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Evaluation of confirmatory data following the Article 12 MRL review for spinosad

The applicant Dow AgroSciences Ltd submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for spinosad in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not availabl...

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Detalles Bibliográficos
Autores principales: Abdourahime, Himdata, Anastassiadou, Maria, Brancato, Alba, Brocca, Daniela, Carrasco Cabrera, Luis, De Lentdecker, Chloe, Ferreira, Lucien, Greco, Luna, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, Lythgo, Christopher, Medina, Paula, Miron, Ileana, Molnar, Tunde, Nave, Stefanie, Pedersen, Ragnor, Raczyk, Marianna, Reich, Hermine, Ruocco, Silvia, Sacchi, Angela, Santos, Miguel, Stanek, Alois, Sturma, Juergen, Tarazona, Jose, Theobald, Anne, Vagenende, Benedicte, Verani, Alessia, Villamar‐Bouza, Laura
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009118/
https://www.ncbi.nlm.nih.gov/pubmed/32626219
http://dx.doi.org/10.2903/j.efsa.2019.5592
Descripción
Sumario:The applicant Dow AgroSciences Ltd submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for spinosad in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to residue trials on globe artichokes, flowering brassica and the nature of residues in processed commodities were satisfactorily addressed. A new feeding study on poultry has been submitted as requested, but the information is not sufficient to derive conversion factors (CF) for risk assessment for poultry liver and eggs to replace the tentative conversion factors obtained from the metabolism study. The new information provided justifies the lowering of the MRLs for flowering brassica and products of poultry origin. The consumer risk assessment performed for spinosad was updated taking into account the acute reference dose (ARfD) which was recently derived by EFSA. Since for spinach a potential consumer intake concern was identified, the lowering of the existing MRL is recommended. For the remaining commodities assessed under this application (globe artichokes, flowering brassica, products derived from poultry), a consumer intake concern was not identified. For a number of commodities for which MRLs have been established previously but which are not subject of the current assessment, EFSA recommends a review of the MRLs because of potential short‐term intake concerns.