EU legislation currently requires microbial agricultural products developed with biotechnology, including biocontrol products, to undergo dual regulatory assessment under both GMO legislation and sectoral frameworks. This can duplicate risk assessment requirements already addressed under product-specific rules, creating delays without providing a clear additional safety benefit.
A science-based, product-focused regulatory approach can ensure a high level of safety while avoiding unnecessary duplication. As recognised by EFSA, risk assessment should be based on the characteristics and risk profile of the microorganism/product itself, rather than solely on the technique used to develop it.
The EU simplification agenda presents a timely opportunity to improve regulatory coherence and proportionality for microbial products used in agriculture. Directive 2001/18/EC should be amended to explicitly exclude microorganisms developed through self-cloning and new genomic techniques (NGTs) from its scope. Products derived from such microorganisms should be regulated exclusively under the relevant sectoral legislation, ensuring a single, product characteristics-based regulatory pathway.
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