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CoR amendment

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(2). 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(3) and of the 'Farm to Fork'(4), Biodiversity(5) and Adaptation to Climate Change(6) Strategies, to global food security(7), the Bioeconomy Strategy(8) and to the Union's strategic autonomy(9).

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(2). This includes plants with potentially improved tolerance or resistance to plant diseases and pests or tolerance to herbicides , plants with potentially improved tolerance or resistance to climate change effects and environmental stresses, improved nutrient and water-use efficiency, plants with higher yields and resilience and improved quality characteristics. Thus, NGTs might have the potential to contribute to the innovation and sustainability goals of the European Green Deal(3) and of the 'Farm to Fork'(4), Biodiversity(5) and Adaptation to Climate Change(6) Strategies, to global food security(7), the Bioeconomy Strategy(8) and to the Union's strategic autonomy(9). However, a significant number of NGTs in the pre-commercial stage relate to pesticide tolerance. Increased herbicide use resulting from NGT cultivation in the European Union must be avoided. Additionally, the different action pathways to fulfil the objectives of the European Green Deal(3) and of the 'Farm to Fork'(4), Biodiversity(5) and Adaptation to Climate Change(6) Strategies, global food security(7), the Bioeconomy Strategy(8) and the Union's strategic autonomy(9), must not undermine one another.

Text proposed by the European Commission

CoR amendment

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

Text proposed by the European Commission

CoR amendment

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

Text proposed by the European Commission

CoR amendment

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

Text proposed by the European Commission

CoR amendment

The European Green Deal and the 'Farm to Fork' and EU Biodiversity Strategies put organic farming at the core of a transition to sustainable food systems, with a target of expanding European agricultural land under organic production to 25 % by 2030. This is a clear recognition of the environmental benefits of organic farming, for less dependency on inputs for farmers, and a resilient food supply and food sovereignty. This Regulation must not adversely undermine the pathway to a transition of European food systems to organic farming to 25 % by 2030.

Text proposed by the European Commission

CoR amendment

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 (10) of the European Parliament and of the Council and, in the case of food and feed, also to Regulation (EC) No 1829/2003 (11), 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').

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 (10) of the European Parliament and of the Council and, in the case of food and feed, also to Regulation (EC) No 1829/2003 (11), 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’) , in line with the Cartagena Protocol on Biosafety .

Text proposed by the European Commission

CoR amendment

In its judgment in case C-528/16 Confédération paysanne and Others (12) the Court of Justice of the European Union held that GMOs obtained by means of new techniques/methods of mutagenesis that had appeared or had been mostly developed since Directive 2001/18/EC was adopted could not be considered excluded from the scope of that Directive.

In its judgment in case C-528/16 Confédération paysanne and Others (12) the Court of Justice of the European Union held that GMOs obtained by means of new techniques/methods of mutagenesis that had appeared or had been mostly developed since Directive 2001/18/EC was adopted could not be considered excluded from the scope of that Directive , as the new mutagenesis techniques/methods have a comparable risk potential to the production of transgenic plants. In accordance with the precautionary principle, the regulations of the Genetic Engineering Law would therefore have to be applied (Article 2(2) of Directive 2001/18; recitals 4, 8 and 25). These organisms and all products derived from them must therefore be subject to a comprehensive safety assessment for humans, animals and the environment before being placed on the market. Likewise, they must be traceable and labelled.

Text proposed by the European Commission

CoR amendment

The European Committee of the Regions, in its opinion NAT-VII/033 ‘Legislative framework for sustainable food systems’ expressed its concern about a possible re-introduction of genetically modified organisms (GMOs) in our European food with the future European regulation proposal on plants produced by new genomic techniques (NGTs). This should be based on a robust assessment and sound scientific evidence from the European Food Safety Authority (EFSA). In any case, every food product containing GMOs should show a front-of-the-pack label indicating the presence of GMOs.

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CoR amendment

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.

Text proposed by the European Commission

CoR amendment

The European Parliament has called(  (13a) 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.

