Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 9 : Suitability of taxonomic units notified to EFSA until september 2018
Koutsoumanis, Kostas ; Allende, Ana ; Álvarez-Ordóñz, Avelino ; Bolton, Declan ; Bover-Cid, Sara ; Chemaly, Marianne ; Davies, Robert ; Hilbert, Friederike ; Lindqvist, Roland ; Nauta, Maarten ; Peixe, Luisa ; Ru, Giuseppe ; Simmons, Marion ; Skandamis, Panagiotis ; Suffredini, Elisabetta ; Cocconcelli, Pier Sandro ; Escámez, Pablo Salvador Fernández ; Maradona, Miguel Prieto ; Querol, Amparo ; Suarez, Juan Evaristo ; Sundh, Ingvar ; Vlak, Just ; Barizzone, Fulvio ; Correia, Sandra ; Herman, Lieve - \ 2019
EFSA Journal 17 (2019)1. - ISSN 1831-4732
Bacteria - Corynebacterium glutamicum - Komagataeibacter sucrofermentans - Mycobacterium setense - Pseudomonas fluorescens - QPS - Safety - Yeast
The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA’s Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected by ‘qualifications’ which should be assessed at the strain level by the EFSA’s Scientific Panels. During the current assessment, no new information was found that would change the previously recommended QPS taxonomic units and their qualifications. Between April and September 2018, the QPS notification list was updated with 48 microorganisms from applications for market authorisation. Of these, 30 biological agents already had QPS status, 15 were excluded from the QPS exercise by the previous QPS mandate (five filamentous fungi) or from further evaluations within the current mandate (two notifications of Enterococcus faecium, one of Streptomyces spp. and seven of Escherichia coli). One taxonomic unit was (re)evaluated: Pseudomonas fluorescens had been previously evaluated in 2016, and was now re-evaluated within this mandate. The revision of the literature supports the previously identified safety concerns (e.g. production of biocompounds with antimicrobial activity and virulence features), preventing the inclusion of P. fluorescens in the QPS list. Mycobacterium setense and Komagataeibacter sucrofermentans were evaluated for the first time. M. setense cannot be considered for the QPS assessment because there are significant safety concerns. K. sucrofermentans (Acetobacter xylinus subsp. sucrofermentans) can be proposed for the QPS list but only for production purposes. The QPS status of Corynebacterium glutamicum is confirmed with the qualification extended to other production purposes.
The qualified presumption of safety assessment and its role in EFSA risk evaluations: 15 years past
Herman, Lieve ; Chemaly, Marianne ; Cocconcelli, Pier Sandro ; Fernandez, Pablo ; Klein, Günter ; Peixe, Luisa ; Prieto, Miguel ; Querol, Amparo ; Suarez, Juan Evaristo ; Sundh, Ingvar ; Vlak, Just ; Correia, Sandra - \ 2018
FEMS Microbiology Letters 366 (2018)1. - ISSN 0378-1097
Microorganisms are intentionally added at different stages of the food and feed chain (food or feed additive, novel food or plant protection product) and are subjected to regulation and safety assessment by the European Food Safety Authority. Safety evaluation is based on application dossiers for market authorisation to the European Commission. The qualified presumption of safety (QPS) concept was developed in 20031 to provide a harmonised generic safety pre-appraisal of the above microorganisms. Unambiguously defined biological taxonomic units (TUs) are assessed for their body of knowledge, their safety and their end use. Identified safety concerns for a certain TU can be, where reasonable in number and not universally present, reflected as 'qualifications.' Strains belonging to TUs having QPS status may benefit of a fast track evaluation. The lowest TU for which the QPS status is granted is the species level for bacteria and yeasts and the family for viruses. The QPS concept is also applicable to genetically modified microorganisms used for production purposes. Based on the current body of knowledge and/or the ambiguous taxonomic position, some TUs, such as filamentous fungi, bacteriophages, Enterococcus faecium, Escherichia coli, Streptomyces spp. and Oomycetes, are not considered liable for QPS status.
Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms
Ockleford, Colin ; Adriaanse, Paulien ; Berny, Philippe ; Brock, Theodorus ; Duquesne, Sabine ; Grilli, Sandro ; Hernandez‐Jerez, Antonio F. ; Bennekou, Susanne Hougaard ; Klein, Michael ; Kuhl, Thomas ; Laskowski, Ryszard ; Machera, Kyriaki ; Pelkonen, Olavi ; Pieper, Silvia ; Smith, Robert H. ; Stemmer, Michael ; Sundh, Ingvar ; Tiktak, Aaldrik ; Topping, Christopher J. ; Wolterink, Gerrit ; Cedergreen, Nina ; Charles, Sandrine ; Focks, Andreas ; Reed, Melissa ; Arena, Maria ; Ippolito, Alessio ; Byers, Harry ; Teodorovic, Ivana - \ 2018
EFSA Journal 16 (2018)8. - ISSN 1831-4732
Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three different types of TKTD models are described, viz., (i) the ‘General Unified Threshold models of Survival’ (GUTS), (ii) those based on the Dynamic Energy Budget theory (DEBtox models), and (iii) models for primary producers. All these TKTD models follow the principle that the processes influencing internal exposure of an organism, (TK), are separated from the processes that lead to damage and effects/mortality (TD). GUTS models can be used to predict survival rate under untested exposure conditions. DEBtox models explore the effects on growth and reproduction of toxicants over time, even over the entire life cycle. TKTD model for primary producers and pesticides have been developed for algae, Lemna and Myriophyllum. For all TKTD model calibration, both toxicity data on standard test species and/or additional species can be used. For validation, substance and species‐specific data sets from independent refined‐exposure experiments are required. Based on the current state of the art (e.g. lack of documented and evaluated examples), the DEBtox modelling approach is currently limited to research applications. However, its great potential for future use in prospective ERA for pesticides is recognised. The GUTS model and the Lemna model are considered ready to be used in risk assessment.
Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 6: suitability of taxonomic units notified to EFSA until March 2017
Ricci, Antonia ; Allende, Ana ; Bolton, Declan ; Chemaly, Marianne ; Davies, Robert ; Girones, Rosina ; Koutsoumanis, Kostas ; Lindqvist, Roland ; Nørrung, Birgit ; Robertson, Lucy ; Ru, Giuseppe ; Fernandez Escamez, Pablo Salvador ; Sanaa, Moez ; Simmons, Marion ; Skandamis, Panagiotis ; Snary, Emma ; Speybroeck, Niko ; Kuile, Benno Ter; Threlfall, John ; Wahlström, Helene ; Cocconcelli, Pier Sandro ; Peixe, Luisa ; Maradona, Miguel Prieto ; Querol, Amparo ; Suarez, Juan Evaristo ; Sundh, Ingvar ; Vlak, Just ; Correia, Sandra ; Herman, Lieve - \ 2017
EFSA Journal 15 (2017)7. - ISSN 1831-4732 - 32 p.
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, reflected as ‘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. Between the end of September 2016 and March 2017, the QPS notification list was updated with 87 applications for market authorisation. From these, 32 biological agents already had a QPS status, and 37 were not included in the evaluation as they are filamentous fungi or enterococci. Streptomyces species (Streptomyces cinnamonensis, Streptomyces mobaraensis and Streptomyces violaceoruber), Bacillus circulans (three notifications) and Escherichia coli (seven notifications) were re-confirmed not suitable for QPS. Streptomyces rubiginosus and Streptomyces netropsis, not evaluated within the previous mandate, were also not recommended for QPS. Streptomyces spp. and E. coli will be excluded from further QPS evaluations within the current QPS mandate. Hyphomicrobium denitrificans, which has never been evaluated before, was not recommended for the QPS list and for Pseudomonas amyloderamosa, the QPS assessment was not applicable because it is not a validated species. Lactobacillus animalis was a new taxonomic unit recommended to have the QPS status.
