulation concerning the authorisation procedure for NGT plants are expected to result in more cultivation in the Union of 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 protect the interests of producers of conventional and organic 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.

Amendment 48
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 40

Text proposed by the Commission

(40) Given the novelty of the NGTs, it will be important to monitor closely the development and presence on the market of NGT plants and products and evaluate any accompanying impact on human and animal health, the environment and environmental, economic and social sustainability. Information should be collected regularly and within five years after the adoption of the first decision allowing the deliberate release or the marketing of NGT plants or NGT products in the Union, the Commission should carry out an evaluation of this Regulation to measure the progress made towards the availability of NGT plants containing such characteristics or properties on the EU market.

Amendment

(40) Given the novelty of the NGTs, it will be important to monitor closely the development and presence on the market of NGT plants and products and evaluate any accompanying impact on human and animal health, the environment and environmental, economic and social sustainability. Information should be collected regularly and within three years after the adoption of the first decision allowing the deliberate release or the marketing of NGT plants or NGT products in the Union, the Commission should carry out an evaluation of this Regulation to assess the possible negative effects on biodiversity, environment and health, the impact on the organic value chain, the trust and freedom of choice of citizens and measure the progress made towards the availability of NGT plants containing such actual favourable characteristics or properties on the EU market.

Amendment 49
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 43

Text proposed by the Commission

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

Amendment

(43) The types of NGT plants developed and the impact of certain traits on environmental, social and economic sustainability are continuously evolving. Therefore, based on the available evidence of such developments and impacts, the Commission should be tasked to evaluate the necessity to adapt the list of traits that should be incentivized or discouraged to achieve the goals of the Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies.’ The Commission should present a legislative proposal if it deems it necessary to amend this list.

Amendment 50
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 43 a (new)

Amendment

(43 a) Member States and the Commission should ensure that systematic and independent research on the potential risks involved in the deliberate release or the placing on the market of NGTs is conducted. The necessary resources should be secured for such research by Member States and the Community in accordance with their budgetary procedures and independent researchers should be given access to all relevant material, while respecting intellectual property rights.

Amendment 51
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 45

Text proposed by the Commission

(45) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the information required to demonstrate that a NGT plant is a category 1 NGT plant, as regards the preparation and the presentation of the notification for that determination, and as regards the methodology and information requirements for the environmental risk assessments of category 2 NGT plants and of NGT food and NGT feed, in accordance with the principles and criteria laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(⁵⁵).

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

(45) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the methodology and information requirements for the environmental risk assessments of NGT plants and of NGT food and NGT feed and NGT products, 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 ).

Amendment 52
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 46

Text proposed by the Commission

(46) The Commission should regularly collect information in order to assess the performance of the legislation in achieving the development and availability of NGT plants and NGT products in the market that can contribute to the objectives of the Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and in order to inform an evaluation of the legislation. A broad set of indicators have been identified⁵⁶ and should be periodically reviewed by the Commission. The indicators should support monitoring of potential risks to health or the environment of category 2 NGT plants and related NGT products, impact of NGT plants on environmental, economic and social sustainability as well as impact on organic agriculture and on consumers acceptance of NGT products. A first monitoring report should be presented three years after the first products have been notified/authorised, to ensure that enough data is available after full implementation of the new legislation, and at regular intervals thereafter. The Commission should carry out an evaluation of this Regulation two years after the first monitoring report has been published, in order to allow for the impact of the first products going through the verification or authorisation to fully materialise.

⁵⁶ SWD(2023) 412

Amendment

(46) The Commission should regularly collect information in order to assess the performance of the legislation in achieving the objectives of the Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and in order to inform an evaluation of the legislation. A broad set of indicators have been identified⁵⁶ and should be periodically reviewed by the Commission. The indicators should support monitoring of potential risks to health or the environment of NGT plants and related NGT products, impact of NGT plants on environmental, economic and social sustainability as well as impact on organic agriculture and on consumers freedom of choice, including their knowledge of and acceptance of NGT products. A first monitoring report should be presented three years after the first products have been notified/authorised, to ensure that enough data is available after full implementation of the new legislation, and at regular intervals thereafter. The Commission should carry out an evaluation of this Regulation two years after the first monitoring report has been published.

⁵⁶ SWD(2023) 412

Amendment 53
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Recital 47

Text proposed by the Commission

(47) Certain references to provisions of the Union GMO legislation in Regulation (EU) 2017/625 of the European Parliament and of the Council (⁵⁷ ) need to be amended to include the specific provisions in this legislation applicable to NGT plants.

⁵⁷ Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).

Amendment

deleted

Amendment 54
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 1 - paragraph 1

Text proposed by the Commission

This Regulation lays down specific rules for the deliberate release into the environment for any other purpose than placing on the market of plants obtained by certain new genomic techniques (‘NGT plants’) and for the placing on the market of food and feed containing, consisting of or produced from such plants, and of products, other than food or feed, containing or consisting of such plants.

