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 Bacillus, to synonyms of yeast species and for the qualifications ‘absence of resistance to antimycotics’ and ‘only for production purposes’. Lactobacillus cellobiosus has been reclassified as Limosilactobacillus fermentum. 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 Clostridium butyricum, one Enterococcus faecium, five Escherichia coli, one Streptomyces sp., one Bacillus nakamurai and 43 TUs that already had a QPS status. Six notifications, corresponding to six TUs were evaluated: Paenibacillus lentus was reassessed because an update was requested for the current mandate. Enterococcus lactis synonym Enterococcus xinjiangensis, Aurantiochytrium mangrovei synonym Schizochytrium mangrovei, Schizochytrium aggregatum, Chlamydomonas reinhardtii synonym Chlamydomonas smithii and Haematococcus lacustris synonym Haematococcus pluvialis were assessed for the first time. The following TUs were not recommended for QPS status: P. lentus due to a limited body of knowledge, E. lactis synonym E. xinjiangensis due to potential safety concerns, A. mangrovei synonym S. mangrovei, S. aggregatum and C. reinhardtii synonym C. smithii, due to lack of a body of knowledge on its occurrence in the food and feed chain. H. lacustris synonym H. pluvialis is recommended for QPS status with the qualification ‘for production purposes only’.

Summary

The European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) to deliver a Scientific Opinion on the maintenance of the qualified presumption of safety (QPS) list. The QPS list contains biological agents, intentionally added to food and feed, which have achieved QPS status. The request included three specific tasks as mentioned in the Terms of Reference (ToR).

The QPS process was developed to provide a harmonised generic pre‐evaluation procedure to support safety risk assessments of biological agents performed by EFSA’s scientific Panels and Units. This process assesses the taxonomic identity, body of relevant knowledge and safety of biological agents. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at strain or product level, reflected as ‘qualifications’ that should be assessed at the strain level by EFSA’s Scientific Panels. A generic qualification for all QPS bacterial TUs applies in relation to the absence of acquired genes conferring resistance to clinically relevant antimicrobials (EFSA, 2008).

The list of microorganisms is maintained and re‐evaluated approximately every 6 months in a Panel Statement. The Panel Statement also includes the evaluation of microbiological agents newly notified to EFSA within the previous 6‐month period.

The first ToR requires ongoing updates of the list of biological agents notified to EFSA, in the context of a technical dossier for safety assessment. The overall list (https://doi.org/10.5281/zenodo.3607183) was updated with the notifications received between April and September 2021. Within this period, 70 notifications were received by EFSA, of which 42 were proposed for evaluation in feed, 17 for use as food enzymes, food additives and flavourings, nine as novel foods and two as plant protection products. The new notifications received between April and September 2021 are included in the current Statement (see Appendix F).

The second ToR concerns the revision of the TUs previously recommended for the QPS list and their qualifications. For this revision, articles published from January until June 2021 were assessed. The articles were retrieved and assessed through an extensive literature search (ELS) protocol available in Appendix B (see https://doi.org/10.5281/zenodo.3607188) and the search strategies in Appendix C (see https://doi.org/10.5281/zenodo.3607192). No new information was found that would affect the QPS status of those TUs or their qualifications.

The QPS list was updated for the following items:

• Related to the recent revision of the taxonomy of the genus Bacillus, all the TUs belonging to a previously designated Bacillus species are transferred to the new species and both the previous and new names are included in the QPS list.

• Lactobacillus cellobiosus was first reclassified to as Lactobacillus fermentum, more recently renamed Limosilactobacillus fermentum.

• The qualification ‘QPS only applies when the species is used for production purposes with absence of viable cells in the product’ has been harmonised among the different TUs concerned.

• Synonyms of yeast species were added and the qualification ‘absence of resistance to antimycotics’ has been deleted for those yeast TUs for which the QPS status only qualifies for production purposes.

• The warning for the probiotic use of Saccharomyces cerevisiae has been deleted because this is out of the scope of the QPS assessment.

The third ToR requires a (re)assessment of new TUs notified to EFSA, for their suitability for inclusion in the updated QPS list at the Knowledge Junction in Zenodo (https://doi.org/10.5281/zenodo.1146566, Appendix E).

Six of the 70 notifications received, corresponding to six TUs, were evaluated for possible QPS status; Paenibacillus lentus was reassessed because an update was requested in relation to the current mandate. Enterococcus lactis synonym Enterococcus xinjiangensis, Aurantiochytrium mangrovei synonym Schizochytrium mangrovei, Schizochytrium aggregatum, Chlamydomonas reinhardtii synonym Chlamydomonas smithii and Haematococcus lacustris synonym Haematococcus pluvialis were assessed for the first time. The following conclusions were drawn:

• Paenibacillus lentus is not recommended for QPS status due to a limited body of knowledge.

• Enterococcus lactis; synonym Enterococcus xinjiangensis, is not recommended for QPS status due to potential safety concerns.

• Aurantiochytrium mangrovei; synonym Schizochytrium mangrovei, is not recommended for QPS status due to lack of a body of knowledge on its occurrence in the food and feed chain.

• Schizochytrium aggregatum is not recommended for QPS status due to lack of a body of knowledge on its occurrence in the food and feed chain.

• Chlamydomonas reinhardtii; synonym Chlamydomonas smithii; is not recommended for QPS status due to a limited body of knowledge on its use in the food and feed chain.

• Haematococcus lacustris synonym Haematococcus pluvialis is recommended for QPS status with the qualification ‘for production purposes only’.

Of the remaining 64 notifications, 43 notifications were related to TUs that already had QPS status and did not require further evaluation in this mandate. Twenty‐one notifications were not included in the assessment because they were related to microorganisms that are generally excluded from QPS evaluation (11 were notifications of filamentous fungi, one of oomycetes, one of Clostridium butyricum (bacterium), one of Enterococcus faecium (bacterium), five of Escherichia coli (bacterium), one of Streptomyces sp. (bacterium)) or because the TU was not valid (one Bacillus nakamurai).

1. Introduction

The qualified presumption of safety (QPS) approach was developed by the EFSA Scientific Committee to provide a generic concept for risk assessment within the European Food Safety Authority (EFSA) for microorganisms intentionally introduced into the food chain, in support of the respective Scientific Panels and Units in the context of market authorisations for their use in food and feed, requiring an EFSA safety assessment (EFSA, 2007). The list, first established in 2007, has been continuously revised and updated. A Panel Statement is published approximately every 6 months. These Panel Statements include the results of the assessment of relevant new papers related to the TUs with QPS status. They also contain the assessment of newly arrived TUs to the EFSA Units currently dealing with feed additives, food enzymes, food additives and flavourings, novel foods, plant protection products and Genetically Modified Organisms (GMO). After 3 years, a QPS opinion is published summarising the results of the Panel Statements published in that period.

1.1. Background and Terms of Reference as provided by EFSA

A wide variety of microorganisms are intentionally added at different stages of the food and feed chain. In the context of applications for market authorisation of these biological agents used, either directly or as sources of food and feed additives, food enzymes and plant protection products, EFSA is requested to assess their safety.

EFSA’s work on QPS activities began in 2004 when the Scientific Committee issued a scientific opinion in continuation of the 2003 working document ‘On a generic approach to the safety assessment of microorganisms used in feed/food and feed/food production’ prepared by a working group consisting of members of the former Scientific Committee on Animal Nutrition, the Scientific Committee on Food and the Scientific Committee on Plants of the European Commission.1 The document, made available for public consultation, proposed the introduction of the concept of Qualified Presumption of Safety (QPS), to be applied to selected groups of microorganisms. Microorganisms not considered suitable for QPS status would remain subject to a full safety assessment. EFSA management asked its Scientific Committee to consider whether the QPS approach could be applied to the safety assessment of microorganisms across the various EFSA Scientific Panels. In doing so, the Committee was required to take into account the response of the stakeholders to the QPS approach. In its 2005 opinion (EFSA Scientific Committee, 2005), the Scientific Committee concluded that the QPS approach could provide a generic assessment system that could be applied to all requests received by EFSA for the safety assessments of microorganisms deliberately introduced into the food and feed chain. Its introduction was intended to improve transparency and ensure consistency in the approach used across the EFSA Panels. Applications involving a taxonomic unit belonging to a species that falls within a QPS group do not require a full safety assessment.

Several taxonomic units (usually species for bacteria and yeasts; families for viruses) have been included in the QPS list, either following notifications to EFSA, or proposals made initially by stakeholders during a public consultation in 2005, even if they were not yet notified to EFSA (EFSA Scientific Committee, 2005). The EFSA Scientific Committee reviewed the range and numbers of microorganisms likely to be the subject of an EFSA Opinion and, in 2007, published a list of microorganisms recommended for the QPS list.

In their 2007 opinion (EFSA, 2007), the Scientific Committee recommended that a QPS approach should provide a generic concept to prioritise and to harmonise safety risk assessment of microorganisms intentionally introduced into the food chain, in support of the respective Scientific Panels and EFSA Units in the frame of the market authorisations for their use in the food and feed chain. The same Committee recognised that there would have to be continuing provision for reviewing and modifying the QPS list and in line with this recommendation, the EFSA Panel on Biological Hazards (BIOHAZ) took the prime responsibility for this and started reviewing annually the existing QPS list. In 2008, the first annual QPS update was published (EFSA, 2008).

In 2014, the BIOHAZ Panel, in consultation with the Scientific Committee, decided to change the revision procedure; the overall assessment of the taxonomic units previously recommended for the QPS list (EFSA BIOHAZ Panel, 2013) was no longer carried out annually but over a 3‐year period. From 2017, the search and revision of the possible safety concerns linked to those taxonomic units started instead to be carried out every 6 months through extensive literature searches (ELS). The update of the 2013 QPS list (EFSA BIOHAZ Panel, 2013) was done in 2016 (EFSA BIOHAZ Panel, 2017). From 2016 on, the QPS list (https://doi.org/10.5281/zenodo.1146566) and the list of notifications to EFSA (https://doi.org/10.5281/zenodo.3607183) are constantly updated, independent of the QPS opinion and available at the Knowledge Junction in Zenodo. The most recent QPS opinion (EFSA BIOHAZ Panel, 2020) summarises the main results of the 3‐year ELS on the QPS TUs, together with an update of the process for granting QPS status. In the meantime, every 6 months a Panel Statement, compiling the assessments for a QPS status of the microbiological agents notified to EFSA requested by the Feed Unit, the Food Ingredients and Packaging (FIP) Unit, the Nutrition Unit, the Pesticides Unit and the Genetically Modified Organisms (GMO) Unit, as well as the summary of each 6‐month ELS exercise, has been produced and published. Each QPS Panel Statement contains the evaluations of the new notifications for microorganisms submitted for possible QPS status. It also contains the result of a standardized extensive literature search performed every 6 months regarding possible new safety concerns related to the TUs already included in the QPS list. The data identified are used to decide whether any TU may or may not remain on the QPS list, and whether any qualifications need to be revised.

