Qualified presumption of safety (QPS)
A wide variety of biological agents (such as bacteria, yeasts, fungi or viruses) are intentionally added at different stages into the food and feed chain. These may be used on their own, or in additives, enzymes or as plant protection products. EFSA is required to assess the safety of these biological agents when they are proposed for use in regulated products that require market authorisation.
In 2007, EFSA’s Scientific Committee recommended that a Qualified Presumption of Safety (QPS) approach should be implemented across EFSA. This should apply equally to all safety considerations of biological agents that EFSA assesses. The Scientific Committee also set out the overall approach to follow and established the first list of proposed biological agents for QPS status.
The QPS list is reviewed by EFSA’s Panel on Biological Hazards (BIOHAZ). New biological agents recommended for QPS status are regularly added to the 2013 QPS list through a Panel statement.
The QPS concept and evaluation procedure
The QPS approach can be used for pre-market safety assessment of notified biological agents by all EFSA’s Scientific Units and Panels. The aim of QPS is to harmonise risk assessment and allow risk assessors to focus on the biological agents with the greatest risks or uncertainties.
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 a simplified assessment by EFSA. In some cases additional specifications (“qualifications”) 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 EFSA.
The QPS evaluation procedure consists of the following activities:
- assess the suitability of biological agents notified to EFSA for inclusion in the 2013 QPS list (evaluations are compiled and published in a statement of the Panel approximately every six months, regardless of whether they have already been assessed or not);
- include biological agents recommended for QPS status in the 2013 QPS list, which is regularly updated and published on the website;
- review new scientific information to check if biological agents previously included in the 2013 QPS list are still suitable for QPS status (a revised Panel scientific opinion will be published at the latest in December 2016).
Biological agents recommended for the QPS list
The QPS approach is currently used for microorganisms in the three broad categories within which the majority of species notified to EFSA fall: bacteria, yeasts and viruses.
Some biological groups have been excluded from QPS evaluation activities since 2014, as they are considered inappropriate for the QPS approach (bacteriophages) or the body of knowledge related to a safe history of use is considered to be insufficient (filamentous fungi and enterococci).