Dossier Preparation, Including IUCLID Data Entry and Chemical Safety Assessment/Report Production

Categorized Under: Environment



ICF International provided comprehensive technical support to several European-based chemical consortia for dossier preparation in advance of the 2010 substance registration deadlines for REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), the European Commission's regulatory system for chemicals. Substances included a wide variety of organic chemicals, as well as some metals and metal compounds. Each Product Dossier includes summary information on production, use, physical and chemical properties, environmental fate, ecological effects, human health effects, exposure, and risk management. ICF provided detailed technical support for more than 100 dossiers and other support for nearly 700 dossiers.

ICF's technical responsibilities included data collection, literature review, data preparation and entry into the International Uniform ChemicaL Information Database (IUCLID), identification of exposure scenarios, exposure modeling, risk characterization, and preparation of various other documentation needed for registration, including Chemical Safety Assessments and Chemical Safety Reports. ICF reviewed available technical information and ensured their completeness, compared exposure estimates with derived-no-effect-levels (DNELs) and predicted-no-effect-concentrations (PNECs) for scenarios and exposure pathways of potential concern, and drafted chapters of the Chemical Safety Reports (CSRs).

Major responsibilities related to exposure and risk assessment included literature searches to identify existing exposure and hazard data, mapping of lifecycle stages for industrial chemicals, exposure modeling using REACH-IT tools such as European Centre for Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment (ECETOC TRA), development of exposure scenarios, and drafting of exposure and risk characterization chapters in chemical safety reports. ICF also reviewed articles to determine if a "substantial" human sensitization response could be anticipated following exposure to high-volume substances.

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Insight Details

Client: European chemical company consortia, international chemical companies
Location: Global

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