Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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Commission Consultation, 24 September 2021
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Commission Consultation: Inception Impact Assessment - Legislation for plants produced by certain new genomic techniques A copy of the full Inception Impact Assessment is available on this site (click on image). The Feedback period is from 24 September 2021 to 22 October 2021. For more details, see the Commission page: Published initiatives: Legislation for plants produced by certain new genomic techniques |
About this initiative: 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 Roadmap Impact Assessment:
Context
In the last decades, advances in biotechnology have led to the development of new genomic techniques (NGTs). These are techniques capable of altering the genetic material of an organism that have emerged or have been developed since 2001, when the current legislation on genetically modified organisms (GMOs) was adopted. The Court of Justice of the EU in 2018 clarified that organisms produced by targeted mutagenesis1 are GMOs, therefore subject to the requirements of the EU GMO legislation. Based on the reasoning followed by the Court, the GMO legislation also applies to organisms produced by other NGTs, including cisgenesis
In November 2019, the Council requested the Commission to prepare a study on the status of NGTs under EU law. The study, published in April 2021, has confirmed that NGTs have developed rapidly in many parts of the world and are expected to continue to do so on a global scale. There is significant interest both in the EU and globally for plant applications of NGTs. Some of their applications are already on the market outside the EU and this trend is likely to continue, across different sectors and countries.
The study has also concluded that plants obtained from NGTs have the potential to contribute to the objectives of the European Green Deal and in particular to the Farm to Fork and Biodiversity Strategies and the United Nations’ Sustainable Development Goals (SDGs) for a more resilient and sustainable agri-food system. Examples of potential benefits include plants more resistant to pests, diseases and environmental conditions or to the effects of climate change (e.g. droughts), or requiring less natural resources and fertilisers. NGTs could also improve the nutrient content of plants for healthier diets, or reduce content of harmful substances such as toxins and allergens. At the same time, the study reported concerns linked to the use of these technologies, e.g. on their potential safety and environmental impacts, including on biodiversity, the coexistence with organic and GM-free agriculture as well as concerns on labelling and consumers’ right to information and freedom of choice.
Among NGTs, targeted mutagenesis and cisgenesis can be used to produce alterations of the genetic material that can also be obtained by natural mutations or conventional breeding techniques. The European Food Safety Authority (EFSA) concluded that plants obtained by targeted mutagenesis and cisgenesis can have the same risk profile as plants produced with conventional breeding. EFSA has not yet assessed the safety of targeted mutagenesis and cisgenesis in microorganisms or animals, nor the safety of other techniques.
The Council also requested the Commission to submit, if appropriate in view of the outcomes of the study, a proposal accompanied by an impact assessment, or otherwise to inform the Council of other measures required. Based on the outcome of the study, the Commission will prepare a policy initiative on plants obtained by targeted mutagenesis and cisgenesis, accompanied by an impact assessment. It will also cover food and feed derived from such plants (hereinafter, references to plants obtained by targeted mutagenesis and cisgenesis will refer as well to their food and feed products). Such an action follows from the study conclusions and is particularly timely in view of the potential contribution of plants obtained by targeted mutagenesis and cisgenesis to the sustainable agri-food system objectives of the European Green Deal and its related strategies, as mentioned above. The initiative shall maintain the objectives of the current legislation as regards a high level of protection of human and animal health and the environment.
Animals and microorganisms, and other NGTs, are outside the scope of this initiative; in these areas, the Commission intends to continue to build up the required scientific knowledge at this stage. Considerations related to the use of NGTs in medicinal products will be addressed in the context of the Commission’s Pharmaceutical Strategy.
For previous news item on this topic, see: 29 April 2021 GMOs - Biotechnologies: Commission seeks open debate on New Genomic Techniques as study shows potential for sustainable agriculture and need for new policy
