Qualified presumption of safety (QPS)
A wide variety of biological agents such as bacterial and fungal species or viruses used for plant protection purposes may be authorised in the European Union for use in the food and feed chain.
EFSA is requested to assess the safety of biological agents notified in the context of authorisation requests. A wide range of microorganisms and viruses have been or are expected to be referred to EFSA for safety assessment. EFSA’s Scientific Committee has recommended that EFSA panels use a common risk assessment approach in order to ensure a consistent approach: the Qualified Presumption of Safety (QPS).
EFSA maintains a list of the biological agents to which the QPS assessment can be applied. In 2007, the Scientific Committee set out the overall approach to be followed and established the first list of the biological agents. The QPS list is reviewed and updated annually by the Panel on Biological Hazards (BIOHAZ).
The QPS concept
The Qualified Presumption of Safety approach can be utilised for pre-market safety assessment of notified biological agents by all EFSA’s Scientific Panels. QPS aims at harmonising risk assessment and allowing risk assessors to focus on the microorganisms with the greatest risks or uncertainties.
A standing working group of the BIOHAZ Panel assesses the safety of biological agents taking into account:
- the definition of the taxonomic unit (establishing identity of the group)
- body of knowledge
- possible safety concerns (pathogenicity)
- intended end use.
If a defined taxonomic unit does not raise safety concerns or if any possible concerns can be excluded, the QPS approach can be applied and the taxonomic unit can be recommended to be included in the QPS list. Biological agents included in the QPS list usually undergo only a simplified assessment by the Scientific Panel concerned. In some cases additional specifications may have to be met which will require a separate assessment.
Biological agents not considered suitable for QPS will undergo a full safety assessment by the Panel responsible for the assessment of the authorisation request.
Biological agents recommended for the QPS list
The QPS approach is used for microorganisms of four broad categories within which the majority of species notified to EFSA fall and for viruses used for plant protection purposes:
- Gram-positive bacteria
- filamentous fungi
- viruses of the families Potyviridae and Baculoviridae
So far, no taxonomic units of filamentous fungi have been recommended for inclusion in the QPS list because the body of knowledge related in particular to a safe history of use has not been sufficient.
- EU database on active substances (European Commission, DG Health and Consumers)
- Animal nutrition (European Commission, DG Health and Consumers)
- Chemical safety of food (European Commission, DG Health and Consumers)