Amendment

This Regulation lays down specific provisions for certain newer genomic manipulation techniques (‘NGT plants’), while ensuring the protection of health and the environment and upholding the precautionary principle.

Amendment 55
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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

Text proposed by the Commission

(1) NGT plants;

Amendment

(1) Annual arable NGT plants that have no potential to persist, reproduce and spread in the environment;

Amendment 56
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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

Text proposed by the Commission

(2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that it does not contain any genetic material originating from outside the breeders’ gene pool that temporarily may have been inserted during the development of the NGT plant;

Amendment

(2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis, on all of the following conditions:

- it does not contain any genetic material prepared outside the cell,

- it is not bred to be intentionally tolerant to herbicides,

- there is no patent attached to the plant, its traits, properties or the technique used to create it;

Amendment 57
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 3 - paragraph 1 - point 4

Text proposed by the Commission

(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precise locations in the genome of an organism;

Amendment

(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precisely defined locations in the genome of an organism;

Amendment 58
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 3 - paragraph 1 - point 5

Text proposed by the Commission

(5) ‘cisgenesis’ means techniques of genetic modification resulting in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool;

Amendment

deleted

Amendment 59
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 3 - paragraph 1 - point 6

Text proposed by the Commission

(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 crosses;

Amendment

deleted

Amendment 60
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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

Text proposed by the Commission

(7) ‘category 1 NGT plant’ means a NGT plant that:

(a) fulfils the criteria of equivalence to conventional plants, set out in Annex I, or

(b) is progeny of the NGT plant(s) referred to in point (a), including progeny derived by crossing of such plants, on the condition that there are no further modifications that would make it subject to Directive 2001/18/EC or Regulation 1829/2003;

Amendment

deleted

Amendment 61
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 3 - paragraph 1 - point 8

Text proposed by the Commission

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

Amendment

deleted

Amendment 62
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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

Text proposed by the Commission

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

Amendment

deleted

Amendment 63
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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

Text proposed by the Commission

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

Amendment

deleted

Amendment 64
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 4

Text proposed by the Commission

Article 4

Deliberate release of NGT plants for any other purpose than placing on the market and placing on the market of NGT products

Without prejudice to other requirements of Union law, a NGT plant may only be deliberately released into the environment for any other purpose than placing on the market, and a NGT product may only be placed on the market, if:

(1) the plant is a category 1 NGT plant and

(a) has obtained a decision declaring that status in accordance with Article 6 or 7; or

(b) is progeny of plant(s) referred to in point (a); or

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

Amendment

deleted

Amendment 65
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Chapter II - title

Text proposed by the Commission

II Category 1 NGT plants and category 1 NGT products

Amendment

The European Parliament deletes this chapter

Amendment 66
Anja Hazekamp, Clare Daly, Manon Aubry, Marine Mesure, Mick Wallace

Proposal for a regulation
Article 5

Text proposed by the Commission

Article 5

Status of category 1 NGT plants

1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants.

2. For the purposes of Regulation (EU) 2018/848, the rules set out in its Articles 5 (f) (iii) and 11 shall apply to category 1 NGT plants and to products produced from or by such plants.

3. The 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 breeding.

Amendment

deleted

Amendment 67
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 6

Text proposed by the Commission

[...]

Amendment

deleted

Amendment 68
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 7

Text proposed by the Commission

[...]

Amendment

deleted

Amendment 69
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 8

Text proposed by the Commission

Article 8

System of exchange of information between Member States, the Commission and the Authority

The Commission shall set up and maintain an electronic system for the submission of verification requests in accordance with Articles 6 and 7 and the exchange of the information under this Title.

Amendment

deleted

Amendment 70
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 9

Text proposed by the Commission

Article 9

Database of decisions declaring the category 1 NGT plant status

The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6).

The database shall contain the following information:

(a) name and the address of the requester;

(b) the designation of the category 1 NGT plant;

(c) a summarised description of the technique(s) used to obtain the genetic modification;

(d) a description of the trait(s) and characteristics which have been introduced or modified;

(e) an identification number, and

(f) the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriate.

2. The database shall be publicly available.

Amendment

deleted

Amendment 72
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 10

Text proposed by the Commission

Article 10

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

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

Amendment

deleted

Amendment 72
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 11

Text proposed by the Commission

Article 11

Confidentiality

1. The requester referred to in Articles 6 and 7 may submit a request to the Member State competent authority or to the Authority, as appropriate, to treat certain parts of the information submitted under this Title as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6.

2. The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1.

3. The competent authority or the Authority, as appropriate, may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the disclosure of such information is demonstrated by the requester to potentially harm its interests to a significant degree:

(a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;

(b) DNA sequence information; and

(c) breeding patterns and strategies.

4. The competent authority or the Authority, as appropriate, shall, after consultation with the requester, decide which information is to be treated as confidential and shall inform the requester of its decision.

