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 to provide a harmonised generic pre-assessment to support safety risk assessments performed by 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' in connection with a recommendation for a QPS status. A total of 85 biological agents were notified to EFSA between October 2014 and March 2015. From those, 35 biological agents already had a QPS status and were not further evaluated, and 45 were also not included as they are filamentous fungi or enterococci, biological groups which have been excluded from the QPS activities since 2014. Two notifications referred to two taxonomic units which were evaluated for the QPS status, one of which was recommended for the QPS list: Xanthomonas campestris, only for the production of xanthan gum, while the other, Bacillus circulans, was not due to insufficient body of knowledge on a safe history of use in foods and feeds. Three notifications belonging to the genus Streptomyces were not evaluated for the QPS status, because the genus was recently considered not suitable for the QPS approach.
SUMMARYThe European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) to deliver a Scientific Opinion on the maintenance of the list of qualifies presumption of safety (QPS) biological agents intentionally added to food or feed. The request included three specific tasks as mentioned in the terms of reference (ToR).The BIOHAZ Panel decided to change the evaluation procedure: the publication of the overall assessment of the taxonomic units previously recommended for the QPS list, published in 2013, will be carried out after three years in a scientific opinion of the BIOHAZ Panel (December 2016).Meanwhile, that list of microorganisms will be maintained and frequently checked based on the evaluation of extensive literature reviews which will be updated regularly with new publications. Intermediate deliverables in the form of a Panel statement will be produced and published, should an assessment for a QPS classification of a microbiological agent notified to EFSA be requested by the Feed Unit, the Food Ingredients and Packaging (FIP) Unit, the Nutrition Unit or the Pesticides Unit. Evaluations of these notifications will be compiled in a single statement for periods of around six months. The results of these assessments will also be included in the scientific opinion of the BIOHAZ Panel to be published in December 2016. The '2013 updated list of QPS status recommended biological agents ...