Presentation
This guide describes rules for the validation of analytical methods used to verify the migration limits specified in Directive 2002/72/EC, and this in accordance with the rules defined in Directive 82/711/EEC and other European directives on the subject, with the aim of controlling the quality of analytical work and ensuring comparable analytical results between laboratories. These various texts have been repealed by regulation (EU) n°10/2011.
This guide presents 4 approaches to validation, to be chosen according to the purpose of the performance evaluation of the methods concerned. This guide will be updated regularly.
The content of this guide is the result of a collective effort by the National Reference Laboratories (NRL), led by the Community Reference Laboratory (CRL). It has been approved by representatives of DG SANCO (EU).