Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017

Abstract

The qualified presumption of safety (QPS) concept was developed to provide a harmonised generic pre‐evaluation to support safety risk assessments of biological agents performed by EFSA's scientific Panels. The identity, body of knowledge, safety concerns and antimicrobial resistance of valid taxonomic units were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, considered to be ‘qualifications’ which should be assessed at the strain level by the EFSA's scientific Panels. No new information was found that would change the previously recommended QPS taxonomic units and their qualifications. The BIOHAZ Panel confirms that the QPS approach can be extended to a genetically modified production strain if the recipient strain qualifies for the QPS status, and if the genetic modification does not indicate a concern. Between April and September 2017, the QPS notification list was updated with 46 applications for market authorisation. From these, 14 biological agents already had QPS status and 16 were not included as they are filamentous fungi or enterococci. One notification of Streptomyces K‐61 (notified as former S. griseoviridis) and four of Escherichia coli were not considered for the assessment as they belong to taxonomic units that were excluded from further evaluations within the current QPS mandate. Eight notifications of Bacillus thuringiensis and one of an oomycete are pending the reception of the complete application. Two taxonomic units were evaluated: Kitasatospora paracochleata, which had not been evaluated before, and Komagataella phaffii, previously notified as Pichia pastoris included due to a change in the taxonomic identity. Kitasatospora paracochleata cannot be granted QPS status due to lack of information on its biology and to its possible production of toxic secondary metabolites. The species Komagataella phaffii can be recommended for the QPS list when used for enzyme production.

The qualified presumption of safety assessment and its role in EFSA risk evaluations: 15 years past

“…Recent examples are: (i) the application of the QPS concept to safety assessment of GMMs used for production purposes (EFSA BIOHAZ Panel et al. 2018a), and (ii) the clarification of the qualification ‘for production purposes’ when microbial biomass is used for food and feed products (EFSA BIOHAZ Panel et al. 2018b).…”

“…In the case of genetically modified microorganisms (GMMs), for which the species of the recipient strain qualifies for the QPS status, and for which the genetically modified state does not give rise to safety concerns, the QPS approach can be extended to genetically modified production strains (EFSA BIOHAZ Panel et al. 2018a). The possible effect of the genetic modification on the safety of the product is assessed for each genetically modified strain by the respective EFSA unit.…”

Safety evaluation of the food enzyme α‐amylase from a genetically modified strain of Bacillus licheniformis (DP‐Dzb54)

“…The parental microorganism is the B. licheniformis strain ■■■■■. B. licheniformis is recommended for the Qualified Presumption of Safety (QPS) status, with the qualification that the absence of acquired antimicrobial resistance genes and toxigenic activity are verified for the specific strain used (EFSA BIOHAZ Panel, , ). The absence of cytotoxicity activity was confirmed for the parental strain ■■■■■ on CHO_K1 (Chinese hamster ovary cells) .…”

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

“…Mycotoxins, particularly ochratoxin A and fumonisins, are produced by many strains of A. niger (Blumenthal, 2004;Frisvad et al, 2007Frisvad et al, , 2011EFSA BIOHAZ Panel, 2018). the strain unable to produce ochratoxin A and fumonisins.…”