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EFSA J. 2017 Nov 13;15(11):e05052. doi: 10.2903/j.efsa.2017.5052. eCollection 2017 Nov.

Guidance on the requirements for the development of microbiological criteria.

EFSA journal. European Food Safety Authority

Antonia Ricci, Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Pablo Salvador Fernández Escámez, Rosina Girones, Lieve Herman, Konstantinos Koutsoumanis, Roland Lindqvist, Lucy Robertson, Giuseppe Ru, Moez Sanaa, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall, Helene Wahlström, Jens Kirk Andersen, Mieke Uyttendaele, Antonio Valero, Maria Teresa Da Silva Felício, Winy Messens, Birgit Nørrung

PMID: 32625345 PMCID: PMC7010099 DOI: 10.2903/j.efsa.2017.5052

Abstract

The European Food Safety Authority asked the Panel on Biological Hazards (BIOHAZ) to deliver a scientific opinion providing: (i) a review of the approaches used by the BIOHAZ Panel to address requests from risk managers to suggest the establishment of microbiological criteria; (ii) guidance on the required scientific evidence, data and methods/tools necessary for considering the development of microbiological criteria for pathogenic microorganisms and indicator microorganisms; (iii) recommendations on methods/tools to design microbiological criteria and (iv) guidelines for the requirements and tasks of risk assessors, compared to risk managers, in relation to microbiological criteria. This document provides guidance on approaches when: (i) a quantitative microbial risk assessment (QMRA) is available, (ii) prevalence and concentration data are available, but not a QMRA model, and (iii) neither a QMRA nor prevalence and/or concentration data are available. The role of risk assessors should be focused on assessing the impact of different microbiological criteria on public health and on product compliance. It is the task of the risk managers to: (1) formulate unambiguous questions, preferably in consultation with risk assessors, (2) decide on the establishment of a microbiological criterion, or target in primary production sectors, and to formulate the specific intended purpose for using such criteria, (3) consider the uncertainties in impact assessments on public health and on product compliance and (4) decide the point in the food chain where the microbiological criteria are intended to be applied and decide on the actions which should be taken in case of non-compliance. It is the task of the risk assessors to support risk managers to ensure that questions are formulated in a way that a precise answer can be given, if sufficient information is available, and to ensure clear and unambiguous answers, including the assessment of uncertainties, based on available scientific evidence.

© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Keywords: food safety targets; indicator microorganisms; microbiological criteria; product compliance; public health; risk assessment

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