Guidelines for performance criteria and validation procedures of analytical methods used in controls of food contact materials

Test methods for materials and articles in contact with foodstuffs are required to determine the concentration of residues of monomers in the materials themselves or to determine the concentration of individual or groups of substances in food (or food simulants) which have migrated from the food contact materials. The Community Reference Laboratory and National Reference Laboratories for food contact materials (FCM) prepared the present Guidelines to illustrate the required performance criteria for the analytical methods applied in the laboratories for FCM and provide procedures for method validation in order to estimate their performance characteristics. The scope of these guidelines is to provide rules for the performance of the analytical methods to be used in the verification of compliance with the migration limits defined in Directive 2002/72/EC,as amended, and in accordance with Directive 82/711/EEC, as amended, and others defined in the European legislation, in order to ensure the quality and comparability of the analytical results. The document presents 4 approaches, according to the different purpose of performance assessment. These guidelines are intended as a dynamic document and they will evolve and expand into further editions. This is the first edition. These guidelines have been endorsed by the European Union official Network of National Reference Laboratories and approved by the EU Commission competent service DG SANCO. This work also highlights an important deliverable for the Network of NRLs. In particular, the members of the task force "Method Performance" that have dedicated time and effort to provide input into the development of these guidelines. They are gratefully acknowledged here for their contribution: NRL-BE (Fabien Bolle, Tina n'Goy), NRL-DE (Oliver Kappenstein), NRL-DK (Jens Petersen), NRL-ES (Juana Bustos), NRL-FR1 (Patrick Sauvegrain), NRL-EL (Timokleia Togkalidou), NRL-IT (Maria Rosaria Milana), NRL-NL (Durk Schakel, Dita Kalsbeek-van Wijk), NRL-PL (Kazimiera Cwiek-Ludwicka), NRL-SI (Viviana Golja), NRL-UK (Emma Bradley). Special thanks are extended to Emma Bradley for her contribution to the editing of the document.