5. Member States, the Commission and the Authority shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public.

6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

7. In the event of a withdrawal of the verification request by the requester, Member States, the Commission and the Authority shall respect the confidentiality as granted by the competent authority or the Authority in accordance with this Article. Where the withdrawal of the verification request takes place before the competent authority or the Authority has decided on the relevant confidentiality request, Member States, the Commission and the Authority shall not make public the information for which confidentiality has been requested.

Amendment

deleted

Amendment 73
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Chapter III - title

Text proposed by the Commission

III Category 2 NGT plants and category 2 NGT products

Amendment

NGT plants and NGT products

Amendment 74
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 12 - title

Text proposed by the Commission

Status of Category 2 NGT plants and category 2 NGT products

Amendment

Status of NGT plants and NGT products

Amendment 75
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 12 - paragraph 1

Text proposed by the Commission

The rules which apply to GMOs in Union 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

The rules which apply to GMOs in Union legislation shall apply to NGT plants and NGT products.

Amendment 76
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Chapter III - Section 1 - title

Text proposed by the Commission

1 Deliberate release of category 2 NGT plants for any other purpose than for placing on the market

Amendment

Deliberate release of NGT plants for any other purpose than for placing on the market

Amendment 77
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 13 - paragraph 1 - introductory part

Text proposed by the Commission

As regards the deliberate release of a category 2 NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:

Amendment

As regards the deliberate release of a NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:

Amendment 78
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 13 - paragraph 1 - point b

Text proposed by the Commission

(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, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Amendment

(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 cell
where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Amendment 79
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 13 - paragraph 1 - point c - point ii

Text proposed by the Commission

(ii) information relating to the category 2 NGT plant(s);

Amendment

(ii) information relating to the NGT plant(s);

Amendment 80
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 13 - paragraph 1 - point c - point iv

Text proposed by the Commission

(iv) information on the interactions between the category 2 NGT plant(s) and the environment;

Amendment

(iv) information on the interactions between the NGT plant(s) and the environment;

Amendment 81
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 13 - paragraph 1 - point c - point v

Text proposed by the Commission

(v) a plan for monitoring in order to identify effects of the category 2 NGT plant(s) on human health or the environment;

Amendment

(v) a plan for monitoring in order to identify effects of the NGT plant(s) on human health or the environment;

Amendment 82
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Chapter III - section 2 - title

Text proposed by the Commission

2 Placing on the market of category 2 NGT products other than food or feed

Amendment

Placing on the market of NGT products other than food or feed

Amendment 83
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 14 - paragraph 1 - introductory part

Text proposed by the Commission

1. As regards the placing on the market of category 2 NGT products other than food and feed, the notification referred to in Article 13(2) of Directive 2001/18/EC, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, shall contain:

Amendment

1. As regards the placing on the market of NGT products other than food and feed, the notification referred to in Article 13(2) of Directive 2001/18/EC, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, shall contain:

Amendment 84
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 14 - paragraph 1 - point b

Text proposed by the Commission

(b) designation and specification of the category 2 NGT plant;

Amendment

(b) designation and specification of the NGT plant;

Amendment 85
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 14 - paragraph 1 - point d

Text proposed by the Commission

(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 plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Amendment

(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 cell
where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Amendment 86
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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

Text proposed by the Commission

(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

(h) 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 only needs a limited monitoring plan, the notifier may propose a limited monitoring plan;

Amendment 87
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 14 - paragraph 1 - point j

Text proposed by the Commission

(j) proposed commercial names of the products and names of category 2 NGT plants contained therein, and a proposal for a unique identifier for the category 2 NGT plant, developed in accordance with Commission Regulation (EC) No 65/2004 (⁶⁰ ). After the consent any new commercial names should be provided to the competent authority;

⁶⁰ Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, p. 5).

Amendment

(j) proposed commercial names of the products and names of NGT plants contained therein, and a proposal for a unique identifier for the NGT plant, developed in accordance with Commission Regulation (EC) No 65/2004 (⁶⁰ ). After the consent any new commercial names should be provided to the competent authority;

Amendment 88
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 14 - paragraph 1 - point 1

Text proposed by the Commission

(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 notifier, 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

(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant.

Amendment 89
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 14 - paragraph 1 - point m

Text proposed by the Commission

(m) samples of the category 2 NGT plant and their control samples, and information as to the place where the reference material can be accessed;

Amendment

(m) samples of the NGT plant and their control samples, and information as to the place where the reference material can be accessed;

Amendment 90
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 14 - paragraph 2

Text proposed by the Commission

2. The notifier shall include in this notification information on data or results from releases of the same category 2 NGT plant or the same combination of category 2 NGT plants previously or currently notified and/or carried out by the notifier either inside or outside the Union.

Amendment

2. The notifier shall include in this notification information on data or results from releases of the same NGT plant or the same combination of NGT plants previously or currently notified and/or carried out by the notifier either inside or outside the Union.

Amendment 91
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 14 - paragraph 3 a (new)

Amendment

3 a. The assessment report as well as all information provided by the applicant shall be made publicly available on a website without undue delay.

