Introduction Of A Qualified Presumption Of Safety (Qps) Approach For Assessment Of Selected Microorganisms Referred To Efsa

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.The Scientific Committee reviewed the range and numbers of microorganisms likely to be the subject of an EFSA opinion. They found that approximately 100 species of microorganisms have been or are expected to be referred to EFSA for a safety assessment; the majority being the result of notifications for market authorisation as sources of food and feed additives, food enzymes and plant protection products. A large majority of these species were found to fall within four broad groupings: i) Gram-positive non-sporulating bacteria; ii) Bacillus species, iii) yeasts and iv) filamentous fungi. Accordingly, bacteria, yeasts and fungi falling within these four groups were selected for an initial assessment of their suitability for QPS status. The Scientific Committee concluded that the weight of evidence available for many species falling within the first three of the four groups was sufficient to ensure that QPS status provided at least the same degree of confidence as a case-by-case safety assessment. However, the Committee found that, in the case of the filamentous fungi, the body of knowledge, particularly that relating to a history of use, was for a specific purpose and did not allow extrapolation to other uses to be made with confidence and so could not recommend QPS status for such fungi.As the number of organisms considered suitable for QPS status is sufficiently extensive to cover a majority of the safety assessments involving microorganisms required of EFSA, the Scientific Committee concluded that the introduction of a QPS system for microorganisms would meet the objectives of providing a practical tool for setting priorities and avoiding the extensive investigations of organisms known not to cause concern. Although QPS status of metabolic products of microorganisms cannot be inferred from the QPS status of the production strain, the Committee considered that the system still had value for the assessment of strains used in the production of such products. Further work, however, would be required to extend the system to encompass those microorganisms used for biological control purposes.Finally, in reaching its conclusion on the value of QPS as an assessment tool, the Scientific Committee recognised that there would have to be continuing provision for reviewing and modifying the list of organisms given QPS status. They recommended that the EFSA via its Science Directorate should take prime responsibility for this and should review the suitability for QPS status of the existing list and any additions at least annually. Reviews may occur more frequently as necessary but there should be a formal requirement that even when no changes are proposed, a statement should be made annually that QPS status is being maintained for the published list.