Establishing a QPS status is based on four pillars: [1] the taxonomic grouping (TU) for which QPS is sought (‘taxonomic identification’); [2] whether sufficient relevant information is available about the proposed group of organisms to conclude on human/animal exposure by food/ feed (‘body of knowledge’); [3] whether the grouping proposed contains known ‘safety concerns’ and, finally, [4] the intended end use (‘intended use’). If a hazard related to a TU is identified, which can be tested at the strain or product level, a ‘qualification’ to exclude that hazard may be established and added. The subject of these qualifications for the microbial strain under investigation is evaluated by the EFSA Unit to which the application dossier has been allocated. Absence of acquired genes coding for resistance to antimicrobials relevant for humans and animals is a generic qualification for all bacterial TUs; the absence of antimycotic resistance should be proven if the pertinent yeasts are to be used as viable organisms in the food or feed chains. The qualification ‘for production purpose only’ implies the absence of viable cells of the production organism in the final product and can also be applied to food and feed products based on microbial biomass (EFSA BIOHAZ Panel, 2020).

Because the QPS evaluation is, after its initial creation, only triggered through an application dossier notified to EFSA, the QPS list is not exhaustive.

In summary, the QPS evaluation provides a generic safety pre‐assessment approach for use within EFSA that covers safety concerns for humans, animals and the environment. In the QPS concept, a safety assessment of a defined taxonomic unit is performed independently of the legal framework under which the application is made in the course of an authorisation process. Although general human safety is part of the evaluation, specific issues connected to type and level of exposure of users handling the product (e.g. dermal contact, inhalation, ingestion) are not addressed. In the case of Genetically Modified Microorganisms (GMM) 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, 2018). The assessment of potential allergenic microbial residual components is beyond the QPS remit; however, if there is science‐based evidence for a microbial species it is reported. These aspects are separately assessed, where applicable, by the EFSA Panel responsible for assessing the application.

The lowest TU for which the QPS status is granted is the species level for bacteria, yeasts and protists/algae and family for viruses.

Filamentous fungi, bacteriophages, Streptomycetes, Oomycetes, Enterococcus faecium, Escherichia coli and recently also Clostridium butyricum (EFSA BIOHAZ Panel, 2020) are excluded from the QPS assessments based on an ambiguous taxonomic position or the possession of potentially harmful traits.

The Terms of Reference are as follows:

ToR 1: Keep updated the list of biological agents being notified in the context of a technical dossier to EFSA Units such as Feed, Pesticides, Food Ingredients and Packaging (FIP) and Nutrition, for intentional use directly or as sources of food and feed additives, food enzymes and plant protection products for safety assessment.

ToR 2: Review taxonomic units previously recommended for the QPS list and their qualifications when new information has become available. The latter is based on a review of the updated literature aiming at verifying if any new safety concern has arisen that could require the removal of a taxonomic unit from the list, and to verify if the qualifications still efficiently exclude safety concerns.

ToR 3: (Re) assess the suitability of new taxonomic units notified to EFSA for their inclusion in the QPS list. These microbiological agents are notified to EFSA and requested by the Feed Unit, the FIP Unit, the Nutrition Unit or by the Pesticides Unit.

2. Data and methodologies

2.1. Data

In reply to ToR 3, (re)assessment of the suitability of TUs notified within the time period covered by this Statement (from April to September 2021) was carried out. The literature review considered the identification, the body of knowledge, the potential safety concerns related to human and animal health and to the environment (EFSA BIOHAZ Panel, 2020). The environmental risk assessment of plant protection products is not included in the QPS assessment but carried out by the Pesticide Peer Review (PPR) Unit. The knowledge on relevant acquired antimicrobial resistance (AMR) is reflected in the safety sections.

Relevant databases, such as PubMed, Web of Science, CAB Abstracts or Food Science Technology Abstracts (FSTA) and Scopus, were searched, based on the judgement of the experts. More details on the search strategy, search keys and approach for each of the assessments are described in Appendix A. Only the literature that is considered, based on expert judgement, to be relevant for the QPS assessment is reflected in the Statement.

Only valid TUs covered by the relevant international committees on the nomenclature for microorganisms are considered for the QPS assessment.

2.2. Methodologies

2.2.1. Evaluation of a QPS recommendation for taxonomic units notified to EFSA

In response to ToR 1, the EFSA Units were asked to update the list of biological agents being notified to EFSA. A total of 70 notifications were received between April and September 2021, of which 42 were for evaluation for use in feed, 17 for use as food enzymes, food additives and flavourings, nine as novel foods and two as plant protection products (Table 1).

Table 1.

Notifications received by EFSA, per risk assessment area and by biological group, from April to September 2021

Risk assessment area	Not evaluated in this Statement		Evaluated in this Statement( b )	Total
Biological group	Already QPS	Excluded in QPS( a )
Feed	32	8	2	42
Bacteria	20	4	2	26
Filamentous fungi	0	4	0	4
Yeasts	12	0	0	12
Novel foods	1	4	4	9
Bacteria	0	2	0	2
Filamentous fungi	0	2	0	2
Protists/Algae	0	0	4	4
Yeasts	1	0	0	1
Plant protection products	0	2	0	2
Bacteria	0	1	0	1
Oomycetes	0	1	0	1
Viruses	0	0	0	0
Food enzymes, food additives and flavourings	10	7	0	17
Bacteria	7	2	0	9
Filamentous fungi	0	5	0	5
Yeasts	3	0	0	3
Genetically modified organism	0	0	0	0
Bacteria	0	0	0	0
Total	43	21	6	70

QPS: qualified presumption of safety.

^(a)The number includes 11 notifications of filamentous fungi, one of oomycetes, one of Clostridium butyricum (bacterium), one of Enterococcus faecium (bacterium), five of Escherichia coli (bacterium) and one of Streptomyces sp. (bacterium), all excluded from QPS evaluation, as well as one of Bacillus nakamurai, a TU that is not valid and therefore not suitable for the QPS approach.

^(b)6 notifications corresponding to six TUs, one of which was last evaluated in 2018 (Paenibacillus lentus) and five were evaluated for the first time (Enterococcus lactis synonym Enterococcus xinjiangensis, Aurantiochytrium mangrovei synonym Schizochytrium mangrovei and Schizochytrium aggregatum, Chlamydomonas reinhardtii synonym Chlamydomonas smithii, Haematococcus lacustris synonym Haematococcus pluvialis).

In response to ToR 3, six of the 70 notifications, corresponding to six TUs, were evaluated for possible QPS status, five of these (Enterococcus lactis synonym Enterococcus xinjiangensis, Aurantiochytrium mangrovei synonym Schizochytrium mangrovei and Schizochytrium aggregatum, Chlamydomonas reinhardtii synonym Chlamydomonas smithii, Haematococcus lacustris synonym Haematococcus pluvialis,) being evaluated for the first time. The other, Paenibacillus lentus was re‐assessed because an update was requested in the current mandate.

Of the remaining 64 notifications, 43 notifications were related to TUs that already had QPS status and did not require further evaluation in this mandate. A further 21 notifications were not included in the assessment because they were related to microorganisms that are generally excluded from QPS evaluation (11 were notifications of filamentous fungi, one of oomycetes, one of Clostridium butyricum (bacterium), one of Enterococcus faecium (bacterium), five of Escherichia coli (bacterium), one Streptomyces sp. (bacterium)) or because the TU was not valid (one Bacillus nakamurai).

2.2.2. Monitoring of new safety concerns related to species with QPS status

In reply to ToR 2, concerning the revision of the TUs previously recommended for the QPS list and their qualifications, an extensive literature search (ELS) was conducted as described in Appendix B – ELS protocol, see https://doi.org/10.5281/zenodo.3607188, and in Appendix C Search strategies – see https://doi.org/10.5281/zenodo.3607192, respectively. The search strategies were updated to include the following synonyms:

• Bacillus clausii: Alkalihalobacillus clausii

• Bacillus coagulans: Weizmannia coagulans

• Bacillus flexus: Priestia flexa

• Bacillus fusiformis: Lysinibacillus fusiformis

• Bacillus lentus: Lederbergia lentus

• Bacillus megaterium: Priestia megaterium

• Candida cylindracea: Limtongozyma cylindracea

• Lindnera jadinii: Cyberlindnera jadinii

• Yarrowia lipolytica: Candida lipolytica

The search period for Cyberlindnera jadinii and Candida lipolytica was extended to include articles from 2010 onwards, the other synonyms were searched for the period covering January–June 2021.

The Artificial Intelligence (AI) function was used for prescreening of papers for Bifidobacterium spp., lactobacilli, Lactococcus lactis, Bacillus spp. and yeasts, followed by a second screening of those articles carried out by two experts.

The aim of the ELS was to identify any publicly available scientific studies reporting on safety concerns for humans, animals or the environment, caused by QPS organisms since the previous QPS review (i.e. publications from January to June 2021).

For case reports of human infections or intoxications, important additional information includes whether specific negative health outcomes are confined to persons with conditions favouring opportunistic infections, e.g. immunosuppression, and whether transmission occurred through food or other routes (e.g. through medical devices). Studies indicating the presence of virulence factors (e.g. toxins and enzymes that may contribute to the pathogenicity of the microorganism) in the TU are also reported as relevant when identifying potential safety concerns.

Several of the QPS‐TUs are sporadically reported as causing infections in individuals with recognised predisposing conditions for the acquisition of opportunistic infections, e.g. cardiovascular conditions associated with endocarditis, people in the lower or upper age spectrum, or with other conditions which can lead to impairment of the immunological system, such as patients subjected to transplants, undergoing cancer therapy, suffering from physical trauma or tissue damage, or HIV patients. Moreover, gastrointestinal tract‐related conditions with, for example mucosal impairment and proton pump inhibitors can also be a predisposing factor for infection. Previous use of the microorganisms being assessed as food supplements for humans was reported in many of these cases. A living microorganism used as a food supplement does not fall under the remit of the QPS assessment because regulation does not require an EFSA assessment. Nevertheless, the QPS assessment takes into consideration these reports, extracting relevant information whenever justified. For a detailed protocol of the process and search strategies, refer to Appendices B and C.

After removal of duplicates, 2,478 records were submitted to the title screening step, which led to the exclusion of 2,291 of these. The remaining 187 records were found eligible for the title and abstract screening step, which led to the exclusion of 118 of these. Of the 69 articles that finally reached the article evaluation step (full text), 27 were considered to report a potential safety concern and were further analysed.

