EFSA is requested to assess the safety of a broad range of biological agents 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 for safety risk assessments to provide a harmonised generic pre-assessment to support EFSA"s scientific Panels. The safety of unambiguously defined biological agents at the highest taxonomic unit 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 possible and reasonable in number reflected as "qualifications" with a recommendation for the QPS list. The list of QPS recommended biological agents is reviewed and updated annually. Therefore, the only valid list is the one in the most recently published scientific opinion. The 2012 update reviews microorganisms previously assessed including bacteria, yeasts, filamentous fungi and viruses used for plant protection purposes. The BIOHAZ Panel confirmed all taxonomic units previously recommended for the QPS list. The notifications were reviewed. Bacillus firmus was re-evaluated and not recommended for the QPS list. A new recommendation was made for Leuconostoc pseudomesenteroides. Carnobacterium maltaromaticum was assessed for the first time and not recommended for the QPS list. Qualifications for the taxonomic units included in the QPS recommended list were reviewed and confirmed. Filamentous fungi and enterococci were not recommended for the QPS list following updating and reviewing of current scientific knowledge. For Enterococcus faecium recent data indicate a possible distinction between pathogenic and non-pathogenic strains. This is considered too recent knowledge for a QPS recommendation, considering the recent information on the evolution of the epidemiology of Enterococcus infections in humans. Tasks three required, for the taxonomic units included in the QPS recommended list, a review and update of knowledge concerning antimicrobial resistance and a review of the qualifications. The information of the previous opinion was updated by the BIOHAZ Panel and the qualifications were confirmed.The final aspect included a review of the body of knowledge for filamentous fungi and enterococci. The BIOHAZ Panel updated the knowledge of filamentous fungi notified to EFSA. Although numerous data, published since the 2011 QPS opinion, have contributed to partially fulfil gaps of knowledge, too many unknowns remain in 2012 to allow a filamentous fungus to be recommended for the QPS list.Enterococcus faecium is not recommended for the QPS list in spite of the recent scientific knowledge allowing a differentiation of pathogenic from non-pathogenic strains. This is of value for the FEEDAP Scientific Panel dealing with the strain specific notification, but it is too recent knowledge for a QPS recommendation, considering the recent information on the evolution of the ep...
