Peer review of the pesticide risk assessment of the active substance Bacillus velezensis RTI301

Author:

,Álvarez Fernando,Arena Maria,Auteri Domenica,Batista Leite Sofia,Binaglia Marco,Castoldi Anna Federica,Chiusolo Arianna,Colagiorgi Angelo,Colas Mathilde,Crivellente Federica,De Lentdecker Chloe,De Magistris Isabella,Egsmose Mark,Fait Gabriella,Ferilli Franco,Santonja German Giner,Gouliarmou Varvara,Halling Katrin,Nogareda Laia Herrero,Ippolito Alessio,Istace Frederique,Jarrah Samira,Kardassi Dimitra,Kienzler Aude,Lanzoni Anna,Lava Roberto,Leuschner Renata,Linguadoca Alberto,Louisse Jochem,Lythgo Christopher,Magrans Oriol,Mangas Iris,Mavriou Galini,Mioč Andrea,Miron Ileana,Molnar Tunde,Padovani Laura,Padricello Vincenzo,Panzarea Martina,Parra Morte Juan Manuel,Rizzuto Simone,Romac Anamarija,Rortais Agnès,Santos Miguel,Serafimova Rositsa,Sharp Rachel,Szentes Csaba,Terron Andrea,Theobald Anne,Tiramani Manuela,Vianello Giorgia,Villamar‐Bouza Laura

Abstract

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance Bacillus velezensis strain RTI301 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of B. velezensis strain RTI301 as a fungicide for the control of soil‐borne diseases in greenhouses (permanent) and walk‐in tunnels (non‐permanent) and field crops; by drip and drench irrigation on lettuce, cucurbit and solanaceous vegetables; field application by treating tubers whilst laying in furrow on potato; seed treatment application on maize, sunflower, sugar beet and winter oilseed rape. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported when identified.

Publisher

Wiley

Reference8 articles.

1. EFSA (European Food Safety Authority) . (2024). Peer review report to the conclusion regarding the peer review of the pesticide risk assessment of the active substance Bacillus velezensis strain RTI301. www.efsa.europa.eu

2. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Rychen, G., Aquilina, G., Azimonti, G., Bampidis, V., Bastos, M. L., Bories, G., Chesson, A., Cocconcelli, P. S., Flachowsky, G., Gropp, J., Kolar, B., Kouba, M., López‐Alonso, M., López Puente, S., Mantovani, A., Mayo, B., Ramos, F., Saarela, M., … Galobart, J. (2018). Guidance on the characterisation of microorganisms used as feed additives or as production organisms. EFSA Journal, 16(3), 5206. https://doi.org/10.2903/j.efsa.2018.5206

3. European Commission . (2003). Guidance Document on Assessment of the Relevance of Metabolites in Groundwater of Substances Regulated under Council Directive 91/414/EEC. SANCO/221/2000‐rev. 10 final, 25 February 2003.

4. European Commission . (2012). Working Document on Microbial Contaminant Limits for Microbial Pest Control Products. SANCO/12116/2012 –rev. 0, September 2012.

5. European Commission . (2013). Guidance document on data requirements on efficacy for the dossier to be submitted for the approval of new active substances contained in plant protection products. SANCO/10054/2013 ‐ rev. 3, 11 July 2013.

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