抄録
For registration of agricultural chemicals in Japan, submission of a data set for safety assessment is required by Notification No.30-Shouan-6278 (Ministry of Agriculture, Forestry and Fisheries). Residue chemistry studies needed for assessment of maximum residue limits (MRLs) include "Metabolism in plants" followed by "Residues in crops" for agricultural crops and "Metabolism in livestock" followed by "Residues in livestock" for livestock products. These studies are required to clarify the nature and magnitude of residues originating from agrochemical use under possible critical Good Agriculture Practice (cGAP) conditions. Metabolism studies also provide important information regarding the analytical method for the corresponding residue studies, especially for extraction procedures, by using radiolabel-incurred samples. All these studies are needed to follow OECD guidelines for the testing of chemicals and must be conducted under Good Laboratory Practice (GLP) standards, thereby producing internationally interoperable test results with high reliability and reproducibility. Based on such strictly obtained scientific evidence, residue definitions for both enforcement and dietary risk assessment purposes, as well as MRLs, can be established to ensure food safety for consumers.
