In July 2018, the Supreme Court of the European Union (ECJ) issued a decision to clarify whether the EU will regulate products from innovative breeding techniques such as gene editing under EU Directive 2001/18. EU law governing GMOs.
as we explained beforeThe European Court of Justice held that while traditional forms of mutagenesis – a plant breeding technique that does not require insertion of the DNA of an external organism – are excluded from the Directive, organisms developed using new genomic technologies (NGT), including gene editing, will Regulated as GMOs and therefore subject to restrictive and onerous regulatory requirements. European Court of Justice It is appropriate to exclude organisms developed using newer mutagenesis techniques, such as gene editing, as newer techniques are not ‘conventional’. . . used in many applications” and has no “long term safety record”.
In November 2019, the EU Council requirements The European Commission submits a study on the status of NGTs under EU law and, where appropriate, a proposal for such a technology, with an impact assessment.
European Commission researchpublished in April 2021, including The following findings:
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“NGT and its products have grown rapidly in many parts of the world over the past 20 years, with some applications already in the markets of some EU trading partners.”
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“Under the current EU regulatory system, there are implementation and enforcement challenges, particularly in terms of detecting and distinguishing NGT products that do not contain any foreign genetic material.”
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“The EU is very interested in NGT-related research.”
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“There are indications of benefits and concerns related to NGT products and their current and future applications.”
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“[P]Rand products with similar risk profiles can be obtained by conventional breeding techniques, targeted mutagenesis[,] and childbirth. “
Among other things, the European Commission concluded: “[t]There are strong indications here that applicable legislation does not apply to some NGTs and their products, and that they need to be adapted to accommodate technological advances. In discussing the next steps, the European Commission noted that it plans to “initiate a policy action on plants produced through directed mutagenesis and cisgenesis, which will involve an impact assessment including public consultation.” Although not explicitly stated, it is clear that the terms ‘targeted mutagenesis and cis-generation’ used by the European Commission refer to certain techniques that can be considered as NGT.
At the end of last month, European Commission begins public consultation Hear “Citizens and stakeholders on the operation of the current GMO legislation for plants obtained through directed mutagenesis and cis-generation and their food and feed products, i.e. under current GMO legislation, and on potential options for a new framework.” In Discussing the public consultation, EU Commissioner for Health and Food Safety Stella Kyriakides said: “Plants obtained with new genomic technologies can contribute to a more resilient and sustainable agri-food system. Our guiding principles will remain the environment and consumers safety.”
The European Commission explained that it is “in the process of developing a policy initiative for plants obtained through directed mutagenesis and cisgenesis” that “will also cover food and feed derived from such plants”.In addition, “the initiative aims to provide appropriate regulatory oversight of relevant plant products, ensure a high level of protection of human and animal health and the environment, and promote innovation and contribution from plants obtained through safe NGT[s] to achieve the goals of the European Green Deal and the Farm-to-Fork strategy. “
This consultation provides a valuable opportunity to help shape the future of broad-impact policy initiatives that have a major impact on this industry.Responses to inquiries may be submitted by completing an online questionnaire, available hereuntil 22 July 2022 (midnight Brussels time).
