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Imprint
Availability of health and environmental data for high tonnage chemicals under REACH – Finalisation of Phase II and Phase III processing: substances with a registration of 100-1,000 t/a - REACH Compliance III
Project
Project code: BfR-CPS-08-1331-200
Contract period: 01.08.2016
- 30.09.2019
Purpose of research: Inventory & Assessment
It is the aim of this project to investigate all registration dossiers of the lead registrants and opt-out dossiers for substances with an annual production volume of 100-1000 tons for selected test areas to verify to the conformity of the REACH Regulation and to obtain detailed knowledge on the data quality of registration dossiers submitted under REACH. The project is the third part of a research project funded by the Federal Ministry of Environment, Nature Conservation, Building and Nuclear Safety and commissioned by the German Evironment Agency. In the first two phases the data availability for substances with over 1,000 tons annual production volume as well as adaptations from standard information requirements were assessed. For this purpose evaluation schemes based on the REACH regulation and the according guidance documents were developed, based on which a standardized screening of the registration dossiers was carried out. After according adjustments, this scheme will be applied to the registration dossiers for substances with annual production volumes of 100-1000 tons.
According to the criteria applied within the project, 14 % to 57 % (on average 45 %) of the evaluated data for a specific endpoint were considered “compliant”, 9 % to 46 % (on average 24 %) “non-compliant”, and 11 % to 76 % (on average 31 %) “complex” (without conclusion within the scope of the project). The results of the project revealed that at least 24 % of the assessed endpoint entries failed to be in compliance with the REACH requirements. Thus, the availability and quality of toxicological and ecotoxicological information provided in registration dossiers may be subjected to improvements.
Section overview
Subjects
- Toxicology
- Computer science
