Validation of Innovative Food Microbiological Methods According to the EN ISO 16140 Standard

Abstract

Reference methods in food microbiology are mostly based on conventional microbiology. Innovative methods have been developed and commercialised, with several advantages, but their users need guarantees on their performance. Validation schemes have thus been established to assess whether these methods perform at least as well as the corresponding reference methods. In addition, a European and International Standard, EN ISO 16140, has been developed to provide a common reference protocol for the validation of alternative methods, as well as to determine general principles for their possible subsequent certification. The content of this standard is summarised, a technical protocol is defined separately for qualitative and quantitative methods and the validation study, which comprises two phases, a comparative study and an inter-laboratory study, is described. This standard is currently being revised and the main directions taken are presented. This paper then briefly introduces the validation/certification systems before addressing several aspects related to the links with laboratory accreditation and European regulations on microbiological criteria, as well as the use of alternative methods.