This document describes minimum requirements and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied to the detection of specific DNA sequences present in foods. The document can be applied to any single-laboratory validation of a qualitative real-time PCR method used for the detection of specific DNA sequences in food and food products, e.g. for detection of genetically modified foodstuffs and for species determination, including species known to produce allergenic proteins. The document does not cover the evaluation of applicability and practicability with respect to the specific scope of the PCR method.