novel microorganism

The qualified presumption of safety (QPS) is a generic approach to assess the safety of microorganisms for use in food and feed. 

The list of microorganisms with QPS status has first been established in 2007 and is updated regularly. The next update of the QPS list is planned for December 2022, based on a scientific opinion carried out by EFSA’s Panel on Biological Hazards (BIOHAZ).

If QPS-Status is granted to a taxonomic unit or most commonly a species, these microorganisms do not need to undergo a full safety assessment. In order to obtain QPS-status, a microorganism must fulfill the following criteria:

  • Its taxonomic identity must be well-defined.
  • The available body of knowledge must be sufficient to establish its safety.
  • The lack of pathogenic properties must be established and substantiated.
  • Its intended use must be clearly described.

However, the QPS status of a species does not automatically exempt novel strains of this species from the Novel Food Regulation. Whereas QPS concerns the safety of the microorganisms, Novel Food (NF) concerns the history of safe use in food before 15 May 1997. In other words, QPS is not a criterion to decide on the novel food status of a microorganism per se. Thus, the history of consumption as or in food before 15 May 1997 is crucial to determine whether a strain of a microbial species with QPS is novel and requires a novel food application. But the QPS status of a species certainly makes the Novel Food authorization much easier.

If you wonder whether your novel microorganism needs an authorization to be used in food, you are invited to contact our experts and discuss your options.