Changes from report parliamentary committee draft to report parliamentary committee draft

RemovedEXPLANATORY STATEMENT

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.