Text proposed by the European Commission

CoR amendment

The Commission's study on new genomic techniques(14) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can be disproportionate or inadequate . The study showed that this is particularly the case for plants obtained by these techniques, given the amount of scientific evidence that is already available, in particular on their safety. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products. In certain cases, genetic modifications introduced by these techniques are indistinguishable with analytical methods from natural mutations or from genetic modifications introduced by conventional breeding techniques, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The Union GMO legislation is also not conducive to developing innovative and beneficial products that could contribute to sustainability, food security and resilience of the agri-food chain.

The Commission's study on new genomic techniques(14) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can be inconducive to the cultivation and release of GMOs into the environment and their placing on the market . The study showed that this is particularly the case for plants obtained by these techniques, given the amount of scientific evidence that is already available, in particular on their safety. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products. In certain cases, until the present day, genetic modifications introduced by these techniques can be considered indistinguishable with analytical methods from natural mutations or from genetic modifications introduced by conventional breeding techniques, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The development of detection methods in the foreseeable future is considered highly probable by scientists and experts. Research and scientific knowledge in the field of genetic engineering and detection technologies are consistently expanding. Further research is necessary to accelerate the development of analytical detection methods. The existence of detection methods is not a prerequisite for traceability. Several existing quality schemes and labels rely on documentary traceability, for which no detection methods are presently available or required.

Text proposed by the European Commission

CoR amendment

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 the purposes of democracy, citizens need to have a say on which public values are incorporated in a new policy for NGTs.

Text proposed by the European Commission

CoR amendment

One of the few studies that have been performed to investigate the attitude of the public, concluded(  (15a) 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 fewer 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.

Text proposed by the European Commission

CoR amendment

This regulation must align with Article 169 of the Treaty on the Functioning of the European Union, which lays down the principle of consumer protection, in seeking to protect consumers' health, safety and economic interests, and promote their right to information.

Text proposed by the European Commission

CoR amendment

The precautionary principle, as enshrined in Article 191 of the Treaty on the Functioning of the European Union, seeks to ensure a higher level of environmental protection and consumer health in the context of food, as well as human, animal, and plant health, through preventative decision-making in the case of risks. This Regulation must align with the precautionary principle, particularly as NGT plants are intended to be released and cultivated in the environment.

Text proposed by the European Commission

CoR amendment

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.

It is therefore necessary to adopt a specific legal framework for GMOs obtained by targeted mutagenesis and cisgenesis and related products when deliberately released into the environment or placed on the market , while maintaining the central principles of GMO legislation that has been in place for over 20 years: sound information and freedom of choice for consumers and farmers, risk assessment and monitoring by health authorities, precautionary principle and reversibility, and coexistence of sectors. A periodic review of the approach to establishing equivalence to conventional breeding methods is required in order to reflect scientific and technological progress.

Text proposed by the European Commission

CoR amendment

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.

The legal framework for NGT plants should share the objectives of the Union GMO legislation to ensure a high level of protection of human and animal health and of the environment, based on the precautionary principle detailed in Article 191 of the Treaty on the Functioning of the European Union, and the good functioning of the internal market for the concerned plants and products, while addressing the specificity of NGT plants. The precautionary principle should be fully implemented to ensure adequate risk assessment and monitoring frameworks for the release of NGT plants into the environment. This legal framework should enable the development and placing on the market of plants, food and feed containing, consisting of or produced from NGT plants and other products containing or consisting of NGT plants ('NGT products') so as to contribute to the innovation and sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and to enhance the competitiveness of the Union agri-food sector at Union and world level.

Text proposed by the European Commission

CoR amendment

The issue of patents on genetic material, plant traits, and characteristics associated with genetic engineering, extending to conventionally bred varieties, must not be disconnected from the new regulatory framework on NGTs. This Regulation aims to facilitate field trials, cultivation, and market placement in the European Union for NGT plants and products, a development anticipated to exacerbate existing challenges impeding the unfettered circulation of genetic material and breeding innovation in Europe. Considering the economic potential of the European SME breeding sector and the importance of reversing genetic erosion in plant breeding for biodiverse and resilient outcomes, innovation in the European breeding sector must be safeguarded. Given that all plant reproductive material modified with genetic engineering (including NGTs) can be assumed to be subject to patents, mandatory traceability provisions for both category 1 and 2 NGT plants and products serve as crucial temporary safeguards. These provisions assist in identifying whether such genetically engineered plants or products have been utilised or introduced throughout the entire supply chain.