The flow of records from their identification by the different search strategies (as reported in Appendix C) to their consideration as potentially relevant papers for QPS is shown in Table 2.

Table 2.

Flow of records by search strategy step

Species	Title screening step	Title/abstract screening step	Article evaluation step (screening for potential relevance)	Article evaluation step (identification of potential safety concerns)
	Number of articles retrieved
Bacteria (total)	1713	94	25	10
Bacillus spp.( a )	249	25	5	3
Bifidobacterium spp.( a )	141	8	2	0
Carnobacterium divergens	1	1	1	0
Corynebacterium glutamicum	26	1	0	0
Gluconobacter oxydans/Xanthomonas campestris	265	3	0	0
Lactobacilli( a )	299	16	7	5
Lactococcus lactis ( a )	69	2	2	1
Leuconostoc spp.	88	8	5	1
Microbacterium imperiale	0	0	0	0
Oenococcus oeni	43	0	0	0
Pasteuria nishizawae	0	0	0	0
Pediococcus spp.	189	7	1	0
Propionibacterium spp.	32	2	0	0
Streptococcus thermophilus	311	21	2	0
Viruses (total)	69	0	0	0
Alphaflexiviridae/Potyviridae	42	0	0	0
Baculoviridae	27	0	0	0
Yeasts ( a )	500	62	39	17
Protists	28	12	4	0
Algae	168	19	1	0
Total	2478	187	69	27
Excluded	2291	118	42

^(a)The numbers of references pre‐screened by AI and excluded are not reported in the table and are for: Bifidobacterium spp. (142), lactobacilli (296), Lactococcus lactis (69), Bacillus spp. (271), yeasts (504).

3. Assessment

The search strategy (key words, literature databases, number of papers found) followed for the assessment of the suitability of TUs notified to EFSA for their inclusion in the updated QPS list (reply to ToR 3) can be found in Appendix A.

3.1. Taxonomic units evaluated during the previous QPS mandate and re‐evaluated in the current Statement

3.1.1. Bacteria

Paenibacillus lentus

Paenibacillus lentus has been previously evaluated and was not included in the QPS list due to lack of body of knowledge (EFSA BIOHAZ Panel, 2014, 2018).

Identity

P. lentus is an aerobic, endospore‐forming and rod‐shaped bacterium, belonging to the phylum Firmicutes. This species was described by Li et al. (2014). P. lentus is not a synonym of Bacillus lentus as demonstrated by the low percentage of 16S rRNA gene sequence identity of the corresponding type strains.

Body of knowledge

The type strain of P. lentus shows β‐mannanase activity and was isolated from soil. The endo‐1,4‐β‐d‐mannanase is of industrial interest and can be used as a feed additive (EFSA FEEDAP Panel, 2017, 2018). No new body of knowledge was found.

Safety concerns

No relevant information on P. lentus was found.

Conclusion on a recommendation for QPS status

Due to a limited body of knowledge, P. lentus is not recommended for QPS status.

3.2. Taxonomic units to be evaluated for the first time

3.2.1. Bacteria

Enterococcus lactis synonym Enterococcus xinjiangensis

Identity

Enterococcus lactis was originally isolated from dairy products and described by Morandi et al. (2012). The species Enterococcus xinjiangensis (Ren et al., 2016; Oren and Garrity, 2020) was accepted as a heterotypic synonym of E. lactis (Li and Gu, 2021). Belloso Daza et al. (2021) reassigned the strains of Enterococcus faecium clade B to E. lactis.

Body of knowledge

E. lactis was isolated from traditional chickpea liquid starter and dough samples for bakeries in Turkey (Gunduz et al., 2020), from traditional (raw) milk cheeses (Morandi et al., 2012; Mangia et al., 2016), artisanal animal rennet pastes (Cruciata et al., 2014) and a traditional cereal based Indian product (idli batter) (Thumu and Halami, 2012). Recent evidence supports the presence of E. lactis, which was previously identified as E. faecium clade B, in the human and animal gut (Belloso Daza et al., 2021).

Several strains of E. lactis show biotechnological properties, probiotic potential and bacteriocinogenic activities for application as starter, adjunct, protective or probiotic cultures in the food industry (Bauer et al., 2009; Sharma et al., 2012; Nami et al., 2015; Albano et al., 2018, 2020; Braïek et al., 2018a, 2018b, 2019,2018a, 2018b, 2019).

Safety concerns

There are insufficient data on the role in human infections and the presence of virulence genes of current ampicillin susceptible E. faecium clade B, that correspond to E. lactis (Freitas et al., 2018; Belloso Daza et al., 2021).

Conclusions on a recommendation for QPS status

Due to potential safety concerns, E. lactis is not recommended for QPS status.

3.2.2. Protists

Aurantiochytrium mangrovei synonym Schizochytrium mangrovei

Identity

Schizochytrium mangrovei isolated on decaying mangrove leaves from Goa, India was described in 1988 by Raghu‐Kumar. Yokoyama and Honda (2007) described Schizochytrium sensu lato and proposed three different genera, i.e. Schizochytrium sensu stricto, Aurantiochytrium and Oblongichytrium gen. nov. Aurantiochytrium mangrovei was proposed as the new name for S. mangrovei. The division into three genera was supported by 18S rRNA gene phylogenetic analysis (Yokoyama and Honda, 2007).

Many references still use the name S. mangrovei.

Body of knowledge

A. mangrovei is cultivated heterotrophically and is often tested for the production of omega‐3 fatty acids, squalene (Jiang et al., 2004; Unagul et al., 2005; Hoang et al., 2016, 2018; Hien et al., 2017) or biodiesel (Hong et al., 2013). Hoang et al. (2016) concluded that squalene isolated from A. mangrovei is a peroxisome proliferator‐activated receptor‐α agonist. Furthermore, studies showed potential effect on anti‐aging of A. mangrovei for Drosophila melanogaster (Huangfu et al., 2013), on anti‐inflammation of an ethanol extract on murine macrophage RAW264 cells (Takahashi et al., 2018) and on enrichment of highly unsaturated fatty acid rich freeze‐dried biomass of A. mangrovei for the rotifer Brachionus plicatilis (Estudillo‐del Castillo et al., 2009).

Safety concerns

Thom and Hong (2021) concluded that A. mangrovei TB17 bio‐oil met the Vietnamese food safety standard. According to the results of assessment of the acute toxicity in mice and the subchronic oral toxicity in rats for 90 days, the bio‐oil rich in omega 3–6 fatty acids is safe.

Conclusion on a recommendation for QPS status

A. mangrovei, synonym S. mangrovei, is not recommended for QPS status due to lack of a body of knowledge on its occurrence in the food and feed chain.

Schizochytrium aggregatum

Identity

Schizochytrium aggregatum was first described by Goldstein and Belsky (1964). S. aggregatum divides by successive bi‐partitioning to form tetrads of zoosporangia (Goldstein and Belsky, 1964). Eventually, the vegetative cells undergo a progressive cleavage to form zoospores (Moss, 1986). S. aggregatum can produce up to 64 zoospores, reniform to ovoid in shape, while the zoosporangium can reach up to 140 μm (Dick, 2001; Fossier Marchan et al., 2018). Yokoyama and Honda (2007) described Schizochytrium sensu lato as showing large pale‐yellow colonies due to the production of β‐carotene, which are characterised by successive binary divisions of its vegetative cells. The authors proposed three different genera, i.e. Schizochytrium sensu stricto, Aurantiochytrium and Oblongichytrium gen. nov. S. aggregatum is the only species within the genus Schizochytrium.

The division into three genera was supported by 18S rRNA gene phylogenetic analysis (Yokoyama and Honda, 2007).

Body of knowledge

S. aggregatum is a heterotrophic microorganism with industrial applications to produce omega‐3 fatty acids.

Safety concerns

No specific information regarding safety in relation to food or feed was found in literature for S. aggregatum.

Conclusion on a recommendation for QPS status

S. aggregatum is not recommended for QPS status due to lack of a body of knowledge on its occurrence in the food and feed chain.

3.2.3. Algae

Chlamydomonas reinhardtii synonym Chlamydomonas smithii

Identity

Chlamydomonas reinhardtii (heterotypic synonym Chlamydomonas smithii) is a freshwater green alga belonging to the family Chlamydomonadaceae and has a standing nomenclature (ITIS ‐ Report: Chlamydomonas reinhardtii). C. reinhardtii is of high interest in genomic research because of rapid growth and ability to grow easily on plates and in liquid media. C. reinhardtii can grow autotrophically with CO₂ as the carbon source, or heterotrophically by consuming acetate or mixotrophically when utilising CO₂ and acetate as the carbon source.

Body of knowledge

An extensive literature screening resulted in one relevant article addressing toxicological aspects of C. reinhardtii. Murbach et al. (2018) investigated the safety of C. reinhardtii for use as a nutritional human food ingredient. No evidence of mutagenicity or genotoxic activity, or toxicity was observed.

Safety concerns

The only toxicological study dealt with a single strain; no safety concerns were identified (Murbach et al., 2018).

Conclusion on a recommendation for QPS status

C. reinhardtii, synonym C. smithii, is not recommended for QPS status due to limited body of knowledge for its use in the food and feed chain.

Haematococcus lacustris synonym Haematococcus pluvialis

Haematococcus lacustris was evaluated in 2008 (EFSA, 2008) and was not recommended for QPS due to a lack of a body of relevant knowledge.

Identity

H. lacustris is a freshwater, unicellular green microalga described by Nakada and Ota (2016). Buchheim et al. (2013) indicated that Haematococcus isolates from diverse localities belonged to a single species based on similarities in their 18S and ITS2 rDNA sequences and currently, only one species is recognised in the genus. Confusingly, two names, Haematococcus lacustris and H. pluvialis, are currently used for this species. Nakada and Ota (2016) indicated H. lacustris as the correct name, however both names are used and are considered appropriate.

Body of knowledge

H. lacustris strains are well known producers of astaxanthin (Mota et al., 2021). Several studies assessed the safety of astaxanthin derived from H. lacustris and no adverse effects were observed within the use levels (Guerin et al., 2003; Spiller and Dewell, 2003; Satoh et al., 2009; Katagiri et al., 2012; EFSA NDA Panel, 2014; Régnier et al., 2015; Brendler and Williamson, 2019).

Steward et al. (2008) determined the no‐observed adverse‐effect‐levels (NOAEL) of the astaxanthin‐rich biomass from H. lacustris for male and female rats as 14,161 and 17,076 mg/kg body weight per day, or 465 and 557 mg astaxanthin/kg per day, respectively. For mice, no adverse effects of administration of astaxanthin from H. lacustris throughout pregnancy on mice were reported (Niu et al., 2020). In a recent study, sea bass fed with H. lacustris biomass‐containing diets did not show negative effects and results indicated that dietary supplementation with the suitable level (0.4–0.6%) of H. lacustris could promote certain performance parameters (Yu et al., 2021).

