Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA 1 Opinion of the Scientific Committee

Abstract

SUMMARY A wide variety of microbial species are used in food and feed production. Some have a long history of apparent safe use, while others are less well understood and their use may represent a risk for consumers. Experience has shown that there is a need for a tool for setting priorities within the risk assessment of those microorganisms used in food/feed production referred to EFSA and consequently the subject of a formal assessment of safety. To meet this need a system was proposed for a pre-market safety assessment of selected groups of microorganisms leading to a “Qualified Presumption of Safety (QPS)”. In essence this proposed that a safety assessment of a defined taxonomic group (e.g. genus or group of related species) could be made based on four pillars (establishing identity, body of knowledge, possible pathogenicity and end use). If the taxonomic group did not raise safety concerns or, if safety concerns existed, but could be defined and excluded (the qualification) the grouping could be granted QPS status. Thereafter, any strain of microorganism the identity of which could be unambiguously established and assigned to a QPS group would be freed from the need for further safety assessment other than satisfying any qualifications specified. Microorganisms not considered suitable for QPS would remain subject to a full safety assessment. EFSA asked its Scientific Committee to consider whether this system could be used to harmonise approaches to the safety assessment of microorganisms across the various EFSA scientific panels. If so, the Committee was requested to develop a strategy for the introduction of an assessment system based on the QPS concept.