Scientific support, literature review and data collection and analysis for risk assessment on microbial organisms used as active substance in plant protection products –Lot 1 Environmental Risk characterisation

Mudgal, Shailendra; Toni, Arianna De; Tostivint, C.; Hokkanen, Heikki; Chandler, David

doi:10.2903/sp.efsa.2013.en-518

Cited by 18 publications

(18 citation statements)

References 131 publications

(204 reference statements)

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“…Occasionally, diseases associated with entomopathogenic fungi are seen in immunocompromised individuals (Roberts and St. Leger, 2004;Strasser et al, 2000;Jani et al, 2001;Goettel et al, 2001). In general, though, these insect-pathogenic specific fungi have a very good safety record both for vertebrate animals as well as for the environment (Zimmerman 2007a and b;Mudgal et al, 2013).…”

Section: 14mentioning

confidence: 99%

Risk profile related to production and consumption of insects as food and feed

2015

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The present opinion has the format of a risk profile and presents potential biological and chemical hazards as well as allergenicity and environmental hazards associated with farmed insects used as food and feed taking into account of the entire chain, from farming to the final product. The opinion also addresses the occurrence of these hazards in non-processed insects, grown on different substrate categories, in comparison to the occurrence of these hazards in other non-processed sources of protein of animal origin. When currently allowed feed materials are used as substrate to feed insects, the possible occurrence of microbiological hazards is expected to be comparable to their occurrence in other nonprocessed sources of protein of animal origin. The possible occurrence of prions in non-processed insects will depend on whether the substrate includes protein of human or ruminant origin. Data on transfer of chemical contaminants from different substrates to the insects are very limited. Substrates like kitchen waste, human and animal manure are also considered and hazards from insects fed on these substrates need to be specifically assessed. It is concluded that for both biological and chemical hazards, the specific production methods, the substrate used, the stage of harvest, the insect species and developmental stage, as well as the methods for further processing will all have an impact on the occurrence and levels of biological and chemical contaminants in food and feed products derived from insects. Hazards related to the environment are expected to be comparable to other animal production systems. The opinion also identifies the uncertainties (lack of knowledge) related to possible hazards when insects are used as food and feed and notes that there are no systematically collected data on animal and human consumption of insects. Studies on the occurrence of microbial pathogens of vertebrates as well as published data on hazardous chemicals in reared insects are scarce. Further data generation on these issues are highly recommended. Risk profile related to production and consumption of insects as food and feed EFSA Scientific Committee AbstractThe present opinion has the format of a risk profile and presents potential biological and chemical hazards as well as allergenicity and environmental hazards associated with farmed insects used as food and feed taking into account of the entire chain, from farming to the final product. The opinion also addresses the occurrence of these hazards in non-processed insects, grown on different substrate categories, in comparison to the occurrence of these hazards in other non-processed sources of protein of animal origin. When currently allowed feed materials are used as substrate to feed insects, the possible occurrence of microbiological hazards is expected to be comparable to their occurrence in other non-processed sources of protein of animal origin. The possible occurrence of prions in nonprocessed insects will depend on whether the substrate includes protein ...

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Section: 14mentioning

confidence: 99%

Risk profile related to production and consumption of insects as food and feed

2015

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“…Several other review papers have appeared to discuss data requirements for risk assessments of microbials, including discussion of environmental fate issues (Kiewnick 2007;Scheepmaker and Butt 2010;Alabouvette and Cordier 2011;Scheepmaker and van de Kassteele 2011;Mudgal et al 2013;Sundh and Goettel 2013). This article elaborates on these reviews, with additional information from recent years and with a focus on dynamics and fate of organisms and environments that were not or were only partially covered in earlier reviews.…”

Section: Risk Perception Of Populations Of Microbial Biocontrol Agentmentioning

confidence: 99%

Ecological arguments to reconsider data requirements regarding the environmental fate of microbial biocontrol agents in the registration procedure in the European Union

Köhl

Booij

Kolnaar³

et al. 2019

BioControl

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“…The EFSA supporting publication, 2013:EN‐518 Mudgal et al. () also indicates mycosubtilin, chlorotetaine, difficidin, bacilysin, bacillaene, macrolactin and plantazolicin as having been indicated to be produced by B . amyloliquefaciens .…”

Section: Data Gapsmentioning

confidence: 99%

“…Also, they did not include bacillomycin D already identified in the dossier, as a search term. The EFSA supporting publication, 2013:EN-518 Mudgal et al (2013) also indicates mycosubtilin, chlorotetaine, difficidin, bacilysin, bacillaene, macrolactin and plantazolicin as having been indicated to be produced by B. amyloliquefaciens. These had not been included as search terms in any way.…”

Section: Data Gapsmentioning

confidence: 99%

Peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain FZB24

2016

EFS2

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The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State (RMS), France, for the pesticide active substance Bacillus amyloliquefaciens strain FZB24 and the considerations as regards the application for inclusion of the active substance in Annex IV of Regulation (EC) This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union.Peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain FZB24 The RMS provided its initial evaluation of the dossier on B. amyloliquefaciens strain FZB24 in the draft assessment report (DAR), which was received by the European Food Safety Authority (EFSA) on 13 April 2015. The peer review was initiated on 20 May 2015 by dispatching the DAR for consultation to the Member States and the applicant, Novozymes France.Following consideration of the comments received on the DAR, it was concluded that additional information should be requested from the applicant and that there was no need to conduct an expert consultation.In accordance with Article 12 of the Regulation, EFSA should adopt a conclusion on whether B. amyloliquefaciens strain FZB24 can be expected to meet the approval criteria provided for in Article 4 of the Regulation taking into consideration recital (10) The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of B. amyloliquefaciens strain FZB24 as a fungicide on cucurbits (cucumber, courgette and melon), potato and grapevine, as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report.The uses of B. amyloliquefaciens strain FZB24 according to the representative uses proposed result in a sufficient fungicidal efficacy against the target organisms.A data gap was identified for a search of the scientific peer-reviewed open literature on the active substance and its relevant metabolites.No data gaps were identified in the section identity, physical-chemical and technical properties and analytical methods.In the area of mammalian toxicology, a data gap and an issue that could not be finalised were identified to address worker risk assessment to secondary metabolites/toxins.In the area of residues and consumer exposure, the risk assessment cannot be finalised due to the possible production of secondary metabolites/toxins and EFSA can therefore not support the inclusion of B. amyloliquefaciens strain FZB24 in Annex IV of Regulation (EC) No 396/2005.The information available was insufficient to demonstrate that B. amyloliquefaciens strain FZB24 would respect the uniform principles criterion of not being expected to persist in soil in concentrations cons...

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Scientific support, literature review and data collection and analysis for risk assessment on microbial organisms used as active substance in plant protection products –Lot 1 Environmental Risk characterisation

Cited by 18 publications

References 131 publications

Risk profile related to production and consumption of insects as food and feed

Risk profile related to production and consumption of insects as food and feed

Ecological arguments to reconsider data requirements regarding the environmental fate of microbial biocontrol agents in the registration procedure in the European Union

Peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain FZB24

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