Safety concerns

No safety concerns on application of astaxanthin from H. lacustris and of the astaxanthin containing biomass were found in the literature.

Conclusion on a recommendation for QPS status

H. lacustris, synonym H. pluvialis, is recommended for QPS status with the qualification ‘for production purposes only’.

3.3. Monitoring of new safety concerns related to organisms on the QPS list

The summaries of the evaluation of the possible safety concerns for humans, animals or the environment described and published since the previous ELS exercise (i.e. articles published between January to June 2021 as described in Appendices B and C with reference to the articles selected as potentially relevant for the QPS exercise (Appendix D) for each of the TUs or groups of TUs that are part of the QPS list (Appendix E), are presented below.

3.3.1. Gram‐positive non‐sporulating bacteria

Bifidobacterium spp.

A search for papers potentially relevant for QPS‐listed Bifidobacterium spp. provided 283 references. The artificial intelligence (AI) analysis left 141. Title screening left eight references for abstract inspection, then two for a full article appraisal. This last step discarded the articles because no safety concerns were identified in these papers.

No articles were identified describing possible safety concerns related to the QPS‐listed Bifidobacterium species. Consequently, the QPS status of these species is not changed.

Carnobacterium divergens

A search for potentially relevant papers on C. divergens provided one reference. No article was considered relevant at the level of title screening for this TU. Consequently, the QPS status of C. divergens is not changed.

Corynebacterium glutamicum

A search for papers potentially relevant to the QPS evaluation of C. glutamicum provided 26 references. One paper reached the level of title and abstract screening but did not reach full text evaluation. Therefore, no new safety concerns were identified and the QPS status of C. glutamicum is not changed.

Lactobacilli

Analysis of papers referring to any of the QPS species formerly belonging to the genus Lactobacillus, and recently divided into 13 new genera, provided 595 references. The AI analysis left 299 articles. Title screening of these provided 16 references for abstract inspection, which further reduced their number to seven. One of them was not in English, another did not describe safety concerns, two (Jimenez‐Gutierrez et al., 2021; Tang et al., 2021) did not provide any information on the microbial identification methods used and one (Campisciano et al., 2020) tried to link vaginal Lactobacillus gasseri colonisation to infertility, but no data on the presence/absence of the organism in the vaginas of fertile women were provided. The two remaining articles described the case of a patient with pyogenic liver abscesses that rendered L. gasseri (Ramos‐Coria et al., 2021) and two cases of bacteraemia by Lacticaseibacillus rhamnosus (Bergas et al., 2021). These last two cases affected old patients with a history of cardiac comorbidities, while the L. gasseri infection occurred in a person that suffered previous multiple abdominal interventions (cholecystectomy, distal pancreatectomy, splenectomy and pancreaticojejunal anastomosis), all of which might have been predisposing conditions leading to the opportunistic infections described. Based on the available evidence as described above, the QPS status of any of the QPS species included in the former genus Lactobacillus is not changed.

Lactococcus lactis

A search for papers potentially relevant for the QPS status of L. lactis provided 138 references. The AI analysis left 69 papers. Title and abstract screenings of these reduced their number to two. No safety concerns were raised by one paper, while the other (El Hattabi et al., 2021) described a liver abscess in an immunocompetent 27‐year‐old person without co‐morbidities. However, the article does not describe how identification was performed and doubts on the correct assignation to L. lactis remain.

Based on the available evidence as described above, the QPS status of L. lactis is not changed.

Leuconostoc spp.

A search for papers potentially relevant for the QPS evaluation of Leuconostoc species provided 88 references. The analysis of their titles left eight articles for title/abstract screening. Five articles reached full text evaluation, and one dealt with possible safety concerns (Gagliardo et al., 2021). It was excluded because the identification procedures were considered unreliable. Consequently, the status of QPS‐listed Leuconostoc spp. is not changed.

Microbacterium imperiale

A search for papers potentially relevant for the QPS evaluation of Microbacterium imperiale provided no references for title/abstract screening. Consequently, the QPS status of M. imperiale is not changed.

Oenococcus oeni

A search for papers potentially relevant for the QPS evaluation of Oenococcus oeni provided 43 references. The analysis of their titles left no articles for title/abstract screening. Consequently, the QPS status of O. oeni is not changed.

Pediococcus spp.

A search for papers potentially relevant for the QPS evaluation of Pediococcus spp. provided 189 references. The analysis of their titles left seven articles for the title/abstract phase. One article reached the full text evaluation stage but did not identify a safety concern. Consequently, the status of QPS‐listed Pediococcus spp. is not changed.

Propionibacterium spp.

A search for papers potentially relevant for the QPS evaluation of Propionibacterium spp. provided 32 references. Following the analysis of their titles, two articles were selected for abstract screening or the full article evaluation phase, but no safety concerns were identified. Consequently, the status of QPS‐listed Propionibacterium spp. is not changed.

Streptococcus thermophilus

A search for papers potentially relevant for the QPS evaluation of Streptococcus thermophilus provided 311 references. The analysis of their titles left 21 articles for title and abstract screening. The two selected articles did not deal with safety concerns. Therefore, no article reached the evaluation phase, and the QPS status of S. thermophilus is not changed.

3.3.2. Gram‐positive spore‐forming bacteria

Bacillus spp.

A search for papers potentially relevant for Bacillus spp. provided 520 references. The AI analysis left 249 articles. The analysis of their titles left 25 articles for the abstract phase and, from these, five articles passed to the full text phase for further analysis. Two papers did not deal with safety concerns. Three papers were further analysed. Russo et al. (2021) reported a spondylodiscitis caused by Bacillus circulans (Niallia circulans) in a 65‐year‐old patient with hypertension without a link to food intake. The identification occurred by MALDI‐TOF MS and no further information, e.g. on cytotoxic properties, was provided. The paper of Khatri et al. (2021) described a bacteraemia case after probiotic use of Bacillus clausii by a 17‐ year‐old person. The identification to the species level was performed by MALDI‐TOF MS and confirmed by a ‘state reference laboratory’ without further details. Basit et al. (2021) reported the isolation of Bacillus subtilis strains from burn wounds in 11 patients without documenting the identification method.

The ELS did not identify any information that would change the status of members of Bacillus spp. included in the QPS list.

Geobacillus stearothermophilus

A search for papers potentially relevant for G. stearothermophilus provided 520 references. The AI analysis left 249 articles. The analysis of their titles by two experts left 25 articles and for five of these the full text was analysed. None dealt with this species. Consequently, the QPS status of G. stearothermophilus is not changed.

Pasteuria nishizawae

A search for papers potentially relevant for the QPS evaluation of P. nishizawae provided no reference. Consequently, the QPS status of P. nishizawae is not changed.

3.3.3. Gram‐negative bacteria

A search for papers potentially relevant to the QPS evaluation of G. oxydans and X. campestris provided 265 references.

Gluconobacter oxydans

The analysis of the titles left no paper. Consequently, the QPS status of G. oxydans is not changed.

Xanthomonas campestris

The analysis of the titles left three articles, which reached the evaluation phase for this TU, but neither eventually dealt with health or safety concerns. Consequently, the QPS status of X. campestris is not changed.

3.3.4. Yeasts

The ELS searches for potentially relevant studies on the yeasts with QPS status provided 1004 references. The AI analysis left 500 articles. After title screening, 62 studies remained for the title/abstract phase, and from these 39 articles passed to the full article appraisal. Out of these, 17 reported a possible safety concern.

The 17 studies that discussed potentially relevant safety concerns for QPS yeast species are discussed below.

For the species Candida cylindracea, Cyberlindnera jadinii, Hanseniaspora uvarum, Kluyveromyces lactis, Komagataella pastoris, Komagataella phaffi, Ogataea angusta, Saccharomyces bayanus, Saccharomyces pastorianus, Schizosaccharomyces pombe, Xanthophyllomyces dendrorhous and Zygosaccharomyces rouxii, no safety concerns were newly reported. Consequently, the QPS status does not change for these species.

Kluyveromyces marxianus

The anamorph name of K. marxianus is Candida kefyr.

Several studies reported opportunistic infections with K. marxianus in humans with various predisposing conditions but could not be appropriately evaluated due to uncertainties regarding methodology for species identification (Nurdin et al., 2021; Alp et al., 2021; Pedaci et al., 2021; Jyothi et al., 2021). Aldejohann et al. (2021) reported eye infection with K. marxianus following surgery (transplantation of a lamellar endothelial corneal graft). In a literature review, Bayoumi et al. (2021) found that K. marxianus was one of several yeasts that had been reported to cause gut fermentation syndrome (GFS), where consumed carbohydrates are converted to alcohol by the gut microbiota. Perez‐Traves et al. (2021) investigated factors potentially related to virulence in opportunistic strains of K. marxianus. All strains, but one, were positive in most virulence related factors and there were no general differences between strains of environmental/food origin and strains of clinical origin. Additionally, the extent to which the investigated properties actually contribute to the ability of K. marxianus to cause opportunistic infections is uncertain. In a study of virulence‐related properties of yeasts isolated from bovine milk, a minor fraction (eight of 66 isolates) were K. marxianus. These cows had subclinical signs of infection, but no signs of disease. Thus, it is uncertain whether the isolated strains can actually cause disease. Desnos‐Ollivier et al. (2021) reported in a retrospective study of antimycotic susceptibility in a collection of clinical yeasts that the K. marxianus strains (ca 1% of the more than 9,000 isolates) were susceptible to fluconazole, voriconazole and posaconazole.

In conclusion, the literature update showed mainly the isolation of K. marxianus from patients who are immunocompromised and/or have underlying disease. Also, methodological problems concerning identification (no confirmation by use of DNA‐based molecular methods) and source attribution were noted. Thus, the papers did not identify any information that would change the QPS status of K. marxianus.

Yarrowia lipolytica

The anamorph name of Y. lipolytica is Candida lipolytica.

Desnos‐Ollivier et al. (2021) reported in a retrospective study of antimycotic susceptibility in a collection of clinical yeasts that the Y. lipolytica strains (0.3% of more than 9,000 isolates) showed intermediate susceptibility to fluconazole.

The literature update did not identify any information that would change the current QPS status of Y. lipolytica.

Debaryomyces hansenii

The anamorph name of D. hansenii is Candida famata.