Amendment 92
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 15 - paragraph 1

Text proposed by the Commission

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 required. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not required by the consent.

Amendment

The written consent referred to in Article 19 of Directive 2001/18/EC shall specify monitoring requirements, as described in Article 19(3) point (f).

Amendment 93
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 17

Text proposed by the Commission

Article 17

Duration of the validity of the consent after renewal

1. The consent granted under Part C of Directive 2001/18/EC shall, after the first renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for an unlimited period, unless the decision referred to in Article 17(6) or (8) provides that the renewal is for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent.

2. The last sentence in Article 17(6) and (8) of Directive 2001/18/EC shall not apply.

Amendment

deleted

Amendment 94
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Chapter III - Section 3 - title

Text proposed by the Commission

3 Placing on the market of category 2 NGT plants for food or feed use and of category 2 NGT food and feed

Amendment

3 Placing on the market of NGT plants for food or feed use and of NGT food and feed

Amendment 95
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 18 - paragraph 1 - point a

Text proposed by the Commission

(a) category 2 NGT plants for food use or for feed use;

Amendment

(a) NGT plants for food use or for feed use;

Amendment 96
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 18 - paragraph 1 - point b

Text proposed by the Commission

(b) food containing, consisting or produced from category 2 NGT plants or containing ingredients produced from category 2 NGT plants (‘category 2 NGT food’);

Amendment

(b) food containing, consisting or produced from NGT plants or containing ingredients produced from NGT plants (‘NGT food’);

Amendment 97
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 18 - paragraph 1 - point c

Text proposed by the Commission

Amendment

Amendment 98
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 19 - title

Text proposed by the Commission

Specific provisions on the application for authorisation referred to in Articles 5 and 17 of Regulation (EC) No 1829/2003

Amendment

Specific provisions on the application for authorisation

Amendment 99
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 19 - paragraph 1 - introductory part

Text proposed by the Commission

1. By way of derogation from Articles 5(3), point (e), and 17(3), point (e), of Regulation (EC) No 1829/2003, and without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, an application for authorisation of a category 2 NGT plant for food or feed use, or category 2 NGT food or feed shall be accompanied by a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out and any other available material to demonstrate that:

Amendment

1. Without prejudice to Articles 5(3), point (e), and 17(3), point (e), of Regulation (EC) No 1829/2003 and to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, an application for authorisation of a NGT plant for food or feed use, or NGT food or feed shall be accompanied by a copy of the studies, including independent, peer-reviewed studies, which have been carried out and any other available material to demonstrate that:

Amendment 100
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 19 - paragraph 1 - point a

Text proposed by the Commission

(a) 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 implementing act adopted in accordance with Article 27, point (a);

Amendment

(a) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the cell where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Amendment 101
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 19 - paragraph 2 - subparagraph 1

Text proposed by the Commission

By way of derogation from Articles 5(3), point (i), and 17(3), point (i), of Regulation (EC) No 1829/2003, an application for authorisation shall be accompanied by methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant and, where applicable, for the detection and identification of the NGT plant in the NGT food or feed.

Amendment

Without prejudice to Articles 5(3), point (i), and 17(3), point (i), of Regulation (EC) No 1829/2003, an application for authorisation shall be accompanied by methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant and, where applicable, for the detection and identification of the NGT plant in the NGT food or feed.

Amendment 102
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 19 - paragraph 2 - subparagraph 2

Text proposed by the Commission

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

deleted

Amendment 103
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 19 - paragraph 3 - introductory part

Text proposed by the Commission

3. By way of derogation from Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, in the case of category 2 NGT plants or food or feed containing or consisting of category 2 NGT plants, the application shall also be accompanied by:

Amendment

3. Without prejudice to Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, in the case of NGT plants or food or feed containing or consisting of NGT plants, the application shall also be accompanied by:

Amendment 104
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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

Text proposed by the Commission

(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

(b) 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 only needs a limited monitoring plan, the applicant may propose to submit a limited monitoring plan.

Amendment 106
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 20 - paragraph 4

Text proposed by the Commission

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 the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph.

Amendment

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).

Amendment 106
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 20 a (new)

Amendment

Article20a

Specific provisions on refusing NGT plants, food, feed and products

Without prejudice to the criteria in Regulation (EC) No 1829/2003 and Directive 2001/18/EC, the deliberate relase of NGT plans and the placing on the market of NGT food, feed and products shall be refused if a Member States deems it probable that it would jeopardise health, the environment or the sustainability of the food chain.

Amendment 107
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 21

Text proposed by the Commission

Article 21

Duration of the validity of the authorisation after renewal

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

Amendment

deleted

Amendment 108
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Chapter III - section 4 - title

Text proposed by the Commission

4 Common provisions for category 2 NGT plants and category 2 NGT products

Amendment

Common provisions for NGT plants and NGT products

Amendment 109
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 22 - title

Text proposed by the Commission

Incentives for category 2 NGT plants and category 2 NGT products containing traits relevant for sustainability

Amendment

Incentives for NGT plants and NGT products containing traits relevant for sustainability

Amendment 110
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 22 - paragraph 1

Text proposed by the Commission

1. The incentives in this Article shall apply to category 2 NGT plants and category 2 NGT products, where at least one of the intended trait(s) of the NGT plant conveyed by the genetic modification is contained in Part 1 of Annex III and it does not have any traits referred to in Part 2 of that Annex.