|BIOCOMES (EU project 612713) develops new biological control products for Integrated Pest Management in agriculture and forestry
Köhl, J. ; Zingg, D. ; Benuzzi, M. ; Ehlers, R.U. ; Perdrix Sapina, V. ; Eiben, U. ; Rosemeyer, V. ; Wikstrom, M. ; Azzaro, A. ; Glazer, I. ; O'Tuama, P. ; Tomanovic, Z. ; Tamm, L. ; Hauschild, R. ; Antonakou, M. ; Skrzecz, I. ; Cal, A. De; Teixidó, N. ; Jehle, J. ; Griffin, C. ; Beliën, T. ; Birnstingl, B. ; Berg, G. ; Simões, N. ; Causin, R. ; Munoz, D. ; Eibl, R. - \ 2016
In: Working Group "Biological and Integrated Control of Plant Pathogens" / Pertot, I., Jensen, D.F., Hökeberg, M., Karlsson, M., Sundh, I., Elad, Y., IOBC-WPRS (IOBC-WPRS bulletin ) - ISBN 9789290672999 - p. 251 - 253.
|EU-project CO-FREE - an update
Schmitt, A. ; Scherf, A. ; Mazzotta, S. ; Kühne, S. ; Pertot, I. ; Köhl, J. ; Markellou, A. ; Andrivon, D. ; Kowalska, J. ; Parveaud, C.E. ; Kelderer, M. ; Lammerts Van Bueren, E. ; Bruns, C. ; Kleinhenz, M.F.B. ; Smith, J. ; Simon-Levert, A. ; Pujos, P. ; Trapman, M. ; Stark, J. ; Cutsem, P. van; Neerakkal, S. ; Kleeberg, H. ; Peters, A. ; Tamm, L. - \ 2016
In: Working Group "Biological and Integrated Control of Plant Pathogens". - IOBC-WPRS (IOBC-WPRS Bulletin ) - ISBN 9789290672999 - p. 255 - 256.
|Biological control of apple scab (Venturia inaequalis) epidemics by Cladosporium cladosporioides H39
Köhl, J. ; Scheer, C. ; Holb, I.J. ; Masny, S. ; Molhoek, W.M.L. - \ 2016
In: Working Group "Biological and Integrated Control of Plant Pathogens". - IOBC-WPRS (IOBC-WPRS Bulletin ) - ISBN 9789290672999 - p. 213 - 215.
Effects of elevated CO2 and N deposition on CH4 emissions from European mires
Silvola, J. ; Saarnio, S. ; Foot, J. ; Sundh, I. ; Greenup, A. ; Heijmans, M.M.P.D. ; Ekberg, A. ; Mitchell, E.P. ; Breemen, N. van - \ 2003
Global Biogeochemical Cycles 17 (2003)2 - 1068. - ISSN 0886-6236 - p. 37 - 1-37-12.
atmospheric carbon-dioxide - methane emissions - boreal mire - raised co2 - northern peatlands - water-table - nitrogen deposition - bog vegetation - forest soils - temperature
 Methane fluxes were measured at five sites representing oligotrophic peatlands along a European transect. Five study plots were subjected to elevated CO2 concentration (560 ppm), and five plots to NH4NO3 (3 or 5 g N yr(-1)). The CH4 emissions from the control plots correlated in most cases with the soil temperatures. The depth of the water table, the pH, and the DOC, N and SO4 concentrations were only weakly correlated with the CH4 emissions. The elevated CO2 treatment gave nonsignificantly higher CH4 emissions at three sites and lower at two sites. The N treatment resulted in higher methane emissions at three sites (nonsignificant). At one site, the CH4 fluxes of the N-treatment plots were significantly lower than those of the control plots. These results were not in agreement with our hypotheses, nor with the results obtained in some earlier studies. However, the results are consistent with the results of the vegetation analyses, which showed no significant treatment effects on species relationships or biomass production.
|Effects on elevated CO2 and N deposition on CH4 emissions from European bogs
Saarnio, S. ; Silvola, J. ; Foot, J.P. ; Sundh, I. ; Greenup, A. ; Heijmans, M. ; Joabsson, A. ; Mitchell, E. ; Breemen, N. van - \ 2000
In: Sustaining Our Peatlands : 11th International Peat Congress, Canada 2000 / Rochefort, L., Daigle, J.Y., Canada : Gerry Hood - ISBN 9789519774442 - p. 1088 - 1088.