OpenFoodTox: EFSA's chemical hazards database

Background: EFSA's remit and chemical risk assessment of regulated products and contaminants

The European Food Safety Authority (EFSA) has the remit to provide scientific advice to risk managers and decision makers through risk assessment and risk communication on issues related to “food and feed safety, animal health and welfare, plant health, nutrition, and environmental issues”. Risk assessment has been defined as "a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation" (EC, 2002). 

In the food and feed safety area, hazard identification and hazard characterisation aim to determine safe levels of exposure for regulated products or contaminants as “reference values¹” to protect human health, animal health, environmental-relevant species or the whole ecosystem. Such reference values for a given species are most often derived by using a “reference point²" determined from the critical toxicological study on which an uncertainty factor³ is applied.

Since its creation in 2002, the European Food safety Authority (EFSA) has produced risk assessments for more than 5500 unique substances in over 2,150 Scientific Opinions, Statements and Conclusions through the work of its scientific Panels, Units and Scientific Committee. 

For regulated products, these risk assessments have been performed by five scientific panels and four supporting units. 

 EFSA's chemical Hazards Database : OpenFoodTox

OpenFoodTox is a structured database summarising the outcomes of hazard identification and characterisation for the human health (all regulated products and contaminants), the animal health (feed additives, pesticides and contaminants) and the environment (feed additives and pesticides). 

OpenFoodTox provides information on the substance characterisation, the links to EFSA’s related output, background European legislation, and a summary of the critical toxicological endpoints and reference values.

The data model of OpenFoodTox has been designed using OECD Harmonised Template (OHTs) as a basis to collect and structure the data in a harmonised manner. OpenFoodTox provides open source data for the substance characterisation, EFSA outputs, reference points, reference values and genotoxicity.

In order to disseminate OpenFoodTox to a wider community, two sets of data can be downloaded:

1. Five individual spreadsheets providing for all compounds: a) substance characterisation, b) EFSA outputs, c) reference points, d) reference values and, e) genotoxicity.

2. The full database.

OpenFoodTox contributes actively to EFSA’s 2020 Science Strategy (EFSA, 2016) and to the aim of widening EFSA’s evidence base and optimising access to its data as a valuable open source toxicological 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 Portal to Information on Chemical Substances (eChemPortal) so that individual substances can be searched as part of the national and international databases. Further description and associated references are described in the EFSA journal editorial (Dorne et al., 2017) and other publications (Dorne et al., 2020).

OpenFoodTox 2.0 and innovative in silico models

Future plans for an ‘OpenFoodTox 2.0’ include enriching the data model to include more chemical properties such as metabolism, bioaccumulation and exposure data and linking the database to computer models used to predict toxicokinetics and toxicity.

In silico models using OpenFoodTox have been developed for ecological risk assessment  (bees and rainbow trout) and  human risk assessment using rat toxicological data (Carnesecchi et al., 2020; Como et al., 2017; Benefenati et al., 2017; Toporov et al., 2017, Toporov et al., 2018). These in silico models provide alternative means to animal experiments for the  hazard identification and characterisation of chemicals, and are becoming of increasing interest in the risk assessment community to deliver the 3Rs (replacement, reduction, refinement) (Hartung, 2004; OECD, 2005) particularly since the banning of animal testing for the approval of cosmetics as consumer products (Regulation (EC) No. 1223/2009, Art.18(2)).

Definitions

¹ Reference Value : The estimated maximum dose (on a body mass basis) or the concentration of an agent to which an individual may be exposed over a specified period without appreciable risk. Reference values are established by applying an uncertainty factor to the reference point. Examples of reference values in human health include acceptable daily intake (ADI) for food and feed additives, and pesticides, tolerable upper intake levels (UL) for vitamins and minerals, and tolerable daily intake (TDI) for contaminants and food contact materials. For acute effects and operators, the acute reference dose (ARfD) and the acceptable operator exposure level (AOEL). In animal health and the ecological area, these include safe feed concentrations and the Predicted no effect concentration (PNEC) respectively (EFSA Scientific Committee, 2018).

² Reference point : Defined point on an experimental dose–response relationship for the critical effect. This term is synonymous to Point of departure (USA). Reference points include the lowest or no observed adverse effect level (LOAEL/NOAEL) or benchmark dose lower confidence limit (BDML), used to derive a reference value or Margin of Exposure in human and animal health risk assessment. In the ecological area, these include lethal dose (LD50), effect concentration (EC5/ECx), no (adverse) effect concentration/dose (NOEC/NOAEC/NOAED), no (adverse) effect level (NEL/NOAEL), hazard concentration (HC5/HCx) derived from a Species Sensitivity Distributions (SSD) for the ecosystem (EFSA Scientific Committee,2018).

³ Uncertainty factor: Reductive factor by which an observed or estimated no observed adverse effect level or other reference point, such as the benchmark dose or benchmark dose lower confidence limit, is divided to arrive at a reference dose or standard that is considered safe or without appreciable risk (WHO, 2009).

Data model based on the OECD harmonised templates (OHTs) for reporting toxicological data;   
http://www.oecd.org/ehs/templates/ http://www.efsa.europa.eu/en/corporate/pub/strategy2020; 
http://www.echemportal.org/echemportal/index?pageID=0&request_locale=en

This version replaces version 3 to include EFSA Opinions, Statements and Conclusions up to September 2020