In July 2018, the EU’s Supreme Court, the Court of Justice of the European Union (ECJ), decided whether the EU would regulate products with innovative breeding technologies such as genetic modification under EU Directive 2001/18. Announced a decision to clarify. EU law governing GMO regulations.
As explained earlier, ECJ has excluded new forms of mutagenesis (plant breeding techniques that do not require the insertion of DNA from external organisms) from the directive, but new genomic techniques that include gene editing ( We considered that organisms developed using NGT) were excluded. Is regulated as GMO and is subject to restrictive and cumbersome regulatory requirements. The ECJ has determined that it is appropriate to exclude organisms developed using new mutagenesis techniques such as gene editing. This is because the new technology was not “traditional”. .. .. It is used in many applications “and” does not have a long safety record “.
In November 2019, the Council of the European Union requested that the Commission submit an investigation into the status of NGT under EU law and, where appropriate, a proposal for such a technique with an impact assessment.
The European Commission’s investigation, published in April 2021, included the following findings:
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“NGT and its products have evolved rapidly in many parts of the world over the last two decades, and some applications are already on the market for some EU trading partners.”
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“The current EU regulatory system presents implementation and enforcement challenges, especially with regard to the detection and differentiation of NGT products that do not contain foreign genetic material.”
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“There is considerable interest in NGT-related research in the EU.”
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“There are signs of both benefits and concerns associated with NGT products and their current and future applications.”
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“”[P]Land products with similar risk profiles can be obtained with conventional breeding techniques, targeted mutagenesis.[,] And cis genesis. “
In particular, the European Commission concluded:[t]It strongly states here that the applicable law does not fit the purpose of some NGTs and their products and needs to be adapted to advances in science and technology. In discussing the next steps, the Commission said, “Initiate policy measures including impact assessment, including public consultation, on plants produced by targeted mutagenesis and sysgenesis.” I paid attention to the plan. Although not explicitly stated, the European Commission’s use of the term “target mutagenesis and cisgenesis” refers to specific techniques that may be considered NGT. Is obvious.
At the end of last month, the European Commission launched a public consultation, “The views of citizens and stakeholders on the functioning of the current GMO Act on plants and their food and feed products obtained by targeted mutagenesis and cisgenesis, ie. Under the current GMO law “. And about the potential options of the new framework. In discussing public talks, the European Commission’s Health and Food Safety Commission, Stella Kyriakides, said: Our guiding principles are to maintain the safety of the environment and consumers. “
The European Commission explained that it is “preparing a policy initiative on plants obtained by targeted mutagenesis and cisgenesis.” It “also covers foods and feeds derived from such plants.” In addition, “This initiative aims to ensure proper regulatory supervision of related plant products, ensure a high level of protection for human and animal health and the environment, and enable plant innovation and contributions gained by safe NGT. increase.[s] For the purposes of the European Green Deal and Farm to Fork Strategy. “
This consultation provides a valuable opportunity to help shape the future of a wide range of policy initiatives that will have a significant impact on the industry. Answers to the consultation can be submitted by completing the online survey available here until July 22, 2022 (midnight Brussels time).
