Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA (2017-2019)

Abstract

The qualified presumption of safety (QPS) was developed to provide a safety pre-assessment within EFSA for microorganisms. Strains belonging to QPS taxonomic units (TUs) still require an assessment based on a specific data package, but QPS status facilitates fast track evaluation. QPS TUs are unambiguously defined biological agents assessed for the body of knowledge, their safety and their end use. Safety concerns are, where possible, to be confirmed at strain or product level, and reflected as 'qualifications'. Qualifications need to be evaluated at strain level by the respective EFSA units. The lowest QPS TU is the species level for bacteria, yeasts and protists/algae, and the family for viruses. The QPS concept is also applicable to genetically modified microorganisms used for production purposes if the recipient strain qualifies for the QPS status, and if the genetic modification does not indicate a concern. Based on the actual body of knowledge and/or an ambiguous taxonomic position, the following TUs were excluded from the QPS assessment: filamentous fungi, oomycetes, streptomycetes, Enterococcus faecium, Escherichia coli and bacteriophages. The list of QPS-recommended biological agents was reviewed and updated in the current opinion and therefore now becomes the valid list. For this update, reports on the safety of previously assessed microorganisms, including bacteria, yeasts and viruses (the latter only when used for plant protection purposes) were reviewed, following an Extensive Literature Search strategy. All TUs previously recommended for 2016 QPS list had their status reconfirmed as well as their qualifications. The TUs related to the new notifications received since the 2016 QPS opinion was periodically evaluated for QPS status in the Statements of the BIOHAZ Panel, and the QPS list was also periodically updated. In total, 14 new TUs received a QPS status between 2017 and 2019: three yeasts, eight bacteria and three algae/protists.

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

Figure 1

Workflow diagram describing how the QPS assessment is triggered by an application for market authorisation of a regulated product

Figure 2

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 3

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 4

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.