Sittings · Document

OPINION (COM(2023)0411 – C90238/2023 – 2023/0226(COD)) 2024-01-08

On the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625

Committee on Agriculture and Rural Development · Rapporteur: Veronika Vrecionová

PA_Legam

AMENDMENTs

The Committee on Agriculture and Rural Development calls on the Committee on Agriculture and Rural Development, as the committee responsible, to take the following into account:

Amendment 1

Proposal for a regulation

Title 1

Text proposed by the Commission

Amendment

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)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain precision breeding techniques and their food and feed, and amending Regulation (EU) 2017/625 and Directive 98/44/EC (Text with EEA relevance)

Amendment 2

Proposal for a regulation

Recital 1

Text proposed by the Commission

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, significant progress in biotechnology has led to the development of new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations.

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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 3

Proposal for a regulation

Recital 2

Text proposed by the Commission

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 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.

(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 targeted 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 4

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(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.

(8) Therefore, category 1 NGT plants and products obtained by targeted mutagenesis and cisgenesis and related 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. Targeted mutagenesis and cisgenesis to obtain Category 1 NGT plants and products should be exempted in Directive 2001/18/EC Annex 1 B like mutagenesis and cell fusion. A periodic review of the approach to establishing equivalence to conventional breeding methods is required in order to reflect scientific and technological progress.

Amendment 5

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(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 time.

(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. For other organisms, such as microorganisms, the available knowledge will be reviewed in view of a future proposal. 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, the wider GMO legislation should be examined in view of the Commission conclusion that it is no longer fit for purpose to ensure that requirements are science-based and proportional to the risk.

Justification

The Explanatory Memorandum notes that “The Union risks being excluded to a significant extent from the technological developments and economic, social and environmental benefits that these new technologies can potentially generate, if its GMO framework is not adapted to NGTs. In turn, this would lead to less strategic autonomy for the Union. Therefore, the Union’s regulatory framework should be adapted to make NGTs subject to the appropriate level of regulatory oversight.” It is therefore relevant to make similar legislation on microorganisms.

Amendment 6

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(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.

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny (‘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 fulfilment 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, extent, dimensions and number of genetic modifications that can occur in nature or through conventional breeding.

Amendment 7

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(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.

(16) 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. NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny (‘category 1 NGT plants’) should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques.

Amendment 8

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(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.

(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 and prior to the placing on the market of NGT products should be conducted by national competent authorities as this would be less administratively burdensome for operators. The verification procedure of category 1 NGT plant status should be conducted at national level based on the scientific opinion of the European Food Safety Authority (‘the Authority’) only if there are reasoned scientific objections by other Member States in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Amendment 9

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(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.

(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. The information listed shall include information on the technique(s) used to obtain the trait(s).

Amendment 10

Proposal for a regulation

Recital 23

Text proposed by the Commission

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, 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.

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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 11

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(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.

(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 indicated by a mention in the national catalogues and/or common catalogue of varieties of agricultural plant species , including information on the technique(s) used to obtain the trait(s).

Amendment 12

Proposal for a regulation

Recital 29 a (new)

Text proposed by the Commission

Amendment

(29a) After the successful authorisation of a category 1 NGT plant based on scientific criteria, the authorisation should be valid for an unlimited period.

Amendment 13

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

(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.

(30) For reasons of proportionality, after a first renewal of the authorisation of a category 2 NGT plant, 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 category 2 NGT plant concerned, subject to reassessment when new information has become available.

Amendment 14

Proposal for a regulation

Recital 32

Text proposed by the Commission

Amendment

(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.

(32) To increase transparency and consumers’ information, operators should be allowed to complement the labelling of category 2 NGT products with information on the trait conferred. 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.

Justification

NGTs should not be labelled as GMOs, but as NGTs.

Amendment 15

Proposal for a regulation

Recital 36

Text proposed by the Commission

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. 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].

deleted

Amendment 16

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(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.

(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 NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC would undermine those goals.

