Whether developing new active substances, expanding older registration packages or supporting generic products, clear planning and scheduling of residues studies is vital to ensure the correct data are generated. Sufficient trials must be conducted according to the critical GAP in order to establish a profile of the observed residues, whilst reducing the number and design of residue trials needed. We provide expertise in all areas.JSC recognise that in a commercial environment where time to market is critical it is often not possible to initiate crop residue trials after the residue definition for monitoring and risk assessment is known. If you are planning residue trials in advance of finalising these parameters we can help you make the best predictions, to ensure the studies remain applicable even if minor changes to the GAP are made at a later date.
All field activities of the trials must be fully recorded to GLP standards and analysis must be performed using fully validated methods. The analytical phase of the trials is where most of the problems arise when evaluated by regulatory authorities. Appropriate storage stability studies must also be included to ensure regulatory acceptance. Expansion of the trials to generate supplementary data to support other parts of the dossier should also be considered.
Residue trial data will be used to propose EUMRLs and to perform the consumer risk assessment. The finding of significant residues may trigger higher tier studies such as processing and/or livestock feeding studies. The residue information should therefore be expertly evaluated as soon as possible to allow the maximum time for these follow on studies.