EuropaBio’s proposal for a future-proof, product-centric enabling regulatory framework for microorganisms

The EU needs a new regulatory approach with a specific safety assessment for microorganisms, built on a science-based classification of microorganisms, reflecting existing knowledge and state-of-the-art scientific development. This framework would be a horizontal Regulation ensuring a cohesive approach across other relevant sector-specific legislation (e.g. feed additives, cosmetics, biocontrol, etc.).

Microorganisms have been used by humans in various applications for thousands of years, such as in food uses (bread, cheese, alcohol fermentation). More recently, biotechnological developments in microorganisms have resulted in a number of innovations in technical, food and feed, and medicinal applications. These help to mitigate some of our current global environmental and societal challenges, such as those linked to climate change and biodiversity, as well as ensuring food security. Considering these developments, EuropaBio calls for an improved regulatory approach for all microorganisms, including those which are used in a live form, that will generate an accessible pathway to market for these sustainable solutions.

To keep up with their fast pace, major scientific and technological developments in biotechnology require adaptation of the current EU GM legislation, which was developed at the end of the 1980s and has not been significantly updated since. In view of this, the European Commission recognised that the EU GM framework is not fit for purpose and has published a proposal for plants produced by certain new genomic techniques (NGTs). It has also tasked EFSA to prepare a scientific opinion on new developments in biotechnology applied to microorganisms¹ - as a first step towards future legislative proposals. EuropaBio has argued extensively for a new legislative proposal for microorganisms. There are significant scientific developments on genetically modified microorganisms (GMMs), and a wealth of scientific knowledge and safety data² to support this.

The current GM framework was built with a focus on plants, which is not sufficiently suitable for microorganisms used in a live form as products, with the corresponding result that there are currently no such microorganisms in the risk assessment pipeline for future commercialisation in the EU. Plants and microorganisms have different specificities and are also used in different contexts and sectors. In this context, it is crucial to further develop an adapted framework for microorganisms, in which microorganisms are considered holistically. Building and expanding on the current proposal for plants developed using NGTs, this proposal will ensure a future-proof, product-centric enabling regulatory framework - where requirements are proportionate to risk.

The proposal is further developed in the Annex. Download it below.

[1]Anticipated publication June 2024, https://open.efsa.europa.eu/questions/EFSA-Q-2022-00508
[2]Lensch, A., Lindfors, H. A., Duwenig, E., Fleischmann, T., Hjort, C., Kärenlampi, S. O., McMurtry, L., Melton, E., Andersen, M. R., Skinner, R., Wyss, M., & Van Kranenburg, R. (2024). Safety aspects of microorganisms deliberately released into the environment. EFB Bioeconomy Journal, 4, 100061. https://doi.org/10.1016/j.bioeco.2023.100061