Amendment 17

Proposal for a regulation

Recital 38

Text proposed by the Commission

Amendment

(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.

(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 for category 2NGT plants 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 18

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

(39) To achieve the goal of ensuring the effective functioning of the internal market, NGT plants and related products should benefit from the free movement of goods, provided they comply with the requirements of other Union law.

(39) To achieve the goal of ensuring the effective functioning of the internal market and the free movement of NGT plant products across the Union, the deliberate release of NGT plants and placing on the market of NGT products should be based on the harmonized requirements and procedures laid down in this Regulation, leading to the adoption of a decision uniformly applicable to all Member States. Member States should not unilaterally derogate from the provisions set out in this Regulation in a way that would restrict, prohibit or hinder the free movement, placing on the market and deliberate release of NGT plants or related products within the territory of the Union.

Amendment 19

Proposal for a regulation

Recital 40

Text proposed by the Commission

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 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.

(40) Given the novelty of the NGTs, it will be important to monitor closely the development and presence on the market of category 2 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 category 2 NGT plants or category 2 NGT products in the Union, the Commission should carry out an evaluation of this Regulation to measure the progress made towards the availability of category 2 NGT plants containing such characteristics or properties on the EU market with the aim of further improving the Regulation

Amendment 20

Proposal for a regulation

Recital 45 a (new)

Text proposed by the Commission

Amendment

(45 a) The European Parliament has called for the EU and its Member States not to grant patents on biological material and to safeguard the freedom to operate and the breeder’s exemption for varieties. It should be ensured that breeders have full access to the genetic material of NGT plants, which by definition are not transgenic plants. Access to genetic materials can best be secured when the right of patent holders is exhausted in the hand of the breeder (breeder’s exemption). As current provisions do not provide for a full breeder’s exemption in patent law, it should be ensured that patents should not restrict the use of NGT plants by breeders and farmers. Hence, these plants should not be subject to patent legislation, but should for the protection of intellectual property solely be subject to the Community Plant Variety Rights (CPVR) system, as laid down in Council Regulation (EC) No 2100/94, which allows the use of the breeder’s exemption. NGT plants, their derived seed, their plant material, associated genetic material such as genes and gene sequences, and plant traits should therefore be excluded from patentability. The exclusion from patentability should be applied in a consistent manner across legislation. Furthermore, in order to avoid that patents are being granted or patent applications can be submitted while further legal provisions on the issue would be postponed, it should be ensured that the plant material is excluded from patentability from the day of entry into force of this Regulation. In addition, the Commission in the announced forthcoming study should assess how the broader problem of patents being granted, directly or indirectly, on plant material despite previous efforts to close loopholes, should be further addressed. The assessment should address in particular the role and impact of patents on breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, as well as on innovation and particularly on the opportunities for SMEs. The Commission should present its report no later than 2026, accompanied by the appropriate legislative proposals in order to ensure further necessary changes to the framework for intellectual property rights.

Amendment 21

Proposal for a regulation

Recital 46 a (new)

Text proposed by the Commission

Amendment

(46 a) Member States should organise factual public information campaigns regarding the safety and the benefits of plants obtained through new genomic techniques, with a particular emphasis on category 1 NGT plants. Member States should aim to dispel myths and misconceptions about new genomic techniques as well as to counteract disinformation and misinformation on this subject via these public information campaigns or by other means. The Commission should provide assistance and guidelines to Member States in this respect, upon request.

Amendment 22

Proposal for a regulation

Article 3 – point 2

Text proposed by the Commission

Amendment

(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;

(2) ‘NGT plant’ means a plant as defined in Article 2 point (1) of Regulation (EU) 2016/2031 (1a) 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 gene pool for breeding purposes that temporarily may have been inserted during the development of the NGT plant;

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1a Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants

Amendment 23

Proposal for a regulation

Article 3– point 4

Text proposed by the Commission

Amendment

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

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

Amendment 24

Proposal for a regulation

Article 3– point 6

Text proposed by the Commission

Amendment

(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;

(6) ‘gene pool for breeding purposes’ 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 25