Two references related to possible concerns for human safety were identified. Ghaith et al. (2021) is a retrospective taxonomic study of a yeast collection from intensive care units of a hospital in Egypt but could not be evaluated appropriately regarding the methodology for species identification by conventional methods and MALDI‐TOF MS. Perez‐Traves et al. (2021) investigated factors potentially related to virulence in a collection of clinical and food/environmental isolated strains of D. hansenii, K. marxianus and W. anomalous. All the tested D. hansenii strains were positive for sporadic virulence‐related properties but there were no statistically significant differences between the clinical and the food/environmental isolates. As has been described above for K. marxianus, it is uncertain whether the strains can cause disease.

The reports on D. hansenii did not add any new information that would change the current QPS status of this species.

Saccharomyces cerevisiae

The anamorph form of S. cerevisiae is not described. A synonym of this species is Saccharomyces boulardii.

In a literature review, Bayoumi et al. (2021) found that S. cerevisiae was one of several yeasts that had been reported to be able to cause the gut fermentation syndrome (GFS), where consumed carbohydrates are converted to alcohol by the gut microbiota. In a retrospective study of cases of S. cerevisiae fungaemia, Poncelet et al. (2021) noted that in rare cases, administration of S. boulardii probiotics to patients with gastrointestinal diseases might lead to dissemination of the yeast across the epithelial barriers, and subsequent fungaemia. In a retrospective study, Desnos‐Ollivier et al. (2021) reported antimycotic susceptibility in a collection of clinical yeasts. The S. cerevisiae strains (61 of more than 9,000 isolates) had intermediate susceptibility to fluconazole.

The reports on S. cerevisiae did not add any new information that would change the current QPS status of this species.

Wickerhamomyces anomalus

The anamorph name of W. anomalus is Candida pelliculosa.

Seven publications reported potential safety concerns. Several studies reported opportunistic infections with W. anomalus in humans or neonate children with various predisposing conditions but could not be evaluated appropriately due to uncertainties or problems with the methodology used for identification of yeasts (Alp et al., 2021; Shubham et al., 2021; Zhang et al., 2021). Desnos‐Ollivier et al. (2021) reported antimycotic susceptibility of 36 strains of W. anomalus in a retrospective study of more than 9.000 clinical strains. Cai et al. (2021) reported a case of C. pelliculosa fungaemia in a neonatal boy. Due to several disease symptoms at birth, he immediately received airway pressure‐assisted ventilation, vitamin supplementation and intravenous fluid. He developed a fever after six days and was diagnosed with fungaemia after 24 days. C. pelliculosa was identified as the causative organism using blood culture, DNA sequencing and mass spectrometric analysis. He recovered after fluconazole therapy. Kaur et al. (2021) performed a systematic epidemiologic study on fungaemia caused by rare yeasts, and from a total of 127 isolates, 43 were identified as W. anomalous. Perez‐Traves et al. (2021) investigated factors potentially related to virulence and pathogenicity in a Galleria mellonella model for a collection of clinical and food/environmental isolates of D. hansenii, K. marxianus and W. anomalous. The W. anomalous clinical isolates were positive in several properties (growth to high temperatures, pseudohyphal growth and agar invasion) and differed statistically significantly from the food/environmental isolates with regard to such properties. The results suggest that these factors are likely to contribute to virulence in strains of W. anomalus causing opportunistic infections.

The literature update did not identify any information that would change the current QPS status of W. anomalus.

3.3.5. Protists

Aurantiochytrium limacinum

A search for papers potentially relevant for A. limacinum provided 28 articles. The analysis of their titles left 12 articles and for four of these the full text was analysed. No article indicated a safety concern, therefore the current QPS status of A. limacinum is not changed.

3.3.6. Algae

A search for papers potentially relevant for algae provided 168 articles. The analysis of their titles left 19 articles and for one of these the full text was analysed.

Euglena gracilis

No article dealt with potential safety concerns of E. gracilis. Therefore, the current QPS status of E. gracilis is not changed.

Tetraselmis chuii

No article dealt with potential safety concerns of T. chuii. Therefore, the current QPS status of T. chuii is not changed.

3.3.7. Viruses used for plant protection

Alphaflexiviridae and Potyviridae

A search for papers potentially relevant for the QPS evaluation of viruses of the Alphaflexiviridae and Potyviridae provided 42 references. After title screening, no paper reached the title/abstract screening stage, thus no new safety concern was identified. Therefore, the current QPS status remains unchanged.

Baculoviridae

A search for papers potentially relevant for the QPS evaluation of Baculoviridae provided 27 references. One article dealing with Baculoviridae passed the title screening but did not reach the full article evaluation stage, thus no new safety concern was identified. Therefore, the current QPS status remains unchanged.

4. Update of the QPS List

4.1. Taxonomic changes in bacilli included in the QPS list

Bacilli are an extremely heterogeneous group within the phylum Firmicutes, exhibiting great phylogenetic and phenotypic diversity. The species traditionally included important agents in industrial microbiology (antibiotic and enzyme producers), food (pathogens, spoilage and fermentation agents) and feed additives or plant protection products.

The systematics of the genus Bacillus has been recently revised (Gupta et al., 2020; Patel and Gupta, 2020) and several changes have been proposed to clarify the evolutionary relationships and taxonomic structure.

Reclassification of a number of TU, which are not related to the Subtilis or the Cereus clades, into other genera has been carried out. Based on phylogenetic and molecular evidence after studying more than 300 Bacillus/Bacillaceae genomes, Gupta et al. (2020) proposed 17 Bacillus species clades that are now recognised as novel genera. Additionally, Patel and Gupta (2020) proposed a transfer of species from several clades into 6 novel Bacillaceae genera.

In Table 3, the previous and current designations of the QPS Bacillus species are presented. To maintain continuity within the QPS list, all the TUs belonging to a previously designated Bacillus species are transferred to the new species. Both the previous and new names are included in the QPS list.

Table 3.

Previous and current designations of the QPS Bacillus species

Species included in the QPS list	New nomenclature
Bacillus amyloliquefaciens
Bacillus atrophaeus
Bacillus circulans	Niallia circulans
Bacillus clausii	Alkalihalobacillus clausii
Bacillus coagulans	Weizmannia coagulans
Bacillus flexus	Priestia flexa
Bacillus fusiformis	Lysinibacillus fusiformis
Bacillus lentus	Lederbergia lentus
Bacillus licheniformis
Bacillus megaterium	Priestia megaterium
Bacillus mojavensis
Bacillus paralicheniformis *
Bacillus pumilus
Bacillus smithii
Bacillus subtilis
Bacillus vallismortis
Bacillus velezensis**

^*Qualification: ‘absence of genetic information to synthesize bacitracin’.

^**Qualification: ‘absence of aminoglycoside production’.

4.2. Reassignment of Lactobacillus cellobiosus

Lactobacillus cellobiosus, originally described by Rogosa et al. (1953) has been deleted from the QPS list because the strains belonging to this species were first reclassified as Lactobacillus fermentum (Dellaglio et al., 2004), and more recently renamed Limosilactobacillus fermentum (Zheng et al., 2020).

4.3. Qualification ’QPS only applies when the species is used for production purposes’

The qualification ‘QPS only applies when the species is used for production purposes’ has been updated for consistency (Table 4).

Table 4.

Update on QPS qualifications

Taxonomic unit	Original qualification	Updated qualification
Gluconobacter oxydans	QPS only applies when the species is used for vitamin production	QPS applies for ‘production purposes only'*
Xanthomonas campestris	QPS only applies when the species is used for the production of xanthan gum.	QPS applies for ‘production purposes only'*
Candida cylindracea	QPS only applies when the species is used for enzyme production.	QPS applies for ‘production purposes only'*
Ogataea angusta	QPS only applies when the species is used for enzyme production.	QPS applies for ‘production purposes only'*
Microbacterium imperiale	QPS only applies when the species is used for enzyme production.	QPS applies for ‘production purposes only'*
Niallia circulans	‘For production purposes only…’	QPS applies for ‘production purposes only'*
Cyberlindnera jadinii	QPS only applies when the species is used for enzyme production	QPS applies for ‘production purposes only'*
Komagataella pastoris	QPS only applies when the species is used for enzyme production	QPS applies for ‘production purposes only'*
Komagataella phaffii	QPS only applies when the species is used for enzyme production	QPS applies for ‘production purposes only’*
Wickerhamomyces anomalus	QPS only applies when the species is used for enzyme production	QPS applies for ‘production purposes only’*

^*‘QPS applies for ‘production purposes only’ (the qualification ‘for production purpose only’ implies the absence of viable cells of the production organism in the final product and can also be applied for food and feed products based on microbial biomass)’.

For some TUs, data are lacking on the direct exposure of humans and animals to viable cells, while there is a long history of use of their fermentation products and/or their biomasses in the food and/or feed chain. This qualification implies the absence of viable production organisms in the final product and is also applicable to food and feed products based on the non‐viable biomass of the microorganism (EFSA BIOHAZ Panel, 2018).

4.4. Synonyms for yeast species

In the QPS list the following synonyms for yeast species were added: Candida lipolytica as the anamorph of Yarrowia lipolytica; Lindnera jadinii as a synonym to the new name Cyberlindnera jadinii; and Candida cylindracea as a synonym to the new name Limtongozyma cylindracea.

4.5. Qualification ‘absence of resistance to antimycotics’

The qualification ‘absence of resistance to antimycotics used for medical treatment of yeast infections in cases where viable cells are added to the food or feed chain’ has been deleted in those cases where the taxonomic unit is only qualified for QPS in the case of production purposes. This is because this qualification implies the absence of viable yeast cells in the product. This was the case for: Cyberlindnera jadinii, Komagataella pastoris, Komagataella phaffii, Limtongozyma cylindracea, Ogataea angusta, Wickerhamomyces anomalus, Yarrowia lipolytica.

In the case of Saccharomyces cerevisiae the qualification ‘absence of resistance to antimycotics used for medical treatment of yeast infections in cases where viable cells are added to the food or feed chain’ applies not only for strains able to grow at 37°C and above but to all strains that are used as viable cells.

4.6. Deletion of the note about Saccharomyces cerevisiae related to its probiotic use

The note ‘Saccharomyces cerevisiae, subtype boulardii is contraindicated for persons with fragile health, as well as for patients with a central venous catheter in place’ has been deleted. This concern is related to the probiotic use of this TU, which is out of the scope of the QPS assessment.

Conclusions

ToR 1: Keep updated the list of biological agents being notified, in the context of a technical dossier to EFSA Units (such as Feed, Food Ingredients and Packaging, Nutrition, Pesticides, Genetically Modified Microorganisms), for intentional use in feed and/or food or as sources of food and feed additives, enzymes, plant protection products for safety assessment:

• Between April and September 2021, the list of notifications was updated with 70 notifications that were received by EFSA, of which 42 were proposed for evaluation as feed additives, 17 for use as food enzymes, food additives and flavourings, nine as novel foods and two as plant protection products.

