Changes from report parliamentary committee draft to report parliamentary committee draft

RemovedRecital 23: (23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(20) 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. Conversely, the use of category 1 NGT plants should be allowed in organic production.

RemovedRecital 24: (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.

RemovedSeed bag labelling for verified conventional-like NGT plants is discriminatory. Conventional-like NGT plants should be treated conventionally, this extra requirement is creating unjustified distinctions and administrative burden. Transparency and consumer choice can be fully ensured by making information about the use of NGTs publicly available (public databases). The additional seed bag labelling provisions create a third category of plant products between conventional and GMOs. This is not in line with the approaches taken in other countries and will create trade issues.

RemovedRecital 37: (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 and should therefore not be provided for.

RemovedRecital 39: (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. Member States should adhere to this.

RemovedRecital 40: (40) Where appropriate, every five years 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 with the aim of further improving the Regulation.

RemovedArticle 3 – paragraph 1 – point 2: (2) ‘NGT plant’ means a 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;

RemovedThe wording “genetically modified” would indicate that the process of using NGT techniques would change the DNA of an organism by introducing elements of DNA from a different organism. It should therefore be deleted.

RemovedArticle 3 – paragraph 1 – point 4: (4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at targeted locations in the genome of an organism;

Removed“Targeted” would give a more appropriate wording since the aim of the techniques resulting in modifications of the DNA sequence could be a specific part in the genome of an organism, but not necessary an exact part in that specific part in the genome.

RemovedArticle 3 – paragraph 1 – point 12: (12) ‘NGT product’ means food and feed containing, consisting of or produced from NGT plants, and other products containing or consisting of such plants;

RemovedA product as such can be described as “food” and/or “feed” hence it gives more clarity to state that ‘NGT product’ means anything that might contain elements from NGT plants.

RemovedArticle 4 – paragraph 1 – point 2: (2) the plant is a category 2 NGT plant, and has been granted consent or has been authorised, in accordance with Chapter III.

RemovedFurther clarification to the text proposed by the European Commission.

RemovedArticle 5 – title: Status of category 1 NGT plants and category 1 NGT products

RemovedAdding on “category 1 NGT products” provides clarity for the meaning of the article.

RemovedArticle 5 – paragraph 1: 1. The rules which apply to the techniques referred to in Annex IB to Directive 2001/18 shall also apply to category 1 NGT plants.

RemovedThe proposal establishes a verification process to verify if an NGT plant is meeting the equivalence criteria to be grouped as Category 1 (conventional-like). Consequently, those Cat 1 plants should also be subject to the same regulatory framework as conventional breeding products. Any additional requirements would be discriminatory and unjustified. Instead, the Commission proposal creates a distinct category and foresees specific requirements for verified conventional-like NGT plants different from conventional plants and from exempted GMOs like random mutagenesis. This creates confusion and legal complexity. It would be much more consistent to include verified conventional like Cat 1 NGT plants under Annex IB of Dir. 2001/18.

RemovedArticle 5 – paragraph 2: deleted

RemovedThe proposal establishes a verification process to verify if an NGT plant is meeting the equivalence criteria to be The prohibition for organic farmers to use conventional-like NGTs (Category 1) in their production is neither science-based nor politically justifiable. Moreover, the prohibition of GMOs is part of the organic farming regulation, but not the GMO Directive 2001/18. Already today certain private standards in the organic sector exclude seeds derived from certain conventional breeding methods based on transparent information from the breeding sector. It should therefore be left to the organic operators to decide which seeds to use in their production and all references to organics should be deleted from the NGT proposal.

RemovedArticle 6 – paragraph 7: 7. The Commission may make, after having consulted the European Food Safety Authority (‘the Authority’) and other Member States, reasoned objections to the verification report, as regards the fulfilment of the criteria set out in Annex I, within 20 days from the date of receipt of that report. Such reasoned objections shall solely refer to the criteria as set out in Annex I and shall include a scientific justification.

RemovedThe verification process should, without prejudice, be based and focused on fulfilling the science-based criteria set out in Annex I defining a category NGT 1 plant and assessed by the competent authority in the Member State subject for the verification request. Allowing other Member States to make comments without any further specifications risk undermining the process and make it go beyond its scope. Any intervention of the Commission should be scientifically justified and based on correct application of the equivalence criteria (Annex I).

RemovedArticle 6 – paragraph 8: 8. In the absence of any reasoned objections from the Commission or Member States, 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.

RemovedConsistency with Art 6(7).

RemovedArticle 6 – paragraph 9: 9. In cases where a reasoned objection 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 upon request make the reasoned objections publicly available without undue delay.

RemovedConsistency with Art 6(7).

