Report on “Data collection and data entry for EFSA’s chemical hazards database NP/EFSA/EMRISK/2011/01”
The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.
Risk assessment of chemicals in food and feed is a major activity of EFSA, covering the work of many units and panels, including: food additives, flavourings, processing aids and materials in contact with food (AFC) (2005-2008), food additives and nutrient sources added to food (ANS); food contact materials, enzymes, flavourings and processing aids (CEF); contaminants in the food chain (CONTAM); additives and products or substances used in animal feed (FEEDAP); plant protection products and their residues (PPR panel and PRAPeR unit); vitamins and minerals (NDA); proteins from genetically modified organisms (GMO); the Scientific Committee and its supporting unit (SCAF). A chemical hazards database has been created to hold summary hazard data from EFSA’s chemical risk assessments in food and feed. The data collection covers the opinions and statements adopted by a number of EFSA panels including NDA, CONTAM, FEEDAP,AFC, ANS and CEF and should facilitate rapid consultation for EFSA staff and scientific experts and optimise sharing of data with other agencies (or external bodies). A data model for the new EFSA’s chemical hazards database has been first devised. The data model of EFSA’s chemical hazards database and its catalogues have been designed on the basis of OECD harmonised templates and OECD picklists respectively, and modified to accommodate EFSA’s remit in terms of human, animal and environmental risk assessment. The data model is a logical map that represents the intrinsic properties of the hazard data to be structured in the database as extracted from the EFSA opinions and statements and describes the following features: chemical identification, document descriptors, hazard identification, and hazard characterisation/risk characterisation. The chemical identification section describes the entity being assessed in the EFSA opinions or statements from a chemical point of view. The document descriptors are used to fully report the bibliographic details of the documents (i.e., EFSA opinion or statement) containing the hazard assessment being extracted and stored in the database. The hazard identification section reports the critical study from which a reference point was identified to derive health-based guidance values, margin of exposure, margin of safety or environmental standards. The hazard characterisation/risk characterisation section provides health-based guidance values, margin of exposure, margin of safety and environmental standard values. The following data have been collected and collated in the database: NDA (vitamins and minerals, novel foods, dietetic products); CONTAM (contaminants in the food chain, contaminants in the feed chain); FEEDAP (feed additives-application linked to 1381/2003, feed additives-application under to 1381/2003, feed-additives other); AFC (food additives, food contact materials, nutrient sources, processing aids); ANS (food additives, nutrient sources); CEF (food contact materials, food manufacturing processes, processing aids). Hazard data on pesticides and flavourings were excluded from the present assignment and are currently being collected in another assignment (Q-2012- 00691). The full EFSA’s Chemical Hazards Database will be available through the EFSA website in the second half of 2014.