The qualified presumption of safety assessment and its role in EFSA risk evaluations: 15 years past

Lieve Herman*, Marianne Chemaly, Pier Sandro Cocconcelli, Pablo Fernandez, Günter Klein, Luisa Peixe, Miguel Prieto, Amparo Querol, Juan Evaristo Suarez, Ingvar Sundh, Just Vlak, Sandra Correia

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

48 Citations (Scopus)


Microorganisms are intentionally added at different stages of the food and feed chain (food or feed additive, novel food or plant protection product) and are subjected to regulation and safety assessment by the European Food Safety Authority. Safety evaluation is based on application dossiers for market authorisation to the European Commission. The qualified presumption of safety (QPS) concept was developed in 20031 to provide a harmonised generic safety pre-appraisal of the above microorganisms. Unambiguously defined biological taxonomic units (TUs) are assessed for their body of knowledge, their safety and their end use. Identified safety concerns for a certain TU can be, where reasonable in number and not universally present, reflected as 'qualifications.' Strains belonging to TUs having QPS status may benefit of a fast track evaluation. The lowest TU for which the QPS status is granted is the species level for bacteria and yeasts and the family for viruses. The QPS concept is also applicable to genetically modified microorganisms used for production purposes. Based on the current body of knowledge and/or the ambiguous taxonomic position, some TUs, such as filamentous fungi, bacteriophages, Enterococcus faecium, Escherichia coli, Streptomyces spp. and Oomycetes, are not considered liable for QPS status.

Original languageEnglish
JournalFEMS Microbiology Letters
Issue number1
Early online date10 Dec 2018
Publication statusPublished - Jan 2019


  • EFSA safety assessment
  • QPS list
  • QPS opinion
  • QPS statement
  • qualified presumption of safety


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