ToR 2: Review taxonomic units previously recommended for the QPS list and their qualifications when new information has become available:

• In relation to the results of the monitoring of possible new safety concerns relevant for the QPS list in the period January to June 2021, there were no results that would justify changing the status of any TU from the QPS list.

• The QPS list was updated for the following items:

  • – Related to the recent revision of the taxonomy of the genus Bacillus, all the TUs belonging to a previously designated Bacillus species are transferred to the new species and both the previous and new names are included in the QPS list.
  • – Lactobacillus cellobiosus (formerly Lactobacillus fermentum) has been deleted from the QPS list because the strains belonging to this species were reclassified as Limosilactobacillus fermentum.
  • – The qualification ‘QPS only applies when the species is used for production purposes with absence of viable cells in the product’ has been harmonised among the different TUs concerned.
  • – The QPS list was updated in relation to synonyms of yeast species.
  • – The qualification ‘absence of resistance to antimycotics’ has been deleted for those yeast TUs for which the QPS status only qualifies for production purposes.
  • – The warning for the probiotic use of Saccharomyces cerevisiae has been deleted because this is out of the scope of the QPS assessment.

ToR 3: (Re)assess the suitability of taxonomic units notified to EFSA not present in the current QPS list for their inclusion in that list:

• Out of the 70 notifications received between April and September 2021, 43 were related to TUs that already had QPS status and did not require further evaluation.

• Of the remaining 27 notifications, 21 notifications were related to microorganisms that are generally excluded from QPS evaluation (11 were notifications of filamentous fungi, one of oomycetes, one of Clostridium butyricum (bacterium), one of Enterococcus faecium (bacterium), five of Escherichia coli (bacterium), one of Streptomyces sp. (bacterium)), and one notification for Bacillus nakamurai was not suitable for the QPS approach because it is not a valid TU.

• Six notifications, corresponding to six TUs, were evaluated for possible QPS status. Paenibacillus lentus was re‐assessed because an update was requested in relation to the current mandate. Enterococcus lactis synonym Enterococcus xinjiangensis, Aurantiochytrium mangrovei synonym Schizochytrium mangrovei, Schizochytrium aggregatum, Chlamydomonas reinhardtii synonym Chlamydomonas smithii and Haematococcus lacustris synonym Haematococcus pluvialis were assessed for the first time:

  • – Paenibacillus lentus is not recommended for QPS status due to a limited body of knowledge.
  • – Enterococcus lactis, synonym Enterococcus xinjiangensis, is not recommended for QPS status due to potential safety concerns.
  • – Aurantiochytrium mangrovei synonym Schizochytrium mangrovei is not recommended for QPS status due to lack of a body of knowledge on its occurrence in the food and feed chain.
  • – Schizochytrium aggregatum is not recommended for QPS status due to lack of a body of knowledge on its occurrence in the food and feed chain.
  • – Chlamydomonas reinhardtii synonym Chlamydomonas smithii is not recommended for QPS status due to a limited body of knowledge for its use in the food and feed chain.
  • – Haematococcus lacustris synonym Haematococcus pluvialis is recommended for QPS status with the qualification ‘for production purposes only’.

Abbreviations

AI

artificial intelligence

AMR

antimicrobial resistance

BIOHAZ

EFSA Panel on Biological Hazards

ELS

extensive literature search

FEEDAP

EFSA Panel on Additives and Products or Substances used in Animal Feed

FIP

EFSA Food ingredients and Packaging Unit

FSTA

Food Science Technology Abstracts

GMM

genetically modified microorganism

GMO

EFSA Unit on Genetically Modified Organisms

MALDI‐TOF

matrix‐assisted laser desorption/ionization (MALDI), time‐of‐flight (TOF)

NDA

EFSA Panel on Nutrition, Novel Foods and Food Allergens

QPS

qualified presumption of safety

PPR

Pesticide Peer Review Unit

rDNA

ribosomal deoxyribonucleic acid

rRNA

ribosomal ribonucleic acid

ToR

Term(s) of reference

TU

taxonomic unit

WG

working group

Appendix A – Search strategy followed for the (re)assessment of the suitability of TUs notified to EFSA not present in the current QPS list for their inclusion in the updated list (reply to ToR 3)

A.1 Paenibacillus lentus

The search on PubMed led to 168 hits related to “Paenibacillus lentus”. All hits were screened for their relevance.

A.2 Enterococcus lactis

The search on PubMed led to 26 hits related to “Enterococcus lactis”. All hits were screened for their relevance.

A.3 Aurantiochytrium mangrovei synonym Schizochytrium mangrovei

A search on PubMed and Scopus (“Schizochytrium mangrovei”) or (“S. mangrovei”) or (“Aurantiochytrium mangrovei”) or (“A. mangrovei”) led to 21 and 48 hits of which 1 was considered relevant for the assessment.

A.4 Schizochytrium aggregatum

A search on PubMed, Scopus and ‘web of science’ (“Schizochytrium aggregatum") or (“S. aggregatum") or (“S. aggregatum") led to 33, 30 and 11 documents, respectively, of which none were considered relevant for the assessment.

A.5 Chlamydomonas reinhardtii synonym Chlamydomonas smithii

A search on PubMed (14.10.2021, Title and abstract, (“Chlamydomonas reinhardtii” or “C. reinhardtii”) AND (safety OR infect* OR diseas* OR toxi* OR antimicrobial resistance) led to 597 results of which 1 was considered appropriate for the assessment.

A.6 Haematococcus lacustris synonym Haematococcus pluvialis

A search on PubMed (12.8.2021, (“H. pluvialis“ OR “Haematococcus pluvialis”) AND (safety OR infect* OR diseas* OR toxi* OR antimicrobial resistance) led to 58 results of which 11 were considered appropriate for the assessment. Scopus and “Web of science” searches did not yield relevant new information. A search on (“Haematococcus lacustris” OR “H. lacustris”) AND (safety OR infect* OR diseas* OR toxi* OR antimicrobial resistance) in PubMed and Scopus did not yield information relevant for the assessment.

Appendix B – Protocol for Extensive literature search (ELS), relevance screening, and article evaluation for the maintenance and update of list of QPS‐recommended biological agents (reply to ToR 2)

The protocol for extensive literature search (ELS) used in the context of the EFSA mandate on the list of QPS‐recommended biological agents intentionally added to the food or feed (EFSA‐Q‐2020‐00080) is available on the EFSA Knowledge Junction community on Zenodo, at: https://doi.org/10.5281/zenodo.3607188

Appendix C – Search strategies for the maintenance and update of list of QPS‐recommended biological agents (reply to ToR 2)

The search strategies for each taxonomic unit (TU), i.e. the string for each TU and the search outcome, are available on the EFSA Knowledge Junction community on Zenodo at: https://doi.org/10.5281/zenodo.3607192

Appendix D – References selected from the ELS exercise with potential safety concerns for searches January to June 2021 (reply to ToR 2)

Gram‐Positive Non‐Sporulating Bacteria

Bifidobacterium spp.

None.

Carnobacterium divergens

None.

Corynebacterium glutamicum

None.

Lactobacilli

Bergas A, Rivera S, Torrecillas M and Cuervo G, 2021. Native and prosthetic transcatheter aortic valve infective endocarditis due to Lactobacillus rhamnosus. Enfermedades infecciosas y microbiologia clinica.

Campisciano G, Iebba V, Zito G, Luppi S, Martinelli M, Fischer L, De Seta F, Basile G, Ricci G and Comar M, 2021. Lactobacillus iners and gasseri, Prevotella bivia and HPV belong to the microbiological signature negatively affecting human reproduction. Microorganisms, 9, 39.

Jimenez‐Gutierrez JM, Pelaez‐Luna M and Campos‐Murguia A, 2021. A rare case of emphysematous gastritis caused by Lactobacillus fermentum in a patient with diabetes. Revista espanola de enfermedades digestivas: organo oficial de la Sociedad Espanola de Patologia Digestiva, 113, 670–671.

Ramos‐Coria D, Canto‐Losa J, Carrillo‐Vazquez D, Carbajal‐Morelos L, Estrada‐Leon R and Corona‐Rodarte E, 2021. Lactobacillus gasseri liver abscess and bacteremia: a case report. Bmc Infectious Diseases, 21.

Tan C, Howard JL and Bondy L, 2021. Lactobacillus paracasei infection of a total hip prosthesis. Canadian Medical Association Journal, 193, E74–E77.

Lactococcus lactis

El Hattabi K, Bouali M, Sylvestre K, Bensardi FZ, El Bakouri A, Khalid Z and Fadil A, 2021. Lactococcus lactis ssp lactis a rare cause of liver abscesses: a case report and literature review. International Journal of Surgery Case Reports, 81, 105831.

Leuconostoc spp.

Gagliardo C, Johnson E and Di Pentima MC, 2021. Leuconostoc lactis sepsis in a child with chromosomal 18 abnormality receiving enteral nutrition. Journal of Paediatrics and Child Health, 57, 17.

Microbacterium imperiale

None.

Oenococcus oeni

None.

Pediococci spp.

None.

Propionibacterium spp.

None.

Streptococcus thermophilus

None.

Gram‐Positive Spore‐forming Bacteria

Bacilli

Basit M, Siddique AB, Aslam B, Zahoor MA, Hussain R and Ulhaq M, 2021. Distribution and antimicrobial susceptibility profile of bacterial and fungal pathogens isolated from burn wounds in hospitalized patients. Journal of the Pakistan Medical Association, 71, 916–920.

Khatri AM, Rai S, Shank C, McInerney A, Kaplan B, Hagmann SHF and Kainth MK, 2021. A tale of caution: prolonged Bacillus clausii bacteraemia after probiotic use in an immunocompetent child. Access microbiology, 3, 000205.

Russo A, Tarantino U, D'Ettorre G, Della Rocca C, Ceccarelli G, Gasbarra E, Venditti M and Iundusi R, 2021. First report of spondylodiscitis caused by Bacillus circulans in an immunocompetent patient: clinical case and review of the literature. IDCases, 23, e01058.

Geobacillus stearothermophilus

None.

Pasteuria nishizawae

None.

Gram‐negative bacteria

Gluconobacter oxydans

None.

Xanthomonas campestris

None.

Yeasts

Aldejohann AM, Theuersbacher J, Haug L, Lamm OS, Walther G, Kurzai O, Hillenkamp J and Kampik D, 2021. First case of Kluyveromyces marxianus (Candida kefyr) late onset keratitis after lamellar endothelial corneal graft. Medical Mycology Case Reports, 32, 21–24.

