Abstract
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) assessment 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 and the completeness of the body of knowledge are assessed. Identified safety concerns for a taxonomic unit are where sensible reflected as 'qualifications' when a recommendation for the QPS list is given. The list of QPS recommended biological agents is reviewed and updated annually. Therefore, the only valid list is the one in the most recent scientific opinion. The 2011 update reviews microorganisms previously assessed including bacteria, yeasts, filamentous fungi and viruses used for plant protection purposes and confirms the previous recommendations. The anamorph yeast form Phaffia rhodozyma of Xanthophyllomyces dendrorhous was included on the QPS list and to the qualification for yeasts 'absence of resistance to antimycotics used for medical treatment of yeast infections', the sentence was added that 'in the case of Saccharomyces cerevisiae this qualification applies for yeast strains able to grow above 37 °C'. The body of knowledge of filamentous fungi and enterococci was updated and their ineligibility for the QPS list confirmed.