Text proposed by the European Commission

CoR amendment

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

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CoR amendment

Organic and conventional operators should be entitled to the right and freedom to abstain from using NGTs in their production processes and throughout their supply chain. This Regulation must provide adequate provisions to ensure operators have the freedom to choose not to use both category 1 and 2 NGT plants and seeds in their production processes. Any additional financial and legal burdens to maintain the GMO and NGT-free status of production should not be imposed on farmers and operators who choose not to use NGTs. Economic losses resulting from the inadvertent presence of GMOs should not be borne by NGT-free conventional and organic operators. Given the challenges in establishing causes, faults, and responsibilities in most cases of adventitious presence, this Regulation should establish coexistence measures, forming the foundation for national liability provisions and compensation funds.

Text proposed by the European Commission

CoR amendment

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

Text proposed by the European Commission

CoR amendment

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

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

Text proposed by the European Commission

CoR amendment

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.

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CoR amendment

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.

All NGT plants should be tested and assessed for their risks before being put on the market and prior to authorisation for cultivation on a case-by-case basis, as unexpected effects on the phenotype and agronomic characteristics of the modified plants are always possible, and that unexpected changes in the composition of the plants or the foods derived from them could also be observed, regardless of the modified trait. When the evaluation 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.

Text proposed by the European Commission

CoR amendment

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 .

Provision should be made to ensure transparency and traceability 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 indicated by a mention in the national and EU variety registers.

Text proposed by the European Commission

CoR amendment

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.

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 levels of risk that they may pose.

Text proposed by the European Commission

CoR amendment

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 intragenesis  (17) and on plants developed through targeted mutagenesis  (18) 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'  (19) , 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.

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.

Text proposed by the European Commission

CoR amendment

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.

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 lead to complex alterations requiring a 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.

Text proposed by the European Commission

CoR amendment

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.

Text proposed by the European Commission

CoR amendment

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.

To increase transparency and consumers' information, operators should label all NGT products indicating the words 'New Genomic Techniques'. If operators would like to complete the labelling with information on the trait conferred by the genetic modification, in order to avoid misleading, 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.

Text proposed by the European Commission

CoR amendment

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.

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 monitored . If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports such risks, the possibility for Member States to adopt measures restricting or prohibiting the cultivation of both categories of NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC should be enabled.

Text proposed by the European Commission

CoR amendment

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.

The special rules laid down in this Regulation concerning the authorisation procedure for category 2 NGT plants are expected to result in more cultivation in the Union of category 2 NGT plants compared to the situation so far under the current Union GMO legislation. That renders necessary for Member States' public authorities to define coexistence measures to balance the interests of producers of conventional, organic and GM plants and thereby allow producers a choice between different types of production, in line with the Farm to Fork Strategy's target of 25 % of agricultural land under organic farming by 2030. In order to ensure that the coexistence measures are consistent, the Commission should draw up an implementing act to cover, in particular, the size of buffer strips between conventional and organic plants and NGT plants, for each type of crop.

Text proposed by the European Commission

CoR amendment

To achieve the goal of ensuring the effective functioning of the internal market, EU-wide legally binding coexistence measures for category 1 and category 2 NGTs have to be adopted.

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CoR amendment

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.

In its judgment of 25 July 2018 in case C-528/1610, the Court of Justice of the European Union held that organisms obtained by means of techniques/methods of mutagenesis which have not conventionally been used in a number of applications and do not have a long safety record come within the scope of Directive 2001/18 and are, therefore, subject to the obligations arising from that directive. 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.

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CoR amendment

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

In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union, Member States must be authorised to opt-out of this regulation. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

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CoR amendment

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  (24).

Text proposed by the European Commission

CoR amendment

The issue of patents on NGTs was raised by many stakeholders during the consultation. It should be ensured that breeders have full access to the genetic material of NGT plants. As current provisions do not provide for a full breeders' exemption in patent law, it should be ensured that patents should not restrict the use of NGT plants by breeders and farmers. Access to genetic materials can best be secured when the right of patent holders is exhausted in the hand of the breeder (breeders' exemption). It should furthermore be avoided that patents are granted or patent applications can be submitted while further legal provisions on the issue would be postponed following the study that the Commission intends to do. It should therefore be ensured that NGT plant material and material resulting from a patented NGT process are excluded from patentability from the day of entry into force of this Regulation. In addition, the Commission should assess in the announced forthcoming study how the broader problem of patents being granted, directly or indirectly, on plant material despite previous efforts to close loopholes should be further addressed.

