Beauveria bassiana strain NPP111B005 is a new active substance for which, in accordance with Article 7 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (hereinafter referred to as ‘the Regulation’), the rapporteur Member State (RMS), France, received an application from Arysta Lifescience S.A.S. on 6 November 2012 for approval. Complying with Article 9 of the Regulation, the completeness of the dossier was checked by the RMS and the date of admissibility of the application was recognised as being 5 February 2013.
The RMS provided its initial evaluation of the dossier on Beauveria bassiana strain NPP111B005 in the draft assessment report (DAR), which was received by the European Food Safety Authority (EFSA) on 7 October 2014. The peer review was initiated on 9 October 2014 by dispatching the DAR for consultation to the Member States and the applicant, Arysta Lifescience S.A.S.
Following consideration of the comments received on the DAR, it was concluded that additional information should be requested from the applicant, and that EFSA should conduct an expert consultation in the area of ecotoxicology.
In accordance with Article 12 of the Regulation, EFSA should adopt a conclusion on whether Beauveria bassiana strain NPP111B005 can be expected to meet the approval criteria provided for in Article 4 of the Regulation taking into consideration recital (10) of the Regulation. Furthermore, this conclusion also addresses the assessment required from EFSA under Article 12 of Regulation (EC) No 396/2005, provided the active substance will be approved under Regulation (EC) No 1107/2009 without restrictions affecting the residue assessment. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Beauveria bassiana strain NPP111B005 as an insecticide on banana plants and ornamental palm trees, as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report.
Sufficient efficacy data were provided to support the use of this material.
A data gap has been identified for a satisfactory search of the scientific peer-reviewed open literature relevant to the scope of the application, dealing with side-effects on the environment and non-target species in relation to Beauveria bassiana strain NPP111B005 and its secondary metabolites/toxins, published within the last 10 years before the date of submission of the dossier, completed in accordance with the Guidance of EFSA on the submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009.
In the area of identity of the microorganism/biological properties/physical and technical properties and methods of analysis data gaps were identified for the validation of analytical methods for secondary metabolites and for a storage stability study for the formulation.
In the area of mammalian toxicity, the risk assessment for operators, workers, bystanders and residents cannot be finalised due to the lack of hazard assessment of the potential secondary metabolites/toxins, and pending on the confirmation of the reliability of the extrapolation of toxicity data from the strain 147 to the strain NPP111B005.
A quantitative consumer risk assessment is considered as not necessary; it is unlikely that there is significant exposure of banana fruit to either viable or non-viable residues. Therefore no residues data are required.
No satisfactory information has been provided to demonstrate that, under the conditions of use, any toxins/secondary metabolites produced by Beauveria bassiana strain NPP111B005 will not occur in the environmental compartments in concentrations considerably higher than under natural conditions. Consequently further data on the persistence, transformation and mobility of these compounds may be needed in order to assess the potential for groundwater contamination and soil and surface water exposure.
A low risk to non-target organisms was concluded for the representative use on banana plants as a pheromone trap. For the representative use using direct application of the microgranules to banana plants and field grown palm trees, data gaps were concluded to address the potential for infectivity and pathogenicity and to address the risk from secondary metabolites/toxins to birds, aquatic organisms, non-target arthropods, earthworms and non-target plants. A high risk to honeybees from the potential for infectivity and pathogenicity was concluded for the representative use to palm trees and banana plants and a data gap was identified to further address the risk to honeybees from infectivity and pathogenicity and the risk from secondary metabolites/toxins.
A low risk to birds, mammals, wild bees, non-target arthropods, earthworms, soil microorganisms and non-target plants was concluded for the representative use to palm trees in glasshouses, however, a data gap was identified to address the risk to aquatic organisms. A data gap for information to address the risk to sewage treatment organisms from the representative use in glasshouses was concluded. No assessment was available for pollinators which may be introduced to glasshouses. Given the concerns raised for honeybees, it cannot be excluded that Beauveria bassiana strain NPP111B005 poses a risk to pollinators if introduced to glasshouses.