Alp S, Gulmez D, Kardas RC, Karahan G, Tas Z, Gursoy G, Ayaz‐Ceylan CM, Arikan‐Akdagli S and Akova M, 2021. Expect the unexpected: fungemia caused by uncommon Candida species in a Turkish University Hospital. European Journal of Clinical Microbiology and Infectious Diseases, 40, 1539–1545.

Bayoumy AB, Mulder CJJ, Mol JJ and Tushuizen ME, 2021. Gut fermentation syndrome: a systematic review of case reports. United European Gastroenterology Journal, 9, 332–342.

Cai Z, Wei W and Cheng Z, 2021. Candida pelliculosa sepsis in a neonate: a case report. Journal of International Medical Research, 49, 300060520982804.

Collares Maia Castelo‐Branco DdS, Graca‐Filho RV, e Oliveira JS, Rocha MG, Araujo GdS, e Araujo Neto MP, Cordeiro RdA, Pereira‐Neto WdA, Costa Sidrim JJ, Nogueira Brilhante RS and Gadelha Rocha MF, 2021. Yeast microbiota of free‐ranging amphibians and reptiles from Caatinga biome in Ceara State, Northeast Brazil: high pathogenic potential of Candida famata. Ciencia Rural, 51.

Desnos‐Ollivier M, Lortholary O, Bretagne S and Dromer F, 2021. Azole susceptibility profiles of more than 9,000 clinical yeast isolates belonging to 40 common and rare species. Antimicrobial agents and chemotherapy, 65, e02615–20.

Ghaith D, Zafer MM, Hosny T and AbdElfattah M, 2021. MALDI‐TOF MS overcomes misidentification of the uncommon human pathogen Candida famata by routine phenotypic identification methods. Current Microbiology, 78, 1636–1642.

Huang Y‐S, Wang F‐D, Chen Y‐C, Huang Y‐T, Hsieh M‐H, Hii I‐M, Lee Y‐L, Ho M‐W, Liu C‐E, Chen Y‐H and Liu W‐L, 2021. Original article high rates of misidentification of uncommon Candida species causing bloodstream infections using conventional phenotypic methods. Journal of the Formosan Medical Association, 120, 1179–1187.

Jyothi L, Reddy NP and Naaz S, 2021. An unusual case of Candida kefyr Fungemia in an immunocompromised patient. Cureus, 13, e14138.

Kaur H, Singh S, Mandya Rudramurthy S, Jayashree M, James Peters N, Ray P, Samujh R, Ghosh A and Chakrabarti A, 2021. Fungaemia due to rare yeasts in paediatric intensive care units: a prospective study. Mycoses, 64, 1387–1395.

Moravkova M, Huvarova V, Vlkova H, Kostovova I and Bacova R, 2021. Raw bovine milk as a reservoir of yeast with virulence factors and decreased susceptibility to antifungal agents. Medical Mycology, 59, 1032–1040.

Nurdin RSC, Vitayani S, Amin S, Kadir D, Djamaluddin W and Adriani A, 2021. Cutaneous candidiasis caused by Candida kefyr. Pan African Medical Journal, 38, 178.

Pedaci FA, Filippeschi C, Giovannini M, Dolce D and Oranges T, 2021. Kerion‐Like Scalp Mycosis Caused by Candida kefyr. The Journal of Pediatrics, 235, 298–300.

Perez‐Traves L, e Llanos R, Flockhart A, Garcia‐Domingo L, Groenewald M, Perez‐Torrado R and Querol A, 2021. Virulence related traits in yeast species associated with food; Debaryomyces hansenii, Kluyveromyces marxianus, and Wickerhamomyces anomalus. Food Control, 124.

Poncelet A, Ruelle L, Konopnicki D, Deyi VYM and Dauby N, 2021. Saccharomyces cerevisiae fungemia: risk factors, outcome and links with S. boulardii‐containing probiotic administration. Infectious Diseases Now, 51, 293–295.

Shubham S, Naseeruddin S, Rekha US, Priyadarshi M, Gupta P and Basu S, 2021. Y Wickerhamomyces anomalus: a rare fungal sepsis in neonates. Indian Journal of Pediatrics, 88, 838.

Zhang Z, Cao Y, Li Y, Chen X, Ding C and Liu Y, 2021. Risk factors and biofilm formation analyses of hospital‐acquired infection of Candida pelliculosa in a neonatal intensive care unit. Bmc Infectious Diseases, 21, 620.

Protists/algae

None.

Viruses used for plant protection

Alphaflexiviridae

None.

Potyviridae

None.

Baculoviridae

None.

Appendix E – Updated list of QPS Status recommended biological agents in support of EFSA risk assessments

The list of QPS status recommended biological agents (EFSA BIOHAZ Panel, 2020) is being maintained in accordance with the mandate of the BIOHAZ Panel (2020–2022), extended for the following years. Possible additions to this list are included approximately every 6 months, with the last Panel Statement (15) adopted in December 2021 (EFSA BIOHAZ Panel, 2022). These additions are published as updates to the Scientific Opinion (EFSA BIOHAZ Panel, 2020); the updated QPS list is available at https://doi.org/10.5281/zenodo.1146566 and, as of January 2018, also as supporting information linked to every Panel Statement.

Appendix F – Microbial species as notified to EFSA, received between April 2021 and September 2021 (reply to ToR 1)