Proposal for a regulation

Article 3– point 6 a (new)

Text proposed by the Commission

Amendment

(6a) 'Polyploidy' means the presence of more than two genomes in a single cell;

Amendment 26

Proposal for a regulation

Article 3– point 7 – point b

Text proposed by the Commission

Amendment

(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;

(b) is progeny of the NGT plant(s) referred to in point (a), including progeny derived by crossing of such plants, or progeny that has undergone further modifications and fulfils the criteria of equivalence to conventional plants, set out in Annex I;

Justification

Breeders constantly improve on commercial varieties, in order to reach incremental productivity gains over time. This provision is not future-proof and would greatly limit the range of what could be achieved when combining complex traits, like drought tolerance with disease resistance.

Amendment 27

Proposal for a regulation

Article 3 – point 7 – point b a (new)

Text proposed by the Commission

Amendment

(b a) for which it is not feasible to provide an analytical method that detects, identifies and quantifies;

Justification

The proposal suggests that for certain Category 2 NGT plants no, or only an adapted, identification method can be developed. However, as they are regulated GMOs, these plants will not be fully identifiable or distinguishable from conventional plants, which makes it a specific challenge for imports where it is not possible to identify unauthorised NGTs with Category 2 changes. It is therefore discriminatory to require GM traceability and labelling of such products. Consequently, such Category 2 NGT plants should logically be treated as Category 1 NGT plants (conventional-like).

Amendment 28

Proposal for a regulation

Article 3 – point 12

Text proposed by the Commission

Amendment

(12) ‘NGT product’ means a product, other than food and feed, containing or consisting of a NGT plant and food and feed containing, consisting of or produced from such a plant;

(12) ‘NGT product’ means food and feed containing, consisting of or produced from NGT plants, and other products containing or consisting of such plants;

Amendment 29

Proposal for a regulation

Article 4 – point 2

Text proposed by the Commission

Amendment

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

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

Amendment 30

Proposal for a regulation

Article 4 - paragraph 1a (new)

Text proposed by the Commission

Amendment

(1 a) The implementation, enforcement and application of this Regulation shall not have the object or effect of preventing or impeding imports from third countries of NGT plants and products that meet the same standards as those laid down in this Regulation.

Amendment 31

Proposal for a regulation

Article 4 a (new)

Text proposed by the Commission

Amendment

Article 4a

Exclusion from patentability

NGT plants, plant material and parts thereof shall not be patentable.

Amendment 32

Proposal for a regulation

Article 5 – paragraph 1

Text proposed by the Commission

Amendment

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

1. The rules which apply to organisms that result from the application of techniques of genetic modification listed in Annex I B to Directive 2001/18/EC shall also apply to category 1 NGT plants.

Amendment 33

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

(1a) Category 1 NGT plants shall be subject to the same legal framework as conventionally bred plants, in particular with regard to plant breeders’ rights and to self-propagation.

Amendment 34

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission

Amendment

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.

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. Seven years after the entry into force of this Regulation, the Commission shall present a report on the evolution of the consumers' and producers' perception, accompanied, if appropriate, by a legislative proposal to lift the ban on the use of NGTs in organic production.

Amendment 35

Proposal for a regulation

Article 5 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Category 1 NGT plants and products obtained from or by such plants shall not be subject to coexistence measures established under Article 24 of this Regulation or Regulation 1829/2003.

Justification

As no specific coexistence measures exist between conventional and organic production systems, and as Cat1 NGT plants are conventional-like, no coexistence measures are needed.

Amendment 36

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

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.

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, extent, dimensions and number of modifications which can occur naturally or through conventional breeding.

Amendment 37

Proposal for a regulation

Article 6 – title

Text proposed by the Commission

Amendment

Verification procedure of category 1 NGT plant status prior to the deliberate release for any other purpose than placing on the market

Verification procedure of category 1 NGT plant status.