Amendment

1. The incentives in this Article shall apply to NGT plants and NGT products, where at least one of the intended trait(s) of the NGT plant conveyed by the genetic modification is contained in Part 1 of Annex III and it does not have any traits referred to in Part 2 of that Annex.

Amendment 111
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 22 - paragraph 2 - point a

Text proposed by the Commission

(a) by way of derogation from Article 20(1), subsection (1) of this Regulation, the Authority shall deliver its opinion on the application within 4 months from the receipt of a valid application, unless the complexity of the product requires application of the time limit referred to in Article 20(1). The time limit shall be extendable under the conditions set out in Article 20(1), subsection (2);

Amendment

(a) where the applicant is a SME, and by way of derogation from Article 20(1), subsection (1) of this Regulation, the Authority shall deliver its opinion on the application within 4 months from the receipt of a valid application, unless the complexity of the product requires application of the time limit referred to in Article 20(1). The time limit shall be extendable under the conditions set out in Article 20(1), subsection (2);

Amendment 112
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 22 - paragraph 2 - point b

Text proposed by the Commission

(b) where the applicant is a SME, it shall be exempted from the payment of the financial contributions to the Union Reference Laboratory and to the European Network of GMO Laboratories referred to in Article 32 of Regulation (EC) No 1829/2003.

Amendment

(b) where the applicant is a micro or small enterprise, it shall be exempted from the payment of the financial contributions to the Union Reference Laboratory and to the European Network of GMO Laboratories referred to in Article 32 of Regulation (EC) No 1829/2003.

Amendment 113
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 22 - paragraph 3 - point a

Text proposed by the Commision

(a) the staff of the Authority shall, at the request of a potential applicant or notifier, provide advice on plausible risk hypotheses that the potential applicant or notifier has identified based on the properties of a plant, product or hypothetical plant or product, that need to be addressed by providing the information under Parts 2 and 3 of Annex II. The advice shall not, however, cover the design of studies to address the risk hypotheses;

Amendment

(a) the staff of the Authority shall, at the request of a potential applicant or notifier where that is a SME, provide advice on plausible risk hypotheses that the potential applicant or notifier has identified based on the properties of a plant, product or hypothetical plant or product, that need to be addressed by providing the information under Parts 2 and 3 of Annex II. The advice shall not, however, cover the design of studies to address the risk hypotheses;

Amendment 114
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 22 - paragraph 3 - point b

Text proposed by the Commission

(b) where the potential applicant or notifier is a SME, it may notify the Authority of how it intends to address the plausible risk hypotheses referred to in point (a) that it has identified based on the properties of a plant, product or hypothetical plant or product, including the design of the studies it intends to perform in accordance with the requirements laid down Parts 2 and 3 of Annex II. The Authority shall provide advice on the notified information, including on the design of the studies.

Amendment

(b) where the potential applicant or notifier is a micro or small enterprise, it may notify the Authority of how it intends to address the plausible risk hypotheses referred to in point (a) that it has identified based on the properties of a plant, product or hypothetical plant or product, including the design of the studies it intends to perform in accordance with the requirements laid down Parts 2 and 3 of Annex II. The Authority shall provide advice on the notified information, including on the design of the studies.

Amendment 115
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 22 - paragraph 4 - point c

Text proposed by the Commission

(c) the Authority shall make public without delay a summary of the pre-submission advice once an application or notification has been considered valid. Articles 38(1a) shall apply mutatis mutandis;

Amendment

(c) the Authority shall make public without delay the pre-submission advice once an application or notification has been considered valid. Articles 38(1a) shall apply mutatis mutandis;

Amendment 116
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 22 - paragraph 5 - point a

Text proposed by the Commission

(a) the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the category 2 NGT plant meet the conditions referred to in paragraph 1;

Amendment

(a) the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the NGT plant meet the conditions referred to in paragraph 1;

Amendment 117
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 22 - paragraph 5 - point b

Text proposed by the Commission

(b) where applicable, the information necessary to demonstrate the (potential) applicant or notifier is a SME;

Amendment

(b) where applicable, the information necessary to demonstrate the (potential) applicant or notifier is a micro, small or medium enterprise;

Amendment 118
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 22 - paragraph 8 - introductory part

Text proposed by the Commission

8. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the lists of traits of NGT plants laid down in Annex III in order to adapt them to scientific and technological progress and to new evidence relating to the impact on sustainability of those traits, subject to the following conditions:

Amendment

8. The Commission may adopt a legislative proposal amending the lists of traits of NGT plants laid down in Annex III in order to adapt them to scientific and technological progress and to new evidence relating to the impact on sustainability of those traits, subject to the following conditions:

Amendment 119
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 23 - title

Text proposed by the Commission

Labelling of authorised category 2 NGT products

Amendment

Labelling of authorised NGT products

Amendment 120
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 23 - paragraph 1

Text proposed by the Commission

In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, and without prejudice to the requirements under other Union legislation, the labelling of authorised category 2 NGT products may also mention the trait(s) conveyed by the genetic modification, as specified in the consent or the authorisation pursuant to Sections 2 or 3 of Chapter III of this Regulation.

