A number of Consortia representing various sectors of industry.
Manufacturers or importers into the EU of high tonnage substances (≥1000 tonnes/year) and/or hazardous chemicals (i.e. CMRs produced at ≥ 1 tonne/yr, or those considered very dangerous to the environment and produced at ≥ 100 tonnes/year) were required under the REACH Regulation to submit a substantial dossier of information on their substances by the end of November 2010. The required dossier includes (amongst other substance-related information) detailed data relating to exposure, physico-chemical properties, environmental fate and behaviour, and (eco)toxicology.
To support consortia with all aspects of their 2010 REACH registration obligations, from project management responsibilities to development and submission of the full technical dossiers required for successful registration.
Bibra helped a number of Consortia with their REACH submissions for the 2010 deadline in a timely and cost-efficient manner. We were involved in all aspects of the registration process including identification of relevant information, data mining, assessment of the reliability and quality of the published and unpublished dataset, extensive data-gap analyses, preparation of (Robust) Study Summaries and associated endpoint summaries, advising on appropriate Integrated Testing Strategies using data waiving, read-across and weight-of-evidence approaches where considered scientifically justifiable, completeness checks, classification and labeling, preparation of CSRs (including calculation of DN(M)ELs, PNECs, related RCRs, and PBT/vPvB assessments) for a number of industrial chemicals, including several substances of very high concern (SVHC). In addition, a client came to us with an urgent request in late October 2010 as their current consultants could not provide the level of assistance that had been promised. We improved and completed the IUCLID files, redrafted the CSR, and submitted the dossier back to the client within just 3 weeks, to enable them to register their substance by late November.
For every substance registration in which bibra scientists were involved, technical dossiers were successfully submitted to ECHA prior to the 30 November 2010 deadline. Positive feedback and repeat business from these clients since the 2010 REACH deadline underlines the level of satisfaction with the work we do for our clients.