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Data Protection Declaration
Imprint
Availability of health and environmental data for high tonnage chemicals under REACH - Phase II: More intensive REACH compliance check
Project
Project code: BfR-CPS-08-1331-199
Contract period: 01.04.2015
- 31.07.2016
Purpose of research: Inventory & Assessment
In the European Union, chemicals manufactured or imported in quantities above one tonne per year (tpa) have to be registered at the European Chemicals Agency (ECHA). Standard information requirements and rules for data waiving and adaptation are set out in Regulation No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of chemicals (REACH). The aim of the project was to evaluate toxicological and toxicological information on selected endpoints in registration dossiers of high tonnage chemicals (≥ 1000 tpa). In total, 1814 lead and individual dossiers of phase-in substances submitted to ECHA until March 2014 were examined. The methodology included screening, formal and refined approaches. Screening of registration dossiers suggested on the one hand shortcomings in data quality or data gaps, respectively, and on the other hand that data waiving and adaptation were frequently used (Springer et al., 2015). Subsequently, these data waiving and adaptations were evaluated with formal and refined approaches and constitute the main focus of this report. The overall outcome of the screening, the formal and refined checking of dossiers was that for 19 to 56 % of the evaluated data for a specific endpoint either fulfils standard information requirements or data waiving/adaptation were of adequate quality. In contrast to this, 12 to 61 % of the evaluated datasets for an endpoint were characterised by a lack of essential information (data) or a need for amendment was identified. Regarding the remaining 12 to 61 % of datasets for the endpoints, the quality of the dossier could not be concluded on because either the assessment of the available information was timewise too extensive (e.g. non-guideline studies) or outside the scope of the project. The sameness of substance identity amongst joint submissions was assessed in lead and respective member registrations submitted to ECHA by July 2015. Additionally, test material used in key studies was compared to the registered substance in lead and individual registrations.
Section overview
Subjects
- Toxicology
- Computer science
