Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2010 update)

Qualified presumption of safety, QPS, microorganisms, viruses
First published in the EFSA Journal
14 December 2010
9 December 2010
Scientific Opinion


EFSA is requested to assess the safety of a broad range of biological agents (including microorganisms and viruses) in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS) concept was developed by EFSA for its own use to provide a generic risk assessment approach applicable across EFSA’s scientific Panels, for biological agents notified for intentional use in the whole food chain. The safety of unambiguously defined biological agents at the highest taxonomic unit that is appropriate for the purpose for which an application is intended are assessed, considering if the body of knowledge is sufficient. Identified safety concerns for a taxonomic unit could be reflected as ‘qualifications’ when considered appropriate for an inclusion on the QPS list. The list of QPS recommended biological agents is reviewed and updated annually. The 2010 update reviews the previously assessed microorganisms including bacteria, yeasts, filamentous fungi and viruses used for plant protection purposes. The recommendations of biological agents of the previous year were confirmed in the current update. Qualifications relating to the agents recommended for QPS were reviewed, clarified and updated where necessary. Specific sections dealing with antibiotic resistance relevant for QPS recommended microorganisms and yeast were included. The methodology used for carrying out the annual review of the list of QPS recommended biological agents was detailed. A list of microbial species from previous notifications and as notified to EFSA, annexed in this opinion, includes information on taxonomic units which are or are not recommended for the QPS list. This list of notifications aims to summarize and maintain important information for future assessments and updates.

Panel members at the time of adoption

John Daniel Collins, Birgit Noerrung, Herbert Budka, Olivier Andreoletti, Sava Buncic, John Griffin, Tine Hald, Arie Havelaar, James Hope, Günter Klein, James McLauchlin, Christine Müller-Graf, Christophe Nguyen-The, Luisa Peixe, Miguel Prieto Maradona, Antonia Ricci, John Sofos, John Threlfall, Ivar Vågsholm and Emmanuel Vanopdenbosch
Panel on Biological Hazards
biohaz [at]
EFSA Journal 2010;8(12):1944
Question Number
On request from