Abstract
The comprehensive EU regulatory framework regarding GMOs aims at preventing damage to human and animal health and the environment, and foresees labelling and traceability. Genome-edited plants and products fall under these EU GMO regulations, which have to be implemented in enforcement control activities. GMO detection methods currently used by enforcement laboratories are based on real-time PCR, where specificity and sensitivity are important performance parameters. Genome editing allows the targeted modification of nucleotide sequences in organisms, including plants, and often produces single nucleotide variants (SNVs), which are the most challenging class of genome edits to detect. The test method must therefore meet advanced requirements regarding specificity, which can be increased by modifying a PCR method. Digital PCR systems achieve a very high sensitivity and have advantages in quantitative measurement. Sequencing methods may also be used to detect DNA modifications caused by genome editing. Whereas most PCR methods can be carried out in an enforcement laboratory with existing technical equipment and staff, the processing of the sequencing data requires additional resources and the appropriate bioinformatic expertise.
Highlights
In the EU, when placing on the market genetically modified (GM) crops and derived food and feed, a rigorous regulatory framework that is based on the precautionary principle aims at protecting consumers and the environment [1]
Genomeedited plants and products fall under these EU GMO regulations, which have to be implemented in enforcement control activities
To be fit for purpose, a method used in an enforcement laboratory should meet the minimum performance criteria and correlate with the environmental conditions prevailing in a laboratory
Summary
In the EU, when placing on the market genetically modified (GM) crops and derived food and feed, a rigorous regulatory framework that is based on the precautionary principle aims at protecting consumers and the environment [1]. Enforcement encompasses protection of the market from the presence of unauthorized GMOs and general requirements on labelling. All EU member states have to designate one or more national reference and official control laboratories to carry out enforcement and official controls Their competent authorities have appointed enforcement “national reference laboratories” (NRLs) and official laboratories to perform analyses for the presence of authorized and unauthorized GMOs in food, feed, and seed products [8]. These laboratories have the expertise, equipment, infrastructure, and staff to perform analyses during official controls. In the EU, enforcement laboratories apply PCR-based methods to detect DNA sequences
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