Amendment

In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, and without prejudice to the requirements under other Union legislation, the labelling of authorised NGT products may also mention the trait(s) conveyed by the genetic modification, as specified in the consent or the authorisation pursuant to Sections 2 or 3 of Chapter III of this Regulation. This information needs to be evidence-based and needs to be accompanied by the statement that sustainable agriculture needs to be seen in a holistic manner and sustainability cannot be captured in a specific trait.

Amendment 121
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 24 - title

Text proposed by the Commission

Measures to avoid the unintended presence of category 2 NGT plants

Amendment

Measures to avoid the unintended presence of NGT plants

Amendment 122
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 24 - paragraph 1

Text proposed by the Commission

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 1829/2003.

Amendment

Member States shall take appropriate measures to avoid the unintended presence of NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003. This shall incude legally binding buffer zones of no less than 2 kilometer between NGT crops and conventional crops and of no less than 5 kilometer between NGT crops and organic crops. It shall also include detailed legally binding meassure to avoid cross contamination further in the food chain, an enforcement plan and appropriately dissuasive penalties.

Amendment 123
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 24 - paragraph 1 a (new)

Amendment

Member States shall set up a public register in which the all locations where NGT plants are bred or cultivated are shown, described by means of latitude and longitude coordinates corresponding to at least one latitude and one longitude point and using at least six decimal digits.

Amendment 124
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 24 - paragraph 1 b (new)

Amendment

Member States shall introduce liability schemes in order to ensure that the costs of cross-contamination of conventional and organic operators with NGTs are born by the operator that released the NGT into the environment. The latter shall also bear the burden of proof.

Amendment 125
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 24 - paragraph 1 c (new)

Amendment

Where operators cultivate NGT crops, they will make this visible to the public by putting up information signs in their field which should be clearly legible.

Amendment 126
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 25

Text proposed by the Commission

Article 25

Cultivation

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

Amendment

deleted

Amendment 127
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 26

Text proposed by the Commission

Article 26

Exercise of the delegation

1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt the delegated acts referred to in Article 5(3) and Article 22(8) 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.

3. The delegations of power referred to in Article 5(3) and Article 22(8) 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.

4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(⁶¹ ).

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Articles Article 5(3) and Article 22(8) 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.

⁶¹ OJ L 123, 12.5.2016, p. 1.

Amendment

deleted

Amendment 128
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 27 - paragraph 1 - point b

Text proposed by the Commission

(b) the preparation and the presentation of the verification requests referred to in Articles 6 and 7;

Amendment

deleted

Amendment 129
Anja Hazekamp, Clare Daly, Manon Arubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 27 - paragraph 1 - point c

Text proposed by the Commission

(c) the methodology and information requirements for the environmental risk assessment of category 2 NGT plants and the safety assessments of category 2 NGT food and feed, in accordance with the principles and criteria laid down in Annex II;

Amendment

(c) the methodology and information requirements for the environmental risk assessment of NGT plants and the safety assessments of NGT food and feed, in accordance with the principles and criteria laid down in Annex II;

Amendment 130
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 27 - paragraph 1 - point e

Text proposed by the Commission

(e) adapted modalities to comply with analytical method requirements referred to in Article 14(1), point (l), and Article 19(2).

Amendment

deleted

Amendment 131
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 28 - paragraph 2

Text proposed by the Commission

2. Where reference is made to this paragraph, Article 4 of Regulation (EC) No 182/2011 shall apply.

Amendment

deleted

Amendment 132
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 30 - paragraph -1 (new)

Amendment

-1. By 31 December 2024, the Commission shall present a report on the issue of patents in the food chain, and their effects on food security, freedom of choice for farmers and consumers, increased corporate control in the plant breeding sector and monopolisation of our food. The Commission shall accompany this report with a legislative proposal to amend the intellectual property legislation to prohibit the use of patents on living organisms, genes, traits and breeding techniques.

Amendment 133
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 30 - paragraph 1

Text proposed by the Commission

1. No sooner than three years after the first decision is adopted in accordance with Article 6(8) or (10) or Article 7(6) or in accordance with Sections 2 or 3 of Chapter III, whichever is the earliest, and thereafter every five years, the Commission shall forward to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Regulation.

Amendment

1. No later than three years after the first decision is adopted in accordance with Article 6(8) or (10) or Article 7(6) or in accordance with Sections 2 or 3 of Chapter III, whichever is the earliest, and thereafter every three years, the Commission shall forward to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Regulation.

