Technical guidance document from the European Union Reference Laboratory for genetically modified food and feed on the implementation of Commission Regulation (EU) No 619/2011 : validation Report

The recently adopted Commission Regulation (EU) No 619/2011 lays down the methods for sampling and analysis for the official control of food as regards to presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which is has expired (the so-called LLP, Low Level presence Regulation). The requirements of this Regulation are technically demanding because they set a non-compliance limit of 0.1% GMO (mass fraction). The European Union Reference Laboratory for Genetically Modified Food and Feed (EU-RL GMFF) plays a crucial role in the implementation of this regulation because only methods validated by the EU-RL that show a RSDr value of maximum 25% at the level of 0.1% related to mass fraction of GM material can be used on falling under that regulation. The aim of this document is to explain how this Regulation will affect the process of validation and how laboratories need to operate under that Regulation.