DIN CEN/TS 16707:2014-12

This Technical Specification describes screening strategies for the detection of genetically modified (GM) DNA in food products by means of PCR methods. The strategies have been established for food matrices, but it can also be applied to other matrices (for example feed, seed and samples from field grown plants). Detection of GM DNA is based on PCR methods targeting segments of transgenic DNA sequences (genetic elements, genetic constructs or insertion sites of transgenes). Various combinations of these PCR methods are involved in screening strategies. The methods are applied simultaneously or hierarchically. The general strategy is based on the matrix approach. Examples for the implementation and application of this approach are described. In order to ensure reliable analytical results, the document also provides guidelines for the validation of the performance of qualitative PCR methods applied in screening approaches. Largely, detection of materials derived from genetically modified organisms (GMOs) in a given sample employs polymerase chain reaction (PCR) analysis, specifically real-time PCR. A general strategy for GMO detection and identification by means of PCR analysis and a stepwise approach is described. In initial screening analysis, DNA sequences of genetic elements common to many GMOs are targeted. According to its purpose, screening is a test to rapidly and reliably sort samples into groups. Grouping of the samples facilitates and potentially reduces subsequent analytical work and results interpretation. The screening strategy should be adjusted to the scope (food, feed or seed, crop-specific etcetera) of the test(s). This document takes the general principle of GMO detection strategies as a basis and describes the underlying analytical steps for complex screening (known as the matrix-approach). This document is written primarily for screening strategies applying real-time PCR methods. Other PCR methodologies may be applicable in the same way. The terms "screening method" and "screening strategies" are not interchangeable and have different meanings in this document. This document has been prepared by CEN/TC 275/WG 11, the secretariat of which is held by DIN. The responsible German committee is NA 057-01-04 AA of the Standards Committee Food and Agricultural Products, NAL.