Safety aspects of microorganisms deliberately released into the environment

Microorganisms are used in a variety of sectors, including food and feed production, agricultural or environmental applications, and can be optimized for efficacy, safety and sustainability using modern biotechnology techniques. In the EU, genetically modified microorganisms (GMMs) are typically used as production organisms for food and feed products, including enzymes, amino acids, vitamins, flavourings, and oligosaccharides under the Contained Use Directive. Applications involving live GMMs would fall under the Deliberate Release Directive. However, its relevant regulations and guidelines are so far not supporting the access to market of GMMs. In this literature review, we examine what is already known or can be inferred about the safety of microorganisms deliberately released into the environment across sectors. We conclude that there is sufficient evidence supporting the establishment of a European framework for the risk assessment of GMMs deliberately released into the environment, which would enable timely market access for live GMM products.