Update of the list of QPS-recommended microbiological agents intentionally added to food or feed as notified to EFSA 16: suitability of taxonomic units notified to EFSA until March 2022

The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of microorganisms, intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. 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, safety concerns and occurrence of antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by 'qualifications'. In the period covered by this statement, no new information was found that would change the status of previously recommended QPS TUs. Of the 50 microorganisms notified to EFSA in October 2021 to March 2022 (inclusive), 41 were not evaluated: 10 filamentous fungi, 1 Enterococcus faecium, 1 Clostridium butyricum, 3 Escherichia coli and 1 Streptomyces spp. because are excluded from QPS evaluation, and 25 TUs that have already a QPS status. Nine notifications, corresponding to seven TUs were evaluated: four of these, Streptococcus salivarius, Companilactobacillus formosensis, Pseudonocardia autotrophica and Papiliotrema terrestris, being evaluated for the first time. The other three, Microbacterium foliorum, Pseudomonas fluorescens and Ensifer adhaerens were re-assessed. None of these TUs were recommended for QPS status: Ensifer adhaerens, Microbacterium foliorum, Companilactobacillus formosensis and Papiliotrema terrestris due to a limited body of knowledge, Streptococcus salivarius due to its ability to cause bacteraemia and systemic infection that results in a variety of morbidities, Pseudonocardia autotrophica due to lack of body of knowledge and uncertainty on the safety of biologically active compounds which can be produced, and Pseudomonas fluorescens due to possible safety concerns

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

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.publishedVersio

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 4: suitability of taxonomic units notified to EFSA until March 2016

EFSA was 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 preassessment 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 were assessed. Safety concerns identified 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 129 biological agents were notified to EFSA between September 2015 and March 2016. From these, 34 biological agents already had a QPS status and did not require further evaluation, and 63 were not included as they are filamentous fungi or enterococci, biological groups which have been excluded from the QPS activities since 2014. Five notifications for species belonging to Streptomyces genus, one for Paenibacillus lentus, four for Escherichia coli and one for one species of Actinomadura were not evaluated for QPS status because these species were recently assessed and considered not suitable for QPS status. Furthermore, it was agreed not to include nine notifications from Pesticides Unit as the respective dossiers (including the literature review) were not yet received. Therefore, there were 12 notifications related to 12 taxonomic units that were evaluated for QPS status. Pediococcus parvulus, Bacillus flexus and Lactobacillus diolivorans may be recommended for the QPS status. Candida rugosa, Cellulosimicrobium cellulans, Geobacillus caldoproteolyticus (Anoxybacilluscaldiproteolyticus), Aeribacillus pallidus (ex-Geobacillus pallidus), ‘Chryseobacterium proteolyticum’, Klebsiella pneumoniae, Paenibacillus macerans, ‘Protaminobacter rubrum’ and Pullulanibacillusnaganoensis are not recommended for the QPS list

Evaluation of the application for a new alternative processing method for animal by‐products of Category 3 material (ChainCraft B.V.)

EFSA received an application from the Dutch Competent Authority, under Article 20 of Regulation (EC)No 1069/2009 and Regulation (EU) No 142/2011, for the evaluation of an alternative method fortreatment of Category 3 animal by-products (ABP). It consists of the hydrolysis of the material to short-carbon chains, resulting in medium-chain fatty acids that may contain up to 1% hydrolysed protein, foruse in animal feed. A physical process, with ultrafiltration followed by nanofiltration to remove hazards, isalso used. Process efficacy has been evaluated based on the ability of the membrane barriers to retainpotential biological hazards present. Small viruses passing the ultrafiltration membrane will be retained atthe nanofiltration step, which represents a Critical Control Point (CCP) in the process. This step requiresthe Applicant to validate and provide certification for the specific use of the nanofiltration membranesused. Continuous monitoring and membrane integrity tests should be included as control measures in theHACCP plan. The ultrafiltration and nanofiltration techniques are able to remove particles of the size ofvirus, bacteria and parasites from liquids. If used under controlled and appropriate conditions, theprocessing methods proposed should reduce the risk in the end product to a degree which is at leastequivalent to that achieved with the processing standards laid down in the Regulation for Category 3material. The possible presence of small bacterial toxins produced during the fermentation steps cannotbe avoided by the nanofiltration step and this hazard should be controlled by a CCP elsewhere in theprocess. The limitations specified in the current legislation and any future modifications in relation to theend use of the product also apply to this alternative process, and no hydrolysed protein of ruminantorigin (except ruminant hides and skins) can be included in feed for farmed animals or for aquaculture