RemovedArticle 6 – paragraph 10: 10. The Commission, after having consulted 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 reasoned objections, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

RemovedThe verification process should, without prejudice, be based and focused on fulfilling the science-based criteria set out in Annex I defining a category NGT 1 plant and assessed by the competent authority in the Member State subject for the verification request.

RemovedArticle 10: deleted / (deleted) / (deleted)

RemovedSeed bag labelling for verified conventional-like NGT plants is discriminatory. Conventional-like NGT plants should be treated conventionally; this extra requirement is creating unjustified distinctions and administrative burden. Transparency and consumer choice can be fully ensured by making information about the use of NGTs publicly available (public databases). However, the additional seed bag labelling provisions create a third category of plant products between conventional and GMOs. This is not in line with the approaches taken in other countries and will create trade issues.

RemovedAnnex I – paragraph 1: A NGT plant is considered equivalent to conventional plants when it contains only genetic modifications referred to in points 1 to 5 and when it differs from the recipient/parental plant by no more than 20 genetic modifications of the types referred to in points 1 to 4, in the targeted site or sites in the monoploid genome.

RemovedThe Criteria to establish equivalence with conventional plants should allow crops with complex genomes (polyploids like e.g. wheat) to benefit from NGTs in the same way as diploid crops – the 20 genetic changes should be based on the haploid genome. In addition, EFSA[1] concluded that off-target changes would be the same types (and fewer) as those produced by conventional breeding techniques. There is a risk that a requirement for the identification of these off-targets might discriminate crops (specifically smaller crops) for which no whole genome sequence is available. Number 5 of Annex I refers to genetic changes existing in the breeders gene pool and therefore the changes as to number (5) should not be counted in the verification that the threshold of 20 genetic modifications is met.

RemovedThere are multiple examples of cisgenesis being used to introduce beneficial traits. As long as the insertion does not result in the creation of an intragenic plant which would express a chimeric protein neither random introductions nor interruptions of endogenous genes by cisgenes should be excluded from Category 1. Excluding these applications from Annex I means less opportunities for developing beneficial traits by cisgene(s) in Category 1 (e.g. introduction of multiple disease resistant cisgenes to ensure durable resistance).

RemovedAnnex I – paragraph 1 – point 3: (3) on the condition that the genetic modification does not create an intragenic plant: / (a) insertion of a contiguous DNA sequence existing in the breeder’s gene pool; / (b) substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool;

RemovedThe Criteria to establish equivalence with conventional plants should allow crops with complex genomes (polyploids like e.g. wheat) to benefit from NGTs in the same way as diploid crops – the 20 genetic changes should be based on the haploid genome. In addition, EFSA[1] concluded that off-target changes would be the same types (and fewer) as those produced by conventional breeding techniques. There is a risk that a requirement for the identification of these off-targets might discriminate crops (specifically smaller crops) for which no whole genome sequence is available. Number 5 of Annex I refers to genetic changes existing in the breeders gene pool and therefore the changes as to number (5) should not be counted in the verification that the threshold of 20 genetic modifications is met.

RemovedThere are multiple examples of cisgenesis being used to introduce beneficial traits. As long as the insertion does not result in the creation of an intragenic plant which would express a chimeric protein neither random introductions nor interruptions of endogenous genes by cisgenes should be excluded from Category 1. Excluding these applications from Annex I means less opportunities for developing beneficial traits by cisgene(s) in Category 1 (e.g. introduction of multiple disease resistant cisgenes to ensure durable resistance).

RemovedNew genomic techniques (NGTs) provide unprecedented opportunities for European agriculture and food production. These techniques enable us to alter the genetic materials of a certain organism providing swift development of different plant varieties with certain characteristics. NGTs are not limited to one specific technique but rather represent a diverse group of techniques that can contribute to a more tailored modification of the genome in comparison to conventional plant breeding. The achieved modification of the genome could or could not be produced in nature or obtained by conventional breeding techniques.

RemovedInnovative technologies such as CRISPR/Cas9, which was awarded the Nobel Prize in Chemistry in 2020, have the ability to improve plant breeding by strengthening various crops through more targeted changes and without the need to add anything new in the genetic composition of a crop.

RemovedNGTs therefore have the ability to enhance agriculture by making crops and harvests more resilient and sustainable. Given their low operating and entry costs, these techniques could also contribute to improving the Union´s trade policy and competitiveness.

RemovedUnfortunately, the European Union currently cannot utilize this potential.

RemovedIn its judgment of 25 July 2018, the Court of Justice of the European Union held that Directive 2001/18 cannot be interpreted as excluding from its scope genetically modified organisms (GMOs) obtained by certain new techniques.

RemovedThe practical implication of this has been significant, as NGTs have still not been introduced within the Union.