Amendment 38

Proposal for a regulation

Article 6 – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c) a description of the trait(s) and characteristics which have been introduced or modified including information on the technique(s) used to obtain the trait(s);

Justification

To align with previous amendments on information in the database - see recital 23.

Amendment 39

Proposal for a regulation

Article 6 – paragraph 4

Text proposed by the Commission

Amendment

4. The competent authority shall acknowledge receipt of the verification request to the requester without undue delay, stating the date of receipt. It shall make available the request to the other Member States and to the Commission without undue delay.

4. The competent authority shall acknowledge receipt of the verification request to the requester within 10 working days, stating the date of receipt. It shall make available the request to the other Member States and to the Commission within 10 working days.

Justification

The timeline should be more predictable with firm number of days to make it easier for particularly SMEs to know the length of the process.

Amendment 40

Proposal for a regulation

Article 6 – paragraph 5

Text proposed by the Commission

Amendment

5. 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.

5. 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 within 10 working days of the inadmissibility of the verification request and shall provide the reasons of its decision.

Amendment 41

Proposal for a regulation

Article 6 – paragraph 6

Text proposed by the Commission

Amendment

6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working 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.

6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the national 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 national competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

Amendment 42

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

7. 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.

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

Amendment 43

Proposal for a regulation

Article 6 – paragraph 8

Text proposed by the Commission

Amendment

8. 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.

8. In the absence of any reasoned scientific objections from a Member State or the Commission, within the deadline referred to in paragraph 7, the national competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. The national competent authority shall transmit the decision within 10 working days to the requester, the other Member States and the Commission.

Amendment 44

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

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

deleted

Amendment 45

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working 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).

10. Where reasoned scientific objections have been made, the national competent authority shall ask the European Food Safety Authority (‘the Authority’) for a scientific opinion on the verification report. The Authority shall issue its scientific opinion on the verification report within 30 days from the date of receipt of that report. The competent authority shall adopt a decision based on the Authority’s scientific opinion within 20 working days from the date of receipt of that opinion. The competent authority shall transmit the decision without undue delay to the requester, the other Member States and the Commission.

Amendment 46

Proposal for a regulation

Article 7

Text proposed by the Commission

Amendment

[...]

deleted

Amendment 47

Proposal for a regulation

Article 7 a (new)

Text proposed by the Commission

Amendment

Article 7a

Free movement of category 1 NGT plants and category 1 NGT products

Member States shall not prohibit, restrict or impede the deliberate release or the placing on the EU single market of category 1 NGT plants and category 1 NGT products, which comply with the requirements of this Regulation.

Amendment 48

Proposal for a regulation

Article 7 b (new)

Text proposed by the Commission

Amendment

Article 7b

Plants resulting from a conventional cross between two category 1 NGT plants

A plant that is the result of a conventional cross between two verified category 1 NGT plants and in which the introduced modifications are maintained is not considered a new NGT plant and automatically maintains category 1 NGT status.

Justification

It is very useful to clarify the category 1 NGT status of plants that are the result of a conventional cross between two verified category 1 NGT plants.

Amendment 49

Proposal for a regulation

Article 10

Text proposed by the Commission

Amendment

Article 10

deleted

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 50

Proposal for a regulation

Article 10 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

It shall be prohibited to label consumer products as containing NGT products or having been developed using NGT. It shall furthermore be prohibited to use ‘negative labelling’ by labelling products as not containing or not having been developed using NGT.

Justification

It is important to ensure that there will not be any labelling on consumer products - also ‘negative labelling’ as described. Such labelling is discriminatory and misleading towards consumers as the knowledge of plant breeding techniques is not widespread and is traditionally never labelled.

Amendment 51

Proposal for a regulation

Article 14 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(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);

Justification

NGT plants for which no unique identification method can be developed, should be regulated as Category 1 NGT plants, as they will be indistinguishable from conventionally-bred plants. Any other outcome will result in enforcement issues and create challenges for imports.

Amendment 52

Proposal for a regulation

Article 16

Text proposed by the Commission

Amendment

Article 16

deleted

Labelling in accordance with Article 23

In addition to Article 19(3) of Directive 2001/18/EC, the written consent shall specify the labelling in accordance with Article 23 of this Regulation.