Text proposed by the European Commission

CoR amendment

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.

This Regulation corresponds to the provisions of Directive 2001/18 and extends those provisions to the deliberate release of plants obtained by certain new genomic techniques ('NGT plants'). In accordance with the precautionary principle, and with the primary objective of ensuring a high level of protection of human and animal health and the environment, 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.

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This Regulation shall not apply to:

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CoR amendment

is not covered by patents or exclusive rights and for which no application has been tabled for such patents or exclusive rights to be granted;

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CoR amendment

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:

Without prejudice to other requirements of Union law , and with strict regard to the precautionary principle , 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 the plant is a NGT plant and has been authorised in accordance with Chapter III, and if :

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an extended producer responsibility (EPR) scheme has been settled at European or national level to ensure the financing of risks and possible future damages of human health, animal health or the environment or cross-contamination of organic food and non-GMO food are financed in line with the polluter pays principle.

Text proposed by the European Commission

CoR amendment

Text proposed by the European Commission

CoR amendment

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.

Text proposed by the European Commission

CoR amendment

Where a person intends to undertake such a deliberate release simultaneously in more than one Member State, that person shall submit the verification request to the competent authority of one of those Member States .

Where a person intends to undertake such a deliberate release simultaneously in more than one Member State, that person shall submit the verification request to the competent authority of each Member State .

Text proposed by the European Commission

CoR amendment

in the cases referred to in paragraph 2, an indication of the Member States in which the requester intends to undertake the deliberate release;

Text proposed by the European Commission

CoR amendment

an environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);

Text proposed by the European Commission

CoR amendment

a monitoring plan for environmental effects as mentioned in Parts 1 and 2 of Annex II;

Text proposed by the European Commission

CoR amendment

If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within 30 working days within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within two months within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

Text proposed by the European Commission

CoR amendment

If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and Annex IV. For that purpose, the competent authority shall forward the request to the European Food Safety Authority ('The Authority') without undue delay. Within six months, the Authority shall make a statement on whether the plant is a NGT plant fulfilling the criteria set out in Annex I, including whether it contains any genetic material originating from outside the breeders' gene pool. The statement shall be forwarded to all Member States and to the Commission, and shall be made public. After receiving this statement, the competent authority shall prepare a verification report within three months from the date of receipt of the verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

Text proposed by the European Commission

CoR amendment

The other Member States and the Commission may make comments to the verification report within 20 days from the date of receipt of that report.

The other Member States and the Commission may make reasoned objections to the verification report within 20 days from the date of receipt of that report. Those reasoned objections shall solely refer to the criteria set out in Annex I and shall include a scientific justification.

Text proposed by the European Commission

CoR amendment

In the absence of any comments from a Member State or the Commission, within 10 working days from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.

In the absence of any comments from a Member State or the Commission, within one month from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.

Text proposed by the European Commission

CoR amendment

In cases where a comment is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the comment(s) to the Commission without undue delay.

In cases where a comment is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the comment(s) to the Commission and to the other Member States, without undue delay.

Text proposed by the European Commission

CoR amendment

The Commission, after having consulted the European Food Safety Authority ('the Authority'), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

The Commission, after having consulted the European Food Safety Authority ('the Authority'), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within three months from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

Text proposed by the European Commission

CoR amendment

The Commission shall publish a summary of the decisions referred to in paragraphs 8 and 10 in the Official Journal of the European Union .

Within 15 days following their full submission, the competent authority of the Member State to which the verification request was submitted and, where relevant, the Commission shall make public the verification request, the verification report referred to in paragraph 6, the comments referred to in paragraph 7 and the decisions referred to in paragraphs 8 and 10.

