Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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Commission consultation, 7 July 2023
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Commission consultation: 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 A copy of the proposal is available on this site (click on image). The Commission has also provided a number of additional supporting documents. These are available from the main consultation page - see: Legislation for plants produced by certain new genomic techniques |
The consultation is open until 10 September 2023. To reply to the consultation, see the main consultation page:Legislation for plants produced by certain new genomic techniques
Summary
This initiative will propose a legal framework for plants obtained by targeted mutagenesis and cisgenesis and for their food and feed products. It is based on the findings of a Commission study on new genomic techniques.
The aim is to maintain a high level of protection for human and animal health and the environment, enable innovation in the agri-food system and contribute to the goals of the European Green Deal and the ‘Farm to Fork’ strategy.
The following is the opening section of the Explanatory Memorandum
Reasons for and objectives of the proposal
New genomic techniques (NGTs) provide new opportunities to alter the genetic material of an organism allowing the rapid development of plant varieties with specific characteristics. NGTs constitute a diverse group of techniques, each of which can be used in various ways to achieve different results. In many cases, these new techniques can lead to more targeted and precise modifications to the genome than conventional breeding or established genomic techniques and these modifications could or could not be produced in nature or obtained by conventional breeding techniques.
Targeted mutagenesis and cisgenesis (including intragenesis) are considered NGTs. They are different from established genomic techniques because they have novel features, for example, higher precision and speed in introducing the desired genetic modifications and the insertion of genetic material only from a crossable species.
Targeted mutagenesis and cisgenesis do not introduce genetic material from non-crossable species -transgenesis- whereas this is the case with established genomic techniques. In addition, in some cases, products containing or consisting of plants with genetic modifications introduced by NGTs cannot be differentiated from products containing or consisting of plants bred with conventional breeding methods by analytical methods, whereas this is always possible for established genomic etechniques.
The scope of this initiative are plants produced by targeted mutagenesis and cisgenesis (including intragenesis), products containing or consisting of these plants and food and feed containing, consisting or produced from these plants. The choice of the scope is based on several reasons. Numerous advanced and early ‘research & development’ applications concern plants, and several plant products are already on or very close to the market. In certain cases, substantially equivalent plants can be obtained with conventional breeding methods and with targeted mutagenesis and cisgenesis. Safety data are mainly available for plants obtained by targeted mutagenesis and cisgenesis, whereas it is at this stage difficult to draw relevant conclusions on other NGTs and applications in animals and micro-organisms.
