Scientific Opinion on the maintenance of the list of QPS microorganisms intentionally added to food or feed (2009 update)

Abstract

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) concept was developed by EFSA for its own use to provide a generic food safety 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 2009 update reviews the previously assessed microorganisms including bacteria, yeasts and filamentous fungi and assesses several additional notifications concerning gram-positive and gram-negative bacteria and yeasts. Lactobacillus cellobiosus, L. collinoides, Propionibacterium acidopropionici and Oenococcus oeni were included in the QPS list. No filamentous fungi were included because of potential production of toxic metabolites. For the first time viruses were assed. Insect viruses (Baculovirideae) and in the case of zucchini yellow mosaic viruses the Potyvirideae family as the highest possible taxonomic unit were added to the QPS list. Bacteriophages were considered as not appropriate for the QPS list. A potential presence of antimycotic resistance of yeasts referred to on the QPS list was considered. It was concluded that yeast strains resistant to antimycotics used for treatment of infections in humans might be of public health concern. KEY WORDSQualified presumption of safety, QPS, food, feed 1 On request of EFSA, Question No EFSA-Q

Probiotics in Pediatrics: How to Choose Effective and Safety Specimen for a Child

“…В целом среди микроорганизмов наилучший профиль безопасности имеют бифидобактерии, при применении которых не зарегистрировано случаев инфекционных осложнений терапии [13]. Европейское агентство по безопасности продуктов питания (European Food Safety Authority, EFSA) разработало свои критерии безопасности и качества пробиотиков с возможностью присвоения им статуса QPS (Qualified Presumption of Safety) [14]. Статус QPS -своеобразная гарантия безопасности микроорганизма, основанная на разумных доказательствах, при этом продукты и препараты, имеющие в своем составе такие микроорганизмы, при получении регистрационного статуса могут проходить оценку безопасности по сокращенной программе [14].…”

“…Европейское агентство по безопасности продуктов питания (European Food Safety Authority, EFSA) разработало свои критерии безопасности и качества пробиотиков с возможностью присвоения им статуса QPS (Qualified Presumption of Safety) [14]. Статус QPS -своеобразная гарантия безопасности микроорганизма, основанная на разумных доказательствах, при этом продукты и препараты, имеющие в своем составе такие микроорганизмы, при получении регистрационного статуса могут проходить оценку безопасности по сокращенной программе [14]. Для получения статуса QPS штамм микроорганизма должен соответствовать следующим критериям [14]:…”

Risk Assessment of Lactobacillus paracasei 8700:2 Used as "Other Substances"

“…The list of the microorganisms have been (and will be) regularly updated by EFSA (EFSA, 2007;EFSA, 2008a;EFSA, 2008b;EFSA, 2009; EFSA, 2010; EFSA, 2011; EFSA, 2012; EFSA, 2013; EFSA, 2015).…”

Statement on the update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 3: Suitability of taxonomic units notified to EFSA until September 2015

“…chlororaphis strains used for plant protection purposes were assessed by the Environmental Protection Agency in the United States and the Standing Committee on the Food Chain and Animal Health -Scientific Committee on Plant in Europe as posing no health concerns for humans (Anonymous, 2001(Anonymous, , 2002(Anonymous, , 2004OJEU, 2004)'. Nevertheless, Pseudomonas clororaphis is further described in the literature for its potential to produce secondary metabolites (EFSA BIOHAZ Panel, 2009). For example, a strain of P. chlororaphis was reported to be capable of producing rhamnolipids (Gunther et al, 2005).…”