RemovedAs the European Commission concluded in a 30 April 2021 study delivered at the request of the Council on 8 November 2019, EU legislation should be adapted in line with scientific and technical progress in this area.

RemovedA new, adapted, legislation is essential to enable the use of these new techniques. It is essential to have adequate risk assessment requirements and authorisation procedures to ensure that a variety of potential plant products can be introduced within the EU. The current requirements and processes for genetically modified crops are not enabling the new techniques or a variety of plant products.

RemovedWithout an enabling framework in line with the scientific and technical progress, these problems continue to affect operators affected by the current regulations across the agri-food system. Consumers, farmers and the innovative sector cannot currently benefit from NGTs.

RemovedIn the absence of a modern regulatory framework in the EU, other countries in the world have already undertaken measures to enable the usage of NGTs. The EU therefore risks falling behind in both competitiveness and scientific and technological research. This would negatively impact European food safety as well as resilience in European food production.

RemovedObjectives and ambitions of the draft proposal

RemovedThe rapporteur supports the overall approach of the European Commission and welcomes its proposal to introduce a new regulation on plants obtained by certain new genomic techniques and their food and feed. Taking into account that the current regulatory framework is not in line with the latest scientific and technological development, the rapporteur welcomes this proposal with its objectives set out in the food safety-strategy Farm to fork. The proposal goes in line with the Farm to fork-strategy and its aim to transform European agriculture and food production towards sustainability and strengthen European competitiveness.

RemovedThe COVID-19 pandemic and Russia´s war of aggression against Ukraine have both aggravated the situation for European agriculture and food production by showing the Union´s external dependencies on critical inputs for agriculture.

RemovedWhile the rapporteur believes that the Commission proposal is a solid starting point, she believes that some further improvements and additions are required to ensure the best possible usage of the techniques.

RemovedClarification and improvement of the criteria for NGT 1-plants

RemovedThe rapporteur is of the opinion that the provisions related to category 1 (NGT 1) should be further improved. She believes that the criteria in annex I that defines an NGT 1 plant should be further clarified and improved. The Commission proposes a threshold of 20 genetically modified changes that cannot be exceeded if a plant were to be defined as an NGT 1.

RemovedConcerning the criteria set out in annex I to fall under NGT 1: the threshold of 20 genetically modified changes should be specified by ensuring that each change in a plant and/or a crop must be relative to the ploidity status in the crop. If, for example, a plant has a duplication of chromosomes and one modification de facto makes two changes, 10 modifications can already make up to 20 potential changes. This would risk going beyond its purpose. The particular change in a crop or a plant must be based on a single copy of a gene.

RemovedOrganic farming

RemovedThe rapporteur also believes that NGTs should be allowed and enabled in organic farming. The purpose of this draft report is to ensure that any operators without discrimination can use the techniques. Thus, the proposed ban by the Commission for the techniques to be used in organic farming is lifted to ensure a fair playing field without imposing the technique on any operator.

RemovedThe proposal should ensure that every operator could have access to these new technologies. The freedom of choice is essential for operators and the technique should remain available.

RemovedEnsuring science-based verification processes

RemovedThe proposed regulation also introduces verification procedures for NGT 1 prior to the deliberate release of plants for this category. The rapporteur believes that is important to ensure full compliance with the regulation. However, she believes that the verification process should be for the competent authority in a Member State where the application is submitted and without additional Member States able to challenge a certain decision of approval without a reasoned objection.

RemovedThe verification process should be based on the scientifically approved criteria set out in the annex defining a category 1 plant and, where appropriate, in close consultation with the European Commission and the European Food Safety Authority.

RemovedTraceability and labelling

RemovedAs regards the traceability and labelling of NGT 1 plants, the rapporteur supports the proposal by the commission by making information about the use of NGTs publicly available in the proposed public database. This ensures transparency and consumer choice. However, the rapporteur does not support seed bag labelling for verified conventional-like NGT plants as that would be discriminatory. Conventional-like NGT plants should be treated conventionally; this extra requirement is creating unjustified distinctions and administrative burden

RemovedPatents and patentability

RemovedThe rapporteur also takes note of the concerns expressed with regard to the patent on NGTs by breeders and farmers. The rapporteur believes that this should be regulated in existing separate regulations where they are currently regulated to avoid having this proposal go beyond its scope. The rapporteur therefore supports the proposed approach by the commission to assess on a regular basis and submit a report on how to address this after the legislation has worked in practice in order to assess if a technique is subject to be patentable.

RemovedThe Committee on Agriculture and Rural Development (AGRI) also has shared competencies on some provisions pursuant to Rule 57 with the Committee on the Environment, Public Health and Food Safety (ENVI). The rapporteur is therefore committed to working constructively with the rapporteur from the AGRI committee to find a good and balanced proposal for these techniques.