Validation of Innovative Food Microbiological Methods According to the EN ISO 16140 Standard
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Validation of Innovative Food Microbiological Methods According to the EN ISO 16140 Standard Bertrand Lombard & Alexandre Leclercq
Received: 7 April 2010 / Accepted: 27 May 2010 / Published online: 2 July 2010 # Springer Science+Business Media, LLC 2010
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 interlaboratory 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.
B. Lombard (*) AFSSA-LERQAP (French Food Safety Agency—Laboratory for Study and Research on Food Quality and Food Processing), 23 avenue du Général de Gaulle, 94706 Maisons-Alfort, France e-mail: [email protected] A. Leclercq WHO Collaborative Center for Foodborne Listeriosis, National Reference Center for Listeria, Institut Pasteur, 28 rue du Docteur Roux, 75724 Paris cedex 15, France e-mail: [email protected]
Keywords Food Microbiology . Method Validation . Innovative Methods . Alternative Methods
Introduction Reference methods in food microbiology, for the analysis of food, animal feeding stuffs, samples from primary production and food processing and handling, are standardised at the international level by International Organization for Standardization (ISO) and at the European level by European Committee for Standardization (CEN) (Lombard et al. 1996; Lombard 2004; Leclercq 2002; Leclercq et al. 1999; Lombard and Leclercq 2010). The standardisation process consists of establishing reference documents in agreement with all parties and countries concerned. These reference methods are mostly based on conventional microbiology, enabling the major characteristic of a standard to be met: the largest consensus and the broadest applicability in food microbiology worldwide, including developed countries themselves. Application of reference methods requires skilled staff and is labour-intensive and time-consuming, due to the time needed by microorganisms to grow in or on culture media. Innovative methods in food microbiology, so called ‘rapid methods’, have been developed
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