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

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.