Amendment 53

Proposal for a regulation

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

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.

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 Article 52(1) of Regulation (EU) …/… (on Plant Reproductive Material) and it does not have any traits referred to in Part 2 of Annex III to this Regulation.

Amendment 54

Proposal for a regulation

Article 23

Text proposed by the Commission

Amendment

Article 23

deleted

Labelling of authorised category 2 NGT products

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 55

Proposal for a regulation

Article 24

Text proposed by the Commission

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 may 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, only in the event that the category 2 NGT plants are able to be detected, identified and quantified by analytical method. These provisions shall not apply to category 1 NGT plants and category 1 NGT products.

Amendment 56

Proposal for a regulation

Article 25

Text proposed by the Commission

Amendment

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

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

Justification

Since Category 1 NGT plants are equivalent to conventional ones, no opt-out from cultivation of these products should be needed.

Amendment 57

Proposal for a regulation

Article 30 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. No later than 2026, the Commission shall present a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the role and impact of patents on breeders' and farmers' access to varied plant reproductive material, as well as on innovation and particularly on the opportunities for SMEs. The report shall assess whether further legal provisions are necessary in addition to those provided for in Article 4a and Article 33a of this Regulation. Where appropriate to ensure breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, as well as the ongoing promotion of innovation, particularly with a view to opportunities for SMEs, the report shall be accompanied by a roadmap to address further necessary adjustments in the intellectual property framework.

Amendment 58

Proposal for a regulation

Article 33 a (new)

Text proposed by the Commission

Amendment

Article 33a

Amendments to Directive 98/44/EC

Article 4 of Directive 98/44/EC on the legal protection of biotechnological inventions is amended as follows:

In paragraph 1, points (c) and (d) are added:

'(c) NGT plants, plant material and parts thereof, as defined in Regulation (EU) .../... [insert reference to this Regulation];

(d) plants, plant material and parts thereof that can be yielded by techniques excluded from the scope of Directive 2001/18/EC as listed in Annex I B to that directive.'

Justification

Technical alignment in relation to the exclusion of the plant material from patentability.

Amendment 59

Proposal for a regulation

Article 34 – paragraph 2

Text proposed by the Commission

Amendment

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

It shall apply from [24 months from the date of entry into force of this Regulation]. However, Article 4a and Article 33a shall apply from the date of entry into force.

Amendment 60

Proposal for a regulation

Annex I – paragraph 1

Text proposed by the Commission

Amendment

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.

A NGT plant is considered equivalent to conventional plants if the following conditions referred to in points 1 and 1a are met:

Amendment 61

Proposal for a regulation

Annex I – point 1

Text proposed by the Commission

Amendment

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

(1) The number of the following mutation events, which can be combined with each other, does not exceed 3 per any protein-coding sequence (mutations in introns and regulatory sequences are excluded from this limit):

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

(b) deletion of any number of nucleotides;

Amendment 62

Proposal for a regulation

Annex I – point 1 a (new)

Text proposed by the Commission

Amendment

(1 a) The following genetic modifications, which can be combined with each other, do not create a chimeric protein that is not present in species from the gene pool for breeding purposes:

(a) targeted insertion of continuous DNA sequences existing in the gene pool for breeding purposes;

(b) targeted substitution of endogenous DNA sequences with continuous DNA sequences existing in the gene pool for breeding purposes;

Amendment 63

Proposal for a regulation

Annex I – point 2

Text proposed by the Commission

Amendment

(2) deletion of any number of nucleotides;

deleted

Amendment 64

Proposal for a regulation

Annex I – point 3

Text proposed by the Commission

Amendment

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

deleted

(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;

Amendment 65

Proposal for a regulation

Annex I – point 4

Text proposed by the Commission

Amendment

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

deleted

Amendment 66

Proposal for a regulation

Annex I – point 5

Text proposed by the Commission

Amendment

(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.

deleted

Amendment 67

Proposal for a regulation

Annex III – Part 1 – introductory part

Text proposed by the Commission

Amendment

Traits justifying the incentives referred to in Article 22:

Traits justifying the incentives referred to in Article 22 are listed in Article 52(1) of Regulation (EU) .../... ( on Plant Reproductive Material).

