DAN - Relatórios científicos e técnicos
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Browsing DAN - Relatórios científicos e técnicos by Author "Assunção, Ricardo"
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- HBM4EU - Deliverable Report D 5.5: Human biomonitoring in risk assessment: 2nd set of examples on the use of HBM in risk assessments of HBM4EU priority chemicalsPublication . Santonen, Tiina; Mahiout, Selma; Bessems, J.; Buekers, J.; Baken, K.; Schoeters, G.; Woutersen, M.; Vermeire, T.; Bil, W.; Ougier, E.; Rousselle, C.; Šömen Joksić, A.; Kirinčič, S.; Louro, Henriqueta; Silva, Maria João; Assunção, Ricardo; Vinggaard, A. M.; Viegas, S.; Huuskonen, P.; Porras, S.; Kiilunen, M.; Uhl, M.; Hartmann, C.; Hauzenberger, I.; Losert, A.; Tratnik, J. Snoj; Horvat, M.; Schaddelee-Scholten, B.; Buist, H.; Westerhout, J.; Fletcher, T.; Rauscher-Gabernig, E.; Plichta, V.; Abraham, K.; Borges, T.; Kadikis, N.The aim of this work was to exemplify the inclusion of human biomonitoring (HBM) data in risk assessment (RA) and health impact assessment (HIA) strategies. RA was performed for six compound groups on HBM4EU’s first list of priority substances: anilines, cadmium/chromium, flame retardants, PAHs, PFAS and phthalates. In addition, burden of disease (BoD) calculations were made for cadmium. The general approach used included: 1) identification of an existing RA for the substance, 2) identification of possible existing biological limit or guidance values or biological equivalents (BEs), or if lacking, existing health based limit values for external exposure, 3) identification of relevant biomonitoring data to be used in the RA, 4) in case no existing biological limit or guidance values or BEs existed, identification of approaches for reverse/forward calculation, including the use of PBPK modelling or calculation of BE values based on one-compartment modelling, 5) RA or BoD calculation based on HBM data, 6) analysing the benefits and challenges of using HBM data in RA compared to the use of external exposure data. The overall result of the work was that HBM can be included in RA even when relatively few data are available, and its inclusion generally benefits the RA. Several methods exist, and a tiered approach is suggested, based on the amount and quality of data available. The recommended 1st tier method is a one-compartment modelling based derivation of BE values or reverse calculation of external exposure based on biomarker levels. This approach is simple and rough, and uses only very basic parameters. However, in many cases this approach can be considered sufficient, especially when conservative assumptions have been used for the FUE, and the calculated RCRs remain well below 1, indicating a low risk. Also, in cases in which risk assessment using this approach supports the RA made based on external exposure estimates, it is often a sufficient approach. Nevertheless, in some cases e.g. where the RCR is close to 1, a more detailed approach may be needed to refine the RA. For the 2nd tier, PBPK modelling is recommended. For the most robust, 3rd tier approach, measured data on correlations between external exposure and internal doses from well controlled studies would be needed. Certain cases were identified where inclusion of HBM would be particularly important for performing RA: for compounds, for which several exposure routes may contribute to the body burden and the health effects, as HBM reflects the total body burden, and cumulative compounds. For cumulative compounds, HBM could also be useful for hazard assessment in addition to exposure assessment. One of the major challenges for the inclusion of HBM into RA is the often limited data available on toxicokinetics. In addition, in some cases, there is an urgent need for more specific biomarkers or more sensitive analytic methods than currently available. It should be noted that these risk assessments were performed purely to determine how HBM data can contribute to the risk assessment of chemicals, and they have no regulatory implications. Overall for the substances on the HBM4EU’s first list of priority substances, more HBM data are needed. This work is ongoing in WP8, and the RAs presented here will be updated when new data become available.
- Human biomonitoring in risk assessment: analysis of the current practice and 1st examples HBM in risk assessments of HBM4EU priority chemicalsPublication . Santonen, T.; Heinälä, M.; Bessems, J.; Buekers, J.; Cornelis, C.; Vermeire, T.; Woutersen, M.; van Engelen, J.; Borges, T.; Rousselle, C.; Ougier, E.; Louro, Henriqueta; Alvito, Paula; Martins, Carla; Assunção, Ricardo; Silva, Maria João Silva; Krul, L.; Pronk, A.; Schaddelee-Scholten, B.; Gonzalez, M.C.; de Alba, M.; Díaz, G.; Castaño, A.; Viegas, S.; Humar-Juric, T.; Kononenko, L.; Abraham, K.; Vinggaard, A.M.In chemicals risk assessment frameworks, the default approach is to assess external intake from different sources of exposure and via different routes of exposure. They are often assessed separately. This approach includes various uncertainties and often overestimates the real uptake since default, conservative estimates are used e.g. for the absorption of the chemical. At the same time, actual (real life) exposure may be underestimated by not taking into account that exposure to a chemical substance may occur from different sources, which may fall under separate legislative frameworks. Examples are triclosan that is used in biocidal products as well as in consumer products and importantly, most if not all chemicals that are produced by workers where at the same time these workers may be exposed as part of the general population. In some cases, other tools to assess exposure via all possible routes may be insufficient; an example is occupational exposure via hand-to-mount exposure, which has been shown to occur for example in the case of many metals, like lead, through contaminated hands. Without biomonitoring, exposure in these cases could become severely underestimated. Human Biomonitoring (HBM) is an important tool to survey the real life body burden – or internal exposure – of humans resulting from ‘total’ exposure to chemicals via different routes (lung, skin, digestive tract) and ‘via’ different legislative frameworks on chemicals. By providing more accurate data on actual body burdens (internal exposure), inclusion of HBM data could improve human health risk assessment for both the general population (exposure via air, consumer products, drinking water and food) as well as for workers (exposure via inhalation and/or skin) separately or as part of the population.
- Risk Benefit for EU - Partnering to strengthen the risk-benefit assessment within EU using a holistic approach: mid-term reportPublication . Alvito, Paula; Assunção, Ricardo; Fernandes, P.; Boué, Géraldine; Membré, Jeanne-Marie; Pires, Sara; Carvalho, Catarina; Torres, D.RiskBenefit4EU – Partnering to strengthen the risk-benefit assessment within EU using a holistic approach (RB4EU) is a project funded by European Food Safety Authority (EFSA) under Partnering Grants (GP/EFSA/AFSCO/2017/01) and was launched on the 17th January 2018, at a kick-off meeting in the EFSA’s premises, Parma, Italy. With the focus on the capacity building, it aims to develop a strategy to strengthen the EU capacity to assess and integrate food risks and benefits in the areas of microbiological, nutritional and chemical components through the development of a harmonized framework that will be available to EU member states organizations. Within the 1st year of the project, several deliverables and expected outputs were attained, including: two submitted manuscripts, eight communications in national and international conferences, one mid-report, two training activities, one harmonized risk-benefit assessment (RBA) framework on RBA capacity building, one flyer, a project website and one international workshop and the respective abstracts book. In order to answer to specific project and team member’s needs, some adjustments concerning the team composition and the budget allocated to travels and missions were performed, all in agreement with EFSA. RB4EU allowed to gather, for the first time, a multidisciplinary team to develop a capacity building framework on RBA in foods. After the first year of the project, the team and the capacity building framework on RBA in foods are consolidated, allowing to progress on the Portuguese case-study involving data at national level on nutritional, toxicological and microbiological areas. A close collaboration between team members and EFSA have been developed promoting an important support for the project progress.