The manual includes a description of the reporting system for outbreaks, definitions used in the system and variables to be reported.
The objective is to provide Member States with clear guidance on what to report, how and why.
The document provides guidance with examples on how to report and classify the causative agents, food vehicles, settings, places of problem origin and contributory factors.
It is an update from the version last year and takes steps to prevent future outbreaks and improve food safety.
Strong and weak evidence
EFSA revised the European Union Foodborne Outbreak Reporting System (EU-FORS) last year so information from all foodborne outbreaks is collected and the same dataset is used for strong- and weak-evidence outbreaks.
It covers the difference between foodborne outbreaks, based on strength of evidence implicating a particular suspected food vehicle and the different sets of data for the two types of outbreaks (those supported by ‘weak’ evidence and those by ‘strong’ evidence) is explained.
Datasets include the number of outbreaks and human cases, hospitalisations and deaths, per causative agent.
Evidence can be epidemiological, microbiological, descriptive environmental or based on product-tracing investigations.
EFSA runs a web-based reporting application for annual reporting as well as the possibility of submitting data in XML/Excel format via the Data Collection Framework (DCF).
The amended web application has to be tested and new XML reporting schemas created before the start of the reporting period in April each year.
Directive 2003/99/EC on the monitoring of zoonoses and zoonotic agents requires Member States to provide the European Commission (EC) with a report on the investigations of foodborne outbreaks, which is sent to the EFSA.
Investigation types
Thorough investigation aims to identify the causative agent, the implicated food and factors in the food preparation and handling contributing to the outbreak.
The reporting system covers all foodborne outbreaks including those caused by any virus, bacterium, alga, fungus, parasite and their products, such as toxins and biological amines (e.g. histamine), not just zoonotic agents.
Strong epidemiological evidence is a statistically significant association in a well-conducted analytical epidemiological study, or convincing descriptive evidence.
Strong microbiological evidence is identification of an indistinguishable causative agent in a human case and in a food or its environment which is unlikely to have been contaminated coincidentally, or after the event.
Or the identification of a causative agent, in the food vehicle, with strongly indicative clinical symptoms and an onset of illness in outbreak cases strongly indicative/pathognomonic to the causative agent.
A comprehensive product-tracing investigation can provide strong evidence in case a common point along the food-production and distribution chain is identified for all or a large proportion of cases exposed and a place of exposure/point of sale could be identified.
The choice of laboratory method (e.g. sero-/phage-/ribotyping, pulsed-field gel electrophoresis (PFGE)) depends on national standards and should be included in the report.