Updated quantitative risk assessment (QRA) of the BSE risk posed by processed animal protein (PAP)

EFSA was requested: to assess the impact of a proposed quantitative real-time polymerase chainreaction (qPCR)‘technical zero’on the limit of detection of official controls for constituents of ruminantorigin in feed, to review and update the 2011 QRA, and to estimate the cattle bovine spongiformencephalopathy (BSE) risk posed by the contamination of feed with BSE-infected bovine-derivedprocessed animal protein (PAP), should pig PAP be re-authorised in poultry feed and vice versa, usingboth light microscopy and ruminant qPCR methods, and action limits of 100, 150, 200, 250 and 300DNA copies. The current qPCR cannot discriminate between legitimately added bovine material andunauthorised contamination, or determine if any detected ruminant material is associated with BSEinfectivity. The sensitivity of the surveillance for the detection of material of ruminant origin in feed iscurrently limited due to the heterogeneous distribution of the material, practicalities of sampling andtest performance. A‘technical zero’will further reduce it. The updated model estimated a total BSEinfectivity four times lower than that estimated in 2011, with less than one new case of BSE expectedto arise each year. In the hypothetical scenario of a whole carcass of an infected cow entering the feedchain without any removal of specified risk material (SRM) or reduction of BSE infectivity via rendering,up to four new cases of BSE could be expected at the upper 95th percentile. A second modelestimated that at least half of the feed containing material of ruminant origin will not be detected orremoved from the feed chain, if an interpretation cut-off point of 100 DNA copies or more is applied. Ifthe probability of a contaminated feed sample increased to 5%, with an interpretation cut-off point of300 DNA copies, there would be a fourfold increase in the proportion of all produced feed that is contaminated but not detected.publishedVersio

Updated quantitative risk assessment (QRA) of the BSE risk posed by processed animal protein (PAP)

EFSA was requested: to assess the impact of a proposed quantitative real-time polymerase chainreaction (qPCR)‘technical zero’on the limit of detection of official controls for constituents of ruminantorigin in feed, to review and update the 2011 QRA, and to estimate the cattle bovine spongiformencephalopathy (BSE) risk posed by the contamination of feed with BSE-infected bovine-derivedprocessed animal protein (PAP), should pig PAP be re-authorised in poultry feed and vice versa, usingboth light microscopy and ruminant qPCR methods, and action limits of 100, 150, 200, 250 and 300DNA copies. The current qPCR cannot discriminate between legitimately added bovine material andunauthorised contamination, or determine if any detected ruminant material is associated with BSEinfectivity. The sensitivity of the surveillance for the detection of material of ruminant origin in feed iscurrently limited due to the heterogeneous distribution of the material, practicalities of sampling andtest performance. A‘technical zero’will further reduce it. The updated model estimated a total BSEinfectivity four times lower than that estimated in 2011, with less than one new case of BSE expectedto arise each year. In the hypothetical scenario of a whole carcass of an infected cow entering the feedchain without any removal of specified risk material (SRM) or reduction of BSE infectivity via rendering,up to four new cases of BSE could be expected at the upper 95th percentile. A second modelestimated that at least half of the feed containing material of ruminant origin will not be detected orremoved from the feed chain, if an interpretation cut-off point of 100 DNA copies or more is applied. Ifthe probability of a contaminated feed sample increased to 5%, with an interpretation cut-off point of300 DNA copies, there would be a fourfold increase in the proportion of all produced feed that is contaminated but not detected

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

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