Preparation technical report
Data evaluation
ARCHE can assist you with compiling the technical dossiers required to register chemical substances under REACH and submitting them to the European Chemicals Agency. A technical dossier needs to contain at least all the information stipulated by the tonnage window.
Each literature item (relevant for human health or environment) needs to be screened in detail, either to verify the initial assignment (based on the literature search evaluation), or to re-assign any document to another data requirement. A reliability rating (based on the inherent quality of the methodology and results) needs to be made for every relevant data point. This quality screening procedure is based on the Klimisch scoring scheme.
IUCLID 5
All existing hazard characterisation studies need to be summarised in detail in a standardised reporting format, which will be provided in the form of IUCLID 5.0 when submitting the technical dossier to ECHA.
Existing information needs to be provided in the form of IUCLID 5.0. IUCLID 5.0 is the platform to communicate with ECHA for the submission of a registration dossier. Apart from a description of the study itself and the results, it is necessary to record all relevant experimental conditions in order to demonstrate the reliability and validity of any particular study.
ARCHE has the necessary knowhow to draft Robust Summaries and prepare IUCLID entries.
Keep track of our latest news
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ARCHE launches its RESCUE program!
ARCHE developed a one-to-one assistance program to help downstream users demonstrate compliance with their extended safety data sheets they get from their supplier.
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New Soil PNEC calculator is available!
A new updated version of the soil PNEC calculator is available for download on our website. Apart from a new layout, this new version now also includes data for Co and Mo. All calculations are now based on the data and methods selected for the EU REACH dossiers (Registration, Evaluation, Authorisation and Restriction of Chemicals; Regulation EC No 1907/2006) for Cu, Ni, Zn, Pb, Cd, Mo and Co, as available in August 2012."
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From Soil screening values to Metal Clean-up values
Dr. Koen Oorts (ARCHE) is invited by the North American Metals Council (NAMC) to actively participate in a workshop on "Ecological Soil Levels-Next Steps in the Development of Metal Clean-up Values" scheduled for September 17-20, 2012 in Utah. The workshop's main goal is to provide regulators with the methods and processes developed over the last ten years to move from soil screening values to clean-up values.
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SPERC tool for metals is updated!
The first version of the metal SPERCs was published in 2010 for the purpose of the 2010 REACH registration deadline and underwent a review process conducted by Lüskow et al. (2011) on behalf of the Federal Environment Agency of Germany (UBA). The second version of the metal SPERCs were improved based on the recommendations by Lüskow et al. (2011) and Tolls et al. (in press) and were further updated with new data for the purpose of the 2013 REACH registration deadline. This second version is currently undergoing a scientific review process but can already been find on this website.
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Our QSARCHE model is released
Vertebrate testing under REACH is discouraged by promoting use of alternative non-testing approaches such as QSARs (Quantitative Structure Activity Relationships). Many QSARs are available, however, robust REACH compliant QSARs predicting chronic ecotoxicity to fish are largely lacking. ARCHE filled this data gap by the release of its QSARCHE fish toxicity model. Click to the right to read on.
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