The draft guidance aims to assist in the preparation of applications of products containing, made from, or produced with microorganisms that are subject to a risk assessment as part of the premarket approval process. The guidance focuses on the requirements to characterize microorganisms and provides the basis for their risk assessment, establishing the requirements to:

• Taxonomically identify the microbe
• Investigate the presence of genes of concern related to antimicrobial resistance (AMR), the production of antimicrobials of therapeutic interest, and the virulence potential of the microorganism
• Establish the presence of viable cells, genetic material, and/or substances of concern (e.g., toxins, toxic metabolites, clinically relevant antimicrobials) that may remain in the product made from or produced with the microbe
• Conduct an environmental risk assessment and study the impact of products containing living microorganisms and products made from microbes on the gut and food microbiome.

The scope includes genetically modified (GM) and non-GM microorganisms like bacteria, yeasts, filamentous fungi, viruses, microalgae, and other protists in the following contexts:

• Active agents capable of multiplication
• Biomasses in which non-viable cells and their genetic material are present
• Production strains that produce substances via a manufacturing process that include steps to remove a microorganism
• Bacteriophages that remain in the final product.

The public consultation on the draft guidance is open until February 7, 2025 and can be accessed here.

Update, December 4, 2024: The article has been edited to include information about EFSA's upcoming webinar on the draft guidance.