All plant protection products used or sold in the European Union (EU) are regulated by Regulation (EC) No 1107/2009. Applications for the approval or renewal of active substances or products in the EU must meet data requirements presented in Regulation (EC) No 283/2013 or Regulation (EC) No 284/2013. These data requirements include several guidance documents on analytical methods. In recent years, the regulatory authorities have scrutinized more strictly the analytical phase of ecotoxicology studies to ensure that a reliable analytical methodology is used to conduct risk assessment. The emphasis by authorities on analytical methods poses new challenges to analytical laboratories that conduct method validations to support exposure concentration verifications in ecotoxicology tests.  In this presentation we will share some of these challenges that our laboratory, Eurofins EAG Agroscience (Easton, MD facility) encountered in recent years and our effort to meet all the regulatory guideline requirements and client expectations. We will provide a brief summary of specific requirements in SANCO/3029/99 rev.4 11/07/00 on analytical methods used in support of ecotoxicology studies and present examples of different interpretations of these requirements by different clients. The focus of requirements will be given to calibration curve range, selection of LOQ level, definition of LOD, confirmatory method and matrix effect evaluation in method validations that are applicable to various matrices (aqueous, sediment, soil, avian and fish feed, etc.).

Obstacle course of running SANCO compliant method validations to support ecotoxicology studies

2019 Fall National Meeting

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