Amendment 134
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 30 - paragraph 2 a (new)

Amendment

2 a. The report shall address the possible negative effects on biodiversity, environment and health, the impact on the organic value chain, the trust and freedom of choice of citizens.

Amendment 135
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 30 - paragraph 2 b (new)

Amendment

2 b. The report shall address invasiveness, allergenic potential, impacts on non targeted organisms and the effects of NGTs in the use and risk of pesticides and fertilisers.

Amendment 136
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 31 - paragraph 1

Text proposed by the Commission

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

Amendment

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

Amendment 137
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 32 - paragraph 1

Text proposed by the Commission

Amendment

Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any natural or legal person with sufficient interest. Any non-governmental organisation promoting environmental protection and the protection of health, and meeting any requirements under national law shall be deemed to have sufficient interest.

Amendment 138
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 32 - paragraph 3

Text proposed by the Commission

The Commission shall prepare a draft decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.

Amendment

The Commission shall prepare a draft decision within one months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.

Amendment 139
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 32 a (new)

Amendment

Article32a

Access to justice

1. Any natural or legal person having sufficient interest shall have access to a court or other independent and impartial public body competent to review the procedural and substantive legality of the decisions, plans, permits, acts or failure to act of the competent authority under this Regulation. Any non-governmental organisation promoting environmental protection and the protection of human health, and meeting any requirements under national law shall be deemed to have sufficient interest.

2. Access to a court or other independent and impartial public body pursuant to paragraph 1 shall be fair, equitable, timely and not prohibitively expensive and provide adequate and effective remedies, including injunctive relief where appropriate. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.

Amendment 140
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 32 b (new)

Amendment

Article32b

Compensation

1. Member States shall ensure that, where damage to health, the environment or GMO-free food and feed chains has occurred as a result of a violation of the provisions of this Regulation, the individuals affected have the right to claim and obtain compensation for that damage from the relevant natural or legal persons and, where appropriate, from the relevant competent authorities responsible for the violation.

2. Member States shall ensure that, as part of the public concerned, non-governmental organisations promoting the protection of health or the environment and meeting any requirements under national law are allowed to represent the individuals affected and bring collective actions for compensation. Member States shall ensure that a claim for a violation leading to a damage cannot be pursued twice, by the individuals affected and by the non-governmental organisations referred to in this paragraph.

Amendment 141
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 33
Regulation (EU) 2017/625
Article 23

Text proposed by the Commission

Article 33

Amendments to Regulation (EU) 2017/625

Article 23 of Regulation (EU) 2017/625 is amended as follows:

(1) in paragraph 2, point (a)(ii) is replaced by the following:

(ii) the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];;

(2) in paragraph 3, point (b) is replaced by the following:

(b) the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];.

Amendment

deleted

Amendment 142
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Article 34 - paragraph 2 - subparagraph 1

Text proposed by the Commission

It shall apply from [24 months from the date of entry into force of this Regulation].

Amendment

It shall apply from [48 months from the date of entry into force of this Regulation].

Amendment 143
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex I

Text proposed by the Commission

Criteria of equivalence of NGT plants to conventional plants

A NGT plant is considered equivalent to conventional plants when it differs from the recipient/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 tools.

(1) substitution or insertion of no more than 20 nucleotides;

(2) deletion of any number of nucleotides;

(3) on the condition that the genetic modification does not interrupt an endogenous gene:

(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool;

(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool;

(4) targeted inversion of a sequence of any number of nucleotides;

(5) any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points (1) and/or (2)) in a species from the breeders’ gene pool.

Amendment

deleted

Amendment 144
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - subheading 1

Text proposed by the Commission

Risk assessment of category 2 NGT plants and category 2 NGT food and feed

Amendment

Risk assessment of NGT plants and NGT food and feed

Amendment 145
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - paragraph 1

Text proposed by the Commission

Part 1 of this Annex describes the general principles to be followed to perform the environmental risk assessment of category 2 NGT plants referred to in Article 13, points (c) and (d), Article 14(1), point (e), and Article 19(3), point (a), and the safety assessment of category 2 NGT food and feed referred to in Article 19(1), point (b). Part 2 describes specific information for the environmental risk assessment of category 2 NGT plants and Part 3 describes specific information for the safety assessment of category 2 NGT food and feed.

Amendment

Part 1 of this Annex describes the general principles to be followed to perform the environmental risk assessment of NGT plants referred to in Article 13, points (c) and (d), Article 14(1), point (e), and Article 19(3), point (a), and the safety assessment of NGT food and feed referred to in Article 19(1), point (b). Part 2 describes specific information for the environmental risk assessment of NGT plants and Part 3 describes specific information for the safety assessment of NGT food and feed.