Justification

The sustainability assessment should be in line with Regulation on Plant Reproductive Material, which establishes the sustainability requirements for all types of Plant Reproductive Material. The following points (1 to 7 ) are deleted.

Amendment 68

Proposal for a regulation

Annex III – Part 1– point 1

Text proposed by the Commission

Amendment

(1) yield, including yield stability and yield under low-input conditions;

deleted

Amendment 69

Proposal for a regulation

Annex III – Part 1– point 2

Text proposed by the Commission

Amendment

(2) tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses and other pests;

deleted

Amendment 70

Proposal for a regulation

Annex III – Part 1 – point 3

Text proposed by the Commission

Amendment

(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change;

deleted

Amendment 71

Proposal for a regulation

Annex III – Part 1– point 4

Text proposed by the Commission

Amendment

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

deleted

Amendment 72

Proposal for a regulation

Annex III – Part 1– point 5

Text proposed by the Commission

Amendment

(5) characteristics that enhance the sustainability of storage, processing and distribution;

deleted

Amendment 73

Proposal for a regulation

Annex III – Part 1– point 6

Text proposed by the Commission

Amendment

(6) improved quality or nutritional characteristics;

deleted

Amendment 74

Proposal for a regulation

Annex III – Part 1– point 7

Text proposed by the Commission

Amendment

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

deleted

Amendment 75

Proposal for a regulation

Annex III – Part 2

Text proposed by the Commission

Amendment

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

deleted

Justification

Annex III, Part 2 excludes NGT plants featuring herbicide-tolerant traits from the regulatory incentives. Such an exclusion is further not consistent with recital 36 which clarifies that the proposed Regulation is not intended to take specific measures on herbicide tolerant NGT plants.

ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

The rapporteur declares under her exclusive responsibility that she did not receive input from any entity or person to be mentioned in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.

PROCEDURE – COMMITTEE ASKED FOR OPINION

Title

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

References

COM(2023)0411 – C9-0238/2023 – 2023/0226(COD)

Committee responsible

Date announced in plenary

ENVI

19.10.2023

Opinion by

Date announced in plenary

AGRI

19.10.2023

Associated committees - date announced in plenary

19.10.2023

Rapporteur for the opinion

Date appointed

Veronika Vrecionová

28.8.2023

Discussed in committee

26.10.2023

Date adopted

11.12.2023

Result of final vote

–:

Members present for the final vote

Mazaly Aguilar, Clara Aguilera, Daniel Buda, Isabel Carvalhais, Asger Christensen, Dacian Cioloş, Ivan David, Paolo De Castro, Jérémy Decerle, Salvatore De Meo, Herbert Dorfmann, José Manuel Fernandes, Paola Ghidoni, Martin Häusling, Martin Hlaváček, Krzysztof Jurgiel, Jarosław Kalinowski, Elsi Katainen, Camilla Laureti, Norbert Lins, Elena Lizzi, Colm Markey, Marlene Mortler, Ulrike Müller, Maria Noichl, Juozas Olekas, Eugenia Rodríguez Palop, Daniela Rondinelli, Katarína Roth Neveďalová, Bert-Jan Ruissen, Anne Sander, Veronika Vrecionová, Sarah Wiener, Juan Ignacio Zoido Álvarez

Substitutes present for the final vote

Anna Deparnay-Grunenberg, Dino Giarrusso, Charles Goerens, Claude Gruffat, Anja Hazekamp, Peter Jahr, Cristina Maestre Martín De Almagro, Sandra Pereira, Michaela Šojdrová, Tom Vandenkendelaere, Thomas Waitz

Substitutes under Rule 209(7) present for the final vote

Mercedes Bresso

FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION

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