REACH Compliance: Data availability in REACH registrations – Part 3: Evaluation of 100 to 1000 tpa substances | Umweltbundesamt

In the project the availability and quality of the information on toxicological and ecotoxicological endpoints in lead and individual registration dossiers of the medium tonnage band (100-1000 tpa) under ⁠REACH⁠ Regulation was examined. The availability of standard information (guideline studies) as well as data waiving/adaptations for eight endpoints and the environmental exposure assessment were analysed. According to the criteria applied within the project, on average 48% of the evaluated data for a specific endpoint were complete. Data gaps and unjustified data adaptation was noted for 2 to 46 % of the endpoints examined. For 31% of the endpoints on average further assessment would be necessary and no decision about the compliance was possible. The results of the project revealed that at least 24 % of the assessed endpoint entries failed to be in compliance with the REACH requirements.