• Assessment of the toxicity of citrinin

      Graven C; Bokkers B; Geraets L; Ezendam J; Mengelers M; VPZ; V&Z (Rijksinstituut voor Volksgezondheid en MIlieu RIVM, 2017-03-16)
      Citrinin is a mycotoxin and usually formed by fungi during storage of food. It is mainly found in grain but it can also be found in other products of plant origin like beans, fruits, vegetables and fruit juices, herbs and spices an tainted dairy products. In a recent biomonitoring study of multiple mycotoxins in the Belgian population low concentrations of citrinin were frequently detected. The Netherlands Food and Consumer Product Safety Authority (NVWA) monitors the occurrence of mycotoxins in the Netherlands and advises the Dutch government on the food safety risks related to mycotoxins. In 2012 the European Food Safety Authority (EFSA) has published an opinion where it was reported that due to limitations and uncertainties in the toxicity database (especially genotoxicity and carcinogenicity), the derivation of a health-based guidance value that would cover all possible adverse outcomes of citrinin was not considered appropriate. Nonetheless, a health-based guidance value was set on the highest dosage of a 90-day general toxicity study (not covering specific endpoints, for example carcinogenicity, developmental effects) because no effects were reported. In this report a new literature search was performed to find out whether new toxicity studies have been published (2011 to 2015). And secondly, if new toxicity studies could be used to derive a benchmark dose or a health-based guidance value. The literature search produced 38 new toxicity articles on citrinin, where seven of these studies contained in vivo animal tests. Two of the seven studies were suitable for BMD analysis. The lowest BMDL of 48 µg/kg bw/day obtained from the endpoint ‘decreased crown rump length’ from the Singh study is considered as the appropriate point of departure for risk assessment. This BMDL is 2.4 times higher than the (conservative estimate of the) NOAEL determined by EFSA in 2012. There are no new scientific articles available on the in vivo genotoxicity or carcinogenicity of citrinin. A re-evaluation of an article published in 1983 on the tumorigenicity of citrinin in rats revealed that the study was not suitable for BMD analysis. Therefore, we agree with EFSA’s concern regarding the genotoxicity and/or carcinogenicity of citrinin and EFSA’s request for a well-designed toxicological study in laboratory animals to further explore the carcinogenic potential of citrinin.
    • Development of Policy Relevant Human Biomonitoring Indicators for Chemical Exposure in the European Population.

      Buekers, Jurgen; David, Madlen; Koppen, Gudrun; Bessems, Jos; Scheringer, Martin; Lebret, Erik; Sarigiannis, Denis; Kolossa-Gehring, Marike; Berglund, Marika; Schoeters, Greet; Trier, Xenia (2018-09-21)
      The European Union's 7th Environmental Action Programme (EAP) aims to assess and minimize environmental health risks from the use of hazardous chemicals by 2020. From this angle, policy questions like whether an implemented policy to reduce chemical exposure has had an effect over time, whether the health of people in specific regions or subpopulations is at risk, or whether the body burden of chemical substances (the internal exposure) varies with, for example, time, country, sex, age, or socio-economic status, need to be answered. Indicators can help to synthesize complex scientific information into a few key descriptors with the purpose of providing an answer to a non-expert audience. Human biomonitoring (HBM) indicators at the European Union (EU) level are unfortunately lacking. Within the Horizon2020 European Human Biomonitoring project HBM4EU, an approach to develop European HBM indicators was worked out. To learn from and ensure interoperability with other European indicators, 15 experts from the HBM4EU project (German Umweltbundesamt (UBA), Flemish research institute VITO, University of Antwerp, European Environment Agency (EEA)), and the World Health Organization (WHO), European Core Health Indicator initiative (ECHI), Eurostat, Swiss ETH Zurich and the Czech environmental institute CENIA, and contributed to a workshop, held in June 2017 at the EEA in Copenhagen. First, selection criteria were defined to evaluate when and if results of internal chemical exposure measured by HBM, need to be translated into a European HBM-based indicator. Two main aspects are the HBM indicator's relevance for policy, society, health, and the quality of the biomarker data (availability, comparability, ease of interpretation). Secondly, an approach for the calculation of the indicators was designed. Two types of indicators were proposed: 'sum indicators of internal exposure' derived directly from HBM biomarker concentrations and 'indicators for health risk', comparing HBM concentrations to HBM health-based guidance values (HBM HBGVs). In the latter case, both the percentage of the studied population exceeding the HBM HBGVs (PE) and the extent of exceedance (EE), calculated as the population's exposure level divided by the HBM HBGV, can be calculated. These indicators were applied to two examples of hazardous chemicals: bisphenol A (BPA) and per- and polyfluoroalkyl substances (PFASs), which both have high policy and societal relevance and for which high quality published data were available (DEMOCOPHES, Swedish monitoring campaign). European HBM indicators help to summarize internal exposure to chemical substances among the European population and communicate to what degree environmental policies are successful in keeping internal exposures sufficiently low. The main aim of HBM indicators is to allow follow-up of chemical safety in Europe.