Lettre à la Commissaire européenne Stella Kyriakides Commissaire à la santé et à la sécurité alimentaire sur les nouvelles techniques génomiques

Ms Stella Kyriakides 

Commissioner for Health and Food Safety European 

Commission Rue de la Loi 200 B-1049 Brussels

Brussels, 7 June 2023

Dear Commissioner Kyriakides, 

Today is the date the Commission originally intended to adopt its proposal on the future regulation of New Genomic Techniques (NGT). NGTs are widely considered as one of the key tools in making agriculture more resilient and less dependent on input such as plant protection products and fertilisers and hence enable the transition in agriculture envisioned by the Farm to Fork Strategy. While the adoption of the proposal has been postponed, it is a good occasion to reach out to you again on other key tools to enable farmers to deliver on expectations. In the context of the proposed Sustainable Use of Pesticides Regulation (SUR), we currently are discussing substantial targets on the reduction of pesticide use and risks. However, reducing the dependency on synthetic pesticides to a large extend relies on the availability of safer, effective non-synthetic alternatives. These alternatives are not yet available for many applications. There are substantial obstacles to the market introduction of these alternatives, which cannot be addressed adequately under the framework of the SUR and require measures under the Plant Protection Products Regulation 1107 /2009. Biological control products in particular have a large potential to fill the gaps in the farmers' toolboxes. However, the approval and authorisation process on average takes 7 to 8 years in the EU, compared to 2 to 3 years in other markets such as the USA, Brasil or China. Further, the requirements of the approval procedure were designed for the characteristics of synthetic substances and do not match the characteristics of different categories of biological control agents, making applications more burdensome and costly than factually justified. The Commission is aware of the problem regarding data requirements and has published new specific requirements on microbiological products in 2022. 

However, specific requirements for other categories are urgently needed to speed up the process of making alternative solutions available. Furthermore, there are several other measures the Commission could take under the current framework of Regulation 1107 /2009 to substantially improve the approval and authorisation system in order to facilitate the market introduction of substances European farmers rely upon to live up to the challenges they are facing due to climate change and ever stricter legal requirements: 

 • The European Parliament has called for the introduction of a fast-track approval procedure in the past (see e.g. Paragraph 9 of European Parliament resolution of 20 October 2021 on a farm to fork strategy for a fair, healthy and environmentally-friendly food system (2020/2260(INI)). Is the Commission preparing such a fast-track procedure to speed up approvals of biological control agents? 

• Delays on the level of Member State competent authorities within the meaning of Regulation 1107 /2009 are frequent causes of delays in the approval procedure. What measures has the Commission taken and plans to take to improve the situation? Does the Commission address the lack of implementation of the system of mutual recognition? 

• When will specific requirements on semiochemicals and on extracts from plants be adopted? Is the Commission preparing or plans to prepare specific requirements on other categories of biological control agents, particularly on protein- and peptide-based agents including enzymes and antibodies and on RNA? 

• What measures has the Commission taken or plans to take to ensure that EU competent authorities, particularly EFSA, have adequate resources and expertise to fulfil their tasks in light of the topics outlined above? 

• Does the Commission consider a new dedicated framework for the approval and authorisation of biological control products? 

Dear Commissioner, I believe we all agree that urgent action is needed to improve the resilience of our nature and agriculture. However, if we expect farmers to deliver, it is our duty to ensure they have the tools at hand. Before setting ambitious targets, we must do our part and deliver on the key enablers for agricultural transition, such as a functional framework for NGTs, but also an approval system that is fit for-purpose for safer alternatives to harmful plant protection products. 

Yours sincerely, 

Ulrike Müller Atidzhe Alieva-Veli Asger Christensen Dacian Ciolos JanHuitema Elsi Katainen Irène Tolleret Hilde Vautmans Emma Wiesner