Editorial: OpenFoodTox: EFSA's open source toxicological database on chemical hazards in food and feed

Since its inception in 2002, the European Food safety Authority (EFSA) has produced risk assessments for more than 4,400 substances in over 1,650 Scientific Opinions, Statements and Conclusions through the work of its Scientific Panels, Units and Scientific Committee. For each individual substance, a summary of human health, animal health and ecological hazard assessments has been collected and structured into EFSA's Chemical Hazards Database: OpenFoodTox. OpenFoodTox provides open source data for substance characterisation, links to the relevant EFSA output, background regulations and summaries of critical toxicological endpoints. An online MicroStrategy1 tool enables the downloading of summary data sheets for each individual substance in PDF or Excel format. OpenFoodTox is a valuable tool and source of information for scientific advisory bodies and stakeholders with an interest in chemical risk assessment. This editorial provides a snapshot description of OpenFoodTox as an open source toxicological database for chemical risk assessment. EFSA provides scientific advice to risk managers and decision makers through risk assessment and risk communication on all issues related to 'food and feed safety, animal health and welfare, plant health, nutrition, and environmental issues' (Regulation EC No 178/20022). Risk assessment has been defined as 'a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation' (Regulation EC No 178/2002; WHO, 2009). In food safety, hazard identification and characterisation aims to determine safe levels of exposure for substances for human health, animal health or the environment from pivotal toxicology studies that provide the basis for a reference point. The reference points are then divided by uncertainty factors to derive reference values. Examples of reference points/points of departure for human health and animal health effects include lowest or no-observed–adverse-effect-level (LOAEL/NOAEL), benchmark dose limit (BMDL, e.g. BMDL10), lethal dose (LD50), or no observed effect concentration (NOEC) for ecotoxicological effects (Daphnia, fish, bees, etc.). Examples of reference values include health-based guidance values for setting safe levels of chronic exposure in humans such as acceptable daily intake (ADI) for food and feed additives, pesticides and food contact materials, tolerable upper intake levels (UL) for vitamins and minerals, and tolerable daily intake (TDI) for contaminants. OpenFoodTox provides a database to access reference points and reference values for all the substances assessed by EFSA.3 For contaminants, the Panel on Contaminants in the Food Chain (CONTAM panel and BIOCONTAM unit) have dealt with human health and animal health risk assessments for contaminants of anthropogenic origin (e.g. brominated flame retardants, dioxins), environmental contaminants (e.g. heavy metals), compounds resulting from food and/or feed processing (e.g. acrylamide), and natural toxins produced as undesirable substances in food and feed by plants, fungi and other microorganisms (e.g. alkaloids, mycotoxins and marine biotoxins). Finally, for compounds falling under the remit of more than one panel (e.g. carvone), the risk assessments have been performed by the EFSA's Scientific Committee4 (EFSA Scientific Committee, 2014). From all these risk assessments performed at EFSA, it has been recognised that a structured database summarising the toxicological endpoints and reference values on a substance-specific basis would be instrumental in disseminating these results to a wider community, and would be of great support for the work of EFSA experts and staff in providing scientific advice. Consequently, over the last 5 years, summary data related to human health, animal health and ecological hazard assessment have been systematically collected and structured into OpenFoodTox. The database has been designed and developed using a data model taking into account the OECD harmonised templates5 to collect and structure the data in a harmonised manner. Detailed descriptions of the data and the structure of OpenFoodTox have been published elsewhere (S-IN 2013, 2014, 2015). Overall, OpenFoodTox contributes actively to objective 2 of EFSA's 2020 Science Strategy6 which aims at 'widening EFSA's evidence base and optimise access to its data' as a valuable open source database that can be shared with all scientific advisory bodies and stakeholders with an interest in chemical risk assessment. In addition, OpenFoodTox has been submitted to the OECD's Global Portal7 to Information on Chemical Substances (eChemPortal) so that individual substances can be searched as part of the national and international databases. By making this summary data available in a readily accessible format, it is anticipated that this will stimulate further analysis of the data by the wider scientific community, so generating new knowledge in the area of chemical risk assessment. Finally, EFSA has recently published a scientific report on 'modern methodologies and tools for human hazard assessment of chemicals' (e.g. -omics, toxicokinetic and in silico models such as QSAR models and read-across tools) which provided, through consultation of the EFSA staff, panels and other international organisations, recommendations for further work in these areas. The further development of QSAR models and read-across tools in chemical risk assessment was identified as a key priority to develop predictive tools and reduce animal testing particularly for compounds for which toxicity data are not available (EFSA, 2014). In this context, OpenFoodTox is currently being explored as a data source to support the development of innovative in silico tools such as QSAR models. These tools will be illustrated in a technical report to be published later this year together with a new version of OpenFoodTox with enhanced features.