Species	Strain	EFSA risk assessment area	Category Regulated product	Intended usage	EFSA Question No ( a )	Previous QPS status of the respective TU( b )	Assessed in this Statement? Yes or no
Algae
Chlamydomonas reinhardtii		Novel foods	Novel Food		EFSA‐Q‐2021‐00476	No	Yes
Haematococcus pluvialis		Novel foods	Novel Food	Production of algal meal and oleoresin as novel foods	EFSA‐Q‐2021‐00319	No	Yes
Schizochytrium aggregatum		Novel foods	Novel Food	Production of docosahexaenoic acid (DHA; 4Z,7Z,10Z,13Z,16Z,19Z)‐docosa‐4,7,10,13,16,19‐hexaenoic acid; CAS# 6217‐54‐5)‐rich oil	EFSA‐Q‐2021‐00168	No	Yes
Schizochytrium mangrovei		Novel foods	Novel Food	Production of docosahexaenoic acid (DHA; 4Z,7Z,10Z,13Z,16Z,19Z)‐docosa‐4,7,10,13,16,19‐hexaenoic acid; CAS# 6217‐54‐5)‐rich oil	EFSA‐Q‐2021‐00168	No	Yes
Bacteria
Bacillus amyloliquefaciens	Ba‐BPD1 (DSM 21836)	Feed additives	Zootechnical additives	Digestibility enhancer and gut flora stabiliser Preparation containing 3 active substances, one enzyme (endo‐1,4‐β‐xylanase) and 2 viable Bacillus spp. (B. amyloliquefaciens Ba‐BPD1 (DSM 21836) and B. licheniformis PWD‐1 (ATCC 53757)).	EFSA‐Q‐2021‐00312	Yes	No
Bacillus licheniformis	Ca63 ‐ DSM 9552, NZYM‐AY (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme alpha amylase	EFSA‐Q‐2021‐00292	Yes	No
Bacillus licheniformis	Ca63 ‐ DSM 9552, NZYM‐CB (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme subtilisin	EFSA‐Q‐2021‐00295	Yes	No
Bacillus licheniformis	Ca63 ‐ DSM 9552, NZYM‐DI (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme Phosphoinositide Phospholipase C	EFSA‐Q‐2021‐00225	Yes	No
Bacillus licheniformis	Ca63 ‐ DSM 9552, NZYM‐JQ (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme glutaminase	EFSA‐Q‐2021‐00290	Yes	No
Bacillus licheniformis	Ca63 ‐ DSM 9552, NZYM‐LU (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme pullulanase	EFSA‐Q‐2021‐00222	Yes	No
Bacillus licheniformis	PWD‐1 (ATCC 53757)	Feed additives	Zootechnical additives	Digestibility enhancer and gut flora stabiliser Preparation containing 3 active substances, one enzyme (endo‐1,4‐β‐xylanase) and 2 viable Bacillus spp. (B. amyloliquefaciens Ba‐BPD1 (DSM 21836) and B. licheniformis PWD‐1 (ATCC 53757))	EFSA‐Q‐2021‐00312	Yes	No
Bacillus nakamurai	F727	Plant protection products	Plant Protection Product	Fungicide against plant pathogenic fungi (e.g. foliar spray applications in grape, legume vegetable crops, application in the furrow lanes for planting potatoes). In particular, Plasmopara viticola, Sclerotinia spp., Rhizoctonia solani and Phytophthora erythroseptica	EFSA‐Q‐2021‐00027	No	No
Bacillus subtilis	RH1018b, AR‐453 (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme maltogenic amylase	EFSA‐Q‐2021‐00299	Yes	No
Bacillus subtilis	RH1018b, AR‐651 (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme alpha amylase	EFSA‐Q‐2021‐00307	Yes	No
Bacillus velezensis	ABS1704	Feed additives	Zootechnical additives	Gut flora stabiliser for chickens for fattening, turkeys for fattening, chickens reared for laying, minor poultry species and turkeys reared for breeding	EFSA‐Q‐2021‐00240	Yes	No
Bacillus velezensis	DSM 15544 (previously B. subtilis C‐3102)	Feed additives	Zootechnical additives	Gut flora stabiliser for chickens reared for laying; breeding chickens; turkeys for rearing/fattening and breeding/laying; minor poultry species and all other avian species for rearing/fattening and laying/breeding	EFSA‐Q‐2021‐00169	Yes	No
Bacillus velezensis	DSM 15544 (previously B. subtilis C‐3102)	Feed additives	Zootechnical additives	Gut flora stabiliser for dairy cows and other dairy ruminants	EFSA‐Q‐2021‐00206	Yes	No
Clostridium butyricum	FERM BP‐2789	Feed additives	Zootechnical additives	Gut flora stabiliser Zootechnical feed additive for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds)	EFSA‐Q‐2021‐00384	No	No
Corynebacterium glutamicum	CGMCC 17927 (GMM)	Feed additives	Nutritional additives	Amino acids, their salts and analogues Enhance L‐lysine production efficacy	EFSA‐Q‐2021‐00439	Yes	No
Corynebacterium glutamicum	CGMCC 20516	Feed additives	Nutritional additives	Amino acids, their salts and analogues Production of L‐Arginine	EFSA‐Q‐2021‐00494	Yes	No
Enterococcus faecium	strain WF‐3	Feed additives	Zootechnical additives	Gut flora stabiliser for dogs	EFSA‐Q‐2021‐00383	No	No
Enterococcus lactis	NCIMB 10415	Feed additives	Zootechnical additives	Gut flora stabiliser	EFSA‐Q‐2020‐00391	No	Yes
Escherichia coli	K12, NITE BP‐02917 (AJ111507) (GMM)	Feed additives	Nutritional additives	As nutritional (amino acids, their salts and analogues) and as sensory feed additives (flavouring compound). Production of L‐lysine	EFSA‐Q‐2021‐00462	No	No
Escherichia coli	K12, (DH1 MDO) MAP 1834 DSM 33416 (GMM)	Novel foods	Novel Food	Production of 3‐fucosyllactose	EFSA‐Q‐2021‐00354	No	No
Escherichia coli	K12, LE1B109_pPB129 (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme sucrose phosphorylase	EFSA‐Q‐2021‐00291	No	No
Escherichia coli	K12, LE1B109_pPB130 (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme cellobiose phosphorylase	EFSA‐Q‐2021‐00297	No	No
Escherichia coli	W (SGR5) (ATCC 9637 – ATCC, 2020)	Novel foods	Novel Food	Production of 2′‐fucosyllactose from glucose and lactose	EFSA‐Q‐2021‐00407	No	No
Lacticaseibacillus casei	K9‐1	Feed additives	Zootechnical additives	Gut flora stabiliser for dogs	EFSA‐Q‐2021‐00383	Yes	No
Lactiplantibacillus plantarum	CNCM I‐3235 (DSM 11672)	Feed additives	Technological additives	Silage additive	EFSA‐Q‐2021‐00426	Yes	No
Lactiplantibacillus plantarum	CNCM I‐3736 (DSM 11672)	Feed additives	Technological additives	Silage additive	EFSA‐Q‐2021‐00426	Yes	No
Lactococcus lactis	NCIMB 30117	Feed additives	Technological additives	Silage additive	EFSA‐Q‐2021‐00237	Yes	No
Lentilactobacillus buchneri	CNCM I‐4323 (NCIMB 40788)	Feed additives	Technological additives	Silage additive	EFSA‐Q‐2021‐00426	Yes	No
Lentilactobacillus hilgardii	CNCM I‐4785	Feed additives	Technological additives	Silage additive	EFSA‐Q‐2021‐00426	Yes	No
Levilactobacillus brevis	WF‐1B	Feed additives	Zootechnical additives	Gut flora stabiliser for dogs	EFSA‐Q‐2021‐00383	Yes	No
Limosilactobacillus fermentum	K9‐2	Feed additives	Zootechnical additives	Gut flora stabiliser for dogs	EFSA‐Q‐2021‐00383	Yes	No
Paenibacillus lentus	CMG3376 (DSM 33618) (GMM)	Feed additives	Technological additives	Digestibility enhancers Production of endo‐1,4‐Beta‐D‐mannanase	EFSA‐Q‐2021‐00346	No	Yes
Pediococcus acidilactici	CNCM I‐3237 (DSM 11673)	Feed additives	Technological additives	Silage additive	EFSA‐Q‐2021‐00426	Yes	No
Pediococcus acidilactici	CNCM I‐4622 (DSM 11673)	Feed additives	Technological additives	Silage additive	EFSA‐Q‐2021‐00426	Yes	No
Pediococcus pentosaceus	DSM 32292	Feed additives	Technological additives	Silage additive	EFSA‐Q‐2021‐00530	Yes	No
Pediococcus pentosaceus	NCIMB 12455	Feed additives	Technological additives	Silage additive	EFSA‐Q‐2021‐00426	Yes	No
Acidipropionibacterium acidipropionici	CNCM I‐4661	Feed additives	Technological additives	Silage additive	EFSA‐Q‐2021‐00426	Yes	No
Streptomyces cinnamonensis	28682	Feed additives	Coccidiostat	Coccidiostat to be used for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breading. Monensin sodium (Carrier Perlite, Calcium Carbonate)	EFSA‐Q‐2020‐00405	No	No
Filamentous Fungi
Aspergillus oryzae	A1560 (IFO 04177), NZYM‐BU (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme leucyl aminopeptidase	EFSA‐Q‐2021‐00224	No	No
Aspergillus oryzae	A1560 (IFO 04177), NZYM‐MK (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme carboxypeptidase D	EFSA‐Q‐2021‐00223	No	No
Aspergillus oryzae	A1560 (IFO 04177), NZYM‐LJ (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme phospholipase A1	EFSA‐Q‐2021‐00226	No	No
Aspergillus oryzae	DMS 33699	Feed additives	Zootechnical additives	Digestibility enhancer Production of 6‐phytase	EFSA‐Q‐2021‐00342	No	No
Fusarium spp.	Fusarium strain flavolapis	Novel foods	Novel food	Production of a nutritional fungi protein	EFSA‐Q‐2021‐00519	No	No
Mortierella alpina		Novel foods	Novel Food	Production of arachidonic acid‐rich oil	EFSA‐Q‐2021‐00317	No	No
Trichoderma citrinoviride	B‐125	Feed additives	Zootechnical additives	Digestibility enhancer Production of endo 1,4 betaxylanase endo 1,4 betaglucanase(cellulase) xyloglucan‐specific‐endo‐beta‐1,4‐glucanase (xyloglucanase)	EFSA‐Q‐2021‐00308	No	No
Trichoderma citrinoviride	Bisset IM SD 135	Feed additives	Zootechnical additives	Digestibility enhancer Production of endo‐1,4‐beta‐xylanase	EFSA‐Q‐2021‐00153	No	No
Trichoderma reesei	RF4847 (mutant deriving from Rut‐C30), AR‐352 (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme glucose oxidase	EFSA‐Q‐2021‐00298	No	No
Trichoderma reesei	RF4847 (mutant deriving from Rut‐C30), AR‐852 (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme cellulase	EFSA‐Q‐2021‐00306	No	No
Trichoderma reesei	RF7727 (GMM)	Feed additives	Zootechnical additives	Digestibility enhancer Production of 6‐phytase	EFSA‐Q‐2021‐00313	No	No
Oomycetes
Pythium oligandrum	B301	Plant protection products	Plant Protection Product	Plant protection product on grapevine against Phaeomoniella chlamydospora	EFSA‐Q‐2021‐00027	No	No
Yeasts
Kluyveromyces lactis	DS 00332 (parental strain), DS 38549 (recipient strain), KLA (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the enzyme β‐galactosidase	EFSA‐Q‐2021‐00311	Yes	No
Komagataella pastoris	SUNHY 002 (DSM 25376) and SUNHY 004 (DSM 26469) (GMM)	Feed additives	Zootechnical additives	Digestibility enhancer Production of xylanase and β‐glucanase	EFSA‐Q‐2021‐00314	Yes	No
Komagataella phaffii	GS115‐VTR 001 (CGMCC 7.370) (GMM)	Feed additives	Zootechnical additives	Digestibility enhancer Production of 6‐phytase	EFSA‐Q‐2021‐00425	Yes	No
Komagataella phaffii	GS115‐VTR001 (GMM)	Feed additives	Zootechnical additives	Digestibility enhancer Production of 6‐phytase	EFSA‐Q‐2021‐00417	Yes	No
Komagataella phaffii	GS115‐VTR002 (CGMCC 7.371) (GMM)	Feed additives	Zootechnical additives	Digestibility enhancer Production of the enzyme endo‐β‐1,4‐xylanase	EFSA‐Q‐2021‐00442	Yes	No
Komagataella phaffii	NCAIM Y001485	Feed additives	Technological additives	Substances for reduction of the contamination of feed by mycotoxins Production of fumonisin esterase	EFSA‐Q‐2021‐00152	Yes	No
Komagataella phaffii	NCAIM Y001485 (GMM)	Feed additives	Technological additives	Substances for reduction of the contamination of feed by mycotoxins Production of fumonisin esterase	EFSA‐Q‐2021‐00470	Yes	No
Komagataella phaffii	Xyl‐2 (DSM 33574)	Feed additives	Zootechnical additives	Digestibility enhancer and gut flora stabiliser Production of Endo‐1,4‐β‐xylanase	EFSA‐Q‐2021‐00312	Yes	No
Saccharomyces cerevisiae		Feed additives	Zootechnical additives	Gut flora stabiliser for rabbits	EFSA‐Q‐2021‐00382	Yes	No
Saccharomyces cerevisiae		Feed additives	Technological additives	Substances for reduction of the contamination of feed by mycotoxins	EFSA‐Q‐2021‐00470	Yes	No
Saccharomyces cerevisiae	CEN.PK113‐7D (GMM)	Food enzymes, food additives and flavourings	Enzyme production	Production of the food additive steviol glycosides (E960)	EFSA‐Q‐2021‐00357	Yes	No
Saccharomyces cerevisiae	CEN.PK113‐7D (GMM)	Novel foods	Novel Food	Production of 2′‐fucosyllactose	EFSA‐Q‐2021‐00415	Yes	No
Saccharomyces cerevisiae	CNCM I‐1079	Feed additives	Zootechnical additives	Digestibility enhancers and gut flora stabilisers	EFSA‐Q‐2021‐00429	Yes	No
Saccharomyces cerevisiae	SC0639 (DS 67494) (GMM)	Feed additives	Nutritional additives	Vitamins, pro‐vitamins and chemically well‐defined substances having similar effect Production of 5,7,24‐cholestatrienol (precursor of 25‐hydroxyvitamin D3)	EFSA‐Q‐2021‐00341	Yes	No
Saccharomyces cerevisiae	Y03‐0	Feed additives	Nutritional additives	Compounds of trace elements Production of selenised yeast	EFSA‐Q‐2021‐00309	Yes	No
Yarrowia lipolytica	GMM	Food enzymes, food additives and flavourings	Enzyme production	Production of the food additive steviol glycosides (E960)	EFSA‐Q‐2021‐00356	Yes	No

^(a)To find more details on specific applications please access the EFSA website – openEFSA.

^(b)Included in the QPS list as adopted in December 2019 (EFSA BIOHAZ Panel, 2020) and respective updates which include new additions (latest: EFSA BIOHAZ Panel, 2022).

Suggested citation: EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards) , Koutsoumanis K, Allende A, Alvarez‐Ordóñez A, Bolton D, Bover‐Cid S, Chemaly M, Davies R, De Cesare A, Hilbert F, Lindqvist R, Nauta M, Peixe L, Ru G, Simmons M, Skandamis P, Suffredini E, Cocconcelli PS, Fernández Escámez PS, Prieto‐Maradona M, Querol A, Sijtsma L, Evaristo Suarez J, Sundh I, Vlak J, Barizzone F, Hempen M and Herman L, 2022. Statement on the 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. EFSA Journal 2022;20(1):7045, 40 pp. 10.2903/j.efsa.2022.7045