Guidance document SANTE/12682/2019 “Analytical quality control and method validation procedures for pesticide residues analysis in food and feed” supersedes guidance document SANTE/11813/2017 from 01 January 2020. It describes the method validation and analytical quality control requirements to support the validity of data used for checking compliance with maximum residue limits, enforcement actions, or assessment of consumer exposure to pesticides in the EU.
Main changes with respect to the previous version are:
- a clarification about the non-inclusion of the contribution of sampling to measurement uncertainty in the document, as sampling is not part of the measurement.
- the use of representative analytes for calibration is no longer relevant: all analytes must now be calibrated in every batch of samples.
- the need to use calibration standards at the beginning and at the end of the sample sequence to ensure the detectability of the analytes.
- an explanation of the different approaches to correct the residues when the mean recovery is outside of 80-120 %.
- the addition of an appendix to clarify the rounding rules of the results and the interpretation of the compliance of these results with respect to measurement uncertainty.
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