PMID- 32626412 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240328 IS - 1831-4732 (Electronic) IS - 1831-4732 (Linking) VI - 17 IP - 8 DP - 2019 Aug TI - Modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds. PG - e05798 LID - 10.2903/j.efsa.2019.5798 [doi] LID - e05798 AB - In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted an application to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for bentazone in soyabeans and poppy seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for both commodities. Adequate analytical methods for enforcement are available to control the residues of bentazone and its metabolites in plant matrices under consideration. The studies requested by EFSA in the framework of the peer review to address the toxicological properties of metabolite 6-hydroxy-bentazone were only partially provided. Instead of studies investigating the general toxicity of this metabolite, the applicant provided an argumentation to justify read-across from the available information on parent bentazone and 8-hydroxy-bentazone. EFSA did not agree with the provided reasoning for read-across. Therefore, the EMS asked EFSA to continue the assessment despite the data gap. EFSA performed an indicative short-term and long-term dietary risk assessment; the calculated dietary exposure was well below the toxicological reference values. The risk assessment however is affected by additional, non-standard uncertainties resulting from data gap related to the toxicological properties for 6-hydroxy-bentazone. CI - (c) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. CN - European Food Safety Authority (EFSA) FAU - Anastassiadou, Maria AU - Anastassiadou M FAU - Brancato, Alba AU - Brancato A FAU - Carrasco Cabrera, Luis AU - Carrasco Cabrera L FAU - Ferreira, Lucien AU - Ferreira L FAU - Greco, Luna AU - Greco L FAU - Jarrah, Samira AU - Jarrah S FAU - Kazocina, Aija AU - Kazocina A FAU - Leuschner, Renata AU - Leuschner R FAU - Magrans, Jose Oriol AU - Magrans JO FAU - Miron, Ileana AU - Miron I FAU - Nave, Stefanie AU - Nave S FAU - Pedersen, Ragnor AU - Pedersen R FAU - Reich, Hermine AU - Reich H FAU - Sacchi, Angela AU - Sacchi A FAU - Santos, Miguel AU - Santos M FAU - Stanek, Alois AU - Stanek A FAU - Theobald, Anne AU - Theobald A FAU - Vagenende, Benedicte AU - Vagenende B FAU - Verani, Alessia AU - Verani A LA - eng PT - Journal Article DEP - 20190802 PL - United States TA - EFSA J JT - EFSA journal. European Food Safety Authority JID - 101642076 PMC - PMC7009028 OTO - NOTNLM OT - MRL OT - bentazone OT - consumer risk assessment OT - pesticide OT - poppy seeds OT - soyabeans EDAT- 2020/07/07 06:00 MHDA- 2020/07/07 06:01 PMCR- 2019/08/02 CRDT- 2020/07/07 06:00 PHST- 2020/07/07 06:00 [entrez] PHST- 2020/07/07 06:00 [pubmed] PHST- 2020/07/07 06:01 [medline] PHST- 2019/08/02 00:00 [pmc-release] AID - EFS25798 [pii] AID - 10.2903/j.efsa.2019.5798 [doi] PST - epublish SO - EFSA J. 2019 Aug 2;17(8):e05798. doi: 10.2903/j.efsa.2019.5798. eCollection 2019 Aug.