Detection of food and feed plant products obtained by new mutagenesis techniques

Criteria 
DNA extraction 
Quantitative PCR 
Qualitative PCR 
Method 
acceptance 
criteria 
 
Applicability 
Practicability 
DNA concentration 
DNA yield 
DNA structural integrity 
Purity of DNA extracts
Applicability 
Practicability 
Specificity 
Limit of Detection (LOD) 
Robustness 
Dynamic Range 
Trueness 
Amplification Efficiency 
R
2
Coefficient 
Precision 
Limit of Quantification (LOQ) 
Applicability 
Practicability 
Specificity 
Limit of Detection (LOD) 
Robustness 
Method 
performance 
requirements 
Trueness 
Precision 
False positive rate 
False negative rate 
Probability of detection 
It should thus be considered to which extent the analytical methods proposed for 
genome-edited plants would (1) comply with the current provisions of the ENGL 
document as it is, and (2) if additional explanatory notes or amendments need to be 
made in order to provide a quality and compliance framework for analytical approaches 
not yet covered. The most critical aspects for consideration include the following 
elements: 
-
Applicability/Practicability of the method
. For new technologies, 
e.g.
next-
generation sequencing, the equipment may not be widely available, the quality 
assurance parameters and uncertainty estimation are still under development, and 
training may be required in the enforcement laboratories to make sure the methods 
can be applied in a reliable way.
-
Specificity to be demonstrated 
in silico
and experimentally
. In order to 
develop a detection method that is specific for identification of the genome-edited 
event, a unique and sufficiently long sequence is required. SNV and short InDels 
may not provide such a unique sequence. It also needs to be specified which 
databases and which plant samples have to be used for demonstrating the event-
specificity of the method. 
-