PMID- 35058997 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240405 IS - 1831-4732 (Electronic) IS - 1831-4732 (Linking) VI - 20 IP - 1 DP - 2022 Jan TI - Review of the existing maximum residue levels for novaluron according to Article 12 of Regulation (EC) No 396/2005. PG - e07041 LID - 10.2903/j.efsa.2022.7041 [doi] LID - e07041 AB - According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance. Although this active substance is not authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States and the UK (including the supporting residues data). Considering that no toxicological reference values are currently established in Europe for novaluron because the peer review for the approval was terminated before an EFSA conclusion was issued, the toxicological profile of novaluron was also assessed, in order to be able to perform the consumer risk assessment in the framework of the art 12 MRL review. Based on the assessment of the available data, toxicological reference values were derived, and a consumer risk assessment was carried out for the existing CXLs and import tolerances. All CXLs and import tolerances were found to be supported by inadequate data and a possible chronic risk to consumers was identified. Hence, further consideration by risk managers is needed. CI - (c) 2022 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 - Bellisai, Giulia AU - Bellisai G FAU - Bernasconi, Giovanni AU - Bernasconi G FAU - Brancato, Alba AU - Brancato A FAU - Cabrera, Luis Carrasco AU - Cabrera LC FAU - Ferreira, Lucien AU - Ferreira L FAU - Giner, German AU - Giner G FAU - Greco, Luna AU - Greco L FAU - Jarrah, Samira AU - Jarrah S 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 - Ruocco, Silvia AU - Ruocco S FAU - Santos, Miguel AU - Santos M FAU - Scarlato, Alessia Pia AU - Scarlato AP FAU - Theobald, Anne AU - Theobald A FAU - Vagenende, Benedicte AU - Vagenende B FAU - Verani, Alessia AU - Verani A LA - eng PT - Journal Article DEP - 20220113 PL - United States TA - EFSA J JT - EFSA journal. European Food Safety Authority JID - 101642076 PMC - PMC8756387 OTO - NOTNLM OT - MRL review OT - Regulation (EC) No 396/2005 OT - consumer risk assessment OT - insecticide OT - novaluron EDAT- 2022/01/22 06:00 MHDA- 2022/01/22 06:01 PMCR- 2022/01/13 CRDT- 2022/01/21 06:19 PHST- 2022/01/21 06:19 [entrez] PHST- 2022/01/22 06:00 [pubmed] PHST- 2022/01/22 06:01 [medline] PHST- 2022/01/13 00:00 [pmc-release] AID - EFS27041 [pii] AID - 10.2903/j.efsa.2022.7041 [doi] PST - epublish SO - EFSA J. 2022 Jan 13;20(1):e07041. doi: 10.2903/j.efsa.2022.7041. eCollection 2022 Jan.