Text proposed by the European Commission

CoR amendment

an environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);

Text proposed by the European Commission

CoR amendment

a monitoring plan for environmental effects as mentioned in Parts 1 and 2 of Annex II;

Text proposed by the European Commission

CoR amendment

a declaration from the applicant that there are:

Text proposed by the European Commission

CoR amendment

a declaration that the placing on the market would not be in breach of the Cartagena Protocol on biosafety under the UN convention on biological diversity, and a description of how the protocol's requirements are fulfilled;

Text proposed by the European Commission

CoR amendment

a declaration that the placing on the market is in conformity with the Regulation on food information to consumers, as well as legislation on nutrition and health claims made on food, and a description of how the relevant provisions are fulfilled;

Text proposed by the European Commission

CoR amendment

a declaration on the non-applicability of Regulation (EU) 2015/2283 of 25 November 2015 on novel foods, or on the correct application of possible obligations arising from this Regulation.

Text proposed by the European Commission

CoR amendment

any other relevant information relating to the file, including possible refusal, withdrawal or acceptance of previous requests or national or European decisions.

Text proposed by the European Commission

CoR amendment

If the verification request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 30 working days within the date of receipt of a verification request. The Authority shall inform the requester, the Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

If the verification request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 60 working days within the date of receipt of a verification request. The Authority shall inform the requester, the Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

Text proposed by the European Commission

CoR amendment

If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within 30 working days from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and the Member States. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.

If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within six months from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and the Member States without undue delay. Member States may make comments on the statement within two months from the date of receipt of that statement . The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement , and where relevant, comments made by Member States, public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.

Text proposed by the European Commission

CoR amendment

The Commission shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 30 working days from the date of receipt of the statement of the Authority, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

The Commission shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within three months from the date of receipt of the statement of the Authority, taking the latter into account. Member States may make comments on the draft decision within two months from the date of receipt of that draft decision. The decision shall be adopted within the three following months, in accordance with the procedure referred to in Article 28(2).

Text proposed by the European Commission

CoR amendment

The Commission shall publish a summary of the decision in the Official Journal of the European Union .

The Commission shall make public its draft decision , the comments referred to in paragraph 6, and its decision .

Text proposed by the European Commission

CoR amendment

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

Transparency, traceability and labelling of category 1 NGT plant reproductive material, including breeding material.

Text proposed by the European Commission

CoR amendment

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.

Plant reproductive material, including for breeding and scientific purposes, as well as food, feed and other products that contains or consists of category 1 NGT plant(s) , and is made available to third parties, whether in return for payment or free of charge, shall bear mention in national variety register automatically transmitted in the EU common register provided for in PRM / FRM indicating the words 'cat 1 NGT' and shall be traceable, including for final consumers , followed by the identification number of the NGT plant(s) it has been derived from.

Text proposed by the European Commission

CoR amendment

Traceability of NGT category 1

Text proposed by the European Commission

CoR amendment

Opt-out possibility for Member States

During the authorisation procedure of a given category 1 NGT or during the renewal of authorisation, a Member State may demand that the geographical scope of the written consent or authorisation be adjusted to the effect that all or part of the territory of that Member State is to be excluded from cultivation, according to Article 26b of Directive 2001/18/EC.

Member States shall take appropriate measures to avoid the unintended presence of category 1 NGTs, including the possibility of applying the opt-out. Member States shall develop crop-specific and adapted measures, based on the latest scientific knowledge and independent science, in order to avoid the unintended presence of category 1 NGTs. Member States shall instate a strict liability system and a compensation fund to compensate operators in the event of contamination. Member States shall take the necessary measures to prevent plants subject to the opt-out being imported from third countries.

Text proposed by the European Commission

CoR amendment

Confidentiality

Text proposed by the European Commission

CoR amendment

Third parties may access confidential information on substantiated grounds based on significant damage to the environment, human or animal health. To that end, they should address a request to the national competent authority, the Commission or the Authority.

Text proposed by the European Commission

CoR amendment

Measures to avoid the unintended presence of category 1 NGT plants

Text proposed by the European Commission

CoR amendment

a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC;

Text proposed by the European Commission

CoR amendment

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.

The consent granted under Part C of Directive 2001/18/EC shall, after each renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for 10 years , unless after three renewal rounds the decision referred to in Article 17(6) or (8) provides that the renewal is for an unlimited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent.

Text proposed by the European Commission

CoR amendment

If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision.

The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter.

Text proposed by the European Commission

CoR amendment

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.

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 a period of 10 years , 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.

Text proposed by the European Commission

CoR amendment

Text proposed by the European Commission

CoR 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 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.

