Certified reference materials for GMO analysis-more than 25 years of GMO CRM production at EC JRC

Certified reference materials (CRMs) play a crucial role in ensuring the quality of analytical measurements. Particularly, the EU labelling legislation on genetically modified organisms (GMOs) in food and feed products explicitly requires CRMs for its implementation. The CRMs are used to calibrate and control the quantitative real-time polymerase chain reaction (qPCR) method and support official control laboratories, such as National Reference Laboratories (NRLs), in maintaining their ISO/IEC 17025 accreditation. The Joint Research Centre of the European Commission (EC JRC) is specialized in the production of reference materials and has been producing GMO CRMs since 1998. Together with a validated event-specific qPCR method, these GMO CRMs form the EU reference system for the quantification of EU-authorized GMO events in food and feed products and ensure a common GMO labelling threshold. This article gives a retrospective view on the more than 25 years of GMO CRM production at JRC. It describes requirements for GMO CRMs in view of an EU market authorization under (EC) No. 1829/2003. The evolution and major improvements of the production of GMO CRMs at JRC are summarized as well as the current understanding of the EU's GMO reference system for GMO quantification and its impact on commutability. It provides insights into GMO CRM sales and their worldwide distribution. This information may be useful for policymakers and researchers in understanding the current EU GMO measurement landscape and to anticipate possible future demands related to GMO events based on new genomic techniques (NGTs).