Amendment 146
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 1 - paragraph 2 - introductory part

Text proposed by the Commission

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 considered include:

Amendment

The type and amount of information necessary for the environmental risk assessment of NGT plants laid down in Annex III of Directive 2001/18/EC and for the food and feed safety assessment of NGT food and feed could be adapted to their risk profile. Factors to be considered include:

Amendment 147
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 1 - paragraph 2 - point e a (new)

Amendment

(e a) The cultivation in the European Union of similar non-GMO plants and the risks of cross-contamination

Amendment 148
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 1 - paragraph 3 - introductory part

Text proposed by the Commission

The environmental risk assessment of category 2 NGT plants and the risk assessment of category 2 NGT food and NGT feed shall consist of the following:

Amendment

The environmental risk assessment of NGT plants and the risk assessment of NGT food and NGT feed shall consist of the following:

Amendment 149
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 1 - paragraph 3 - point a

Text proposed by the Commission

(a) hazard identification and characterisation;

Amendment

(a) problem formulation including hazard identification and characterisation;

Amendment 150
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 1 - paragraph 3 - point b

Text proposed by the Commission

(b) exposure assessment;

Amendment

(b) exposure characterisation and assessment

Amendment 151
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 1 - paragraph 3 - point c a (new)

Amendment

(c a) socio-economic assessment of the consequences of cross-contamination of the NGT plant to non-GMO plants and products thereof

Amendment 152
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallaca

Proposal for a regulation
Annex II - part 1 - paragraph 3 - point c b (new)

Amendment

(c b) risk management strategies

Amendment 153
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - part 1 - paragraph 3 - point c c (new)

Amendment

(c c) overall risk evaluation

Amendment 154
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 1 - paragraph 4 - point a - paragraph 1

Text proposed by the Commission

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 or bioinformatic studies.

Amendment

The information shall be provided by collating already available data from scientific literature and from other sources, generating scientific data where necessary by performing appropriate experimental or bioinformatic studies.

Amendment 155
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - part 1 - paragraph 4 - point b - paragraph 1

Text proposed by the Commission

Information shall be provided 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

Information shall be provided on the likelihood of each identified potential adverse effect, for all expose routes to humans, animals and the environment. This shall be evaluated taking into consideration 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 156
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 1 - paragraph 4 - point c - paragraph 1

Text proposed by the Commission

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 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.

Amendment

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 be characterised by combining, for each potential adverse effect and for each specific protection goal, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk. The uncertainty for each identified risk shall be described.

Amendment 157
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 1 - paragraph 5

Text proposed by the Commission

Any information on hazard identification and characterisation specified under Parts 2 and 3 shall only be required if the specific characteristics and the intended use of the category 2 NGT plant or category 2 NGT food or feed give rise to a plausible risk hypothesis that can be addressed utilising the specified information.

Amendment

deleted

Amendment 158
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 2 - point 6 a (new)

Amendment

(6 a) Impacts on organic cultivation

Amendment 159
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - part 2 - point 8 a (new)

Amendment

(8 a) Effects on protecting and conserving biodiversity

Amendment 160
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 2 - point 8 b (new)

Amendment

(8 b) Effects on protecting ecologically sensitive areas

Amendment 161
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 2 - point 8 c (new)

Amendment

(8 c) Socio-economic effects on the food chain

Amendment 162
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 3 - point 1 a (new)

Amendment

(1 a) Analysis of the potential for persistence and invasiveness resulting from transport, loss, and spillage

Amendment 163
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex II - Part 3 - point 2

Text proposed by the Commission

(2) Toxicology

Amendment

(2) Toxicology and ecotoxicology

Amendment 164
Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex III - part 1 - paragraph 1 - point 4

Text proposed by the Commission

(4) more efficient use of resources, such as water and nutrients;

Amendment

(4) evidence-based
more efficient use of resources, such as water and nutrients;

Amendment 165
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation
Annex III - Part 1 - paragraph 1 - point 7

Text proposed by the Commission

(7) reduced need for external inputs, such as plant protection products and fertilisers.

Amendment

(7) a proven reduced need for external inputs, such as chemical pesticides and fertilisers.

Amendment 166
Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallaca

Proposal for a regulation
Annex III - Part 2 - paragraph 1

Text proposed by the Commission

Traits excluding the application of the incentives referred to in Article 22: tolerance to herbicides.

Amendment

Traits excluding the application of the incentives referred to in Article 22:

- tolerance to herbicides,

- tolerance to antimicrobials,

- plants containing the endospore (or crystal) toxins of the Bacillus thuringiensis (Bt) be resistant to certain insect pests

- patents on the plant, trait(s) or technique used,

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Anja Hazekamp

Lid van het Europees Parlement

Amen­de­menten Hazekamp over planten verkregen met bepaalde nieuwe geno­mi­ca­tech­nieken en levens­mid­delen en dier­voeders daarvoor, en tot wijziging van Veror­dening (EU) 2017/625

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Amendementen Hazekamp over planten verkregen met bepaalde nieuwe genomicatechnieken en levensmiddelen en diervoeders daarvoor, en tot wijziging van Verordening (EU) 2017/625