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, the labelling of authorised category 2 NGT products shall 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. However, if that mention falls under the qualification of an environmental claim as defined in Article 2 point (o) of Directive 2005/29/EC concerning unfair business-to-consumer commercial practices in the internal market, then it must comply with the requirements of Directive 2023/85/EC on substantiation and communication of explicit environmental claims.

Text proposed by the European Commission

CoR amendment

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 .

Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants.

Member States shall develop the definition of crop-specific and adapted measures as a matter of subsidiarity, based on the latest scientific and experiential knowledge, to avoid the unintended presence of category 2 NGTs.

Member States shall instate a strict liability system and a compensation fund to compensate operators in the event of contamination. The category 2 NGT plants should be detected, identified and quantified by analytical method.

Text proposed by the European Commission

CoR amendment

Regulation (EU) 2018/848 should be amended to align the definitions of 'plant reproductive material' and 'heterogeneous material' with the definitions provided for by this Regulation. Moreover, the empowerment for the Commission to adopt specific provisions for the marketing of PRM of organic heterogeneous material should be excluded from Regulation (EU) 2018/848, as all rules concerning the production and marketing of PRM should be set out in this Regulation for reasons of legal clarity.

Text proposed by the European Commission

CoR amendment

The objectives of this Regulation are the following:

The objectives of this Regulation are the following:

Text proposed by the European Commission

CoR amendment

This Regulation does not apply to:

This Regulation does not apply to:

Text proposed by the European Commission

CoR amendment

’professional operator' means any natural or legal person, involved professionally in one or more of the following activities in the Union concerning PRM:

’professional operator' means any natural or legal person, involved professionally in one or more of the following activities in the Union concerning PRM, intended for commercial exploitation of the PRM by the professional operator:

Text proposed by the European Commission

CoR amendment

’marketing' means the following actions conducted by a professional operator: sale, holding, transfer for free , or offering for sale or any other way of transferring or distribution within, or import into, the Union

’marketing' means the following actions conducted by a professional operator: sale, holding, or offering for sale or any other way of transferring or distribution of PRM within, or import into, the Union aimed at the commercial exploitation of the PRM;

Text proposed by the European Commission

CoR amendment

’heterogeneous material' means a plant grouping within a single botanical taxon of the lowest known rank which:

’heterogeneous material' means a plant grouping within a single botanical taxon of the lowest known rank which:

Text proposed by the European Commission

CoR amendment

’ conservation variety' means a variety that is:

’ niche variety' means a variety that is:

Text proposed by the European Commission

CoR amendment

Requirements for the production and marketing of pre-basic, basic and certified seed and material

Requirements for the production and marketing of pre-basic, basic and certified seed and material

Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 76(2), in order to adapt to the developments of the relevant international technical and scientific standards.

Text proposed by the European Commission

CoR amendment

Once a year, professional operators shall submit to the competent authority a declaration concerning the quantities per species of standard seed and material they produced.

Professional operators shall keep data about the quantities per species of standard seed and material they produced for five years.

Text proposed by the European Commission

CoR amendment

Text proposed by the European Commission

CoR amendment

By way of derogation from Article 21(1), Member States may authorise the production and marketing of a mixture of seed of various genera or species listed in Part A of Annex I, and of different varieties of those genera or species, with seed of genera or species of other parts of that Annex, or of genera or species not listed in that Annex, if that mixture fulfils all of the following conditions:

By way of derogation from Article 21(1), Member States may authorise the production and marketing of a mixture of seed of various genera or species listed in Part A of Annex I, and of different varieties of those genera or species, with seed of genera or species of other parts of that Annex, or of genera or species not listed in that Annex, if that mixture fulfils all of the following conditions:

Text proposed by the European Commission

CoR amendment

Text proposed by the European Commission

CoR amendment

By way of derogation from Article 5, PRM of heterogeneous material may be produced and marketed within the Union without belonging to a variety. The heterogeneous material shall be notified to and register by the competent authority prior to its production and/or marketing, in accordance with the requirements set out in Annex VI.

By way of derogation from Article 5, PRM of heterogeneous material of all crop species may be produced and marketed within the Union without belonging to a variety. The heterogeneous material shall be notified to the competent authority three months before marketing, in accordance with the requirements set out in Annex VI and listing should be free of cost to the supplier .

