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Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA

EFSA Panel on Biological Hazards (BIOHAZ) et al. EFSA J. .

Abstract

EFSA is requested to assess the safety of a broad range of biological agents in the context of notification for market authorisation as sources of food and feed additives, food enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide a harmonised generic pre-assessment to support safety risk assessments performed by EFSA's scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended), and the completeness of the body of knowledge are assessed. Identified safety concerns for a taxonomic unit are, where possible and reasonable in number, reflected as 'qualifications' in connection with a recommendation for a QPS status. The list of QPS recommended biological agents was reviewed and updated in the current opinion and therefore becomes the valid list. The 2016 update reviews previously assessed microorganisms including bacteria, yeasts and viruses used for plant protection purposes following an Extensive Literature Search strategy. The taxonomic units related to the new notifications received since the 2013 QPS opinion, were periodically evaluated for a QPS status and the results published as Statements of the BIOHAZ Panel. Carnobacterium divergens, Lactobacillus diolivorans, Microbacterium imperiale, Pasteuria nishizawae, Pediococcus parvulus, Bacillus flexus, Bacillus smithii, Xanthomonas campestris and Candida cylindracea were recommended for the QPS list. All taxonomic units previously recommended for the 2013 QPS list had their status reconfirmed as well their qualifications with the exception of Pasteuria nishizawae for which the qualification was removed. The exclusion of filamentous fungi and enterococci from the QPS evaluations was reconsidered but monitoring will be maintained and the status will be re-evaluated in the next QPS Opinion update. Evaluation of bacteriophages should remain as a case-by-case procedure and should not be considered for QPS status.

Keywords: QPS; bacteria; food and feed; fungi; safety; virus; yeast.

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Figures

Figure 1
Figure 1
Workflow diagram describing how EFSA Units incorporate the QPS status into the safety assessment process of a microorganism notified through an application for market authorisation – overall process

  1. QPS: Qualified Presumption of Safety.

Figure 2
Figure 2
Workflow diagram describing how QPS status is assessed for the TU related to the microorganism notified to the EFSA Units under the frame of applications for market authorisation – elaboration of the BIOHAZ QPS Panel Statements

  1. BIOHAZ: Biological Hazards Panel; QPS: Qualified Presumption of Safety.

Figure 3
Figure 3
Workflow diagram describing how QPS status is reassessed for the TU included in the latest QPS list – elaboration of the BIOHAZ QPS Opinion

  1. BIOHAZ: Biological Hazards Panel; QPS: Qualified Presumption of Safety.

See this image and copyright information in PMC

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