Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 15: suitability of taxonomic units notified to EFSA until September 2021

Abstract

The qualified presumption of safety (QPS) approach was developed to provide a generic pre-evaluation of the safety of biological agents. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns are, where possible, confirmed at the species/strain or product level and reflected by 'qualifications'. The QPS list was updated in relation to the revised taxonomy of the genus <i>Bacillus</i>, to synonyms of yeast species and for the qualifications 'absence of resistance to antimycotics' and 'only for production purposes'. <i>Lactobacillus cellobiosus</i> has been reclassified as <i>Limosilactobacillus fermentum</i>. In the period covered by this statement, no new information was found that would change the status of previously recommended QPS taxonomic units (TU)s. Of the 70 microorganisms notified to EFSA, 64 were not evaluated: 11 filamentous fungi, one oomycete, one <i>Clostridium butyricum</i>, one <i>Enterococcus faecium</i>, five <i>Escherichia coli</i>, one <i>Streptomyces</i> sp., one <i>Bacillus nakamurai</i> and 43 TUs that already had a QPS status. Six notifications, corresponding to six TUs were evaluated: <i>Paenibacillus lentus</i> was reassessed because an update was requested for the current mandate. <i>Enterococcus lactis</i> synonym <i>Enterococcus xinjiangensis</i>, <i>Aurantiochytrium mangrovei</i> synonym <i>Schizochytrium mangrovei</i>, <i>Schizochytrium aggregatum</i>, <i>Chlamydomonas reinhardtii</i> synonym <i>Chlamydomonas smithii</i> and <i>Haematococcus lacustris</i> synonym <i>Haematococcus pluvialis</i> were assessed for the first time. The following TUs were not recommended for QPS status: <i>P. lentus</i> due to a limited body of knowledge, <i>E. lactis</i> synonym <i>E. xinjiangensis</i> due to potential safety concerns, <i>A. mangrovei</i> synonym <i>S. mangrovei</i>, <i>S. aggregatum</i> and <i>C. reinhardtii</i> synonym <i>C. smithii</i>, due to lack of a body of knowledge on its occurrence in the food and feed chain. <i>H. lacustris</i> synonym <i>H. pluvialis</i> is recommended for QPS status with the qualification 'for production purposes only'.