Text proposed by the European Commission

CoR amendment

The Commission is empowered to adopt a delegated act in accordance with Article 75, amending Annex VI. Those amendments may concern all, or particular genera or species only, and shall:

The Commission is empowered to adopt a delegated act in accordance with Article 75, amending Annex VI. Those amendments may concern all, or particular genera or species only, and shall:

Those amendments shall be adopted in order to adapt to the development of the respective technical and scientific evidence, and the international standards, and to follow up on the experience gained by the application of this Article concerning all or certain genera or species only .

Those amendments shall be developed through a multi-actor stakeholder consultation involved in heterogeneous material, in order to adapt to the development of the respective technical and scientific evidence, and the international standards, and to follow up on the experience gained by the application of this Article concerning all species.

Text proposed by the European Commission

Amendment

By way of derogation from Articles 5 - 12, 14, 15 and 20, PRM may be marketed to final users, if it complies with all of the following requirements:

By way of derogation from Articles 5 - 12, 14, 15 and 20, PRM may be marketed to final users, if it complies with all of the following requirements:

Text proposed by the European Commission

CoR amendment

PRM marketed to and between gene banks, organisations and networks

It can be marketed as well from those gene banks, organisations and networks to persons who carry out conservation of that PRM as final consumers, for non-profit purposes.

In the cases provided for in the first and the second subparagraphs, PRM shall fulfil the following requirements:

Text proposed by the European Commission

CoR amendment

Text proposed by the European Commission

CoR amendment

The Commission, by means of implementing acts, may authorise the Member States to impose, with regards to production and marketing of PRM, more stringent production or marketing requirements than those referred to in Articles 7 and 8, in all or part of the territory of the Member State concerned, provided that those more stringent requirements correspond to specific production conditions in, and agro-climatic needs, of that Member State in regard to the respective PRM.

The Commission, by means of implementing acts, may authorise the Member States to impose, with regards to production and marketing of PRM, more stringent production or marketing requirements than those referred to in Articles 7 and 8, in all or part of the territory of the Member State concerned, provided that those more stringent requirements correspond to specific production conditions in, and agro-climatic needs, of that Member State in regard to the respective PRM. These requirements should be proportionate in light of the costs of PRM production and marketing and the foreseen impact of these more stringent requirements.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).

Text proposed by the European Commission

CoR amendment

Professional operators, which produce PRM, shall:

Professional operators, which are not micro-enterprises , which produce PRM with the aim of commercial exploitation, shall:

[…]

[…]

This article does not apply to professional operators producing or marketing PRM in accordance with Articles 28,29 and 30.

Text proposed by the European Commission

CoR amendment

Traceability

Traceability

On request, they shall make such information available to the competent authorities.

On request, they shall make such information available to the competent authorities.

Text proposed by the European Commission

CoR amendment

Each Member State shall establish and publish, in electronic format, and shall keep updated a single national register of varieties ('national variety register') containing:

Each Member State shall establish and publish, in electronic format, and shall keep updated a single national register of varieties ('national variety register') containing:

Text proposed by the European Commission

CoR amendment

In the case of the conservation varieties referred to in Article 44(1), point (b), those registers shall indicate at least a brief summary of the officially recognised description, the initial region of their origin, their denomination and the person that maintains them.

In the case of the conservation varieties referred to in Article 44(1), point (b), those registers shall indicate at least a brief summary of the officially recognised description, the initial region of their origin, their denomination and the person that maintains them.

Text proposed by the European Commission

CoR amendment

Varieties shall be registered in a national variety register in accordance with Articles 55 to 68, only if:

Varieties shall be registered in a national variety register in accordance with Articles 55 to 68, only if:

[…]

[…]

Text proposed by the European Commission

CoR amendment

Text proposed by the European Commission

CoR amendment

Any Member State or region may, upon an application which shall be dealt with under the procedure referred to in Article 76, be authorised to prohibit the use of the variety in all or in part of its territory or to lay down appropriate conditions for cultivating the variety, particularly varieties consisting of a GMO or a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) …/… or of a category 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation ...), where it is established that the cultivation of the variety could be harmful from the point of view of plant health to the cultivation of other varieties or species; or where it has valid reasons other for considering that the cultivation of the variety in their territory presents a risk for human health or the environment.

Text proposed by the European Commission

CoR amendment

For the purpose of registering a variety in its national variety register, a competent authority shall accept, without any further examination, an official description or an official examination of the requirements for value for sustainable cultivation and use, as referred to in paragraph 1, point (a)(i), which has been produced by a competent authority of another Member State.

For the purpose of registering a variety in its national variety register, a competent authority may accept, without any further examination, an official description , an officially recognised description or an official examination of the requirements for value for sustainable cultivation and use, as referred to in paragraph 1, point (a)(i), which has been produced by a competent authority of another Member State.

Text proposed by the European Commission

CoR amendment

For the purposes of registration of organic varieties suitable for organic production as defined in Article 3(19) of Regulation (EU) 2018/848, the examination of the value for sustainable cultivation and use shall be conducted under organic conditions, in accordance with that Regulation, and in particular Article 5, points (d), (e), (f) and (g), and Article 12 thereof and Part I of Annex II to that Regulation.

The examination of the value for cultivation and use shall be conducted under organic conditions, in accordance with that Regulation, and in particular Article 5, points (d), (e), (f) and (g), and Article 12 thereof and Part I of Annex II to that Regulation.

Where competent authorities are not able to carry out an examination under organic conditions, or the examination of certain characteristics, including disease susceptibility, testing may be carried out under low-input conditions and with only the absolutely necessary for the completion of the testing treatments with pesticides and other external inputs.

For the purposes of registration of organic varieties suitable for organic production as defined in Article 3(19) of Regulation (EU) 2018/848 no exemptions from organic testing conditions should be made. For all other varieties, where competent authorities are not able to carry out an examination under organic conditions, or the examination of certain characteristics, including disease susceptibility, testing may be carried out under organic conversion or low-input conditions and with only the absolutely necessary for the completion of the testing treatments with pesticides and other external inputs. Where applicable, the Member States must report yearly to the European Commission on the reasons behind and implementation of testing under non-organic conditions, and the measures foreseen to enable this transition in future. These reports should be published annually by the European Commission.

Text proposed by the European Commission

CoR amendment

Text proposed by the European Commission

CoR amendment

By way of derogation from Article 59(2), the technical examination of whether the variety has a sustainable value for cultivation and use, in accordance with Article 52, or part of it, may be carried out by the applicant if:

By way of derogation from Article 59(2), the technical examination of whether the variety has a value for cultivation and use, in accordance with Article 52, or part of it, may be carried out by the applicant if:

Paragraph 1 does not apply in the cases where the variety:

Text proposed by the European Commission

CoR amendment

In the case of varieties of PRM intended exclusively for the production of agricultural raw materials for industrial purposes, certain elements of the technical examination and the intended uses of those varieties, whose public disclosure may affect the competitive position of the applicant, shall be treated as confidential, if that applicant requests so.

Text proposed by the European Commission

CoR amendment

After the formal examination of the application provided for in Article 57, and prior to the registration of a variety in a national variety register pursuant to Article 67, the competent authority shall consult the CPVO on the variety denomination proposed by the applicant.

After the formal examination of the application provided for in Article 57, and prior to the registration of a variety in a national variety register pursuant to Article 67, the competent authority shall consult relevant stakeholders at national level, as well as the Committee mentioned in Article 76(1) on the suitability of the variety denomination proposed by the applicant in light of the requirements of Article 54. The competent authority may also consult the CPVO, which shall submit to the competent authority a recommendation on the suitability of the variety denomination proposed by the applicant, in accordance with Article 54. The competent authority shall inform the applicant on the recommendation.

The CPVO shall submit to the competent authority a recommendation on the suitability of the variety denomination proposed by the applicant, in accordance with Article 54. The competent authority shall inform the applicant on that recommendation.

Text proposed by the European Commission

CoR amendment

Text proposed by the European Commission

CoR amendment

Amendment of Regulation (EU) 2018/848

Regulation (EU) 2018/848 is amended as follows:

[…]

Text proposed by the European Commission

CoR amendment

The national variety registers and the Union variety register shall contain all of the following elements:

The national variety registers and the Union variety register shall contain all of the following elements: